EXHIBIT 10.17
CONFIDENTIAL
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[* * *]: CONFIDENTIAL TREATMENT REQUESTED FOR PORTIONS OF THIS EXHIBIT
GRANT TERMS AND CONDITIONS AGREEMENT
This agreement documents the grant terms and conditions between BioMarin
Pharmaceuticals at 00 Xxxxxxxx Xxxxx, Xxxxxx, XX 00000 (hereinafter referred to
as "BioMarin") and Harbor-UCLA Research and Education Institute at 0000 Xxxx
Xxxxxx Xxxxxx, Xxxxxxxx, XX 00000-0000 (hereinafter referred to as "REI"), and
each referred to as the "Party" or collectively as the "Parties".
1. Principal Investigator:
The Principal Investigator on behalf of REI is Xxxx X. Xxxxxx, M.D., Ph.D.
(hereinafter referred to as "Dr. Kakkis" or "Principal Investigator").
2. Research Project:
The Research Project is titled, "Enzyme Replacement Therapy for MPS I with
Recombinant a-L-iduronidase". The research plan for this project is
attached as Appendix A, and includes work which is to be done beyond the
current term of the initial grant period. It is understood that changes to
the protocol may occur as dictated by the progress and needs of the
project.
3. Grant Period:
The Initial grant period is for a period of one year and shall be effective
as of the date the Initial payment #1 (see clause #5(a)) is received by
REI and the date this agreement is fully executed, whichever occurs later.
It is anticipated that this period will be extended with additional funds
based upon project progress and funding available to BioMarin.
4. Grant Amount:
(a) [***]
(b) Appendix B contains the budget for the initial period of the Research
Project. REI can rebudget funds between the major cost categories
(e.g., personnel, facilities, equipment, etc.) as necessary with the
consent of BioMarin, such consent not to be unreasonably withheld, to
achieve the goals of the Research Project. REI may make changes within
the major cost categories without seeking the consent of BioMarin.
(c) The first year's budget reflects the current anticipated costs for the
Initial grant period.
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Grant Terms and Conditions Agreement
Page 2
(d) The second year's budget represents an estimate of the operating
budget for the second year. REI shall submit to BioMarin at least 90
days prior to the end of the Initial grant period its request for the
second year's funding. BioMarin shall advise REI of its approval of
the second year's budget, including any additional funding to be
provided if applicable, at least 60 days prior to the end of the
initial grant period.
(e) It is understood that the budgets prepared by REI are based upon the
current best estimates of anticipated costs, and that additional funds
may be necessary for the project, including funds for costs in year 2
and those described under clause #5(c). If at any time REI and
BioMarin determine that the funding provided by BioMarin will not be
adequate to meet the project's needs, REI and BioMarin will decide on
a need for a funding change and BioMarin will endeavor to provide such
funding. If REI and BioMarin are unable to agree on an adequate amount
of funding, then REI shall have the right to terminate the Research
Project and this Agreement in accordance with clause #18(c).
5. PAYMENT TERMS:
(a) BioMarin shall, within ten (10) days of signing this Agreement or
within ten (10) days of the time BioMarin has been funded and has
approved the Research Project, whichever occurs later, make its
initial payment #1 to REI. BioMarin shall make quarterly payments
thereafter which are due two weeks in advance of the start of the next
quarter and in amounts as indicated below.
[***]
(b) If spending needs to be changed due to the progress of the Research
Project, REI and BioMarin shall negotiate in good faith the payment
amounts and due dates. It is understood that, in addition to any other
remedy provided to REI hereunder, REI shall not be obligated to
continue to work on the Research Project, and may terminate this
Agreement in accordance with clause #18, if funds are not received
when due or are otherwise determined by REI in its good faith
discretion to be inadequate to
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Grant Terms and Conditions Agreement
Page 3
fulfill the project needs (pay personnel, purchase supplies, etc.)
(See also clause #18(a).)
