MASSACHUSETTS INSTITUTE OF TECHNOLOGY
and
BIOMARIN PHARMACEUTICAL INC.
EXCLUSIVE PATENT LICENSE AGREEMENT
TABLE OF CONTENTS
TABLE OF CONTENTS.............................................................ii
R E C I T A L S................................................................1
1. Definitions................................................................2
2. Grant of Rights............................................................5
3. Company Diligence Obligations..............................................6
4. Royalties and Payment Terms................................................8
5. Reports and Records.......................................................10
6. Patent Prosecution........................................................12
7. Infringement..............................................................13
8. Indemnification and Insurance.............................................15
9. No Representations or Warranties..........................................16
10. Assignment................................................................17
11. General Compliance with Laws..............................................17
12. Termination...............................................................18
13. Dispute Resolution........................................................19
14. Miscellaneous.............................................................21
APPENDIX A....................................................................24
APPENDIX B....................................................................30
APPENDIX C....................................................................31
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Portions of this document have been redacted pursuant to a Request for
Confidential Treatment. Redacted portions are indicated with
the notation "*****"
MASSACHUSETTS INSTITUTE OF TECHNOLOGY
EXCLUSIVE PATENT LICENSE AGREEMENT
This Agreement, effective as of the date set forth above the signatures of
the parties below (the "EFFECTIVE DATE"), is between the Massachusetts Institute
of Technology ("M.I.T."), a Massachusetts corporation, with a principal office
at 77 Massachusetts Avenue, Cambridge, MA 02139-4307 and BioMarin Pharmaceutical
Inc. ("BIOMARIN"), a Delaware corporation, with a principal place of business at
371 Bel Marin Keys Blvd., Suite 210, Novato, CA 94949.
R E C I T A L S
WHEREAS, M.I.T. is the owner of certain PATENT RIGHTS (as later defined
herein) relating to heparinases and to the technology disclosed under M.I.T.
Case No. 4236, "Neutralization of the Anticoagulant Activities of the Low
Molecular Weight Heparin Fractions and Fragments With Flavobacterial
Heparinase," by Howard Bernstein, Charles L. Cooney, Robert S. Langer and Victor
C. Yang; M.I.T. Case No. 4330, "Procedure for Purification of High Purity
Heparinase," by Charles L. Cooney and Joseph J. Zimmermann; M.I.T. Case No.
4370, "Extracorporeal Systems for Heparin Neutralizaton Using Porous Fibers or
Tubes," by Ann R. Comfort, Robert A. Heft and Robert S. Langer; and M.I.T. Case
No. 5546, "The Heparinase Gene from Flavobacterium Heparinum," by Charles L.
Cooney, Robert S. Langer, Kelley W. Moreman and Ram Sasisekharan; and has the
right to grant licenses under said PATENT RIGHTS;
WHEREAS, M.I.T. and the President and Fellows of Harvard College are the
owners of certain PATENT RIGHTS (as later defined herein) relating to
heparinases and to the technology disclosed under M.I.T. Case No. 4176, "The
Heparinase Activated Clotting Time: A New Coagulation Test," by Judah Folkman,
Robert L. Hannon, Robert S. Langer and Robert W. Thompson, and HARVARD has
authorized M.I.T. to act as its agent for the purposes of licensing its rights
in this intellectual property in return for a share of royalties.
WHEREAS, M.I.T. and the University of Iowa ("U of I") are the joint owners
of certain PATENT RIGHTS (as later defined herein) relating to heparinases and
to the technology disclosed under M.I.T. Case No. 5981, "Purification,
Composition and Characterization of Heparinase II from Flavobacterium
Heparinum," by Charles L. Cooney, Robert S. Langer, Robert Lindhardt, Daniel
Lohse and Ram Sasisekharan; and U of I has authorized M.I.T. to act as its agent
for the purposes of licensing its right in this intellectual property in return
for a share in royalties.
WHEREAS, BIOMARIN acquired by assignment in November 2001, the rights
and responsibilities of two License Agreements to the PATENT RIGHTS by and
between M.I.T. and IBEX Technologies Inc. (the "IBEX License Agreements", and
attached herein in Appendix C) and, along with M.I.T., desires to restate and
modify the terms of the IBEX License Agreements in this new Agreement;
WHEREAS, M.I.T. desires to have the BIOMARIN continue to develop and
commercialize the PATENT RIGHTS to benefit the public and is willing to grant a
license to the BIOMARIN thereunder;
WHEREAS, to induce M.I.T. to enter into this Agreement, BIOMARIN has
represented to M.I.T. that it shall commit itself to a thorough, vigorous and
diligent program to commercialize the PATENT RIGHTS so that public utilization
shall result therefrom; and
WHEREAS, BIOMARIN desires to obtain a license under the PATENT RIGHTS upon
the terms and conditions hereinafter set forth.
NOW, THEREFORE, M.I.T. and BIOMARIN, in consideration of the premises, the
mutual promises and covenants contained herein, and other good and valuable
consideration, hereby agree as follows:
1. Definitions.
1.1 "AFFILIATE" shall mean any legal entity (such as a corporation,
partnership, or limited liability company) that is controlled by BIOMARIN. For
the purposes of this definition, the term "control" means (i) beneficial
ownership of at least fifty percent (50%) of the voting securities of a
corporation or other business organization with voting securities or (ii) a
fifty percent (50%) or greater interest in the net assets or profits of a
partnership or other business organization without voting securities.
