corresp
|
|
|
|
|
|
|
1290 AVENUE OF THE AMERICAS
NEW YORK, NY 10104-0050
TELEPHONE: 212.468.8000
FACSIMILE: 212.468.7900
WWW.MOFO.COM
|
|
morrison & foerster llp
new york, san francisco,
los angeles, palo alto,
san diego, washington, d.c.
northern virginia, denver,
sacramento, walnut creek
tokyo, london, brussels,
beijing, shanghai, hong kong |
|
|
|
|
|
Writers Direct Contact |
|
|
212.468.8163 |
|
|
JTanenbaum@mofo.com |
October 12, 2010
Mr. Jeffery Riedler
Assistant Director
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549
|
|
|
RE:
|
|
Protalix BioTherapeutics, Inc. |
|
|
Form 10-K for the Fiscal Year Ended December 31, 2009 |
|
|
Filed February 26, 2010 |
|
|
File No. 001-33357 |
Ladies and Gentlemen:
On behalf of our client, Protalix BioTherapeutics, Inc., a Florida corporation (the
Company), transmitted herewith are responses to the Staffs comments to the Companys Annual
Report on Form 10-K for the fiscal year ended December 31, 2009 (the 2009 Form 10-K), which
comments were set forth in the Staffs letter dated September 22, 2010 (the Comment Letter) to
David Aviezer, Ph.D., the Companys Chief Executive Officer. For purposes of reference, the
Company, formerly named Orthodontix, Inc., acquired Protalix Ltd. on December 31, 2006 through a
reverse merger and Protalix Ltd. is currently the Companys wholly-owned subsidiary. The Company
subsequently changed its name to Protalix BioTherapeutics, Inc. Prior to the merger, the Company
had no disclosure obligations with respect to Protalix Ltd. References to the Company in this
response letter include the Company and Protalix Ltd., unless stated otherwise. For ease of
reference, we have noted the Staffs comments in bold faced type and the responses in regular type.
Item 1. Business
Other Drug Candidates in Our Pipeline, page 14
1. |
|
Please provide us with draft disclosure for an amendment to your annual report that provides
additional information about your agreement with Yissum Research and Development Company and
the Boyce Thompson Institute, Inc., which includes the term of the agreement, its termination
provisions, the aggregate potential milestone payments, the amount of the license maintenance
fee, and an indication of the royalty percentage, e.g., single-digits, teens, twenties,
etc. |
Response: In response to this comment, the Company proposes that it provide
disclosure substantially in the form set forth on Exhibit A in future filings, as
applicable. The Company respectfully notes that the amount of the license maintenance fee under
the Research and License Agreement made on August 8, 2007, by and between Yissum Research
Development Company of Jerusalem (Yissum), the Boyce Thompson Institute (Boyce) and Protalix
Ltd. (the Yissum Agreement) is the subject of a confidential treatment request granted by the
Staff on December 3, 2007.
2. |
|
Please explain each partys obligations with respect to the collaborative research program in
the laboratory of Professor Hermona Soreq. |
Response: The Company has no material obligations with respect to the laboratory of
Professor Hermona Soreq. Rather, the Companys obligations are to Yissum and Boyce under the
Yissum Agreement, as described in the 2009 Form 10-K and as discussed in the Companys answer to
Comment No. 1. Professor Soreq is currently the researcher under the Yissum Agreement. The
Company does not know what obligations Yissum and Boyce have to Professor Soreqs laboratory.
Further, the Company is not required to disclose the obligations of Yissum and Boyce in its public
disclosure.
Strategic Collaborations, page 16
3. |
|
With respect to your agreement with Weizmann Institute of Science, please provide us with
draft disclosure for an amendment to your annual report that includes the term and termination
provisions, the aggregate potential milestone payments, the
amount of the research budget amount, and an indication of the range of royalty payments to
be made, e.g., single-digits, teens, twenties, etc. |
Response: In response to this comment, the Company proposes that it provide
disclosure substantially in the form set forth on Exhibit B in future filings, as
applicable. The Company respectfully notes that the amount of the research budget under the
agreement is the subject of a confidential treatment request granted by the Staff on January 18,
2008.
Intellectual Property, page 17
4. |
|
Please indicate not only that your patents relate to your ProCellEx protein expression system
but also the individual products they relate to. Additionally, disclose when the patents
expire. |
Response: In response to this comment, the Company proposes that it provide
disclosure substantially in the form set forth on Exhibit C in future filings, as
applicable.