(c) The items listed below may be needed in order to complete the work,
but they have not been budgeted as these costs cannot be predicted at
this time. BioMarin and REI will determine if any of these or
additional items are necessary in order to complete the Research
Project, and BioMarin will provide these services directly to the
Research Project at its own expense.
- FDA or other special consultant fees
- Biologics or other safety testing by outside subcontractors
- Validation of purification system performed off-site at outside
subcontractor facility
- Computer consultants
- CGMP or other specialized training from staff
- Genotyping of patients by a subcontractor facility
- Costs relating to clinical trial complications and needed medical
specialists and treatment
(d) [***]
(e) In addition, REI will at its own expense deposit and maintain in a
secure, off site location adequate copies of protocols and operating
procedures, and backup cultures or cryopreserved specimens of any
living biological property such as cell lines, cultures, etc.
(f) Checks are to be made payable and sent to:
Harbor-UCLA Research and Education Institute
X.X. Xxx 00000 Xxxxxxxx Xxxxx
Xxx Xxxxxxx, Xxxxxxxxxx 00000
ATTN: Project No. 008831-00-00
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Grant Terms and Conditions Agreement
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6. Equipment Title:
REI shall retain title to all equipment purchased with grant funds under
this Agreement.
7. Financial Reports:
REI shall submit to BioMarin quarterly financial reports detailing research
project expenses by major cost category (e.g., personnel, facilities,
equipment, supplies, animal costs, other expenses, and travel) within 45
days after the end of each quarter. At BioMarin's request, a detailed audit
can be done by BioMarin or its authorized agent at its own expense with
reasonable advance notice during REI's normal business hours in order to
satisfy BioMarin that payments have been used in accordance with this
Agreement anti REI will cooperate with such audit. REI will maintain annual
financial records for the Research Project for a period of five (5) years.
8. Compliance Committee Approvals:
The Principal Investigator will obtain the necessary approvals from the
Institutional Animal Care and Use Committee for animal studies and
approvals from the Institutional Review Board for human studies and
approvals from the FDA to perform the manufacture of recombinant a-L-
iduronidase for clinical use.
9. Ownership of Data and Records
REI shall own all data and records which it generates relating to or
resulting from the Research Project. BioMarin shall have the right to
inspect such data and records with reasonable advance notice during REI's
normal business hours. It also is understood that applicable governmental
agencies shall have the right to inspect such data and records as required
by law.
10. Right to Publish
(a) The Principal Investigator has the right to publish all research
preclinical and clinical data, methods, negative results or adverse
effects resulting from the Research Project it is understood that
Intellectual property will be protected prior to submission of such
research results for publication. The Principal Investigator will
submit to BioMarin all manuscripts and abstracts containing data or
proprietary Information derived from this grant for review and
comment. BioMarin will have 30 days in which to conduct such review
and comment end shall have the right to require that all confidential
and/or proprietary information be removed. Failure by BioMarin to
respond within
Grant Terms and Conditions Agreement
Page 5
30 days will indicate their approval to publish in the form in which
it was submitted.
(b) BioMarin has the right to request that any publications and abstracts
resulting from this research acknowledge funding from BioMarin.
11. Use of Name:
BioMarin shall not use the names of REI, the County of Los Angeles, or the
University of California, Los Angeles, or their agents, officers, or
employees, for promotional or advertising purposes without the prior
written approval of REI. However, BioMarin has the right to use REI's name
with actual and potential investors for the purpose of raising capital for
this project.
12. Existing Intellectual Property:
The following list delineates the existing patentable or proprietary
Inventions, trade secrets, scientific knowledge, materials or processes
belonging to and/or known to REI which are covered by this Agreement and
are described more fully in Appendix C:
(a) Cell line 2.131.
(b) Microcarrier culture and harvest process/medium used.
(c) Purification system: heparin phenyl rapid two-step protocol.
(d) ELISA procedure to detect anti-iduronidase antibodies.
(e) Enzyme replacement as therapy for MPS I.
