Florida | 000-27836 | 65-0643773 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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| Most of Protalix Ltd.s operations and activities shall be directed to research and development activities. The Encouragement of Industrial Research and Development Law, 1984, of the State of Israel defines research and development activity to include certain expenses incurred by a company in connection with the transition to the manufacturing and marketing of the products or technology that result from the research and development efforts. | ||
| The consideration received and to be received in connection with the issuance of our shares or rights, those of Protalix Ltd. or Orthodontix shall be used and reinvested in research and development activity as defined above. Such consideration includes any investment made in Protalix Ltd. prior to the merger |
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and the cash held by us as of the closing of the merger, after the deduction of any amounts required for the operation of our company in the United States. | |||
| at least 75% of the research and development expenditures of Protalix Ltd. shall be made in Israel. However, the Israeli tax authorities may establish a lower percentage if Protalix Ltd. makes expenditures in connection with clinical and toxicology trials that cannot be conducted in Israel. |
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| The glycosilation of a protein is the addition of a glycan, or sugar, residue structure on the protein which, in certain cases, binds the protein to a target cell and enables the proteins therapeutic function and/or its bioactivity. In certain cases, Protalixs proprietary manufacturing methods for expressing proteins may provide patent protection for the production method and potential market advantage for the proteins produced through our system. Patent protection and potential market advantage may be achieved for a protein as well as the glycosilation structure of the protein; |
| Our plant cell expression system is a contained regulatory-compliant bioprocess that significantly reduces the risk of contamination with pathogenic agents, such as viruses, which are ordinarily associated with mammalian expression methodologies; and |
| A degree of control of the glycosilation process that is available through our expression system enables the control of the glycosilation process, thereby allowing for the production of highly uniform therapeutic protein products which is necessary for large scale production. |
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| The expression of certain proteins through our proprietary plant cell system does not infringe certain patents that cover the mammalian cell production of such proteins; | ||
| A protein expressed using our system may provide the basis for patents covering both the protein and methods of producing the protein, thereby providing potential market advantage; | ||
| There is significantly reduced risk of disease transmission to humans as our system does not involve the use of mammalian cells or mammalian components; | ||
| The relatively uniform glycosilation pattern of proteins produced in our system enables drug product consistency; | ||
| When compared to other protein production techniques, our system includes simpler production elements, is easily scalable, and requires less capital expenditures and initial capital investments; and | ||
| We expect our system to involve lower operational expenses as it requires minimal personnel training and less hands-on maintenance. |
| The system is novel and is still in the early stages of development and optimization; | ||
| Mammalian cells have been used in connection with recombinant therapeutic protein expression for more than 20 years and are the subject of a wealth of data; similar amounts of data have not been generated for plant cell expression; | ||
| Protein glycosilation is not identical to the natural human glycosilation pattern and its long term effect on human patients is still unknown; and | ||
| There is a need to design custom-made equipment and to generate specific growth media for the plant cells, as this is a new technology that cannot always rely on existing equipment. |
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Percent of | Rate of | |||||
Foreign Ownership | Reduced Tax | |||||
0-25%
|
25 | % | ||||
25-49%
|
25 | % | ||||
49-74%
|
20 | % | ||||
75-90%
|
15 | % | ||||
90-100%
|
10 | % |
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| the Approved Enterprises revenues from any single country or a separate customs territory may not exceed 75% of the Approved Enterprises total revenues; or | ||
| at least 25% of the Approved Enterprises revenues during the benefits period must be derived from sales into a single country or a separate customs territory with a population of at least 12 million. |
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| Where a companys equity, as calculated under the Inflationary Adjustments Law, exceeds the depreciated cost of its fixed assets (as defined in the Inflationary Adjustments Law), a deduction from taxable income is permitted equal to this excess multiplied by the applicable annual rate of inflation. The maximum deduction permitted under this provision in any single tax year is 70% of taxable income, with the unused portion permitted to be carried forward, linked to the Israeli consumer price index. | ||
| Where a companys depreciated cost of fixed assets exceeds its equity, then the excess multiplied by the applicable annual rate of inflation is added to taxable income. | ||
| Subject to specified limitations, depreciation deductions carryforwards on fixed assets and losses are adjusted for inflation based on the change in the consumer price index. |
| amortization of the cost of purchased know-how and patents over an eight-year period for tax purposes; | ||
| accelerated depreciation rates on equipment and buildings; |
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| under specified conditions, an election to file consolidated tax returns with additional related Israeli Industrial Companies; and | ||
| expenses related to a public offering are deductible in equal amounts over three years. |
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| the announcement of new products or product enhancements by us or our competitors; | ||
| developments concerning intellectual property rights and regulatory approvals; | ||
| variations in our and our competitors results of operations; | ||
| changes in earnings estimates or recommendations by securities analysts, if our common stock is covered by analysts; | ||
| developments in the biotechnology industry; | ||
| the results of product liability or intellectual property lawsuits; | ||
| future issuances of common stock or other securities; | ||
| the addition or departure of key personnel; |
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| announcements by us or our competitors of acquisitions, investments or strategic alliances; and | ||
| general market conditions and other factors, including factors unrelated to our operating performance. |
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| delay commercialization of, and Protalixs ability to derive product revenues from, its drug candidates; | ||
| impose costly procedures on Protalix; and | ||
| diminish any competitive advantages that Protalix may otherwise enjoy. |
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| continues to undertake pre-clinical development and clinical trials for its current and new drug candidates; | ||
| seeks regulatory approvals for its drug candidates; | ||
| implements additional internal systems and infrastructure; | ||
| seeks to license in additional technologies to develop; and | ||
| hires additional personnel. |
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| Restrictions on the products, manufacturers or manufacturing processes; | |
| Warning letters; | |
| Civil or criminal penalties, fines and/or injunctions; | |
| Product seizures or detentions; | |
| Import or export bans or restrictions; | |
| Voluntary or mandatory product recalls and related publicity requirements; | |
| Suspension or withdrawal of regulatory approvals; | |
| Total or partial suspension of production; and | |
| Refusal to approve pending applications for marketing approval of new products or supplements to approved applications. |
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With respect to intellectual property rights, Protalix cannot predict: | ||
| the degree and range of protection any patents will afford Protalix against competitors, including whether third parties will find ways to invalidate or design around its own or licensed patents; | |
| if and when patents will issue; | |
| whether or not others will obtain patents claiming aspects similar to those covered by its own or licensed patents and patent applications; or | |
| whether it will need to initiate litigation or administrative proceedings that may be costly whether it wins or loses. |
| obtain licenses, which may not be available on commercially reasonable terms, if at all; | ||
| redesign its products or processes to avoid infringement; |
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| stop using the subject matter claimed in the patents held by others, which could cause it to lose the use of one or more of its drug candidates; | ||
| pay damages; or | ||
| defend litigation or administrative proceedings which may be costly whether Protalix wins or loses, and which could result in a substantial diversion of its management resources. |
| unforeseen safety issues; | ||
| determination of dosing issues; | ||
| lack of effectiveness or efficacy during clinical trials; | ||
| failure of third party suppliers to perform final manufacturing steps for the drug substance; | ||
| slower than expected rates of patient recruitment; | ||
| inability to monitor patients adequately during or after treatment; | ||
| inability or unwillingness of medical investigators and institutional review boards to follow Protalixs clinical protocols; and | ||
| lack of sufficient funding to finance the clinical trials. |
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| perceptions by members of the health care community, including physicians, about the safety and effectiveness of Protalixs drugs; | ||
| pharmacological benefit and cost-effectiveness of Protalixs products relative to competing products; | ||
| availability of reimbursement for its products from government or other healthcare payers; | ||
| effectiveness of marketing and distribution efforts by Protalix and its licensees and distributors, if any; and | ||
| the price at which Protalix sells its products. |
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| developing drugs; | ||
| undertaking pre-clinical testing and human clinical trials; | ||
| obtaining FDA and other regulatory approvals of drugs; |
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| formulating and manufacturing drugs; and | ||
| launching, marketing and selling drugs. |
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| Protalix may be required to relinquish important rights to its products or product candidates; | ||
| Protalix may not be able to control the amount and timing of resources that its distributors or collaborators may devote to the commercialization of its product candidates; |
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| Protalixs distributors or collaborators may experience financial difficulties; | ||
| Protalixs distributors or collaborators may not devote sufficient time to the marketing and sales of Protalixs products thereby exposing Protalix to potential expenses in terminating such distribution agreements; and | ||
| business combinations or significant changes in a collaborators business strategy may adversely affect a collaborators willingness or ability to complete its obligations under any arrangement. |
| these agreements may be breached; | ||
| these agreements may not provide adequate remedies for the applicable type of breach; | ||
| Protalixs trade secrets or proprietary know-how will otherwise become known; |
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| Protalixs competitors will independently develop similar technology; or | ||
| Protalixs competitors will independently discover our proprietary information and trade secrets. |
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| Protalix may be required to pay the OCS a portion of the consideration it receives upon any sale of such technology by an entity that is not Israeli. The scope of the support received, the royalties that were paid by Protalix, the amount of time that elapsed between the date on which the know-how was transferred and the date on which the grants were received, as well as the sale price, will be taken into account in order to calculate the amount of the payment; and | ||
| the transfer of manufacturing rights could be conditioned upon an increase in the royalty rate and payment of increased aggregate royalties (up to 300% of the amount of the grant plus interest, depending on the percentage of the manufacturing that is foreign). |
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| the judgment was rendered by a court which was, according to the laws of the state of the court, competent to render the judgment; | ||
| the judgment may no longer be appealed; | ||
| the obligation imposed by the judgment is enforceable according to the rules relating to the enforceability of judgments in Israel and the substance of the judgment is not contrary to public policy; and | ||
| the judgment is executory in the state in which it was given. |
| the judgment was obtained by fraud; | ||
| there is a finding of lack of due process; | ||
| the judgment was rendered by a court not competent to render it according to the laws of private international law in Israel; | ||
| the judgment is at variance with another judgment that was given in the same matter between the same parties and that is still valid; or | ||
| at the time the action was brought in the foreign court, a suit in the same matter and between the same parties was pending before a court or tribunal in Israel. |
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| The glycosilation structure and proprietary manufacturing methods of certain of the expressed proteins can provide patent protection and potential market advantage; | ||
| Protalix Ltd.s plant cell expression system is a contained regulatory-compliant bioprocess which significantly reduces the risk of contamination with pathogenic agents, such as viruses, which are ordinarily associated with mammalian production processes; and | ||
| The control of the glycosilation process which is available through Protalix Ltd.s system enables the production of highly uniform therapeutic protein products. |
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| internal costs associated with research and development activities; | ||
| payments made to third party contract research organizations, contract manufacturers, investigative sites, and consultants; | ||
| manufacturing development costs; | ||
| personnel-related expenses, including salaries, benefits, travel, and related costs for the personnel involved in the research and development; | ||
| activities relating to the advancement of product candidates through preclinical studies and clinical trials; and |
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| facilities and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, as well as laboratory and other supplies. |
| the time needed for the research phase prior to preclinical and clinical trials; | ||
| completion of such preclinical and clinical trials; |
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| receipt of necessary regulatory approvals; | ||
| the number of clinical sites included in the trials; | ||
| the length of time required to enroll suitable patients; | ||
| the number of patients that ultimately participate in the trials; | ||
| adverse medical events or side effects in treated patients; | ||
| lack of comparability with complementary technologies; | ||
| obtaining capital necessary to fund operations, including the research and development efforts; and | ||
| the results of clinical trials. |
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| interest earned on Protalix Ltd.s cash and cash equivalents; | ||
| interest expense on short term bank credit and loan; | ||
| expense or income resulting from fluctuations of the New Israeli Shekel, which a portion of Protalix Ltd.s assets and liabilities are denominated in, against the United States Dollar and other foreign currencies. |
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Period from | ||||||||||||||||||||
December 27, | ||||||||||||||||||||
1993 | Nine months | |||||||||||||||||||
through | Ended | |||||||||||||||||||
Year ended December 31, | December 31, | September 30, | ||||||||||||||||||
2003 | 2004 | 2005 | 2005 | 2005 | ||||||||||||||||
(In thousands, except per share data) | ||||||||||||||||||||
Loss as reported |
$ | (646 | ) | $ | (2,421 | ) | $ | (5,746 | ) | $ | (11,122 | ) | $ | (3,816 | ) | |||||
Add: stock based
employee compensation
expense included in
the reported loss |
61 | 149 | 509 | 732 | 350 | |||||||||||||||
Deduct: stock-based
employee compensation
expense determined
under fair value
method
|
(67 | ) | (170 | ) | (539 | ) | (788 | ) | (370 | ) | ||||||||||
Pro forma loss |
$ | (652 | ) | $ | (2,442 | ) | $ | (5,776 | ) | $ | (11,178 | ) | $ | (3,836 | ) | |||||
Loss per share: |
||||||||||||||||||||
Basic as reported |
$ | (2.10 | ) | $ | (7.86 | ) | $ | (18.67 | ) | $ | (12.40 | ) | ||||||||
Basic pro forma |
$ | (2.12 | ) | $ | (7.93 | ) | $ | (18.76 | ) | $ | (12.46 | ) | ||||||||
Diluted as reported |
$ | (2.10 | ) | $ | (7.86 | ) | $ | (18.67 | ) | $ | (12.40 | ) | ||||||||
Diluted pro forma |
$ | (2.12 | ) | $ | (7.93 | ) | $ | (18.76 | ) | $ | (12.46 | ) | ||||||||
2003 | 2005 | |||||||
Dividend yield |
0 | % | 0 | % | ||||
Expected volatility |
59.00 | % | 54.00 | % | ||||
Risk-free interest rate |
3.28 | % | 3.83 | % | ||||
Expected life in years |
6.00 | 5.70 | ||||||
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| expected pre-money value at the realization date; | ||
| standard deviation around the above pre-money value; | ||
| expected date of the realization scenario occurring; | ||
| standard deviation around the expected realization scenario occurrence date (in days); and | ||
| an appropriate risk-adjusted discount rate. |
| Share options are granted at the money; | ||
| Exercisability is conditional only on performing service through the vesting date; | ||
| If an employee terminates service prior to vesting, the employee forfeits the share options; | ||
| If an employee terminates service after vesting, the employee has a limited period of time (typically 30-90 days) to exercise the share options; and | ||
| Share options are nontransferable and nonhedgeable |
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Security | Year | Number of Shares | Amount(1) | |||||||||
Ordinary Shares |
1996-2000 | 307,813 | (2) | $ | 1,100,000 | |||||||
Series A Convertible Preferred Shares |
2001 | 190,486 | $ | 2,000,000 | ||||||||
Series B Convertible Preferred Shares(3) |
2004-2005 | 117,477 | $ | 4,500,000 | ||||||||
Series C Convertible Preferred Shares(4) |
2005 | 90,264 | $ | 7,700,000 | ||||||||
Ordinary
Shares(5) |
2006 | 163,774 | $ | 15,000,000 |
(1) | Represents gross proceeds. | |
(2) | Includes the issuance of ordinary shares to founders. | |
(3) | During 2005, 16,954 Series B Preferred Shares were converted on a 1:1 basis, into Series C Preferred Shares for no consideration. Also in connection with such funding, warrants to purchase 2,967 Series B Preferred Shares were issued for no additional consideration with a total exercise price of $0.1 million. As of the closing date of the merger, 2,751 of such warrants were exercised for net proceeds to Protalix Ltd. equal to approximately $96,000 and 216 of such warrants have been forfeited. | |
(4) | In connection with such funding, warrants to purchase an additional 145,099 Series C Preferred Shares were granted to the investors for no additional consideration with a total exercise price equal to $9.0 million. As of the closing date of the merger, 86,613 of such warrants were exercised for net proceeds to Protalix Ltd. equal to $8.7 million, 55,410 were assumed by our company and 3,076 expired. | |
(5) | In connection with such funding, warrants to purchase 57,691 ordinary shares of Protalix Ltd. were issued for no additional consideration with a total exercise price equal to $5 million. |
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(i) | each person who is known by us to own beneficially more than 5% of our common stock; | |
(ii) | each director; | |
(iii) | our Chief Executive Officer and our two most highly compensated officers other than our Chief Executive Officer who served in such capacities in 2005 (collectively, the Named Executive Officers); and | |
(iv) | all of our directors and Named Executive Officers collectively. |
Title of | Name and Address or | Amount and Nature of | Percentage of | |||||||||
Class | Number in Group | Beneficial Ownership | Class (%) | |||||||||
Common Stock |
Biocell Ltd. (1) | 14,466,319 | (7) | 23.42 | ||||||||
Common Stock |
Pontifax G.P. Ltd. (2) | 5,394,436 | (8) | 8.39 | ||||||||
Common Stock |
Techno-Rov Holdings (1993) Ltd. (3) | 6,186,046 | (9) | 10.01 | ||||||||
Common Stock |
Marathon Investments Ltd. (4) | 6,556,381 | (10) | 10.61 | ||||||||
Common Stock |
Frost Gamma Investment Trust (5) | 9,766,273 | (11) | 15.27 | ||||||||
Common Stock |
Yoseph Shaaltiel, Ph.D. (6) | 3,188,431 | (12) | 5.14 |
(1) | The address is Moshe Aviv Tower, 7 Jabotinsky Street, Ramat Gan, Israel. | |
(2) | The address of Pontifax (Israel) L.P. and Pontifax (Cayman) L.P. is 8 Hamanofim St. Herzliya 46725, Israel. | |
(3) | The address is Alrov Tower, 46 Rothschild Blvd., Tel Aviv. | |
(4) | The address is 7 Hanagar Street, Holon, Israel. | |
(5) | The address is 4400 Biscayne Blvd., Miami, Florida 33137. | |
(6) | The address is c/o Orthodontix, Inc., 2 Snunit Street, Science Park, POB 455, Carmiel, Israel, 21000. | |
(7) | Biocell Ltd.s investment and voting decisions are made collectively by its Board of Directors. | |
(8) | Consists of 2,575,843 shares of our common stock held by Pontifax (Cayman) L.P., 1,378,278 of which shares are owned of record and 1,197,565 of which shares are issuable upon exercise of options that are exercisable within 60 days of the closing date of the merger and 2,818,593 shares of our common stock held by Pontifax (Israel) L.P., 1,508,169 of which shares are owned of record and 1,310,424 of which shares are issuable upon exercise of options that are exercisable within 60 days of the closing date of the merger. Pontifax (Cayman) L.P. and Pontifax (Israel) L.P. are governed by Pontifax Management L.P. Pontifax G.P. Ltd. is the general partner of Pontifax Management L.P. Pontifax G.P. Ltd.s investment and voting decisions are made collectively by its Board of Directors. | |
(9) | Mr. Amos Bar-Shalev is the manager of Techno-Rov Holdings (1993) Ltd. and has the power to control its investment decisions. | |
(10) | Marathon Investments Ltd.s investment and voting decisions are made collectively by its Board of Directors. |
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(11) | Includes warrants to purchase 2,157,302 shares of common stock issuable upon exercise of outstanding warrants exercisable within 60 days of the closing date of the merger. Frost Gamma, L.P. is the sole and exclusive beneficiary of Frost Gamma Investments Trust. Dr. Phillip Frost is the sole limited partner of Frost Gamma, L.P. The general partner of Frost Gamma, L.P. is Frost Gamma, Inc. and the sole shareholder of Frost Gamma, Inc. is Frost-Nevada Corporation. Dr. Frost is also the sole shareholder of Frost-Nevada Corporation. Does not include options to purchase 1,937,708 shares of common stock issued to Dr. Frost with vesting periods that commence upon the listing of our common stock on the American Stock Exchange, if at all. | |
(12) | The address is c/o Orthodontix, Inc., 2 Snunit Street, Science Park, POB 455, Carmiel, Israel, 21000. Includes 244,324 shares of our common stock issuable upon exercise of outstanding options within 60 days after the closing date of the Merger, held by Dr. Shaaltiel. |
Title of | Name and Address or | Amount and Nature of | Percentage of | |||||||||
Class | Number in Group | Beneficial Ownership | Class (%) | |||||||||
Common Stock |
Eli Hurvitz | 5,394,436 | (1) | 8.39 | ||||||||
Common Stock |
Yoseph Shaaltiel, Ph.D. | 3,188,431 | (2) | 5.14 | ||||||||
Common Stock |
Phillip Frost, M.D. | 9,766,273 | (3) | 15.27 | ||||||||
Common Stock |
Jane H. Hsiao, Ph.D., MBA | 1,134,060 | (4) | 1.83 | ||||||||
Common Stock |
David Aviezer, Ph.D., MBA | 930,020 | (5) | 1.48 | ||||||||
Common Stock |
Zeev Bronfeld | 14,466,319 | (6) | 23.42 | ||||||||
Common Stock |
Amos Bar-Shalev | 6,186,046 | (7) | 10.01 | ||||||||
Common Stock |
Sharon Toussia-Cohen | 6,556,381 | (8) | 10.61 | ||||||||
Common Stock |
Eyal Sheratzki | 14,466,319 | (9) | 23.42 | ||||||||
Common Stock |
Pinhas Barel Buchris | | | |||||||||
Common Stock |
Einat Brill Almon, Ph.D. | 125,827 | (10) | * | ||||||||
Common Stock |
Yossi Maimon | | | |||||||||
Common Stock |
All Executive Officers and Directors as a group (12 persons) | 47,747,793 | (11) | 70.21 |
* | less than 1%. |
(1) | Consists of 2,575,843 shares of our common stock held by Pontifax (Cayman) L.P., 1,378,278 of which shares are owned of record and 1,197,565 of which shares are issuable upon exercise of options that are exercisable within 60 days of the closing date of the merger and 2,818,593 shares of our common stock held by Pontifax (Israel) L.P., 1,508,169 of which shares are owned of record and 1,310,424 of which shares are issuable upon exercise of options that are exercisable within 60 days of the closing date of the merger. Mr. Hurvitz disclaims beneficial ownership of these shares. | |
(2) | Includes 244,324 shares of our common stock issuable upon exercise of outstanding options within 60 days after the closing date of the Merger, held by Dr. Shaaltiel. | |
(3) | Includes 7,608,971 shares of common stock and 2,157,302 shares of common stock issuable upon exercise of outstanding warrants owned by Frost Gamma Investments Trust exercisable within 60 days of the closing date of the merger. Does not include options to purchase 1,937,708 shares of common stock issued to Dr. Frost with vesting periods that commence upon the listing of our common stock on the American Stock Exchange, if at all. Frost Gamma, L.P. is the sole and exclusive beneficiary of Frost Gamma Investments Trust. Dr. Frost is the sole limited partner of Frost Gamma, L.P. The general partner of Frost Gamma, L.P. is Frost Gamma, Inc. and the sole shareholder of Frost Gamma, Inc. is Frost-Nevada Corporation. Dr. Frost is also the sole shareholder of Frost-Nevada Corporation. | |
(4) | Includes 258,355 shares of our common stock issuable upon exercise of outstanding warrants held by Dr. Hsiao. Does not include options to purchase 387,542 shares of common stock issued to Dr. Hsiao with vesting periods that commence upon the listing of our common stock on the American Stock Exchange, if at all. | |
(5) | Includes 930,020 shares of common stock issuable upon exercise of outstanding options within 60 days after the closing date of the merger, held by Dr. Aviezer. | |
(6) | Consists of 14,466,319 shares of our common stock held by Biocell Ltd. Mr. Bronfeld is a director and Chief Executive Officer of Biocell. Mr. Bronfeld disclaims beneficial ownership of these shares. | |
(7) | Consists of 6,186,046 shares of our common stock held by Techno-Rov Holdings (1993) Ltd. Mr. Bar-Shalev is the manager and has the power to control its investment decisions. Mr. Bar-Shalev disclaims beneficial ownership of these shares. | |
(8) | Consists of 6,556,381 shares of our common stock held by Marathon Investments Ltd. Mr. Toussia-Cohen is a director and Chief Executive Officer of Marathon Investments Ltd. Mr. Toussia-Cohen disclaims beneficial ownership of these shares. | |
(9) | Consists of 14,466,319 shares of our common stock held by Biocell Ltd. Mr. Sheratzki is the Chairman of the Board of Biocell. Mr. Sheratzki disclaims beneficial ownership of these shares. | |
(10) | Consists of 125,827 shares of our common stock issuable upon exercise of outstanding options within 60 days after the closing date of the merger, held by Dr. Brill Almon. | |
(11) | Includes of 6,223,817 shares of our common stock issuable upon exercise of warrants or options, as applicable, within 60 days after the closing date of the merger. |
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Name | Age | Position | ||
Directors |
||||
Eli Hurvitz |
74 | Chairman of the Board | ||
David Aviezer, Ph.D., MBA |
42 | Director, President and Chief Executive Officer | ||
Yoseph Shaaltiel, Ph.D. |
53 | Director and Executive VP, Research and Development | ||
Zeev
Bronfeld(1) |
55 | Director | ||
Amos
Bar-Shalev(2)(3) |
53 | Director | ||
Sharon
Toussia-Cohen(1)(2) |
47 | Director | ||
Eyal
Sheratzki(1) |
38 | Director | ||
Pinhas Barel
Buchris(2)(3) |
56 | Director | ||
Phillip Frost, M.D. |
70 | Director | ||
Jane
H. Hsiao, Ph.D., MBA(3) |
59 | Director | ||
Executive Officers |
||||
Einat Brill Almon, Ph.D. |
47 | Vice President, Product Development | ||
Yossi Maimon |
37 | Chief Financial Officer, Treasurer and Secretary |
(1) | Member of Nominating Committee | |
(2) | Member of Audit Committee | |
(3) | Member of Compensation Committee |
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Nonqualified | ||||||||||||||||||||||||||||||||||||
Non-Equity | Deferred | All Other | ||||||||||||||||||||||||||||||||||
Stock | Option | Incentive Plan | Compensation | Compen- | ||||||||||||||||||||||||||||||||
Name and Principal | Salary | Bonus | Award(s) | Award(s) | Compensation | Earnings | sation | Total | ||||||||||||||||||||||||||||
Position | Year | ($) | ($) | ($) | ($) | ($) | ($) | ($)(1) | ($) | |||||||||||||||||||||||||||
David Aviezer, Ph.D., MBA (2) |
2005 | 198,890 | 75,000 | | 272,879 | | | | 546,769 | |||||||||||||||||||||||||||
President and CEO |
2004 | 161,409 | 20,000 | | 147,124 | | | | 328,533 | |||||||||||||||||||||||||||
Yoseph Shaaltiel, Ph.D. |
2005 | 120,855 | 8,022 | | 4,077 | | | 40,283 | 173,237 | |||||||||||||||||||||||||||
Executive Vice President, Research and Development |
2004 | 96,809 | | | 5,302 | | | 32,269 | 134,380 | |||||||||||||||||||||||||||
Einat Brill Almon, Ph.D. |
2005 | 79,818 | 3,915 | | 67,824 | | | 26,605 | 178,162 | |||||||||||||||||||||||||||
Vice President, Product Development |
2004 | 2,316 | | | | | | 772 | 3,088 |
(1) | Includes employer contributions to pension and/or insurance plans and other miscellaneous payments. | |
(2) | Dr. Aviezer served as Protalix Ltd.s Chief Executive Officer on a consultancy basis, until September 2006, pursuant to a Consulting Services Agreement between Protalix Ltd. and Agenda Biotechnology Ltd., a company wholly-owned by Dr. Aviezer. |
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Option Awards | Stock Awards | |||||||||||||||||||||||||||||||||||
Equity | ||||||||||||||||||||||||||||||||||||
Incentive | ||||||||||||||||||||||||||||||||||||
Plan | ||||||||||||||||||||||||||||||||||||
Equity | Awards: | |||||||||||||||||||||||||||||||||||
Incentive | Market or | |||||||||||||||||||||||||||||||||||
Plan | Payout | |||||||||||||||||||||||||||||||||||
Equity | Awards: | Value | ||||||||||||||||||||||||||||||||||
Incentive | Market | Number | of | |||||||||||||||||||||||||||||||||
Number | Plan Awards: | Number | Value of | of | Unearned | |||||||||||||||||||||||||||||||
of | Number | Number | of Shares | Shares or | Unearned | Shares, | ||||||||||||||||||||||||||||||
Securities | of Securities | of Securities | or Units | Units of | Shares, | Units or | ||||||||||||||||||||||||||||||
Underlying | Underlying | Underlying | of Stock | Stock | Units or | Other | ||||||||||||||||||||||||||||||
Unexercised | Unexercised | Unexercised | Option | That Have | That | Other | Rights | |||||||||||||||||||||||||||||
Options | Options | Unearned | Exercise | Option | Not | Have Not | Rights | That Have | ||||||||||||||||||||||||||||
(#) | (#) | Options | Price | Expiration | Vested | Vested | That Have | Not Vested | ||||||||||||||||||||||||||||
Name | Exercisable | Unexercisable | (#) | ($) | Date | (#) | ($) | Not Vested (#) | ($) | |||||||||||||||||||||||||||
David Aviezer, Ph.D. |
19,670 | 6,557 | | 7.35 | 8/1/2013 | | | | | |||||||||||||||||||||||||||
Yoseph Shaaltiel, Ph.D. |
4,000 | | | 0.01NIS | 6/30/2011 | | | | | |||||||||||||||||||||||||||
Einat Brill Almon, Ph.D. |
1,030 | 3,089 | | 24.36 | 8/1/2013 | | | | |
Nonqualified | ||||||||||||||||||||||||||||
Non-Equity | Deferred | |||||||||||||||||||||||||||
Fees Earned or | Option | Incentive Plan | Compensation | All Other | ||||||||||||||||||||||||
Paid in Cash | Stock Award | Awards | Compensation | Earnings | Compensation | Total | ||||||||||||||||||||||
Name | ($) | ($) | ($) | ($) | ($) | ($) | ($) | |||||||||||||||||||||
Eli
Hurvitz (1) |
24,549 | 855,388 | | | | | 879,936 | |||||||||||||||||||||
Zeev Bronfeld |
| | | | | | | |||||||||||||||||||||
Amos Bar-Shalev |
| | | | | | | |||||||||||||||||||||
Sharon Toussia-Cohen |
| | | | | | | |||||||||||||||||||||
Eyal Sheratzki |
| | | | | | | |||||||||||||||||||||
Alon
Dumanis, Ph.D. (2) |
| | | | | | | |||||||||||||||||||||
Phillip
Frost, M.D. (3) |
| | | | | | | |||||||||||||||||||||
Jane H.
Hsiao, Ph.D., MBA (3) |
| | | | | | |
(1) | Represents amounts paid to Pontifax Management Company, Ltd. pursuant to a management consulting agreement. | |
(2) | Dr. Dumanis ceased to serve as a director of Protalix Ltd. in December 2006. | |
(3) | Dr. Frost and Dr. Hsiao did not serve as directors of Protalix Ltd. during fiscal year 2005. |
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74
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| We believe a majority of the members of our Board of Directors are independent from management. When making determinations from time to time regarding independence, the Board of Directors will reference the listing standards adopted by the American Stock Exchange as well as the independence standards set forth in the Sarbanes-Oxley Act of 2002 and the rules and regulations promulgated by the SEC under that Act. In particular, our Audit Committee periodically evaluates and reports to the Board of Directors on the independence of each member of the Board. We anticipate our audit committee will analyze whether a director is independent by evaluating, among other factors, the following: |
1. | Whether the member of the Board of Directors has any material relationship with us, either directly, or as a partner, shareholder or officer of an organization that has a relationship with us; | ||
2. | Whether the member of the Board of Directors is a current employee of our company or our subsidiaries or was an employee of our company or our subsidiaries within three years preceding the date of determination; | ||
3. | Whether the member of the Board of Directors is, or in the three years preceding the date of determination has been, affiliated with or employed by (i) a present internal or external auditor of our company or any affiliate of such auditor, or (ii) any former internal or external auditor of our company or any affiliate of such auditor, which performed services for us within three years preceding the date of determination; | ||
4. | Whether the member of the Board of Directors is, or in the three years preceding the date of determination has been, part of an interlocking directorate, in which any of our executive officers serve on the compensation committee of another company that concurrently employs the member as an executive officer; | ||
5. | Whether the member of the Board of Directors receives any compensation from us, other than fees or compensation for service as a member of the Board of Directors and any committee of the Board of Directors and reimbursement for reasonable expenses incurred in connection with such service and for reasonable educational expenses associated with Board of Directors or committee membership matters; | ||
6. | Whether an immediate family member of the member of the Board of Directors is a current executive officer of our company or was an |
76
executive officer of our company within three years preceding the date of determination; | |||
7. | Whether an immediate family member of the member of the Board of Directors is, or in the three years preceding the date of determination has been, affiliated with or employed in a professional capacity by (i) a present internal or external auditor of ours or any of our affiliates, or (ii) any former internal or external auditor of our company or any affiliate of ours which performed services for us within three years preceding the date of determination; and | ||
8. | Whether an immediate family member of the member of the Board of Directors is, or in the three years preceding the date of determination has been, part of an interlocking directorate, in which any of our executive officers serve on the compensation committee of another company that concurrently employs the immediate family member of the member of the Board of Directors as an executive officer. |
| Our non-management directors hold formal meetings, separate from management, at least two times per year. | ||
| We have no formal policy regarding attendance by our directors at annual shareholders meetings, although we encourage such attendance and anticipate most of our directors will attend these meetings. Last year all directors attended Protalixs annual shareholder meeting and Orthodontixs annual shareholder meeting. | ||
Audit Committee | |||
| We require that all Audit Committee members possess the required level of financial literacy and at least one member of the Committee meet the current standard of requisite financial management expertise as required by the American Stock Exchange and applicable SEC rules and regulations. Messrs. Toussia-Cohen, Buchris and Bar-Shalev have been appointed by the Board of Directors to serve on the Audit Committee. |
77
| Messrs. Toussia-Cohen and Bar-Shalev qualify as audit committee financial experts under the applicable rules of the Securities and Exchange Commission. In making the determination as to these individuals status as audit committee financial experts, our board of directors determined they have accounting and related financial management expertise within the meaning of the aforementioned rules, as well as the listing standards of the American Stock Exchange. | ||
| Our Audit Committee operates under a formal charter that governs its duties and conduct. | ||
| All members of the Audit Committee are independent from our executive officers and management. | ||
| Our independent registered public accounting firm reports directly to the Audit Committee. | ||
| Our Audit Committee meets with management and representatives of our registered public accounting firm prior to the filing of officers certifications with the SEC to receive information concerning, among other things, effectiveness of the design or operation of our internal controls over financial reporting, as required by section 404 of the Sarbanes-Oxley Act of 2002. | ||
| Our Audit Committee has adopted a Policy for Reporting Questionable Accounting and Auditing Practices and Policy Prohibiting Retaliation against Reporting employees to enable confidential and anonymous reporting of improper activities to the Audit Committee. | ||
Compensation Committee | |||
| Our Compensation Committee operates under a formal charter that governs its duties and conduct. | ||
| All members of the Compensation Committee are independent from our executive officers and management. Messrs. Buchris and Bar-Shalev and Dr. Hsiao have been appointed by the Board of Directors to serve on the Compensation Committee. | ||
Nominating Committee | |||
| Our Nominating Committee operates under a formal charter that governs its duties and conduct. | ||
| All members of the Nominating Committee will be independent from our executive officers and management. Messrs. Toussia-Cohen, Bronfeld and Shervatzki have been appointed by the Board of Directors to serve on the Nominating Committee. |
78
Code of Business Conduct and Ethics | |||
| We have adopted a Code of Business Conduct and Ethics that includes provisions ranging from restrictions on gifts to conflicts of interest. All of our employees and directors are bound by this Code of Business Conduct and Ethics. Violations of our Code of Business Conduct and Ethics may be reported to the Audit Committee. | ||
| The Code of Business Conduct and Ethics includes provisions applicable to all of our employees, including senior financial officers and members of our Board of Directors. We anticipate posting this Code of Business Conduct and Ethics on our website (http://www.Protalix.com/). We intend to post amendments to or waivers from any such Code of Business Conduct and Ethics. | ||
Personal Loans to Executive Officers and Directors | |||
| We currently prohibit extensions of credit in the form of a personal loan to or for our directors and executive officers. | ||
Communications with the Board of Directors | |||
| Anyone who has a concern about our conduct, including accounting, internal accounting controls or audit matters, may communicate directly with the Audit Committee. These communications may be confidential or anonymous, and may be mailed, e-mailed, submitted in writing or reported by phone. All of these concerns will be forwarded to the appropriate directors for their review, and will be simultaneously reviewed and addressed by our Chief Financial Officer in the same way that we address other concerns. |
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| reasonable litigation expenses, including attorneys fees, incurred by the office holder as a result of an investigation or proceeding instituted against him or her by an authority authorized to conduct such investigation or proceeding, provided that (i) no indictment was filed against such office holder as a result of such investigation or proceeding; and (ii) no financial liability, such as a criminal penalty, was imposed upon him or her as a substitute for the criminal proceeding as a result of such investigation or proceeding or, if such financial liability was imposed, it was imposed with respect to an offense that does not require proof of criminal intent; and | ||
| reasonable litigation expenses, including attorneys fees, incurred by the office holder or imposed by a court in proceedings instituted against him or her by the company, on its behalf or by a third party or in connection with criminal proceedings in which the office holder was acquitted or as a result of a conviction for a crime that does not require proof of criminal intent. |
| a breach of duty of loyalty to the company, to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not be detrimental to the interests of the company; | ||
| a breach of duty of care to the company or to a third party; and | ||
| a financial liability imposed on the office holder in favor of a third party in respect of an act performed in his or her capacity as an office holder. |
| a breach of duty of loyalty, except to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not be detrimental to the interests of the company; | ||
| a grossly negligent or intentional violation of an office holders duty of care; | ||
| an act or omission committed with intent to derive illegal personal benefit; or | ||
| a fine levied against the office holder. |
82
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(a) | Financial statements of business acquired. | |
(b) | Pro forma financial information. |
84
Page | ||
REPORT OF INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM |
2 | |
FINANCIAL STATEMENTS: |
||
Balance Sheets |
3-4 | |
Statements of Operations |
5-6 | |
Statements of Changes in Shareholders Equity |
7 | |
Statements of Cash Flows |
8-10 | |
Notes to Financial Statements |
11-40 |
/s/Kesselman & Kesselman | ||
Tel-Aviv, Israel
|
Kesselman & Kesselman | |
December 27, 2006
|
Certified Public Accountant (Isr.) | |
A member of PricewaterhouseCoopers | ||
International Limited |
F-2
December 31, | September 30, | |||||||||||
2004 | 2005 | 2006 | ||||||||||
(Unaudited) | ||||||||||||
ASSETS |
||||||||||||
CURRENT ASSETS: |
||||||||||||
Cash and cash equivalents |
$ | 1,477 | $ | 4,741 | $ | 15,621 | ||||||
Accounts receivable |
666 | 254 | 833 | |||||||||
Total current assets |
2,143 | 4,995 | 16,454 | |||||||||
FUNDS IN RESPECT OF EMPLOYEE
RIGHTS UPON RETIREMENT |
132 | 195 | 268 | |||||||||
PROPERTY AND EQUIPMENT, NET |
1,680 | 2,035 | 2,285 | |||||||||
Total assets |
$ | 3,955 | $ | 7,225 | $ | 19,007 | ||||||
F-3
December 31, | September 30, | |||||||||||
2004 | 2005 | 2006 | ||||||||||
(Unaudited) | ||||||||||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||||||
CURRENT LIABILITIES: |
||||||||||||
Accounts payable and accruals: |
||||||||||||
Trade |
$ | 591 | $ | 426 | $ | 757 | ||||||
Other |
655 | 419 | 544 | |||||||||
Total current liabilities |
1,246 | 845 | 1,301 | |||||||||
LONG-TERM LIABILITIES: |
||||||||||||
Loan |
1,028 | |||||||||||
Liability for employee rights upon retirement |
206 | 285 | 388 | |||||||||
Total long-term liabilities |
1,234 | 285 | 388 | |||||||||
COMMITMENTS |
||||||||||||
Total liabilities |
2,480 | 1,130 | 1,689 | |||||||||
SHAREHOLDERS EQUITY: |
||||||||||||
Convertible preferred shares of NIS 0.01 par value: |
||||||||||||
Authorized as of December 31, 2004 and 2005 -
390,486 and 773,532 shares, respectively and
no shares as of September 30, 2006 (unaudited); |
||||||||||||
Issued and outstanding as of December 31, 2004
and 2005 - 291,009 and 398,227, respectively,
and no shares as of September 30, 2006 (unaudited) |
1 | 1 | ||||||||||
Ordinary Shares of NIS 0.01 par value: |
||||||||||||
Authorized as of December 31, 2004 and 2005
and September 30, 2006 (unaudited), 1,899,514,
1,516,468 and 2,290,000 shares respectively; |
||||||||||||
Issued and outstanding as of December 31, 2004
and 2005 and September 30, 2006 (unaudited);
307,813, 307,813 and 870,661 shares,
respectively |
1 | 1 | 2 | |||||||||
Additional paid-in capital |
6,849 | 16,188 | 32,985 | |||||||||
Warrants |
1,027 | 1,379 | ||||||||||
Deficit accumulated during the development stage |
(5,376 | ) | (11,122 | ) | (17,048 | ) | ||||||
Total shareholders equity |
1,475 | 6,095 | 17,318 | |||||||||
Total liabilities and shareholders equity |
$ | 3,955 | $ | 7,225 | $ | 19,007 | ||||||
F-4
Period from | Period from | |||||||||||||||||||||||||||
December 27, 1993* | Nine months ended | December 27, 1993* | ||||||||||||||||||||||||||
Year ended December 31, | through | September 30, | through | |||||||||||||||||||||||||
2003 | 2004 | 2005 | December 31, 2005 | 2005 | 2006 | September 30, 2006 | ||||||||||||||||||||||
(Unaudited) | (Unaudited) | |||||||||||||||||||||||||||
REVENUES |
$ | 250 | $ | 430 | $ | 150 | $ | 830 | $ | 150 | $ | 830 | ||||||||||||||||
COST OF REVENUES |
51 | 120 | 35 | 206 | 35 | 206 | ||||||||||||||||||||||
GROSS PROFIT |
199 | 310 | 115 | 624 | 115 | 624 | ||||||||||||||||||||||
RESEARCH AND DEVELOPMENT
EXPENSES - |
668 | 2,493 | 4,708 | 10,664 | 3,215 | $ | 4,759 | 15,423 | ||||||||||||||||||||
less grants |
(429 | ) | (573 | ) | (935 | ) | (3,365 | ) | (787 | ) | (1,510 | ) | (4,875 | ) | ||||||||||||||
239 | 1,920 | 3,773 | 7,299 | 2,428 | 3,249 | 10,548 | ||||||||||||||||||||||
GENERAL AND ADMINISTRATIVE
EXPENSES |
603 | 807 | 2,131 | 4,471 | 1,541 | 2,787 | 7,258 | |||||||||||||||||||||
OPERATING LOSS |
643 | 2,417 | 5,789 | 11,146 | 3,854 | 6,036 | 17,182 | |||||||||||||||||||||
FINANCIAL EXPENSES
(INCOME) NET |
3 | 4 | (43 | ) | (24 | ) | (38 | ) | (73 | ) | (97 | ) | ||||||||||||||||
NET LOSS BEFORE CHANGE IN
ACCOUNTING PRINCIPLE |
646 | 2,421 | 5,746 | 11,122 | 3,816 | 5,963 | 17,085 | |||||||||||||||||||||
CUMULATIVE EFFECT OF
CHANGE IN ACCOUNTING
PRINCIPLE |
(37 | ) | (37 | ) | ||||||||||||||||||||||||
NET LOSS FOR THE PERIOD |
$ | 646 | $ | 2,421 | $ | 5,746 | $ | 11,122 | $ | 3,816 | $ | 5,926 | $ | 17,048 | ||||||||||||||
F-5
Nine months ended | ||||||||||||||||||||
Year ended December 31, | September 30, | |||||||||||||||||||
2003 | 2004 | 2005 | 2005 | 2006 | ||||||||||||||||
(Unaudited) | ||||||||||||||||||||
NET LOSS PER ORDINARY SHARE BASIC: |
||||||||||||||||||||
Prior to cumulative effect of change in
accounting principle |
$ | 2.10 | $ | 7.86 | $ | 18.67 | $ | 12.40 | $ | 17.27 | ||||||||||
Cumulative effect of change in accounting principle |
$ | (0.11 | ) | |||||||||||||||||
$ | 2.10 | $ | 7.86 | $ | 18.67 | $ | 12.40 | $ | 17.16 | |||||||||||
NET LOSS PER ORDINARY SHARE DILUTED: |
||||||||||||||||||||
Prior to cumulative effect of change in
accounting principle |
$ | 2.10 | $ | 7.86 | $ | 18.67 | $ | 12.40 | $ | 17.27 | ||||||||||
Cumulative effect of change in accounting principle |
$ | (0.11 | ) | |||||||||||||||||
$ | 2.10 | $ | 7.86 | $ | 18.67 | $ | 12.40 | $ | 17.16 | |||||||||||
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN
COMPUTING LOSS PER ORDINARY SHARE: |
||||||||||||||||||||
Basic |
307,813 | 307,813 | 307,813 | 307,813 | 345,364 | |||||||||||||||
Diluted |
307,813 | 307,813 | 307,813 | 307,813 | 345,364 | |||||||||||||||
F-6
Deficit | ||||||||||||||||||||||||||||||||
accumulated | ||||||||||||||||||||||||||||||||
Convertible | Convertible | Additional | during | |||||||||||||||||||||||||||||
Ordinary | preferred | Ordinary | preferred | paid in | development | |||||||||||||||||||||||||||
shares | shares | shares | shares | Warrants | capital | stage | Total | |||||||||||||||||||||||||
Number of shares | Amount | |||||||||||||||||||||||||||||||
Beginning balance December 27, 1993* |
||||||||||||||||||||||||||||||||
Changes during the period from December 27, 1993 through December 31, 2002: |
||||||||||||||||||||||||||||||||
Ordinary and convertible preferred A shares issued for cash (net of issuance costs of $124) |
307,813 | 190,486 | $ | 1 | ** | | $ | 2,305 | | $ | 2,306 | |||||||||||||||||||||
Share based compensation |
| | | | | 109 | | 109 | ||||||||||||||||||||||||
Net Loss |
| | | | | | $ | (2,309 | ) | (2,309 | ) | |||||||||||||||||||||
Balance at December 31, 2002 |
307,813 | 190,486 | 1 | | | 2,414 | (2,309 | ) | 106 | |||||||||||||||||||||||
Changes during 2003: |
||||||||||||||||||||||||||||||||
Additional consideration for Convertible A preferred shares (net of issuance costs of $38) |
| | | | | 612 | | 612 | ||||||||||||||||||||||||
Share based compensation |
| | | | | 222 | | 222 | ||||||||||||||||||||||||
Net Loss |
| | | | | | (646 | ) | (646 | ) | ||||||||||||||||||||||
Balance at December 31, 2003 |
307,813 | 190,486 | 1 | | | 3,248 | (2,955 | ) | 294 | |||||||||||||||||||||||
Changes during 2004: |
||||||||||||||||||||||||||||||||
Convertible preferred B shares issued for cash (net of issuance costs of $216) |
| 100,523 | | 1 | | 3,283 | | 3,284 | ||||||||||||||||||||||||
Share based compensation |
| | | | | 318 | | 318 | ||||||||||||||||||||||||
Net Loss |
| | | | | (2,421 | ) | (2,421 | ) | |||||||||||||||||||||||
Balance at December 31, 2004 |
307,813 | 291,009 | 1 | 1 | | 6,849 | (5,376 | ) | 1,475 | |||||||||||||||||||||||
Changes during 2005: |
||||||||||||||||||||||||||||||||
Convertible preferred B and C shares and warrants issued for cash (net of issuance costs
of $192) |
| 107,218 | | ** | $ | 1,027 | 7,452 | | 8,479 | |||||||||||||||||||||||
Share based compensation |
| | | | | 1,887 | | 1,887 | ||||||||||||||||||||||||
Net Loss |
| | | | | | (5,746 | ) | (5,746 | ) | ||||||||||||||||||||||
Balance at December 31, 2005 |
307,813 | 398,227 | 1 | 1 | 1,027 | 16,188 | (11,122 | ) | 6,095 | |||||||||||||||||||||||
Changes during the nine month period ended September 30, 2006 (unaudited): |
||||||||||||||||||||||||||||||||
Ordinary shares and warrants issued for cash (net of issuance costs of $139) |
163,774 | | | ** | 352 | 14,509 | | 14,861 | ||||||||||||||||||||||||
Exercise of options granted to nonemployees |
| 847 | | ** | | 30 | | 30 | ||||||||||||||||||||||||
Share based compensation |
| | | | | 2,295 | | 2,295 | ||||||||||||||||||||||||
Conversion of convertible preferred shares into ordinary shares, see Note 6b |
399,074 | (399,074 | ) | 1 | (1 | ) | | | | | ||||||||||||||||||||||
Net Loss |
| | | | | | (5,963 | ) | (5,963 | ) | ||||||||||||||||||||||
Change in accounting principle |
| | | | | (37 | ) | 37 | | |||||||||||||||||||||||
Balance at September 30, 2006 (unaudited) |
870,661 | | $ | 2 | | $ | 1,379 | $ | 32,985 | $ | (17,048 | ) | $ | 17,318 | ||||||||||||||||||
* | Incorporation date, see Note 1a. | |
** | Represents an amount less than $1. |
F-7
Period from | Period from | |||||||||||||||||||||||||||
December 27, 1993* | Nine months ended | December 27, 1993* | ||||||||||||||||||||||||||
Year ended December 31, | through | September 30, | through | |||||||||||||||||||||||||
2003 | 2004 | 2005 | December 31, 2005 | 2005 | 2006 | September 30, 2006 | ||||||||||||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||||||||||||||||
CASH FLOWS FROM OPERATING
ACTIVITIES: |
||||||||||||||||||||||||||||
Net Loss |
$ | (646 | ) | $ | (2,421 | ) | $ | (5,746 | ) | $ | (11,122 | ) | $ | (3,816 | ) | $ | (5,926 | ) | $ | (17,048 | ) | |||||||
Adjustments required to reconcile net loss to
net cash used in operating activities |
||||||||||||||||||||||||||||
Income and expenses not involving cash |
||||||||||||||||||||||||||||
Cumulative effect of change in accounting principle |
| | | | | (37 | ) | (37 | ) | |||||||||||||||||||
Share based compensation |
222 | 297 | 1,887 | 2,515 | 1,337 | 2,295 | 4,810 | |||||||||||||||||||||
Depreciation |
62 | 123 | 311 | 678 | 226 | 314 | 992 | |||||||||||||||||||||
Interest in respect of loan |
2 | 26 | (28 | ) | | 19 | | | ||||||||||||||||||||
Changes in accrued liability for employee
rights upon retirement |
45 | 67 | 79 | 285 | 52 | 103 | 388 | |||||||||||||||||||||
Loss (gain) on amounts funded in respect of
employee rights upon retirement |
2 | (4 | ) | (40 | ) | | 5 | (35 | ) | |||||||||||||||||||
Changes in operating assets and liabilities: |
||||||||||||||||||||||||||||
Decrease (increase) in accounts receivable |
43 | (534 | ) | 412 | (254 | ) | 174 | (579 | ) | (833 | ) | |||||||||||||||||
Increase (decrease) in accounts payable
and accrual |
(113 | ) | 691 | (117 | ) | 804 | (243 | ) | 523 | 1,327 | ||||||||||||||||||
Net cash used in operating activities |
$ | (385 | ) | $ | (1,749 | ) | $ | (3,206 | ) | $ | (7,134 | ) | $ | (2,251 | ) | $ | (3,302 | ) | $ | (10,436 | ) | |||||||
CASH FLOWS FROM INVESTING
ACTIVITIES: |
||||||||||||||||||||||||||||
Purchase of property and equipment |
(184 | ) | (1,291 | ) | (844 | ) | (2,645 | ) | (664 | ) | (639 | ) | (3,284 | ) | ||||||||||||||
Investment grant received in respect of fixed assets |
| | | 38 | | | 38 | |||||||||||||||||||||
Amount funded in respect of employee rights
upon retirement |
(42 | ) | (48 | ) | (83 | ) | (295 | ) | (46 | ) | (85 | ) | (380 | ) | ||||||||||||||
Amount paid in respect of employee rights
upon retirement |
| 3 | 24 | 140 | 2 | 7 | 147 | |||||||||||||||||||||
Net cash used in investing activities |
$ | (226 | ) | $ | (1,336 | ) | $ | (903 | ) | $ | (2,762 | ) | $ | (708 | ) | $ | (717 | ) | $ | (3,479 | ) | |||||||
F-8
Period from | Period from | |||||||||||||||||||||||||||
December 27, | December 27, | |||||||||||||||||||||||||||
1993 | 1993 | |||||||||||||||||||||||||||
through | Nine months ended | through | ||||||||||||||||||||||||||
Year ended December 31, | December 31, | September 30, | September 30, | |||||||||||||||||||||||||
2003 | 2004 | 2005 | 2005 | 2005 | 2006 | 2006 | ||||||||||||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||||||||||||||||
CASH FLOWS FROM FINANCING
ACTIVITIES: |
||||||||||||||||||||||||||||
Loan and convertible bridge loan received |
$ | 1,000 | $ | 800 | | $ | 2,145 | | | $ | 2,145 | |||||||||||||||||
Repayment of loan |
| | $ | (1,000 | ) | (1,000 | ) | | | (1,000 | ) | |||||||||||||||||
Issuance of shares and warrants |
612 | 2,546 | 8,373 | 13,492 | $ | 6,039 | $ | 14,869 | 28,361 | |||||||||||||||||||
Exercise of options |
| | | | | 30 | 30 | |||||||||||||||||||||
Net increase (decrease) in short-term bank credit |
45 | (45 | ) | | | | | | ||||||||||||||||||||
Net cash provided by financing activities |
1,657 | 3,301 | 7,373 | 14,637 | 6,039 | 14,899 | 29,536 | |||||||||||||||||||||
NET INCREASE IN CASH AND CASH
EQUIVALENTS |
1,046 | 216 | 3,264 | 4,741 | 3,080 | 10,880 | 15,621 | |||||||||||||||||||||
BALANCE OF CASH AND CASH
EQUIVALENTS AT BEGINNING OF PERIOD |
215 | 1,261 | 1,477 | | 1,477 | 4,741 | | |||||||||||||||||||||
BALANCE OF CASH AND CASH
EQUIVALENTS AT END OF PERIOD |
$ | 1,261 | $ | 1,477 | $ | 4,741 | $ | 4,741 | $ | 4,557 | $ | 15,621 | $ | 15,621 | ||||||||||||||
F-9
Period from | Period from | |||||||||||||||||||||||||||
December 27, | December 27, | |||||||||||||||||||||||||||
1993* | 1993* | |||||||||||||||||||||||||||
through | Nine months ended | through | ||||||||||||||||||||||||||
Year ended December 31, | December 31, | September 30, | September 30, | |||||||||||||||||||||||||
2003 | 2004 | 2005 | 2005 | 2005 | 2006 | 2006 | ||||||||||||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||||||||||||||||
SUPPLEMENTARY DISCLOSURE OF
CASH FLOW INFORMATION: |
||||||||||||||||||||||||||||
CASH PAID DURING THE YEAR FOR - |
||||||||||||||||||||||||||||
interest |
$ | 2 | $ | 2 | $ | 65 | $ | 80 | $ | 1 | ** | $ | 80 | |||||||||||||||
Supplementary information on investing
and financing activities not involving cash
flows: |
||||||||||||||||||||||||||||
Conversion of convertible bridge loan into shares |
800 | 1,145 | 1,145 | |||||||||||||||||||||||||
Purchase of property and equipment |
$ | 15 | 284 | $ | 106 | 106 | 92 | 31 | 31 | |||||||||||||||||||
Issuance cost setoff against accounts
and accruals other |
121 | 15 | 15 | 30 | 23 | 23 | ||||||||||||||||||||||
Consultants and director credit balance
converted into shares |
80 | 80 | 80 | |||||||||||||||||||||||||
Issuance cost paid by a grant of options |
$ | 21 | $ | 21 | 21 | |||||||||||||||||||||||
Conversion of convertible preferred
shares into ordinary shares |
$ | 13,651 | $ | 13,651 | ||||||||||||||||||||||||
* | Incorporation date, see Note 1a. |
|
** | Represents an amount less than $1. |
F-10
a. | Operation. | ||
Protalix Ltd. (the Company) was incorporated on December 27, 1993 under the laws of the State of Israel, and, since its inception, has been engaged in the biotechnology field and more recently in the development of protein based medicines in particular, using genetically engineered plant-based cultures. The Companys business is located in Carmiel, Israel. | |||
The Company is engaged in research and development in the biotechnology field developing plant-derived human proteins, with its main product, prGCD, being a plant-derived protein used as a treatment for Gaucher Disease. The Company has completed Phase I of a clinical study on prGCD, is exempt from Phase II, and expects to initiate a pivotal Phase III clinical trial in 2007. | |||
During the years 2003 to 2005, the Company was a party to a research and development services contract with a pharmaceutical company pursuant to which the Company agreed to provide certain research and development services. The Company earned total revenues of $830 throughout the duration of the contract in consideration for the performance of such services. The contract expired in the first quarter of 2005, and since that time, the Company has not provided any further research and development services for third parties. The Companys plan of operations is to commercialize the results of its research and development efforts, not to provide research and development services. | |||
The Company has been in the development stage since its inception. The Companys successful completion of its development program and its transition to profitable operations is dependent upon obtaining necessary regulatory approvals from the United States Food and Drug Administration (FDA) prior to selling its products within the U.S., and foreign regulatory approvals must be obtained to sell its products internationally. There can be no assurance that the Companys products will receive regulatory approvals, and a substantial amount of time may pass before the Company achieves a level of sales adequate to support the Companys operations, if at all. The Company will also incur substantial expenditures in connection with the regulatory approval process and it will need to raise additional capital during the developmental period. Obtaining marketing approval will be directly dependent on the Companys ability to implement the necessary regulatory steps required to obtain marketing approval in the U. S. and other countries and the success of the Companys clinical trials. The Company cannot predict the outcome of these activities. | |||
The Company currently does not have sufficient resources to complete the commercialization of any of its proposed products. Based on its current cash resources and commitments, the Company believes it should be able to maintain its current planned development activities and the corresponding level of expenditures for at least the next 12 months, although no assurance can be given that it will not need additional cash prior to such time. Unexpected increases in general and administrative expenses and research and development expenses may cause the Company to seek additional financing during the next 12 months. |
F-11
On August 21, 2006, the Company entered into a merger agreement (the Merger Agreement) with Orthodontix, Inc., a publicly-held shell company (Orthodontix). Dr. Frost, a controlling shareholder of Orthodontix, and other additional investors (the Frost Group) were the principal investors in a private offering of the Companys ordinary shares which closed on September 14, 2006. See Note 6h. | |||
Under the terms of the Merger Agreement, the shareholders of Protalix will own in excess of 99% of the outstanding capital stock of Orthodontix. The merger is subject to customary covenants and several additional conditions to closing. See Note 10e for information regarding the tax ruling issued by the Israeli tax authorities in connection with the proposed merger. | |||
The merger will be accounted for as a reverse acquisition and a recapitalization. | |||
b. | Basis of presentation | ||
The financial statements have been prepared in accordance with generally accepted accounting principles in the United States (U.S. GAAP) and Statement of Financial Accounting Standards (SFAS) No. 7 Accounting and Reporting by Development Stage Enterprises. The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. | |||
The financial statements and these notes to the financial statements are expressed in U.S. dollars ($ or dollar), in thousands, except for the per share amounts. | |||
c. | Functional currency | ||
