The Harvard-BMS Cre-Lox License
Non-Commercial Research License Agreement
THIS AGREEMENT, effective on the 15th day of July, 1999 (the "Effective Date"), is entered into by and between DUPONT PHARMACEUTICALS COMPANY, a general partnership of the State of Delaware with its principal place of business at Chestnut Run Plaza, Walnut Run, 974 Centre Road, Wilmington, Delaware 19807 ("DPC")
and
President and Fellows of Harvard College, with offices located at Office for Technology and Trademark Licensing, Holyoke Center, Suite 727, 1350 Massachusetts Avenue, Cambridge, Massachusetts 02138 ("LICENSEE").
[NOTE: In 2001, Bristol-Myers Squibb Company (BMS) acquired DuPont Pharmaceuticals Company (DPC) and thus this agreement is now with Bristol-Myers Squibb.]
RECITALS
WHEREAS, DPC has certain rights in and to certain Cre-Lox Technology (as defined below) involving site-specific recombination of DNA in eukaryotic cells; and
WHEREAS, LICENSEE is desirous of obtaining a research license under the Licensed Patents (as defined below) to use the Cre-Lox Technology under the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the above premises and the mutual covenants contained herein, the parties agree as follows.
1. DEFINITIONS
The terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, shall have the meaning set forth below or, if not listed below, the meaning designated in places throughout this Agreement. LICENSEE and DPC are sometimes referred to herein individually as a party and collectively as the parties.
1.1 "Cre-Lox Material" means any material covered by Valid Claim within the Licensed Patents, including but not limited to (i) any eukaryotic organism or cell containing DNA capable of expressing a Cre recombinase protein and/or containing lox DNA or (ii) any DNA or RNA vector capable of expressing a Cre recombinase protein in a eukaryotic cell and/or transferring lox DNA into a eukaryotic cell; provided however, that Cre-Lox Material shall not include any higher plant or plant cell or any vector designed for expression or transfer of Cre or lox into any higher plant or plant cell.
1.2 "Cre-Lox Technology" means all inventions described, embodied by and claimed in the Licensed Patents. The terms "Cre", "cre" and "lox" (also referred to as "loxP") as used in this Agreement have the meaning as described and embodied by the Licensed Patents.
1.3 "Effective Date" means the date indicated above as the effective date of this Agreement.
1.4 "Licensed Patents" means the United States and foreign patents and patent applications listed on Attachment A hereto, any continuation-in-part, continuation or divisional applications thereof, any patent granted on any aforesaid patent application, and any extension, revival, re-examination, or reissue of any of such patent, and any continuations, continuations-in-part, divisionals, reissues or extensions of any of the foregoing.
1.5 "Research Field" means use by LICENSEE for its internal non-commercial biomedical research purposes, provided however, that such research purposes specifically excludes (i) use of cre DNA and/or lox DNA in higher plants or agricultural applications, (ii) use of cre DNA and/or lox DNA in the alteration of mouse embryonic stem cells or other pluripotential mouse cells for the purpose of preparing a library of such mouse embryonic stem cells or other pluripotential mouse cells containing cre and/or lox DNA, and (iii) use of any material containing cre DNA and/or lox DNA which is encompassed by the Licensed Patents for any commercial purpose or for the benefit of any for-profit institution. Specifically excluded from the Research Field is the development, manufacture, use, lease, sale (or other transfer for consideration) or importation of any product for sale (or lease or other transfer of a product for consideration) wherein the manufacture, use, sale or importation of such product would infringe a Valid Claim of the Licensed Patents, including but not limited to wherein the product is manufactured using a composition or method which would infringe a Valid Claim of the Licensed Patents. Also specifically excluded from the Research Field is the use of any Cre-Lox Material to generate scientific data or information that is conveyed to a Third Party for consideration.
1.6 "Third Party" means any entity other than LICENSEE or DPC.
1.7 "Valid Claim" means a claim of an issued and unexpired patent which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal.
2. GRANT OF RIGHTS TO LICENSEE
2.1 Grant of Research License to LICENSEE. Subject to the terms and conditions of this Agreement, DPC hereby grants to LICENSEE a non-transferable, non-exclusive, worldwide field of use license under the Licensed Patents, without the right to grant sublicenses, to use the Cre-Lox Technology solely for use in the Research Field. The use of the Cre-Lox Technology outside of the Research Field is outside the scope of this Agreement and shall only be permitted under the terms of a separate written agreement between LICENSEE and DPC (or E.I. DuPont de Nemours, and Company). The license granted hereunder includes the right to make, use, breed and cross-breed (where applicable) Cre-Lox Materials solely for internal research purposes in the Research Field. LICENSEE shall have the right to transfer Cre-Lox Materials to third party non-profit institutions subject to Section 2.2 below. LICENSEE shall have the right to transfer Cre-Lox Materials to third party for-profit institutions subject to Section 2.3 below. LICENSEE shall have the right to receive Cre-Lox Materials from a Third Party subject to the terms and conditions of this Agreement.