An exclusive worldwide license to this existing Intellectual property is
hereby granted to BioMarin subject to the terms in clause #5(d), 15, and
18(f).
13. New Inventions, Materials, or Processes Anticipated to be Produced and
Which are Covered Under This Agreement:
(a) Methods developed to produce enzyme in Chinese Hamster Ovary Cells.
(b) Methods developed to purify protein or ensure it is safe.
(c) New cell lines produced to make enzyme.
(d) Reagents created to assess enzyme purity or quality.
(e) Use of the enzyme in diagnostic applications.
An exclusive worldwide licensing agreement to the new inventions, materials
or processes produced and covered under this Agreement will be negotiated
subject to the terms in clause #15.
Grant Terms and Conditions Agreement
Page 6
14. Inventions or Research Discoveries Excluded From This Agreement:
Inventions or research discoveries excluded from this agreement include,
but are not limited to, all research developments or techniques initially
developed during studies of the canine MPS I model during this grant period
since these experiments will be 100% funded by other sources. The excluded
items include, but are not limited to, the following:
(a) A non-invasive method for monitoring enzyme that is currently
under development in the canine model.
(b) Localized application methods of enzyme therapy to be developed in the
dog such as intrathecal, ophthalmic or intrajoint administration.
(c) Optimized administration methods or dosing regimens developed first in
dog studies.
(d) Methods to induce immune tolerance using the enzyme.
(e) Computer software developed to monitor and control the manufacturing
process produced without funding from BioMarin.
15. Inventions and Patent Rights:
.
(a) For purposes of this Agreement, the term "Invention" shall mean any
inventions or discoveries made during the term of this Agreement and
also the existing intellectual property as listed In clause #12,
whether or not patentable, and any know-how or patent rights relating
thereto, which arise out of or relate to the Research Project, with
the exclusions noted in Clause #14 above.
(b) In the event that the inventorship of an Invention under applicable
patent law is attributed solely to personnel performing work on
research on behalf of REI, then such Invention shall be assigned to
and shall be the sole property of REI. The Principal Investigator
agrees to notify BioMarin and REI promptly of the existence of such
invention.
(c) In the event that the inventorship of an Invention under applicable
patent law is attributed solely to personnel performing work on the
research on behalf of BioMarin, then such Invention shall be assigned
to and shall be the sole property of BioMarin. BioMarin agree to
notify REI and Principal Investigator promptly of the existence of
such invention.
(d) In the event that the Inventorship of an Invention under applicable
patent law is attributed jointly to personnel performing work on the
research on behalf of REI and to personnel performing work on the
research on behalf of BioMarin.
Grant Terms and Conditions Agreement
Page 7
then such Invention shall be assigned by each such person referenced
in this paragraph Jointly and shall be the joint property of BioMarin
and REI.
(e) REI and BioMarin shall in a timely manner jointly review all
Inventions and shall mutually decide whether to prepare and file
patent applications at BioMarin's expense, REI's expense or Jointly.
(f) REI agrees that with respect to any Invention which is assigned solely
to REI hereunder or which is assigned Jointly to BioMarin and REI
hereunder, BioMarin shall have an exclusive worldwide license, with a
right to sublicense, all rights owned by REI in such Invention to
make, have made, use and sell such Invention and products embodying
such Invention, but subject to the provisions of clause 15(g) hereof.
(g) (i) BioMarin shall pay to REI a royalty of [***] of net sales and
net leasing income, of products, processes and/or apparatus, or
otherwise arising out of or resulting from the Inventions as
defined in clause #12, 13, and 15(a) hereof. Such royalty shall
be paid until the expiration of the last of any patents arising
out of or resulting from the inventions, and if no such patents
exist for a period of ten (10) years from the effective date of
this Agreement.