The currency of the primary economic environment in which the operations of the Company are conducted is the dollar. The Company is currently in the development stage with no significant source of revenues, therefore the Company considered the currency of the primary economic environment to be the currency in which the Company expended cash. Most of the Companys expenses and capital expenditures are incurred in dollars, and a significant source of the Companys financing has been provided in U.S. dollars. | |||
Since the dollar is the functional currency, monetary items maintained in currencies other than the dollar are remeasured using the rate of exchange in effect at the balance sheet dates and non-monetary items are remeasured at historical exchange rates. Revenue and expense items are remeasured at the average rate of exchange in effect during the period in which they occur. Foreign currency translation gains or losses are recognized in the statement of operations. |
F-12
d. | Unaudited Interim Results | ||
The accompanying balance sheet as of September 30, 2006, the statements of operations and cash flows for the nine months ended September 30, 2006 and 2005, and the statement of changes in shareholders equity for the nine months ended September 30, 2006 are unaudited. | |||
The unaudited interim financial statements have been prepared on the same basis as the annual financial statements except for the first time application of SFAS No. 123(R) Share-Based Payments (SFAS 123(R)) as of January 1, 2006 and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Companys financial position as of September 30, 2006 and the results of operations and cash flows for the nine months ended September 30, 2006 and 2005. | |||
The financial data and other information disclosed in these notes to the financial statements related to such nine month periods are unaudited. The results for the nine months ended September 30, 2006 are not necessarily indicative of the results to be expected for the year ending December 31, 2006 or for any other interim period or for any future year. | |||
e. | Cash equivalents | ||
The Company considers all short term, highly liquid investments, which include short-term deposits with original maturities of three months or less from the date of purchase, that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash, to be cash equivalents. | |||
f. | Property and equipment: |
1) | Property and equipment are stated at cost, net of accumulated depreciation and amortization. | ||
2) | The assets are depreciated by the straight-line method, on basis of their estimated useful lives at the following annual rates: |
% | ||||
Laboratory equipment |
20 | |||
Furniture |
7 10 | |||
Computer equipment |
33 |
Leasehold improvements are amortized by the straight-line method over the term of the lease, plus optional renewals period that is expected to be used, which are generally shorter than the estimated useful life of the improvements. |
F-13
g. | Impairment of Long-Lived Assets | ||
SFAS No. 144 Accounting for the Impairment or Disposal of Long-Lived Assets (SFAS 144), requires that long-lived assets, including definite life intangible assets to be held and used or disposed of by an entity, be reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. Under SFAS 144, if the sum of the expected future cash flows (undiscounted and without interest charges) of the long-lived assets is less than the carrying amount, the Company must recognize an impairment loss and write down the assets to their estimated fair values. | |||
h. | Deferred income taxes | ||
Deferred taxes are determined utilizing the assets and liabilities method based on the estimated future tax effects of differences between the financial accounting and tax bases of assets and liabilities under the applicable tax laws. Deferred tax balances are computed using the tax rates expected to be in effect when those differences reverse. A valuation allowance in respect of deferred tax assets is provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company has provided a full valuation allowance with respect to its deferred tax assets. | |||
Paragraph 9(f) of SFAS 109 Accounting for Income Taxes, prohibits the recognition of deferred tax liabilities or assets that arise from differences between the financial reporting and tax bases of assets and liabilities that are measured from the local currency into dollars using historical exchange rates, and that result from changes in exchange rates or indexing for tax purposes. Consequently, the abovementioned differences were not reflected in the computation of deferred tax assets and liabilities. | |||
i. | Revenue Recognition | ||
Revenue generated from research and development services is recognized upon performance of the services and when persuasive evidence of an arrangement exists, the price is fixed or determinable, and collection is reasonably assured. | |||
Revenue from the performance milestone payments in connection with research and development agreements is recognized upon achievement of the milestones as specified in the agreement, provided payment is proportionate to the effort expended as measured by the ratio of costs expended to the total estimated development costs. | |||
j. | Research and development costs | ||
Research and development costs are expensed as incurred and consist primarily of personnel, facilities, equipment and supplies for research and development activities. Grants received from the Office of the Chief Scientist of the Ministry of Industry and Trade of Israel and other |
F-14
research foundations are recognized when the grant becomes receivable, provided there is reasonable assurance that the Company will comply with the conditions attached to the grant and there is reasonable assurance the grant will be received. The grant is deducted from the related research and development expenses as the costs are incurred. See also Note 5(a). | |||
In connection with purchase of assets, amounts assigned to intangible assets to be used in a particular research and development project that has not reached technological feasibility and has no alternative future use, are charged to in-process research and development costs at the purchase date. | |||
k. | Comprehensive loss | ||
The Company has no other comprehensive loss components other than loss for the reported periods. | |||
l. | Concentration of credit risks | ||
Financial instruments that subject the Company to credit risk consist primarily of cash and cash equivalents in dollars, which are deposited in major financial institutions in Israel. | |||
m. | Share-based compensation | ||
Prior to January 1, 2006, the Company accounted for employee share-based compensation under the intrinsic value model in accordance with Accounting Principles Board Opinion No. 25 Accounting for Stock Issued to Employees (APB 25) and related interpretations. Under APB 25, compensation expense is based on the difference, if any, on the date of the grant of a stock option, between the fair value of the shares underlying the option and the exercise price of the option. In addition, in accordance with SFAS No. 123 Accounting for Stock-Based Compensation (SFAS 123), which was issued by the Financial Accounting Standards Board (FASB), the Company disclosed pro forma data assuming it had accounted for employee share option grants using the fair value-based method defined in SFAS 123. | |||
In December 2004, the FASB issued the SFAS 123R which addresses the accounting for share-based payment transactions in which a company obtains employee services in exchange for (a) equity instruments of a company or (b) liabilities that are based on the fair value of a companys equity instruments or that may be settled by the issuance of such equity instruments. In March 2005, the Securities and Exchange Commission (SEC) issued Staff Accounting Bulletin No. 107 (SAB 107) regarding the SECs interpretation of SFAS 123R. | |||
SFAS 123R eliminates the ability to account for employee share-based payment transactions using APB 25, and requires instead that such transactions be accounted for using the grant-date fair value based method. SFAS 123R is effective as of the annual reporting period that begins after June 15, 2005. SFAS 123R applies to all awards granted or modified after the effective date |
F-15
of the standard. In addition, compensation cost for the unvested portion of previously granted awards that remain outstanding on the effective date shall be recognized on or after the effective date, as the related services are rendered, based on the awards grant-date fair value as previously calculated for the pro forma disclosure under SFAS 123. | |||
The Company adopted SFAS 123R as of January 1, 2006, using the modified prospective application transition method, as permitted by SFAS 123R. Under such transition method, the Companys financial statements for periods prior to the effective date of SFAS 123R have not been restated. | |||
SFAS 123R requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from initial estimates. Stock-based compensation expense was recorded net of estimated forfeitures for the nine months ended September 30, 2006, such that expense was recorded only for those stock-based awards that are expected to vest. Under APB 25, to the extent awards were forfeited prior to vesting, the corresponding previously recognized expense was reversed in the period of forfeiture. Upon adoption of SFAS 123R, for the nine months ended September 30, 2006, the Company recorded a cumulative adjustment to account for the expected forfeitures of stock-based awards granted prior to January 1, 2006, for which the Company previously recorded an expense. The adoption of SFAS 123R resulted in a cumulative benefit from accounting change in the amount of $37 in 2006. | |||
The fair value of stock options granted with service conditions was determined using the Black-Scholes valuation model, which is consistent with the valuation techniques previously utilized by the Company for options in footnote disclosures required under SFAS 123, as amended by SFAS No. 148 Accounting for Stock-Based Compensation Transition and Disclosure. Such value is recognized as an expense over the service period, net of estimated forfeitures, using the graded method under SFAS 123R. | |||
The Black-Scholes model takes into account a number of valuation parameters. See also Note 6. | |||
The following table illustrates the pro forma effect on net loss and net loss per ordinary share assuming the Company had applied the fair value recognition provisions of SFAS 123 to its share-based employee compensation: |
F-16
Period from | ||||||||||||||||||||
December 27, | ||||||||||||||||||||
1993 | ||||||||||||||||||||
through | Nine months ended | |||||||||||||||||||
Year ended December 31, | December 31, | September 30, | ||||||||||||||||||
2003 | 2004 | 2005 | 2005 | 2005 | ||||||||||||||||
(Unaudited) | ||||||||||||||||||||
(Dollars in thousands, except per share data) | ||||||||||||||||||||
Net loss as reported |
($ | 646 | ) | ($ | 2,421 | ) | ($ | 5,746 | ) | ($ | 11,122 | ) | ($ | 3,816 | ) | |||||
Add: share based employee
Compensation expense included in the
reported net loss |
61 | 149 | 509 | 732 | 350 | |||||||||||||||
Deduct: share-based employee compensation
expense determined under fair value
method |
( | 67 | ) | ( | 170 | ) | ( | 539 | ) | ( | 788 | ) | ( | 370 | ) | |||||
Pro forma net loss |
($ | 652 | ) | ($ | 2,442 | ) | ($ | 5,776 | ) | ($ | 11,178 | ) | ($ | 3,836 | ) | |||||
Net loss per ordinary share: |
||||||||||||||||||||
Basic as reported |
($ | 2.10 | ) | ($ | 7.86 | ) | ($ | 18.67 | ) | ($ | 12.40 | ) | ||||||||
Basic pro forma |
($ | 2.12 | ) | ($ | 7.93 | ) | ($ | 18.76 | ) | ($ | 12.46 | ) | ||||||||
Diluted as reported |
($ | 2.10 | ) | ($ | 7.86 | ) | ($ | 18.67 | ) | ($ | 12.40 | ) | ||||||||
Diluted pro forma |
($ | 2.12 | ) | ($ | 7.93 | ) | ($ | 18.76 | ) | ($ | 12.46 | ) | ||||||||
The fair value of options granted to employees during fiscal years 2005, 2004 and 2003 was $939, $0, and $389, respectively. The Company estimated the fair value of each option on the date of grant using the Black-Scholes option-pricing model, with the following weighted average assumptions: |
2005 | 2003 | |||||||
Dividend yield |
0 | % | 0 | % | ||||
Expected volatility |
54 | % | 59 | % | ||||
Risk-free interest rate |
3.83 | % | 3.28 | % | ||||
Expected life in years |
5.7 | 6.0 | ||||||
When stock options are granted as consideration for services provided by consultants and other non-employees, the transaction is accounted for based on the fair value of the consideration received or the fair value of the stock options issued, whichever is more reliably measurable, pursuant to the guidance in EITF 96-18 Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling Goods or Services. The fair value of the options granted is recalculated over the related service period and is recognized over the respective service period using the straight-line method. |
F-17
n. | Net Loss per share (LPS) | ||
Basic and diluted LPS is computed by dividing net loss by the weighted average number of ordinary shares outstanding for each period. | |||
Convertible preferred shares were not taken into account in the computation of the basic LPS since the holders of the convertible preferred shares do not have a contractual obligation to share in the losses of the Company. | |||
Convertible preferred shares, options, and warrants were not included in the computation of diluted LPS because the effect would be anti-dilutive. | |||
The total weighted average number of ordinary shares related to the convertible preferred shares has been excluded from the calculations of diluted loss per share were 190,486, 209,214, and 338,045 for the years 2003, 2004, and 2005, respectively. | |||
o. | Accounting Pronouncements | ||
Recently Issued Accounting Pronouncements: |
1) | In June 2006, the FASB issued FASB Interpretation (FIN) No. 48 Accounting for Uncertainty in Income Taxes (FIN 48), an interpretation of FASB Statement 109. FIN 48 prescribes a comprehensive model for recognizing, measuring, presenting and disclosing in the financial statements tax positions taken or expected to be taken on a tax return, including a decision whether to file or not to file in a particular jurisdiction. FIN 48 is effective for fiscal years beginning after December 15, 2006 (January 1, 2007 for the Company). If there are changes in net assets as a result of application of FIN 48, these will be accounted for as an adjustment to retained earnings. The Company is currently assessing the impact of FIN 48 on its financial position and results of operations. | ||
2) | In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). SFAS 157 defines fair value, establishes a framework for measuring fair value in accordance with generally accepted accounting principles, and expands disclosures about fair value measurements. The provisions of SFAS 157 are effective for the fiscal year beginning September 1, 2008. The Company is currently evaluating the impact of the provisions of SFAS 157 on its financial position and results of operations. | ||
3) | In September 2006, the SEC released Staff Accounting Bulletin (SAB) No. 108, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements (SAB 108), which provides interpretive guidance on the consideration of the effects of prior year misstatements in quantifying current year misstatements for the purpose of a materiality assessment. The Company is required to initially apply SAB 108 during fiscal year 2007. The Company is currently evaluating the impact of the provisions of SAB 108 on its financial position and results of operations. |
F-18
a. | Composition of property and equipment grouped by major classifications, and changes, is as follows: |
December 31, | ||||||||
2004 | 2005 | |||||||
In thousands | ||||||||
Laboratory equipment |
$ | 766 | $ | 1,039 | ||||
Furniture and computer equipment |
90 | 129 | ||||||
Leasehold improvements |
988 | 1,342 | ||||||
1,844 | 2,510 | |||||||
Less accumulated depreciation
and amortization |
(164 | ) | (475 | ) | ||||
$ | 1,680 | $ | 2,035 | |||||
b. | Depreciation and amortization in respect of property and equipment totaled $62, $123, and $311, for the years ended December 2003, 2004, and 2005, respectively. |
a. | In connection with a research and development services arrangement entered into with a third party, as discussed in Note 1a, the Company issued a debenture to the same third party with a face amount equal to $1,000. The debenture bore interest at the annual rate of EURIBOR plus 0.75%, and matured on March 31, 2004. In the event of default upon the maturity of the loan, the debenture was convertible into 127,690 convertible preferred A shares of the Company. However, the debenture was not convertible at the third partys option at any time prior to an event of default. The maturity date of the debenture was March 31, 2004, which was subsequently extended to December 31, 2004, and later to January, 2006. In December 2005, the Company paid the loan in full. | ||
b. | Bridge loan | ||
In 2004, the Company signed a convertible bridge loan agreement with a shareholder of the Company, with a principal amount of $800. The loan bore interest at an annual rate of LIBOR plus 1%. The loan was convertible into convertible preferred A shares until December 31, 2004 at the same terms and conditions of the first investment transaction by new investors after the date of the loan. In the event that the Company did not close any new investment transaction until December 31, 2004, the convertible bridge loan was convertible into convertible preferred A shares upon terms and conditions that were to be settled on that date. In October 2004, the Company entered into a share purchase agreement with new investors and the convertible bridge loan was converted into convertible preferred B shares. See Note 6d. |
F-19
Israeli labor laws and agreements require severance payments upon dismissal of an employee or upon termination of employment in other circumstances. The severance pay liability of the Company, which reflects the undiscounted amount of the liability as if it were payable at each balance sheet date, is calculated based upon length of service and the latest monthly salary (one months salary for each year worked). The Companys liability for severance pay required by Israeli law is covered by the purchase of insurance policies in the employees names, by deposits with financial institutions, and by accrual. The accrued severance pay liability is presented as a long-term liability. The amounts funded are presented separately as employee rights upon retirement funded. | |||
The Company contributed in fiscal years 2003, 2004, and 2005 to the insurance companies, in respect to its severance obligations to employees, $42, $48, and $83, respectively. | |||
The Company expects to contribute $128 to insurance companies for the year ended December 31, 2006 (includes $85 contributed in the nine months ended September 30, 2006), in respect to its severance obligations to employees. | |||
Severance expenses totaled $45, $72, and $104 for the fiscal years ended December 31, 2003, 2004, and 2005, respectively. | |||
Loss (gain) on employee severance pay funds in respect of employee severance obligations totaled $0, $2, and $(4) for the fiscal years ended December 31, 2003, 2004, and 2005, respectively. | |||
During the 10-year period following September 30, 2006, the Company expects to pay future benefits only to one of its employees upon his normal retirement age, which is anticipated to amount to $41 during 2010. This amount was determined based on the employees current salary rates and the number of service years that will be accumulated upon his retirement date. This expectation does not include additional amounts that might be paid to employees that will cease working with the Company before their normal retirement age. |
a. | Royalty commitments: |
1) | The Company is obligated to pay royalties to the Office of the Chief Scientist on proceeds from the sale of products developed from research and development activities for which the Office of the Chief Scientist partially funded by way of grants. At the time the grants were received, successful development of the related projects was not assured. |
F-20
In the case of failure of a project that was partly financed as described above, the Company is not obligated to pay any such royalties or repay funding from the Office of the Chief Scientist. | |||
Under the terms of the Companys funding arrangements with the Office of the Chief Scientist, royalties of 3% to 6% are payable on the sale of products developed from projects funded by the Office of the Chief Scientist, which payments shall not exceed, in the aggregate, 100% of the amount of the grant received by the Company (dollar linked), since January 1, 2001, with the addition of an annual interest rate based on LIBOR. In addition, if the Company receives approval to manufacture the products developed with government grants outside of Israel, it will be required to pay an increased total amount of royalties (possibly up to 300% of the grant amounts plus interest), depending on the manufacturing volume that is performed outside of Israel, as well as a possible increased royalty rate. | |||
At December 31, 2005 and September 30, 2006, the maximum royalty amount payable by the Company under these funding arrangements is $3,200 and $4,200, respectively (without interest). However, as of December 31, 2005 and September 30, 2006, no royalty payments are accrued as the Company has not earned any revenues from the sale of products. | |||
2) | The Company is obligated under several research and license agreements to pay royalties at variable rates from its future revenues and obligated to pay fees under certain milestone agreements. |
b. | The Company has entered into sub-contracting agreements with several clinical and pre-clinical service providers, both in Israel and in the U.S., in connection with its primary product development process. As of September 30, 2006, total liabilities under said agreements amount to approximately $1,600. | ||
c. | The Company entered into operating lease agreement for its facilities, effective until 2010. The Company has the option to extend the agreement for another five-year period. Under this lease, the monthly rental payment is approximate $9. The future minimum lease payments required in each of the next five years under the operating lease for premises are as follows: 2006 $108, 2007 $108, 2008 $108 and 2009 $27. Lease expenses totaled $19, $103, and $101 for the fiscal years ended December 31, 2003, 2004, and 2005, respectively. | ||
d. | In July 2004, the Company entered into three-year lease agreements in connection with Company vehicles. The monthly lease fees aggregate approximately $5. The expected lease payments for the three months ended December 31, 2006 and for the fiscal years 2007, 2008, and 2009 are $24, $102, $101, and $29, respectively. | ||
e. | In March 2005, the Company entered into an agreement with a consultant. Pursuant to the agreement, the Company pays the consultant a monthly consulting fee of $10 which will be increased to $20 upon the initiation of a Phase III study of the Companys lead product candidate, prGCD. To date, the Company has completed Phase I of a clinical study of prGCD. The agreement is for a period ending nine months after the consummation of the study. |
F-21
f. | On September, 14, 2006, the Company entered into a collaboration and licensing agreement with Teva Pharmaceutical Industries Ltd. (Teva) for the development and manufacturing of two proteins, using its plant cell system. Mr. Hurvitz, the Chairman Board of Directors of the Company is the Chairman of Tevas Board of Directors, and Dr. Frost, one the Companys directors, is the Vice Chairman of Tevas Board of Directors. Pursuant to the agreement, the Company will collaborate on the research and development of the two proteins utilizing its plant cell expression system. The Company will grant to Teva an exclusive license to commercialize the developed products in return for royalty and milestone payments payable upon the achievement of certain pre-defined goals. The Company will retain certain exclusive manufacturing rights with respect to the active pharmaceutical ingredient of the proteins following the first commercial sale of a licensed product under the agreement and other rights thereafter. |
a. | Ordinary Shares | ||
Each ordinary share is entitled to one vote. The holders of ordinary shares are also entitled to receive dividends whenever funds are legally available and when and if declared by the Board of Directors. Since inception, no dividends have been declared. See b below with respect to the conversion of all convertible preferred shares into ordinary shares. | |||
b. | Convertible Preferred Shares | ||
The convertible preferred shares conferred the following rights upon their holders: |
1) | The holders of the convertible preferred shares had the right to convert the convertible preferred shares into ordinary shares on a 1:1 basis | ||
The conversion price for the preferred C shares was subject to adjustment. | |||
In certain events, if the Company issued shares at a price per share less than the original price per share of the convertible preferred stock, the conversion price would have been reduced accordingly. In any event, the conversion ratio will not be reduced below the par value of the shares, NIS 0.01. | |||
2) | Voting rights in shareholders meetings. | ||
3) | In the event of any liquidation of the Company or in the event of a deemed liquidation (as defined in the applicable share purchase agreement), all assets and/or surplus funds of the Company legally available for distribution to the shareholders by reason of their ownership of shares would have been distributed among the shareholders in accordance with the terms and conditions set forth in the Companys articles of association. In such event, the convertible preferred shareholders would have been entitled to receive in preference to the ordinary shareholders, the return of their investment in addition to a 6% interest rate per annum and certain other adjustments. |
F-22
4) | The convertible preferred shares were entitled to receive dividends, on a pro rata, pari passu, as converted basis out of any assets legally available, as and when declared by the Board of Directors. | ||
As of September 11, 2006, all of the preferred shareholders have converted their convertible preferred shares into ordinary shares on a 1:1 basis, thereby waiving any and all right and privileges associated with the convertible preferred shares. In addition, all outstanding warrants and options of the Company are exercisable into ordinary shares. |
c. | The number of shares options and warrants as of December 31, 2004 and 2005, and September 30, 2006 (unaudited) is composed as follows: |
Number of shares | ||||||||||||||||||||||||
Authorized | Issued | |||||||||||||||||||||||
September 30, | December 31, | September 30, | December 31, | |||||||||||||||||||||
2006 | 2005 | 2004 | 2006 | 2005 | 2004 | |||||||||||||||||||
(unaudited) | (unaudited) | |||||||||||||||||||||||
Ordinary shares of NIS 0.01 par value |
2,290,000 | 1,516,468 | 1,899,514 | 870,661 | 307,813 | 307,813 | ||||||||||||||||||
Total Ordinary shares |
2,290,000 | 1,516,468 | 1,899,514 | 870,661 | 307,813 | 307,813 | ||||||||||||||||||
Preferred A shares of NIS 0.01 par value |
190,486 | 190,486 | 190,486 | 190,486 | ||||||||||||||||||||
Preferred B shares of NIS 0.01 par value |
183,046 | 200,000 | 100,523 | 100,523 | ||||||||||||||||||||
Preferred C shares of NIS 0.01 par value |
400,000 | 107,218 | ||||||||||||||||||||||
Total convertible preferred shares |
773,532 | 390,486 | 398,227 | 291,009 | ||||||||||||||||||||
Number of warrants and options | ||||||||||||
September 30, | December 31, | |||||||||||
2006 | 2005 | 2004 | ||||||||||
(unaudited) | ||||||||||||
Ordinary shares of NIS 0.01 par value |
341,130 | 97,954 | 74,219 | |||||||||
Total Ordinary shares |
341,130 | 97,954 | 74,219 | |||||||||
Preferred A shares of NIS 0.01 par value |
||||||||||||
Preferred B shares of NIS 0.01 par value |
2,967 | 2,967 | ||||||||||
Preferred C shares of NIS 0.01 par value |
116,399 | |||||||||||
Total convertible preferred shares |
119,366 | 2,967 | ||||||||||
F-23
d. | In October 2004, the Company entered into a share purchase agreement with shareholders of the Company and other third parties for the issuance of 100,523 convertible preferred B shares for total consideration of approximately $3,300 (net of issuance costs of $216). Pursuant to the agreement, the investors invested $2,700 in exchange for convertible preferred B shares of the Company. In addition, a convertible bridge loan in the amount of $800 from a shareholder of the Company was converted into convertible preferred B shares under the same terms and conditions as the other investors. | ||
e. | In February 2005, the Company entered into a share purchase agreement with an investor pursuant to which 16,954 convertible preferred B shares were issued for consideration of $900 (net of issuance costs of $71). In addition to the convertible preferred B shares, the Company also granted to the investor fully detachable warrants, which vested immediately and were exercisable over a period of 24 months. The warrants entitled the investor to purchase an additional 13,563 convertible preferred B shares at a purchase price per share of $95.85. | ||
The Company estimated the fair value of the warrants by using a Black-Scholes option-pricing model to be $82.85. The fair value of the warrants was based on the following assumptions: dividend yield of 0% for all years; expected volatility of 48%; risk-free interest rates of 3.4%; and expected life of two years. For accounting purposes, the proceeds from the sale of the convertible preferred B shares were allocated to the convertible preferred B shares and the warrants on a pro rata basis, based on the relative fair values of the convertible preferred B shares and the warrants. The portion of the proceeds allocated to the warrants has been reflected as warrants. | |||
The convertible preferred B shares and warrants were converted into convertible preferred C shares and warrants on a 1:1 basis in July 2005 together with a subsequent financing as agreed with the investor in the share purchase agreement. | |||
f. | In July 2005, the Company entered into a share purchase agreement with shareholders of the Company and third parties, pursuant to which 62,486 convertible preferred C shares were issued for consideration of $5,200 (net of issuance costs of $108). | ||
In addition, each investor received warrants to purchase a number of convertible preferred C shares equal to up to 50% of its original amount of investment, at an exercise price of $100.76 per share (represents in aggregate 26,349 warrants). The first warrant is exercisable from the closing date until 14 business days after the date of commencement of the Companys Phase III clinical study. In the event an investor exercises more than 50% of its first warrant, such investor shall be granted an option to purchase a number of convertible preferred C shares, with an aggregate exercise price equal to the amount of exercise of such investors first warrant, at a price of $100.76 per share. The second warrant shall be exercisable from the date of the exercise of the first warrant for four years. |
F-24
The Company estimated the fair value of the warrants using the Black-Scholes option-pricing model to be approximately $686. The fair value of the warrants was based on the following weighted average assumptions: dividend yield of 0% for all years; expected volatility of 45%; risk-free interest rates of 3.6%; and expected life of 1.75 to 2.47 years. For accounting purposes, the proceeds from the sale of the convertible preferred C shares were allocated to the convertible preferred C shares and the warrants on a pro rata basis, based on the relative fair values of the convertible preferred C shares and the warrants. The portion of the proceeds allocated to the warrants has been reflected as warrants. | |||
g. | In December 2005, the Company entered into a share purchase agreement with shareholders of the Company and third parties, pursuant to which 27,778 convertible preferred C shares of NIS 0.01 par value each were issued for consideration of $2,300 (net of issuance costs of $12.467). | ||
Pursuant to the share purchase agreement, the investors were entitled to all of the rights and preferences included in the share purchase agreement that was signed in July 2005. See f above. | |||
At the closing date, the Company granted the investors warrants, on the same terms and conditions as mentioned in f above. | |||
The Company estimated the fair value of the warrants using the Black-Scholes option-pricing model to be approximately $279. The fair value of the warrants was based on the following assumptions: dividend yield of 0% for all years; expected volatility of 48%; risk-free interest rates of 4.4%; and expected life of 0.48-1.97 years. For accounting purposes, the proceeds from the sale of the convertible preferred C shares were allocated to the convertible preferred C shares and the warrants on a pro rata basis, based on the relative fair values of the convertible preferred C shares and the warrants. The portion of the proceeds allocated to the warrants has been reflected as warrants. | |||
h. | In August 2006, the Company entered into a share purchase agreement with investors pursuant to which 163,774 ordinary shares were issued for consideration of $15,000. In case of a merger as described in Note 1a, those shares shall be converted into shares of Orthodontix so that, together with the shareholders of Orthodontix prior to the merger, the investors shall hold 15% of the issued and outstanding share capital of Orthodontix upon the closing of the merger, calculated on a fully diluted basis immediately after the closing of the merger. | ||
In addition, the Company issued to the investors warrants to purchase an additional 57,691 ordinary shares of the Company, at an exercise price of $91.59 per share. The fair value of the warrants estimated using the Black-Scholes option-pricing model is U.S.$ 356,000. The fair value of the warrants was based on the following assumptions: dividend yield of 0% for all years; expected volatility of 37%; risk-free interest rates of 5%; and expected life of 0.25 years. For accounting purposes, the proceeds from the sale of the ordinary |
F-25
shares were allocated to the ordinary shares and warrants on a pro rata basis, based on the relative fair values of the ordinary shares and the warrants. The portion of the proceeds allocated to the warrants has been reflected as warrants. | |||
The warrants, to the extent not exercised or expired prior to the closing of the merger, shall be exchangeable into warrants to purchase, in the aggregate, a number of ordinary shares equal to 5% of the shares of Orthodontix calculated on a fully-diluted basis immediately after the closing of the merger. In the event that the warrants are exercised prior to the closing of the merger, the holders of the shares issued in connection therewith shall be entitled to receive a similar number of a similar number of shares of common stock of Orthodontix. | |||
Upon the closing of the merger, the warrants shall be terminated and Orthodontix shall issue new warrants to the investors with an exercise price per share equal to $106.67 divided by the aggregate number of outstanding shares of common stock of Orthodontix, on a fully diluted basis, calculated immediately after the closing, and will expire within one month. | |||
Upon the closing of the merger, Orthodontix will issue to Dr. Frost and/or certain of his associates or affiliated entities that have or will provide services to the merged company options to acquire a number of shares equal to 3.5% of the issued and outstanding shares of common stock of Orthodontix calculated on a fully diluted basis immediately after the closing of the merger. The options shall vest ratably over a period of 2.5 years in connection with future services and are exercisable until the end of 10 years from the date of grant. | |||
i. | See Note 10b with respect to the deposit of the consideration in connection with the exercise of warrants. | ||
j. | Options to employees and consultants: |
1) | In June 2000, the Board of Directors approved the grant of options to purchase 5,714 ordinary shares to a consultant in return for consulting services provided. The exercise price is the par value of the shares. According to the option agreement as amended, the options vested immediately and are exercisable from the grant date until the end of 2005. | ||
The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $35, and was based on the following assumptions: dividend yield of 0%; expected volatility of 50%; risk-free interest rates of 7%; and expected lives of four years. | |||
In June 2005, the Companys Board of Directors modified the terms of these options by extending the life of the options, until the earlier of an IPO or the end of 2008. At the date of modification all of the options were fully vested. |
F-26
Modifications to the terms of an award are treated as an exchange of the original award for a new award, incurring additional compensation cost for that incremental value. The incremental value is measured by the difference between (a) the fair value of the modified option and (b) the value of the old option immediately before its terms are modified. The modification had no effect on the accounting records of the Company. | |||
2) | In July 2001, the Companys Board of Directors approved the grant of 4,000 options to an employee, which is also a related party of the Company. Each option may be exercised into one ordinary share at par value. The options vested immediately on the date of grant. | ||
The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $42 and was based on the following assumptions: dividend yield of 0%; expected volatility of 50%; risk-free interest rates of 5%; and expected lives of eight years. | |||
3) | In January 1999, the Companys Board of Directors approved the grant of 6,300 options to the former chairman of the Board of Directors at an exercise price of $6.19 per share. Each option may be exercised into one ordinary share par value. The options are fully vested and exercisable in three equal parts until the end of 2006, 2007, and 2008. | ||
The Company estimated the fair value of the options on the date of grant using a Black-Scholes option-pricing model to be approximately $27 based on the following assumptions: dividend yield of 0%; expected volatility of 50%; risk-free interest rates of 3.5%; and expected lives of six years. | |||
In March 2005, the Companys Board of Directors modified the terms of the options by extending the life of the options, until the earlier of an IPO or the end of 2008. At the date of modification, all of the options were fully vested. | |||
Modification of the terms of an award are treated as an exchange of the original award for a new award, incurring additional compensation cost for that incremental value. The incremental value is measured by the difference between (a) the fair value of the modified option and (b) the value of the old option immediately before its terms are modified. The modification had no effect on the accounting records of the Company. | |||
4) | In August 2003, the Companys Board of Directors approved a share option plan pursuant to which up to 60,307 ordinary shares are available for options to be granted to the Companys employees, consultants, directors, and service providers. With regard to employees, office holders, and directors of the Company, the share option plan is subject to the terms stipulated by Section 102 of the Israeli Income |
F-27
a) | In November 2001, 13,715 options were granted to the former chairman of the Companys Board of Directors, with an exercise price of $10.499 per share. Each option may be exercised into one ordinary share. The options vest as follows: | ||
11,428 options vest over 24 months in equal tranches from the date of grant. | |||
2,287 options vested according to specified performance milestones which were achieved in September 2003. | |||
Each option is exercisable over a three-year period commencing on the applicable vesting date. | |||
The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $51 based on the following assumptions: dividend yield of 0%; expected volatility of 50%; risk-free interest rates of 2%; and expected lives of three years. | |||
In March 2005, the Companys Board of Directors modified the terms of these options by extending the life of the options, until the earlier of an IPO or the end of 2008. At the date of modification all of the said options were fully vested. | |||
Modifications of the terms of an award are treated as an exchange of the original award for a new award, incurring additional compensation cost for that incremental value. The incremental value amounting to $24 is measured by the difference between (a) the fair value of the modified option and (b) the value of the old option immediately before its terms are modified. | |||
b) | In December 2003, the Company issued options to purchase 26,226 ordinary shares to the Chief Executive Officer of the Company, with an exercise price of $7.35 per share. The options vest as follows: 25% within one year from the date of grant, with the remainder vesting in 12 equal quarterly tranches over 36 months. Each option is exercisable over a 10-year period commencing on the vesting date. |
F-28
The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $498, and was based on the following assumptions: dividend yield of 0%; expected volatility of 59.35%; risk-free interest rates of 3.28%; and expected lives of 5.6 years. | |||
c) | On December 8, 2003, the Company issued options to purchase 20,366 ordinary shares to employees of the Company at an exercise price of $7.35 per share; 9,987 of the options vested immediately; and 10,379 options vest in four equal yearly tranches commencing in December 2004. | ||
Each option is exercisable over a 10-year period commencing on the vesting date. | |||
The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $389 and was based on the following weighted average assumptions: dividend yield of 0%; expected volatility of 59%; risk-free interest rates of 3.28%; and expected lives of six years. | |||
d) | In June 2005, the Company issued options to purchase 14,088 and 5,273 ordinary shares to employees, at an exercise price of $.7.34 and $24.36 per share, respectively. Each option is exercisable for one ordinary share. The options are to be divided into 13 batches, with the first batch constituting 25% of the options and the balance of the options being divided equally over the remaining 12 batches. The vesting period differs for each employee and some of the batches vested on the grant date. | ||
The options are exercisable over a 10-year period commencing on the date of grant. | |||
The Company estimasted the fair value of the options on the date of grant using the Black- Scholes option-pricing model to be approximately $718 and $221, respectively, and was based on the following weighted average assumptions: dividend yield of 0% for all years; expected volatility of 54%; risk-free interest rates of 3.83%; and expected life of 5.7 years. | |||
e) | On March 27, 2005, the Company issued options to purchase 8,238 ordinary shares to a consultant as consideration for consulting services, exercisable for NIS 0.01. | ||
The aggregate number of options granted to the consultant is equal to the aggregate number of ordinary shares constituting 1% of the lower of (i) the issued and outstanding share capital of the Company, on an as-converted fully-diluted basis, on the date of the full exercise of the options; or (ii) the issued |
F-29
and outstanding share capital of the Company, on an as-converted, fully-diluted basis, on such date as the Company value equals $100,000. As a consequence of the anti dilution effect of up to 1%, the Company has reserved and additional 2,659 options to purchase ordinary shares at the same terms and conditions. | |||
These options vest in 16 equal installments on a quarterly basis, over a period of 45 months, with the first installment vesting on the date of grant. The options are exercisable over a 10-year period commencing on the date of grant. The estimated fair value of these options, estimated by the services to be rendered, is approximately $1,000. | |||
f) | In September 2006, the Companys shareholders approved the grant of options to purchase 16,000 ordinary shares to the Chief Executive Officer of the Company, at an exercise price of $59.40 per share. Each option may be exercised for one ordinary share. | ||
The options vest in 16 equal installments on a quarterly basis, over a four-year period, commencing on June 1, 2006. | |||
The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $856, and was based on the following assumptions: dividend yield of 0%; expected volatility of 43%; risk-free interest rates of 4.6%; and expected lives of 5.8 years. | |||
In September 2006, the Chief Executive Officer of the Company entered into an employment agreement with the Company. | |||
g) | In August 2006, the Company issued options to purchase 9,900 ordinary shares to its employees at an exercise price of $59.40 per share. The options vest in 16 equal quarterly tranches over a four-year period. | ||
The options are exercisable over a 10-year period commencing on the date of grant. The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $547, and was based on the following weighted average assumptions: dividend yield of 0% for all years; expected volatility of 45%; risk-free interest rates of 4.91%; and expected life of six years. | |||
h) | In September 2006, the Company issued to its Chief Financial Officer options to purchase 10,150 ordinary shares with an exercise price of $59.40 per share. The options vest over a four-year period and are exercisable for a seven-year period commencing on the date of grant. |
F-30
5) | In January 2005, the Company issued to service providers options to purchase 1,063 and 1,904 convertible preferred B shares exercisable from the day of the closing date of the transaction set forth in the share purchase agreement entered into at such time with certain investors (see Note 6d) for periods of between 18 and 30 months, respectively. The options are exercisable at $.0348 per share. During 2006, 847 options were exercised into shares. | ||
The Company estimated fair value of said options on the date of the grant using BlackScholes option pricing model to be approximately $5 and $16 for the 1,063 and 1,904 options respectively, based on the following assumptions: dividend yield 0%, expected volatility 29% and 37% respectively, risk free interest 2.90% and 3.27% respectively and expected lives of 1.17 and 2.17 years. | |||
The fair value of the options were charged against additional paid in capital as issuance expenses. | |||
6) | In March 2005 as part of a management services agreement with the investor mentioned in Note 6e, the Company granted to the investor options to purchase 26,710 convertible preferred C shares. | ||
The options vest as follows: 12.5% on their grant date and additional 12.5% of the options vest at the end of each three month period thereafter. The exercise price of each option is NIS 0.01. | |||
The estimated fair value of the options on the date of grant was approximately $1,445. | |||
In January 2006, Mr. Eli Hurvitz was nominated as the Chairman of the Board of Directors. In connection with the management services agreement described above and with this nomination, the investor was granted additional options to purchase an additional 28,700 convertible preferred B shares. The options are exercisable at par value and vest as follows: 10% of the options vest at the date of the appointment and an additional 10% of the options vest at the end of each three month period thereafter. The exercise price of each option is NIS 0.01. | |||
The estimated fair value of the options on the date of grant was approximately $2,124. |
F-31
The options granted in connection with the appointment of Mr. Hurvitz provide for full acceleration of vesting of these options within 60 days prior to a merger. Upon the acceleration of the vesting provisions, unrecognized compensation costs related to these options shall be recognized. As at September 30, 2006, the unrecognized compensation cost was approximately $2.0 million. On September 11, 2006, the Company entered into a merger agreement with Orthodontix, see note 1a. However, as of September 30, 2006, the merger has not been closed and is still subject to further approvals. Therefore, as of September 30, 2006, the Company had not accelerated the vesting provisions of Mr. Hurvitzs options. | |||
On December 12, 2006, the Companys Board of Directors approved the cancellation of the acceleration and the expiration of these options. |
k. | A summary of share option plans, shares of restricted shares and related information, under all of the Companys equity incentive plans for the fiscal years ended December 31, 2003, 2004, and 2005, and for the nine months ended September 30, 2006 are as follows : |
Nine months ended | ||||||||||||||||||||||||||||||||
Year ended December 31, | September 30, 2006 | |||||||||||||||||||||||||||||||
2003 | 2004 | 2005 | (Unaudited) | |||||||||||||||||||||||||||||
Weighted | Weighted | Weighted | Weighted | |||||||||||||||||||||||||||||
Number | Average | Number | average | Number | average | Number | average | |||||||||||||||||||||||||
of | Exercise | Of | exercise | Of | exercise | Of | exercise | |||||||||||||||||||||||||
options | Price | options | price | Options | price | options | price | |||||||||||||||||||||||||
Outstanding at beginning of
period |
29,729 | 6.16 | 76,321 | 6.89 | 77,186 | 7.95 | 127,631 | 6.40 | ||||||||||||||||||||||||
Granted |
46,592 | 7.35 | 2,967 | 34.80 | 54,309 | 4.27 | 67,409 | 31.77 | ||||||||||||||||||||||||
Forfeited |
2,102 | 7.35 | 3,864 | 7.34 | 443 | 24.19 | ||||||||||||||||||||||||||
Exercised |
847 | 34.80 | ||||||||||||||||||||||||||||||
Outstanding at end of period |
76,321 | 6.89 | 77,186 | 7.95 | 127,631 | 6.40 | 193,750 | 15.06 | ||||||||||||||||||||||||
Exercisable at end of period |
38,782 | 6.44 | 52,757 | 8.22 | 86,055 | 6.86 | 113,353 | 5.89 | ||||||||||||||||||||||||
F-32
December 31, 2005 | ||||||||||||||||
Options outstanding | Options exercisable | |||||||||||||||
Number of | Weighted | Number of | Weighted | |||||||||||||
options | average | options | average | |||||||||||||
outstanding | remaining | outstanding | remaining | |||||||||||||
Exercise | at end of | contractual | at end of | contractual | ||||||||||||
prices | year | life | year | life | ||||||||||||
$ * |
44,662 | 5.21 | 24,614 | 4.73 | ||||||||||||
$ 6.19 |
6,300 | 3.00 | 6,300 | 3.00 | ||||||||||||
$ 7.35 |
54,714 | 8.22 | 37,223 | 8.22 | ||||||||||||
$10.50 |
13,715 | 3.00 | 13,715 | 3.00 | ||||||||||||
$24.36 |
5,273 | 9.41 | 1,236 | 9.41 | ||||||||||||
$34.80 |
2,967 | 0.93 | 2,967 | 0.93 | ||||||||||||
127,631 | 86,055 | |||||||||||||||
* | Represents an amount equal to less than $0.01. |
September 30, 2006 | ||||||||||||||||
Options outstanding | Options exercisable | |||||||||||||||
(Unaudited) | (Unaudited) | |||||||||||||||
Number of | Weighted | Number of | Weighted | |||||||||||||
options | average | options | average | |||||||||||||
outstanding | remaining | outstanding | remaining | |||||||||||||
Exercise | at end of | contractual | at end of | contractual | ||||||||||||
prices | period | life | period | life | ||||||||||||
$ * |
76,021 | 4.06 | 44,785 | 4.06 | ||||||||||||
$ 6.19 |
6,300 | 2.25 | 6,300 | 2.25 | ||||||||||||
$ 7.35 |
54,577 | 7.47 | 43,652 | 7.47 | ||||||||||||
$10.50 |
13,715 | 2.25 | 13,715 | 2.25 | ||||||||||||
$24.36 |
5,183 | 8.66 | 2,286 | 8.66 | ||||||||||||
$34.80 |
1,904 | 0.54 | 1,904 | 0.54 | ||||||||||||
$59.40 |
36,050 | 9.83 | 711 | 9.83 | ||||||||||||
193,750 | 113,353 | |||||||||||||||
* | Represents an amount equal to less than $0.01. |
F-33
l. | The following table illustrates the share-based compensation effect on the statement of operations: |
Period from | Period from | |||||||||||||||||||||||||||
December 27, | December 27, | |||||||||||||||||||||||||||
1993 | Nine months | 1993 | ||||||||||||||||||||||||||
through | ended | through | ||||||||||||||||||||||||||
Year ended December 31, | December 31, | September 30, | September 30, | |||||||||||||||||||||||||
2003 | 2004 | 2005 | 2005 | 2005 | 2006 | 2006 | ||||||||||||||||||||||
(Unaudited) | (Unaudited) | |||||||||||||||||||||||||||
Research and development
expenses |
98 | 194 | 692 | 1,483 | 510 | 511 | 1,543 | |||||||||||||||||||||
General and administrative
expenses |
124 | 103 | 1,195 | 1,032 | 827 | 1,784 | 3,267 | |||||||||||||||||||||
222 | 297 | 1,887 | 2,515 | 1,337 | 2,295 | 4,810 | ||||||||||||||||||||||
m. | See Note 10a for information regarding the exercise of options in respect of employees and consultants after September 30, 2006. |
a. | Measurement of results for tax purposes under the Income Tax (Inflationary Adjustments) Law, 1985 (hereafter the inflationary adjustments law) | ||
Under the Israeli Inflationary Adjustments Law, 1985, results for tax purposes are measured in real terms, having regard to the changes in the consumer price index. The Company is taxed under this law. | |||
b. | Tax rates | ||
The income of the Company (other than income from approved enterprises (see c. below) is taxed in Israel at the regular rate. Through December 31, 2003, the corporate tax was 36%. In July 2004, Amendment No. 140 to the Income Tax Ordinance was enacted. One of the provisions of this amendment is that the corporate tax rate is to be gradually reduced from 36% to 30%. In August 2005, a further amendment (No. 147) was published, which makes a further revision to the corporate tax rates prescribed by Amendment No. 140. As a result of the aforementioned amendments, the corporate tax rates for 2004 and thereafter are as follows: 2004 35%, 2005 34%, 2006 31%, 2007 29%, 2008 27%, 2009 26% and for 2010 and thereafter 25%. |
F-34
c. | The Law for the Encouragement of Capital Investments, 1959 (hereinafter - - the law) | ||
The Company has been granted Approved Enterprise status under the Law for the Encouragement of Capital Investments, 1959. Income derived from the Approved Enterprise during a period of 10 years from the year in which the enterprise first realizes taxable income is tax exempt, provided that the maximum period to which it is restricted by the law has not elapsed. | |||
The Company has an Approved Enterprise plan from 2004. The plan expires in 2017. | |||
If the Company subsequently pays a dividend out of income derived from the Approved Enterprise during the tax exemption period, it will be subject to tax on the amount distributed, including any company tax on these amounts, at the rate which would have been applicable had such income not been exempted (25%). | |||
The entitlement to the above benefits is conditional upon the Company fulfilling the conditions stipulated by the law, regulations published thereunder, and the instruments of approval for the specific investment in an approved enterprise. In the event of failure of the Company to comply with these conditions, the benefits may be cancelled and the Company may be required to refund the amount of the benefits, in whole or in part, with the addition of interest. The Investment Center is currently reviewing the Companys final implementation report and, as a result, the Company has not yet received a final implementation approval with respect to its Approved Enterprise from the investment Center. Additionally, given the Companys significant amount of net operating losses and the limitation mentioned above to the benefit period, the Company cannot predict when it would be able to enjoy the tax benefits described above, if at all. | |||
d. | Tax losses carried forward to future years | ||
The Company has no current tax provision due to its accumulated losses, which result in net operating loss carryforwards. At December 31, 2005, the Company had approximately $6,700 of net operating loss carryforwards that are available to reduce future taxable income. |
F-35
e. | Deferred income taxes: | ||
The components of the Companys net deferred tax asset at December 31, 2005 and 2004 were as follows: |
December 31, | ||||||||
2004 | 2005 | |||||||
U.S. dollars in thousands | ||||||||
In respect of: |
||||||||
R&D expenses |
$ | 84 | $ | 499 | ||||
Property and equipment |
24 | 21 | ||||||
Holiday and recreation pay |
23 | 33 | ||||||
Severance pay obligation |
52 | 71 | ||||||
Net operating loss carryforwards |
4,368 | 6,669 | ||||||
Valuation allowance |
(4,551 | ) | (7,293 | ) | ||||
| | |||||||
f. | Reconciliation of the theoretical tax expense to actual tax expense | ||
The main reconciling item, between the statutory tax rate of the Company and the effective rate is the non-recognition of tax benefits from carryforward tax losses due to the uncertainty of the realization of such tax benefits (see above). | |||
g. | Tax assessments | ||
In accordance with the Income Tax Ordinance, as of December 31, 2005, all of the Companys tax assessments through tax year 2001 are considered final. |
F-36
December 31, | ||||||||
2004 | 2005 | |||||||
U.S. dollars in thousands | ||||||||
a. Accounts receivable: |
||||||||
Institutions |
$ | 220 | $ | 49 | ||||
Income receivable |
100 | |||||||
State of Israel (see note 5a) |
322 | 178 | ||||||
Prepaid expenses |
15 | 22 | ||||||
Sundry |
9 | 5 | ||||||
$ | 666 | $ | 254 | |||||
b. Accounts payable and accruals other: |
||||||||
Payroll and related expenses |
$ | 112 | $ | 118 | ||||
Provision for vacation and recreation pay |
68 | 107 | ||||||
Accrued expenses |
191 | 84 | ||||||
In respect of purchase of property and
Equipment |
284 | 106 | ||||||
Other |
4 | |||||||
$ | 655 | $ | 419 | |||||
F-37
Period from | ||||||||||||||||
December 27, | ||||||||||||||||
1993 | ||||||||||||||||
through | ||||||||||||||||
Year ended December 31, | December 31, | |||||||||||||||
2003 | 2004 | 2005 | 2005 | |||||||||||||
U.S. dollars in thousands | ||||||||||||||||
c. Research and development expenses net: |
||||||||||||||||
Payroll and related expenses |
$ | 300 | $ | 940 | $ | 1,602 | $ | 4,378 | ||||||||
Subcontractors |
24 | 714 | 926 | 1,769 | ||||||||||||
Materials and consumables |
102 | 298 | 720 | 1,613 | ||||||||||||
Rent, insurance and maintenance |
42 | 188 | 325 | 675 | ||||||||||||
Professional fees |
53 | 81 | 473 | 814 | ||||||||||||
Patent registration |
54 | 39 | 201 | 388 | ||||||||||||
Depreciation |
*53 | 99 | 249 | 577 | ||||||||||||
Other |
40 | 134 | 212 | 450 | ||||||||||||
668 | 2,493 | 4,708 | 10,664 | |||||||||||||
Less grants (see Note 5a) |
429 | 573 | 935 | 3,365 | ||||||||||||
$ | 239 | $ | 1,920 | $ | 3,773 | $ | 7,299 | |||||||||
* | Including $28 in respect of impairment of leasehold improvement that are not expected to be used in the future. |
d. Administrative and general expenses: |
||||||||||||||||
Payroll and related expenses |
79 | $ | 223 | $ | 380 | $ | 1,006 | |||||||||
Management and consulting fees |
321 | 326 | 1,327 | 2,102 | ||||||||||||
Rent, insurance and maintenance |
4 | 27 | 42 | 207 | ||||||||||||
Professional fees |
108 | 98 | 147 | 467 | ||||||||||||
Depreciation |
*9 | 24 | 62 | 101 | ||||||||||||
Other |
82 | 109 | 173 | 588 | ||||||||||||
$ | 603 | $ | 807 | $ | 2,131 | $ | 4,471 | |||||||||
* | Including $3 in respect of impairment of leasehold improvement that are not expected to be used in the future. |
F-38
Period from | ||||||||||||||||
December 27, | ||||||||||||||||
1993* | ||||||||||||||||
through | ||||||||||||||||
Year ended December 31, | December 31, | |||||||||||||||
2003 | 2004 | 2005 | 2005 | |||||||||||||
US $ in thousands | ||||||||||||||||
a. Management and
consulting fees to
the chairman of the
Board |
$ | 60 | $ | 96 | $ | 89 | $ | 315 | ||||||||
b. capital raising
commission to the
chairman of the Board |
$ | 33 | $ | 33 | ||||||||||||
c. | With respect as to options granted to the Chief Executive Officer of the Company and to a shareholder, see Notes 6(j)4b, 6(j)4f and 6(j)2. | ||
d. | In March 2005, in addition to a share purchase agreement (see Note 6e), the Company entered into a management services agreement with the investor. The monthly management fees amount to $3. The management agreement shall be in full force as long as Mr. Hurvitz serves as a member of the Board of Directors. As to options granted to the investor, see Note 6(j)6. |
a. | During the months of October through December 2006, certain former employees, consultants and an officer of the Company exercised options and warrants for 38,004 ordinary shares for aggregate consideration of approximately $367. | ||
b. | After September 30, 2006, certain warrant holders deposited approximately $8,660 representing the total exercise price for warrants exercisable for 86,613 ordinary shares, into a trustee account. Upon the closing of the merger, these amounts shall be released from the trust account and transferred to the Company in consideration for the issuance of the ordinary shares underlying the warrants. See Note 1a. | ||
c. | On December 12, 2006, the Companys Board of Directors approved the proposed merger transaction. See note 1a. | ||
d. | See Note 6(j)6 with respect to the cancellation of the acceleration and the expiration of options granted to the Chairman of the Board of Directors. | ||
e. | In connection with a tax ruling agreement granted by the Israeli tax authorities after September 30, 2006, the Company and certain of its shareholders consented to restrictions, over specified periods after the closing of the merger, on the sale of common stock of Orthodontix by the shareholders, the retention of minimum percentages of the capital stock of Orthodontix by such shareholders, and the retention of minimum percentages of the capital stock of Othodontix by the Company Protalix. |
F-39
F-40
F-41
Adjustment | ||||||||||||||||||||
Orthodontix | Protalix | (1) | (2) | Consolidated | ||||||||||||||||
Assets |
||||||||||||||||||||
Current Assets |
||||||||||||||||||||
Cash and cash equivalents |
$ | 826 | $ | 15,621 | (400 | ) | 8,660 | $ | 24,718 | |||||||||||
Prepaid expenses |
12 | 11 | 23 | |||||||||||||||||
Accounts Receivable |
822 | 822 | ||||||||||||||||||
Total Current Assets |
838 | 16,454 | (400 | ) | 8,660 | 25,563 | ||||||||||||||
FUNDS IN
RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT |
| 268 | 268 | |||||||||||||||||
PROPERTY AND EQUIPMENT, NET |
| 2,285 | 2,285 | |||||||||||||||||
Total Assets |
$ | 838 | $ | 19,007 | (400 | ) | 8,660 | $ | 28,116 | |||||||||||
Liabilities and Stockholders Equity |
||||||||||||||||||||
Current Liabilities |
||||||||||||||||||||
Accounts payable, Trade |
$ | 11 | $ | 757 | $ | 768 | ||||||||||||||
Accounts payable related parties |
1 | | 1 | |||||||||||||||||
Accounts payable, Other |
| 544 | 544 | |||||||||||||||||
Total Current Liabilities |
12 | 1,301 | | | 1,313 | |||||||||||||||
LIABILITY
FOR EMPLOYEE RIGHTS UPON RETIREMENT |
| 388 | 388 | |||||||||||||||||
Stockholders Equity |
||||||||||||||||||||
Common stock |
1 | 2 | 68 | 71 | ||||||||||||||||