2
5. |
|
Please indicate the product or products that are dependent on the jointly held patent and the
licensed patent rights and identify the joint holder and licensees. If the licensing
agreements have not been filed, please provide your analysis supporting your determination
that you are not required to file them as exhibits. |
Response: The jointly held patent relates to a new splice variant of human
follicle-stimulating hormone, or FSH. The Company is not proceeding with its FSH project at this
time. Accordingly, the license agreement relating to the joint patent is not material to the
Company. The other licensed patents and patent applications were licensed to the Company from
Yissum, Virginia Tech Intellectual Properties, Inc. (VTIP), Yeda and Icon. All of the applicable
agreements have been filed by the Company other than its agreement with VTIP. In response to this
comment, the Company has decided to file the agreement with VTIP as an exhibit to its Quarterly
Report on Form 10-Q for the quarter ended September 30, 2010.
6. |
|
Please provide us with draft disclosure for an amendment to your annual report that provides
additional information about your agreement with Icon Genetics AG, such as the term of the
agreement, its termination provisions, the aggregate potential milestone payments you are
required to make and an indication of the royalty range, e.g., single-digits, teens,
twenties, etc. Additionally, indicate which product candidates are dependent on this
agreement and provide an analysis supporting your determination that you are not required to
file the agreement as an exhibit. |
Response: Protalix has entered into two agreements with Icon Genetics AG (Icon).
The first is a Collaborative Research Agreement dated April 30, 2004 (the Research Agreement) and
the second is the Research and License Agreement between Yeda Research and Development Company
Limited and Protalix Ltd. dated as of March 15, 2006 (the License Agreement). The Research
Agreement is no longer in effect and neither the Company nor Icon has any continuing material
obligations under the Research Agreement. The only material obligation to survive the expiration
of the Research Agreement was an option by Protalix Ltd. to license the know-how, data, information
and inventions developed under the Research
Agreement to the extent the foregoing relates to plant cell cultures. Protalix Ltd. exercised
this right by entering into the License Agreement. Upon the execution of the License Agreement,
the Research Agreement ceased to be material to the Company. Consequently, the Company has not
filed the Research Agreement as an exhibit to any of its filings under the Securities Exchange Act
of 1934. In response to this comment, the Company proposes that it provide disclosure
substantially in the form set forth on Exhibit D in future filings with respect to the
License Agreement, as applicable. The Company respectfully notes that the amount of the license
maintenance fee under the License Agreement is the subject of a confidential treatment request
granted by the Staff on January 18, 2008.
Item 10. Directors, Executive Officers and Corporate Governance, page 62
General
7. |
|
Please, provide us with draft disclosure for an amendment to your annual report
that states for each incumbent director and director nominee the particular |
3
|
|
experience,
qualifications, attributes or skills that led your Board of Directors to conclude that these
individuals should serve as your directors. We refer you to Item 401(e) of Regulation S-K. |
Response: The Company provided disclosure regarding the particular experience,
qualifications, attributes or skills of each incumbent director and director nominee that led the
Companys Board of Directors to conclude that these individuals should serve as the Companys
directors as required under Item 401(e) of Regulation S-K. The Company intends to include
substantially similar disclosure in its future Annual Reports on Form 10-K and its proxy
statements, to the extent required by such filings.
Item 11. Executive Compensation
Compensation Discussion and Analysis, page 65
8. |
|
We note your statement that the Compensation Committee evaluates individual executive
performance with a goal of setting compensation levels the committee believes are comparable
with executives in other companies of similar size and stage of development operating in your
industry. From this disclosure, it appears that you engage in benchmarking activities.
Please provide draft disclosure identifying the peer companies that you use for benchmarking
purposes. |
Response: The Companys Compensation Committee does not engage in benchmarking
activities as contemplated in Item 402(b) of Regulation S-K. Rather, the Compensation Committee
reviews the executive compensation practices of other companies of similar size and stage of
development operating in its industry for comparative purposes to ensure that its compensation
decisions are not inconsistent with the practices of its peer companies. In response to this
comment, the Company proposes that it provide disclosure substantially in the form set forth on
Exhibit E in future filings, as applicable, in response to this comment.