(ii) Net sales for the purpose of computing royalties means
BioMarin's invoice price, f.o.b, factory, after deduction of
regular trade and quantity discounts, but before deduction of
other Items, including but not limited to freight allowances,
cash discounts and agents commissions. For purposes of this
agreement, "regular trade discounts" shall include pricing
discounts to foreign distributors given in the ordinary course
of business.
(iii) [***]
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Page 8
(iv) BioMarin shall maintain accurate books of account and other
records respecting the sale of such products and payment of
royalties and shall make such books of accounts and other
records available to REI for inspection and copying on
reasonable advance notice at all reasonable times. BioMarin
shall provide in connection with each royalty payment a schedule
setting forth the basis for such payment in a form satisfactory
to REI.
(v) In order to maintain the license, BioMarin agrees to pursue the
development of enzyme therapy with due diligence acceptable to
REI.
(h) REI represents that it is authorized to grant license. REI represents
that all personnel performing work on the Research Project on behalf of
REI have a legal obligation to assign to REI all inventions and
discoveries made by such personnel during the course of their work
performed pursuant to this Agreement.
(i) BioMarin represents that all personnel performing work on the Research
Project on behalf of BioMarin have a legal obligation to assign to
BioMarin all inventions and discoveries made by such personnel during the
course of their work performed pursuant to this agreement.
(j) REI represents that, to the best of its knowledge and belief, the
intellectual property listed in clause #12, and described more fully in
Appendix C, constitutes the trade secrets of, and is proprietary to, REI.
It is understood and agreed that certain background proprietary rights
may be held by third parties, those known to REI being described in
Appendix C. It is further understood and agreed that REI does not
Indemnify nor hold harmless BioMarin from and against any claims,
liabilities, costs, attorneys fees, and expenses arising out of a claim
that the manufacture, use, or sale of the intellectual property listed in
clause #12, as described more fully in Appendix C, infringes any third
party patent or other intellectual property right.
(k) BioMarin shall have the right but not the obligation to prosecute at its
own expense any third party infringement of intellectual property owned
by BioMarin or jointly held by REI and BioMarin which relates to this
Research Project. REI shall have the right but not the obligation to
prosecute at its own expense any third party infringement of intellectual
property owned exclusively by REI or jointly by BioMarin and REI which
relates to this Research Project.
Grant Terms and Conditions Agreement
Page 9
16. Other Scientific Pursuits and Obligations of Principal Investigator
(a) Dr. Kakkis is a co-Investigator on an NIH grant in which Xx.
Xxxxxxxxx Xxxxxxx is Principal Investigator. The project is a high
dose dog trial and intrathecal enzyme trial. Dr. Kakkis shall have the
right to work on this project.
(b) Dr. Kakkis is the Principal Investigator of a subcontract to purify
iduronidase under a pending NIH SBIR grant to Croptech Development
Corporation. This will be performed using space, equipment, and
personnel not covered by this Agreement. Dr. Kakkis has the right to
work on this project. If the methods used under the NIH SBIR grant are
covered by this Agreement and are needed for commercial use by
Croptech, Croptech will negotiate for this with REI and BioMarin.
(c) Dr. Kakkis has the right to pursue other gene therapy research in MPS
I. It is understood that the other work may generate an alternative
therapy which may at some time impact the revenue BioMarin might
receive from enzyme replacement therapy.
(d) Dr. Kakkis also has the right to participate in and submit other grant
and/or contract proposals to any potential funding agency, with the
understanding that he will still have adequate time to complete the
work on this project in a timely fashion.
(e) Dr. Kakkis has a right to develop funding methods to lessen the impact
of enzyme costs on affected families without restraint by BioMarin.
Such alternative sources of funding would enhance the positive impact
of this therapy, provide a paradigm for payment in other rare
disorders, and improve the financial position of BioMarin by lessening
economic resistance to therapy.
17. Progress Reports
(a) Principal Investigator will provide verbal progress reports as
requested by BioMarin.
(b) Principal Investigator will provide quarterly written progress reports
to BioMarin within 45 days after the end of each quarter.