Additional paid-in capital |
4,727 | 32,985 | (4,370 | ) | 9,687 | 43,040 | ||||||||||||||
Warrants |
1,379 | | (1,027 | ) | 352 | |||||||||||||||
Accumulated deficit |
(3,902 | ) | (17,048 | ) | 3,902 | (17,048 | ) | |||||||||||||
Total Stockholders Equity |
826 | 17,318 | 400 | 8,660 | 26,415 | |||||||||||||||
Total Liabilities and
Stockholders Equity |
$ | 838 | $ | 19,007 | (400 | ) | 8,660 | $ | 28,116 | |||||||||||
(1) | Adjustment to reflect the reclassification within equity to present the exchange of shares in the Merger with a resulting 61,785,765 ordinary shares outstanding (Protalix stockholders (61,198,679 ordinary shares) and Orthodontix stockholders (583,086 ordinary shares)). The adjustment also reflects the elimination of Orthodontixs accumulated deficit. The transaction is accounted for as a reverse merger and recapitalization. | |
(2) | Adjustment to reflect the aggregate exercise of 86,613 of Protalix warrants for an aggregate amount of $8,660 which were exercised immediately prior to giving effect to the merger with Orthodontix. Any remaining unexercised warrants of Protalix were forfeited by the holders, resulting in an adjustment of $1,027 to additional paid-in capital. Protalix warrants that were granted to certain investors led by Dr. Frost were exchanged into warrants of Orthodontix, concurrent with the merger transaction. |
F-42
For the Nine | ||||||||||||||||
Months Ended | ||||||||||||||||
September 30, 2006 | ||||||||||||||||
Orthodontix | Protalix | Adjustments (1) | Consolidated | |||||||||||||
Revenues |
$ | | $ | | $ | | ||||||||||
Cost of Revenues |
| | | |||||||||||||
Gross Profit |
| | | | ||||||||||||
Research and Development expenses |
| 4,759 | 4,759 | |||||||||||||
Less Grants |
| (1,510 | ) | (1,510 | ) | |||||||||||
| 3,249 | | 3,249 | |||||||||||||
General and administrative expenses |
165 | 2,787 | 560 | 3,512 | ||||||||||||
Loss from Operations |
(165 | ) | (6,036 | ) | (560 | ) | (6,761 | ) | ||||||||
Financial income |
28 | 73 | 101 | |||||||||||||
Other Income |
48 | | 48 | |||||||||||||
Net Loss Before change in
accounting principle |
$ | (89 | ) | $ | (5,963 | ) | $ | (560 | ) | $ | (6,612 | ) | ||||
Cumulative effect of change in
accounting principle |
0 | 37 | 37 | |||||||||||||
Net Loss for the period |
$ | (89 | ) | $ | (5,926 | ) | $ | (560 | ) | $ | (6,575 | ) | ||||
(1) | Adjustment to reflect additional compensation costs associated with stock options granted to directors, employees and consultants in connection with the closing of the Merger Agreement. |
F-43
Orthodontix | Protalix | Adjustments (1) | Consolidated | |||||||||||||
Revenues |
$ | | $ | 150 | $ | 150 | ||||||||||
Cost of Revenues |
| 35 | 35 | |||||||||||||
Gross Profit |
| 115 | | 115 | ||||||||||||
Research and Development expenses |
| 4,708 | 4,708 | |||||||||||||
Less Grants |
| (935 | ) | (935 | ) | |||||||||||
| 3,773 | | 3,773 | |||||||||||||
General and administrative expenses |
93 | 2,131 | 747 | 2,971 | ||||||||||||
Loss from Operations |
(93 | ) | (5,789 | ) | (747 | ) | (6,629 | ) | ||||||||
Financial income |
14 | 43 | 57 | |||||||||||||
Other Income |
4 | | 4 | |||||||||||||
Net Loss Before change in
accounting principle |
$ | (75 | ) | $ | (5,746 | ) | $ | (747 | ) | $ | (6,568 | ) | ||||
Cumulative effect of change in
accounting principle |
0 | 0 | 0 | |||||||||||||
Net Loss for the period |
$ | (75 | ) | $ | (5,746 | ) | $ | (747 | ) | $ | (6,568 | ) | ||||
(1) | Adjustment to reflect additional compensation costs associated with stock options granted to directors, employees and consultants in connection with the closing of the Merger Agreement. |
F-44
4.1
|
Form of Warrant. | |
10.1
|
2006 U.S. Stock Incentive Plan. | |
10.2
|
Employment Agreement between Protalix Ltd. and Yoseph Shaaltiel, dated as of September 1, 2004. | |
10.3
|
Employment Agreement between Protalix Ltd. and Einat Almon, dated as of December 19, 2004. | |
10.4
|
Employment Agreement between Protalix Ltd. and David Aviezer, dated as of September 11, 2006. | |
10.5
|
Employment Agreement between Protalix Ltd. and Yossi Maimon, dated as of October 15, 2006. | |
10.6
|
License Agreement entered into as of April 12, 2005, by and between Icon Genetics AG and Protalix Ltd. | |
10.7
|
Research and License Agreement between Yeda Research and Development Company Limited and Protalix Ltd. dated as of March 15, 2006. | |
10.8
|
Agreement between Teva Pharmaceutical Industries Ltd. and Protalix Ltd., dated September 14, 2006. | |
10.9
|
Lease Agreement between Protalix Ltd. and Angel Science Park (99) Ltd., dated as of October 28, 2003 as amended on April 18, 2005. | |
10.10
|
Merger Agreement and Plan of Reorganization made and entered into as of August 21, 2006, by and among Orthodontix, Inc, Protalix Acquisition Co., Ltd. and Protalix Ltd. |
| Portions of this exhibit were omitted and have been filed separately with the Secretary of the Securities and Exchange Commission pursuant to the Registrants application requesting confidential treatment under Rule 406 of the Securities Act. |
86
ORTHODONTIX, INC. (Registrant) |
||||
Date: January 4, 2007 | By: | /s/ David Aviezer | ||
Name: | David Aviezer, Ph.D. | |||
Title: | President and Chief Executive Officer |
87
1.1. | Cash Exercise of Warrant. This Warrant may be exercised from time to time or at any time during the Warrant period by presentation and surrender thereof to the Company at its principal office or at such other office or agency as it may designate from time to time, accompanied by: |
1.1.1. | A duly executed notice of exercise, in the form attached hereto as Exhibit A (the Exercise Notice); and |
1.1.2. | Payment to the Company, for the account of the Company, of the aggregate Exercise Price for the number of Warrant Stock specified in the applicable Exercise Notice, payable in immediately available funds by wire transfer to the following bank account at Bank Hapoalim, branch 615, account number 113323 or by bankers check or by any other means of payment agreed upon between the Company and the Holder. The Exercise Price will be paid in United States Dollars. |
1.2. | Partial Exercise, Etc. If this Warrant should be exercised in part only, the Company shall, upon surrender of this Warrant for cancellation, execute and deliver a new Warrant evidencing the rights of the Holder to purchase the balance of the Warrant Stock purchasable hereunder. |
1.3. | Issuance of Warrant Stock Upon Cash Exercise. Upon presentation and surrender of this Warrant accompanied by a duly executed Exercise Notice and the payment of the applicable aggregate Exercise Price pursuant to Section 1.1 above, the Company shall promptly (i) issue to the Holder the Warrant Stock to which the Holder is entitled; and (ii) deliver to the Holder the share certificate(s) evidencing such Warrant Stock. Upon receipt by the Company of this Warrant, the applicable Exercise Notice and the applicable aggregate Exercise Price, the Holder shall be deemed to be the holder of record of the Warrant Stock issuable upon such exercise, notwithstanding that the stock transfer books of the Company shall then be closed or that certificates representing such stock shall not then be actually delivered to the Holder. |
1.4. | Fractional Stock. No fractions of shares shall be issued in connection with the exercise of this Warrant, and the number of shares issued shall be rounded up to the nearest whole number. |
1.5. | Taxes. The Holder acknowledges that the grant of the Warrant, the issue of the Warrant Stock and the execution and/or performance of this Warrant may have tax consequences to the Holder and that the Company is not able to ensure or represent to the Holder the nature and extent of such tax consequences. The Company shall pay all of the applicable taxes and other charges payable by the Company in connection with the issuance of the Warrant Stock and the preparation and delivery of share certificates pursuant to this Section 1 in the name of the Holder (such as documentary stamp or similar issue or transfer taxes in respect of the issue or delivery of shares of Common Stock on exercise of this Warrant), but shall not pay any taxes payable by the Holder by virtue of the holding, issuance, exercise or sale of this Warrant or the Warrant Stock by the Holder and the Holder shall indemnify the Company, without derogating from the Holders obligation to pay such amounts, for any and all charges or payments as aforesaid, which may be deducted at source or set-off from any amounts payable to the Holder (including, without limitation, dividends, consideration for the sale of stock or from any other source), at the Companys absolute and sole discretion, subject to applicable law. |
1.6. | Additional Documents. The Holder will sign any and all documents required by law, the Companys Articles of Association and/or any agreement to which the Company is a |
- 2 -
1.7. | Loss or Destruction of Warrant. Upon receipt by the Company of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant, and (in the case of loss, theft or destruction) of reasonably expenses reimbursement and satisfactory indemnification, and upon surrender and cancellation of this Warrant, if mutilated, the Company will execute and deliver a new Warrant of like tenor and date. |
2.1. | Reservation of Stock. The Company hereby agrees that, at all times prior to the expiration or exercise of this Warrant, it will maintain and reserve, free from pre-emptive or similar rights, such number of authorized but unissued Common Stock so that this Warrant may be exercised without additional authorization of Common Stock after giving effect to all other warrants, convertible securities and other rights to acquire shares of the Company. |
2.2. | Preservation of Rights. The Company will not, by amendment of its organizational documents or through reorganization, recapitalization, consolidation, merger, dissolution, transfer of assets, issue or sale of securities or any other voluntary act, avoid or seek to avoid the observance or performance of any of the covenants, stipulations, conditions or terms to be observed or performed hereunder, but will at all times in good faith assist in the carrying out of all the provisions hereof and in taking of all such actions and making all such adjustments as may be necessary or appropriate in order to fulfill the provisions hereof. |
3.1. | Adjustments. The number of Warrant Stock purchasable upon the exercise of this Warrant and the payment of the Exercise Price shall be subject to adjustment from time to time or upon exercise as provided in this Section 3. |
3.2. | Bonus Stock. In the event that during the Warrant Period the Company shall distribute a dividend or stock pursuant to a reclassification of its stock capital to all of the stockholders of the Company (i.e., bonus shares), then this Warrant shall represent the right to acquire, in addition to the number of Warrant Stock indicated in the caption of this Warrant, the amount of such bonus shares and/or to receive the stock dividends, without payment of any additional consideration therefor, to which the Holder would have been entitled had this Warrant been exercised prior to the distribution of the stock dividends or the bonus shares. |
3.3. | Consolidation and Division. In the event that during the Warrant Period the Company consolidates its stock capital into stock of greater par value, or subdivides them into stock of lesser par value, then the number of Warrant Stock to be allotted on exercise of this Warrant after such consolidation or subdivision shall be reduced or increased accordingly, as the case may be, such increase or decrease, as the case may be, to become effective immediately after the opening of business on the day following the day |
- 3 -
3.4. | Capital Reorganization. In the event that during the Warrant Period a reorganization of the stock capital of the Company is effected (other than subdivision, combination or reclassification provided for elsewhere in this Section 3) and the Common Stock are exchanged for other securities of the Company, then, as part of such reorganization, provision shall be made so that the Holder shall be entitled to purchase upon exercise of this Warrant such kind and number of stock or other securities of the Company to which the Holder would have been entitled had this Warrant been exercised prior to such reorganization, and such that the aggregate consideration to the Company hereunder shall not change. |
- 4 -
8.1. | Entire Agreement; Amendment. This Warrant sets forth the entire understanding of the parties with respect to the subject matter hereof and supersedes all existing agreements among them concerning such subject matter. All article and section headings herein are inserted for convenience only and shall not modify or affect the construction or interpretation of any provision of this Warrant. No modification or amendment of this Warrant will be valid unless executed in writing by the Company and the Holder. |
8.2. | Waiver. No failure or delay on the part of any of the parties in exercising any right, power or privilege hereunder and/or under any applicable laws or the exercise of such right or power in a manner inconsistent with the provisions of this Warrant or applicable law shall operate as a waiver thereof. Any waiver must be evidenced in writing signed by the party against whom the waiver is sought to be enforced. |
8.3. | Successors and Assigns; Assignment. Except as otherwise expressly limited herein, this Warrant shall inure to the benefit of, be binding upon, and be enforceable by the Holder and its respective successors, assigns, and administrators. The Holder represents and warrants to the Company that the Warrant Stock, if and when purchased by the Holder, are for the Holders own account and for investment purposes only and not with a view for resale or transfer and that all the rights pertaining to the Warrant Stock, by law or equity, shall be purchased and possessed by the Holder for the Holder exclusively. Holder may not assign, transfer, pledge or otherwise encumber or dispose any of the rights, privileges, or obligations set forth in, arising under, or created by this Warrant, other than in accordance with the Articles of Association of the Company, applicable law and any other contractual undertaking of the Holder, including any lock up undertaking. In any event no assignment or transfer of the Warrant or the Warrant Stock may be effected if any such assignment or transfer may render the Company a public company or require, as a result thereof, the Company to file any registration statement, prospectus reports or documents with the US Securites and Exchange Commission or any Stock Exchange or other similar institution in any jurisdiction. |
8.4. | Notices. Any notice required or permitted to be given to a party pursuant to the provisions of this Warrant will be in writing and will be effective and deemed delivered to such party on the earliest of the following: (a) all notices and other communications delivered in person or by courier service shall be deemed to have been delivered as of actual delivery thereof; or, (b) those given by facsimile transmission shall be deemed delivered on the following business day after transmission, with confirmed transmission thereof; or (c) all notices and other communications sent by registered mail (or air mail if the posting is international) shall be deemed given seven (7) days after posting. |
- 5 -
8.5. | Severability. If any provision of this Warrant is held to be unenforceable, this Warrant shall be considered divisible and such provision shall be deemed inoperative to the extent it is deemed unenforceable, and in all other respects this Warrant shall remain in full force and effect; provided, however, that if any such provision may be made enforceable by limitation thereof, then such provision shall be deemed to be so limited and shall be enforceable to the maximum extent permitted by applicable law. |
8.6. | Counterparts. This Warrant may be executed in any number of counterparts, each of which shall be an original, but all of which together shall constitute one instrument. Facsimile signatures of a party shall be binding as evidence of such partys agreement hereto and acceptance hereof. |
- 6 -
Dated: 31 December, 2006 | ORTHODONTIX, INC. | |||||
By: | ||||||
Name: | David Aviezer, Ph.D. | |||||
Title: | Chief Executive Officer |
- 7 -
Signature: | ||||||
Address: | ||||||
- 8 -
2
3
4
5
6
7
8
9
10
11
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13
14
15
16
17
18
19
20
21
22
23
24
BETWEEN:
|
Metabogal Ltd. (corporate no. 51-190328-8) Of the Kiryat Shmona Industrial Zone (hereinafter: the Company) |
AND:
|
Dr. Yoseph Shaaltiel (I.D. 05174848-1) Of: Beit Hillel (hereinafter: the Employee or the R&D Director) |
WHEREAS
|
The Company is engaged in biotechnology; and | |
WHEREAS
|
The Employee is desirous of working for the Company in the position of the Companys R&D Director; and | |
WHEREAS
|
The Company is desirous of employing the Employee in the position of the Companys R&D Director, all pursuant and subject to the provisions hereinafter contained; |
It is therefore declared, stipulated and agreed between the parties as follows: | ||
1. | Preamble, Appendices and interpretation |
1.1 | The preamble and the Appendices hereto constitute an integral part thereof and are to be read as one with the remaining clauses thereof. | ||
1.2 | The headings to the clauses are for ease of reference only and are not to be applied in the interpretation of this Agreement. |
2. | Declarations of the parties | |
The parties declare and acknowledge as follows: |
2.1 | This Agreement is personal and special, and regulates the relationship between the Company and the Employee and no general or special collective agreement will therefore apply to the Employee. | ||
2.2 | This Agreement encompasses all the payments and/or benefits and/or other conditions of any kind whatsoever to which the Employee is entitled from the Company. | ||
2.3 | No custom between the Company and other employees (if any) or practice will apply to the relationship between the Employee and the Company unless expressly adopted by this Agreement and to the extent so adopted. If the Company grants the Employee in a certain case or cases, any benefit or payment that has not been specified in this Agreement the grant thereof will not create a custom between the parties or obligate the Company in any other or additional cases. |
2
3. | Description of the position | |
It is hereby agreed that the Employee will work at and be employed by the Company in the position of the Companys R&D Director. | ||
4. | Undertakings of the Employee |
4.1 | The Employee undertakes to devote all his working time, energies, skills, knowledge and experience to his work in the Company, to work loyally for the Company and use his best efforts to advance the Companys business and affairs. | ||
4.2 | The Employee undertakes not, for the duration of his employment with the Company, to engage, directly or indirectly, in any other or additional work or employment, either during or after working hours, for consideration or otherwise, unless he receives the prior written consent of the Company and approval thereto. | ||
4.3 | The Employee will not accept in connection with his employment at the Company any consideration or benefit whatsoever from any party, including from customers or suppliers of the Company, either directly or indirectly. | ||
4.4 | The Employee undertakes to notify the Company immediately of any matter or thing in which he has a personal interest or that could constitute a conflict of interest with his work at the Company. |
5. | Salary |
5.1 | The Employees salary will be $7,000 (seven thousand dollars) gross per month1 which will be paid to him by the 9th of each month in respect of the preceding month (hereinafter: the Salary). | ||
5.2 | The Salary will be linked, without any capped limit, to the Cost of Living Index (Tosefet Hayoker) that will be fixed from time to time pursuant to the provisions of the general agreements in the economy regarding the Cost of Living Index (hereinafter: the Updated Salary). | ||
5.3 | The Board of Directors of the Company will discuss the terms of the Employees Salary once a year. |
6. | Managers Insurance |
6.1 | The Company will preserve the continuity of the Employees managers insurance policy (or the Company will acquire managers insurance for the Employee), as it did, immediately prior to the execution of this Agreement. Calculation of the contributions to the pension insurance plan will be made based on the gross monthly Salary. | ||
The contributions to the pension insurance plan will be as follows: |
8.3% for severance compensation
|
to be contributed by and at the expense of the Company. |
1 | $7,000 will be translated into new Israeli shekels on the date of the execution of this Agreement. |
3
5% for provident payments
|
to be contributed by and at the expense of the Company. | |
5% for provident payments
|
to be deducted, with the consent of the R&D Director, from the monthly Salary and contributed at his expense. | |
2.5% for working disability allowance -
|
to be contributed by and at the expense of the Company. |
6.2 | The managers insurance policy will be owned by the Company from the date of the Employee commencing his employment, and will pass to the Employees ownership in the event of a termination of the employer-employee relationship between the Company and the Employee, provided such termination has not occurred in the circumstances set out in clause 13.2 hereof. | ||
6.3 | Should the working relationship between the Employee and the Company come to an end in the circumstances set out in clause 13.2 hereof, all the sums accrued according to the managers insurance policy before the commencement of his employment with the Company, will be transferred to the Employee from the managers insurance save that out of the sums that have accrued from the date of the commencement of his employment with the Company there will be transferred to the Employee from the managers insurance, the sums that have accrued in respect of the Employees contributions only, and the amounts that have accrued on account of severance pay only, will be refunded to the Company. |
7. | Study fund | |
The Employer will set aside for the Employees benefit in a Clal Study fund (hereinafter: the Study Fund) on account of the Employer 7.5% of the amount of the monthly Salary as existing from time to time (hereinafter: the Employers Contribution), up to the ceiling recognized by the income tax authorities. The Employee will contribute to the Study Fund, in addition to the Employers contributions, 2.5% of his monthly Salary as existing from time to time (hereinafter: the Employees Contributions to the StudyFund). | ||
The Employee hereby agrees to the Employer deducting from his monthly Salary, the Employees contribution to the Study Fund. The Employees signature on this Employment Agreement will be tantamount to the giving of irrevocable instructions to the Employer. | ||
8. | Working hours |
8.1 | The Employee hereby declares and acknowledges that he is employed by the Company in management positions, that his work and position in the Company require a special method of personal trust and that the terms of his employment do not allow the Company to supervise his work and rest hours, and, therefore, the Work and Rest Hours Law, 5711-1951 does not apply to him. | ||
8.2 | The Employee hereby declares and acknowledges that he is aware and agrees that his employment with the Company will require him to work also at hours outside the usual working hours and he undertakes to work overtime in accordance with the Companys requirements and pursuant to the needs of the work. The |
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Employees Salary has been set taking into account that stated above, and he will not be entitled to any additional payment for working overtime. |
9. | Fringe Benefits |
9.1 | Vacation leave | ||
The R&D Director will be entitled to 24 vacation days per year, and proportionately for part of the year. In reckoning the vacation days, Saturdays and Festivals will not be taken into account. The date of the vacation will be arranged between the R&D Director and the Companys management. The Company will pay the R&D Director on the annual vacation days his Salary in full and all the benefits and ancillary fringe benefits. The vacation days may be accumulated up to a maximum of 48 days or may be encashed, at the discretion of the R&D Director. | |||
9.2 | Sick leave | ||
The Employee will be entitled to 30 calendar days sick leave per year. The sick leave may be accumulated in accordance with the law. For the duration of the Employees sickness until the expiration of the sick leave to which the Employee is entitled, the Company will pay the R&D Director the monthly Salary in full and all the benefits and accompanying fringe benefits from the first day of sickness, less disability allowance payments that will be paid by the insurance company in respect of the sick leave to which the Employee is entitled. Sick leave may not be redeemed in cash. | |||
9.3 | Vacation allowance | ||
The Employee will be entitled to payment of vacation allowance pursuant to the provisions of the Extension Order regarding the Employees participation in vacation costs and holiday, according to the Collective Agreements Law, 5717-1957 or any other law in substitution therefor, for 12 vacation days per year. |
10. | Cellular telephone | |
The Employee is entitled to a cellular telephone of the Company and the maintenance and user expenses will be borne by the Company. | ||
11. | Company Vehicle |
11.1 | The Company will provide the Employee with a suitable vehicle matching the requirements of his position ( ), in which an automatic fuelling device will be installed (of the type prescribed by the Company). The class of the vehicle, engine capacity and year of manufacture will be at the Companys absolute discretion. The Company may change the vehicle in the Employees possession from time to time, at its discretion. | ||
11.2 | The vehicle will be owned by the Company and the Company will bear all the maintenance and user costs thereof. The Employees family members will be entitled to use the vehicle after working hours, and at weekends. |
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12. | Expenses | |
The Employee will be entitled to reimbursement of expenses incurred by him in connection with his position in the Company pursuant to the Companys procedures as set from time to time, against appropriate receipts being furnished. Reimbursement of the expenses will be made on the payment date of the Salary in respect of receipts provided by the Employee to Accounts by the 20th of each preceding month, for the month in which the Salary will be paid. | ||
13. | Term of the Agreement |
13.1 | This Agreement will enter into effect as of the execution hereof, and is made for an indefinite period and may be brought to an end by the Companys Board of Directors, by prior notice of not less than 90 days. Notwithstanding the foregoing it is hereby agreed, that the Employee will not be entitled to give a notice of the termination of his employment according to this Agreement before 33 months have elapsed from the date of the execution thereof. It is hereby further agreed that notwithstanding the foregoing, the Company reserves the right to dismiss the Employee immediately, provided that the Company pays him prior notice redemption monies. | ||
13.2 | Notwithstanding the foregoing the Company will be entitled to terminate this Agreement, without any prior notice, upon the occurrence of one or more of the following events: |
13.2.1 | The Employee has been convicted of an infamous offence; | ||
13.2.2 | The Employee has betrayed his position with the Company or has breached his fiduciary duty towards it; | ||
13.2.3 | The Employee has breached his Confidentiality duty towards the Company; | ||
13.2.4 | The Employee has wilfully caused or wilfully assisted others to cause damage to the Company or its property. |
13.3 | Where the Employee has been dismissed by the Company in the circumstances set out in clause 13.2 above, the Company may immediately terminate payment of the Employees Salary and payment of the fringe benefits and immediately cease providing a vehicle and cellular telephone to the Employees use, in which case the Employee will not be entitled to receive any sum from the Company except as stated in clause 6.3 above. | ||
13.4 | The Employee undertakes, upon the termination of his employment with the Company, for any reason whatsoever, to hand over his position in an orderly fashion and fully co-operate with such person as the Company will instruct, and hand over to the Company all the documents, information, equipment and material that has reached him or that has been prepared by him in connection with his employment at the Company. |
14. | Confidentiality |
14.1 | The Employee hereby declares and acknowledges that he is aware that the information and knowledge of any kind whatsoever that has been or will be conveyed to him and/or which has or will reach his knowledge during the course |
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of and/or consequent upon his employment with the Company, and in particular the information relating to the Companys business, its know-how, technology, suppliers, customers and the like are highly confidential and of great value to the Company, and constitute professional and trade secrets of the Company and the disclosure thereof could cause damages and losses to the Company. | |||
14.2 | The Employee undertakes to keep absolutely secret all the information and knowledge that has been or will be given to him and/or which will reach his knowledge during the course of and/or in consequence of his employment with the Company and which pertain to the Company in any manner or form, including technical or professional knowledge of the Company, trading and financial know-how, its engagements with suppliers, customers, contractors for its business, its plans, etc., and not to disclose the same to any other person or persons, nor enable the disclosure thereof by others, directly or indirectly, except in the scope of, or for the sake of, his employment in the Company, either during the period of his employment with the Company as well as after the termination, for any reason whatsoever, of his employment with the Company, without any limitation in time, with the exception of information which he is under a duty to disclose by law and information that has fallen into the public domain, otherwise than by reason of any act or omission of the Employee. |
15. | Non-competition | |
The Employee undertakes that unless he receives the prior written consent of the Company, during the entire term of the existence of the employer-employee relationship between him and the Company and for a period of 24 months thereafter, for any reason whatsoever, he will not work for nor take part in the position of R&D Director or in a like position, directly or indirectly, in any business, whether incorporated or unincorporated, that competes with the Company or its business, all within the area of the State of Israel. | ||
In addition the Employee undertakes that for a period of 24 months after the date of expiration of his employment with the Company, not to turn to or have any business connection whatsoever with any person or entity who, on the date of the termination of the Employees employment, were customers and/or suppliers of the Company, or were in negotiations with the Company in connection with the carrying out of any business with it and/or the Companys employees and/or contractors and/or advisors, all this with the object of carrying out, directly or indirectly, any act which could interfere with the relationship between the Company and any of the parties mentioned above. | ||
For the avoidance of any doubt the Employees undertaking for non-competition contained in this clause is in addition to the Employees undertaking to keep confidentiality mentioned in clause 14 above, and the amount of the Employees Salary has, inter alia, been set on reliance on this undertaking and constitutes appropriate consideration for such undertaking. | ||
For the purpose of this clause 15 directly or indirectly includes engaging as an independent owner, shareholder, partner, manager, agent, employee, clerk or advisor. | ||
16. | Intellectual property |
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16.1 | In this Agreement, the expression development means, any idea and/or invention and/or design and/or plan and/or document and/or software and/or computer programs of any kind whatsoever and/or process and/or system and/or procedure, all these including all and any accompanying documentation or annexed thereto, on any media whatsoever and including all the versions and copies thereof and everything stated and pertaining thereto or resulting therefrom, that have been developed and/or written and/or created by the Employee during the period of the employment, whether alone or together with others, in their entirety or in part. | ||
16.2 | It is agreed and declared that the developments are the Companys full and exclusive property and that the Employee has no right therein whatsoever. For the avoidance of any doubt, the Employee hereby transfers and assigns to the Company all of his rights, including, but without derogating from the generality of that stated, the right of ownership which he has or will have, alone or jointly with others, in all the developments, whether they are registrable as a patent or protectable as copyright, or protectable as intellectual or material property in any other way. | ||
16.3 | For the avoidance of any doubt it is stated that the Company will be entitled to use and market the developments and also make changes and/or translations and/or derivative works thereof without the need of the Employees licence and without his being entitled by reason thereof to any consideration and the Company will further be entitled not to distribute any such developments and/or not to name the Employee as the originator of such development, if it is generally publicized. | ||
16.4 | The Employee will not be entitled to any payment or other consideration in respect of the developments in addition to regular Salary in respect of the period of his employment in the Company. This undertaking serves an agreement with respect to section 134 of the Patents Law, 5727-1967. | ||
16.5 | In connection with any one of the developments which are the Companys property and/or which has been conferred upon it as stated above, the Employee undertakes to convey all information and particulars and also, at the Companys request, to promptly sign any document, including a specific transfer of ownership to the Company and effect any act that is reasonably required in order to enable the Company to register a patent, copyright or other protection, in any country whatsoever, or to realize its rights in any other way. |
This undertaking is in addition to and does not derogate from any other right of the Company by law. | ||
17. | Miscellaneous |
17.1 | This Agreement is subject to the approval by the Board of Directors of the Company and be of no binding effect on the Company until such approval has been received. | ||
17.2 | This Agreement encompasses the agreement between the parties and no negotiations, statement, representation, undertaking or agreement, if at all, whether in writing or by word of mouth, expressly or impliedly between the parties prior to the signature of this Agreement, will be of any effect. |
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17.3 | With the exception of the matters for which it has been expressly provided that the Company will gross up the tax payments, it is hereby agreed that the Employee will bear all taxes and other compulsory payments that will apply to him in respect of all the amounts that will be paid to him under this Agreement and in respect of all the benefits and/or advantages that will be conferred upon him, and the Company will deduct from his Salary the amount of any tax and/or other compulsory payment the deduction of which is required by any law. | ||
17.4 | No conduct by any of the parties will be deemed to be a waiver of any of that partys rights hereunder or under any law and/or as a waiver or consent on its part to any breach or non-performance of any condition whatsoever unless such waiver, consent, delay, variation, cancellation or addition has been made or given expressly and in writing. | ||
17.5 | No modification to this Agreement will be of any effect nor may any of the conditions thereof be varied without a written document bearing the signature of the parties. For the avoidance of any doubt it is clarified that none of the conditions of this Agreement may be varied by way of conduct, custom, and the like. | ||
17.6 | The addresses of the parties for the purposes of this Agreement are as set out below: | ||
The Company The Employee |
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Any notice that will be sent by registered mail by one party to the other according to the above address will be deemed to have been received by the addressee from the time of being posted in an Israeli Post Office, and if served personally from the time of its service and, if despatched by fax, at the end of the transmission thereof. |
/s/ Zeev Bronfeld |
/s/ Yoseph Shaaltiel
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Metabogal Ltd. |
BETWEEN:
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Protalix Ltd. Of 2 Snonit Road, Science Park, P.O.B. 455, Carmiel 20100 (hereinafter: the Company) |
AND:
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Dr. Einat Almon (I.D. 55614481) Of: 10 Hadass St., Timrat, (hereinafter: the Employee) |
WHEREAS
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The Company is engaged in biotechnology; and | |
WHEREAS
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The Employee is desirous of working in the position of Senior Director of Product Development in the field of biotechnology (the Position); and | |
WHEREAS
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The Employee declares that she has the know-how, skills and experience required in order to fulfill the Position pursuant to the terms of this Agreement; and | |
WHEREAS
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On reliance on the Employees declarations and undertakings contained in this Agreement, the Company is desirous of employing the Employee, and the Employee is desirous of being employed by the Company in the Position, pursuant to the terms contained in this Agreement; |
It is therefore declared, stipulated and agreed between the parties as follows: | ||
1. | Preamble, Appendices and interpretation |
1.1 | The preamble and the Appendices hereto constitute an integral part thereof and are to be read as one with the remaining clauses thereof. | ||
1.2 | The headings to the clauses are for ease of reference only and are not to be applied in the interpretation of this Agreement. |
2. | Declarations of the parties | |
The parties declare and acknowledge as follows: |
2.1 | This Agreement is personal and special, and regulates the relationship between the Company and the Employee and no general or special collective agreement will therefore apply to the Employee. | ||
2.2 | This Agreement encompasses all the payments and/or benefits and/or other conditions of any kind whatsoever to which the Employee is entitled from the Company in connection with her employment. | ||
2.3 | No custom between the Company and other employees (if any) or practice will apply to the relationship between the Employee and the Company unless |
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expressly adopted by this Agreement and to the extent so adopted. If the Company grants the Employee in a certain case or cases, any benefit or payment that has not been specified in this Agreement the grant thereof will not create a custom between the parties or obligate the Company in any other or additional cases. |
3. | Description of the position |
3.1 | It is hereby agreed that the Employee will work at and be employed by the Company in the position of Senior Director of Product Development in the field of biotechnology, on a full-time basis; the Position will include: |
3.1.1 | The identification, absorption and development of new protein to be used as products in and by the Company; | ||
3.1.2 | Pre-clinical and clinical development of enzymes to treat Gaucher disease; | ||
3.1.3 | Working with the FDA and clinical researchers; | ||
3.1.4 | Responsibility for managing the Companys patents portfolio with the patent editor; and | ||
3.1.5 | The carrying out of any other task or assignment required in connection with the performance of the Position by the Employee, in accordance with the CEOs decision. |
3.2 | The Employee will, in her work in the Company, be subordinate to the CEO of the Company; participate at the discretion of the CEO, in discussions pertaining to tracking the methods of operating in the Company, to the extent they pertain to her Position and acting in accordance with the Company policy and procedures, as prevailing from time to time. |
4. | Undertakings of the Employee |
4.1 | The Employee undertakes to devote all her working time for the purpose of performing the Position, to the extent of the work stated in clause 3.1 above, and will apply all her energies, skills, knowledge and experience to her employment in the Company, carry out her work in the Company professionally, devotedly and diligently, faithfully act vis-à-vis the Company and use her best endeavours to promote the business and affairs of the Company. | ||
4.2 | The Employee undertakes not, for the duration of her employment with the Company, to engage, directly or indirectly, in any other or additional work or employment, either during or after working hours, for consideration or otherwise, unless she receives the prior written consent and approval of the CEO at his discretion. | ||
4.3 | The Employee will not accept in connection with her employment at the Company any consideration or benefit whatsoever from any party, including from customers or suppliers of the Company, either directly or indirectly. | ||
4.4 | The Employee undertakes to notify the Company immediately of any matter or thing in which she has a personal interest or that could constitute a conflict of interest with her work at the Company. |
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5. | Salary and bonuses |
5.1 | The Employees salary during the period of her employment with the Company will be NIS. 28,000 (twenty-eight thousand shekels) (gross) per month that will be paid to her by the 10th of each month in respect of the preceding month (hereinafter: the Salary). The Salary consists of any increment that it is obligatory or usually paid to employees at the Employees grade and status. It is clarified that any benefit, contribution or bonus to which the Employee will be entitled pursuant to the terms of this Agreement will be computed on the basis of the Salary only, without any benefit, contribution or bonus being taken into account or included in, the Salary. | ||
5.2 | In addition, if (and only if) any of the circumstances set out in clauses 5.2.1 and 5.2.3 hereof apply, will the Employee receive bonuses as prescribed in those clauses, as follows: |
5.2.1 | A bonus in the sum of US$15,000 for each new protein that will, after passing initial and successful due diligence investigation, be integrated by means of the Employee in the Companys development program (if at all); | ||
5.2.2 | A bonus in the sum of US$10,000 upon commencement of Phase III of the development of the enzyme to treat Gaucher disease (if at all); | ||
5.2.3 | A bonus in the sum of US$30,000 for approval as a medication by the FDA of the protein developed by the Company to treat Gaucher disease (if at all). |
6. | Discussion of Grade and Salary |
6.1 | Six months after the date of the commencement of the Employees employment a discussion will be held with the Employee pertaining to her appointment as Vice-President of the Company, including the terms of her employment derivative therefrom (VP). | ||
6.2 | As from the second year of the Employees employment, at the end of each year during the term of this Agreement, a discussion will be held on the amount of the Employees salary, and the possibility of the Employees advancement in salary by the Company will be considered, that promotion, inter alia, to be weighed in light of the Companys condition, compliance with the Companys goals, employees skills, performance and devotion to the work. | ||
6.3 | It is hereby clarified that notwithstanding the stated in this clause 6, the definition of the Employee as Vice-President and/or change in the terms of her employment as stated in clause 6.1 and/or the advancement of the Employee in her salary as stated in clause 6.2 will be at the sole discretion of the Company, and the Company assumes no obligation whatsoever to promote the Employee in the Position and/or in Salary as stated in these clauses. |
7. | Managers and work disability insurance |
7.1 | The Company will contribute in respect of a managers insurance policy for the benefit of the Employee amounts to the extent of 8.3% of the monthly salary in respect of severance compensation and 5% of the monthly salary in respect of provident savings payments. The Employee hereby agrees that the Company will deduct from her monthly salary and remit to the above policy contributions in the |
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sum of 5% of the monthly salary on account of the Employee, in respect of provident pay. It is further agreed that the Company will make contributions at its expense to the Employees work disability insurance policy, in the sum of 2.5% of the Salary. | |||
7.2 | The managers insurance policy will be owned by the Company from the date of the Employee commencing her employment. In the event of a severance of the employer-employee relationship between the Company and the Employee, the Employee will be entitled to assign such insurance policy, including the severance pay fund therein, into her name, provided such termination has not occurred in the circumstances set out in clause 15.2 hereof, in which case and subject to any law, the Company will be exempt from releasing to the Employee the monies that have been contributed at the expense of the Company to such insurance policy, and it will not be bound to instruct the insurance company or the severance compensation fund, as appropriate, to pay the Employee such monies. |
8. | Study fund | |
The Employer will contribute to a Study fund in favour of the Employee 7.5% of the amount of the monthly Salary at the expense of the Company and 2.5% of the amount of the monthly salary at the expense of the Employee. The Employee hereby agrees to the making of the contributions from her salary by the Company as stated for purposes of the Study fund. | ||
9. | Granting of options | |
Subject to the conditions contained in this clause 9, the Company will grant the Employee options to acquire ordinary shares of the Company at the rate of 0.5% (half a percent) of the issued share capital of the Company as of the date of this Agreement, pursuant to the Companys option plan as applicable from time to time. Notwithstanding that stated, the allotment will be subject to the approval of the Board of Directors of the Company, and the signature of an option agreement between the Employee and the Company, to the Companys satisfaction. If such options are granted, the exercise price thereof will be as determined by the Board of Directors, and they will vest gradually over a four (4) year vesting period, pursuant to the conditions that will be set in the option agreement or such option plan, and will be subject to all the remaining conditions of the option plan, option agreement and the law. | ||
10. | Working hours |
10.1 | The Employee hereby declares and acknowledges that she is employed by the Company in an executive position, that her work and position in the Company require a special method of personal trust and that the terms of her employment do not allow the Company to supervise her work and rest hours, and, therefore, the Work and Rest Hours Law, 5711-1951 does not apply to her. | ||
10.2 | The Employee hereby declares and acknowledges that she is aware and agrees that her employment with the Company will require her to work also at hours outside the usual working hours and may include trips inside and out of Israel, and she undertakes to work overtime and take such trips in accordance with the Companys requirements and pursuant to the needs of the work. It is agreed and stated that the Employees salary has been set taking into account that stated |
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above, and she will not be entitled to any additional payment beyond that expressly provided in this Agreement for working overtime and for such trips. |
11. | Fringe Benefits |
11.1 | Vacation leave | ||
The Employee will be entitled to 22 vacation days per year, and proportionately for part of the year. In reckoning the vacation days, Saturdays and Festivals will not be taken into account. The date of the vacation will be arranged between the Employee and the Companys CEO. The Company will pay the Employee on the annual vacation days her Salary in full and all the benefits and ancillary fringe benefits. The vacation days may be accumulated up to a maximum of 44 days, but may not be redeemed in cash by the Employee except (and without derogating from any of the Companys rights pursuant to this Agreement and/or at law) in the case of termination of the employer-employee relationship (in which case the Employee will be entitled to encash the vacation days that have accrued in her favor, but in no event for more than such period of 44 days). | |||
11.2 | Vacation allowance | ||
The Employee will be entitled to payment of vacation allowance pursuant to the provisions of law. |
12. | Vehicle |
12.1 | The Company will provide the Employee with a vehicle during the course of her employment, such vehicle having an engine capacity of 1600cc., like a Toyota Corolla, Mazda 3 or like vehicle, at the discretion of the Company (the Vehicle). The expenses of using the Vehicle will be borne and paid by the Company. | ||
12.2 | Notwithstanding that stated, it is hereby clarified that (1) without derogating from the generality of that stated in clause 19.2 hereof, any tax liability in respect of providing vehicle to the Employee as stated and the use thereof will be borne solely by the Employee, who will also bear every such expense, and (2) the Company will bear no responsibility (a) to pay fines that will be imposed in respect of the Vehicle and/or (b) for the unlawful or unreasonable use of the Vehicle, and any such liability will attach exclusively to the Employee. |
13. | Expenses | |
The Company will reimburse the Employee for her expenses in connection with performance of the Position, up to the monthly sum of NIS. 500, against receipts and in accordance with the Companys procedures existing from time to time. Notwithstanding the foregoing, the amount of the reimbursement in respect of traveling and staying abroad within the scope of the Employees Position in the Company will be in accordance with the Companys procedures, as existing from time to time. The reimbursement of additional expenses beyond the above amount will only be paid to the extent approved in advance by the CEO of the Company. |
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14. | Telephone | |
During the term of this Agreement, the Company will provide the Employee with a cellular telephone. The expenses of using the cellular telephone up to the sum of NIS. 1,000 will be borne and paid by the Company. The expenses of using the cellular telephone that exceed the sum of NIS. 1,000 per month will be borne by the Employee. In addition, the Company will reimburse the Employee for further telephone expenses for calls made within the course of the work, if any. | ||
The cellular telephone will at all times remain in the ownership of the Company and be returned to the Company immediately upon the termination of this Agreement, for any reason whatsoever. | ||
15. | Term of the Agreement |
15.1 | This Agreement will enter into effect on 19th December, 2004, and is made for an indefinite period and may be brought to an end by the parties by 60 days prior notice in writing. It is further hereby agreed that notwithstanding the foregoing, the Company reserves the right not to use the Employees services during the period of the prior notice mentioned or part thereof, provided that the Company pays her for the equivalent of the prior notice. | ||
15.2 | Notwithstanding the foregoing the Company will be entitled to bring this Agreement to an end immediately, upon the occurrence of one or more of the following events: |
15.2.1 | The Employee has committed a fundamental breach of this Agreement and has failed to rectify the same within 5 days of receiving notice to do so. | ||
15.2.2 | The Employee has been convicted of an infamous; | ||
15.2.3 | The Employee has betrayed her position with the Company or has breached her fiduciary duty towards it; | ||
15.2.4 | The Employee has breached the provisions contained in clauses 16, 17 and/or 18 hereof. | ||
15.2.5 | The Employee has wilfully caused or with gross negligence or assisted others wilfully or with gross negligence, to cause damage to the Company or its property. | ||
15.2.6 | In any case where full or partial payment of severance pay to the Employee may be denied, in accordance with the law customary in Israel. |
15.3 | Without derogating from any of the Companys rights pursuant to this Agreement and/or under the law, where the Employee has been dismissed by the Company in the circumstances set out in clause 15.2 above, the Company may immediately terminate payment of the Employees Salary and payment of the fringe benefits and immediately cease providing a vehicle for the Employees use. | ||
15.4 | The Employee undertakes, upon the termination of her employment with the Company, for any reason whatsoever, to hand over her position in an orderly fashion and fully co-operate with such person as the Company will instruct. The Employee further undertakes that upon the termination of her work in the Company, for any reason whatsoever, or at the Companys first request, whichever is the earlier, she will hand over to the Company all the documents, information, equipment and material in any form whatsoever, that has reached her |
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or that has been prepared by her in connection with her employment at the Company. |
16. | Confidentiality |
16.1 | The Employee hereby declares and acknowledges that she is aware that the information and knowledge of any kind whatsoever that has been or will be conveyed to her and/or which has or will reach her knowledge during the course of and/or consequent upon her employment with the Company, including, and without derogating from the generality of the foregoing, information relating to the Companys business, its know-how, (including technical, professional, trading and/or economic know-how), technology, suppliers, products, plans, customers, contractors, employees and the like (hereinafter: the Information) are highly confidential and of great value to the Company, and constitute professional and trade secrets of the Company and the disclosure thereof could cause damages and losses to the Company. | ||
16.2 | The Employee undertakes to keep absolutely secret all the Information, and not to disclose the same to any other person or entity, nor enable the disclosure thereof by others, directly or indirectly, (except as required in order to perform her Position, pursuant to this Agreement), either during the period of her employment with the Company as well as after the termination, for any reason whatsoever, of her employment with the Company, without any limitation in time. The foregoing will not apply to Information for which there is a duty to disclose by order of the court (subject to the Employee notifying the Company a reasonable time in advance of the duty to disclose the Information according to the order, and only disclose that part of the Information the disclosure of which is required by the order) and information that has fallen into the public domain, otherwise than by reason of any act or omission of the Employee. | ||
Pursuant to the Companys demand, from time to time, the Employee will sign a letter of undertaking to maintain confidentiality and prevent a conflict of interest, such letter to be in the form acceptable for the time being in the Company. | |||
16.3 | The Employee undertakes not to effect with the Information any use of whatsoever kind (directly or indirectly) otherwise than for the purpose of performing her Position, pursuant to this Agreement, both during and after the termination, for any reason whatsoever, of her employment with the Company, without limitation in time. | ||
16.4 | The Employee declares and acknowledges that the Company is not granting to her by virtue of this Agreement and/or her employment in the Company and/or otherwise, any right of any kind whatsoever, in or in connection with the Information, and that the Information is the Companys exclusive property and will remain the Companys exclusive property at all times, and without limitation in time. | ||
16.5 | The Employee declares and acknowledges that irreversible damages will be caused the Company, that cannot be remedied and/or compensated for financially, in the event of the Employee failing to meet her commitments under this Agreement, and that the Company could find itself in a situation in which it will have no suitable remedy by virtue of the law in the event of a breach by the |
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Employee of such undertakings. In light of the foregoing, the parties hereby agree that the Company will be entitled to apply for and obtain an injunction or such other relief as it may request, in the event of a breach or reasonable concern of a breach of the Employees undertakings under this Agreement. |
17. | Non-competition |
17.1 | The Employee undertakes that unless she receives the prior written consent of the Company, during the entire term of the existence of the employer-employee relationship between her and the Company and for a period of 12 months thereafter, for any reason whatsoever, she will not work for nor take part, directly or indirectly, in any business, whether incorporated or unincorporated, that competes with the Company or its business directly, all whether within the area of the State of Israel or abroad. | ||
17.2 | In addition the Employee undertakes that for a period of 24 months after the date of expiration of her employment with the Company, not to turn to or have any business connection whatsoever with any person or entity who, on or around the date of the termination of the Employees employment, were customers and/or suppliers of the Company, or were in negotiations with the Company in connection with the carrying out of any business with it and/or were the Companys employees and/or contractors and/or advisors and/or with any person or entity who, on such date was in any other business contact with the Company, all this in order to carry out directly or indirectly any act which might interfere with the relationship between the Company and any of the parties mentioned above, and/or damage the Company in any form or manner whatsoever. | ||
17.3 | For the avoidance of any doubt, the Employees undertakings according to this clause 17 are in addition to all the Employees undertakings under this Agreement, including, but without derogating from the generality of the foregoing, her undertaking according to clauses 16 and 18 of this Agreement. The Employee hereby declares and acknowledges that her undertakings according to this clause 17 are reasonable in the circumstances and that the amount of her salary has, inter alia, been set on reliance on these undertakings and constitutes proper consideration for such undertakings. | ||
17.4 | For the purpose of this clause 17 directly or indirectly includes, without derogating from the generality of the foregoing, by means of engaging in business as an owner, self-employed person, shareholder, partner, director, manager, agent, distributor, supplier, contractor, sub-contractor, employee, clerk or advisor. |
18. | Inventions and Developments |
18.1 | In this Agreement, the expression development means, any idea and/or invention and/or design and/or patent and/or copyright and/or document and/or software and/or computer programs of any kind whatsoever and/or process and/or system and/or procedure, all these including all and any accompanying documentation or annexed thereto, on any media whatsoever and including all the versions and copies thereof and everything pertaining thereto or resulting therefrom, including, and without derogating from the generality of the foregoing, any intellectual property right in connection therewith, all that has been developed and/or invented and/or written and/or created by the Employee during the period |
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of the employment in the Company and/or as a result of her work in the Company, whether alone or together with others, in their entirety or in part. | |||
18.2 | It is agreed and declared that the developments are and will be the Companys full and exclusive property and that the Employee has and will have any right therein whatsoever. For the removal of any doubt the Employee hereby transfers and assigns to the Company all of her rights, including, but without derogating from the generality of that stated, the right of ownership which she has or will have, alone or jointly with others, in all the developments, whether they are registrable as a patent or protectable as copyright, or protectable as intellectual or material property in any other way, or not. | ||
18.3 | For the avoidance of any doubt it is clarified that the Company will be entitled to use and market the developments and/or protect the same with registration by law or by any other method and also make changes and/or translations and/or derivative works thereof and/or translations thereof and/or exploit or use the same in any other way, for any purpose whatsoever, and on such terms as the Company will deem fit, at its sole discretion, without the need of the Employees consent and without derogating from the generality of that stated in clause 18.4 hereof, without the Employee being entitled by reason thereof to any consideration whatsoever. | ||
18.4 | The Employee will have no claim of any kind whatsoever against the Company in connection with any development. Without derogating from the foregoing, the Employee will not be entitled to receive any payment or other consideration in respect of the developments in addition to regular salary in respect of the period of her employment in the Company. | ||