9. |
|
Please provide us with draft disclosure for an amendment to your annual report that includes
the following: |
The individual and corporate performance objectives applicable to each named
executive officer and used to determine their annual bonuses and how each objective was
weighted, if applicable. To the extent that any of the performance objectives were
quantitative, your disclosure should also be quantitative;
The threshold, target, and maximum levels of achievement of each performance
measure, if applicable;
The intended relationship between the level of achievement of corporate and
individual performance objectives and the amount of bonus to be awarded;
The evaluation by the Committee of the level of achievement by each named executive
officer of the corporate and individual performance objectives applicable to them; and
4
Any other factors that were considered by the Committee that modified the actual
cash bonuses awarded.
Response: In response to this comment, the Company proposes that it provide
disclosure in the format set forth on Exhibit F in future filings, as applicable.
10. |
|
Your Summary Compensation Table includes a dollar value for option awards you granted to your
named executive officers in fiscal year 2009 but your Grants of Plan-Based Awards table
displays no awards made in the last fiscal year and your narrative disclosure concerning
options on page 66 omits any mention of option grants made last year. Please reconcile this
discrepancy in your disclosure. |
Response: The lack of disclosure in the Grants of Plan-Based Awards table for fiscal
year 2009 was the result of an error. The corrected table is included in the Grants of Plan-Based
Awards table set forth in the Companys proxy statement filed by the Company on October 4, 2010 in
connection with the Companys annual meeting of shareholders to be held on November 7, 2010.
11. |
|
We note that you have not included any disclosure in response to Item 402(s) of Regulation
S-K. Please advise us of the basis for your conclusion that disclosure is not necessary and
describe the process you undertook to reach that conclusion. |
Response: The Company does not believe that its employee compensation policies and
practices are reasonably likely to have a material adverse effect on the Company. The Companys
employees, and hence the Companys compensation structure, is not allocated among different
business units. Accordingly, there is no risk that the Companys compensation structure will
create risks among business units. In addition, although the Company has, from time to time,
granted cash bonuses to certain employees in connection with the Companys achievement of
designated regulatory or clinical milestones, most of the bonuses paid by the Company are paid
after the year end. Last, the Companys Compensation Committee decisions are generally made on an
annual basis after a review of financial and other developments by the Company limiting the risk
that a compensation decision would have a material adverse effect on
the Company. For the foregoing reasons, the Company does not believe that it has any risks to
disclose under Item 402(s) of Regulation S-K.
General
12. |
|
You state in your list of exhibits that Exhibits 10.6, 10.7, and 10.8, which are incorporated
by reference to your current report on Form 8-K filed on September 20, 2007, have been granted
confidential treatment under Rule 24b-2 of the Exchange Act. A search of our records does not
reflect an application for confidential treatment with respect to these exhibits being
received from you. Please provide us with a copy of the confidential treatment application
you submitted after these agreements were filed. |
Response: On January 8, 2007, the Company submitted a confidential treatment request
for Exhibits 10.6, 10.7 and 10.8 which are incorporated by reference to the 2009 Form 10-K.
5
The
Company submitted an amended confidential treatment request for the same exhibits on August 22,
2007. The SEC granted the Companys confidential treatment in an order dated January 18, 2008.
The Company has faxed a copy of the order granting confidential
treatment for those exhibits to the SEC separately.
* * *
Please call the undersigned at the telephone number set forth above or Joseph Magnas at
212-336-4170 with any question or comment you may have regarding the responses set forth herein.
In addition, please send all written correspondence directly to the undersigned and Joseph Magnas
of Morrison & Foerster LLP, 1290 Avenue of the Americas, New York, New York 10104, telecopy
212-468-7900, with copies to David Aviezer, Ph.D., the Companys President and Chief Executive
Officer, at 2 Snunit Street, Science Park, P.O.B. 455, Carmiel 20100, Israel, telecopy
+972-4-988-9489.
Sincerely,
/s/ James R. Tanenbaum
cc: David Aviezer, Ph.D.