Grants Terms and Conditions Agreement
Page 10
18. Termination
(a) REI may immediately stop work on this project if BioMarin fails for
any reason to fully fund the Research Project as provided for herein.
REI shall provide BioMarin prompt written notice of its election to
stop work under this Agreement, and BioMarin shall not thereafter be
responsible for further funding of the Research Project; provided,
however, that BioMarin shall remain obligated to pay, for a period of
ninety (90) days after work stoppage, the salaries and fringe benefits
of all project personnel who were assigned to work on the Research
Project on the date that the work stopped, at the rates and benefits
in effect as of the date of work stoppage, and including REI's
Indirect costs.
(b) In the event of a breach of this Agreement by any party hereto, then
any party not in breach may terminate this Agreement effective ninety
(90) days after providing written notice of termination. The failure
of BioMarin to timely make any scheduled payment as set forth in
clauses #5(a) and 5(d) shall be deemed a material breach of this
Agreement.
(c) The failure or inability of BioMarin and REI to agree in accordance
with clauses #4(d) and 4(e), within thirty (30) days after written
request therefor, on the amount or payment date of any additional
funding that REI deems in its good faith judgment is necessary to
conduct the Research Project, shall be cause for termination of this
Agreement (but shall not be breach of this Agreement). In such
event, any party hereto may terminate this Agreement effective ninety
(9O) clays after providing written notice of termination.
(d) Notwithstanding anything to the contrary in this Agreement, BioMarin
shall be obligated to REI to pay all costs and reasonable
noncancellable obligations (including those indicated under clause
#18(a))incurred by REI on or before the effective date of termination.
Such payment shall be made within 30 days after receipt of an invoice
therefor from REI.
(e) Expiration or termination of this Agreement shall not relieve the
parties of any obligation accruing prior to such expiration or
termination. The provisions of this clause #18, as well as any rights
of the parties hereto arising out of a breach by the other party of
any obligations hereunder, shall survive termination of this
Agreement.
(f) (I) In the event of termination of this Agreement for lack of full
funding of
Grant Terms and Conditions Agreement
Page 11
the Research Project during the Initial grant period (see clause #3,
5(a), 5(b), 5(c), 18(a), 18(b), 18(c), and 18(d)), or for any breach
by BioMarin during the initial grant period (see clause #3 and
18(b)), or at any time for lack of payment of licensing fees when
due, or if at any time BioMarin is in breach of clause #18(d), any
and all rights and licensee granted hereunder to BioMarin with
respect to REI's patents or intellectual property shall terminate
immediately.
(11) Upon termination of this Agreement subsequent to the Initial grant
period (see clause #3 and 18), the license granted herein, and any
sublicenses issued thereunder, may survive the said termination
provided that BioMarin is in full compliance with payment of
licensing fees when due and clause #18(d) and the terms and
conditions of said license including but not limited to clause #1
5(f) and 15(g), and provided further, that there is full compliance
with the terms and conditions of any sublicense issued by BioMarin.
In addition the licensing rights will only survive if the grant is
terminated in a coordinated, planned manner satisfactorily to REI,
including a minimum ninety-day notification of termination of
funding. If the licensing rights survive termination of the
agreement, Dr. Kakkis shall retain the right to produce the
iduronidase enzyme at REI with all the materials and processes
included in the license, such production to be for research purposes
only.
19. Notices
Notices regarding this agreement shall be sent to:
If to BioMarin:
BioMarin Pharmaceuticals
00 Xxxxxxxx Xxxxx
Xxxxxx, Xxxxxxxxxx 00000
Facsimile 000-000-0000
ATTN: Chief Executive Officer
If to REI:
Xxxx Xxxxxx, M.D., Ph.D.