18.5 | In connection with any one of the developments, the Employee undertakes to convey all information and particulars and, at the Companys request, to co-operate and promptly sign any document, including a specific transfer of ownership or any other right to the Company and effect any act that is required in order to enable the Company to register a patent, copyright or any protection, in any country whatsoever, or to realize its rights in any other way. | ||
18.6 | The Employees undertakings and the rights of the Company by virtue of this clause 18 are unlimited in time and are in addition to and does not derogate from any other right of the Company by law. |
19. | Miscellaneous |
19.1 | This Agreement encompasses the agreement between the parties and no agreement, memorandum, negotiations, statement, representation, undertaking or accord, whether made in writing or by word of mouth, expressly or impliedly between the parties prior to the signature of this Agreement, will be of any effect. | ||
19.2 | It is hereby agreed that the Employee will bear all taxes and other compulsory payments that will apply to her in respect of all the amounts that will be paid to her under this Agreement and in respect of all the benefits and/or advantages that will be conferred upon her, and the Company will deduct from her Salary the amount of any tax and/or other compulsory payment the deduction of which is required by any law. |
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19.3 | No conduct by any of the parties will be deemed to be a waiver of any of that partys rights hereunder or under any law and/or as a waiver or consent on its part to any breach or non-performance of any condition whatsoever unless such waiver or consent (as appropriate) has been approved by that party in writing. | ||
19.4 | Insofar as any of the undertakings of any party to this Agreement as set out herein are declared to be void or unenforceable this will not derogate from any of the other undertakings of that party, which will remain in full force and effect. Insofar as such undertaking is found to be void or unenforceable by reason of the extent or period thereof or like limitations, such unenforceable undertaking will be restricted so as to be enforceable in the extent and for the maximum period permitted by law, and which do not exceed the extent and period specified in this undertaking. | ||
19.5 | This Agreement is subject to Israeli law and any dispute relating thereto will be disposed of in the authorized court in Tel Aviv Yafo. | ||
19.6 | This Agreement may not be assigned or transferred by the Employee in any manner or to any person or body. | ||
19.7 | No modification to this Agreement will be of any effect nor may any of the conditions thereof may be amended without a written document bearing the signature of the parties. For the avoidance of any doubt it is clarified that none of the conditions of this Agreement may be amended by way of conduct, custom, and etc. | ||
19.8 | The addresses of the parties for the purposes of this Agreement are as set out at the head of this Agreement. Any notice (1) which will be sent by registered mail by one party to the other according to such address will be deemed to have been received by the addressee within 72 hours of the time of posting in Israel; (2) which has been delivered personally will be deemed to have been received by the addressee at the time of service and, (3) if despatched by fax, will be deemed to have been received by the addressee at the end of the transmission thereof and the receipt of a confirmation of despatch by the fax device from which the notice was sent. | ||
19.9 | The provisions of clauses 2.2, 7.2 and 12.2, the second paragraph of clause 14, 15.3, 15.4, 16, 17, 18, 19.2, 19.3, 19.5, 19.6, 19.8 and 19.9 will remain in force even after the termination of this Agreement for any reason whatsoever. |
/s/ David Aviezer
|
/s/ Einat Almon
|
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By:
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David Aviezer
|
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Protalix Ltd. Corporate no. 511903288 |
WHEREAS,
|
the Company is engaged, inter alia, in the research and development of proteins and expression thereof in plant cells cultures; and | |
WHEREAS,
|
the Company desires to engage David as an employee of the Company in the position of Companys Chief Executive Officer (CEO) and the Employee desires to serve the Company as an employee in such position, on the terms and conditions hereinafter set forth; |
1. | Employment. | |
1.1. | Commencing as of the Effective Date, the Company shall engage David as an employee in the position of CEO, reporting to the Board of Directors of the Company. | |
1.2. | The Employees duties and responsibilities shall be those duties and responsibilities customarily performed by a Chief Executive Officer of a company. | |
1.3. | The Employee shall be employed on a full-time basis. The Employee shall devote his full and undivided attention and full working time to the business and affairs of the Company and the fulfillment of his duties and responsibilities under this Agreement. | |
Without derogating from the generality of the above, during the term of this Agreement the Employee shall not be engaged in any other employment nor engage in any other business activity or render any services, with or without compensation, for any other person or entity. Notwithstanding the foregoing, it is agreed that (i) Employee shall be entitled to engage in academic activity and teaching during no more than two (2) hours per week and provided that such activity does not derogate from or hinder the performance of his obligations hereunder, as may be determined by the Board of Directors; and (ii) Employee shall be entitled to render limited consulting services to customers for up to a limited number of hours per month, provided however that (a) the provision of such services does not derogate from, or impair or hinder Employees performance of, any of Employees obligations hereunder; (b) the provision of such services is not against the Companys interests; and (c) the written consent of the Chairman of the Board for the provision of such services has been obtained in advance. The Chairman of the Board shall be entitled to withdraw or revoke his consent. | ||
The Employee shall notify the Company immediately of any event or circumstance which may hinder the performance of his obligations hereunder or result in the Employee having a conflict of interest with his position with the Company. |
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1.4. | The Employee acknowledges that the Companys facilities are located in Carmiel and that he will be required to attend such facilities at least two (2) working days per week. Employee further acknowledges and agrees that the performance of his duties hereunder may require significant domestic and international travel at the Companys needs. | |
1.5. | It is agreed between the Parties that the position that Employee holds within the Company is a management position, which demands a special level of loyalty and accordingly the Work Hours and Rest Law (1951) shall not apply to Employees employment by the Company and this Agreement. The Employee further acknowledges and agrees that his duties and responsibilities may entail irregular work hours and extensive traveling in Israel and abroad, for which he is adequately rewarded by the compensations provided for in this Agreement. The Parties confirm that this is a personal services contract and that the relationship between the Parties shall not be subject to any general or special collective bargaining agreement or any custom or practice of the Company in respect of any of its other employees or contractors. |
2. | Salary and Employee Benefits. |
2.1. | Salary. Effective as of January 1, 2006, the Company shall pay the Employee a gross salary of NIS 80,000 per month (the Salary). The Salary will be adjusted from time to time in accordance with the Cost of Living Index (Tosefet Yoker) as may be required by law. The Salary shall be payable monthly in arrears, and shall be paid to the Employee in accordance with Companys policy. A Salary increase shall be considered by Board annually. Without limiting the generality of the last paragraph of Section 2, the Employee confirms the receipt of the entire Salary in respect of the period commencing on January 1, 2006 and expiring on the Effective Date. |
2.2. | Bonuses. |
2.2.1 | Annual Bonus. |
2.2.2 | Bonus upon a Public Offering or Sale. |
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2.2.3 | Bonus Upon Achievement of Certain Clinical Development Milestones. |
(a) | Employee hereby confirms the receipt of a bonus in the amount of US$25,000 for IND approval of the Companys GCD product. | ||
(b) | Employee hereby confirms the receipt of a bonus in the amount of US$25,000 for the completion of the Companys Phase I Clinical Trial for the Companys GCD product | ||
(c) | Employee shall be entitled to a bonus in the amount of US$200,000 conditional upon the obtaining from the FDA or EMEA of a marketing approval of the Companys GCD product. |
2.3. | Options. Employee shall be entitled to options to purchase Ordinary Shares of the Company (Ordinary Shares), as follows: |
(a) | an option under the Companys 2003 Israeli Stock Option Plan (the Plan) to purchase 26,226 Ordinary Shares, pursuant to the terms of the Option Agreement attached hereto as Exhibit B; and | ||
(b) | an option under the Plan to purchase additional 16,000 Ordinary Shares (the Additional Option), subject to the following terms and conditions: |
2.4. | Managers Insurance. The Company shall insure the Employee under a Managers Insurance Policy, including insurance in the event of illness or loss of capacity for work (the Policy), and shall pay a sum of up to an aggregate of 15.83% of the Salary towards the Policy, of which (i) 8.33% shall be on account of severance compensation, which shall be payable to the Employee upon severance, in accordance with the provisions of this Agreement; (ii) 5% of the Salary on account of pension fund payments; and (iii) up to 2.5% of the Salary on account of disability pension payments. The Company shall deduct 5% from the Salary to be paid on behalf of the Employee towards the Policy. The Employee may extend an existing policy or plan and incorporate it into the Policy, at his discretion. |
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2.5. | Vocational Studies. The Company shall open and maintain a Keren Hishtalmut Fund for the benefit of the Employee (the Fund). The Company shall contribute to such Fund an amount equal to 7-1/2% of the Salary and the Employee shall contribute to the Fund an amount equal to 2-1/2% of the Salary. The Employee hereby instructs the Company to transfer to the Fund Employees contribution from the Salary. | |
2.6. | Vacation. The Employee shall be entitled to annual paid vacation of 24 working days. Subject to applicable law, up to two (2) years equivalent of vacation days may be accumulated and may, at the Employees option, upon thirty (30) days prior written notice to the Company, be converted into cash payments in an amount equal to the proportionate part of the Salary for such days. Without limiting the generality of the last paragraph of Section 2, the Employee confirms that neither he nor Agenda is entitled to any vacation and/or vacation pay with respect to the services provided by any of them to the Company through the Effective Date or activities conducted under the Services Agreement (as defined in Section 7 below) or otherwise, prior to the Effective Date. |
2.7. | Sick Leave. The Employee shall be entitled to fully paid sick leave pursuant to the Sick Pay Law (1976). | |
2.8. | Annual Recreation Allowance (Dmei Havraa). The Employee shall be entitled to annual recreation allowance according to applicable law. | |
2.9. | Company Car. |
(a) | The Company shall provide the Employee with a Company car (the Company Car), as determined by the Board of Directors of the Company (the Board of Directors or Board), at its discretion, which car shall be categorized Group 4. The Company Car shall be placed with the Employee for his business and personal use. Employee shall take good care of the Company Car and ensure that the provisions of the insurance policy and the Companys rules relating to the Company Car are strictly, lawfully and carefully observed. | ||
(b) | Subject to applicable law, the Company shall bear all fixed and ongoing expenses relating to the Company Car and to the use and maintenance thereof, excluding expenses incurred in connection with any violations of law, which shall be paid |
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solely by Employee. The Employee shall bear any and all taxes applicable to him in connection with said Company Car and the use thereof, in accordance with income tax regulations applicable thereto. | |||
(c) | Upon the termination of employment hereunder, the Employee shall return the Company Car (together with its keys and any other equipment supplied and/or installed therein by Company and any documents relating to the Company Car) to the Companys principal office. Employee shall have no rights of lien with respect to the Company Car and/or any of said equipment and documents. |
2.10. | Telephone. The Company shall furnish, for the use of the Employee, a cellular telephone (the Company Phone), and shall bear all the costs and expenses associated with the use of the Company Phone. The Company will bear the tax applicable to the use of the Company Phone by the Employee, according to applicable law. All such costs, expenses and tax payments borne and payable by the Company pursuant to this Section 2.10 are included in the Salary. The provisions of Section 2.9(c) above shall apply to the Company Phone, mutatis mutandis. | |
2.11. | Certain Reimbursements. The Employee shall be entitled to full reimbursement from the Company for reasonable expenses incurred during the performance of his duties hereunder upon submission of substantiating documents, according to the Companys policy. | |
2.12. | Taxes. The Employee will bear any tax applicable on the payment or grant of any of the above Salary and/or benefits, according to the then applicable law. The Company shall be entitled to and shall deduct and withhold from any amount or benefit payable to the Employee, any and all taxes, withholdings or other payments as required under any applicable law. |
3. | Confidentiality | |
3.1. | The Employee hereby agrees that he shall not, directly or indirectly, disclose or use at any time any trade secrets or other confidential information of any type or nature, whether patentable or not, of the Company, its subsidiaries or affiliates now or hereafter existing, including but not limited to, any (i) processes, formulas, trade secrets, copyrights, innovations, inventions, discoveries, improvements, research or development and test results, specifications, data, patents, patent applications and know-how of any type or nature; (ii) marketing plans, business plans, strategies, forecasts, financial information, budgets, projections, product plans and pricing; (iii) personnel information, salary, and qualifications of employees; (iv) agreements, customer and supplier information, including identities and product sales forecasts; and (v) any other information of a confidential or proprietary nature (collectively, Confidential Information), of which the Employee is or becomes informed or aware during the employment, whether or not developed by the Employee, it being agreed that for purposes of this Section 3.1, the term Confidential Information shall not include information that has entered into the public domain through no wrongful act by Employee. Upon termination of this Agreement, or at any other time upon request of the Company, the Employee shall promptly deliver to the |
5
Company all physical and electronic copies and other embodiments of Confidential Information and all memoranda, notes, notebooks, records, reports, manuals, drawings, blueprints and any other documents or things belonging to the Company, and all copies thereof, in all cases, which are in the possession or under the control of the Employee. |
3.2. | Employee hereby acknowledges and that all Confidential Information and any other rights in connection therewith are and shall at all times remain the sole property of the Company. | |
4. | Non-Competition and Non-Solicitation | |
4.1. | The Employee agrees and undertakes that he will not, for so long as (i) this Agreement is in effect, or (ii) he serves as a member of the Board of Directors and for a period of two (2) years after the later of the above lapses for whatever reason (the Non-Competition Period), compete or to assist others to compete, whether directly or indirectly, with the business of the Company, as currently conducted and as conducted and/or proposed to be conducted during the Non-Competition Period. | |
4.2. | The Employee further agrees and undertakes that during the Non-Competition Period, he will not directly or indirectly solicit any business which is similar to the Companys business from individuals or entities that are customers, suppliers or contractors of the Company, any of its subsidiaries or affiliates during the Non-Competition Period, without the prior written consent of the Companys Board of Directors. | |
4.3. | The Employee further agrees and undertakes that during the Non-Competition Period, without the prior written consent of the Companys Board of Directors, he will not offer to employ, in any way directly or indirectly solicit or seek to obtain or achieve the employment by any business or entity of, and/or during the term hereof, employ, any person employed by either the Company, its subsidiaries, affiliates, or any successors or assigns thereof during the Non-Competition Period. | |
4.4. | The Parties hereto agree that the duration and area for which the covenants set forth in this Section 4 are to be effective are necessary to protect the legitimate interests of the Company and its development efforts and accordingly are reasonable, in terms of their geographical and temporal scope. In the event that any court determines that the time period and/or area are unreasonable and that such covenants are to that extent unenforceable, the Parties hereto agree that such covenants shall remain in full force and effect for the greatest period of time and in the greatest geographical area that would not render them unenforceable. In addition, the Employee acknowledges and agrees that a breach of Sections 3, 4 or 5 hereof, shall cause irreparable harm to the Company, its subsidiaries, and/or affiliates and that the Company shall be entitled to specific performance of this Agreement or an injunction without proof of special damages, together with the costs and reasonable attorneys fees and disbursements incurred by the Company in enforcing its rights under Sections 3, 4 or 5. The Employee acknowledges that the compensation and benefits he receives hereunder are paid, inter alia, as consideration for his undertakings contained in Sections 3, 4 and 5. |
5. | Creations and Inventions | |
5.1. | The Company shall be the sole and exclusive owner of any Inventions (as defined below), and Employee hereby assigns to the Company any and all of his rights, title and interest in such intellectual property free and clear of any third parties rights. The Employee shall inform the Company of any Invention relating to the Companys technology, its applications components or any intellectual property relating thereto, and shall execute any necessary assignments, patent forms and the like and will assist in the drafting of any |
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description or specification of the Invention as may be required for the Companys records and in connection with any application for patents or other forms of legal protection that may be sought by the Company. The Employee shall treat all information relating to any Invention as Confidential Information according to Section 3 above. |
5.2. | Without limiting the foregoing, Inventions shall include any and all intellectual property, including without limitation, ideas, inventions, processes, formulas, source and object codes, data, programs, know how, improvements, discoveries, designs, techniques, trade secrets, patents and patents applications, copyrights, mask work and any other intellectual property rights throughout the world, generated, produced, reduced to practice, or developed by Employee during or in connection with his employment by the Company. | |
5.3. | The Companys rights under this Section 5 shall be worldwide, and shall apply to any such Invention notwithstanding that it is perfected or reduced to specific form after the Employee has ceased his services hereunder. | |
6. | Term and Termination. | |
6.1. | This Agreement shall be in effect commencing as of the Effective Date and shall continue in full force and effect for an undefined period, unless and until terminated by either Party by ninety (90) days prior written notice to the other Party. Each of such prior notice periods shall be referred to as the Notice Period, as applicable. | |
6.2. | Notwithstanding anything to the contrary herein, the Company may terminate this Agreement in the event of the inability of the Employee to perform his duties hereunder, whether by reason of injury (mental or physical), illness or otherwise, incapacitating the Employee for a period exceeding 90 days. | |
6.3. | Notwithstanding anything to the contrary herein, the Company may terminate this Agreement at any time, effective immediately and without need for prior written notice, and without derogating from any other remedy to which the Company may be entitled, for Cause. | |
For the purposes of this Agreement, the term Cause shall mean: (i) a material breach by Employee of this Agreement; (ii) any breach by Employee of his fiduciary duties or duties of care to the Company; (iii) Employees dishonesty or fraud or felonious conduct; (iv) Employees embezzlement of funds of the Company; (v) any conduct by Employee, alone or together with others, which is materially injurious to the Company, monetary or otherwise; (vi) Employees gross negligence or willful misconduct in performance of his duties and/or responsibilities hereunder; (vii) Employees disregard or insubordination of any lawful resolution and/or instruction of the Board of Directors with respect to Employees duties and/or responsibilities towards the Company; (viii) the occurrence of an event or circumstance which may result in the Employee having a conflict of interest with his position with the Company, without Employee having notified the Company thereof, as provided herein; (ix) any breach by Employee of his confidentiality undertakings to the Company; or (x) any consequences which would entitle the Company to terminate Employees employment without severance payments under the Severance Pay Law. | ||
6.4. | The Employee shall cooperate with the Company and assist the integration into the Companys organization of the person or persons who will assume the Employees responsibilities, pursuant to Companys instructions. At the option of the Company, the Employee shall, during such period, either continue with his duties or remain absent from the premises of the Company, subject to applicable law. At any time during the |
7
Notice Period, the Company may elect to terminate this Agreement and the relationship with the Employee immediately, provided, that Employee shall be entitled to all payments and other benefits due to him hereunder as he would have been entitled to receive for the remaining period of the Notice Period. |
6.5. | Upon termination of Employees employment with the Company hereunder, for any reason whatsoever, the Company shall have no further obligation or liability towards the Employee in connection with his employment as aforesaid. The Company may set-off any outstanding amounts due to it by Employee against any payment due by the Company to the Employee, subject to applicable law. Without limiting the generality of the foregoing, in the event that Employee fails to comply with his prior notice or other obligations hereunder or under applicable law, the Company shall be entitled to set-off any amount to which Employee would have been entitled during the Notice Period, from any payment due by the Company to the Employee, all without prejudice to any other remedy to which the Company may be entitled pursuant to this Agreement or applicable law. | |
6.6. | The provisions of Sections 2.9(c), last sentence of Section 2.10, 3, 4, 5, 6.5, 6.6 and 9.4 shall survive the termination or expiration of this Agreement for any reason whatsoever. | |
7. | Termination of Services Agreement. | |
7.1. | The Company and Agenda Biotechnology Ltd., a company wholly owned by David (Agenda), hereby terminate the Advisory and Consultancy Services Agreement between the Company and Agenda dated February 11, 2003, as amended on May 24, 2004 (the Services Agreement), and agree that, as from the Effective Date, Davids engagement by the Company shall be governed solely by this Agreement. | |
8. | Notices. | |
8.1. | Any and all notices and communications in connection with this Agreement shall be in writing, addressed to the parties as follows: |
If to the Company: | Protalix Ltd. | |||
2 Snunit Street, POB 455, Carmiel, 20100, Israel | ||||
It to the Employee: | David Aviezer | |||
4 Hatena St., POB 1914, Hashmonaim, 73127, Israel |
8.2. | All notices shall be given by registered mail (postage prepaid), by facsimile or email or otherwise delivered by hand or by messenger to the Parties respective addresses as above or such other address as may be designated by notice. Any notice sent in accordance with this Section 8 shall be deemed received upon the earlier of: (i) if sent by facsimile or email, upon transmission and electronic confirmation of transmission or (if transmitted and received on a non-business day) on the first business day following transmission and electronic confirmation of transmission, (ii) if sent by registered mail, upon 3 (three) days of mailing, (iii) if sent be messenger, upon delivery; and (iv) the actual receipt thereof. |
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9. | Miscellaneous. | |
9.1. | Headings; Interpretation. Section and Subsection headings contained herein are for reference and convenience purposes only and shall not in any way be used for the interpretation of this Agreement. | |
9.2. | Entire Agreement. This Agreement constitutes the entire agreement between the Parties with respect to the subject matters hereof and cancels and supersedes all prior agreements, understandings and arrangements, oral or written, between the Parties with respect to such subject matters. | |
9.3. | Amendment; Waiver. No provision of this Agreement may be modified or amended unless such modification or amendment is agreed to in writing and signed by the Employee and the Company. The observance of any term hereof may be waived (either prospectively or retroactively and either generally or in a particular instance) only with the written consent of the Party against which/whom such waiver is sought. No waiver by either Party at any time to act with respect to any breach or default by the other Party of, or compliance with, any condition or provision of this Agreement to be performed by such other Party shall be deemed a waiver of similar or dissimilar provisions or conditions at the same or at any prior or subsequent time. | |
9.4. | Governing Law; Dispute Resolution. This Agreement shall be governed by and construed in accordance with the laws of the State of Israel. Any dispute arising out of or relating to this Agreement shall be resolved by a single arbitrator to be appointed by the Parties, or in the event the Parties fail to agree on the identity of the arbitrator within ten (10) days of a Partys request to appoint same, the arbitrator shall be appointed by the Chairman of the Israeli Bar Association. | |
Arbitration proceedings shall be conducted for no longer than forty-five (45) days. The proceedings shall be conducted in Hebrew and according to the rules of substantive law. The arbitrator will not be bound by rules of evidence or procedure and will give a reasoned decision, in writing. The arbitrators decision shall be final and binding in any court. Unless otherwise determined by the arbitrator, each party to the proceedings shall bear its own expenses and the arbitrators fees and expenses shall be borne in equal parts by the parties to the proceedings. | ||
This Section shall constitute an arbitration agreement between the Parties. | ||
9.5. | Severability. The provisions of this Agreement shall be deemed severable and the invalidity or unenforceability of any provision shall not affect the validity or enforceability of the other provisions hereof. If any part of this Agreement is determined to be invalid, illegal or unenforceable, such determination shall not affect the validity, legality or enforceability of any other part of this Agreement; and the remaining parts shall be enforced as if such invalid, illegal, or unenforceable part were not contained herein, provided, however, that in such event this Agreement shall be interpreted so as to give effect, to the greatest extent consistent with and permitted by applicable law, to the meaning and intention of the excluded provision as determined by such court of competent jurisdiction. | |
9.6. | Assignment. Neither this Agreement or any of the Employees rights, privileges, or obligations set forth in, arising under, or created by this Agreement may be assigned or transferred by the Employee without the prior consent in writing of the Company. The Company shall be entitled to assign its rights and obligations hereunder to any entity |
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acquiring a material part of its assets or to a subsidiary or affiliate thereof (as such terms are defined in the Israeli Securities Law-1968). |
/s/ Eli Hurvitz
|
/s/ David Aviezer
|
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By: Eli Hurvitz |
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Agreed as applicable to it: |
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/s/ David Aviezer
|
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By: David Aviezer |
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WHEREAS, | the Company is engaged, inter alia, in the research and development of proteins and expression thereof in plant cells cultures; and |
WHEREAS, | the Company desires to employ the Employee in the position of Companys Chief Financial Officer (CFO) and the Employee desires to be employed by the Company in such position, on the terms and conditions hereinafter set forth; |
1. | Employment. | |
1.1. | Commencing as of the Effective Date, the Company shall employ the Employee in the position of CFO, reporting to the Chief Executive Officer of the Company (CEO). | |
1.2. | The Employees duties and responsibilities shall be those duties and responsibilities customarily performed by a Chief Financial Officer of a company, as may be determined from time to time by the CEO. These will include, inter alia, the following: |
| Supervision of recording of transactions and balances | ||
| Supervision of administrative accounting staff | ||
| Management of tax and related payments | ||
| Banking relations |
| Ensuring overall integrity of accounting systems | ||
| Ensuring that applicable data is standardized and systems are well structured for proper and easily accessible reporting | ||
| Acting as Chief Accounting Officer (CAO) to determine accounting policies and assist others in accounting related matters | ||
| Working with others in the company to determine financial policies and reporting practices | ||
| Identifying emerging tax and reporting issues and coordinating policies with outside accountants and lawyers | ||
| Implementation of internal control procedures |
| Preparing cash flow projections | ||
| Preparing monthly financial summaries and key performance indicators | ||
| Preparing and implementing budget and financial portion of business plan |
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| Preparing quarterly and annual financial statements, notes and related information, and any other information as may be required according to US GAAP, tax, securities and other applicable statutes and regulations, SEC reports, etc. | ||
| Working with public and private investors to explain financial information and verify integrity of systems. |
1.3. | The Employee shall be employed on a full-time basis. The Employee shall devote his full and undivided attention and full working time to the business and affairs of the Company and the fulfillment of his duties and responsibilities under this Agreement, it being agreed that during the period from the Effective Date until the end of calendar year 2006 (the Assistance Period) Employee shall be entitled to assist his immediately prior employer in the integration into such employers organization of the person who will assume the Employees position therein, provided however that (i) such assistance is given up to a limited amount of hours per month during the Assistance Period, (ii) the provision of such assistance is coordinated promptly in advance with the CEO, and (iii) is the provision of such assistance does not derogate from any of Employees obligations hereunder or the performance of any of its duties or responsibilities hereunder. | |
Without derogating from the generality of the above, during the term of this Agreement the Employee shall not be engaged in any other employment nor engage in any other business activity or render any services, with or without compensation, for any other person or entity. | ||
The Employee shall notify the Company immediately of any event or circumstance which may hinder the performance of his obligations hereunder or result in the Employee having a conflict of interest with his position with the Company. | ||
1.4. | The Employee acknowledges that the Companys facilities are located in Carmiel and that he will be required to attend such facilities at least three (3) working days per week, unless coordinated otherwise with the CEO. Employee further acknowledges and agrees that the performance of his duties hereunder may require significant domestic and international travel at the Companys request. | |
1.5. | It is agreed between the Parties that the position that Employee holds within the Company is a management position, which demands a special level of loyalty and accordingly the Work Hours and Rest Law (1951) shall not apply to Employees employment by the Company and this Agreement. The Employee further acknowledges and agrees that his duties and responsibilities may entail irregular work hours and extensive traveling in Israel and abroad, for which he is adequately rewarded by the compensations provided for in this Agreement. The Parties confirm that this is a personal services contract and that the relationship between the Parties shall not be subject to any general or special collective bargaining agreement or any custom or practice of the Company in respect of any of its other employees or contractors. | |
2. | Salary and Employee Benefits. |
2.1. | Salary. The Company shall pay the Employee a gross salary of NIS 45,000 per month (the Salary). The Salary will be adjusted from time to time in accordance with the |
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Cost of Living Index (Tosefet Yoker) as may be required by law. The Salary shall be payable monthly in arrears, and shall be paid to the Employee in accordance with Companys policy. | ||
2.2. | Bonuses. | |
2.2.1 Annual Bonus. | ||
At the end of each calendar year, the Company shall consider granting the Employee an annual bonus, at the Companys sole discretion and without any obligation on Companys part to grant such bonus. Without limiting such Companys sole discretion, Employees skills, performance of, and dedication to, his duties hereunder shall serve as a factor in Companys determination as aforesaid. | ||
2.2.2 Bonus upon Achievement of Significant Milestones. | ||
The Company shall consider granting the Employee a bonus upon achievement of a significant milestone by the Company, at the Companys sole discretion and without any obligation on Companys part to grant such bonus. Without limiting such Companys sole discretion, Employees contribution to the achievement of such a significant milestone shall serve as a key factor in Companys determination as aforesaid. | ||
2.3. | Options. Employee shall be entitled to an option (the Option) to purchase 9,300 Ordinary Shares of the Company (Ordinary Shares) under the Companys 2003 Israeli Stock Option Plan, subject to the approval of the Board of Directors of the Company (the Board) and the following additional terms and conditions: |
2.4. | Managers Insurance. The Company shall insure the Employee under a Managers Insurance Policy, including insurance in the event of illness or loss of capacity for work (the Policy), and shall pay a sum of up to an aggregate of 15.83% of the Salary towards the Policy, of which (i) 8.33% shall be on account of severance compensation, which shall be payable to the Employee upon severance, in accordance with the provisions of this Agreement; (ii) 5% of the Salary on account of pension fund payments; and (iii) up to 2.5% of the Salary on account of disability pension payments. The Company shall deduct 5% from the Salary to be paid on behalf of the Employee towards the Policy. The Employee may extend an existing policy or plan and incorporate it into the Policy, at his discretion. | |
The Company and the Employee agree and acknowledge that in the event the Company transfers ownership of the Policy or the right to receive such policy to the Employee, then such transfer shall be credited against any obligation that the Company may have to pay severance pay to the Employee pursuant to the Severance Pay Law 1963 (the Severance Pay Law). Employee agrees that the payments by the Company to the Policy in accordance with the terms hereof, shall be instead of any statutory obligation of the Company to pay severance pay to the Employee, and not in addition thereto, all |
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in accordance with Section 14 of the Severance Pay Law. The Parties hereby adopt the General Approval of the Minister of Labor and Welfare, on Employers Payments to Pension Funds and Insurance Policies Instead of Severance Pay According to Section 14 of the Severance Pay Law, attached hereto as Exhibit A. | ||
The Company hereby waives its right to a refund of payments it made to the Policy, except: (i) in the event that Employees right to severance pay was denied by a final judgment pursuant to Section 16 or 17 of the Severance Pay Law (in which case Company shall only be entitled to a refund of such funds to the extent that severance pay was denied); or (ii) in the event that the Employee withdrew monies from the Policy (other than by reason of an Entitling Event, i.e. death, disability or retirement at or after the age of sixty (60)). | ||
2.5. | Vocational Studies. The Company shall open and maintain a Keren Hishtalmut Fund for the benefit of the Employee (the Fund). The Company shall contribute to such Fund an amount equal to 7-1/2% of the Salary and the Employee shall contribute to the Fund an amount equal to 2-1/2% of the Salary. The Employee hereby instructs the Company to transfer to the Fund Employees contribution from the Salary. Upon termination of this Agreement by either Party, other than termination by the Company for Cause, the Company shall assign and transfer to the Employee the ownership in the Fund. | |
2.6. | Vacation. The Employee shall be entitled to annual paid vacation of 24 working days. Subject to applicable law, up to two (2) years equivalent of vacation days may be accumulated and may, at the Employees option, upon thirty (30) days prior written notice to the Company, be converted into cash payments in an amount equal to the proportionate part of the Salary for such days. | |
Employee shall coordinate in advance with the CEO the dates of the vacation hereunder. | ||
2.7. | Sick Leave. The Employee shall be entitled to fully paid sick leave pursuant to the Sick Pay Law (1976). | |
2.8. | Annual Recreation Allowance (Dmei Havraa). The Employee shall be entitled to annual recreation allowance according to applicable law. | |
2.9. | Company Car. |
(a) | The Company shall provide the Employee with a Company car (the Company Car), as determined by the CEO, at his discretion, which car shall be categorized Group 4. The Company Car shall be placed with the Employee for his business and personal use. Employee shall take good care of the Company Car and ensure that the provisions of the insurance policy and the Companys rules relating to the Company Car are strictly, lawfully and carefully observed. | ||
(b) | Subject to applicable law, the Company shall bear all fixed and ongoing expenses relating to the Company Car and to the use and maintenance thereof, excluding expenses incurred in connection with any violations of law, which shall be paid solely by Employee. The Company shall gross-up any and all taxes applicable in connection with said Company Car and the use thereof, in accordance with applicable income tax regulations. All such expenses borne, and tax payments grossed-up, by the Company pursuant to this Section 2.9(b) are included in the Salary. | ||
(c) | Upon the termination of employment hereunder, the Employee shall return the Company Car (together with its keys and any other equipment supplied and/or |
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installed therein by Company and any documents relating to the Company Car) to the Companys principal office. Employee shall have no rights of lien with respect to the Company Car and/or any of said equipment and documents. |
2.10. | Telephone. The Company shall furnish, for the use of the Employee, a cellular telephone (the Company Phone), and shall bear all the costs and expenses associated with the use of the Company Phone. The Company will bear the tax applicable to the use of the Company Phone by the Employee, according to applicable law. All such costs, expenses and tax payments borne and payable by the Company pursuant to this Section 2.10 are included in the Salary. The provisions of Section 2.9(c) above shall apply to the Company Phone, mutatis mutandis. | |
2.11. | Certain Reimbursements. The Employee shall be entitled to full reimbursement from the Company for reasonable expenses incurred during the performance of his duties hereunder up to a limit of NIS 1,500 per month, upon submission of substantiating documents, according to the Companys policy. The reimbursement of any expenses in excess of the foregoing limit shall require the prior approval of the CEO. | |
2.12. | Taxes. The Employee will bear any tax applicable on the payment or grant of any of the above Salary and/or benefits, according to the then applicable law. The Company shall be entitled to and shall deduct and withhold from any amount or benefit payable to the Employee, any and all taxes, withholdings or other payments as required under any applicable law. | |
3. | Confidentiality | |
3.1. | The Employee hereby agrees that he shall not, directly or indirectly, disclose or use at any time any trade secrets or other confidential information of any type or nature, whether patentable or not, of the Company, its subsidiaries, affiliates or parent company now or hereafter existing, including but not limited to, any (i) processes, formulas, trade secrets, copyrights, innovations, inventions, discoveries, improvements, research or development and test results, specifications, data, patents, patent applications and know-how of any type or nature; (ii) marketing plans, business plans, strategies, forecasts, financial information, budgets, projections, product plans and pricing; (iii) personnel information, salary, and qualifications of employees; (iv) agreements, customer and supplier information, including identities and product sales forecasts; and (v) any other information of a confidential or proprietary nature (collectively, Confidential Information), of which the Employee is or becomes informed or aware during the employment, whether or not developed by the Employee, it being agreed that for purposes of this Section 3.1, the term Confidential Information shall not include information that has entered into the public domain through no wrongful act by Employee. Upon termination of this Agreement, or at any other time upon request of the Company, the Employee shall promptly deliver to the Company all physical and electronic copies and other embodiments of Confidential Information and all memoranda, notes, notebooks, records, reports, manuals, drawings, blueprints and any other documents or things belonging to the Company, and all copies thereof, in all cases, which are in the possession or under the control of the Employee. | |
3.2. | Employee hereby acknowledges and that all Confidential Information and any other rights in connection therewith are and shall at all times remain the sole property of the Company. | |
4. | Non-Competition and Non-Solicitation | |
4.1. | The Employee agrees and undertakes that he will not, for so long as this Agreement is in effect and for a period of two (2) years thereafter (the Non-Competition Period), |
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compete or to assist others to compete, whether directly or indirectly, with the business of the Company, as currently conducted and as conducted and/or proposed to be conducted during the Non-Competition Period. | ||
4.2. | The Employee further agrees and undertakes that during the Non-Competition Period, he will not directly or indirectly solicit any business which is similar to the Companys business from individuals or entities that are customers, suppliers or contractors of the Company, any of its subsidiaries, affiliates or parent company during the Non-Competition Period, without the prior written consent of the CEO. | |
4.3. | The Employee further agrees and undertakes that during the Non-Competition Period, without the prior written consent of the CEO, he will not employ, offer to employ, or in any way directly or indirectly solicit or seek to obtain or achieve the employment by any business or entity of any person employed by either the Company, its subsidiaries, affiliates, parent company or any successors or assigns thereof during the Non-Competition Period. | |
4.4. | The Parties hereto agree that the duration and area for which the covenants set forth in this Section 4 are to be effective are necessary to protect the legitimate interests of the Company and its development efforts and accordingly are reasonable, in terms of their geographical and temporal scope. In the event that any court determines that the time period and/or area are unreasonable and that such covenants are to that extent unenforceable, the Parties hereto agree that such covenants shall remain in full force and effect for the greatest period of time and in the greatest geographical area that would not render them unenforceable. In addition, the Employee acknowledges and agrees that a breach of Sections 3, 4 or 5 hereof, shall cause irreparable harm to the Company, its subsidiaries, affiliates and/or parent company and that the Company shall be entitled to specific performance of this Agreement or an injunction without proof of special damages, together with the costs and reasonable attorneys fees and disbursements incurred by the Company in enforcing its rights under Sections 3, 4 or 5. The Employee acknowledges that the compensation and benefits he receives hereunder are paid, inter alia, as consideration for his undertakings contained in Sections 3, 4 and 5. | |
5. | Creations and Inventions | |
5.1. | The Company shall be the sole and exclusive owner of any Inventions (as defined below), and Employee hereby assigns to the Company any and all of his rights, title and interest in such intellectual property free and clear of any third parties rights. The Employee shall inform the Company of any Invention relating to the Companys technology, its applications components or any intellectual property relating thereto, and shall execute any necessary assignments, patent forms and the like and will assist in the drafting of any description or specification of the Invention as may be required for the Companys records and in connection with any application for patents or other forms of legal protection that may be sought by the Company. The Employee shall treat all information relating to any Invention as Confidential Information according to Section 3 above. | |
5.2. | Without limiting the foregoing, Inventions shall include any and all intellectual property, including without limitation, ideas, inventions, processes, formulas, source and object codes, data, programs, know how, improvements, discoveries, designs, techniques, trade secrets, patents and patents applications, copyrights, mask work and any other intellectual property rights throughout the world, generated, produced, reduced to practice, or developed by Employee during or in connection with his employment by the Company. |
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5.3. | The Companys rights under this Section 5 shall be worldwide, and shall apply to any such Invention notwithstanding that it is perfected or reduced to specific form after the Employee has ceased his services hereunder. | |
6. | Term and Termination. | |
6.1. | This Agreement shall be in effect commencing as of the Effective Date and shall continue in full force and effect for an undefined period, unless and until terminated by either Party by sixty (60) days prior written notice to the other Party. Each of such prior notice periods shall be referred to as the Notice Period, as applicable. | |
6.2. | Notwithstanding anything to the contrary herein, the Company may terminate this Agreement in the event of the inability of the Employee to perform his duties hereunder, whether by reason of injury (mental or physical), illness or otherwise, incapacitating the Employee for a period exceeding 90 days. | |
6.3. | Notwithstanding anything to the contrary herein, the Company may terminate this Agreement at any time, effective immediately and without need for prior written notice, and without derogating from any other remedy to which the Company may be entitled, for Cause. | |
For the purposes of this Agreement, the term Cause shall mean: (i) a material breach by Employee of this Agreement; (ii) any breach by Employee of his fiduciary duties or duties of care to the Company; (iii) Employees dishonesty or fraud or felonious conduct; (iv) Employees embezzlement of funds of the Company; (v) any conduct by Employee, alone or together with others, which is materially injurious to the Company, monetary or otherwise; (vi) Employees gross negligence or willful misconduct in performance of his duties and/or responsibilities hereunder; (vii) Employees disregard or insubordination of any lawful resolution and/or instruction of the CEO with respect to Employees duties and/or responsibilities towards the Company; (viii) the occurrence of an event or circumstance which may result in the Employee having a conflict of interest with his position with the Company, without Employee having notified the Company thereof, as provided herein; (ix) any breach by Employee of his confidentiality undertakings to the Company; or (x) any consequences which would entitle the Company to terminate Employees employment without severance payments under the Severance Pay Law. | ||
6.4. | The Employee shall cooperate with the Company and assist the integration into the Companys organization of the person or persons who will assume the Employees responsibilities, pursuant to Companys instructions. At the option of the Company, the Employee shall, during such period, either continue with his duties or remain absent from the premises of the Company, subject to applicable law. At any time during the Notice Period, the Company may elect to terminate this Agreement and the relationship with the Employee immediately, provided, that Employee shall be entitled to all payments and other benefits due to him hereunder as he would have been entitled to receive for the remaining period of the Notice Period. | |
6.5. | Upon termination of Employees employment with the Company hereunder, for any reason whatsoever, the Company shall have no further obligation or liability towards the Employee in connection with his employment as aforesaid. The Company may set-off any outstanding amounts due to it by Employee against any payment due by the Company to the Employee, subject to applicable law. Without limiting the generality of the foregoing, in the event that Employee fails to comply with his prior notice or other obligations hereunder or under applicable law, the Company shall be entitled to set-off |
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any amount to which Employee would have been entitled during the Notice Period, from any payment due by the Company to the Employee, all without prejudice to any other remedy to which the Company may be entitled pursuant to this Agreement or applicable law. | ||
6.6. | The provisions of Sections 2.9(c), last sentence of Section 2.10, Sections 3, 4, 5, 6.5, 6.6 and 8.4 shall survive the termination or expiration of this Agreement for any reason whatsoever. The provisions of the last sentence of Section 2.5 shall survive the termination of this Agreement subject to the terms set forth in such sentence. | |
7. | Notices. | |
7.1. | Any and all notices and communications in connection with this Agreement shall be in writing, addressed to the parties as follows: |
If to the Company: | Protalix Ltd. | |||
2 Snunit Street, POB 455, Carmiel, 20100, Israel | ||||
It to the Employee: | Yossef Maimon | |||
10 Feinstein St., Tel Aviv |
7.2. | All notices shall be given by registered mail (postage prepaid), by facsimile or email or otherwise delivered by hand or by messenger to the Parties respective addresses as above or such other address as may be designated by notice. Any notice sent in accordance with this Section 7 shall be deemed received upon the earlier of: (i) if sent by facsimile or email, upon transmission and electronic confirmation of transmission or (if transmitted and received on a non-business day) on the first business day following transmission and electronic confirmation of transmission, (ii) if sent by registered mail, upon 3 (three) days of mailing, (iii) if sent by messenger, upon delivery; and (iv) the actual receipt thereof. | |
8. | Miscellaneous. | |
8.1. | Headings; Interpretation. Section and Subsection headings contained herein are for reference and convenience purposes only and shall not in any way be used for the interpretation of this Agreement. | |
8.2. | Entire Agreement. This Agreement constitutes the entire agreement between the Parties with respect to the subject matters hereof and cancels and supersedes all prior agreements, understandings and arrangements, oral or written, between the Parties with respect to such subject matters. | |
8.3. | Amendment; Waiver. No provision of this Agreement may be modified or amended unless such modification or amendment is agreed to in writing and signed by the Employee and the Company. The observance of any term hereof may be waived (either prospectively or retroactively and either generally or in a particular instance) only with the written consent of the Party against which/whom such waiver is sought. No waiver by either Party at any time to act with respect to any breach or default by the other Party of, or compliance with, any condition or provision of this Agreement to be performed by such other Party shall be deemed a waiver of similar or dissimilar provisions or conditions at the same or at any prior or subsequent time. | |
8.4. | Governing Law; Dispute Resolution. This Agreement shall be governed by and construed in accordance with the laws of the State of Israel. Any dispute arising out of or relating to this Agreement shall be exclusively resolved by the competent court in Tel-Aviv Jaffa. |
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8.5. | Severability. The provisions of this Agreement shall be deemed severable and the invalidity or unenforceability of any provision shall not affect the validity or enforceability of the other provisions hereof. If any part of this Agreement is determined to be invalid, illegal or unenforceable, such determination shall not affect the validity, legality or enforceability of any other part of this Agreement; and the remaining parts shall be enforced as if such invalid, illegal, or unenforceable part were not contained herein, provided, however, that in such event this Agreement shall be interpreted so as to give effect, to the greatest extent consistent with and permitted by applicable law, to the meaning and intention of the excluded provision as determined by such court of competent jurisdiction. | |
8.6. | Assignment. Neither this Agreement or any of the Employees rights, privileges, or obligations set forth in, arising under, or created by this Agreement may be assigned or transferred by the Employee without the prior consent in writing of the Company. The Company shall be entitled to assign its rights and obligations hereunder to any entity acquiring a material part of its assets or to a subsidiary, affiliate or parent company thereof (as such terms are defined in the Israeli Securities Law-1968). |
/s/ David Aviezer
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Yossef Maimon
|
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1. | DEFINITIONS |
1.1. | Terms defined in this Section 1 and elsewhere, parenthetically, in this Agreement, shall have the same meaning throughout this Agreement. |
1.1.1. | Affiliate when used with respect to any person or entity, shall mean any individual, firm, partnership, corporation, trust, joint venture or other entity, whether de jure or de facto, which, directly or indirectly, controls, is controlled by or is under common control with such person or entity. As used in this definition, control shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the policies and management of a person or entity, whether by the ownership of stock, by contract or otherwise. | ||
1.1.2. | Confidential Information shall mean any technical, business or other information in any form whatsoever, with respect to a Partys technology, its applications, business and operations, including but not limited to any materials, know-how, inventions, data, software programs and their sources, processes, methods and formula, all whether or not covered by patents, patent applications, copyrights or other proprietary rights protection, and any financial information, trade secrets, agreements, documents, names of potential suppliers, customers, partners or investors, proposed business deals, reports, plans, market studies, surveys and projections, and any other information which is confidential or proprietary in nature. | ||
1.1.3. | Effective Date shall mean the date upon which the Licenses may go into force and effect as provided in Section 2.1 below. | ||
1.1.4. | [***]. | ||
1.1.5. | Icons Technology shall have the meaning set out in the Premises to this Agreement. |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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1.1.6. | Indemnitee shall have the meaning set out in Section 9.1 of this Agreement. | ||
1.1.7. | Indemnitor shall have the meaning set out in Section 9.1 of this Agreement. | ||
1.1.8. | Improvement shall mean any invention, discovery or further development of Icon Technologys Patents generated by Protalix. | ||
1.1.9. | Licensed Product(s) shall mean any pharmaceutical Research Protein and each additional pharmaceutical Protein expressed by Protalix or its Affiliates or sub-licensees using Icons Technology. For the avoidance of doubt, active ingredients for drugs developed by Protalix with the use of Icons Technology and sold as such, shall be deemed as Licensed Product(s). | ||
1.1.10. | Licenses shall have the meaning set out in Section 2.1 of this Agreement. | ||
1.1.11. | Net Sales shall mean amounts received by Protalix or any of its Affiliates or sub-licensees for the sale of Licensed Products, less: |
1.1.12. | Owner shall have the meaning set out in Section 10.1 of this Agreement. |
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1.1.13. | Patents shall mean the Patents listed in Annex A that are owned or controlled (with rights sufficient to grant the licenses herein granted) by Icon or its Affiliates, together with all divisions, continuations or continuations-in-part, reissues, re-examinations, renewals, extensions, supplementary protection certificates, or the like of any such Patents, as well as any certificates of invention or applications therefore, and all foreign counterparts, with respect to any of the foregoing. | ||
1.1.14. | Protalix Field shall have the meaning set out in the Premises to this Agreement. | ||
1.1.15. | Protein shall mean any protein, protein fragment, peptide or polypeptide regardless of formation or structure. | ||
1.1.16. | Recipient shall have the meaning set out in Section 10.1 of this Agreement. | ||
1.1.17. | Research Proteins shall have the meaning set out in the Premises to this Agreement. | ||
1.1.18. | Research Program shall have the meaning set out in the Premises to this Agreement. | ||
1.1.19. | Research Agreement shall have the meaning set out in the Premises to this Agreement. | ||
1.1.20. | Royalties shall have the meaning set out in Section 5.1 of this Agreement. | ||
1.1.21. | Royalty Period shall have the meaning set out in Section 5.4 of this Agreement. | ||
1.1.22. | Semi-Annual Payment shall have the meaning set out in Section 5.4 of this Agreement. | ||
1.1.23. | Term shall have the meaning set out in Section 12.1 of this Agreement. | ||
1.1.24. | Third Party shall mean any person or entity other than Icon, Icon Affiliates, Protalix and Protalix Affiliates. | ||
1.1.25. | Third Party Claim shall have the meaning set out in Section 9.3 of this Agreement. |
1.2. | The following terms shall have the meanings ascribed to them in the Option Agreement: Option, Option Period, Exercise Fee. |
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1.3. | The headings in this Agreement are intended solely for convenience or reference and shall be given no effect in the interpretation of this Agreement. |
2. | THE LICENSE; IMPROVEMENTS |
2.1. | Immediately upon and subject to the exercise of the Option by Protalix during the Option Period or any longer period agreed upon between the Parties in writing, and to the receipt by Icon of the Exercise Fee determined pursuant to Section 1.5 of the Option Agreement, the following licenses (Licenses) shall be deemed as having been granted by Icon to Protalix and to be in full force and effect: |
2.1.1. | a non-exclusive worldwide license under the Patents listed in Annex A to develop, test, use and commercialize Icons Technology in the Protalix Field and to make and have made Proteins expressed by using Icons Technology in the Protalix Field; and | ||