Yossi Maimon
6
Exhibit A
In August 2007, Protalix Ltd. licensed the rights to certain technology under a research
and license agreement with Yissum Research and Development Company, or Yissum, and the Boyce
Thompson Institute, Inc., or Boyce Thompson. Pursuant to the agreement, we are developing a
proprietary plant cell-based acetylcholinesterase (AChE) and its molecular variants for the use in
several therapeutic and prophylactic indications, as well as in a biodefense program and an
organophosphate-based pesticide treatment program. Under the terms of the agreement, Yissum and
Boyce Thompson granted us an exclusive, worldwide right and license to certain technology,
including patents and certain patent applications relating to AChE for the therapeutic and
prophylactic indications as well as an exclusive license not limited to such indications with
respect to certain of those patents and patent applications. As consideration for the license, we
are obligated to pay Yissum and Boyce Thompson, collectively, an annual, non-refundable initial
maintenance fee. The maintenance fee shall only become payable a number of years after the
execution of the agreement and is subject to annual increases. In addition, we are obligated to
make royalty payments equal to varying low, single-digit percentages of net sales of products under
the agreement. These royalty rates are evaluated on a country-by-country basis, and are subject to
reduction if a third party commercializes a competing product or commercializes an authorized
generic version of the applicable product, subject to certain conditions. We also have the right
to grant sublicenses relating to the licensed technology under the agreement, subject to the
payment of sublicensing fees. The fees payable in connection with any sublicense are equal to
varying percentages, in the low-teens through the low-twenties, of the consideration we receive in
connection with the sublicense, depending on the level of clinical development of the product at
the time we enter into the sublicense. Last, we are obligated to pay Yissum and Boyce Thompson,
collectively, milestone payments equal to $700,000, in the aggregate, upon the achievement of
certain milestones under the license agreement.
The license agreement remains in effect until the expiration of all obligations to Yissum and
Boyce Thompson under the agreement, determined on a country-by-country basis. We have the right to
terminate the agreement for any reason upon 60 days prior written notice to Yissum and Boyce
Thompson. Subject to certain conditions, Yissum and Boyce Thompson may terminate the agreement
immediately upon written notice to us in connection with certain events relating to bankruptcy,
lapses in our insurance coverage, failures to defend against third party claims or claims we may
make regarding the validity or enforceability of any licensed patent. We or Yissum and Boyce
Thompson may terminate the agreement within 60 days after receiving written notice if the
non-terminating party passes a resolution for a voluntary wind up, if a receiver or liquidator is
appointed for the non-terminating party, or the non-terminating party enters into an insolvency or
bankruptcy proceeding. In addition, either party may terminate the agreement due to a material
breach by the other party if the breaching party is unable to cure the breach within 60 days after
receiving written notice of the breach from the non-breaching party. Any termination of the
agreement will result in a loss of our rights to the licensed technology, which will revert back to
Yissum and Boyce Thompson.
Exhibit B
In March 2006, Protalix Ltd. entered into a research and license agreement with the Yeda
Research and Development Company Limited, or Yeda, the technology transfer arm of the Weizmann
Institute of Science. Under the terms of the agreement, Yeda agreed to use its technology to
design a next generation of glucoceribrosidase (GCD) for the treatment of Gaucher disease that can
be expressed using our ProCellEx protein expression system and that may have certain benefits over
the first generation treatments used today. The technology licensed from Yeda provides a
methodology for the rational design of an improved drug for the treatment of Gaucher disease by
enzyme replacement therapy, based on the three-dimensional crystal structure of glucoceribrosidase
(GCD) that was solved by scientists from the Weizmann Institute of Science. Yeda has granted us an
exclusive worldwide license to use their technology and discoveries for the development, production
and sale of enzymatically active mutations of glucoceribrosidase (GCD) and derivatives thereof for
the treatment of Gaucher disease. Under the terms of the agreement, we are required to take all
necessary steps to develop and commercialize the products subject to the agreement.
As consideration for the license, we agreed to pay Yeda a fixed research budget amount,
subject to certain conditions. We have since completed the research phase of the arrangement with
Yeda. Accordingly, we are no longer making any research-related payments to Yeda under the
agreement. In addition, we are obligated to make a non-refundable license fee of during the term
of the agreement, commencing on the fifth anniversary of the execution of the agreement until, and
including, the 19th anniversary thereof. We are also obligated to make royalty payments
equal to varying low, single-digit percentages of net sales of products under the agreement.