Harbor-UCLA Research end Education Institute
0000 Xxxx Xxxxxx Xxxxxx, Xxxxxxxx X0
Xxxxxxxx, Xxxxxxxxxx 00000-0000
Facsimile 310-328-9921
Grant Terms and Conditions Agreement
Page 12
and
Xxxxxxxx Xxxxxxx
Grants and Contracts Officer
Harbor-UCLA Research and Education Institute
0000 Xxxx Xxxxxx Xxxxxx, Xxxxxxxx X00
Xxxxxxxx, Xxxxxxxxxx 00000-0000
Facsimile 000-000-0000
20. Confidentiality Maintained
(a) Proprietary Information
Each Party agrees that the other Party has a proprietary interest in
any information provided by it, whether in connection with this
Agreement or otherwise, and whether in written or oral form, which is
(i) a trade secret, confidential, or proprietary information, (ii) not
publicly known, and (iii) annotated by legend, stamp, or other
written identification as confidential or proprietary information
(hereinafter referred to as "Proprietary Information"). Each Party
shall disclose the Proprietary Information provided by the other
Party only to those of its agents and employees to whom it is
necessary in order to carry out its obligations in accordance with the
terms and conditions hereof. Both during and after the term of this
Agreement, all disclosures by the Party receiving Proprietary
Information to its agents and employees shall be held in strict
confidence by such agents and employees. During and after the term of
this Agreement, such receiving Party, its agents, and employees shall
not use the Proprietary Information for any purpose other than in
connection with discharging its duties in the Territory pursuant to
this Agreement. The receiving Party shall, at its expense, return to
the disclosing Party the Proprietary Information provided by the
disclosing Party as soon as practicable after the term or expiration
of this Agreement. During the term of this Agreement and thereafter,
all such Proprietary Information shall remain the exclusive property
of the Party which provided it. This clause #20 shall, also apply to
any consultants or subcontractors that the receiving Party may engage
in connection with its obligations under this Agreement. The
confidentiality obligations set forth in this clause #20 shall survive
for a period of five (5) years alter termination or expiration of this
Agreement.
(b) Exceptions
Notwithstanding anything contained in this Agreement to the contrary,
each of the Parties shall not be liable for a disclosure of the
Proprietary Information of the other Party if the information so
disclosed: (i) was in the public domain
Grant Terms and Conditions Agreement
Page 13
at the time of disclosure without breach of this Agreement; (ii)
was known to or contained in the records of receiving Party at
the time of disclosure by the providing Party, as evidenced by
written records; (iii) was independently developed and is so
demonstrated promptly upon receipt of the documentation and
technology by receiving Party; (iv) becomes known to the
receiving Party from a source other than the providing Party
without breach of this Agreement by receiving Party, and can be
so demonstrated; (v) must be disclosed pursuant to a contract or
subcontract with a governmental agency in order to obtain/retain,
procurement contract; or (vi) was disclosed pursuant to court
order or as otherwise compelled by law, provided that the Party
compelled to make such disclosure provides the other Party notice
thereof sufficiently in advance of such disclosure so as to
provide the other Party a reasonable time within which to seek a
protective or similar order.
21. Assignment:
This agreement and all of the provisions hereof shall be binding upon
and inure to the benefit of the parties hereto and their respective
affiliates, successors, transferees and assignees; provided, however,
that neither party hereto may assign or transfer this agreement or any
interest herein, either directly or indirectly, in whole or in part,
without the prior written consent of the other party, which consent
shall not be unreasonably withheld. A change in control of the company
shall be considered an assignment.