2.1.2. | an exclusive worldwide license under the Patents listed in Annex A to develop, test, use and commercialize Icons Technology to make and have made Research Proteins in the Protalix Field for the following Protein products: [***]. For the avoidance of doubt, the license in respect to any [***] shall be non-exclusive, pursuant to Section 2.1.1 above. | ||
2.1.3. | Notwithstanding the above said, the scope of the Licenses granted under Sections 2.1.1. and 2.1.2. of this Agreement in case of each specific Patent is further limited as specified in Annex A. | ||
2.1.4. | For the avoidance of doubt, the exclusivity under Section 2.1.2. of this Agreement and any section of the Option Agreement is granted only in the Protalix Field, and nothing in the legal relationship between the Parties implies any limitation imposed on Icons business activity and relationships with any Third Party outside the granted exclusivity area. |
2.2. | Protalix shall be permitted to sublicense its rights under the Licenses, for the purpose of its sub-licensee(s) further developing, testing, using, making and having made, marketing and selling Licensed Products, and for no other purpose whatsoever. | ||
2.3. | For the avoidance of doubt, Protalix shall be entitled to market and sell Licensed Products through distributors. |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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2.4. | Protalix shall use commercially reasonable efforts to exploit the rights licensed under this Agreement. | ||
2.5. | Protalix may register the License with the appropriate patent offices if necessary or desirable under any applicable law, at its own expense. Icon shall cooperate with Protalix for such purpose, sign all papers in support of such registration, and execute a formal license that reflects the terms of this Agreement, for such registration purposes. | ||
2.6. | Improvement License to Icon | ||
Subject to the terms and conditions set forth in this Agreement, if Protalix creates any Improvements of Icons Patents licensed to Protalix under Section 2.1 herein, Protalix grants Icon a non-exclusive, worldwide, royalty-free fully paid up license (with the right to grant sublicenses) under Protalix intellectual property arising from such Improvements of Icons Patents to make, have made, use, sell, and import any products other than research, development, production and commercialization of (i) pharmaceutical proteins and the expression thereof in plant cell culture systems or (ii) commercialization of Research Proteins. | |||
2.7. | Limited research license. As from the signing this Agreement and throughout the Research Program (ending no later than May 1, 2006), Protalix is granted a non-transferable research license to practice Icon Patents listed in Annex A solely for its internal research and development efforts, said research license being limited to research activities not involving production of material for clinical testing. |
3. | TECHNOLOGY TRANSFER/ASSISTANCE |
3.1. | Icon shall provide Protalix with copies of all of the Icon Patents listed in Annex A within 10 (ten) days of the Effective Date. | ||
3.2. | Icon shall provide Protalix with training in the use of the Icon Technology and Confidential Information which Icon is free to divulge in relation to the Icon Technology, at Protalixs reasonable request, from time to time during the Term, so as to facilitate Protalixs exploitation of the License. |
4. | LUMP SUM PAYMENTS. |
4.1. | Protalix will make the following lump sum payments to Icon upon achievement of each of the following development milestones in respect of each Licensed Product: |
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4.1.1. | [***]; and | ||
4.1.2. | [***]. |
4.2. | Sections 5.7 and 5.8 of this Agreement shall apply mutatis mutandis to lump sum payments made under this Section 4. |
5. | ROYALTIES. |
5.1. | As from the first commercial sale by Protalix, its Affiliates and/or sub-licensees of any Licensed Product, Protalix shall pay Icon royalties (Royalties) on Net Sales of such Licensed Product at the rate of [***] of such Net Sales, until such time as Net Sales in respect of such Licensed Product reach an aggregate amount of [***]. Thereafter, and for the remainder of the Royalty Period (as defined below), Protalix shall pay Royalties to Icon with respect to such Licensed Product at a rate of [***] on Net Sales of such Licensed Product, unless otherwise provided hereunder. | ||
5.2. | Notwithstanding the provisions of the preceding Section 5.1 of this Agreement: |
5.3. | For the avoidance of doubt, it is hereby clarified that sales of one Licensed Product shall not be taken into consideration for purposes of calculation of the Royalties required to be paid in connection with any other Licensed Product. It is hereby further clarified that Protalix or its licensee have to pay royalties once only, on Licensed Product sold in the form of a pharmaceutical, and not on sales of an active ingredient. |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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5.4. | Protalixs obligation to pay Royalties to Icon in respect of Licensed Products shall remain in force and effect until the first to occur of the following (the Royalty Period): (i) the expiration of the [***] period commencing as from the first commercial sale of the first US Food and Drug Administration or European Medicines Agency approved Licensed Product or (ii) until the expiration of [***] years from the first commercial sale of any Licensed Product not requiring FDA or similar approval as a active drug ingredient. | ||
5.5. | Royalties shall be payable on a [***] basis with respect to the Net Sales of the preceding [***]. Each [***] shall be made no later than [***]as from the lapse of the [***] period for which the payment is due and shall be accompanied by a report specifying the Net Sales during such [***] along with a calculation of the Royalties owed to Icon. | ||
5.6. | For the avoidance of doubt, it is hereby recorded and agreed that following the expiry of the Royalty Period by reason of the passage of time pursuant to Section 5.4 of this Agreement, then notwithstanding such expiry, Protalix shall be entitled to continue to utilize the Icon Patents, to make commercial use of the Icon Technology in the Protalix Field, without having to pay royalties to Icon in respect of such activities. | ||
5.7. | All payments to be made to Icon pursuant to this Agreement shall be made in United States Dollars to such bank account as Icon may direct from time to time during the Term. | ||
5.8. | All payments are quoted net and are made by adding the statutory value added tax, if any. | ||
5.9. | Protalix shall withhold and pay to the appropriate authorities in respect of any amount due to Icon, any and all withholding and other taxes as may be imposed by any taxing authority. In such event, Protalix shall provide Icon with evidence of such withholding and payment. | ||
5.10. | Foreign currency shall be converted into United States Dollars using an exchange rate equal to the exchange rate for the purchase of United States Dollars, as reported by The Wall Street Journal, on the last business day of the [***] period for which the payment is due. | ||
5.11. | Protalix shall endeavor to prepare accurate and complete records relating to the Net Sales of the Licensed Products during each accounting period. Icon or its duly authorized representatives may during the Term of this Agreement and for up to 6 (six) months thereafter upon giving reasonable notice in any event of not less than 14 (fourteen) days to Protalix within the premises of Protalix during |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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6. | REPRESENTATIONS, WARRANTIES AND RELATED UNDERTAKINGS OF THE PARTIES. |
6.1. | Each Party hereby represents, warrants, and covenants to the other Party as of the date hereof and as of the Effective Date, as follows: |
6.1.1. | such Party (i) has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder, and (ii) has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder, | ||
6.1.2. | the Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, binding obligation of such Party and is enforceable against it in accordance with its terms subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights; and | ||
6.1.3. | the execution and delivery of this Agreement and the performance of such Partys obligations hereunder; (i) do not conflict with or violate any requirement of applicable law or regulation or any provision of articles of incorporation of such Party, in any material way, and (ii) do not conflict with, violate, or breach or constitute a default or require any consent under, any contractual obligation or court or administrative order by which such Party is bound. |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
9
6.2. | Other than the representations and warranties contained in this Agreement, neither Icon nor Protalix makes any representations or warranties of any type or nature, whether express or implied. |
7. | ADDITIONAL REPRESENTATIONS AND WARRANTIES OF ICON. |
7.1. | Icon hereby represents, warrants and covenants that it is together with its Affiliates the sole owner and possesses all rights, title and interest to the Icon Technology and the Icon Patents, subject to certain licenses that have already been granted in respect to those Patents and divulged to Protalix under to the Research Agreement. | ||
7.2. | Icon hereby further represents, warrants and covenants that it has not transferred any ownership interest in the Icon Technology or the Icon Patents or granted any license to a Third Party that would be inconsistent with the Licenses and that it will not do so as of the date hereof and during the Term. Moreover, Icon shall not, whether directly or indirectly, by itself or through third parties, compete with Protalix by commercializing the Icon Technology to make or have made Research Proteins in the Protalix Field. | ||
7.3. | Icon and its Affiliates have no knowledge, having conducted such inquiries and diligence as is generally exercised by bio-pharmaceutical companies with respect to their own inventions and patenting thereof of any: (i) material legal deficiencies of any Icon Patents, including any prior act that could reasonably be determined to invalidate or prevent the issuance of the Icon Patents; (ii) Third Partys prior rights to use; (iii) dependency of any inventions under any Icon Patent on a Third Partys patents or intellectual property; (iv) technical deficiencies of the invention on which any Icon Patent licensed hereunder is based; or (v) allegations, claims or other statements made by a Third Party prior to the Effective Date of any of the foregoing. For the avoidance of doubt, the foregoing representations and warranties are limited to the actual knowledge as of the Effective Date of Icon, its Affiliates, and their respective officers and directors, together with knowledge that such entities or persons should have after having conducted such inquiries and diligence as is generally exercised by bio-pharmaceutical companies with respect to their own inventions and patenting thereof. | ||
7.4. | Icon will use its reasonable efforts to obtain issuance of the Icon Patents under the patent applications as set forth on Annex A to this Agreement; however, Icon makes no warranty that any or all claims of the patent applications set forth on Annex A will ultimately be |
10
approved and issued by the relevant governmental patenting agencies. Except as provided above, Icon guarantees neither the patentability and validity of the Icon Patents nor the commercial exploitability and/or readiness for plant use of the inventions, and shall not be liable accordingly. Except as provided above, Icon does not guarantee the commercial applicability of granted rights, nor is Icon responsible for any financial or legal consequences resulting from the application of the licensed Icon Technology and Icon Patents, which exclusion of liability does not apply in case of intent or gross negligence. | |||
7.5. | As from the date hereof, Icon shall not take any action or assist or facilitate any Third Party to take any such action that would materially impair the ability of Protalix, its Affiliates or sub-licensees to practice and exploit the Icon Technology and Icon Patents that may be licensed under this Agreement. |
8. | MAINTENANCE AND PROTECTION OF PATENT RIGHTS; INFRINGEMENT. |
8.1. | Icon shall notify Protalix on a current basis, of any matter which may affect the scope or validity of an Icon Patent. | ||
8.2. | In the event that Icon should fail to prosecute and/or maintain any of the Icon Patents by the date being 60 (sixty) days prior to the date prescribed by the relevant patent office or by applicable law for the taking of action with respect to the prosecution and/or maintenance of such Icon Patents, and if no such date is prescribed as aforesaid, within 30 (thirty) days of a request by Protalix to take such action, then Protalix may assume sole control over the prosecution and/or the maintenance of such Icon Patent at its own cost and expense and at its sole discretion, and Icon shall render Protalix all documents and assistance that may be required by Protalix therefore. In such event, for as long as Protalix continues to prosecute and maintain an Icon Patent, then, in respect of such jurisdiction, Protalix shall not be obligated to pay Icon any Royalties or other consideration whatsoever with respect to utilizing such Icon Patent in such jurisdiction. Protalix shall notify Icon in writing of Protalixs election as aforesaid. For the avoidance of doubt, it is hereby clarified that should Protalix assume control over the filing, prosecution and maintenance of such Icon Patent(s) as aforesaid, then at any time thereafter Protalix may, in its sole and absolute discretion, cease the filing, prosecution and maintenance of such Icon Patent, upon prior written notice to Icon. Icon hereby irrevocably waives any claim it may have against Protalix regarding |
11
the filing, prosecution and maintenance of any such Icon Patent or the cessation of any such action by Protalix. | |||
8.3. | If either Party acquires knowledge of any infringement of a claim of an Icon Patent in the Protalix Field, the Party having such knowledge shall promptly inform the other Party thereof. The Parties shall thereafter discuss the action, if any, which should be taken, including whether any legal proceedings should be instituted. If the Parties mutually agree on the course of action to be taken, they shall jointly select counsel and equally share any expenses, and in such event, any settlement or recovery shall be shared equally by the Parties. If the Parties do not agree on the course of action to be taken as aforesaid, then Protalix shall have the right, at its own expense, to initiate a suit or take other appropriate action that it believes is reasonably required to provide full protection against a Third Partys infringement of such Icon Patent(s). Protalix shall have the sole and exclusive right to select counsel for any suit initiated by it. Any settlement or recovery as a result of any such action initiated by Protalix, shall belong solely to Protalix. If Protalix fails to initiate a suit or take such other appropriate action within 90 (ninety) days after becoming aware of the alleged infringement of an Icon Patent in the Protalix Field, then Icon shall have the right, upon sufficient advance notice to Protalix of its intent to do so, to take action at Icons expense and through counsel of Icons choice, and in such event, any settlement or recovery shall belong solely to Icon. | ||
8.4. | [***] undertakes that it shall fully cooperate with [***]in the preparation and prosecution of any litigation duly initiated by [***] and, to the extent required by the relevant law, [***] shall consent to being joined to such suit and to being named as a party in any such litigation; provided that: (a) any reasonable expenses or costs incurred in connection therewith and with such litigation (including attorneys fees, costs and other sums awarded to the counterparty in such action) shall be borne by [***]. | ||
8.5. | [***] shall have no obligation to defend any claim or suit, or to hold harmless or immune or to indemnify against any loss, cost, expense, payment or damage, arising from any allegation of infringement or violation of any alleged or actual patent or intellectual property right of a Third Party by reason of [***] development, commercialization, use or sale of the Licensed Products, provided however [***] shall fully cooperate with [***] in the preparation and prosecution of any defense against any claim of infringement or violation of any alleged or actual patent or intellectual property right of a Third Party by reason of [***] development, use or sale of a Licensed Product and/or the Icon |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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9. | MUTUAL INDEMNIFICATION. |
9.1. | Each Party (an Indemnitor) agrees to indemnify, hold harmless and defend the other Party, its officers, employees, and agents (each an Indemnitee), against any and all claims, suits, losses, damages, costs, fees, and expenses asserted by third parties, both government and non-government, against such Indemnitee to the extent resulting from or arising out of: (a) the Indemnitors gross negligence or intentional misconduct, (b) any breach of a representation, warranty or covenant made by the Indemnitor in this Agreement. No indemnity shall be provided to an Indemnitee for any such claims, suits, losses, damages, costs, fees provided to an Indemnitee for any such claims, suits, losses, damages, costs, fees of expenses to the extent resulting from such Indemnitees use of technology licensed under this Agreement in violation of applicable governmental laws, regulations and requirements (it being understood that such laws, regulations and requirements do not include violation of private Third Party rights even though enforceable under applicable law, such as intellectual property rights, as to which indemnity shall be provided if such violation is due to a breach of a representation, warranty or covenant in this Agreement). | ||
9.2. | In order for an Indemnitee to be entitled to any indemnification provided for under this Section 9, such Indemnitee must notify the Indemnitor in writing, and in reasonable detail, of the claim as promptly as reasonably possible after receipt by such Indemnitee of notice of such claim; provided, however, that failure to give such notification on a timely basis shall not affect the indemnification provided hereunder except to the extent the Indemnitor shall not have had knowledge of the facts on which such claim is based and shall have been actually materially prejudiced as a result of such failure. Thereafter, the Indemnitee shall, promptly after the Indemnitees receipt thereof deliver to Indemnitor copies of all notices and documents (including court papers) received by the Indemnitee relating to the claim. |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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9.3. | If one of more Indemnitees makes a claim for indemnification relating to losses, damages, costs, fees or expenses arising in connection with any claim asserted by a Third Party against one or more Indemnitees (a Third Party Claim), the Indemnitor shall be entitled to assume the defense thereof and, if it so chooses and acknowledges in writing its obligation to indemnify the Indemnitees therefor, to assume the defense thereof with counsel selected by Indemnitor and reasonably satisfactory to the Indemnitees, and to settle such suit, action, claim or proceeding in its discretion with a full release of the Indemnitees and no admission of criminal liability; provided, that the written consent of the Indemnitees (which shall not be unreasonably withheld) shall be required for any settlement if as a result thereof the Indemnitees would become subject to injunctive relief or any remedy other than the payment of money by Indemnitor. Should Indemnitor so elect to assume the defense of a Third Party Claim, Indemnitor shall not be liable to the Indemnitees for legal expenses subsequently incurred by the Indemnitees in connection with the defense thereof unless (i) Indemnitor has failed to defend, contest or otherwise protest in a timely manner against Third Party Claims or (ii) a conflict of interest exists such that separate representation of the Indemnitees is appropriate. If Indemnitor assumes such defense, the Indemnitees shall have the right to participate in the defense thereof and to employ counsel, at their own expense, separate from the counsel employed by Indemnitor. Indemnitor shall be liable for the reasonable fees and expenses of counsel employed by the Indemnitees for any period during which Indemnitor has not assumed the defense thereof and for any period in which a conflict of interest exists such that separate representation of one or more of the Indemnitees is appropriate. If Indemnitor chooses to defend any Third Party Claim, both Parties hereto shall cooperate in the defense or prosecution of such Third Party Claim. | ||
9.4. | Protalix will take out a liability insurance coverage appropriate to the risk involved in commercializing the Licensed Products if Protalix or any of its sublicenses commences any clinical trials of the Licensed Products. Such insurance shall list Icon and the inventors of the patents as additional insureds if possible. Protalix shall provide Icon with at least 30 (thirty) days prior written notice of the commencement of clinical trials. Within 30 (thirty) days after the start of the clinical trials and thereafter annually between January 1 and January 31 of each year, Protalix will present evidence to Icon that the coverage is be maintained. In addition, Protalix shall provide Icon with at leas 30 (thirty) days prior written notice of any change in or cancellation of the insurance coverage. |
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10. | CONFIDENTIALITY. |
10.1. | Each Party (a Recipient) shall, at all times during the term of this Agreement and for a 5 (five) year period following termination or expiration hereof, keep, and shall use reasonable best efforts to ensure that its officers, directors, employees, subcontractors and agents keep, confidential and shall not publish or otherwise disclose and shall not use, directly or indirectly, for any purpose, any Confidential Information furnished to it by the other Party (the Owner), except to the extent such disclosure or use is expressly permitted by the terms of this Agreement or is reasonably necessary for the performance of this Agreement, including without limitation, for the practice and exercise of the licenses or other rights granted pursuant to this Agreement. | ||
10.2. | Each Party may disclose Confidential Information to the extent that such disclosure is: |
10.2.1. | made in response to a valid order of a court of competent jurisdiction or other governmental body of a country or any political subdivision thereof of competent jurisdiction; provided, however, that the Recipient shall first have given notice to the Owner of the Confidential Information and given the Owner a reasonable opportunity to quash such order and to obtain a protective order requiring that the Confidential Information that is the subject of such order be held in confidence by such court or agency or, if disclosed, be used only for the purposes for which the order was issued; and provided further that if a disclosure order is not quashed or a protective order is not obtained, the Confidential Information disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in such response to such court or governmental order; | ||
10.2.2. | otherwise required by law (subject to seeking confidential treatment where available and to providing prior notification to the Owner); | ||
10.2.3. | as required in connection with any filings made with, or by the disclosure policies of a major stock exchange (subject to seeking confidential treatment where available and to providing prior notification to the Owner); | ||
10.2.4. | made by the Recipient to governmental regulatory authorities as required in connection with applications for regulatory approvals (such as an NDA or ANDA); |
15
provided, however, that reasonable measures shall be taken to assure confidential treatment of such information; or | |||
10.2.5. | made by the Recipient to third-parties as may be necessary in connection with (i) the development and commercialization of the Licenses as contemplated by this Agreement, including, without limitation, subcontracting transactions in connection therewith, or (ii) the proposed sale of all or substantially all of the Recipients assets, or to its proposed successor or acquirer through merger, consolidation or change of control; provided, however, that the Recipient shall in each case obtain from the proposed Third Party recipient a written confidentiality undertaking containing confidentiality obligations no less onerous than those set forth herein. |
11. | NON-CONTESTATION CLAUSE | |
The Parties shall not contest any rights of the other Party, in particular patent, license or any other property rights that are subject to this Agreement nor support any Third Party in any attempt to destroy property rights of the other Party. However, each Party remains entitled to file a claim against the other Party in the case of a disagreement arising from this Agreement. | ||
12. | TERM AND TERMINATION |
12.1. | Save for the provisions of Sections 6, 7.1, 7.2, 7.4 and 7.5 of this Agreement which shall be binding upon the Parties in accordance with their terms as of the date hereof, this Agreement shall enter into force and effect on the Effective Date and, unless earlier terminated pursuant to the provisions hereof, shall remain in full force and effect until the last to expire of the Icon Patents or, should all of the patent applications listed in Annex A be finally rejected, until [***] after the first commercial sale of any Licensed Product. (the Term). | ||
12.2. | Without limiting from Section 12.1 of this Agreement above, Icon may terminate this Agreement by written notice to Protalix: |
12.2.1. | In the event of a material breach of the Protalix obligations hereunder, which breach is not cured within 30 (thirty) days following delivery thereto of a written notice to that effect; and | ||
12.2.2. | Upon the occurrence of any of the following events: (i) a request for the liquidation and/or dissolution and/or winding up is filed against Protalix, which request is not |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
16
12.3. | Without limiting from Section 12.1 of this Agreement above, Protalix may terminate this Agreement by written notice to Icon in case of serious material breach of this Agreement by Icon if such breach is not cured within 30 (thirty) days. |
12.4. | Without limiting from Section 12.1 of this Agreement above, Icon may terminate the exclusivity granted under this Agreement by written notice to Protalix, should Protalix fail to reach the following development milestones with respect to such Research Protein(s): | ||
[***] | |||
[***] | |||
12.5. | For the avoidance of doubt, and without derogating from the provisions of Section 5.6 above, upon expiration of the Term by reason of the passage of time pursuant to Section 12.1 of this Agreement, then notwithstanding such expiry, Protalix shall be entitled to continue to utilize the Icon Patents, to make commercial use of the Icon Technology in the Protalix Field, without having to pay royalties to Icon in respect of such activities. |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
17
13. | RELATIONSHIP OF PARTIES. | |
Nothing contained in this Agreement shall be deemed to establish any partnership, joint venture or agency relationship and the Parties shall act at all times as independent contractors. | ||
14. | GOVERNING LAW AND ARBITRATION. | |
This Agreement shall be governed by and construed in accordance with English law. All disputes between the Parties shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce (ICC) by a single arbitrator appointed in accordance with said Rules. The seat of arbitration shall be London, England and the language to be used in the arbitration shall be English. Notwithstanding the foregoing, neither Party shall be precluded from bringing an action in any court of competent jurisdiction for injunctive or other provisional relief as necessary or appropriate. The arbitrator shall have the power to award the costs of the arbitration and the prevailing Partys attorneys fees and costs. The arbitrators award shall be based on a reasoned written opinion to be delivered to the Parties. | ||
15. | NOTICES. | |
All notices and other communications required or desired to be given or sent by one Party to the other Party shall be in writing and shall be deemed to have been given: (a) on the date of delivery, if personally delivered, (b) 3 (three) business days after mailing if mailed by certified or registered mail, postage prepaid, return receipt requested, to the address of the applicable Party set forth in the preamble of this Agreement, or (c) on the date of transmission if sent by a confirmed facsimile delivery to the number set forth below: | ||
Protalix: +972-4-9889489 | ||
Icon: +49-345-555-9884 | ||
Either Party may change the address or facsimile number for giving notice from time to time by written instructions to the other Party of such change, conveyed pursuant to the terms of this Section 15. | ||
16. | ASSIGNMENT. | |
The rights and obligations of a Party hereto may not be assigned or delegated by such Party to any person or entity, save an entity to which all or substantially all |
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17. | PARTIES IN INTEREST. | |
This Agreement is binding upon and is for the benefit of the Parties hereto and their respective successors and permitted assigns. This Agreement is not made for the benefit of any person or entity not a party hereto, and no person or entity (including without limitation any sub-contractors, vendors, suppliers or customers) other than the Parties hereto or their respective successors and permitted assigns will acquire, have or be entitled to any benefit, right, remedy or claim under or by reason of or may otherwise rely on any provision of this Agreement. | ||
18. | WAVIER; REMEDIES. | |
No failure or delay on the part of a Party hereto in exercising any right, power or privilege under this Agreement will operate as a waiver thereof, nor will any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder. The rights and remedies herein provided are cumulative and are not exclusive of any rights or remedies which the Parties hereto may otherwise have at law or in equity. | ||
19. | SEVERABILITY. | |
The provisions of this Agreement are severable and, in the event that any court of competent jurisdiction determines that any one or more of the provisions or part of a provision contained in this Agreement shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision or part of a provision of this Agreement; but this Agreement shall be reformed and construed to the maximum extent possible as if such invalid, illegal or unenforceable provision, or part of a provision, had never been contained herein. | ||
20. | ORDER OF PRECEDENCE. | |
Unless otherwise provided herein, all terms and conditions of the Option Agreement and Research Agreement shall remain in force and effect and continue to apply in accordance with their terms, to the extent consistent with the terms of this Agreement. In the event of any contradiction or discrepancy |
19
between the provisions of this Agreement on one hand and the provisions of the Option Agreement and/or Research Agreement on the other hand, the provisions of this Agreement shall take precedence and prevail. Once the Licenses become operative pursuant to Section 2.1 of this Agreement above they shall remain in full force and effect in accordance with the terms hereof, notwithstanding the termination or expiration of any of the Option Agreement and/or Research Agreement for any reason whatsoever. | ||
21. | AMENDMENT. | |
This Agreement may not be amended, modified, altered, or supplemented except by a written agreement executed by both Parties hereto. | ||
22. | SURVIVAL. | |
The provisions of Sections 5.6, 6, 7.1, 7.3, 8, 9, 10, 11, 13, 14, 15, 16, 17, 18, 20, 21 of this Agreement and this Section 22 shall survive the termination or expiration of this Agreement for any reason whatsoever. | ||
23. | FURTHER ACTION. | |
Each Party agrees to execute and deliver such further documents and instruments and perform any further acts, from time to time, as may be reasonably necessary, to effectuate the purposes of this Agreement. | ||
24. | ENTIRE AGREEMENT. | |
This Agreement, together with all Annexes and attachments hereto, sets forth the entire understanding between the Parties hereto with respect to the License and supersedes all prior agreements, arrangements and communications, whether oral or written, with respect thereto. |
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Protalix Ltd. | ||||
By:
|
/s/ David Aviezer | |||
Title:
|
CEO | |||
Date:
|
April 12, 2005 | |||
Icon Genetics AG | ||||
By: |
/s/ Yuri Gleba | |||
Title:
|
CEO | |||
Date:
|
April 12, 2005 |
21
[***] | ||
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
22
[***] | ||
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
23
WHEREAS:
|
(A) | in the course of research conducted at the Weizmann Institute of Science (the Institute), under the supervision of Professor Anthony H. Futerman of the Department of Biological Chemistry, Professor Joel L. Sussman of the Department of Structural Biology and Professor Israel Silman of the Department of Neurobiology (the Scientists), the Scientists together with other scientists of the Institute, all of the aforementioned persons, collectively the Inventors arrived at an invention entitled [***](the Invention), being the subject of and more fully described in PCT patent application number [***] and the other patent applications listed in Appendix A hereto [***](the Existing Patent Applications) and created and/or generated the know- |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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how and other information relating to the Invention as described in Appendix B hereto (the Know-How); and | ||||
(B) | the Company is: (i) interested in the performance of further research at the Institute under the supervision of the Scientists in the field of the Invention, as specified in the research program attached hereto, marked Appendix C (the Research Program and the Research); and (ii) willing, subject to and in accordance with the terms and conditions of this Agreement, to finance the performance of the Research in accordance with the budget attached hereto and marked Appendix D (the Research Budget); and | |||
(C) | Yeda is willing, subject to and in accordance with the terms and conditions of this Agreement, to procure the performance of the Research at the Institute as aforesaid; and | |||
(D) | by operation of Israeli law and/or under the terms of employment of the Inventors at the Institute and pursuant to an agreement between the Institute, Yeda and the Inventors, all right, title and interest of the Inventors and/or the Institute in and to the Invention, in any results deriving from the performance of the Research at the Institute and in the Existing Patent Applications vests and shall vest in Yeda; and | |||
(E) | subject to and in accordance with the terms of this Agreement, the Company wishes to receive, and Yeda is willing to grant to the Company, a worldwide exclusive licence in respect of the Licensed Information (as hereinafter defined) and under the Patents (as hereinafter defined), for the development, manufacture, production, and sale of enzymatically active mutants of glococerebrosidase and derivatives therefrom for the treatment of Gaucher disease and/or any other indication (Products), all subject to and in accordance with the terms and conditions of this Agreement below; and | |||
(F) | the Company declares that on 12 January 2006 the Magneton Committee (appointed by the General Manager of the Ministry of Industry, Trade and Employment (MITE)) approved the application filed by the Company |
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for the receipt of government grants within the framework of the Magneton Program (as hereinafter defined) for the performance of the Research and for research and development activities by the Company in respect of the Products, pursuant to a letter dated 15 January 2006 from the manager of the Magneton Program, a copy of which is annexed hereto as Appendix E (the Magneton Approval), |
1.1. | The Preamble and Appendices hereto form an integral part of this Agreement. | |
1.2. | In this Agreement the terms below shall bear the meanings assigned to them below, unless the context shall indicate a contrary intention: |
1.2.1.
|
Affiliated Entity | | shall mean, with respect to any party hereto, any company, corporation, other entity or person (hereinafter, collectively, entity), which directly or indirectly, is controlled by, or controls, or is under common control with, such party. For the purposes of this definition, control shall mean the ability, directly or indirectly, to direct the activities of the relevant entity (save for an ability flowing solely from the fulfilment of the office of director or another office) and shall include, without limitation, the holding, directly or indirectly, of more than 30% (thirty percent) of the issued share capital or of the voting power of the relevant entity or the holding, directly or indirectly, of a right to appoint more than 30% (thirty percent) of the directors of such entity or of a right to appoint the chief executive officer of such entity; |
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1.2.2.
|
Development Program | | shall mean, with respect to any Product or Products, a development program specifying the activities and timetable necessary to develop such Products to commercialisation, including the performance of steps required for obtaining regulatory approvals from all relevant authorities for such Products and/or the sale of such Products ; | |||
1.2.3.
|
Exchange Rate | | shall mean, with respect to any amount to be calculated, or which is paid or received in a currency other than US Dollars, the average of the selling and buying exchange rates of such currency (in respect of cheques and remittances) and the US Dollar prevailing at Bank Hapoalim B.M. at the end of business on the date of calculation, payment or receipt, as the case may be; | |||
1.2.4.
|
First Commercial Sale | | shall mean, with respect to any Product in any country, the first commercial sale of such Product in such country after U.S. Food and Drug Administration (FDA) New Drug Approval, European Medicines Agency (EMEA) or national medicinal agency marketing approval or equivalent approval in such country has been obtained for such Product; | |||
1.2.5.
|
Licence | | shall mean an exclusive worldwide licence under the Licensed Information and the Patents, for the development, manufacture, production, use, marketing, distribution and sale of the Products, subject to the provisions of clause 7.1 below and the other terms and conditions of this Agreement; | |||
1.2.6.
|
Licensed Information | | shall mean: (i) the Invention; (ii) the Know-How; and (iii) all and any inventions, products, |
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materials, compounds, compositions, substances, methods, processes, techniques, know-how, data, information, discoveries and other results of whatsoever nature discovered or occurring in the course of, or arising from, the performance of the Research; | ||||||
1.2.7.
|
Magneton Directive | | shall mean Directive 8.6 of the General Manager of MITE dated 22 August 2001 entitled The Encouragement of Technology Transfer from Academia to Industry Magneton | |||
1.2.8.
|
Magneton Program | | shall mean the program for the encouragement of the transfer of generic technology from academic to commercial bodies administered by MITE, as described in the Magneton Directive; | |||
1.2.9.
|
Net Sales | | shall mean the total amount invoiced by the Company and the total amount invoiced by each Sublicensee (and, subject to clause 7.4.4.6 below, each Further Sublicensee (as hereinafter defined)) in connection with the sale of Products (for the removal of doubt, whether such sales are made before or after the First Commercial Sale of any Product in any country); provided that, with respect to sales which are not at arms-length and/or are not in the ordinary course of business and/or are not according to then current market conditions for such a sale, the term Net Sales shall mean the total amount that would have been due in an arms-length sale made in the ordinary course of business and according to the then current market conditions for such sale or, in the absence of such current market conditions, according to market conditions for |
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sale of products similar to the Products, in all cases after deduction of: | ||||||||
(i) | sales taxes (including value added taxes) or customs duties to the extent applicable to such sale and included in the invoice in respect of such sale; | |||||||
(ii) | credits or allowances, if any, actually granted on account of price adjustments, recalls, rejections or returns of Products previously sold; | |||||||
(iii) | freight and insurance charges to the extent such items are applicable to such sale and are separately itemised on invoices; and | |||||||
(iv) | bad debts (as determined in accordance with relevant GAAP rules) deriving from Net Sales in respect of which royalties were paid by the Company pursuant hereunder; | |||||||
and provided further that, with respect to sales by the Company and/or a Sublicensee and/or a Further Sublicensee, as applicable, to any Affiliated Entity of the Company or of such Sublicensee or Further Sublicensee, as the case may be, the term, Net Sales shall mean the higher of (but for the avoidance of doubt, not both of): (a) Net Sales, as defined above, with respect to sales which are not at arms-length and/or in the ordinary course of business and/or according to current market conditions; and (b) the total amount invoiced by such Affiliated Entity on resale to an independent third party purchaser after the |
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deductions specified in subparagraphs (i) and (ii) above, to the extent applicable; | ||||||
1.2.10.
|
OCS | | shall mean the Office of the Chief Scientist at MITE; | |||
1.2.11.
|
Patents | | shall mean: (i) the Existing Patent Applications and all patents which may be granted thereon; and (ii) all other patent applications or applications for certificates of invention covering portions of the Licensed Information and all patents or certificates of invention which may be granted thereon; as well as all continuations, continuations-in-part, patents of addition, divisions, renewals, reissues and extensions (including any patent term extension) of any of the aforegoing patents, but excluding: (a) patents that have been invalidated or cancelled pursuant to the final (i.e., unappealed or unappealable) judgment of a competent court; and (b) patent applications that have been withdrawn or have expired, in each case such exclusion to be effective only from the date of such invalidation, cancellation, withdrawal or expiry, as the case may be. | |||
For the purposes of this Agreement, the term Patent shall also mean a Supplementary Protection Certificate (within the meaning of such term under Council Regulation (EU) No. 1768/92) or any other similar statutory or supplementary protection; | ||||||
1.2.12.
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Research Period | | shall mean the [***]period commencing on the date of signature of this Agreement, as may be extended in accordance with clause 2.1 below; |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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1.2.13. | Sublicence and Sublicensee |
| Sublicence shall mean any right granted, licence given, or agreement entered into, by the Company (or, but without derogating from clause 7.4.4.6 below, a Sublicensee) to or with any other person or entity, permitting any use of the Licensed Information and/or the Patents (or any part thereof) for the independent development and/or manufacture and/or production and/or marketing and/or distribution and/or sale of Products (whether or not such grant of rights, licence given or agreement entered into is described as a sublicence or as an agreement with respect to the development and/or manufacture and/or production and/or distribution and/or marketing and/or sale of Products or otherwise) and the term Sublicensee shall be construed accordingly; | |||||
1.2.14. | Sublicensing Receipts | | shall mean consideration, whether monetary or otherwise, received (for the removal of doubt, whether received before or after the First Commercial Sale in any country) by the Company for or from the grant of Sublicences or Further Sublicences and/or pursuant thereto, or in connection with the grant of an option for a Sublicence, except for: | |||||
(i) | amounts received by the Company which constitute royalties based on sales of the Products by Sublicensees in respect of which the Company has paid royalties to Yeda; and | |||||||
(ii) | amounts received by the Company from a Sublicensee and actually |
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expended by the Company (as evidenced by invoices, receipts or other appropriate documentation) in respect of Product-related research and/or development activities to be performed by the Company for such Sublicensee after the date of signature of the relevant Sublicence (or, as the case may be, option for a Sublicence), provided that: | ||||||||
(a) | any such amounts constitute research and/or development funding only and not payment for Products nor any other type of grant or benefit, | |||||||
(b) | such research and/or development activities are performed pursuant to a defined research and development program and research and development budget agreed with the relevant Sublicensee, a copy of which is provided to Yeda; and | |||||||
(c) | the Company submits to Yeda a written expense report, confirmed by the Companys independent accountant or chief financial officer, setting out the time and materials utilised, and reasonable overhead costs and other expenses actually incurred by the Company in the conduct of the said research and |
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development activities, which report demonstrates that such amounts have actually been expended by the Company in the conduct of such research and/or development activities in accordance with such work program and budget, | ||||||||||
it being agreed, for the removal of doubt, that any amounts received by the Company as aforesaid, but not expended as set out above, shall be deemed to be Sublicensing Receipts. | ||||||||||
1.2.15. | the terms: Yeda, the Company, the Institute, the Scientist, the Inventors, the Invention, the Existing Patent Applications, the Know-How, the Magneton Approval", the Magneton Directive, the Magneton Program, "MITE, the Research Program, the Research, the Research Budget and Products | | shall bear the definitions assigned to them respectively in the heading or the preamble hereto, as the case may be. | |||||||
1.3. In this Agreement: | ||||||||||
1.3.1. | words importing the singular shall include the plural and vice-versa and words importing any gender shall include all other genders and references to persons shall include partnerships, corporations and unincorporated associations; | |||||||||
1.3.2. | any reference in this Agreement to the term patent shall also include any re-issues, divisions, continuations or extensions thereof (including measures having equivalent effect); |
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1.3.3. | any reference in this Agreement to the term patent applications shall include any provisional patent applications, PCT, national or regional patent applications, applications for continuations, continuations-in-part, divisions, patents of addition or renewals, as well as any other applications or filings for similar statutory protection; | |
1.3.4. | any reference in this Agreement to the term sale shall include the sale, lease, rental or other disposal of any Product with the exception of disposition, without charge, for demonstration and/or testing purposes; and | |
1.3.5. | including and includes means including, without limiting the generality of any description preceding such terms. |
2.1. | In consideration of the sums to be paid by the Company to Yeda pursuant to clause 3.1 below and, subject to the execution of such payments and to clause 3.2 below, Yeda undertakes, subject to clause 2.2 below, to procure the performance of the Research at the Institute under the supervision of the Scientists during the Research Period. By written agreement of the parties, the Research Period may be extended by such period and upon such terms and conditions as the parties shall so agree. | |
2.2. | If all of the Scientists shall cease to be available for the supervision of the performance of the Research, such cessation shall not constitute a breach of this Agreement by Yeda. In the event that all of the Scientists shall cease to be available as aforesaid, Yeda shall use its reasonable efforts to find from amongst the scientists of the Institute a replacement scientist or scientists acceptable to the Company (such acceptance to be in writing, and not to be unreasonably withheld), but no undertaking to find such a replacement is given by Yeda. If all of the Scientists cease to be available and no acceptable replacement scientists can be found within 60 (sixty) days of all of the Scientists becoming unavailable as aforesaid, then the Company shall be entitled, by written notice to Yeda, to terminate the Research Period, in which event the Research Period and the performance of Research hereunder shall cease at the end of a further period of 60 (sixty) days from the date of receipt by Yeda of such written notice. In the event of such termination, Yeda shall be released from any obligation to procure the |
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performance of the Research during the period after such termination, and the Company shall be released from any obligation to finance the Research in respect of the period commencing after such termination, but without affecting the Licence and all the other terms and conditions of this Agreement which shall remain in full force and effect (save for those relating to the performance and financing of the Research). | ||
2.3. | It is agreed that if the performance of the Research shall involve the conduct of experiments on and/or using animals, the performance of the Research and the Research Program shall be subject to the Israeli Anti-Cruelty Law, 1994 and to the approval of, and any modifications requested by, the Institutional Animal Care and Use Committee and the Safety Committee of the Institute, in order to ensure compliance with the above law. It is agreed that, in view of the fact that the performance of the Research may involve the conduct of experiments using human material (such as cells, blood, tissue, DNA, RNA, lysates, or body fluids) the performance of the Research and the Research Program shall be subject to the approval of, and any modifications requested by the Safety Committee of the Institute and the Institutional Review Board for Human Experimentation. | |
2.4. | For the avoidance of doubt, it is agreed that nothing in this Agreement shall constitute a representation or warranty by Yeda, express or implied, that any results will be achieved by the Research or that the Licensed Information or any part thereof or any results achieved by the Research are or will be commercially exploitable or of any other value and Yeda furthermore makes no warranties and representations, express or implied, whatsoever as to the Research, any results of the Research, the Patents or the Licensed Information. |
3.1. | Subject only to clause 3.2 below, the Company undertakes to pay to Yeda the total amount (in US Dollars) of the Research Budget (being [***]per year for each year of the Research Period) in [***] equal [***] instalments, payable in advance at the beginning of each [***] period during the Research Period, the first such payment to be made on the date [***] following the signature of this Agreement. An invoice in respect of an instalment paid as aforesaid shall be issued by Yeda promptly after the receipt by Yeda of such instalment. All payments of the Research Budget shall be made by direct wire transfer to Yedas bank account, the details of which are set out in clause 17.7 |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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below. For the removal of doubt, nothing contained in this Agreement shall prevent Yeda and/or the Institute from obtaining further finance for the Research from other entities (subject to the approval of the OCS should such approval be required pursuant to the Magneton Program and/or the Magneton Directive), provided that such other entities are not granted any rights in respect of the Research and/or the Licensed Information which prejudice any rights granted to the Company under the Licence. | ||
3.2. | If funding approved pursuant to the Magneton Program is withheld or delayed by the OCS solely due to a delay by Yeda in fulfilling its reporting obligations as required by such Program, then the Company shall be entitled, by written notice to Yeda, to suspend further payments to Yeda pursuant to clause 3.1 above until such time as such reporting obligations are fulfilled by Yeda (and such suspension shall cease immediately upon the fulfilment by Yeda of such reporting obligations). In the event of such suspension of payment, Yeda shall be entitled to discontinue the performance of the Research and its reporting obligations pursuant to section 4 below until funding recommences. |
4.1. | Yeda will procure the preparation by the Scientists of, and shall submit to the Company: (i) during the time that funding is provided pursuant to the Magneton Program, interim written reports on the progress of the Research during the Research Period on a quarterly basis, and, after such time, on a yearly basis, in both cases within 60 (sixty) days of the end of the period covered by such report, (ii) a written report summarising the results of the Research within 60 (sixty) days of the end of the Research Period; and (iii) reports of any significant findings in the Research promptly upon such findings being made. | |
4.2. | Yeda shall submit to the Company financial reports setting forth the monies received and expended in connection with the Research on a quarterly basis in accordance with the requirements of the Magneton Directive. A financial report as aforesaid shall be submitted to the Company during the Research Period on a quarterly basis, and, after such time on a yearly basis, in both cases within 60 (sixty) days after the end of the period covered by such report. Charges in respect of Research expenditures shall be made in accordance with the procedures prevailing at the Institute for charging research expenditures to individual projects of applied research and in |
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accordance with the Magneton Directive and/or the directives of the OCS. |
6.1. | ||
6.1.1. | Subject to clauses 6.3 and 6.4 below, [***]shall prosecute the Existing Patent Applications using the outside patent counsel retained by [***] for such purpose prior to the execution of this Agreement, unless otherwise agreed by the parties in writing, and shall maintain at the applicable patent office any patents issuing from the Existing Patent Applications. The Company and Yeda shall consult with one another and cooperate fully with regard to the prosecution of the Existing Patent Applications and in maintenance of such patents. | |
6.1.2. | At the initiative of either party, the parties shall consult with one another regarding the filing of patent applications in respect of any portion of the Licensed Information and/or corresponding to the Existing Patent Applications, including the jurisdictions in which such applications should be filed, the timing of the filing of such applications and the contents thereof. Following such consultations, and subject to clauses 6.3 and 6.4 below, [***] shall retain outside patent counsel to prepare, file and prosecute patent applications as aforesaid in such jurisdiction or jurisdictions as shall be determined by the parties in consultation as aforesaid. Subject to clauses 6.3 and 6.4 below, [***]shall also maintain at the applicable patent office any patents granted as a result of any of the above patent applications. The parties agree that their joint policy will be to seek comprehensive patent protection for all Licensed Information licensed to the Company hereunder. The Company and Yeda shall cooperate fully in the preparation, filing, prosecution and maintenance of such patent applications and patents. [***] shall: (i) deliver to [***], promptly, copies of all documentation prepared in connection with the maintenance or |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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prosecution of the Existing Patent Applications; and (ii) procure that [***] receives a copy of correspondence between [***] and any patent attorney or other professional or any competent authority (where the Patents may be filed, maintained or made) all, in each case, relating to the prosecution and/or maintenance of the Patents. | ||
6.1.3. | Without derogating from the aforegoing, [***] shall, at its expense, take all necessary steps as commercially feasible in order to obtain, or, at [***] election, assist [***] to obtain, the extension of each patent referred to in this clause 6.1 above, or, in the case of a patent in any member state of the European Union, a Supplementary Protection Certificate as referred to in clause 1.2.11 above (including the preparation and filing of applications for such extensions and Supplementary Protection Certificates), within the period prescribed therefor under applicable law and, if applicable, take all necessary steps as commercially feasible in order to obtain Orphan Drug status (within the meaning of such term under the US Orphan Drug Act or under Council Regulation (EU) No. 141/2000, as the case may be), or any other form of protection that affords exclusivity, within the period prescribed therefor under applicable law. [***] shall notify [***] promptly in writing and shall provide a copy to [***] of each marketing authorisation granted in respect of each Product in each country and, if applicable, of Orphan Drug or other form of protection affording exclusivity granted in respect of a Product and shall keep [***] informed and shall provide copies to [***] of all documents regarding all applications, activities and/or proceedings regarding such extensions and/or any Supplementary Protection Certificates and/or Orphan Drug or other form of protection affording exclusivity, as aforesaid. |
6.2. | All applications to be filed in accordance with the provisions of clauses 6.1.2 and 6.1.3 above, shall be filed in the name of [***] or, should the law of the relevant jurisdiction so require, in the name of the relevant inventors and then assigned to [***]. | |
6.3. | In the event that, following such consultations between the parties regarding the filing, prosecuting and/or maintenance (as applicable) of patent applications and/or patents pursuant to clauses 6.1.1 and 6.1.2 above, [***]shall not wish to file and/or continue to prosecute a patent application and/or maintain a patent in any country in relation to any part of the Licensed Information (including any of the Existing |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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Patent Applications), then [***], in its discretion, may elect to file and/or continue to prosecute such patent application and/or maintain such patent in such country at its own cost and expense. [***] shall notify [***] in writing of [***] election to file and/or continue to prosecute such patent application and/or maintain such patent in such country as aforesaid, at [***] expense (such notice, [***]), and, in the event that [***] shall not, within 30 (thirty) days of receipt of the [***] Notice: (i) reimburse [***] for all out-of-pocket costs and fees incurred by [***] until the date of the [***] (the [***] to be supported by receipts or other appropriate documents evidencing such costs and fees) in connection with the said patent application (in the preparation and/or filing and/or prosecution and/or maintenance of such application) and/or such patent, such costs and fees to be expressed in the currency in which paid by [***] and to be reimbursed or paid (as the case may be) by [***] to [***] in US Dollars in accordance with the Exchange Rate of such currency on the date of reimbursement or payment; and (ii) undertake in writing to [***] to bear all additional and future expenses relating to such patent application and/or patent, then [***] shall be entitled, at any time after the expiry of the said 30 (thirty) day period after such notice, to terminate the Licence granted to [***] under this Agreement in respect of such patent application and/or patent in such country, and to take whatever action it deems fit (in its sole discretion) with respect to such patent application and/or patent. |
6.4. | ||
6.4.1. | The Company shall, on the date of signature of this Agreement, reimburse Yeda the sum of US [***], constituting the costs and fees paid by Yeda prior to March 14, 2006 in connection with the Existing Patent Applications, and shall pay to Yeda all additional amounts incurred, but not as yet paid, by Yeda prior to the date of signature of this Agreement, within 30 (thirty) days of Yedas first written request. | |
6.4.2. | [***] shall bear and pay all costs and fees incurred in the preparation, filing, prosecution and the like of the Existing Patent Applications and of all patent applications filed in accordance with the provisions of clauses 6.1.2 and 6.1.3 above (including patent applications corresponding to the Existing Patent Applications), and the maintenance at the appropriate patent office and the like of all patents issuing from the Existing Patent Applications and all patent applications |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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referred to above, and all costs and fees incurred in undertaking any activities referred to in clause 6.1.3 above. | ||||
6.4.3. | Unless otherwise instructed by [***] in writing, [***] shall pay directly to [***] relevant outside patent counsel amounts payable by [***] pursuant to this clause 6.4 above or clause 6.3 above. | |||
6.5. |
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6.5.1.