Sublicenses relating to the licensed technology may be granted under the agreement, subject to the
payment of sublicensing fees. The fee for any sublicense is equal to a percentage, ranging from
the low-teens through the low-twenties, of the consideration we receive in connection with the
sublicense, depending on the level of clinical and regulatory development of the products under the
agreement at the time we enter into the sublicense.
The license agreement remains in effect until the earlier of the expiration of the last patent
licensed under the agreement or if there are no commercial sales of any products for a continuous
period of 20 years. Yeda may modify the exclusivity component of the agreement by written notice
to us and without our consent. Yeda may terminate the agreement by written notice to us if we fail
to satisfy any one or more specified milestones, and we fail to cure any such failure within a
certain time period after we receive the notice. Yeda is not entitled to exercise this termination
right if we demonstrate that we are making all necessary efforts to achieve such milestones, that
our inability to satisfy the milestones is due to factors beyond our control, and that the total
delay with respect to any one milestone does not exceed 12 months and the total cumulative delay in
respect of all milestones has not exceeded 30 months. Yeda may also terminate the agreement if we
contest the validity of any of the patents included in the agreement. We or Yeda may terminate the
agreement due to a material breach by the other party if the breach is unable to be cured or, if
curable, the breach is not cured within 21 days after the breaching partys receipt of written
notice of the breach from the non-breaching party. In addition, either party may terminate the
agreement in connection with certain events relating to a wind up or bankruptcy.
2
Exhibit C
Intellectual Property
We maintain a proactive intellectual property strategy which includes patent filings in multiple
jurisdictions, including the United States and other commercially significant markets. At the end
of the first quarter of 2010, we held 17 granted patents and 80 pending patent applications with
respect to various compositions, methods of production and methods of use relating to our ProCellEx
protein expression system and our proprietary product pipeline. At the end of the first quarter of
2010 we also held one joint patent with a third party and held licensed rights to five patents and
eight patent applications.
Our competitive position and future success depend in part on our ability, and that of our
licensees, to obtain and leverage the intellectual property covering our product candidates,
know-how, methods, processes and other technologies, to protect our trade secrets, to prevent
others from using our intellectual property and to operate without infringing the intellectual
property of third parties. We seek to protect our competitive position by filing United States,
European Union, Israeli and other foreign patent applications covering our technology, including
both new technology and improvements to existing technology. Our patent strategy includes
obtaining patents, where possible, on methods of production, compositions of matter and methods of
use. We also rely on know-how, continuing technological innovation, licensing and partnership
opportunities to develop and maintain our competitive position.
Our patent portfolio consists of several patent families (consisting of patents and/or patent
applications) covering our technology, protein expression methodologies and system and product
candidates, as follows:
With respect to our ProCellEx protein expression system, we have been issued, and hold
licensed rights to, patents in the United States, the European Union, Israel, Canada, the Czech
Republic, Hungary, Japan, Poland, Mexico, Hong Kong and India, and to 11 pending patent
applications. Among other things, the patents cover the methods that we use for culturing and
harvesting plant cells and/or tissues in consecutive cycles. The issued patents in this patent
family are expected to expire in 2016.
With respect to our ProCellEx protein expression system, we also hold 14 patent
applications relating to the large scale production of proteins in cultured plant cells. The
patents to issue in the future based on the pending patent applications in this patent family are
expected to expire in 2028.
We hold a patent family containing four granted patents in India, South Africa, Russia
and the Ukraine, and 32 patent applications, relating to the production of glycosylated lysosomal
proteins in our plant culture platform, particularly proteins having a terminal mannose
glycosylation, including taliglucerase alfa. The issued patents and any patents to issue in the
future based on pending patent applications in this patent family are expected to expire in 2024.
We hold a patent family containing four pending patent applications relating to a
system and method for production of antibodies in a plant cell culture, and antibodies produced in
such a system. The patents to issue in the future based on the patent applications in this patent
family are expected to expire in 2025.
We hold a patent family containing one issued patent in South Africa and 11 pending
patent applications relating to a new method for delivering active recombinant proteins
systemically through oral administration of transgenic plant cells. The issued patents and any
patents to issue in the future based on patent applications in this patent family are expected to
expire in 2026.
We hold a patent family containing seven pending patent applications relating to
saccharide containing protein conjugates. The patents to issue in the future based on the patent
applications in this patent family will expire in 2028.