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1.2 "DIAGNOSTIC FIELD" shall mean clinical diagnostics using the
HEPARINASES for in vitro testing of external tissue samples from patients.
1.3 "EXCLUSIVE PERIOD" shall mean the period of time set forth in Section
2.2.
1.4 "FIELDS" shall mean the DIAGNOSTIC FIELD, RESEARCH REAGENT FIELD, and
THERAPEUTIC FIELD, but shall specifically exclude any use of the HEPARINASES in
sequencing machines.
1.5 "HEPARINASES" shall mean the heparinase I, II, and III enzymes
covered under the PATENT RIGHTS.
1.6 "LICENSED PRODUCT" shall mean any product or part thereof that:
(i) absent the license granted hereunder, would infringe one or more
claims of the PATENT RIGHTS; or
(ii) is manufactured by using a LICENSED PROCESS or that, when
used, practices a LICENSED PROCESS.
1.7 "LICENSED PROCESS" shall mean any process that, absent the license
granted hereunder, would infringe one or more claims of the PATENT RIGHTS or
which uses a LICENSED PRODUCT.
1.8 "NET SALES" shall mean the gross amount billed by BIOMARIN and its
AFFILIATES and SUBLICENSEES for LICENSED PRODUCTS and LICENSED PROCESSES, less
the following:
(i) customary trade, quantity, or cash discounts to the extent
actually allowed and taken;
(ii) amounts repaid or credited by reason of rejection or return;
(iii) to the extent separately stated on purchase orders, invoices,
or other documents of sale, any taxes or other governmental charges levied on
the production, sale, transportation, delivery, or use of a LICENSED PRODUCT or
LICENSED PROCESS which is paid by or on behalf of BIOMARIN; and
(iv) outbound transportation costs prepaid or allowed and costs of
insurance in transit.
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No deductions shall be made for commissions paid to individuals whether
they are with independent sales agencies or regularly employed by BIOMARIN and
on its payroll, or for cost of collections. NET SALES shall occur on the date of
billing for a LICENSED PRODUCT or LICENSED PROCESS. If a LICENSED PRODUCT or a
LICENSED PROCESS is distributed at a discounted price that is substantially
lower than the customary price charged by BIOMARIN, or distributed for non-cash
consideration (whether or not at a discount), NET SALES shall be calculated
based on the non-discounted amount of the LICENSED PRODUCT or LICENSED PROCESS
charged to an independent third party during the same REPORTING PERIOD or, in
the absence of such sales, on the fair market value of the LICENSED PRODUCT or
LICENSED PROCESS
Non-monetary consideration shall not be accepted by BIOMARIN, any
AFFILIATE, or any SUBLICENSEE for any LICENSED PRODUCTS or LICENSED PROCESSES
without the prior written consent of M.I.T.
1.10 "PATENT RIGHTS" shall mean:
(a) the United States and i nternational patents listed on
Appendix A;
(b) the United States and international patent applications
and/or provisional applications listed on Appendix A and the resulting patents;
(c) any patent applications resulting from the provisional
applications listed on Appendix A, and any divisionals, continuations,
continuation-in-part applications, and continued prosecution applications (and
their relevant international equivalents) of the patent applications listed on
Appendix A and of such patent applications that result from the provisional
applications listed on Appendix A, to the extent the claims are directed to
subject matter specifically described in the patent applications listed on
Appendix A, and the resulting patents;
(d) any patents resulting from reissues, reexaminations, or
extensions (and their relevant international equivalents) of the patents
described in (a), (b), and (c) above; and
(e) international (non-United States) patent applications and
provisional applications filed after the EFFECTIVE DATE and the relevant
international equivalents to divisionals, continuations, continuation-in-part
applications and continued prosecution applications of the patent applications
to the extent the claims are directed to subject matter specifically described
in the patents or patent applications referred to in (a), (b), (c), and (d)
above, and the resulting patents.
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1.11 "REPORTING PERIOD" shall begin on the first day of each calendar
quarter and end on the last day of such calendar quarter.
1.12 "RESEARCH REAGENT FIELD" shall mean research reagent uses of the
HEPARINASES designated for "research purposes only, not to be used in humans."
1.13 "SUBLICENSEE" shall mean any non-AFFILIATE sublicensee of the rights
granted BIOMARIN under Section 2.1.
1.14 "TERM" shall mean the term of this Agreement, which shall commence on
the EFFECTIVE DATE and shall remain in effect until the expiration or
abandonment of all issued patents and filed patent applications within the
PATENT RIGHTS, unless earlier terminated in accordance with the provisions of
this Agreement.
1.15 "TERRITORY" shall mean worldwide.
1.16 "THERAPEUTIC FIELD" shall mean human use of the HEPARINASES as
therapeutics in pharmaceutical compositions for reversal of anticoagulants,
inflammation, reperfusion injury, restenosis and wound healing.
2. Grant of Rights.
2.1 License Grants. Subject to the terms of this Agreement, M.I.T. hereby
grants to BIOMARIN and its AFFILIATES for the TERM a royalty-bearing license
under the PATENT RIGHTS to develop, make, have made, use, sell, offer to sell,