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(i) | Should the Company determine that a third party is infringing one or more of the Patents, then the Company shall notify Yeda promptly in writing, giving full particulars thereof and the Company shall, after first having consulted Yeda, be entitled to sue for such infringement. | ||
(ii) | Yeda may elect, at its own initiative, to join as a party to such action, or Yeda may consent to being named as a party to such action (such consent by Yeda may for the removal of doubt, be conditional upon, inter alia, the provision by the Company of security, satisfactory to Yeda, for the payment of the expenses or costs referred to in subparagraph (a) below). | |||
(iii) | Yeda shall cooperate and shall use its reasonable efforts to cause the Scientists to cooperate with the Company in prosecuting such litigation. | |||
The provisions of paragraphs (i) and (iii) above shall be subject to the following: | ||||
(a) | any expenses or costs or other liabilities incurred in connection with such litigation (including attorneys fees, costs and other sums awarded to the counterparty in such action) shall be borne by the Company, which shall indemnify Yeda against any such expenses or costs or other liabilities, the above without derogating from the provisions of clause 12 below; | |||
(b) | in the event that Yeda shall be named as a party in any such litigation then Yeda shall be entitled to select its own legal counsel in such litigation, at the Companys expense and, if Yeda elects not to do so, the selection of the legal counsel representing the Company and Yeda in such litigation shall be subject to the prior written approval of |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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Yeda, which approval shall not be withheld unreasonably; and | ||||
(c) | no settlement, consent order, consent judgment or other voluntary final disposition of such action may be entered into without the prior written consent of Yeda. | |||
6.5.2.
|
(i) | Should the Company discover any allegation by a third party that, or be sued on the grounds that, the manufacture, use or sale of a Product by it or by a Sublicensee or a Further Sublicensee under any of the Patents or using the Licensed Information or any portion thereof infringes upon the patent rights of a third party, then the Company shall notify Yeda promptly in writing, giving full particulars thereof, and the Company shall, after first having consulted Yeda, be entitled to defend such action. | ||
(ii) | Yeda may elect, at its own initiative, to join as a party to such action. | |||
(iii) | Yeda shall cooperate and shall use its reasonable efforts to cause the Scientists to cooperate with the Company in defending such litigation. | |||
(iv) | If an action is brought against the Company alleging the invalidity of any of the Patents, Yeda shall have the right to take over the sole defence of the action and the Company shall cooperate fully with Yeda in connection with any such action. In such event, no settlement, consent order, consent judgment or other voluntary final disposition of such action may be entered into without the prior written consent of the Company, which consent shall not be unreasonably withheld or delayed. | |||
(v) | All expenses, costs and/or other liabilities incurred in connection with such litigation (including attorneys fees, costs and other sums awarded to the counterparty in such action) shall be borne by the Company. | |||
(vi) | The provisions of clause 6.5.1(c) above shall apply, mutatis mutandis. |
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6.5.3. | Any recovery in any litigation relating to an infringement as aforesaid in clauses 6.5.1 and 6.5.2 above shall first be applied to cover costs and thereafter divided [***]to the Company and [***] to Yeda. | |
6.5.4. | For the removal of doubt, Yeda shall not itself be obliged to take any action to sue for any infringement or to defend any action as referred to in this clause 6.5 above. |
6.6. | If the Company fails to take action to abate any alleged infringement of a Patent, or to defend any action as aforesaid, within 60 (sixty) days of a request by Yeda to do so (or within a shorter period, if required to preserve the legal rights of Yeda under applicable law), then Yeda shall have the right (but not the obligation) to take such action at its expense and the Company shall cooperate in such action at the Companys expense and, if required under applicable law or contract, consent to be named as a party to any such action. Yeda shall have full control of such action and shall have full authority to settle such action on such terms as Yeda shall determine. Any recovery in any such litigation shall be for the account of Yeda only. | |
6.7. | Each party shall promptly keep the other informed and provide copies to the other of all documents regarding all such actions or proceedings instituted by or against either party as contemplated under any of the provisions of clause 6.5 above. |
7.1. | Yeda hereby grants the Licence to the Company, and the Company hereby accepts the Licence from Yeda, during the period, for the consideration and subject to the terms and conditions set out in this Agreement. For the removal of doubt, no licence is granted hereunder with regard to the Licensed Information and/or the Patents and/or any portion of any of the aforegoing, with respect to any exploitation or activities (including the activities referred to in clause 1.2.5 above) relating to any product or services, other than Products). | |
7.2. | For the removal of doubt, nothing contained in this Agreement shall prevent Yeda or the Institute from using the Licensed Information and the Patents for academic research or other scholarly purposes, or from applying for or receiving grants to finance such activities (provided that such grants do not prejudice the Licence granted to |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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the Company hereunder), or from transferring any materials created in the course of the performance of the Research financed by the Company in accordance with the provisions of this Agreement, to scientists at the Institute or to other scientists at other institutions for academic research purposes, provided that any such transfer of materials shall be in accordance with a material transfer agreement substantially in the form of the specimen agreement annexed hereto as Appendix F. For the avoidance of doubt, the materials transferable pursuant to this clause 7.2 shall not include any derivatives of the human acid-beta-glucosidase developed and produced by the Company. Should Yeda obtain rights to any invention or application deriving from such academic research in connection with the materials transferred under any such material transfer agreement, as contemplated by such agreement, Yeda shall immediately grant Protalix a licence (or sublicence, as the case may be) in respect of such rights upon the terms of the Licence, mutatis mutandis (subject to any restrictions upon the rights obtained by Yeda). | ||
7.3. |
7.3.1. | The Licence shall remain in force in each of Israel and the United States of America, with respect to each Product (if not previously terminated in accordance with the provisions of this Agreement) until the later of: |
7.3.1.1. | the date of expiry of the last of any Patent (including, for the removal of doubt, any patent application, as referred to in the definition of Patents in clause 1.2.11 above) in such country covering such Product to expire; and | |
7.3.1.2. | if there is any Licensed Information that is identifiable, secret and of value relating to such Product, the date of expiry of a period of [***]commencing on the date that FDA, EMEA marketing approval or equivalent approval is obtained in respect of such Product in such country, provided that and for so long as such Licensed Information remains secret and of value. |
7.3.2. | The Licence shall remain in force in each country in the world (other than Israel and the United States of America) with respect to each Product (if not previously terminated in accordance with the provisions of this Agreement) until the later of: |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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7.3.2.1. | the date of expiry in such country of the last of any Patent (including, for the removal of doubt, any patent application, as referred to in the definition of Patents in clause 1.2.11 above) in such country covering such Product to expire; and | |
7.3.2.2. | if there is any Licensed Information that is identifiable, secret and of value relating to such Product, the date of expiry of a period of [***] commencing on the date that FDA, EMEA marketing approval or equivalent approval is obtained in respect of such Product in such country. |
For the purposes of clauses 7.3.1.1 and 7.3.2.1 above and clause 9. 2 (Royalties) below, a Product shall be deemed to be covered by a Patent in any country even after the Patent in such country covering such Product has expired, in the event that, and for so long as, such Product is protected and/or covered by Orphan Drug status as referred to in clause 6.1.3 above, and/or by any type of data exclusivity or data protection or by any other regulations and/or provisions granting similar statutory or regulatory protection of such Product in such country. The Company shall notify Yeda in writing immediately upon the obtaining of FDA, EMEA or equivalent approval in any country, as referred to in clauses 7.3.1.2 and 7.3.2.2 above, specifying the date thereof, the country and the type of Product in respect of which such approval was granted. | ||
7.4. | Except as provided in clause 7.5 below, a Sublicence under the Licence may be granted by the Company only with the prior written consent of Yeda, which shall not be withheld unreasonably, and Yedas response to a request for consent as aforesaid shall not be delayed unreasonably. The Company shall only be entitled to request Yedas consent if: |
7.4.1. | the proposed Sublicence is for monetary consideration only or other valuable consideration that can reasonably be assessed in monetary terms; | |
7.4.2. | the proposed Sublicence is to be granted in a bona fide arms-length commercial transaction; | |
7.4.3. | the terms of the proposed Sublicence are submitted to Yeda prior to the signature thereof; |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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7.4.4. | the proposed Sublicence is made by written agreement, the provisions of which are consistent with the terms of the Licence and contains, inter alia, the following terms and conditions: |
7.4.4.1. | the Sublicence shall expire automatically on the termination of the Licence for any reason; | |
7.4.4.2. | the Sublicensee shall be bound by provisions substantially similar to those in clause 10 below relating to confidentiality binding the Company (the obligations of the Sublicensee so arising being addressed also to Yeda directly); | |
7.4.4.3. | an exclusion of liability and indemnification undertaking in the same form, mutatis mutandis, as the provisions of clause 12 below (the indemnification obligations of the Sublicensee to be given also in favour of, and shall be actionable by Yeda, the Institute, any director, officer or employee of Yeda or of the Institute, or by the Inventors); | |
7.4.4.4. | all terms necessary to enable performance by the Company of its obligations hereunder; | |
7.4.4.5. | that the Sublicence shall not be assignable or otherwise transferable, save as set out in clause 7.4.4.6 below. | |
7.4.4.6. | that the Sublicence shall not be further sublicenseable other than with Yedas prior written consent, which consent: (i) shall not be unreasonably withheld (and Yedas response to a request for consent to a further sublicence shall not be unreasonably delayed), and (ii) may be conditioned by Yeda on, inter alia, the payment to Yeda of: |
(a) | royalties based on the sales of the further sublicensee (the Further Sublicensee), in accordance with the provisions of clause 9.2 below; and | ||
(b) | royalties on all consideration received (whether monetary or otherwise) by the Company or the Sublicensee from the Further Sublicensee (except for amounts received by such Sublicensee which constitute royalties based on sales of the Products |
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by such Further Sublicensee in respect of which the Sublicensee has paid royalties to Yeda), in accordance with the provisions of clause 9.3 below, which consideration shall be deemed to be Sublicensing Receipts received by the Company. |
A) | the proposed Further Sublicence shall be in writing; | ||
B) | the proposed Further Sublicence shall be consistent with the terms of this Agreement; | ||
C) | the proposed Further Sublicence shall be for monetary consideration only or other valuable consideration that can reasonably be assessed in monetary terms; | ||
D) | the proposed Further Sublicence shall be granted in a bona fide arms-length commercial transaction; | ||
E) | the terms of the proposed Further Sublicence shall be submitted to Yeda prior to the signature thereof; | ||
F) | the proposed Further Sublicence shall contain, inter alia, the terms and conditions set out in clauses 7.4.4.2 and, 7.4.4.3 above and clauses 7.4.4.7, 7.4.4.8 and 7.4.4.9 below (and the references in such clauses to Sublicence or Sublicensee shall, for the purposes of this clause, be deemed to refer to the Further Sublicence or the Further Sublicensee, as the case may be; and |
7.4.4.6.1. | the Further Sublicence shall not be assignable, otherwise transferable or further sublicenseable; and | |
7.4.4.6.2. | the Further Sublicence shall expire automatically upon the termination of this Agreement or of the Sublicence; |
7.4.4.7. | that: (i) a copy of the agreement granting the Sublicence shall be made available to Yeda, promptly upon its |
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execution; (ii) all amendments to any such Sublicence agreement shall be subject to Yedas prior written consent; and (iii) the Company shall submit to Yeda copies of all such amendments (as approved by Yeda), promptly upon execution thereof; | ||
7.4.4.8. | that the Sublicensee shall grant to Yeda the right, at reasonable times and upon reasonable notice to the Sublicensee, to send representatives in order to examine those books of accounts, records and other documentation of the Sublicensee as may be necessary in order to determine the correctness or completeness of any payment made by the Company to Yeda under this Agreement, all without derogating from clause 9.7 below; and | |
7.4.4.9. | that the Sublicensee shall, forthwith upon written request by the Company and/or Yeda, pay directly to Yeda all royalties and/or other payments that Yeda is entitled to receive in respect of sales by or on behalf of such Sublicensee pursuant to clause 9.2 below and the percentage of Sublicensing Receipts as provided in clause 9.3 below and, in such event, the last 2 (two) sentences of clause 9.7 below shall apply to the Sublicensee as if it were the Company, mutatis mutandis; |
and | ||
7.4.5. | any act or omission by the Sublicensee or the Further Sublicensee which would have constituted a breach of this Agreement by the Company had it been the act or omission of the Company and which is not cured within the applicable cure period, shall constitute a breach of the Sublicence agreement with the Company entitling the Company to terminate the Sublicence, and the Company hereby undertakes to inform Yeda forthwith upon receipt of knowledge by the Company of such breach and, at the request of Yeda, and at the Companys cost and expense, to exercise such right of termination. |
7.5. | For the removal of doubt, the Company shall not be entitled to grant, directly or indirectly, to any person or entity any right of whatsoever nature to exploit or use in any way the Licensed Information or the Patents or to develop, manufacture, produce and/or sell the Products or any part of any of the aforegoing, save by way of Sublicence |
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within the meaning of such term in clause 1.2.11 above and subject to the conditions of this clause 7 relating to any such grant. | ||
7.6. | Nothing contained in this Agreement shall be deemed to be a representation or warranty, express or implied, by Yeda that the Existing Patent Applications or any of them or any patent applications relating to the Licensed Information or any portion thereof will be granted or that patents obtained on any of the said patent applications are or will be valid or will afford proper protection or that the Invention or any other portion of the Licensed Information are or will be commercially exploitable or of any other value or that the exploitation of the Patents, the Invention or the Licensed Information will not infringe the rights of any third party. | |
7.7. | Notwithstanding the aforesaid in this clause 7, the Company may grant Sublicences to subcontractors solely to manufacture the Products or solely to perform research and development services related to the Products on its behalf without obtaining Yedas consent, provided that: (i) the terms of clauses 7.4.2, 7.4.4.1, 7.4.4.2, 7.4.4.3 (to the extent relating to clauses 12.2 and 12.3 (but not 12.1)), 7.4.4.4 and 7.4.5 above are observed; (ii) the proposed Sublicence is made by written agreement, the provisions of which are consistent with the terms of the Licence; (iii) the Company is jointly and severally liable with the subcontractor to Yeda for any obligations owed to or damage caused to Yeda in connection with or resulting from the grant of such Sublicence; (iv) such Sublicence shall not be assignable, further sublicenseable or otherwise transferable without the prior written consent of Yeda; and (v) such subcontractor is not granted any additional right under the Licence other than the right solely to manufacture the Products or solely to perform the research and development services, in both cases as subcontractor for the Company. |
8.1. | Within [***]of the date of signature of this Agreement, the Company shall submit to Yeda a Development Program for the development of Products (such Development Program, as approved by Yeda, the Initial Development Program). | |
8.2. | The Company undertakes, [***] to take all necessary steps to develop and commercialise the Products and, without derogating from the generality of the foregoing, to use its best efforts to expedite the commencement of the commercial sale of the Products. For |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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such purpose and without derogating from the generality of the aforegoing, the Company shall carry out and/or have a third party carry out on its behalf the performance of the trials, tests and other works and activities detailed in the Initial Development Program and in all further Development Programs (if any) submitted pursuant to clause 8.5 below, in accordance with the respective timetables included therein. The Company further undertakes to continue with commercialisation of the Products diligently throughout the period of the Licence. Without prejudice to the foregoing, the Company undertakes to comply with all the requirements of the Magneton Approval, including that it will perform all development activities necessary in order to meet any milestones set out therein. | ||
8.3. | The Company shall provide Yeda on December 31 of each calendar year with written progress reports (Progress Reports) which shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials (if applicable) conducted and all other actions taken by the Company pursuant to the Initial Development Program or any other Development Program delivered and approved pursuant to clause 8.5 below; (ii) manufacturing, sublicensing, marketing and sales during the preceding 12 (twelve) months; (iii) the Companys plans in respect of the testing, undertaking of trials (if applicable) or commercialisation of Products for the following 12 (twelve) months; (iv) projections of sales and marketing efforts; and (v) a summary of all protocols or minutes of meetings with the FDA, EMEA or any other regulatory authority in connection with any Product and copies of any opinions, decisions, and approvals issued by any of the aforementioned authorities. If the Company has provided a Development Program for more than 1 (one) Product, then such Progress Report shall provide such information separately for each such Product. If progress in respect of a Product differs from that anticipated in its Development Program or preceding Progress Report, then the Company shall explain, in its Progress Report, the reason therefor and prepare a modified Development Program for Yedas review. The Company shall also provide any reasonable additional data that Yeda requires to evaluate the performance of the Company hereunder. | |
8.4. | For the removal of doubt, without derogating from the remaining provisions of this clause 8 or of clause 13.2 below, nothing contained in this Agreement shall be construed as a warranty by the Company that any Development Program to be carried out by it as aforesaid will actually achieve its aims and the Company makes no warranties |
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whatsoever as to any results to be achieved in consequence of the carrying out of any such Development Program. | ||
8.5. | Without derogating from the obligations of the Company pursuant to this clause 8 or from the provisions of clause 13.2 below, in the event that the Company shall wish to develop and/or commercialise Products in addition to those specified in the Initial Development Program or to update the Initial Development Program, the Company shall submit to Yeda a further Development Program in respect of such additional Products or updates and the provisions of this clause 8 shall apply also with respect to such further Development Program and to the development and commercialisation of such additional Products, mutatis mutandis. | |
8.6. | The Company agrees to supply to Yeda and/or the Institute, for (and in quantities customary for) academic research purposes, any Products developed and/or manufactured and/or produced under this Agreement at no cost to Yeda, the Institute or the Scientists. | |
8.7. | The Company shall mark, and cause all its Sublicensees and Further Sublicensees to mark, all Products that are manufactured or sold under this Agreement with the number or numbers of each Patent applicable to such Product. |
9.1. | In consideration for the grant of the Licence, the Company shall pay Yeda a non-refundable licence fee of US $[***] per year (or part thereof) during the term of this Agreement (the Annual Licence Fee) to be paid in advance at the beginning of each 1 (one) year period during the term of this Agreement, commencing on the fifth (5th) anniversary of the date of signature of this Agreement and until (and including) the nineteenth (19th) anniversary thereof. For the removal of doubt, the first Annual Licence Fee shall be paid on the fifth (5th) anniversary of the date of signature of this Agreement and thereafter on each anniversary of the date of signature of this Agreement until (and including) the nineteenth (19th) anniversary thereof. The amount of the Annual Licence Fee paid by the Company as aforesaid shall be credited against royalties and/or other payments due and payable by the Company pursuant to clause 9.2 below during the 1 (one) year period in respect of which the Company shall have paid such Annual Licence Fee provided that the total amount of such royalties and other payments so payable during such 1 (one) year period exceeds US[***]. For the removal of |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
doubt the amount of the Annual Licence Fee paid for a particular 1 (one) year period cannot be credited against royalties payable during another 1 (one) year period. | ||
9.2. | In addition to the above, the Company shall pay Yeda royalties at the rate of: |
9.2.1. | [***] of Net Sales of Products used to treat Gaucher disease and | |
9.2.2. | [***] of Net Sales of Products used for other indications; provided that in the event that there are any sales of a Product in any country that are not, at the time of such sales, covered by a Valid Patent Claim (as defined below) in such country, then the royalty rate referred to in this clause 9.2 shall, with respect to Net Sales of such Product made in such country during the period such Product is not so covered by a Valid Patent Claim as aforesaid, be reduced to [***]for Products used to treat Gaucher disease and [***] for Products used for other indications. For the purposes of this clause 9.2, Valid Patent Claim shall mean (i) a claim under an issued and unexpired patent which is included in the Patents; (ii) a claim in a pending patent application (including a provisional application) which is included in the Patents; (iii) any protection for such Product due to Orphan Drug status (as referred to in clause 6.1.3 above); or (iv) data exclusivity or data protection or by any other regulations and/or provisions granting similar statutory or regulatory protection of such Product in such country. |
9.3. | The Company shall additionally pay Yeda the following royalty in respect of the Sublicensing Receipts: |
9.3.1. | [***] of all Sublicensing Receipts received pursuant to or in connection with Sublicences (or options for a Sublicence) signed prior to the date of submission by the Company of an Investigational New Drug Application (IND) to the FDA or equivalent EMEA approval with respect to any Product; | |
9.3.2. | [***] of all Sublicensing Receipts received pursuant to or in connection with Sublicences (or options for a Sublicence) signed on or after the date of the submission of an IND application as aforesaid but prior to the date of commencement of phase III clinical trials with respect to any Product; |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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9.3.3. | [***] of all Sublicensing Receipts received pursuant to or in connection with Sublicences (or options for a Sublicence) signed on or after the date of commencement of phase III clinical trials as aforesaid but prior to the date of FDA or EMEA approval of any Product; and | |
9.3.4. | [***] of all Sublicensing Receipts received pursuant to or in connection with Sublicences (or options for a Sublicence) signed on or after the date of FDA or EMEA approval. |
9.4. | For the removal of doubt, the Company undertakes that all sales (within the meaning of such term in clause 1.3.4 above) of Products by the Company and each Sublicensee or Further Sublicensee (as the case may be) shall be for cash consideration only. | |
9.5. | In calculating Net Sales and Sublicensing Receipts, all amounts shall be expressed in US Dollars and any amount received or invoiced in a currency other than US Dollars shall be translated into US Dollars, for the purposes of calculation, in accordance with the Exchange Rate between the US Dollar and such currency on the date of such receipt or invoice, as the case may be. For the removal of doubt, in calculating amounts received by the Company, whether by way of Net Sales or Sublicensing Receipts, any amount deducted or withheld in connection with any such payment on account of taxes on net income (including income taxes, capital gains tax, taxes on profits or taxes of a similar nature) payable by the Company in any jurisdiction, shall be deemed, notwithstanding such deduction or withholding, to have been received by the Company. In the event that the Sublicensing Receipts comprise, in whole or in part, non-cash consideration (including shares or other securities of the Sublicensee or Further Sublicensee or any other entity), then the Company agrees, promptly upon Yedas request, to execute and deliver such documents and instruments and do any other acts as may be necessary, so that Yeda receives the percentage share of such non-cash consideration as provided in clause 9.2. |
9.6.1. | Amounts payable to Yeda in terms of this clause 9 shall be paid to Yeda in US Dollars: (i) in the case of Net Sales, on a [***]and no later than [***] after the end of each [***], commencing with the first [***] in which any Net Sales are made by the Company; or (ii) in the case of Sublicensing Receipts, no later than [***] after any such Sublicensing Receipts are received by the Company from any Sublicensees or Further Sublicensees. |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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9.6.2. | The Company shall submit to Yeda: (i) no later than [***] days after the end of each [***], commencing with the first [***] in which any Net Sales are made; and (ii) no later than [***] after any Sublicensing Receipts are received, an interim written report setting out amounts owing to Yeda in respect of such Sublicensing Receipts, a full and detailed report, in a form acceptable to Yeda, certified as being correct by the chief financial officer of the Company, setting out all amounts owing to Yeda in respect of such previous [***]to which the report refers, and with full details of: |
9.6.2.1.
|
(i) | the sales made by the Company, Sublicensees and, if applicable, Further Sublicensees, including a breakdown of Net Sales according to country, identity of seller, currency of sales, dates of invoices, number and type of Products sold; | ||
(ii) | the Sublicensing Receipts, including a breakdown of Sublicensing Receipts according to identity of Sublicensees and, if applicable, Further Sublicensees, countries, the currency of the payment and date of receipt thereof; | |||
(iii) | deductions applicable, as provided in the definition of Net Sales; and |
9.6.2.2. | any other matter necessary to enable the determination of the amounts of royalties payable hereunder. |
9.7. | The Company shall keep and shall cause Sublicensees (and, if applicable, Further Sublicensees) to keep complete, accurate and correct books of account and records consistent with sound business and accounting principles and practices and in such form and in such details as to enable the determination of the amounts due to Yeda in terms hereof. The Company shall supply Yeda at the end of each calendar year, commencing with the first calendar year in which any amount is payable by the Company to Yeda under this clause 9, a report signed by the Companys independent auditors in respect of the amounts due to Yeda pursuant to this clause 9 in respect of the year covered by the said report and containing details in accordance with clause 9.6 above in respect of the quarterly reports. The Company shall retain and shall require and cause its Sublicensees (and, if applicable, Further Sublicensees) to retain the aforegoing |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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books of account for 6 (six) years after the end of each calendar year during the period of this Agreement, and, if this Agreement is terminated for any reason whatsoever, for 6 (six) years after the end of the calendar year in which such termination becomes effective. |
9.8. | At Yedas expense, Yeda shall be entitled to appoint representatives to inspect during normal business hours and to make copies of the Companys and Sublicensees (and, if applicable, Further Sublicensees) books of account, records and other documentation (including technical data and lab books) to the extent relevant or necessary for the ascertainment or verification of the amounts due to Yeda under this clause 9, provided however that Yeda shall coordinate such inspection with the Company or Sublicensee or such Further Sublicensee (as the case may be) in advance. The Company shall take all steps necessary (or in the case of its Sublicensees or, if applicable, Further Sublicensees, use its best efforts) to ensure that all such books of account, records and other documentation of the Company and its Sublicensees (and, if applicable, Further Sublicensees) are available for inspection as aforesaid at a single location for each of the Company and its Sublicensees (and, if applicable, Further Sublicensees). In the event that any inspection as aforesaid reveals any underpayment by the Company to Yeda in respect of any year of the Agreement in an amount exceeding [***]of the amount actually paid by the Company to Yeda in respect of such year then the Company shall (in addition to paying Yeda the shortfall together with interest thereon in accordance with clause 13.4 below), bear the costs of such inspection. The parties agree that the inspection of technical data and lab books as aforesaid may only be conducted for the purposes of determining whether the product developed, manufactured, sold, marketed, distributed and/or used by the Company and/or Sublicensee or Further Sublicensee is a Product, such inspection to be carried out by a representative of Yeda who is bound by an obligation of confidentiality. The provisions of this clause 9 shall survive the termination of this Agreement for whatsoever reason. |
10. | CONFIDENTIALITY |
10.1. | The Company shall maintain in confidence all information or data relating to the Patents, the Licensed Information, this Agreement and the terms hereof (hereinafter, collectively referred to as the Confidential Information), except and to the extent that the Company can prove that any such information or data is in the public domain at the date of the signing hereof or becomes part of the |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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public domain thereafter (other than through a violation by the Company or a Sublicensee or Further Sublicensee of this obligation of confidentiality) and except with regard to that portion, if any, of the Confidential Information expressly released by Yeda from this obligation of confidentiality by notice in writing to the Company to such effect. Notwithstanding the foregoing, the Company may disclose to its personnel and Sublicensees the Confidential Information to the extent necessary for the exercise by it of its rights hereunder or in the fulfilment of its obligations hereunder, provided that it shall bind such personnel and such Sublicensees with a similar undertaking of confidentiality in writing. The Company shall be responsible and liable to Yeda for any breach by its personnel or any Sublicensee of such undertakings of confidentiality as if such breach were a breach by the Company itself. |
10.2. | In addition to and without derogating from the aforegoing, the Company undertakes not to make mention of the names of Yeda, the Inventors, the Institute or any scientists or other employees of the Institute or any employee of Yeda in any manner or for any purpose whatsoever in relation to this Agreement, its subject-matter and any matter arising from this Agreement or otherwise, other than as set out in clause 10.3 below. | |
10.3. | Notwithstanding the provisions of clauses 10.1 and 10.2 above, the Company shall not be prevented from mentioning the name of Yeda, the Inventors, the Institute and/or any scientists or other employees of the Institute or any employee of Yeda or from disclosing any information (i) if, and to the extent that, such mention or disclosure is to competent authorities for the purposes of obtaining approval or permission for the exercise of the Licence, or in the fulfilment of any legal duty owed to any competent authority (including a duty to make regulatory filings); provided that any mention in a private placement memorandum or a public offering registration statement shall not be deemed fulfilment of a legal duty to a competent authority, and any such mention shall be subject to Yedas consent, which consent shall not be withheld unreasonably, or (ii) provided that such disclosure is in the form attached hereto as Appendix G. | |
10.4. | No termination of this Agreement, for whatever reason, shall release the Company from any of its obligations under this clause 10 and such obligations shall survive any termination as aforesaid. | |
10.5. | Yeda shall maintain in confidence all information received by Yeda from the Company which has been designated by the Company in |
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writing and in advance as confidential, except and to the extent that: (i) any such information or data is in the public domain at the date of the signing hereof or becomes part of the public domain thereafter (other than through a violation by Yeda of this obligation of confidentiality) or is released by the Company from this obligation of confidentiality by notice in writing; (ii) Yeda is required to disclose such information in order to fulfil its obligations under this Agreement (including in connection with the filing and prosecution of patent applications in accordance with the provisions of clause 6 above); or (iii) Yeda is required to disclose such information in fulfilment of any legal duty owed to any competent authority (the Company hereby acknowledging that it is aware that such competent authority may not be bound by any confidentiality obligations and may disclose or be required to disclose such information to a third party, whether by order of court or by law or otherwise). For the removal of doubt, the provisions of this clause 10.5 shall not apply in respect of any information (not being Licensed Information) independently developed at the Institute without reference to the confidential information received from the Company. |
10.6. | In addition to but without derogating from the aforegoing, Yeda undertakes not to make mention of the names of the Company or any employees thereof in any manner or for any purpose whatsoever in relation to this Agreement, its subject-matter and any matter arising from this Agreement or otherwise, unless the prior written approval of the Company thereto has been obtained. The aforegoing notwithstanding, Yeda shall not be prevented from mentioning the names of the Company or any employees thereof if and to the extent that such mention is to any competent authority in the fulfilment of any duty owed to such authority or that such mention is required for the purpose of fulfilling Yedas obligations hereunder. |
10.7. | For the removal of doubt, Yeda shall have the right to allow the scientists of the Institute to publish articles relating to the Licensed Information in scientific journals or posters or to give lectures or seminars to third parties relating to the Licensed Information, on the condition that, to the extent that the information to be published or disclosed is Licensed Information which is not in the public domain, a draft copy of the said contemplated publication or disclosure shall have been furnished to the Company at least 45 (forty-five) days before the making of any such publication or disclosure and the Company shall have failed to notify Yeda in writing, within 21 (twenty one) days from receipt of the said draft publication or disclosure, of its opposition to the making of the contemplated publication or |
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disclosure. Should the Company notify Yeda in writing within 21 (twenty one) days from the receipt of the draft contemplated publication or disclosure that it opposes the making of such publication or disclosure because it includes material (which has been specified in said notice) in respect of which there are reasonable grounds (which have also been specified in said notice) requiring the postponement of such publication or disclosure so as not adversely to affect the Companys interests under the Licence because such Licensed Information is patentable subject-matter for which patent protection pursuant to clause 6.1 above should be sought, then Yeda shall not permit such publication or disclosure unless and until there shall first have been filed an appropriate patent application in respect of the material to be published or disclosed as aforesaid. The Company acknowledges that it is aware of the importance to the researchers of publishing their work and, accordingly, the Company will use its best efforts not to oppose such publications. |
10.8. | Yedas obligations under this clause 10 (other than this clause 10.8) shall terminate upon termination of this Agreement; provided, however, that any transfer by Yeda following such termination of information received from the Company which it was previously required to keep confidential pursuant to clause 10.5 above shall only be made following the signature by the potential transferee thereof of a non-disclosure agreement with Yeda substantially in the form of the specimen agreement attached hereto as Appendix H. |
11. | NO ASSIGNMENT |
11.1. | The Company shall not be entitled to assign or encumber all or any of its rights or obligations under this Agreement or arising therefrom, unless it shall have received the prior written consent of Yeda to such assignment or encumbrance, which consent shall not be unreasonably withheld, and Yedas response to a request for consent as aforesaid shall not be unreasonably delayed, and which consent, if given, may be conditioned by Yeda on, inter alia, the payment of a fee or other consideration in relation thereto (including, if so conditioned by Yeda, that any consideration received by the Company in respect of an assignment to which Yeda consents as aforesaid shall be deemed to be Sublicensing Receipts and the provisions of clause 9 above shall apply with respect thereto, mutatis mutandis). For the purposes of this clause 11, the merger of the Company with another entity, in the event that the Company is not the surviving entity, and the sale of all or substantially all of the |
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Companys assets or business to a third party shall be deemed to be an assignment. |
11.2. | Notwithstanding the aforegoing, the merger of the Company with another entity as described in clause 11.1 above or the sale of all or substantially all of the assets or the business of the Company to a third party (collectively the M&A) will not require the written consent of Yeda as aforesaid if all of the following conditions are met: (i) the Company provides written notice of the M&A to Yeda at least 20 (twenty) days prior to the effective date of the M&A; (ii) Yeda receives from the assignee (or purchaser or surviving entity in a merger, as the case may be), in writing, at least 10 (ten) days prior to the effective date of the M&A: (a) an undertaking to be bound by the terms of this Agreement; and (b) an undertaking to perform the obligations of the Company under this Agreement; and (iii) that the Company is not, as at the effective date of the M&A, in breach of any of its obligations hereunder. |
12. | EXCLUSION OF LIABILITY AND INDEMNIFICATION |
12.1. | Yeda, the Inventors, the Institute and the directors, officers and employees of Yeda and/or of the Institute (hereinafter collectively the Indemnitees) shall not be liable for any claims, demands, liabilities, costs, losses, damages or expenses (including legal costs and attorneys fees) of whatever kind or nature (all of the aforegoing, collectively, Liabilities) caused to or suffered by any person or entity (including the Company or any Sublicensee or Further Sublicensee) that directly or indirectly arise out of or result from or are encountered in connection with this Agreement, the exercise of the Licence or the conduct of the Research, including directly or indirectly arising out of or resulting from or encountered in connection with: (i) the development, manufacture, sale or use of any of the Products by the Company, any Sublicensee or Further Sublicensee or any person acting in the name of or on behalf of any of the aforegoing, or acquiring, directly or indirectly, any of the Products from any of the aforegoing; or (ii) the exploitation or use by the Company or any Sublicensee or Further Sublicensee of the Licensed Information or any part thereof, including of any data or information given, if given, in accordance with this Agreement. | |
12.2. | In the event that any of the Indemnitees should incur or suffer any Liabilities that directly or indirectly arise out of or result from or are encountered in connection with this Agreement or the exercise of the Licence as aforesaid in clause 12.1 above, or shall be requested or |
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obliged to pay to any person or entity any amount whatsoever as compensation for any Liabilities as aforesaid in clause 12.1 above, then the Company shall indemnify and hold harmless such Indemnitees from and against any and all such Liabilities. Without limiting the generality of the aforegoing, the Companys indemnification as aforesaid and the exclusion of liability in clause 12.1 above shall extend to product liability claims and to damages, claims, demands, liabilities, losses, costs and expenses attributable to death, personal injury or property damage or to penalties imposed on account of the violation of any law, regulation or governmental requirement. |
If an action as contemplated by this clause 12 is brought against any Indemnitee, Yeda shall, or shall procure that such Indemnitee shall, notify the Company promptly in writing of such claim. Yeda may, at its sole option, allow the Company, at the Companys expense, to assume control over defending such claim, in which case it will provide the Company with reasonable assistance and any information reasonably required for such defence, at the Companys expense; provided that if the Company shall assume control over the defence of such claim, no settlement, consent order, consent judgment or other voluntary final disposition of such action may be entered into without the prior written consent of Yeda. | ||
12.3. | The Company shall at its own expense insure its liability pursuant to clause 12.2 above during the period beginning not later than the date of the commencement of the first clinical studies or clinical trials of any Product in humans and continuing during the entire period that the Licence is in force in any country, plus an additional period of 7 (seven) years. Such insurance shall be in reasonable amounts and on reasonable terms in the circumstances, having regard, in particular, to the nature of the Products, and shall be subscribed for from a reputable insurance company. The named insured under such insurances shall be the Company, the Inventors, Yeda and the Institute and the beneficiaries thereof shall include also the respective employees, officers and directors of Yeda and the Institute. The policy or policies so issued shall include a cross-liability provision pursuant to which the insurance is deemed to be separate insurance for each named insured (without right of subrogation as against any of the insured under the policy, or any of their representatives, employees, officers, directors or anyone in their name) and shall further provide that the insurer will be obliged to notify each insured in writing at least 30 (thirty) days in advance of the expiry or cancellation of the policy or policies. The Company |
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hereby undertakes to comply punctually with all obligations imposed upon it under such policy or policies and in particular, without limiting the generality of the aforegoing, to pay in full and punctually all premiums and other payments for which it is liable pursuant to such policy or policies. The Company shall be obliged to submit to Yeda copies of the aforesaid insurance policy or policies within 14 (fourteen) days of the date of issue of each such policy. |
12.4. | The provisions of this clause 12 shall survive the termination of this Agreement for whatsoever reason. |
13. | TERM AND TERMINATION |
13.1. | Unless otherwise agreed to in writing, this Agreement shall terminate upon the occurrence of the later of the following: |
13.1.1. | the date of expiry of the last of the Patents; or | |
13.1.2. | the expiry of a continuous period of [***]during which there shall not have been a First Commercial Sale of any Product in any country. |
13.2. | Notwithstanding anything to the contrary contained in this Agreement: |
13.2.1. | Yeda shall be entitled, at its option: (i) to modify the Licence hereunder so that it is non-exclusive only, by written notice to the Company (any such amendment of this Agreement by Yeda as aforesaid, being effective immediately, the Companys consent thereto (written or otherwise) not being required, notwithstanding the provisions of clause 17.2 below); or (ii) to terminate this Agreement, including the Licence hereunder, with respect to any Product, by written notice to the Company, if the Company shall fail to achieve any one of the following milestones, in each case in respect of at least one Product, by the dates specified therefor: |
(1) | within [***] of the signature of this Agreement, to have commenced required Good Laboratory Practice (GLP) pre-clinical development; | ||
(2) | within [***] of the signature of this Agreement, to have commenced phase I clinical trials; |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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(3) | within [***] of the signature of this Agreement, to have commenced phase II clinical trials; | ||
(4) | within [***]of the signature of this Agreement, to have commenced phase III clinical trials; | ||
(5) | within [***] of the date of signature of this Agreement, to have submitted a New Drug Application to the FDA or a Marketing Authorisation Application (MAA) to the EMEA; | ||
(6) | First Commercial Sale of at least one Product shall not have commenced within [***] of the first Product approval obtained as a result of an application submitted pursuant to clause 13.2.1(a)(5); and | ||
(7) | commercial sale of any Product having commenced, there shall be a period of [***] or more during which no sales of any Product shall take place (except as a result of force majeure or other factors beyond the control of the Company) |
13.2.2. | Without derogating from the aforegoing, Yeda shall be entitled to terminate this Agreement (unless previously terminated in accordance with the provisions of this Agreement), by written notice to the Company (effective immediately), if the Company contests the validity of any of the Patents. |
13.3. | Without derogating from the parties rights hereunder or by law to any other or additional remedy or relief, it is agreed that either Yeda or the Company may terminate this Agreement and the Licence |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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hereunder by serving a written notice to that effect on the other upon or after: (i) the commitment of a material breach hereof by the other party, which material breach cannot be cured or, if curable, which has not been cured by the party in breach within 21 (twenty-one) days (or, in the case of failure by the Company to pay any amount due from the Company to Yeda pursuant to or in connection with this Agreement on or before the due date of payment, 10 (ten) days) after receipt of a written notice from the other party in respect of such breach, or (ii) the granting of a winding-up order in respect of the other party, or upon an order being granted against the other party for the appointment of a receiver, or if such other party passes a resolution for its voluntary winding-up, or if a temporary or permanent liquidator or receiver is appointed in respect of such other party, or if a temporary or permanent attachment order is granted on such other partys assets, or a substantial portion thereof, or if such other party shall seek protection under any laws or regulations, the effect of which is to suspend or impair the rights of any or all of its creditors, or to impose a moratorium on such creditors, or if anything analogous to any of the aforegoing in this clause 13.3(ii) above under the laws of any jurisdiction occurs in respect of such other party; provided that in the case that any such order or act is initiated by any third party, the right of termination shall apply only if such order or act as aforesaid is not cancelled within 60 (sixty) days of the grant of such order or the performance of such act. |
13.4. | Any amount payable hereunder by one of the parties to the other, that has not been paid by its due date of payment, shall bear interest from its due date of payment until the date of actual payment, at the rate of [***]per month and pro rata for part of a month. | |
13.5. | Upon the termination of this Agreement for whatever reason (other than the passage of time), all rights in and to the Licensed Information and the Patents shall revert to Yeda and the Company shall not be entitled to make any further use thereof and the Company shall deliver to Yeda all drawings, plans, diagrams, specifications, other documentation, models or any other physical matter in the Companys possession in any way containing, representing or embodying the Licensed Information; and (ii) the Company shall grant to Yeda a non-exclusive, irrevocable, perpetual, worldwide licence, with the right to sublicense (subject to the provisions of clause 13.7 below), in respect of the Development Results. In this clause 13.5, the term the Development Results shall mean any invention, product, material, method, process, technique, know-how, data, information or other result which does |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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not form part of the Licensed Information, discovered or occurring in the course of or arising from the performance by the Company of the development work pursuant to clause 8 above, including any regulatory filing or approval, filed or obtained by the Company in respect of the Products, all communications with the regulatory authorities, the drug master file and any data, information or document covered by data protection or data exclusivity. |
13.6. | The termination of this Agreement for any reason shall not relieve the Company or Yeda of any obligations which shall have accrued prior to such termination. | |
13.7. | In the event that this Agreement shall be terminated, other than by way of termination by Yeda pursuant to clause 13.2.2 or 13.3 above, and that, subject to the Magneton Directive and/or the directives of the OCS, at any time within 5 (five) years following such termination, Yeda shall grant to a third party a licence in respect of the Development Results or any part thereof (alone or together with any part of the Licensed Information) and Yeda shall receive in respect of such licence consideration, then Yeda shall pay to the Company [***]of the Net Proceeds actually received by Yeda in respect of such a licence, provided however that Yeda shall be entitled to set off against such amounts sums owed or which become owed by the Company to Yeda, until such time as the Company shall have received an amount equal to [***] of the Companys direct expenditure incurred in respect of the process of obtaining the Development Results (excluding any Magneton or other OCS or other non-commercial funding), as confirmed in writing by the Companys independent accountants. Yeda shall pay to the Company amounts, if any, payable under this clause 13.7 above, within 90 (ninety) days of receipt of the relevant Net Proceeds. | |
For the purpose of this clause 13.7, Net Proceeds means royalties and all other monetary consideration actually received by Yeda in respect of such licence (excluding funds for research and/or development at the Institute or payments for the supply of services) after deduction of all costs, fees and expenses incurred by Yeda in connection with such licence (including, without limitation, patent related costs, and all attorneys fees and expenses and other costs and expenses in connection with the negotiation, conclusion and administration of such licence). | ||
13.8 | For the avoidance of doubt, it is hereby agreed that following the expiry of the Licence in any country pursuant to clause 7.3 above, |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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the Company and its Sublicensees shall be entitled to continue to produce, manufacture, use, market, distribute and/or sell Products in the said country without having to pay royalties or any other consideration to Yeda in respect of such activities subsequent to such expiry date. |
14. | NOTICES | |
Any notice or other communication required to be given by one party to the other under this Agreement shall be in writing and shall be deemed to have been served: (i) if personally delivered, when actually delivered; or (ii) if sent by facsimile, the next business day after receipt of confirmation of transmission; or (iii) 10 (ten) days after being mailed by certified or registered mail, postage prepaid (for the purposes of proving such serviceit being sufficient to prove that such notice was properly addressed and posted) to the respective addresses of the parties set out below, or to such other address or addresses as any of the parties hereto may from time to time in writing designate to the other party hereto pursuant to this clause 14: |
14.1.
|
to Yeda at: | P.O. Box 95 | ||
Rehovot 76100 | ||||
Attention: the CEO | ||||
Facsimile: (08) 9470739 | ||||
14.2.
|
to the Company at: | 2 Snunit St, Science Park | ||
P.O. Box 455 | ||||
Carmiel 20100 | ||||
Attention: the CEO | ||||
Facsimile: (04) 988 9489 |
15. | VALUE ADDED TAX | |
The Company shall pay to Yeda all amounts of Value Added Tax imposed on Yeda in connection with the transactions under this Agreement. All amounts referred to in this Agreement shall be exclusive of Value Added Tax. | ||
16. | GOVERNING LAW AND JURISDICTION | |
This Agreement shall be governed in all respects by the laws of Israel and the parties hereby submit to the exclusive jurisdiction of the competent Israeli courts, except that Yeda may bring suit against the Company in any other jurisdiction outside Israel in which the Company has assets or a place of business. |
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17. | MISCELLANEOUS |
17.1. | The headings in this Agreement are intended solely for convenience or reference and shall be given no effect in the interpretation of this Agreement. | |
17.2. | This Agreement constitutes the entire agreement between the parties hereto in respect of the subject-matter hereof, and supersedes all prior agreements or understandings between the parties relating to the subject-matter hereof (including the Memorandum of Understanding between Yeda and the Company dated 29 November 2005) and, subject to clause 13.2.1(i) above, this Agreement may be amended only by a written document signed by both parties hereto. No party has, in entering into this Agreement, relied on any warranty, representation or undertaking, except as may be expressly set out herein. | |
17.3. | This Agreement may be executed in any number of counterparts (including counterparts transmitted by telecopier or fax), each of which shall be deemed to be an original, but all of which taken together shall be deemed to constitute one and the same instrument. | |
17.4. | No waiver by any party hereto, whether express or implied, of its rights under any provision of this Agreement shall constitute a waiver of such partys rights under such provisions at any other time or a waiver of such partys rights under any other provision of this Agreement. No failure by any party hereto to take any action against any breach of this Agreement or default by another party hereto shall constitute a waiver of the former partys rights to enforce any provision of this Agreement or to take action against such breach or default or any subsequent breach or default by such other party. | |
17.5. | If any provision of this Agreement is held to be unenforceable under applicable law, then such provision shall be modified as set out below and the balance of this Agreement shall be interpreted as if such provision were so modified and shall be enforceable in accordance with its terms. The parties shall negotiate in good faith in order to agree on the terms of an alternative provision which complies with applicable law and achieves, to the greatest extent possible, the same effect as would have been achieved by the invalid or unenforceable provision. |
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17.6. | Nothing contained in this Agreement shall be construed to place the parties in a relationship of partners or parties to a joint venture or to constitute either party an agent, employee or a legal representative of the other party and neither party shall have power or authority to act on behalf of the other party or to bind the other party in any manner whatsoever. | |
17.7. | All payments to be made to Yeda hereunder shall be made in US Dollars (save that payments received by the Company in New Israeli Sheqels may be made in that currency) by bankers cheque or by bank transfer to Yedas bank account, the details of which are as follows: Bank Hapoalim B.M. Rehovot branch #615, account no. [***]; swift: [***]. | |
17.8. | All payments to be made to Yeda hereunder shall be made free and clear of, and without any deduction for or on account of, any set-off, counterclaim or tax (except any deductions that the Company is required to make from the payments to be made to Yeda on account of income tax, tax on profit or any other taxes of a similar nature imposed on Yeda by law, (withholding tax), provided that: (a) the Company shall immediately notify Yeda of such requirement and the Company shall deduct the withholding tax from the payments referred to above, as prescribed by applicable law, and pay such withholding tax to the tax authorities, unless Yeda provides the Company with evidence of an exemption from such tax; and (b) any such deduction (if any) made by the Company does not exceed the minimum amount legally required and is supported by an official receipt of the applicable taxation authority for all amounts deducted as aforesaid). | |
17.9. | Each party agrees to execute, acknowledge and deliver such further documents and instruments and do any other acts, from time to time, as may be reasonably necessary, to effectuate the purposes of this Agreement. | |
17.10. | None of the provisions of this Agreement shall be for the benefit of, or enforceable by, any person who is not a party to this Agreement, save for clauses 10 and 12 above. |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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DEVELOPMENT COMPANY LIMITED |
BIOTHERAPEUTICS LIMITED |
|||||||||
Signature:
|
/s/ Illegible | Signature: | /s/ David Aviezer | |||||||
Name
|
Name: | |||||||||
Title
|
Title: | |||||||||
Date:
|
Date: | |||||||||
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[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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1. | The RECIPIENT agrees that the MATERIAL: | |
1.1. | is to be used solely for the purpose of the RESEARCH ; | |
1.2. | will not be used for any commercial purposes; | |
1.3. | will not be used in human subjects, in clinical trials, or for diagnostic purposes involving human subjects. | |
1.4. | is to be used only at the RECIPIENT organization and only in. s laboratory (the RECIPIENT SCIENTIST) under the direction of RECIPIENT SCIENTIST or others working under his/her direct supervision; and | |
1.5. | will not be transferred to anyone else including within the RECIPIENT organization at (please complete address) without the prior written consent of the PROVIDER. | |
2. | The RECIPIENT acknowledges that the MATERIAL is or may be the subject of a patent application. No expressed or implied licenses or other rights are provided to the RECIPIENT under any patents, patent |
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applications, trade secrets or other proprietary rights of the PROVIDER, including any altered forms of the MATERIAL made by the PROVIDER. In particular, no expressed or implied licenses or other rights are provided to use the MATERIAL, or any related patents of the PROVIDER for COMMERCIAL PURPOSES. |
3. | Any MATERIAL delivered pursuant to this Agreement is understood to be experimental in nature and may have hazardous properties. The PROVIDER MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED. WITHOUT DEROGATING FROM THE AFOREMENTIONED, THERE ARE NO EXPRESSED OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE MATERIAL WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS. | |
4. | The RECIPIENT assumes all liability for damages which may arise from its use, storage or disposal of the MATERIAL. The Scientist, the PROVIDER and any of its employees will not be liable to the RECIPIENT for any loss, claim or demand made by the RECIPIENT, or made against the RECIPIENT by any other party, due to or arising from the use of the MATERIAL by the RECIPIENT. | |
5. | The RECIPIENT agrees to use the MATERIAL in compliance with all applicable statutes, laws, treaties, regulations and guidelines such as, for example, those relating to research involving the use of animals or recombinant DNA. | |
6. | This Agreement will terminate on the earliest of the following dates: (a) on completion of the RECIPIENTs Research with the MATERIAL, or (b) on thirty (30) days written notice by either party to the other. | |
6.1. | If termination should occur under clause 6 above, the RECIPIENT will discontinue its use of the MATERIAL and will, upon direction of the PROVIDER, return or destroy any remaining MATERIAL. | |
7. | The RECIPIENT obligates to treat in confidence any information related to the Material including RESEARCH results, except for information the RECIPIENT can prove was previously known to him or that is or becomes publicly available not as a result of a breach of this Agreement. Any disclosure of such confidential information shall be presented for the Scientists approval, at least 30 (thirty) days prior to the proposed disclosure. | |
8. | Paragraphs 2, 3, 4, 7, 10 and 11 shall survive termination. | |
9. | The RECIPIENT shall provide the PROVIDER with the results of the RESEARCH. |
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10. | EITHER: [Should any useful invention, or application arise as a result of the performance of the RESEARCH, RECIPIENT hereby agrees to inform the undersigned, and the right and title to such invention or application shall vest in Yeda Research and Development Company Ltd. (YEDA), the PROVIDERs technology transfer office. The RECIPIENT undertakes, upon YEDAs request from time to time, to execute and deliver to YEDA all documents, including, without limitation, instruments of conveyance, transfer, assignment and confirmation and to take such other steps and render such assistance as YEDA may deem necessary, in order effectively to transfer, assign, convey, vest and confirm in and to YEDA the ownership of such invention.] | |
OR: [The Weizmann Institute, or any of its designees, is hereby granted an option to obtain a worldwide, exclusive, royalty-bearing license, with the right to grant sublicenses, of any patentable invention arising from the Research outside the scope of the Material. Such license shall include terms and conditions to be negotiated in good faith between your institution and the Institute.] | ||
11. | In the event that RECIPIENT conceives an invention related to the MATERIAL in the course of activities that are in breach of RECIPIENTs obligations under this Agreement, YEDA shall be the sole and exclusive owner of such invention and all intellectual property rights therein, and RECIPIENT shall execute and deliver any documents of assignment or conveyance to effectuate the ownership rights of YEDA in such invention and related intellectual property rights. | |
12. | The PROVIDER shall be given advance notice of any intent to publish any information relating to the results of the RESEARCH, not being in the public domain, and shall be furnished with a copy of the contemplated publication at least 30 days before making any such disclosure, in order to allow YEDA to evaluate patent protection in respect thereof and implement a decision to file a patent application. The RECIPIENT agrees to provide appropriate acknowledgment of the source of the MATERIAL in all written and oral publications. | |
13. | RECIPIENT shall pay stamp duty as required by law. |
Agreed and accepted: |
||
Recipient Scientists Name:
|
Recipients Name: |
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Authorized Persons Name and Title: | ||||||||||||||||||||
Signature: |
||||||||||||||||||||
Signature and Date: | ||||||||||||||||||||
Date: |
||||||||||||||||||||
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1. | Confidential Information shall include any documents, patent applications, materials, models, marketing, financial and investment plans, contacts, advice, recommendations, drawings, plans, diagrams, specifications, technical material, techniques, compounds, compositions, substances, seeds or any other physical matter in any way containing, representing or embodying any of the aforegoing or any other information given, whether verbally, in written or other form, by or on behalf of YEDA to Recipient. | |
2. | Recipient undertakes to use the Confidential Information only for the purpose of this Agreement. | |
3. | Recipient undertakes to treat and maintain in strict confidence and secrecy, the Confidential Information including any aspect thereof that may have been disclosed prior to the signature hereof, and to make such information available only to those of its employees and/or consultants who need to have access to it for the purpose of this |
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Agreement, provided that such employees and/or consultants are bound by a confidentiality undertaking not less stringent than this Agreement. |
4. | Recipients undertakings and obligations under clause 3 above shall not apply to any part of the Confidential Information for which the Recipient proves: |
4.1. | that it was known to Recipient prior to disclosure thereof by YEDA; | ||
4.2. | that it was generally available to the public prior to disclosure by YEDA, or becomes generally available to the public after such disclosure (other than as a result of the breach by the Recipient of its obligations hereunder). |
5. | This Agreement shall not by implication or otherwise be construed as a grant of a license or as an obligation to grant a license or any other right to the Recipient. | |
6. | No warranty of any kind is being provided with respect to the Confidential Information including any warranty of accuracy, completeness and/or non-infringement. | |
7. | This Agreement shall be terminated upon the expiry of the earlier of: |
7.1. | 12 months from the effective date of this Agreement; or | ||
7.2. | Receipt of 14 days written notice by YEDA to Recipient, at any time. | ||
Upon termination, Recipient will cease all study, evaluation or other examination of YEDAs Confidential Information and the Confidential Information shall be returned to YEDA or destroyed upon YEDAs request. |
8. | Notwithstanding termination of this Agreement Recipients confidentiality obligations under this Agreement will continue for 5 years from the date of disclosure of the Confidential Information. | |
9. | The rights of the parties shall inure to, and the obligations hereunder shall be binding on the legal successors and assigns of the parties to this Agreement. | |
10. | The law of Israel shall govern this Agreement for all purposes excluding the choice of law provisions. | |
11. | All notices or demands of any kind which either party may be required or desire to serve upon the other shall be in writing and shall be delivered by (i) personal service, or (ii) by mail at the address of the receiving party set forth above (or at such different address as may be designated by such party by written notice to the other party) and by fax. | |
12. | This Agreement contains the entire agreement of the parties relating to its subject matter and supersedes all prior or contemporaneous oral or written agreements. |
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13. | This Agreement may not be amended except by mutual written agreement of the parties. |
Protalix Biotherapeutics Ltd. | Yeda Research and Development Co. Ltd. | |||||||||
Signature:
|
Signature: | |||||||||
Name:
|
Name: | |||||||||
Position:
|
Position: | |||||||||
Date:
|
Date: | |||||||||
1. | Preamble and Definitions |
1.1. | The Preamble and Annexes hereto form an integral part of this Agreement. |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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1.2. | In this Agreement the terms below shall bear the meanings assigned to them below and other capitalized terms shall bear the meaning assigned to them in their parenthetical definition, unless specifically stated otherwise: |
1.2.1. | Additional Patents - shall mean the patents and patent applications listed in Annex 1.2.1, which constitute all of the patents and patent applications that are proprietary to Protalix and existing on the Effective Date, other than the Platform Patents and patent application number [***]entitled [***], and any patent that may be issued thereon. | ||