Our patent portfolio includes a patent that we co-own that covers human glycoprotein
hormone and chain splice variants, including isolated nucleic acids encoding these variants. More
specifically, this patent
covers a new splice variant of human FSH. This patent was issued in the United States and is
expected to expire in 2026.
With respect to taliglucerase alfa, we have licensed the rights to two patents from
Virginia Tech Intellectual Properties, Inc. that are expected to expire in 2016; We also hold the
licensed rights from Yeda to three pending patent applications with respect to the research and
development of the glucocerebrosidase (GCD) protein.
With respect to Acetylcholinesterase, we have licensed the rights to three patents
issued in the United States that are expected to expire in 2013, 2017 and 2021, and to five patent
applications from Yissum.
We monitor third parties for activities that may infringe our intellectual property, as well as the
progression of third party patent applications that may cover our product candidates or expression
methods and thus, potentially, interfere with the development of our business. We are aware, for
example, of U.S patents, and corresponding international counterparts of such patents, owned by
third parties that contain claims covering methods of producing GCD. We do not believe that, if
any claim of infringement were to be asserted against us based upon such patents, taliglucerase
alfa would be found to infringe any valid claim under such patents. However, there can be no
assurance that a court would find in our favor or that, if we choose or are required to seek a
license to any one or more of such patents, a license would be available to us on acceptable terms
or at all.
In April 2004, we entered into a Collaborative Research Agreement with Icon Genetics AG (which was
subsequently acquired by Bayer Corporation), or Icon, regarding an option to license Icons
amplification technology for utilization in the expression of our products under development in
order to improve our yield. In connection with such option, we entered into a license agreement
with Icon in April 2005, pursuant to which we received an exclusive worldwide license to develop,
test, use and commercialize Icons technology to express certain proteins in our ProCellEx protein
expression system. In addition, we are entitled to a non-exclusive worldwide license to make and
have made other proteins expressed by using Icons technology in our technology. In consideration
for the licenses, we are obligated to pay to Icon development milestone payments and royalties.
See Risk FactorsIf we fail to adequately protect or enforce our intellectual property rights or
secure rights to third party patents, the value of our intellectual property rights would diminish
and our business, competitive position and results of operations would suffer.
C-2
Exhibit D
In April 2005, Protalix Ltd. entered into a license agreement with Icon Genetics AG, or
Icon, pursuant to which we received an exclusive worldwide license to develop, test, use and
commercialize Icons technology to express certain proteins in our ProCellEx protein expression
system. Under the terms of the agreement, we are also entitled to a non-exclusive worldwide
license to make and have made other proteins expressed by using Icons technology in our
technology. As consideration for the license, we are obligated to make royalty payments equal to
varying low, single-digit percentages of net sales of products by us, our affiliates, or any
sublicensees under the agreement. In addition, we are also obligated to make milestone payments
equal to $350,000, in aggregate, upon the achievement of certain milestones.
The license agreement remains in effect until the earlier of the expiration of the last patent
under the agreement or, if all of the patents under the agreement expire, 20 years after the first
commercial sale of any product under the agreement. Icon may terminate the agreement upon written
notice to us that we are in material breach of our obligations under the agreement and we are
unable to remedy such within 30 days after we receive such notice. Further, Icon may terminate the
agreement in connection with certain events relating to a wind up or bankruptcy, if we make a
general assignment for the benefit of our creditors, or if we cease to conduct operations for a
certain period. Icon may also terminate the exclusivity granted to us by written notice if we fail
to reach certain milestones within a designated period of time.
Exhibit E
The companies reviewed by the Compensation Committee in making its compensation decisions in
February 2010 were as follows:
|
|
|
Keryx Biopharmaceuticals, Inc. |
|
|
|
|
Savient Pharmaceuticals, Inc. |
|
|
|
|
Biomarin Pharmaceutical Inc. |
|
|
|
|
Amicus Therapeutics, Inc. |
|
|
|
|
Mannkind Corporation |
|
|
|
|
Nektar Therapeutics |
|
|
|
|
Theravance, Inc. |
The Compensation Committee intends to continue reviewing and revising the peer group periodically to ensure that it continues to reflect companies similar to us in size and development stage. The
Compensation Committee also reviews an executive compensation report and analysis of
publicly-traded biotechnology companies prepared by a third party for additional data and other
information regarding executive compensation for comparative purposes.