ACCEPTANCE
BioMarin Pharmaceuticals Harbor-UCLA Research and Education
Institute
/s/ Xxxx X Xxxxx 01 Apr 97 /s/ Xxxxx X. Xx Xxxxxx, 4/1/97
--------------------------------------- --------------------------------
Signature and Date Signature and Date
Xxxxx X. Xx Xxxxxx, CAE
Xxxx Xxxxx - President President
------------------------------------- ---------------------------------
Typed Name and Title Typed Name and Title
Principal Investigator:
/s/ [SIGNATURE]
---------------------------------
Signature and Date
[LOGO OF BIOMARIN APPEARS HERE]
Harbor-UCLA Research and Education Institute
0000 Xxxx Xxxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxxxx 00000-0000
Attn: Xxxxxx X. Xxxxxx
August 21, 1998
RE: REI-BIOMARIN GRANT TERMS AND CONDITIONS AGREEMENT
Dear Xx. Xxxxxx:
This Letter Agreement (the "Agreement") sets forth the understanding
between Harbor-UCLA Research and Education institute ("REI") and BioMarin
Pharmaceutical, Inc. ("BioMarin") in connection with BioMarin's sublicense of
certain of the rights (the "REI Technology") granted to BioMarin pursuant to
that certain Grant Terms and Conditions Agreement between REI and BioMarin
executed April 1, 1997 (the "Grant Agreement"). This Agreement represents the
agreement of the REI and BioMarin as follows:
1. This Agreement hereby revises the Grant Agreement to incorporate the
terms and conditions set forth in this Agreement. The relationship of the
parties shall continue to be governed by the terms and conditions of the Grant
Agreement, as amended and revised herein; and in the event that there is any
conflict between the terms and conditions of the Grant Agreement and this
Agreement, the terms and conditions of this Agreement shall control. As used in
this Agreement all capitalized terms shall have the meanings defined for such
terms in this Agreement or, if not defined in the Agreement, the meanings
defined in the Grant Agreement.
2. REI hereby consents and approves of BioMarin's entering into an
arrangement with a limited liability company to :be formed by BioMarin and
Genzyme Corporation for the purpose of commercializing among other things the
REI Technology ("BioMarin/Genzyme LLC") pursuant to which BioMarin will grant to
BioMarin/Genzyme LLC a sublicense under the REI Technology (the "Sublicense").
3. In connection with the Sublicense, BioMarin hereby agrees to pay to REI
a running royalty of [* * *] of net sales (as such term is defined in the Grant
Agreement) and net leasing income of products, processes and/or apparatus or
otherwise arising out of or resulting from the Inventions (as such term is
defined in paragraph 15(a) of the Grant Agreement) resulting from
BioMarin/Genzyme LLC's exercise of the Sublicense. The foregoing royalty shall
be paid until the expiration of the last of any patents arising out of or
resulting from the Inventions, and if no such patents exist until April 1, 2007.
Accordingly and notwithstanding the provisions of clause 15(g)(iii) of the Grant
Agreement, BioMarin shall not have any obligation to share the gross income
derived from the Sublicense and REI shall have no right to such gross income.
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4. This Agreement and the Grant Amendment (together with the Appendices
thereto) constitute the entire agreement between the parties in connection with
the subject matter thereof and supersede all prior and contemporaneous
agreements, understandings, negotiations and discussions, whether oral or
written, of the parties.
5. This Agreement shall become effective on the date when BioMarin/Genzyme
LLC has executed this agreement as indicated below and shall remain in effect
until expiration or termination of the Grant Agreement.
6. This Agreement shall bind and inure to the benefit of the parties
hereto and BioMarin/Genzyme LLC and their successors and assigns. This Agreement
shall be governed by the laws of the State of California, without reference to
conflict of laws principles. This Agreement may not be amended, nor any
obligation waived, except by a writing signed by both parties hereto.
If the foregoing is acceptable, please indicate acceptance by having this
Agreement executed by the appropriate officer of REI and returning an executed
copy to BioMarin to my attention
Very truly yours,
BioMarin Pharmaceutical Inc.
/s/ Xxxx X Xxxxx
Xxxx X. Xxxxx, M.D.
President
APPROVED AND ACCEPTED this 24 day of August, 1998.
Harbor-UCLA Research and Education Institute
Print Name: C. Xxxxxxx Xxxxxx, CAE
Title: Executive Vice President,
APPROVED AND ACCEPTED this ___ day of _______,1998
BioMarin/Genzyme LLC
Print Name: ___________________
Title: ___________________
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