1.2.2. | Affiliate shall mean, with respect to any Party, any person, organization or entity directly or indirectly controlling, controlled by or under common control with, such Party. For purposes of this definition only, control of another person, organization or entity shall mean the ability, directly or indirectly, to direct the activities of the relevant entity, and shall include, without limitation (i) ownership or direct control of fifty percent (50%) or more of the outstanding voting stock or other ownership interest of the other organization or entity, or (ii) direct or indirect possession, of the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the organization or other entity. | ||
1.2.3. | Annual Protalix Payment shall bear the meaning assigned to such term in Section 10.5 below. | ||
1.2.4. | API shall mean the bulk Proteins active pharmaceutical ingredient. | ||
1.2.5. | API COGS shall bear the meaning assigned to such term in Section 10.4 below. | ||
1.2.6. | Backup Manufacturing File shall bear the meaning assigned to such term in Section 10.7 below. | ||
1.2.7. | Breakthrough Technology shall bear the meaning assigned to such term in Section 13.2 below. | ||
1.2.8. | Budget shall bear the meaning assigned to such term in Section 4.14 below. | ||
1.2.9. | Combination Product shall mean a product which comprises (a) a Licensed Product and (b) at least one other active ingredient, which, if administered independently of the Licensed Product, would have a clinical effect. | ||
1.2.10. | Change of Control shall bear the meaning assigned to such term in Section 11.5 below. | ||
1.2.11. | Commercial GCD Services shall bear the meaning assigned to such term in Section 14A.6 below. | ||
1.2.12. | Development Plan shall bear the meaning assigned to such term in Section 4.4 below. | ||
1.2.13. | Effective Date shall bear the meaning assigned to such term in Section 15.1 below. | ||
1.2.14. | EU shall mean the member countries of the European Union, from time to time. | ||
1.2.15. | EU Market shall mean all of Spain, the UK, Italy, Germany and France. |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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1.2.16. | Evaluation Period shall bear the meaning assigned to such term in Section 14.2 below. | ||
1.2.17. | External Development Expenses shall bear the meaning assigned to such term in Section 4.14.2 below. | ||
1.2.18. | External Manufacturing Expenses shall bear the meaning assigned to such term in Section 10.4 below. | ||
1.2.19. | Exclusive Manufacturing Term shall bear the meaning assigned to such term in Section 10.1 below. | ||
1.2.20. | Escrow Agent shall bear the meaning assigned to such term in Section 10.7(A) below. | ||
1.2.21. | Feasibility Program(s) shall bear the meaning assigned to such term in Section 3.1.1 below. | ||
1.2.22. | Final Feasibility Report shall bear the meaning assigned to such term in Section 3.1.7 below. | ||
1.2.23. | First Commercial Sale shall mean, with respect to any Licensed Product the first commercial sale to a third party, in exchange for cash or some equivalent to which value can be assigned, after the obtaining of all necessary regulatory and other approvals required in order to commercially sell and market the Licensed Product in the country in which the sale is made, other than the sale of the Licensed Product for experimental, testing, compassionate or promotional purposes. | ||
1.2.24. | Further Sublicense and Further Sublicensee shall bear the meaning assigned to such terms in Section 6.3 below. | ||
1.2.25. | GCD License shall bear the meaning assigned to such term in Section 14.1 below. | ||
1.2.26. | GCD Product shall bear the meaning assigned to such term in Section 14.1 below. | ||
1.2.27. | GCD Services shall bear the meaning assigned to such term in Section 14A.1 below. | ||
1.2.28. | Innovator shall mean the first to market with a specific proprietary Product. | ||
1.2.29. | Internal Expenses shall bear the meaning assigned to such term in Section 4.14.1 below. | ||
1.2.30. | IP shall mean (i) all inventions, materials, compounds, compositions, substances, methods, processes, techniques, know-how, technology, data, information, discoveries and other results of whatsoever nature, and any patents, copyrights, proprietary intellectual or industrial rights directly or indirectly deriving therefrom, as well as provisionals, patent applications (whether pending or not), and patent disclosures together with all reissuances, continuations, continuations in part, revisions, extensions, and reexaminations thereof; (ii) all trademarks, service marks, copyrights, designs, trade styles, logos, trade dress, and corporate names, including all goodwill associated therewith; (iii) any work of authorship, regardless of copyrightability, all |
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compilations, all copyrights; and (iv) all trade secrets, confidential information and proprietary processes. | |||
1.2.31. | License shall bear the meaning assigned to such term in Section 6.1 below. | ||
1.2.32. | Licensed Information shall bear the meaning assigned to such term in Section 6.1 below. | ||
1.2.33. | Licensed Product(s) shall bear the meaning assigned to such term in Section 6.1 below. | ||
1.2.34. | Major Countries shall mean the United States of America, Canada, the EU Market, China, Japan, Israel, Mexico, India, Australia and New Zealand. | ||
1.2.35. | Manufacturing Know-how shall bear the meaning assigned to such term in Section 10.7 below. | ||
1.2.36. | Market Advantage shall [***] | ||
1.2.37. | Milestone shall bear the meaning assigned to such term in Section 8.1 below. | ||
1.2.38. | Milestone Payments shall bear the meaning assigned to such term in Section 8.1 below. | ||
1.2.39. | Net Sales shall mean with respect to a Licensed Product, the total gross amounts [***] in respect of such Licensed Product, as established in a bona fide arms-length transaction with an unrelated third party, less the following items (as they apply to such Licensed Product): (i) quantity and/or cash discounts actually allowed or taken; (ii) customs, duties, sales and similar taxes, if any, imposed on the Licensed Product, to the extent applicable to such sale and included in the invoice in respect of such sale; (iii) amounts actually allowed or credited by reason of rejections, return of goods (including as a result of recalls), any retroactive price reductions or allowances specifically identifiable as relating to the Licensed Product; (iv) amounts incurred resulting from government mandated rebate programs (or any agency thereof); (v) third party (a) rebates, (b) freight, postage, shipping and applicable insurance charges, to the extent the same are separately |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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itemized on invoices and actually paid as evidenced by invoices or other appropriate supporting documentation, and (c) chargebacks or similar price concessions related to the sale of the Licensed Product; (vi) bad debts deriving from Net Sales in respect of which Royalty Payments were paid to Protalix pursuant hereto, (vii) royalties paid to third parties [***] in respect of the use of such third partys intellectual property rights (provided that in no event shall the amounts deducted in respect of such third party royalties under (vii) result in the reduction of the Royalty Payments to Protalix to less than [***]of the Net Sales attributable to any particular Licensed Product, (without derogating from any lower royalty rates as determined by Sections 8.2(a) or 8.2(b) below), and (vi) reasonable quantities of samples, provided the quantity of Licensed Product actually utilized for purposes of such samples shall not exceed [***] of the volume of annual Licensed Product sales during any given year during this Agreement. All of the foregoing shall be calculated in accordance with U.S. GAAP. | |||
[***] | |||
In addition, the Net Sales shall be furthermore adjusted and reduced in the event that a Licensed Product is sold as part of a Combination Product as set forth in Section 8.4 hereto. | |||
With respect to sales which are not at bona fide arms-length and/or are not in the ordinary course of business, the term Net Sales shall mean the total amount that would have been due in an arms-length sale made in the ordinary course of business and according to the then current market conditions for such sale or, in the absence of such current market conditions, according to market conditions for sale of products similar to the Licensed Products. If Licensed Products are sold or supplied in a currency other than United States Dollars then the sum of Net Sales shall first be determined in the currency in which such Licensed Products were invoiced and then converted into equivalent United States Dollars at the middle market rate of such foreign currency as quoted in the Financial Times at the close of business of the last business day of the quarter with respect to which the payment is made. | |||
1.2.40. | Non-Platform IP shall mean all Licensed Information and Teva IP, other than Platform IP. | ||
1.2.41. | Other IP shall mean any and all IP developed within the framework of the collaboration hereunder (including both the performance of the Feasibility Program and the performance of Stage 2, in the event that Teva exercises its option to have Stage 2 performed), which is neither Platform IP nor Protein IP. | ||
1.2.42. | Platform IP shall mean Protalixs existing and future proprietary recombinant plant culture process and technologies directly related to such process, and improvements thereto, as may be further developed in the course |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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1.2.43. | Protalix Competitor shall mean: [***] | ||
1.2.44. | Protein(s) each of the two (2) therapeutic proteins as selected by Teva and agreed upon by Protalix (such agreement not to be unreasonably withheld, conditioned or delayed), expressed in plant cell-expression system, to be described in Annex 1.2.44 hereto, as might be substituted subject to the terms of this Agreement. | ||
1.2.45. | Protein IP shall mean any and all IP developed during the collaboration hereunder (including both the performance of the Feasibility Program and the performance of Stage 2, in the event that Teva exercises its option to have Stage 2 performed), which relates specifically to the Proteins and which is not Platform IP. Notwithstanding the foregoing, any patent(s) related to the Platform IP that specifically and directly and solely relates to one or both of the Proteins shall be considered part of the Protein IP, and not Platform IP. | ||
1.2.46. | ROFL shall bear the meaning assigned to such term in Section 14.1 below. | ||
1.2.47. | ROFO ROFO Notice and ROFO Period shall bear the meanings assigned to such terms in Section 3.2.1 below. | ||
1.2.48. | Royalty Payments shall bear the meaning assigned to such term in Section 8.2 below. | ||
1.2.49. | [***] | ||
1.2.50. | Stage 2 shall bear the meaning assigned to such term in Section 3.4 below. | ||
1.2.51. | Stage 2 Notice and Stage 2 Notice Period shall bear the meaning assigned to such terms in Section 3.4 below. | ||
1.2.52. | Sublicence shall mean any right granted, license given, or agreement entered into, by Teva and/or its Affiliates to or with any other person or entity |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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(whether or not such grant of rights, license given or agreement entered into is described as a sublicence or otherwise), permitting any use of the Licensed Information (or any part thereof) or any right to research, develop, make, have made, register, import, manufacture, use, sell, offer for sale, produce, sublicense, commercialize and/or distribute the Proteins and/or the Licensed Products for any indication; and the term Sublicensee shall be construed accordingly. | |||
1.2.53. | Teva Competitor shall bear the meaning ascribed to such term in Section 11.5 below. | ||
1.2.54. | Teva IP shall bear the meaning assigned to such term in Section 11.6 below. |
1.3. | In this Agreement, words importing the singular shall include the plural and vice-versa and words importing any gender shall include all other genders and references to persons shall include partnerships, corporations and unincorporated associations. | ||
1.4. | The words including and includes mean including, without limiting the generality of any description preceding such terms. | ||
1.5. | In the event of any discrepancy between the terms of this Agreement and any of the Annexes hereto, the terms of this Agreement shall prevail. |
2.1. | The Parties hereby agree to collaborate in the development, and the manufacturing of the Proteins, on the basis of the Platform IP. | ||
2.2. | The collaboration in respect of the development of the Licensed Products shall initially be carried out through the performance of the Feasibility Program. Following completion of same, should Teva so elect at its sole and exclusive discretion, the collaboration shall continue by way of the development of Licensed Products. | ||
2.3. | The commercialization of the Licensed Products shall be performed solely by Teva (or any third party on its behalf in accordance herewith), without the collaboration of Protalix, under the License granted to Teva hereunder. |
3. | The Collaboration |
3.1. | The Feasibility Program Stage 1 |
3.1.1. | Protalix shall carry out a feasibility program in respect of each of the Proteins in accordance with the protocol and time schedule as agreed between the Parties to be attached hereto within thirty (30) days of the Effective Date as Annex 3.1.1 (the Feasibility Program). An outline of the activities to be performed by Protalix under the Feasibility Program, as currently envisaged, is attached hereto as Annex 3.1.1A. The Feasibility Program will mainly consist of producing [***]. One (1) Protein shall be agreed upon between the Parties, within thirty (30) days of the |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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Effective Date, and shall be described in Annex 1.2.44 (the First Protein) and the other Protein (the Second Protein) shall be selected by Teva by [***] following the execution hereof, and agreed upon by Protalix, such agreement not to be unreasonably withheld. | |||
3.1.2. | Protalix shall begin performing the Feasibility Program in respect of the First Protein immediately after the First Protein is selected by the Parties, and, shall begin performing the Feasibility Program in respect of the Second Protein, as soon as practicable, but no later than four (4) weeks following the selection of Second Protein by Teva and its approval by Protalix, as aforementioned. | ||
3.1.3. | Each Feasibility Program will be carried out by Protalix at its sole cost and expense in accordance with a budget reasonably determined by it in accordance with industry standards, and based on the Feasibility Program. A Feasibility Program may be adjusted with the consent of the R&D Committee (as defined below) from time to time. A non-binding estimate of the resources and expenses that Protalix expects to dedicate to, and incur in the conduct of each Feasibility Program (inclusive, inter alia, of the estimated costs of FTEs and materials) will be submitted to the R&D Committee at the beginning of each Feasibility Program and an updated non-binding estimate pertaining to the remainder of the Feasibility Program shall be submitted twelve (12) months following commencement of each Feasibility Program. Protalix shall keep separate records of the expenses actually incurred by it in the conduct of each Feasibility Program and shall provide Teva and the R&D Committee with detailed quarterly reports of its expenses. For the avoidance of doubt, it is clarified that any major deviation by Protalix from the activities set forth under a Feasibility Program shall require the prior written approval of the R&D Committee. Any material increase in the cost of the conduct of the Feasibility Program deriving solely from an agreed change in the activities included in the Feasibility Program will be discussed and negotiated in good faith between the management of both Parties. | ||
3.1.4. | Protalix shall complete each Feasibility Program within [***]. Any extension of such time period that may be requested by Protalix, with respect to each or any Protein, must be approved in advance and in writing by Teva, which approval shall not be unreasonably withheld. For avoidance of doubt, Protalix shall bear all costs and expenses related to the performance of the Feasibility Program until its completion regardless of the term of its duration. | ||
3.1.5. | At the end of each calendar quarter during the course of the performance of each Feasibility Program, Protalix shall provide Teva with periodic progress reports regarding the progress of such Feasibility Program, in a form to be agreed in advance between the Parties. | ||
3.1.6. | Tevas representative(s) on the R&D Committee may, from time to time, request updates regarding the progress of Stage 1, in addition to the periodic progress reports, and Protalix shall provide any additional update that Tevas representative(s) on the R&D Committee may reasonably request. | ||
3.1.7. | Not later than sixty (60) days after the completion of the performance of |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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each Feasibility Program in respect of each Protein, Protalix shall provide Teva with a written report detailing the results of such Feasibility Program in respect of each Protein, in a form acceptable to Teva (each, a Final Feasibility Report). | |||
3.1.8. | After receipt by Teva of each Final Feasibility Report, if Teva wishes to receive further information from Protalix it shall so advise Protalix by written notice specifying such additional information requested (the First Notice), to be delivered to Protalix no later than sixty (60) days as of the date of provision to Teva of the Final Feasibility Report. Protalix will provide such additional information within a reasonable time, but not later than sixty (60) days following receipt of the First Notice (the Initial Response). In the event that following receipt of the Initial Response, Teva wishes to receive further information from Protalix, it shall so advise Protalix by written notice specifying such additional information requested (the Second Notice), to be delivered to Protalix no later than forty five (45) days as of the date of provision to Teva of the Initial Response. Protalix will provide such additional information within a reasonable time but not later than forty five (45) days following receipt of the Second Notice (the Additional Response). In the event that following receipt of the Additional Response, Teva wishes to receive further information from Protalix, it shall so advise Protalix by written notice specifying such additional information requested (the Third Notice), to be delivered to Protalix no later than thirty (30) days as of the date of provision to Teva of the Additional Response. Protalix will provide such additional information within a reasonable time but not later than thirty (30) days following receipt of the Third Notice (the Final Response). In the event that the Initial Response, together with the Additional Response and the Final Response provide the full and complete information reasonably requested by Teva, then following submission of the Final Response Protalix shall not be required to provide any additional information to Teva in connection with the Final Feasibility Report. | ||
3.1.9. | Protalix shall NOT be entitled to subcontract its obligations to perform the Feasibility Programs to any third party whatsoever without the prior written approval of Teva, which approval shall not be unreasonably withheld. | ||
3.1.10. | Without limiting the generality of the second sentence of Section 16.6, the Parties hereby acknowledge that Protalix has not guaranteed that Stage 1 will be successful or achieve any specific results at all or within the specified time period. |
3.2. | Right of First Offer |
3.2.1. | Until the lapse of a [***] period from the Effective Date or until the selection by Teva of the Second Protein, whichever comes first (the ROFO Period) Protalix shall refrain from entering into an agreement with any third party the purpose of which is the development or commercialization of any [***] protein utilizing the Platform IP, unless Protalix shall first offer Teva in writing to select such protein as the Second Protein (the ROFO and the ROFO Notice, respectively). Upon receipt of the ROFO Notice Teva will have the right, within thirty (30) days of the date of the |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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ROFO Notice, to select such protein as the Second Protein, by written confirmation of such selection which selection Protalix shall be deemed as being in agreement with. Protalix shall immediately notify Teva in writing of the commencement of any negotiations with any third party regarding the development or commercialization of any [***] protein during the ROFO Period, and any such notice shall be deemed as a ROFO Notice pursuant to this Section 3.2.1, it being understood and agreed that Protalix shall not be required to divulge the identity of such third party or any other detail of such negotiations. The ROFO Notice shall in both cases be accompanied by any Protalixs available information in respect of such [***] protein. | |||
3.2.2 | For the avoidance of doubt, Protalix shall not be required to offer any protein to Teva more than once pursuant to this Section 3.2. |
3.3. | Substitution of a Protein |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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3.4. | Tevas Option for Stage 2 |
4.1. | In the event that Teva elects to exercise its option to initiate the performance of Stage 2 of the collaboration as to one or both Proteins, Stage 2 shall be carried out by the Parties in accordance with Development Plans (defined below) to be determined pursuant to this Section 4. | ||
4.2. | Teva shall prepare preliminary development plans (the Preliminary Plan(s)), in consultation with Protalix within [***] of Teva exercising its option to initiate the Stage 2 collaboration. The Preliminary Plan(s) shall include projected Licensed Product development activities, timelines and obligations of each Party up to the completion of Phase I clinical trials in respect of the relevant Protein. | ||
4.3. | Stage 2 shall commence, as to each Protein (as applicable), immediately upon the relevant Preliminary Plan being presented to the R&D Committee (or in its absence to Protalix) which shall be given the opportunity to comment thereon prior to implementation, provided that in no event shall such entitlement to comment |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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derogate in any way from the full and sole discretion of Teva in respect of all aspects of the Preliminary Plan(s) (and the Development Plan(s)) and the performance thereof. | |||
4.4. | The Preliminary Plan shall be updated from time to time but not less often than once every six (6) months, by Teva, in consultation with the R & D Committee, as per the progress of the different development phases (the Preliminary Plan so updated being referred to hereinafter as the Development Plan(s)). The Development Plan shall incorporate detailed development activities in respect of the Licensed Product for the upcoming phase. Teva, in consultation with Protalix will consider and determine Phase II clinical trial target activities, timelines and the Parties obligations, which will become specific obligations of the Parties. Notwithstanding the foregoing, Teva may update the Development Plan, at Tevas discretion, in consultation with the R&D Committee, at any time and from to time, to reflect progress made as per the Development Plan. Without derogating from any of the above, the outline of the activities of the Parties under the Development Plan, as currently envisaged, is attached hereto as Annex 4.4. | ||
4.5. | The Development Plan shall specify the activities, timelines and division of responsibilities between Teva and Protalix in respect of the performance of the Stage 2 collaboration. Teva and Protalix shall each make commercially reasonable efforts consistent with their respective normal business practices to each pursue their obligations under the Development Plan, and shall each diligently perform its tasks as set forth in the Development Plan. Without derogating from the foregoing, in the course of the performance of Stage 2, Protalix shall be obligated to provide Teva with manufacturing information as may be reasonably required by Teva solely for the purpose of Tevas pursuing clinical development, and obtaining regulatory approvals for and commercializing, Licensed Products. | ||
4.6. | At the end of each calendar quarter during the course of the performance of Stage 2, each Party shall provide the other Party with periodic progress reports regarding the progress of such Partys activities under Stage 2, in a form to be agreed between the Parties. Each Party may, from time to time, request updates regarding the progress of the other Partys activities during Stage 2, in addition to the periodic progress reports, and pursuant to any reasonable request, the other Party shall provide same. | ||
4.7. | In addition, Protalix shall provide Teva, at Tevas request, with reports, in an agreed form, including financial reports in the format required by the Office of the Chief Scientist (CSO) which Teva may be required to provide to the CSO in order to obtain CSO support for Stage 2, in addition to the periodic progress reports to be provided hereunder. | ||
4.8. | Each Party shall perform its obligations under the Development Plan in accordance with all applicable laws and regulations, and each Party shall procure the receipt of all approvals and consents necessary for the performance of such Partys obligations under the Development Plan. Without derogating from the foregoing, it is clarified that approvals and consents necessary for the performance by Protalix of its portion of the Development Plan and specifically related to the Protein but also usable by Protalix in respect of other proteins shall be procured by Protalix and the costs of same shall be allocated between Teva and Protalix in accordance with the relative use of same in respect of the relevant Protein. |
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4.9. | Tevas representatives shall have the right to visit and audit Protalixs facility where Licenced Product is manufactured, at times to be coordinated between the Parties in advance, once Protalix commences the manufacture of clinical quantities of Licensed Product, but not more often than twice every calendar year. | ||
4.10. | Teva shall provide Protalix with copies of all regulatory filings and approvals, investigational new drug (IND), chemistry manufacture and control (CMC) files, new drug applications (NDA), drug master files, clinical protocols and reports, and all modifications thereto, as well as material correspondence with regulatory authorities. Teva shall keep Protalix currently informed about the progress made towards obtaining regulatory approval of the Licensed Products in each country and shall provide Protalix with written status reports on a quarterly basis. Teva shall also notify Protalix, in writing, immediately upon the receipt of regulatory approval of any Licensed Product in each country. | ||
4.11. | No later than [***] prior to the commencement by Teva of Phase III clinical trials in respect of the Licensed Product(s), Protalix shall provide to Teva (or shall instruct the Escrow Agent to release to Teva) the Backup Manufacturing File. | ||
4.12. | Protalix shall not be entitled to subcontract all or part of its tasks under the Development Plan, without Tevas prior written consent. Should Protalix wish to do so, Protalix shall so notify the R&D Committee and Teva in writing, and Teva shall have the right, at its sole discretion (but shall not be obligated), to perform such tasks as Protalixs subcontractor, on the condition that Teva shall perform same over a reasonable time period no longer than the time period that it would take another reasonable third party to perform such task(s). For the sake of clarity, in the event that Teva shall elect not to perform as Protalixs subcontractor, and Protalix shall use a permitted subcontractor that is not Teva, Protalix shall bear all responsibility and liability vis-à-vis Teva arising from the performance by such subcontractor. To the extent Teva wishes to subcontract any part of its tasks under the Development Plan to any third party, it shall so notify the R&D Committee, it being understood and agreed that no subcontract by Teva shall be made to a Protalix Competitor, except if and to the extent that Protalix is not capable of performing the same service for Teva at a competitive market price. For the sake of clarity and without limiting the foregoing, in the event that Teva shall use a subcontractor for the performance of any of its obligations hereunder, Teva shall bear all responsibility and liability vis-à-vis Protalix arising from the performance by such subcontractor. | ||
4.13. | The Parties hereby acknowledge that neither Party has guaranteed that Stage 2 will be successful or achieve any specific results or that any regulatory approvals shall be granted with respect to the Licensed Products. | ||
4.14. | From the commencement of the performance of Protalixs obligations under Stage 2, Teva shall bear all actual costs incurred or expended by Protalix directly related to the performance of Protalixs activities included in Stage 2, according to the budget proposed by Protalix and pre-approved in writing by Teva (the Budget), as follows: |
4.14.1. | [***] |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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4.14.2. | [***]. |
4.15. | The amounts of the Budget described above shall be paid by Teva every [***] months on a [***] rolling basis, whereby [***] of the relevant Budget for each [***] shall be paid upfront at the beginning of such [***] period and the balance shall be paid at the end of the relevant [***], unless only part of the relevant tasks were carried out during such period, in which case the balance shall be adjusted accordingly. All payments shall be made against receipt of a proper tax invoice. | ||
4.16. | For the avoidance of doubt, it is clarified that (i) any in-licensing of third party technology by Protalix for the purposes of the performance of the Feasibility Programs or the Development Programs (or any one of them) and/or for the incorporation of such third party technology into the process of the development or manufacture of the Proteins and/or (ii) any use of third party technology (including that of [***] already licensed to Protalix) by Protalix in the performance of the Feasibility Programs (or any one of them) or in the development or manufacture of the Proteins, shall require the prior written agreement of Teva, and shall not be in-licensed or used, as applicable, in the event that such prior written agreement of Teva is not provided. Payments to third parties in respect of such licenses shall be borne and paid by [***]. For the avoidance of doubt, any such approval by Teva rendered in the course of a Feasibility Program, shall continue to apply during the Development Program and thereafter for as long as the third party technology is in use in relation to Licensed Products commercialized by Teva, its Affiliates, Sublicensees or Further Sublicensees, and may not be retracted by Teva. | ||
4.17. | Protalix shall be obligated to manufacture the Proteins, both for development and commercial purposes for the sole consideration provided in Section 4.14 above and 10 below, in such quantities as shall be set forth in the Feasibility Program (during Stage 1) and the Development Plan (during Stage 2), and thereafter, as per orders placed by Teva pursuant to a separate manufacturing and supply agreement (the Supply Agreement) to be entered into between the Parties by no later than the initiation of Phase III regulatory clinical trials in respect of a Licensed Product. Protalix shall manufacture the Proteins in accordance with applicable regulatory requirements (such as GMP and GLP, as determined by Teva in consultation with Protalix) and shall be fully responsible for its manufacturing activities (and those of |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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any third party on its behalf). The Supply Agreement shall govern the procedures for ordering and deliveries, lead time for deliveries, quality assurance, specifications and all other matters related to the manufacture and supply of the API by Protalix in accordance with the relevant regulatory requirements as shall be determined by Teva in consultation with Protalix, reflecting the commercial terms set out in Section 10.4 hereunder. Key elements of the Supply Agreement shall be set forth in Annex 4.17 which shall be attached hereto within thirty (30) days of the Effective Date. | |||
4.18. | Any deviation from the approved Budget for Stage 2 shall require notification to Teva in advance, provided that any such deviation in excess of [***] shall also require the prior approval of Teva. |
5.1. | The Parties shall form a Research and Development Committee (the R & D Committee), that shall be active for the duration of the Feasibility Program and the Development Plan. During Stage 1 the R & D Committee shall have the charter to adjust and amend the Feasibility Program (per Protein), as required for scientific or technological reasons. During Stage 2 the R & D Committee shall monitor the performance of the Development Plans, the research and other activities being conducted thereunder, and shall issue its recommendations in writing to the Parties, but shall have no decision making authority. The R&D Committee shall be comprised of four (4) members, having one vote each, of which two (2) shall be appointed by each Party, including one co-chairperson appointed by each Party. Only employees of the Parties can be appointed to serve on the R&D Committee. The R&D Committee shall meet periodically (but in any event no less than quarterly) during the performance of the Feasibility Program and Development Plan. | ||
In the event that, during the term of a Feasibility Program, the members of the R&D Committee cannot agree on an issue within the scope of its authority within thirty (30) days of its initial consideration, the matter shall be referred by either co-chairpersons in writing to one (1) expert, the identity of whom shall be mutually agreed upon, for a reasoned determination in writing. In the event that, during the term of the Development Plan, the members of the R&D Committee cannot agree on a recommendation to be made to Teva, then the members appointed by Teva shall have a casting vote in respect of such recommendation. | |||
5.2. | At each R&D Committee meeting, at least one (1) member appointed by each Party present in person or by telephone shall constitute a quorum. Each Party shall have equal voting power, whether represented by one or two Committee members, on all matters before the R&D Committee. |
6.1. | Subject only to the provision of the Stage 2 Notice by Teva, Protalix hereby grants Teva, and Teva hereby accepts from Protalix, an exclusive world-wide license under the Platform IP, the Protein IP and the Other IP owned by or licensed to Protalix (collectively, the Licensed Information) to research, develop, make, have made, register, import, manufacture, use, sell, offer for sale, produce, sublicense, commercialize, distribute the Proteins and/or pharmaceutical products embodying, |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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based on or using the Proteins (the Licensed Products) for all indications (the License) and for no other purposes whatsoever. |
6.1A | To the extent that the Parties shall mutually agree that any Additional Patents are reasonably required to be licensed to Teva in order for Teva to commercialize any Licensed Product(s), then the same shall be added to the list of the Platform Patents and as of such time shall be deemed as being covered by the License hereunder, as part of the Platform IP, provided that at the relevant point in time an exclusive license in respect of such Additional Patent has not already been granted to a third party by Protalix, it being understood and agreed, however, that any such Additional Patents may not be sub-licensed by Teva on a stand alone basis. |
6.2. | From the Effective Date and at all times prior to [***] with respect to any particular Protein, Protalix shall not, without Tevas prior written consent, grant or enter into any agreement, arrangement or commitment according to which a third party is granted any rights which may derogate from or hinder Tevas ability to exercise Tevas option to obtain the License. |
6.3. | Teva shall have the right to grant (whole or partial) Sublicenses to third parties (and such third parties shall be entitled to grant further Sublicenses (each, a Further Sublicense and the term Further Sublicensee shall be construed accordingly) and so on under the License, on terms and conditions consistent with the terms of this Agreement and Teva shall be entitled to determine the commercial terms of any such Sublicense, all provided that under no circumstances may any Sublicense or Further Sublicense be granted to a Protalix Competitor, unless such Sublicense or Further Sublicense is not granted in respect of the core technology of Protalix (for example, but without limitation, a Sublicense or Further Sublicense may be granted in respect of the marketing and/or distribution of the Licensed Products(s) even to a Protalix Competitor), and provided further that all of Protalixs rights hereunder shall be ensured and, without limiting the generality of the foregoing, that, with respect to each Sublicense or Further Sublicense agreement: (i) Teva notifies Protalix immediately upon signature thereof, and provides Protalix with the name of the Sublicensee or Further Sublicensee and the scope and territory of the Sublicense or Further Sublicense; (ii) each such Sublicense and Further Sublicense agreement (a) provides that the Sublicense or Further Sublicense thereunder shall immediately terminate upon termination of the License hereunder for any reason, and (b) restricting the right to grant a Further Sublicense to a Protalix Competitor. The grant of any Sublicenses and Further Sublicenses shall not derogate from the rights of Protalix and/or the obligations of Teva under this Agreement. Without limiting the foregoing or any of Tevas obligations hereunder relating to the grant of Sublicenses or Further Sublicenses pursuant hereto, Teva shall be entitled to conduct or to perform any activity in respect of the Licensed Products by means of any third party sub-contractor, and such conduct shall not be considered to be a grant of a sublicense, provided it shall notify the R&D Committee and/or Protalix of any such subcontract and provided further that under no circumstances may Teva subcontract any of its tasks or obligations hereunder to a Protalix Competitor unless such subcontract is made not in respect of the core technology of Protalix (i.e. Teva shall be entitled to conduct marketing or distribution activities through subcontractors which are Protalix Competitors). For the sake of clarity and without limiting the foregoing, in the event that Teva shall use a subcontractor, Teva shall bear all responsibility and liability vis-à-vis Protalix arising from the performance by such subcontractor. |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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7.1. | Teva undertakes, at its own expense, to make such commercially reasonable efforts to commercialize the Licensed Products as are consistent with the commercial efforts generally applied to products of similar potential at similar stages in their life cycles, by Teva. | ||
7.2. | Teva shall provide Protalix with a non-binding sales forecast for each of the Major Countries, in writing, in respect of each Licensed Product, by no later than [***] prior to the anticipated date of the first regulatory approval in respect thereto. Such report shall be updated by Teva, in writing, on a [***] basis. Moreover, each sales forecast shall be accompanied by a report of Tevas and its Affiliates launch dates and main regulatory filings on a [***] basis with respect to the Licensed Products. Teva shall also provide Protalix with similar information with regard to such launch dates and filings in territories in which Sublicensees and Further Sublicensees have conducted similar activities, to the extent available to Teva. | ||
7.3. | For the removal of doubt, nothing contained in this Agreement shall be construed as a warranty by Teva that any efforts to be exerted by Teva in connection with this Agreement, including without limitation any development or any commercialization to be carried out by it in connection with this Agreement, will actually achieve their aims or any other results or succeed, and Teva makes no warranties whatsoever as to any results to be achieved in consequence of the carrying out of any such development, commercialization, efforts or activities. Furthermore, Teva makes no representation to the effect that the commercialization of the Licensed Products, or any part thereof, will succeed, or that it shall be able to sell the Licensed Products in any quantity. |
8.1. | In consideration for the grant of the License, Teva shall make the following milestone payments to Protalix, upon achievement of the relevant milestones on a [***] basis (each, a Milestone) (the Milestone Payments): |
8.1.1. | [***] | ||
[***] | |||
[***] |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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8.1.2. | [***] | ||
[***] | |||
[***] | |||
[***] | |||
[***] |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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8.2. | In addition, in consideration for the grant of the License, Teva shall, throughout the Royalty Term (as such term is defined below), pay to Protalix royalties at the following rates on annual Net Sales, during each calendar year in respect of each Licensed Product, on a [***] (the Royalty Payments), as specified in this Section 8.2 below: |
8.3. | [***]. |
8.4. | Notwithstanding the foregoing, in the event that any [***] is sold in the form of a Combination Product, then the proportion of such Combination Product to |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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be attributed to Net Sales that are subject to the Royalty Payments (the
Relevant Proportion) shall be calculated as
provided below. Provided that both active ingredients of the Combination Product are sold on a stand-alone basis at the time in question, the Relevant Proportion shall be as follows: [***]. |
8.5. | Payments to Protalix pursuant to this Section 8 will be due and payable hereunder until the expiration of [***]years after the First Commercial Sale in any country calculated on [***] basis (in each case, the Royalty Term). |
8.6. | Following the expiry of the Royalty Term, [***], Teva shall have a fully paid up license to continue to exploit the License without having to make Royalty Payments with respect thereto. |
9.1. | As of the achievement of the first Milestone pursuant to Section 8.1.1 above, and for the duration of the Royalty Terms, Teva shall submit to Protalix, no later than [***] after the end of each [***], [***] reports setting out all amounts owing to Protalix in respect of the [***] to which the report refers, and with respect to each Licensed Product, (i) the Net Sales [***], including a breakdown of Net Sales according to country and currency of sales, (ii) amounts deducted as royalties to third parties pursuant to Section 1.2.39(vii), (iii) total Milestone Payments and Royalty Payments due to Protalix in respect of such [***] or, if no such payments are due to Protalix in respect of such [***], a statement that no payments are due; and (iv) any calculations made in relation to Combination Products. Teva shall submit to Protalix, by no later than [***] after the end |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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9.2. | Amounts payable to Protalix in terms of Section 8 shall be paid to Protalix (i) in respect of Royalty Payments, on a [***] basis, and no later than [***] after the end of each [***], commencing with the first [***] in which Net Sales are made, (ii) in respect of Milestone Payments, within [***] following the achievement of the applicable Milestone. | ||
9.2A | Notwithstanding, the [***] payments of Royalty Payments shall be paid based on the assumption that no Market Advantage exists. Not later than [***] following the end of a [***], Teva shall pay Protalix the additional nominal amounts of Royalty Payments due in the event Market Advantage existed during such [***]. | ||
9.3. | Each payment due to Protalix hereunder shall be paid by wire transfer of immediately available funds to an account designated by Protalix in writing. | ||
9.4. | Teva shall maintain and shall cause its Affiliates to maintain, complete and accurate records of Licensed Products sold under this Agreement, any amounts payable to Protalix in relation to such Licensed Products and which records shall contain information to reasonably permit Protalix to confirm the accuracy of any payments made to Protalix. Teva shall retain and shall cause its Affiliates to retain such records relating to a given calendar year for at least [***] after the conclusion of that calendar year, during which time Protalix shall have the right, at its expense, to cause an independent, certified public accountant to inspect such records during normal business hours for the sole purpose of verifying any payments delivered under this Agreement. Such accountant shall not disclose to Protalix any information other than information relating to the accuracy of reports and payments delivered under this Agreement. In the event that any audit performed under this Section 9.4 reveals an underpayment in excess of [***]in any calendar year, and if such underpayment is proven to the satisfaction of a mutually agreed external auditor (it being agreed that absent such mutual agreement as to the identity of the auditor within thirty (30) days of a Partys written notice to the other Party that it wishes to have such external auditor appointed, the external auditor shall be one of the big four accounting firms), then Teva shall bear the full cost of such audit. Protalix may exercise its rights under this Section only once every year and only with reasonable prior notice to Teva, and the relevant Affiliate and subject to prior coordination. Any such audit shall be made during Tevas or the relevant Affiliates normal business hours and shall not unreasonably interfere with the business of Teva or the relevant Affiliate, and shall be completed within a reasonable time. Teva shall promptly transfer to Protalix any payment due pursuant to such auditors audit. Such payment shall bear interest as set forth in Section 23.17. | ||
9.5. | Without derogating from the provisions of the preceding Section 9.4, Protalix shall have the right to request that Teva inspect records of Licensed Products sold under this Agreement by Sublicencees and Further Sublicensees, for the sole purpose of verifying any payments delivered under this Agreement, in which case Teva shall exert its reasonable commercial efforts to perform such audit. In the event that any audit performed under this Section 9.5 reveals an underpayment in excess of [***], |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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and if such underpayment is proven to the satisfaction of a mutually agreed external auditor (to be appointed in accordance with the procedure set out in Section 9.4 above), then Teva shall bear the full cost of such audit. In any other event (of overpayment or underpayment of less [***], Protalix shall bear the full cost of such audit. Protalix may exercise its rights under this Section only once every year. Teva or Protalix, as applicable, shall immediately pay to the other Party any underpayment or overpayment together with interest provided in Section 23.17 below. | |||
9.6. | Protalix shall maintain, and shall cause its Affiliates to maintain, complete and accurate records of both its Internal Expenses and External Development Expenses, as well as records of costs incurred in the performance of each Feasibility Program (for the event that Teva reimburses Protalix for same pursuant to the substitution of a Protein), which records shall contain information to reasonably permit Teva to confirm the accuracy of any payments made to Protalix. Protalix and/or its Affiliates shall retain such records relating to a given calendar year for at least seven (7) years after the conclusion of that calendar year, during which time Teva shall have the right, at its expense, to cause an independent, certified public accountant to inspect such records during normal business hours for the sole purpose of verifying any payments delivered under this Agreement. Such accountant shall not disclose to Teva any information other than information relating to the accuracy of reports and payments delivered under this Agreement. In the event that any audit performed under this Section 9.6 reveals an overpayment in excess of [***]in respect of any Protein, and if such overpayment is proven to the satisfaction of a mutually agreed external auditor (to be appointed in accordance with the procedure set in Section 9.4 above), then Protalix shall bear the full cost of such audit and shall promptly pay to Teva such overpayment together with interest as provided in Section 23.17 below. Teva may exercise its rights under this Section only once every year and only with reasonable prior notice to Protalix, and subject to prior coordination. Any such audit shall be made during Protalixs or the relevant Affiliate (as applicable) normal business hours and shall not unreasonably interfere with the business of Protalix or the relevant Affiliate (as applicable) and shall be completed within a reasonable time. |
10.1. | Notwithstanding Section 6 above, Protalix shall retain the exclusive right to manufacture the API and to continuously supply same to Teva and its Affiliates, Sublicensees and Further Sublicensees, for the Licensed Products, during the first [***] years following the First Commercial Sale of the first Licensed Product on a per Protein basis (the Exclusive Manufacturing Term). Teva shall be responsible for the formulation of the API into finished Licensed Product. Without derogating from any other visit and audit right under this Agreement, as from [***] prior to the expected commencement of the Exclusive Manufacturing Term, Tevas representatives shall have the right to visit and audit Protalixs facilities where the API is being manufactured, during normal business hours, and following prior coordination with Protalix. | ||
10.2. | Following the expiry of the Exclusive Manufacturing Term, Teva shall have the right to manufacture the API [***] in its own facility or elsewhere, or through any third party which is not a Protalix Competitor, at its sole discretion, subject to the appropriate undertakings by the transferee of non-disclosure and non-use other than the supply to Teva and its |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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Affiliates, Sublicensees and Further Sublicensees, and shall use the Manufacturing Know-how (as such term is defined below) solely for such purpose. | |||
10.3. | Without derogating from the above, Teva may elect, at its sole discretion, to continue receiving Protalixs manufacturing services after expiration of the Exclusive Manufacturing Term. In such event, Protalix undertakes to perform such manufacturing services, for the sole consideration set forth in Section 10.4 hereinafter. | ||
10.4. | As of the First Commercial Sale, Teva shall pay Protalix consideration based on the actual direct cost of the manufacturing of the API incurred by Protalix to be calculated pursuant to the Supply Agreement as shall be mutually agreed [***]: |
10.4.1. | [***]. | ||
10.4.2. | [***]. |
10.5. | Notwithstanding the foregoing, in the event that the annual payments to Protalix that consist of the [***] (calculated according to Section 10.4 above) plus the Royalty Payments on a [***] basis during any given calendar year (the Annual Protalix Payment), shall exceed the amount of [***] of the aggregate amount of annual Net Sales in such calendar year on a [***] basis (the Ceiling Amount), then the Annual Protalix Payment, in respect of the [***], shall be reduced to an amount equal to the Ceiling Amount, provided that in no event shall the Annual Protalix Payment in respect of the [***], be reduced to an amount less than [***] calculated on the basis of [***]. Any over payment by Teva shall be set-off, by written notice from Teva to Protalix, detailing the calculation of such over-payment, from the upcoming Royalty Payment due to Protalix hereunder. | ||
10.6. | The Parties hereby acknowledge and agree that a back-up manufacturing facility should be available in respect of the Proteins. Not later than six (6) months prior to the commencement of Phase III clinical trials to be performed in respect of the First Licensed Product on a per Protein basis, the Parties shall mutually agree on the site at which such back-up manufacturing facility shall be located, and the Party by whom such facility shall be established. |
10.7. | (A) Protalix shall transfer, on a per-Protein basis, to an agreed third party (the Escrow Agent), by not later than date of the completion of Phase I (last patient out) as set forth in the Development Plan, a complete file (the Back-Up Manufacturing File) consisting of all engineering schemes, standard operating procedures, protocols, plans, master manufacturing file, know how and any other information, tangible or intangible, whether in writing, electronic form or otherwise, and any updates thereof, which is reasonably necessary for Teva in |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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11.1. | The Parties agree that, as between the Parties, Protalix does and shall own all rights, title and interest in and to the Platform IP. The Parties acknowledge that certain of the Platform IP that might be developed by or for Protalix or a subsidiary of Protalix (if such shall exist) following the Effective Date may be subject to contractual limitations vis-à-vis third parties. Such limitations (which by their nature, would apply to the Proteins and/or the Licensed Products) shall apply to Teva only if and to |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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the extent Teva shall approve them in writing in advance. Otherwise, Protalix shall be fully responsible for such contractual limitations whether monetary or other. | |||
11.2. | In the event that during the collaboration hereunder, any subsidiary of Protalix or any company with which Protalix merges (if such shall exist) shall generate or own any IP that if generated or owned by Protalix would have been considered part of the Licensed Information hereunder, then Protalix shall immediately notify Teva of such IP and shall act immediately and ensure that such IP shall be licensed to Protalix (or directly to Teva) and will become part of the Licensed Information, licensed to Teva as provided hereunder, at no additional cost to Teva. Such IP shall be classified as Platform IP, Protein IP or Other IP in accordance with the terms hereof as if it had been generated by Protalix in the first place. | ||
11.3. | All rights, title and interest in and to the Protein IP and Other IP developed during the performance of the Feasibility Program, will be owned by Protalix (Protalixs Protein and Other IP). For avoidance of doubt, Protalixs Protein and Other IP will be considered part of the Licensed Information, and as such, covered by the License hereunder. | ||
11.3A | In the event that there is any portion of Platform IP that specifically and directly relates (but does not solely relate) to one or more of the Proteins, and Protalix shall seek patent protection in respect of such portion of the Platform IP, then, to the extent possible: the Parties shall co-operate in order that the patent protection sought shall be filed in a manner that will split/ distinguish between patents covering Platform IP that solely relates to the Proteins and other Platform IP. The patent applications/ patents filed in respect of Platform IP that solely relates to the Proteins(s) shall be considered part of the Protein IP, and not Platform IP. | ||
11.4. | Notwithstanding the above, in the event that a Change of Control of Protalix is effected following the commencement of Stage 2, such that a Teva Competitor acquires Control of Protalix, Teva shall have the right, at its sole discretion, to receive an assignment of all Protalix Protein and Other IP without any assignment fee. Protalixs Protein and Other IP so assigned to Teva shall be treated hereunder as Teva IP (as defined below) for all intents and purposes, provided however that the economic benefits to Protalix under this Agreement, including inter alia, its right to receive Royalty Payments and Milestone Payments, shall not be diminished as a result of such assignment, in any way. | ||
11.5. | A Change of Control means (i) the sale of all or substantially all of the assets of Protalix, or (ii) any transaction between Protalix or its shareholders and another entity/ies as a result of which another company/ies, or another company/ies ultimate shareholder/s, directly or indirectly shall own more than fifty percent (50%) of the shares of Protalix or its successor, or has/ve the power to elect more than half of Protalixs or its successors directors. A Teva Competitor means [***]. | ||
11.6. | All Protein IP and Other IP developed as of the date on which Teva provides the Stage 2 Notice, by or for Protalix, jointly by or for both Parties, or by or for Teva, shall be exclusively owned by Teva, and Teva shall have all right, title and interest thereto (the Teva IP). |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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11.7. | Teva hereby grants Protalix a non-exclusive, royalty-free, perpetual license to use such portion of the Other IP included in the Teva IP that shall be developed solely by Protalixs employees, for any purpose that is not related in any manner to the manufacturing, developing, selling and/or commercialization of the Proteins or the Licensed Products (which Teva IP, for the avoidance of doubt, shall include any Other IP that may be assigned to Teva pursuant to Section 11.4 above). | ||
11.8. | Except as otherwise set forth in this Agreement, Teva and Protalix shall retain their respective unrestricted rights to make, have made, use and sell all such data, information, discoveries or inventions that are or may be owned by them, provided however that Protalix shall not be entitled to sell, pledge (other than in the ordinary course of business for the receipt of credit-lines) or assign any portion of the Licensed Information without prior written approval by Teva. | ||
11.9. | Each Party hereto undertakes to sign, execute and deliver all documents and papers that may be required, and perform such other acts as may be reasonably required in the circumstances, in order to ensure the division of the intellectual property rights between the Parties in accordance with the terms of this Section 11, as well as the filing of any and all patents arising hereunder and the registration of the License granted hereunder. |
12.1. | Throughout the term of the License granted hereunder, [***]shall be obligated, at its own expense, to file, record, prosecute, and maintain all patent rights with respect to the [***] in the countries as set forth in Annex 12.1 attached hereto (the Current Countries). In addition, throughout the performance of the Feasibility Program only, [***] shall be obligated to file, record, prosecute and maintain, all patent rights with respect to the [***] in all the Major Countries. In addition, [***] shall have the right, at its own expense, to file, record, prosecute, and maintain all patent rights with respect to the [***], in all other countries which are not the Current Countries. | ||
12.2. | Notwithstanding 12.1 above, as of the provision of Stage 2 Notice by [***], [***] shall, at [***] expense and as long as this Agreement is in effect, file, record, prosecute and maintain all patent rights with respect to the [***], in the Major Countries, and, at its discretion, in the other countries of the world. | ||
12.3. | Each Party shall provide the other Party with a prior written notice regarding filing of each patent application which is filed pursuant to section 12.1 or 12.2, and shall furthermore give reasonable consideration to the comments received by the other with respect to the filing of such patents. Each Party shall provide the other with reasonable information relating to the prosecution of such Partys IP [***], and the maintenance and other proceedings relating thereto including, without limitation, by providing copies of substantive communications, notices, actions, search reports and third party observations submitted to or received from patent offices. Provision of all such documentation and information from one Party to the other shall be at no cost to the receiving Party. | ||
12.4. | In the event that [***] fails to file, record, prosecute or maintain all patent rights with respect to the [***] in all the Current Countries or, as applicable throughout the |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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performance of the Feasibility Program, the [***] in any of the Major Countries, which failure constitutes a breach of its obligations under Section 12.1 above, then [***] shall be entitled to terminate this Agreement and to any other remedy provided to it under law. | |||
12.5. | If [***] elects not to file, record, prosecute or maintain all patent rights with respect to the [***] in countries other than the Current Countries or, as applicable, [***], in any country of the world which is not one of the Major Countries, [***] shall notify [***]in writing of such election to allow [***], in its sole discretion, to file and/or continue to prosecute such patent application and/or maintain such patent in such country at its own cost and expense. In such event, for as long as [***] continues to prosecute and maintain such patents, then, in respect of such country, [***] shall not be obligated to pay [***] in such country protected or to be protected by such patent until such time as [***] out of pocket expenses incurred in prosecuting and/or maintaining such patents are recouped. [***] shall notify [***] in writing of [***] election as aforesaid. For the avoidance of doubt, it is hereby clarified that should [***] assume control over the prosecution and maintenance of such patents as aforesaid, then at any time thereafter [***] may, in its sole discretion, cease the prosecution and maintenance of such patents, upon prior written notice to [***]. | ||
12.6. | If [***] elects not to file, record, prosecute or maintain all patent rights with respect to the [***] in any of the Major Countries, [***] shall notify [***] in writing of such election to allow [***], in its sole discretion, to file, record and/or continue to prosecute such patent application and/or maintain such patent in such country. In such event, for as long as [***] continues to file, record, prosecute and maintain such patents or patent applications and notifies [***] of same, then, in respect of such country, with respect to the [***] in any of the Major Countries, [***] shall reimburse [***] for [***] out of its patent expenses. | ||
12.7. | Nothing contained herein shall be deemed to be a warranty by either of the Parties that they can or will be able to obtain patents on patent applications included in the Licensed Information or that any such patents will afford adequate or commercially worthwhile protection. |
12.8. | In the event that either Party hereto becomes aware of any product that is made, used, or sold or any action that it believes infringes or misappropriates the Licensed Information applicable to the Licensed Products or the Teva IP (collectively, Product IP), such Party will promptly advise the other of all the relevant facts and circumstances known to such first-mentioned Party in connection with such infringement or misappropriation. | ||
12.9. | Prior to the provisions of a Stage 2 Notice, with respect to [***], [***] shall, at its own expense, enforce the [***], or any part thereof, against infringement or misappropriation, bring an action against any third party suspected of infringement or misappropriation of same and control the defense of any counterclaim or declaratory judgment action (or other action) relating thereto; [***] will fully cooperate with [***] at [***] expense, with respect to the investigation and prosecution of such alleged infringement or misappropriation including the eventual joining of [***] as a party to such action, as may be required by the law of the particular forum where enforcement is being sought. Any recovery obtained as a result of such action shall |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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be applied first to the documented costs and expenses actually incurred by [***], and [***] shall retain any and all remaining amounts recovered. | |||
12.10. | As of provision of the Stage 2 Notice, with respect to the [***], [***] shall have the first right, but not the obligation, to bring an action against any third party suspected of infringement or misappropriation of same, and to control the defense of any counterclaim or declaratory judgment action alleging invalidity or non-infringement (or other action) relating thereto. If [***]elects to bring such action against a third party, [***] will fully cooperate with [***], at [***] expense, with respect to the investigation and prosecution of such alleged infringement or misappropriation, including the joining of [***] as a party to such action, as may be required by the law of the particular forum where enforcement is being sought. Any recovery obtained as a result of such action shall be split, after the deduction of the documented costs and expenses actually incurred by [***], so that [***] will be entitled to [***] and [***] shall retain [***] out of the amounts which constitute compensation for loss of sales. All other amounts shall be retained by [***]. | ||
As of provision of the Stage 2 Notice [***] may, at its own expense, enforce the [***], or any part thereof, against infringement or misappropriation, bring an action against any third party suspected of infringement or misappropriation of same and control the defense of any counterclaim or declaratory judgment action (or other action) relating thereto if [***] fails, within sixty (60) days after becoming aware of such infringement, or receiving notice from [***] of such infringement, to take reasonable action to investigate such alleged infringement. [***] will fully cooperate with [***], at [***] expense, with respect to the investigation and prosecution of such alleged infringement or misappropriation including the joining of [***] as a party to such action, as may be required by the law of the particular forum where enforcement is being sought. Any recovery obtained as a result of such action taken by [***] shall be retained by [***] in full. | |||
12.11. | Each Party shall execute all necessary and proper documents, take such actions as shall be appropriate to allow the other Party to institute and litigate such infringement actions referred to in this Section 12, and shall otherwise cooperate in the institution and litigation of such actions (including, without limitation, consenting to being named as a party thereto). Each Party, in litigating any such infringement actions, shall keep the other Party reasonably informed as to the status of such actions. |
12.12. | As of the provision of Stage 2 Notice by Teva, in the event that either Teva or Protalix, or both of them, are sued by a third party alleging that the commercialization of the Licensed Products infringes upon any intellectual property rights of such third party the Party being so sued shall immediately give the other Party notice of same. | ||
Teva shall have the right to defend against such action, on behalf of both Parties, as aforesaid within twenty (20) business days from the date the relevant suit becomes known to Teva, and any expenses or costs incurred by Teva in connection with such action(s), and any costs or amounts awarded to the counterparties in such action(s) shall be fully borne by Teva and any recovery in such action shall be retained by Teva in full. In the event that Teva does not exercise its right to defend in a certain country, then Protalix shall be entitled to defend against such claim at its own cost and |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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expense in such country and any recovery in such action shall be retained by Protalix in full. In addition, in such event that Protalix defends against such claim, Protalix shall have the right to terminate the License provided hereunder in respect of such country (in which the defense is taken) only with respect to the certain Licensed Product as to which the claim relates. |
12.13. | A Party shall be deemed to have met its obligation to file, record, prosecute, maintain, enforce and defend patents in accordance with Section 12 above if its decision is commercially reasonable solely in view of the foreseeable impact of any action or inaction on the development or commercialization of Licensed Products. For the sake of clarity, such obligations shall apply to the Platform Patents only in respect of actions that may be taken in the Current Countries after the Effective Date. | ||
12.14. | Protalix and Teva will reasonably co-operate in the defense of any claims brought against the other Party pursuant to this Agreement and shall voluntarily join any such litigation if so required by law. Protalix and Teva will execute all documents reasonably necessary for the relevant Party to defend against such action, and shall provide documents and help with making contact with witnesses that are or were their employees, consultants or otherwise connected to them, whose testimony in the judgment of the attorneys handling the law suit (or Tevas or Protalixs counsel in the event the proceedings will be brought only on the name of one Party) is necessary to allow such litigation to go forward. | ||
12.15. | In no event shall either Party enter into any settlement, consent order, consent judgment or any voluntary disposition of such action that would adversely affect the rights of the other without the prior written consent of such other Party, which consent shall not be unreasonably withheld. |
13.1. | Should Protalix develop on its own or receive a license to Breakthrough Technology, Protalix shall notify Teva thereof as soon as practicable, and provide Teva with all information related thereto, and enter into discussions with Teva, in good faith, with a view towards granting Teva or procuring the grant to Teva of an exclusive worldwide license to utilize such Breakthrough Technology as it relates solely to the Proteins and/or the Licensed Products, but shall not be bound to such discussions if Teva did not initiate negotiation with Protalix in such respect for a period exceeding [***] of its provision of such information to Teva as provided above. | ||
13.2. | The license to the Breakthrough Technology shall be granted by Protalix to Teva in return for [***], as shall be discussed and agreed in good faith between the Parties. |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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14.1. | Protalix hereby grants Teva and Teva hereby accepts from Protalix a right of first look (the ROFL) at Protalixs proprietary product based on glucocerebrosidase which is currently under development, for the treatment of Gauchers Disease and for other clinical indications (the GCD Product), to enable Teva to evaluate its interest in obtaining an exclusive, worldwide license to develop, commercialize, manufacture, market, distribute and sell the GCD Product for all indications, including without limitation Gauchers Disease (the GCD License). | ||