Exhibit F
Annual Bonus. The Compensation Committee has the authority to award discretionary annual
bonuses to our executive officers. For 2010, the Compensation Committee has established a formal
bonus plan for certain milestones, as described below. The discretionary annual bonus awards are
intended to compensate officers for achieving financial, clinical, regulatory and operational goals
and for achieving individual annual performance objectives. For any given year, the compensation
objectives vary, but relate generally to strategic factors such as developments in our clinical
path, the execution of a license agreement for the commercialization of product candidates, the
establishment of key strategic collaborations, the build-up of our pipeline and financial factors
such as raising capital. Bonuses are awarded generally based on corporate performance, with
adjustments made within a range for individual performance, at the discretion of our Compensation
Committee. Our Compensation Committee determines, on a discretionary basis, the size of the entire
bonus pool and the actual award to each named executive officer.
Our Compensation Committee will select, in its discretion, the executive officers of our
company or our subsidiary who are eligible to receive bonuses for any given year. Any bonus
granted by the Compensation Committee will generally be paid in the first quarter of the year,
unless such bonuses were specifically granted for a specific milestone achieved during the year
which was payable immediately after the achievement of the milestone. The Compensation Committee
has not fixed a minimum or maximum award for any officers annual discretionary bonus, unless
specified in an executives employment agreement.
Each of our executive officers is eligible for a discretionary annual bonus under his or her
employment agreement. The Compensation Committee determined the discretionary annual bonus to be
paid to our executive officers for performance in 2009 and in 2008, and the discretionary bonus to
be awarded to certain officers in 2010 for upon achievement of certain milestones. The
Compensation Committee has not fixed a minimum or a maximum amount for any officers annual
discretionary bonus.
On February 25, 2010, our Board of Directors, acting upon the resolution of a majority of our
independent directors, awarded a total of approximately $2.6 million in bonuses to our named
executive officers and other employees. Of the aggregate award, approximately $1.1 million was
paid to our named executive officers and other employees during the first quarter of 2010 for
general corporate performance relating to the completion of our phase III clinical trial of our
lead product candidate, taliglucerase alfa, and the upgrade of our manufacturing facility during
the years 2008 and 2009, and specifically in connection with the execution of the license and
supply agreement with Pfizer relating to taliglucerase alfa. In addition, the Compensation
Committee elected to make these awards to the executive officers as bonuses were generally not paid
in 2009 due to the general market conditions and our cash balance at that time. Of the
approximately $1.1 million made available for these bonuses, our Board of Directors awarded Dr.
Aviezer $500,000; Dr. Shaaltiel $160,000; Dr. Brill Almon $160,000; and Mr. Maimon $160,000.
The Board of Directors, acting upon the resolution of a majority of our independent directors,
reserved the remaining approximately $1.5 million for additional awards to our named executive
officers and other employees for 2010. The following table describes the general nature of the
goals for the award of the future awards to our named executive officers:
|
|
|
|
|
General Description |
|
Funding Amount |
|
First shipment of taliglucerase alfa |
|
$ |
140,000 |
|
Approval of taliglucerase alfa by the FDA |
|
$ |
820,000 |
|
Total |
|
$ |
960,000 |
|
The remaining approximately $500,000 was allocated to other employees, subject to the same
criteria. Upon the achievement of the foregoing milestones, if at all, the Compensation Committee
intends to consider the performance of the executive management team as a whole and the individual
performance of the named executive officers in the determination of the final awards.
The Board of Directors allocated the aggregate amount payable for the first milestone as
follows: Dr. Shaaltiel $100,000; Dr. Brill Almon $20,000; and Mr. Maimon $20,000. None of the
aggregate award payable upon the achievement of the first milestone was allocated to Dr. Aviezer.
The Board of Directors allocated the aggregate amount payable for the second milestone as follows:
Dr. Aviezer $400,000; Dr. Shaaltiel $140,000; Dr. Brill Almon $140,000; and Mr. Maimon $140,000.
Generally, if a company milestone is met, the applicable awards will be paid in full. However,
notwithstanding the allocations, upon the achievement of any company goal, our Board of Directors
or the Compensation Committee has the discretion to award the full allocated amounts to our named
executive officers or to award lesser amounts, if any. The Compensation Committee, or the Board of
Directors acting upon resolution of a majority of the independent directors, may elect to increase
the size of the awards at any time.
D-2