14.2. | The period of time during which the ROFL shall be valid, is referred to hereunder as the Evaluation Period. The Evaluation Period shall start as of the Effective Date and shall automatically terminate, on a per country basis, upon: (x) Protalix exclusively licensing the GCD Product (with respect to all indications) to one or more third parties in all of the Major Countries, or (y) the commercial launch of the GCD Product by Protalix in all of the Major Countries, provided Protalix fully complied with the provisions of this section 14. If licenses to third parties in respect of the Major Countries subsequently terminates, the ROFL to Teva shall be reinstated pursuant to the terms of this Section 14. | ||
14.3. | Throughout the Evaluation Period, Protalix shall submit to Teva within thirty (30) days after the end of each calendar quarter, a written report briefly describing all updates in its research and development activities in relation to the GCD Product and the results thereof. Notwithstanding the above, if a material event has occurred relating to the development of the GCD Product then Protalix shall so notify Teva promptly. | ||
14.4. | At any time or times during the Evaluation Period Teva may notify Protalix in writing, that it wishes to negotiate the terms and conditions of the GCD License (the Notice). In such event, Protalix shall be bound to an exclusive negotiation period of [***] as of the date of the Notice (the Negotiation Period) during which time the Parties shall act in good faith and endeavor to finalize the terms and conditions of a license agreement to govern the grant to Teva of the GCD License (the GCD License Agreement). If the Parties fail to execute GCD License Agreement by the expiry of the Negotiation Period, the Parties shall endeavor to finalize the GCD License Agreement as soon as possible thereafter, without Protalix being barred, however, from negotiating with any third party. The exclusive [***] Negotiation Period shall not occur more than [***]. For the avoidance of doubt, under no circumstances shall Protalix be barred from launching or commercially selling the GCD Product by itself and/or through an Affiliate, and for as long as Protalix intends to do so in any Major Country (as evidenced by a board resolution), Protalix shall not be required to conduct negotiations with Teva following receipt of any Notice pursuant to this Section 14.4, in respect to such Major Country. Protalix shall provide Teva with a copy of such board resolution, at its request. | ||
14.5. | During the Negotiation Period: (i) Teva shall have the right to evaluate the GCD Product to determine its interest in receiving the GCD License, and to receive all data and information related to the GCD Product generated or received by Protalix prior to the commencement of or during the Negotiation Period, excluding only information regarding commercial terms related to previous negotiations with third parties; (ii) Protalix shall not grant any third party any rights to or in respect of the GCD Product |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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which may interfere with the grant of the GCD License to Teva or provide any third party with any information relating to the GCD Product. |
14.6. | Without derogating from the above, should a third party show interest in acquiring a license for the GCD Product for any indication from Protalix at any time during the Evaluation Period except during a Negotiation Period, and Protalix will decide to enter into negotiations with such third party (the Third Party Negotiation Period), Protalix shall so notify Teva immediately in writing, and will disclose to Teva all updated information regarding the GCD Product available during and throughout the Third Party Negotiation Period such that Teva may be able to negotiate in parallel with full and complete updated GCD Product information disclosed. For the avoidance of doubt, Protalix shall not be entitled to accept an offer from any third party in connection with the licensing of GCD Product for any indication unless Protalix has first complied with the terms of this Section 14. | ||
14.7. | In the event that, at the time Teva exercises its right to enter into the Negotiation Period, Protalix is already in a Third Party Negotiation Period, then, notwithstanding the exclusivity provision set forth above, Protalix may continue negotiating with such third party ONLY, but not with any other third party or parties (for so long as the Negotiation Period is in effect). | ||
14.8. | It is hereby agreed that in the event that the Parties will agree upon a definitive agreement with respect to the GCD License, such agreement shall include a provision setting out a mechanism whereby Protalix will not compete with Teva through a second generation GCD Product. |
14A.1 | Teva will provide Protalix with [***] with respect to the [***] for the performance of Phase III clinical trials, as set forth in Section 14A.3 below, all in accordance with applicable regulatory requirements (collectively, the [***] Services). | ||
14A.2 | The price of the [***] Services shall be [***] in the aggregate, and such price shall be invoiced on a [***] basis, and paid within thirty (30) days of the end of the [***] during which Protalix receives an invoice from Teva, subject to performance of such [***] Services. Any material increase in the cost of the [***] Services stated above will be discussed and negotiated in good faith between the management of both Parties. | ||
14A.3 | The [***] Services shall entail the provision of [***]. |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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15.1. | This Agreement shall be effective from the date of receipt of all necessary corporate approvals of Teva required in respect of this Agreement (the Effective Date) and shall continue in full force and effect until terminated in accordance with the terms hereof. For the avoidance of doubt, Protalix hereby acknowledges that the approval of the Board of Directors of Teva is required, and that in the event that such approval is not received, this Agreement shall have no force or effect whatsoever. | ||
15.2. | Teva shall have the right to terminate this Agreement for any reason with respect to both or any specific Protein (the Terminated Protein), by providing Protalix with |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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thirty (30) days prior written notice of such decision. In the event that only one Protein is terminated, this Agreement shall remain in full force and effect with respect to the remaining Protein which is not a Terminated Protein. No compensation from Teva to Protalix shall be due as a result of such termination. | |||
15.3. | Upon the termination of this Agreement by Teva pursuant to Section 15.2 above, with respect to any specific Protein, the following shall apply: |
15.3.1. | the License granted to Teva by Protalix, with regard to Licensed Products based on such Protein shall be terminated; | ||
15.3.2. | Teva shall provide Protalix with a report summarizing its development activities and the results up to termination. |
15.4. | Without derogating from any other remedies that either Party hereto may have under the terms of this Agreement or at law, each Party hereto shall have the right to terminate this Agreement forthwith upon the occurrence of any of the following: |
(i) | the commission of a material breach by the other Party hereto of its obligations hereunder, and such other Partys failure to remedy such breach within sixty (60) days after being requested in writing to do so by the non-breaching Party; or | ||
(ii) | the other Partys liquidation, whether voluntarily or otherwise, or its entering into any arrangement with its creditors. |
15.5. | Notwithstanding anything to the contrary in this Agreement, to the extent that a Party (the Respondent) reasonably and in good faith disagrees with any assertion by the other Party (the Claimant) that there has been a material breach of this Agreement by Respondent, and Respondent provides written notice to Claimant of its disagreement and the basis for its belief (a Rebuttal Notice) within fifteen (15) days after Respondent receives notice from Claimant of a breach, this Agreement will remain in effect and any termination of this Agreement further to Section 15.4(i) hereunder will be suspended pending resolution of such disagreement between the Parties as provided in Section 23.18 below. The Parties will attempt to resolve such disagreement as expeditiously as possible and Respondent will continue to comply with the provisions of this Agreement, to the extent that they are not the subject of the disagreement between the Parties. For the avoidance of doubt, it is clarified that nothing in this Section 15.5 shall derogate from Tevas right of termination pursuant to Section 15.2, at any time and for any reason. | ||
15.6. | Upon termination of this agreement for whatever reason, each Party shall immediately return to the other party all materials, reports, updates, documentation, written instructions, notes, memoranda, discs or records or other documentation or physical matter of whatsoever nature or description provided by the other Party, except in the event that such material is owned by such Party pursuant to the terms of this Agreement, and provided that each Party shall be allowed to retain one (1) copy for archival purposes. | ||
15.7. | In the event that following termination of this Agreement for convenience or breach by Teva, Protalix shall request the license to utilize the Teva IP for the sole purpose of the further development, manufacturing, commercialization, marketing and sale of a Licensed Product, then Teva will enter into discussions with Protalix, in good faith, with a view towards granting Protalix such license, but shall not be bound to grant |
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such license. Such license to the Teva IP shall be granted by Teva in return for reasonable consideration by industry standards, as shall be discussed and agreed in good faith between the Parties. For the avoidance of doubt, following termination of this Agreement pursuant to Section 15.4 due to a breach hereof by Protalix, Teva shall not be required to enter into discussions with Protalix regarding any request of Protalix to grant any license to the Teva IP. |
15.8. | Upon termination hereof for any reason, each Party shall be entitled to collect any debt then owed to it by the other Party. | ||
15.9. | Save as explicitly stipulated otherwise in any Agreement, any provision, that by its nature, is intended to survive termination, shall survive the termination or expiration of this Agreement. |
16.1. | Each Party hereby represents to the other Party that: |
16.1.1. | it has the full power and authority to enter into this Agreement and to perform its obligations hereunder, and that subject to Section 15.1 with respect to Teva, that all corporate approvals have been obtained. | ||
16.1.2. | entering this Agreement shall not constitute a breach of any agreement, contract, understanding and/or obligation, including such Partys documents of incorporation, that it is currently bound by, and as long as this Agreement is in effect and without derogating from the rights to terminate the Agreement pursuant to Section 15 above, such Party shall not undertake any obligations which conflict with its obligations under this Agreement. |
16.2. | In addition, Protalix hereby represents and warrants that: |
16.2.1. | it is the sole and exclusive owner of the existing Platform Patents, and the existing Platform IP, and that all right, title and interest therein and thereto vest in Protalix, and that no third party, other than the CSO to the extent applicable, has any rights whatsoever (including the right to receive royalties or any other compensation) in respect of the existing Platform Patents, and the existing Platform IP; | ||
16.2.2. | No third party, has or shall have any rights whatsoever (including the right to receive royalties or any other compensation) in respect of any results of the Feasibility Program and Stage 2 activities to be conducted by or for Protalix, except as might be agreed pursuant to Section 4.16; | ||
16.2.3. | To the best of its knowledge, the performance of Protalixs obligations under this Agreement, and the exploitation of the Platform IP do not infringe upon any third party intellectual property rights currently existing; | ||
16.2.4. | it has the right and authority, as the proprietor of the Platform IP, to grant the License; | ||
16.2.5. | it has no knowledge of any legal suit or proceeding by a third party against Protalix contesting the ownership or validity of the Licensed |
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Information or any part thereof or contesting the possible exploitation of the License granted hereunder (including as it relates to the commercialization of the Licensed Products) as infringing upon any third party intellectual property rights; |
16.2.6. | it shall not, during the term of this Agreement, perform any work or other activities on or in respect of the Proteins, except in the course of the collaboration hereunder; | ||
16.2.7. | it has the financial capacity to carry out all its obligations hereunder, including, the performance of the Feasibility Programs in accordance with the timelines set forth therein; | ||
16.2.8. | other than in respect of the Platform IP, it has not received and hereby undertakes that it shall not receive any funding from the CSO in respect of the Licensed Information, the Feasibility Programs or the performance thereof, or the performance of any other of its obligations under this Agreement; and in respect of the Platform IP, Protalix shall bear any and all amounts due to the CSO; | ||
16.2.9. | it has the necessary experience and expertise to perform each of the Feasibility Programs, and its share of the Development Plan during Stage 2; | ||
16.2.10. | Protalix does not have any Affiliates; and that | ||
16.2.11. | in carrying out its undertakings and responsibilities pursuant to this Agreement, Protalix shall comply with all applicable laws and regulations, licenses, permits, approvals and procedures. |
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20.2.1. | safeguard and keep secret all Confidential Information, and will not directly or indirectly disclose to any third party the Confidential Information without written permission of the other. | ||
20.2.2. | in performing its duties and obligations hereunder, use at least the same degree of care as it does with respect to its own confidential information of like importance but, in any event, at least reasonable care. |
20.3.1. | was known to the recipient of the Confidential Information (Recipient) prior to disclosure by the disclosing Party (Discloser); | ||
20.3.2. | was generally available to the public prior to disclosure to the Recipient; | ||
20.3.3. | is disclosed to Recipient by a third party who is not bound by any confidentiality obligation, having a legal right to make such disclosure; | ||
20.3.4. | has become through no act or failure to act on the part of the Recipient public information or generally available to the public; | ||
20.3.5. | was independently developed by Recipient without reference to or reliance upon the Confidential Information; | ||
20.3.6. | is required to be disclosed by Recipient by law, by court order, or governmental regulation (including securities laws and/or exchange regulations), provided that the Recipient gives Discloser reasonable notice prior to any such disclosure and cooperates (at Disclosers expense) with Discloser to assist Discloser in obtaining a protective order or other suitable protection from disclosure (if available) with respect to such Confidential Information. |
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23.10. | Defined terms used in this Agreement and in the annexes shall have the meanings ascribed thereto herein and therein. References to Section numbers in this Agreement and in the annexes are to sections of this Agreement. References to Paragraphs in the annexes are to paragraphs in the respective annex in which the reference is made or in other annexes, if so specified. | ||
23.11. | No waiver of a breach or default hereunder shall be considered valid unless in writing and signed by the Party giving such waiver and no such waiver shall be deemed a waiver of any subsequent breach or default of the same or similar nature. |
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23.12. | VAT will be added, where applicable, to all payments to be made hereunder and shall be paid against proper invoices. | ||
23.13. | Each Party agrees to execute, acknowledge and deliver such further documents and instruments and do any other acts, from time to time, as may be reasonably necessary, to effectuate the purposes of this Agreement. | ||
23.14. | None of the provisions of this Agreement shall be enforceable by, any person who is not a party to this Agreement. | ||
23.15. | The remedies afforded to any of the Parties hereto, whether hereunder, or under applicable law or otherwise, shall be cumulative in nature and not alternative. | ||
23.16. | Any notice, declaration or other communication required or authorized to be given by any Party under this Agreement to any other Party shall be in writing and shall be personally delivered, sent by facsimile transmission (with a copy by ordinary mail in either case) or dispatched by courier addressed to the other Party at the address stated below or such other address as shall be specified by the Parties hereto by notice in accordance with the provisions of this Section. Any notice shall operate and be deemed to have been served, if personally delivered, sent by fax or by courier on the next following day. | ||
Tevas and Protalixs addresses for the purposes of this Agreement shall be as follows |
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23.17. | Any payment not received when due pursuant hereto shall bear interest from the due date until the date of actual payment at the rate of [***] (or such other percentage, if lower, as shall not exceed the maximum rate permitted by law). | ||
23.18. | This Agreement shall be governed and interpreted according to the laws of the State of Israel. Any dispute arising from this Agreement shall be resolved exclusively by the competent Courts of Tel Aviv-Jaffa, Israel, and by no other court or jurisdiction. | ||
23.19. | This Agreement may be executed in any number of counterparts (including counterparts transmitted by fax), each of which shall be deemed to be an original, but all of which taken together shall be deemed to constitute one and the same instrument. |
TEVA PHARMACEUTICAL INDUSTRIES LTD. |
Protalix Bio-Pharmaceuticals Ltd. |
|||||||
signature:
|
/s/ Amir Elstein | signature: | /s/ David Aviezer | |||||
name:
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Amir Elstein | name: | David Aviezer | |||||
designation:
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Group VP, Global Specialty Pharmaceutical Products | designation: | CEO | |||||
signature:
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/s/ Keren Siemon | signature: | ||||||
name:
|
Keren Siemon | name: | ||||||
designation:
|
Sr. Director BD and Finance, Global | designation: | ||||||
Specialty | ||||||||
Pharmaceutical Products | ||||||||
Date: 14 September 2006 | ||||||||
Date: 14 September 2006 |
[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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[***] | Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. |
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Between:
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Engel Science Parks (99) Ltd. | |
66 Hahistadrut Blvd., Haifa Bay By Yitzchak Yaacovinsky |
||
The party authorized to undertake and sign in the name of the Lessor (hereinafter: the Lessor) |
||
of the first part | ||
And:
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Metabogal Ltd. | |
P.O.Box 432, Kiryat Shmonah, Zip code 11013 (hereinafter: the Lessee) |
||
of the second part |
WHEREAS
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The Lessor has contracted with the Israel Lands Administration by agreement whereby it acquired the development rights in the plot known as Block 18984, Parcels 187 (part of), 188 (part), 190 (part of), 191 (part of), 192 (part of), 193 (part of), 194 (part of), 199 (part of) and 206 (part of) in Carmiel, plot/s no. 1, according to Detailed Plan no. C/8880, in Carmiel, (hereinafter: the Land) all pursuant to the Development Agreement and the Appendices thereto attached to this Agreement and marked as (Appendix A); and | |
WHEREAS
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The Lessor intends to establish a science park on the Land, consisting of industrial buildings for leasing (hereinafter: the Science Park); and | |
WHEREAS
|
The Lessor is the proprietor of development rights from the Israel Lands Administration under a Development Agreement and is entitled to effect transactions with the Land, including leasing buildings that it will construct thereon, as set out below in this Agreement and there is nothing by law or agreement or otherwise to prevent the Lessor from entering into this Agreement; and | |
WHEREAS
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The destination of the premises is compatible with the Purpose of the Lease; and | |
WHEREAS
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The Lessor declares that the Development Contract has not been rescinded by the Israel Lands Administration and is about to be further extended; and | |
WHEREAS
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The Lessee is desirous to lease the Premises (as hereinafter defined) from the Lessor under an unprotected lease according to the Tenants Protection Laws, and the Lessor is prepared to grant such a lease of the Premises to the Lessee, subject to all of the conditions hereinafter contained; |
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1. | Preamble | |
The preamble to this Contract and the Appendices thereto will constitute an integral part hereof. | ||
2. | Interpretation |
2.1 | The headings to the clauses in this Contract are set out for ease of reference only and do not constitute part of the Contract nor will they be applied for purposes of interpretation. | ||
2.2 | Save where the context or the meaning otherwise requires, everything stated in the singular includes the plural and vice-versa, and everything stated in the masculine includes the feminine and vice-versa. | ||
2.3 | Unless the context otherwise requires, the following words shall bear the meanings set out opposite them when used in this Contract: |
the Premises - | means the gross area of some 750sq.m., situated on the
ground floor of Building no. 1 of the industrial building distended to be
constructed by the Lessor and/or on its behalf, on the Land, within the boundaries
of the Science Park in Carmiel. The Premises will consist of offices according to
the specification attached, and be totally finished and have a basic
infrastructure, but be without installations and furniture. The Premises will be constructed in accordance with plans, the Lessors specification and the Lessees specification respectively attached hereto as Appendices B, C and D. The Lessors and the Lessees specification will be hereinafter collectively called the Specification. The area of the Premises for the purpose of determining the rent will be set in accordance with an actual survey thereafter, after construction is completed. |
3 | Term of the Lease, Purpose thereof and Non-applicability of the Tenants Protection Laws |
3.1 | Term of the Lease |
3.1.1 | The Lessor hereby leases to the Lessee and the Lessee hereby takes on lease from the Lessor the Premises for a term of 5 years, commencing on 15.2.04 and expiring on 14.2.09 (hereinafter: the Lease Term). | ||
If and to the extent the actual delivery date is deferred by reason of that stated in clause 5.1 hereof, the date of the commencement of the Lease Term will be deemed to be the date of actual delivery, and the expiration date of the Lease Term will be correspondingly deferred. |
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Subject to the agreed time schedule mentioned in clause 19.9, the Lessor will, in respect of each day of deferral of the date of the commencement of the Lease Term, pay the Lessee an amount equal to twice the amount of the Rent plus VAT, calculated on a daily basis as from the date prescribed above for the commencement of the Lease Term until the actual date of the commencement of the Lease Term. The deferral of the date of commencement of the Lease Term by reason of any act or omission of the Lessee will not obligate the Lessor to make such payment and the date of the commencement of the Lease will remain unchanged. | |||
3.1.2 | Notwithstanding the foregoing in relation to the Lease Term, the Lessee will be entitled to terminate the Lease Term by four months prior notice, during the periods and on the following terms and conditions: |
3.1.2.1 | After 3 years of the lease, against payment of the sum of NIS. 150,000 (plus VAT) in addition to the rent that has been paid in respect of such three-year lease. | ||
3.1.2.2 | After 4 years of the lease, against payment of the sum of NIS. 75,000 (plus VAT) in addition to the rent that has been paid in respect of such four-year lease. |
The sums mentioned in the above sub-clause will be linked to the residential construction inputs index, the base index being that known on the date of the execution of this Contract, the operative index being that which will be known on the date of the making of the payment according to this clause. | |||
3.1.3 | The Lessee hereby undertakes to open the Premises for regular business activity and carry on in the Premises for the entire duration of the Lease Term, a business the purpose of which is set out below. | ||
3.1.4 | Subject clause 3.1.2 above, the cessation by the Lessee of the use of the Premises or quitting the same prior to the expiration of the Lease Term will not release it from fully performing its undertakings, including payment of the rent and the remaining payments payable by it under this Contract until the expiration of the Lease Term, except in a case where an alternative tenant is found for the Premises whose identity has been agreed to by the Lessor, in which case the Lessee will be released from the performance of its undertakings under this Agreement from the date on which a contract is forged with the alternative tenant and thereafter. | ||
It is clarified that the Rent will be paid by the expiration of the Lease Term or until an alternative tenant is found who is acceptable to and approved by the Lessor, whichever is the earlier. | |||
The Lessors approval will not be unreasonably withheld save that where the Lessor will have agreed to an alternative tenant that has been found by the Lessee, the Lessee will remain liable, jointly with the alternative tenant, for the performance of the undertakings under this Agreement. |
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3.2 | Purpose of the Lease | ||
The Lessee hereby leases the Premises for the management of a business in the field of biotechnology including the management of biotechnology laboratories, research, development and production of medications and the Lessee is prohibited from making any other use whatsoever of the Premises. | |||
3.3 | Non-applicability of the Tenants Protection Laws |
3.3.1 | There was no tenant entitled to occupy the Premises on the date of the commencement of the Tenants Protection Law (Consolidated Version), 5732-1972. | ||
3.3.2 | The Lessee hereby declares that it has not been requested to pay nor has it paid any key money or payments which could be construed as key money and that all the works, alterations, improvements and enhancements that will be made in the Premises, if at all, are not and will not be fundamental alterations and further that the provisions of Part Three of the Tenants Protection Law (Consolidated Version), 5732-1972 dealing with key money, will not apply to the Contract. | ||
3.3.3 | The Lease, the Lessee and the Premises are not protected according to the provisions of the Tenants Protection Law (Consolidated Version), 5732-1972 nor according to the provisions of any other law protecting tenants or occupiers in any manner whatsoever and such Laws as amended and the regulations promulgated now or hereafter thereunder do not and will not apply to the building and/or the Lease and/or the Lessee and/or the Premises and/or this Contract. | ||
3.3.4 | The Lessee will not be entitled, when quitting the Premises, to any payment whatsoever either in the form of key money or in any other form. | ||
3.3.5 | For the avoidance of any doubt the Lessee hereby declares and warrants that if in the future any claims are raised to the effect that the engagement under this Contract is protected according to the Tenants Protection Law or any other law, the Lessee will compensate the Lessor in respect of any damage that will be incurred by it, including the difference between the value of the property at the expiration of the Lease Term as occupied, and the value thereof in the open market, as vacant property. |
4. | Rent |
4.1 | The Lessee undertakes to pay the Lessor monthly rent pursuant to the following conditions and dates: |
4.1.1 | The Lessee will pay for the duration of the Lease Term the sum of $9 per month for each sq.m., of the area of the Premises. | ||
4.1.2 | The parties agree that in respect of each 11-month period of the Lease, the Lessee will be exempt from paying rent for one month. The month of the Lease without payment of the rent will be granted in relation to each year of the Lease, in the seventh month of the Lease, that is to say in each year of |
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the Lease the Lessee will be exempt from payment of rent in respect of the period between 15.4 14.5. |
4.1.3 | The Lessee will deduct from the rent, amount mentioned, tax at source as required by law, unless the Lessor produces to the Lessee a lawful certificate regarding the exemption from deduction of tax at source. |
VAT will be added to the above rent against a lawful VAT receipt, at the rate in force on the date on which each payment is made. | |||
4.2 | Payment of the rent will be made in new shekels according to the representative rate of exchange of the dollar on the date on which each payment will be made pursuant to the publications of the Bank of Israel. | ||
4.3 | Deleted. | ||
4.4 | The rent will be paid in quarterly installments in advance, on the 15th of each month of February, May, August, November. | ||
4.5 | Deleted. | ||
4.6 | Arrears in payment of the rent as well as arrears in any other payment imposed upon the Lessee under this Contract exceeding 14 (fourteen) days, will constitute a fundamental breach of this Contract. | ||
4.7 | Every sum which the Lessee is liable to pay under this Contract and which will not have been paid on due date will bear interest on arrears at the maximum rate customary for the time being in Bank Leumi le-Israel B.M., with respect to overruns of unauthorized credit, from the date prescribed for payment under this Contract until the date of actual payment, together with VAT as required by law. The interest rates will vary during the period of the arrears in accordance with changes occurring from time to time in the interest customary in Bank Leumi as stated. Nothing contained in this clause shall derogate from any relief or other right conferred upon the Lessor according to the provisions of this Contract or at law. In respect of the first three days of arrears, no interest on arrears as stated above will be payable. |
5. | Acceptance of the Premises |
5.1 | The Lessor will place the Premises at the Lessees disposal in accordance with the Execution Plans (as hereinafter defined) and the Specification attached hereto, complete with connection to the electricity and water supply and after having duly received a certificate from the Electric Corporation and the Lessee undertakes to accept the same in such condition. | ||
As part of the Lessors undertakings it undertakes to allocate to the Lessee, for the duration of the actual Lease Term, 20 parking places adjacent to the entrance to the Premises. | |||
5.2 | It is hereby agreed that by no later than 15.11.03, the parties will confirm in writing the detailed Execution Plans in respect of the works that will be carried out by the Lessor at the Premises (in this Agreement referred to as: the |
6
Execution Plans). The Execution Plans will be prepared based on the plans contained in
Appendix B to the Contract by and at the expense of the Lessor, except for plans in
respect of the Lessees dedicated purposes and any planning in excess of the Lessors
Specification will be borne by the Lessee. The Lessors Specification and the Lessees
Specification will be delivered to the Lessee at least 7 days prior to the date of the
approval thereof as stated above. The Lessor will provide the Lessee with an assessment of the cost differentials prior to commencing execution. |
|||
For the avoidance of any doubt it is hereby emphasized that the Lessor will not be required to execute any work or alteration or improvement whatsoever in the Premises, in addition to its undertakings in the Execution Plans and the Specification. | |||
5.3 | The parties agree that a delay of up to three months in the completion of the development works surrounding the Premises does not constitute a breach of this Agreement or a cause for any delay/refusal of the delivery of the Premises and/or the taking of the possession thereof, all on the condition that the Lessee will be able to make actual use of the Premises. | ||
5.4 | The parties will, 7 days prior to delivery of possession of the Premises, make a memorandum of delivery within the scope of which the Lessee will itemize all the defects and deficiencies in the Premises. The Lessor will rectify or make good, as appropriate, everything that requires repair and completion by the date of the delivery of possession. |
6. | Additional payments to be borne by the Lessee |
6.1 | The Lessee undertakes, in addition to the rent and the VAT, to pay all the taxes, fees, levies and compulsory payments applicable now or hereafter to the Premises and/or to the use thereof during the Lease Term including general municipal taxes and business tax as well as expenses for the use of electricity, gas and telephone, and all the remaining maintenance expenses of the Premises in the area of the Premises only (including maintenance and cleaning) as well as the facilities serving the Premises, (such as elevators, air-conditioning, fire-fighting systems and the like). | ||
It is clarified that all the above payments and any other payment applicable to the Premises or the construction thereof (including property tax, amelioration levies and/or sewerage, drainage and water fees), as well as any payment in respect of the period culminating with the date of the delivery of the possession to the Lessee, will be borne and paid for by the Lessor. | |||
The Lessee undertakes to transfer the municipal tax bill in respect of the Premises into its name immediately after taking actual possession of the Premises. | |||
It is clarified and agreed that the Lessee will also be liable for a proportionate share equal to the floor area of the Premises compared with the total floor area of the building in which the Premises are situated, of the cost of maintaining the common areas for the building. |
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It is clarified that the Lessee will bear the maintenance costs of the Premises including all the installations and systems that are situated within the area of and serve the Premises. | |||
6.2 | The Lessee will be liable also after the termination of the Lease Term, for the payments mentioned in this clause above if the liability has been created following the use or consumption made during the currency of the Lease Term, even if the liability or the demand for payment has arrived after the expiration of the Lease Term. | ||
6.3 | The Lessee will pay the payments mentioned in this clause above immediately when they fall due. | ||
6.4 | The parties will, on the date of the delivery of possession of the Premises, make an accounting with respect to the alterations, additions and/or reductions that have actually been made at the Premises compared with the Lessors Specification (Appendix C) and which will be priced according to the full price thereof according to the Dekel price list. The amount due to either of the parties following such accounting will be paid by way of a reduction or addition to the first quarterly payment of the rent as appropriate. | ||
6.5 | In the event of the Lessor making any payment which, by the provisions of this Contract, is payable by the Lessee, the Lessee will be bound to pay the Lessor such payment immediately upon the Lessors first demand, with the addition of exchange rate differentials (if any) plus interest on arrears according to clause 9.2 hereof, computed from the date of the making of the payment by the Lessor until the actual payment thereof to the Lessor provided the Lessor has given 14 days advance notice of its intention to make the payment and the Lessee has failed to pay the same. |
7. | Possession of the Premises during the Lease Term |
7.1 | The Lessee will keep the Premises in good and proper condition, keep the Premises tidy and clean including the surroundings, installations and fittings thereof, and use the same cautiously and carefully and fulfil the instructions of any competent authority as they exist from time to time in connection with arrangements regarding cleanliness, the removal of waste garbage, and keeping the drainage system and all the remaining systems at the Premises in order. | ||
7.2 | The Lessee will repair at its own expense, any defect, malfunction or fault that will be caused or come about or be discovered in the Premises and in any part thereof belonging to the Lessee, including plumbing and various other repairs when they arise and/or have been caused or discovered, except for repairs or damages that have been caused by reason of fair wear and tear following the reasonable use of the Premises and/or as a result of construction and/or infrastructure defects (including sewage, electricity, water) in the construction of the Premises, the responsibility for which will apply to the Lessor. | ||
Repairs which are the Lessors responsibility will be repaired by it, failing which they will be executed by the Lessee after notices as set out in this clause will have been given, mutatis mutandis. |
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7.3 | If the need to make a repair arises that a party is responsible to fix according to clause 7.2 above, the party liable for the repair will be bound to carry out the same at its own expense, within a reasonable time of the date of discovery. Failure by the party liable to carry out the repair will entitle the other party, that is not liable, to carry out the same after giving 30 days prior written notice and all the repair expenses will be borne by the party liable, who shall be under an obligation to reimburse the party actually carrying out the repair for expenses, immediately upon first demand with the addition of linkage differentials and interest on arrears according to clause 9.2 hereof, computed from the date of payment for the repair until the actual payment thereof, to the repairing party. Notwithstanding the foregoing it is agreed that in the event of an urgent repair, the party entitled may carry out the same after giving 24 hours prior notice to the other party. | ||
7.4 | The Lessee undertakes to comply with the provisions of any law including any Law, Regulation, Order, By-law or instruction of any competent authority pertaining to the management of its business at the Premises and in connection with the maintenance of the Premises and the use thereof. The Lessee will also be responsible for paying any fine that will be imposed following the failure to fulfil such instructions. | ||
7.5 | The Lessee undertakes not to effect any internal or external alteration at the Premises nor make any addition thereto nor demolish any part of the Premises or any of the installations thereof nor suffer any such alterations or additions or repairs or demolition, to be made, without receiving the prior written consent of the Lessor, which consent shall not be unreasonably withheld by the Lessor. | ||
It is clarified that this clause will not apply to works at the Premises that will be carried out by the Lessee or any person on its behalf within the scope of the clean room installation in that part of the Premises that is designated for production. | |||
7.6 | It is expressly agreed that signage and advertising will only be made by arrangement with the Lessor (including the architect of the building in which the Premises are situated) and with its prior consent only, which consent will not be unreasonably withheld by the Lessor. | ||
7.7 | Alterations made to the Premises with the Lessors consent, will require the Lessee, at the end of the Lease Term, to reinstate the Premises to its former condition before the alterations were made, or leave the same in its condition, all as decided and notified by the Lessor. Upon such agreement by the Lessor being given to the alterations remaining, the Lessee may not remove from the Premises or reinstate the alterations or any part thereof that the Lessor has required remain at the Premises or make any alteration therewith, and the alterations will, at the end of the Lease Term, pass into the Lessors ownership and possession, without the Lessee being able to demand and/or receive any compensation or payment for them. | ||
7.8 | The Lessor and each of its managers may enter upon the Premises by prior arrangement, at any reasonable time acceptable in order to check the condition of the Premises and carry out repairs, works, technical or other arrangements for the Premises all this without unreasonably effecting the Lessees activity at the Premises. |
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Nothing herein contained shall impose any duty whatsoever on the Lessor to carry out anything which is mentioned in this Contract. | |||
7.9 | The Lessor will independently install, at its own expense, fire fighting and safety measures as appearing in the plans and Specifications attached hereto as Appendices B and C. | ||
The Lessee will, at its own expense, fulfil the instructions of any competent authority relating to the fire fighting arrangements and procedures, fire prevention, civil defense and safety, to the extent these will be required in relation to the Premises and the use made thereof, over and above those measures which will be installed by the Lessor. |
8. | Assignment of rights |
8.1 | The Lessee undertakes to use the Premises personally only or with its employees and the Lessee will be prohibited from authorizing any other person or persons to use the Premises or any part thereof for consideration or otherwise, directly or indirectly. | ||
8.2 | The Lessee undertakes not to transfer and/or assign and/or convey and/or pledge and/or charge in any manner whatsoever, without first receiving the written consent of the Lessor (if and to the extent it will be granted) this Contract and/or any right thereunder to any other party or parties, nor grant any leases of the Premises or any part thereof by sub-lease or convey possession or use thereof or any part thereof to any other person or persons for consideration or otherwise, in any manner whatsoever. Any transfer and/or assignment and/or conveyance and/or pledge and/or charge that will be made by the Lessee contrary to that stated above will be null and void ab initio and devoid of any effect. | ||
8.3 | Notwithstanding the foregoing the Lessee will be entitled to share the use of the Premises under this Agreement or sub-lease parts thereof to a parent, subsidiary or affiliated company of the Lessee (as these terms are defined in the Companies Law, 1999) without the need to obtain the Lessors consent provided that the Lessee will remain liable for all its obligations under this Agreement. |
9. | Breaches and remedies | |
This Contract will be governed by the provisions of the Contracts (Remedies for Breach of Contract) Law, 5731-1970 and the provisions of the Contracts (General Part) Law, 5733-1973. | ||
10. | Licensing and Licences |
10.1 | The Lessee hereby undertakes to obtain any licence it requires and ensure that the business is carried on according to every licence that is required by law, including from any municipal, governmental, local or other authority, for the purpose of operating and managing the Lessees business at the Premises. | ||
The Lessor will sign any document that will be required by the landlord [sic] in order to obtain a business licence, but does not deviate from the conditions of this |
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Agreement, within and by no later than 14 days after delivery thereof for signature to the Lessor. | |||
10.2 | The Lessee shall ensure that throughout the entire Lease Term the licences and approvals required in order to carry on and operate its business mentioned, will be renewed. | ||
10.3 | For the avoidance of any doubt the Lessor is not responsible towards the Lessee for obtaining licences or approvals from any authority except where failure to obtain receipt of the licence results from any act or omission of the Lessor or of any person on its behalf and where a duty attaches to the Lessor by law and/or this Agreement to carry out or refrain from carrying out such act, as appropriate. | ||
Without derogating from the Lessees undertaking mentioned above, the Lessor declares that the Premises comply with the zoning thereof according to the Town Building Plan in force in respect of the Land. |
11. | Insurance |
11.1 | The Lessee hereby undertakes to insure at its own expense for the duration of the Lease Term, the building of the Premises and the contents thereof against: |
11.1.1 | Fire, explosion, earthquake risks. | ||
11.1.2 | Flooding, water damage of any kind. |
11.2 | The Lessee hereby undertakes to insure at its own expense, for the duration of the Lease Term, its activity at the Premises, with the following insurances: |
11.2.1 | Third party liability insurance with liability limits that will not be less than the amount equal to US$1,000,000 Million per event, and in the aggregate for the insurance period, which will endure for the duration of the Lease Term. | ||
11.2.2 | Employers liability insurance. The Lessee further undertakes to maintain at its own expense for the duration of the Lease Term loss of rent insurance following the Premises being taken out of use by reason of damage that has been caused thereto or to the contents thereof by the risks set out in clause 11.1 above, for an indemnity period of 12 months. This insurance may be made by means of extending the fire insurance policy to cover loss of rent. |
11.3 | The Lessee undertakes to add the Lessors name as an additional insured in the policies mentioned above. | ||
11.4 | The Lessee will produce to the Lessor upon demand, all the insurance policies which have been issued as required by this Contract and also produce to the Lessor on a regular basis every new policy that has been issued to it or any amendment thereto. The Lessee will, upon the Lessors reasonable demand, add to or update and/or amend the insurance policies to the Lessors satisfaction in order to comply with the criteria prescribed in this clause 11, and the amounts will in any event be linked to the Index each year. |
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11.5 | The Lessee will cause an express condition to be added to the insurance policy whereby the insurer expressly waives any right of subrogation or other right under any law to have recourse against the Lessor in a claim of subrogation or repayment or indemnity in respect of direct or indirect damage that has been caused by reason of the Lessor, if any such damage is caused. | ||
11.6 | The Lessors right of inspection and its exercise or right to refrain from exercising its right to view the policies and demand any update, addition or change as set out in clause 11.1 above, will not impose upon it any liability whatsoever with respect to the policies, or the nature and validity thereof, or with respect to the absence thereof. | ||
11.7 | The Lessee undertakes to comply with all of the conditions of the policies mentioned above in this clause, punctually pay the insurance premiums and ensure that the policies are renewed and remain in full force for the entire duration of the Lease Term. Failure to renew the policies in the full value thereof, including linkage to the Index for any reason whatsoever will constitute a fundamental breach of this Contract. | ||
11.8 | The policy will include a clause determining that it will not be varied, cancelled or renewed without at least 30 days prior notice being given to the Lessor. |
12. | Liability of the Lessee |
12.1 | The Lessor, its agents and any person acting in its name and on its behalf will
not be responsible in any manner whatsoever with respect to any damage or harm that will
be caused to the Lessee or its property, subject as hereinafter provided. It is hereby expressly agreed and declared that no liability will attach to the Lessor of any kind whatsoever towards the Lessee in respect of any damage that has been caused to the Premises or its contents or to any third party for any reason whatsoever regardless of whether the reasons for the damage or the malfunction are known or not, with the exception of any wilful act of damage by the Lessor and/or by any person on its behalf. |
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12.2 | The Lessor will bear no responsibility whatsoever or liability with respect to any physical damage or loss and/or damage to property of any kind whatsoever (whether direct or indirect) that will be caused to the Lessee and/or its workers and/or those employed by it and/or to its agents or customers or visitors or invitees or to any other person who is found at the Premises or in any other area occupied by the Lessee with the licence of the Lessor and/or any property of the Lessee, and the Lessee assumes total responsibility for any damage of that kind and undertakes to compensate and indemnify the Lessor against any damages that it will become liable for or compelled to pay following damage of such kind, against any expense that it will lay out in connection with such damage. |
13. | Grounds for eviction | |
Without derogating and/or detracting from any other provision herein contained, upon the occurrence of any of the following events, the Lessor will be entitled to immediately terminate the engagement and the Lease under this Contract, and demand the immediate vacation of the Premises by the Lessee: |
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13.1 | If the Lessee is in arrears for more than 14 days in the payment of any amount that has fallen due to the Lessor according to the provisions hereof, and under any law, and the breach has not been cured within 5 days of receiving a written notice from the Lessor to do so; | ||
13.2 | If a receiver (whether temporary or permanent) is appointed or receiver and manager (whether temporary or permanent) or liquidator (temporary or permanent) for the Lessees business or property or any part thereof and such appointment will not be vacated within 60 days; | ||
13.3 | If the Lessee passes a resolution for dissolution or if any dissolution order is issued against it and such order is not vacated within 60 days or if the Lessee reaches a compromise or arrangement (within the meaning of the Companies Ordinance) with its creditors or any of them; | ||
13.4 | If any final attachment is imposed over all the assets of the Lessee; | ||
13.5 | If the Lessee is in breach of any of the provisions contained in clause 8 above and grants to any other person the right of use or any other right whatsoever in the Premises or in any part thereof and such breach will not have been cured within 5 days of the despatch of notice in writing by registered mail by the Lessor. |
It is clarified that the termination of the engagement and eviction of the Lessee in the circumstances mentioned above will not terminate or detract from any obligation of the Lessee to fulfil all of its financial obligations under this Contract, for the entire duration of the Lease Term. | ||
14. | Vacation of the Premises |
14.1 | The Lessee undertakes, upon the expiration of the Lease Term or the termination of the Lease and/or the rescission of this Contract for any reason, to vacate the Premises and surrender possession thereof to the Lessor, the Premises being clear and vacant of any person and thing belonging to the Lessee, in clean and orderly condition as the Lessee received the same from the Lessor, subject to fair wear and tear. Should the Lessor demand, as stated in clause 7.6 above, that supplementary works, alterations and additions that have been made by the Lessee in the Premises, if at all, will be left by it at the Premises, then any improvement, enhancement, addition which is permanently affixed to the Premises even if these were installed and added to the Premises by and at the expense of the Lessee, will be left by the Lessee at the Premises. | ||
14.2 | In the event of the Lessee failing to vacate the Premises on the date specified above, then, in addition to the Lessors right to sue for eviction from the Premises, and in addition to any other right that the Lessor may have according to this Contract or at law, and without derogating from any right or relief conferred upon the Lessor stated above, the Lessee will pay the Lessor for the period commencing on the date it ought to have vacated the Premises until the date on which it vacates the Premises, an amount equal to twice the amount of the rent, plus interest on arrears according to clause 9.2 above, and Value Added Tax, computed on a daily basis, from the date of creation of the liability to pay until the full and actual payment to the Lessor, and which would have been payable according to this Contract had the Lease been extended according to the conditions hereof. The |
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above payment has been set and agreed as proper user fees and/or fixed and pre-agreed damages as estimated in advance by the parties in accordance with their prior calculations. | |||
14.3 | It is hereby stipulated and agreed between the parties that nothing contained above in this clause shall confer upon the Lessee any right to continue to occupy the Premises (against payment of the agreed compensation) and/or constitute any waiver on the part of the Lessor of any of its rights and/or derogate from the Lessors right to obtain any other remedy or relief, including, but without derogating from the generality of the foregoing, the ejection or removal of the Lessee from the Premises. |
15. | Charge or pledge by the Lessor |
15.1 | The Lessor may pledge and/or charge this Contract in whole or in part, assign any of its rights thereunder to others, transfer the whole or part thereof in any form whatsoever as the Lessor deems fit, from time to time, either for the purpose of obtaining financing or for any other purpose, all at the Lessors absolute discretion, all this being without derogating from the Lessees rights under this Contract of Lease. | ||
15.2 | The Lessor may assign all or any of its rights in the Premises, transfer all or partial ownership thereof, at its absolute and exclusive discretion, without requiring the Lessees consent, and the Lessee accepts in advance and expressly any such act which will be effected by the Lessor, unconditionally, and the Lessee will have no claim or demand or action of any kind whatsoever against the Lessor or its successors, subject to the Lessees rights under this Agreement not being affected. |
16. | Lessors Remedies in respect of Breach |
16.1 | Without derogating from that stated in clause 9 above, and further to this clause and the specific remedies appearing in this Contract, the provisions of the Contracts (Remedies for Breach of Contract) Law, 5731-1970 will apply to a breach of this Contract, as well as the provisions of the Contracts (General Part) 5733-1973. | ||
16.2 | If the Lessee fails to keep the Premises in proper condition or fails to repair that necessary in the Premises and/or fails to return the Premises to the Lessor at the expiration of the Lease Term in proper condition or if any damage is caused whatsoever to the Premises during the Lease Term, and has not been rectified by the Lessee, then, in addition to any other right that the Lessor may have in such a case pursuant to the provisions of this Contract and/or at law, the Lessor may effect any repair or do any act that it deems fit in order to repair the damage or restore the condition to what it was previously, at the Lessees expense and after giving the Lessee seven days prior written notice and the Lessee has failed to rectify the breach within the 7 day period mentioned. The Lessee will reimburse the repair expenses against presentation of invoices for the repair. | ||
16.3 | Deleted. |
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16.4 | In the event of a termination of the rights of the Lessee under this Contract by reason of a breach thereof by the Lessee, the Lessor will be entitled to any additional remedy that it has by law on account of the breach, including the remedy of compensation, or injunctive or mandatory orders. Notwithstanding anything stated herein and in addition thereto, in the event of a breach by the Lessee by reason of which the Lessee has been evicted from the Premises prior to the expiration of the Lease Term, the Lessee will be required to pay the Lessor, for the period from the date of the eviction until the expiration of the Lease Term, damages at the rate of double the amount of the rent which applied prior to the termination of the Lease, all subject as provided in clause 3.1.4 above, and subject to the fact that if the Premises will be re-leased to an alternative lessee according and subject to the provisions of this Agreement, only the difference between the rent prescribed by this Contract and the rent that will be charged from the alternative tenant, will be paid by the Lessee. |
17. | Guarantees Collateral |
17.1 | To secure the performance by the Lessee of its undertakings under this Agreement, the Lessee will deposit with the Lessor on the date of the signature of this Agreement, an autonomous bank guarantee payable upon demand, linked to the Consumer Price Index, according to the details contained in this Contract, or deposit an amount equal to six months rent, or a guarantee of the directors and shareholders of the Lessee (hereinafter: the Guarantee or the Deposit). | ||
17.2 | It is hereby expressly agreed and declared between the parties that the giving of the Guarantee or the Deposit to perform the terms of this Contract does not amount to any waiver on the part of the Lessor of any right to any other relief against the Lessee, whether such relief is set out in the body of this Contract or is available to the Lessor by virtue of any law existing at the time of the execution of this Contract or will exist in Israel on the date of the breach. | ||
The Lessor will give the Lessee seven days prior notice of its intention to exercise the Guarantee or realize the Deposit. | |||
17.3 | The forfeiture of the Guarantee or the Deposit will not derogate from the Lessors right to sue for and receive against the Lessee any other relief. | ||
17.4 | The Lessee will, at the expiration of the Lease Term and on the date of the surrender of the Premises to the Lessor, furnish the Lessor with certifications according to its demand in writing, indicating that all the payments and the fees which it was subject to have been paid by it up till the date of the surrender of the Premises or in relation to such period. | ||
17.5 | It is expressly agreed that in the event of the Lessee becoming liable to vacate the Premises, the Lessor will be entitled to give notice to and demand from the Electric Corporation and the municipality the disconnection of the electricity and water supply to the Premises. |
18. | Option |
18.1 | It is hereby agreed that as long as vacant areas remain on the floor on which the Premises are situated, the Lessee will be entitled to demand to increase the area of |
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the Premises by no more than an additional 450sq.m., on the conditions of the Lease under this Contract. | |||
It is clarified that the Lessee will have a first right of refusal in relation to the leasing of the adjacent areas and that these areas will not be leased until the Lessee has been given notice by the Lessor seeking to lease the same to any third party, 30 days in advance. The Lessee will notify the Lessor within 30 days of its wish to take a lease of those areas. | |||
18.2 | An option is granted to the Lessee to lease an additional 1,000sq.m., in Building no. 2, when it will be erected (and without this option amounting to any representation or assurance and/or undertaking regarding the construction thereof) on conditions identical to those of the Lease under this Agreement. | ||
Upon a decision being taken to construct Building no. 2, the Lessor will notify the Lessee of its intention to embark upon the construction of the second building, and the Lessee will be given a 30-day option to advise if it wishes to exercise its right to lease an additional area, as stated above. |
19. | General |
19.1 | The option will be afforded to the Lessee to place on the roof of the building of the Premises, without any further payment, installations such as: air-conditioning units, a generator, gas containers, air purification units, etc. | ||
19.2 | Use of the elevator (to ascend to the roof of the building) and payment of the maintenance and use thereof will be done in accordance with a direct arrangement between the Lessee and the Ort Braude College, without reference to and any involvement of the Lessor. | ||
The Lessee gives notice that it is aware and knows that it is under an obligation to arrange this matter directly with the Ort Braude College and will have no claims or demands against the Lessor regarding the use of the elevator and/or the costs that will be required of it in respect of the use and maintenance thereof. | |||
19.3 | No delay or grant of time or lack of response, lack of action or lack of taking any measures on the part of the Lessor will be construed in any form or manner as a waiver on its part of its rights under this Contract against a continuing or further breach on the part of the Lessee, unless the Lessor has waived any of its rights expressly and in writing. | ||
19.4 | All payments paid by the Lessee under this Contract will be made by the Lessee to the Lessor by means of a bank transfer to the bank account instructed by the Lessor to the Lessee in writing. | ||
19.5 | The addresses of the parties for the purposes of to this Contract appear at the head of this Contract. If the parties or any of them change their addresses they will give notice in writing to the other party of the new address in Israel and such address will from that time onwards serve as the address of that party for the purposes of this Contract. |
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19.6 | Any notice that will be sent by one party to the other pursuant to the Contract will be sent by registered mail or delivered personally, and will be deemed to have been delivered within a reasonable time of notice arriving at the addressee. | ||
19.7 | The stamping expenses of this Contract will be borne by the parties to this Agreement in equal shares. | ||
19.8 | The conditions of this Contract reflect the conditions stipulated between the parties in full and supersede any engagement, assurance, representation and undertaking formerly made by the parties prior to the execution of this Contract. No change of this Contract or any addition thereto if at all will be binding unless made in writing and signed by all parties. | ||
19.9 | Notwithstanding that stated in this Agreement and/or in the Plans, the Lessor undertakes to induce, at its own expense, in the part of the Premises that are designated to be a production zone according to the Plans, the making of passages (shafts) to the roof for the use of the Lessees infrastructure conduits, between the Premises and the roof, in a ceiling area of up to 6sq.m., according to the definition of the Lessees requirements. It is further agreed that in the period preceding the commencement of the Lease Term, the Lessee or any person on its behalf may, (but will not be obliged) to carry out works at the Premises, at its own expense, for the purpose of installing clean rooms in that part of the Premises designated to be a production zone, as from 10 January, 2004 onwards. The Lessor undertakes to complete the installation of the electricity and water supply infrastructures to the Premises that are required to carry out such installation, until such date. It is further agreed that in the period preceding the commencement of the Lease Term, the Lessee or any person on its behalf will be entitled (but not obliged) to effect at the Premises at its own expense, installation works for furniture and laboratory infrastructure at the Premises, as from 1 February, 2004 onwards. | ||
19.10 | The Lessor undertakes to grant the Lessee a right to use the internal security shelter room situated on the floor of the Premises, subject to the provisions of any law applicable in this respect in consideration of monthly user fees in an amount equal to $3 (three) per sq.m., (gross) per month (plus VAT). These user fees will be subject to the provisions of this Agreement in all matters pertaining to the rent mutatis mutandis. |
20. | Approved enterprise |
20.1 | It is agreed that the Lessee will deliver to the Lessor the original application that it will personally prepare for the purpose of filing the same with the authorities in order to obtain a certificate of an approved enterprise. | ||
The application will be filed by the Lessor shortly after receiving the necessary documents, as stated. | |||
20.2 | If and to the extent the application for the approved enterprise that will be filed on behalf of the Lessee will in fact be approved, the Lessee will be credited with the rent on a monthly basis and with a proportionate share of the benefit that the Lessor will receive at the rate which the area of the total areas of the building (and |
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that part linked thereto) bears to the area of the Premises (and that part linked thereto). | |||
It is clarified and agreed that in such a case, the bank guarantee that has been deposited with the Lessor according to the provisions of clause 17.1 will similarly serve to secure to indemnify of the Lessor in relation to the monies that it may be required to repay to the State, if it is compelled to repay them, as a result of a breach by the Lessee of the conditions for obtaining the definition of approved enterprise. |
/s/ Yitzhak Yankopanski
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/s/ David Aviezer
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Engel Science Parks (99) Ltd.
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Metabogal Ltd. |
27 May, 2003 | ||
Carmiel Science Park /10610 |
Dr. David Aviezer, CEO | ||
Metabogal Laboratories Ltd., | ||
Kiryat Shmonah | By fax: 08-9762596 |
c.c. | Menachem Rosenblum- _____Engineer Yael Miller, accountant Engel Eyal Floumin, Chief Engineer Engel |
Between:
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Engel Science Parks (99) Ltd. | |
66 Hahistadrut Bldv., Haifa Bay By Yossi Ashkenazi |
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The party authorized to undertake and sign in the name of the Lessor (hereinafter: the Lessor) |
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of the first part | ||
And:
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Protalix Ltd. | |
2 Snonit Road, Science Park, P.O.B. 455, Carmiel 20100 (hereinafter: the Lessee) |
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of the second part |
WHEREAS
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A Lease Contract including Appendices was signed between the parties on 28 October, 2003, (hereinafter: the Contract) to lease a property situated on the ground floor of Building no. 1 of the building known as Science Park industrial buildings in Carmiel (hereinafter: the Premises) that have been erected by the Lessor; and | |
WHEREAS
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The Lessee is desirous leasing, and the Lessor has agreed to lease an additional measured area of 239sq.m., (196sq.m., of principal area + 43sq.m., of ancillary area) from the Lessor (hereinafter: | |
the Additional Area), which, together with the Premises according to the original contract will constitute the entire balance of the area on the ground floor of Building no. 1; |
1. | The Lessor hereby leases to the Lessee and the Lessee hereby leases from the Lessor an additional area in the Science Park, as described below, so that the Premises as defined in clause 2.3 of the Original Contract, will from henceforth be called, a measured area of 1,177sq.m., constituting the entire ground floor of Building no. 1, and after reducing the area of the lobby used by Ort for an entrance to their property as marked on the plan attached hereto this Supplement (hereinafter: the New Premises Area). | |
2. | The Additional Area of the lease according to the Supplement together with the Lease under the Original Agreement will both expire on 30 April, 2010 (hereinafter: the New Lease Term). | |
3. | The additional rent relating to the Additional Area according to this Supplement will be as follows: | |
In respect of 196 sq.m., of principal area, the Lessee will pay the sum of $5.5 (in words: five and a half U.S. dollars) per sq.m., per month and in respect of 43sq.m., of ancillary area, the Lessee will pay the sum of $3 (in words: three U.S. dollars) per sq.m., per month (hereinafter: the Additional Rent). |
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The Additional Rent will be paid from 1.5.2005 onwards until the expiration of the New Lease Term, according to this Supplement. | ||
It is clarified that clause 4.1.2 of the Original Agreement does not apply to payment of the Additional Rent in respect of the Additional Area according to this Supplement. | ||
4. | The Additional Area will be conveyed to the Lessee upon the signature of this Supplement, in its condition as is as of today, the planning of the adaptations and supplemental work in the additional leased area to be carried out by, at the expense of and according to the discretion of the Lessee, under the supervision and escorted by the Lessors representatives. | |
5. | For the Additional Leased Area according to this Supplement, the Lessor will designate 7 additional parking places for the use of the Lessee. | |
6. | An option is hereby granted to the Lessee for five years with respect to the entire Premises, including the New Premises Area which will commence from the expiration of the New Lease Term, that is, from 1.5.2010 and end on 30.4.2015 (hereinafter: the Option Term). | |
The Lessee will be required to give notice of its wish to exercise the Option Term, not less than 60 days prior to the expiration of the New Lease Term, according to this Supplement. | ||
The rent during the Option Term, will be equal to the New Rent in respect of the New Premises Area. In the last month of the Lease preceding the commencement of the Option Term with the addition of 7.5% (in words: seven and a half percent) linked according to the provisions of the Original Agreement and to be paid in accordance with the terms thereof. | ||
7. | The clauses of the Original Contract will apply in full to this Supplement, including the relative Appendices, except for the changes arising from the above clauses. |
/s/ Yossi Ashkenazi
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/s/ David Aviezer
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Engel Science Parks (99) Ltd.
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Protalix Ltd. |
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ORTHODONTIX, INC. |
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By: | /s/ Glenn L. Halpryn | |||
Name: | Glenn L. Halpryn | |||
Title: | Chief Executive Officer | |||
PROTALIX ACQUISITION CO. LTD. |
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By: | /s/ Glenn L. Halpryn | |||
Name: | Glenn L. Halpryn | |||
Title: | President | |||
PROTALIX LTD. |
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By: | /s/ David Aviezer | |||
Name: | David Aviezer, Ph.D. | |||
Title: | Chief Executive Officer | |||
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1 | Insert number equal to ten percent (10%) of the Shares held by person executing the Agreement. |
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Very truly yours, |
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By: | ||||
Name: | ||||
Title: | ||||
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