2.2 Transfer of Cre-Lox Materials to Non-profit Institutions. LICENSEE may transfer Cre-Lox Materials it makes or acquires during the term of this Agreement to non-profit institutions, provided that:
such non-profit institution has entered into a license agreement with DPC or E.I. DuPont de Nemours and Company granting rights under U.S. patent number 4,959,317, such licensed non-profit institution being identified in a list provided by DPC; or alternatively,
such transfer is subject to a written material transfer agreement between LICENSEE and the non-profit institution having the terms set forth in Attachment B hereto, and
no transfer of materials shall be made for consideration, other than reimbursement for the costs of producing and shipping the Materials to another non-profit institution.
2.3 Transfer of Cre-Lox Materials to For-profit Institutions. LICENSEE may transfer Cre-Lox Materials it makes or acquires during the term of this Agreement to Third Party for-profit institutions subject to the following: (a) the for-profit institution has entered into a written license agreement with DPC which expressly permits the for-profit institution to receive Cre-Lox Materials from third parties subject to the payment of a transfer fee to DPC and (b) prior to any such transfer to the for-profit institution, LICENSEE shall have received written confirmation from DPC that DPC has received payment of the applicable transfer fee for such Cre-Lox Material from the for-profit institution. LICENSEE shall not otherwise be permitted to transfer Cre-Lox Materials to any for-profit institutions. The transfer and use of the Cre-Lox Material by the recipient for-profit institution shall be subject to the terms and conditions of the license agreement between the recipient for-profit institution and DPC.
2.4 Non-assertion. During the term of this Agreement and so long as LICENSEE has not committed any material breach with respect to any obligation hereunder, neither DPC nor E.I. DuPont de Nemours and Company will assert any patent or patent application licensed hereunder against LICENSEE to prevent LICENSEE from practicing the rights granted to LICENSEE under Article 2 hereof.
2.5 No Other Licenses. No right or license is granted hereunder, except as expressly and specifically set forth herein.
3.GRANT BACK OF RIGHT TO DPC
3.1 DPC Access to Cre-Lox Material. Upon DPC's written request, LICENSEE agrees to provide to DPC without cost reasonable quantities of any Cre-Lox Material identified in a public disclosure that LICENSEE makes during the term of this Agreement, solely for DPC's internal research purposes.
4. REPRESENTATIONS AND WARRANTIES; LIABILITY
4.1 Representations and Warranties. DPC represents and warrants to LICENSEE that (a) it has all requisite power and authority to enter into this Agreement and to grant the licenses granted by it hereunder, (b) execution of this Agreement has been duly authorized, and (c) this Agreement is fully binding and enforceable in accordance with its terms. LICENSEE represents and warrants to DPC that (a) it has all requisite power and authority to enter into this Agreement and to perform its obligations under this Agreement, (b) execution of this Agreement has been duly authorized, (c) this Agreement is fully binding and enforceable in accordance with its terms, (d) that all of its activities related to its use of the Licensed Patents pursuant to this Agreement will comply with all applicable federal, state and local laws, statutes, rules and regulations and (e) that LICENSEE will not during the term of this Agreement enter into any agreements, contracts or other arrangements that would be inconsistent with its obligations under this Agreement. DPC recognizes that while LICENSEE will use its good faith effort to inform its faculty of the restrictions of this Agreement on an annual basis, LICENSEE cannot ensure that no violations by its employees will occur. LICENSEE agrees that the timely cure of any such violation is the responsibility of LICENSEE. Further, if LICENSEE becomes aware of violations, it will inform DPC and promptly seek to terminate those violations and will actively monitor the laboratory involved for the next year.
4.2 Liability. LICENSEE shall bear all risk and responsibility and liability for all of its activities in exercising its rights under this Agreement and shall hold DPC and its affiliates and parent companies harmless against any and all claims, demands, losses, costs, expenses (including attorney fees), damages and judgments whatsoever, arising out of or resulting from acts or omissions of LICENSEE in connection with the exercise of its rights under this Agreement. DPC shall not be liable to LICENSEE because of the infringement of any patent rights of any third party by LICENSEE in practicing the rights granted hereunder.
5. TERM AND TERMINATION
5.1 Term. This Agreement, unless terminated earlier, shall remain in full force and effect on a country-by-country basis until the expiration of the last to expire of any Valid Claim included in the Licensed Patents in such country.
5.2 Termination by DPC. DPC shall have the right to terminate this Agreement, at DPC's sole discretion, upon 60 days written notice to LICENSEE in the event that any material provision or stipulation of this Agreement shall have been breached by LICENSEE and in the event that LICENSEE shall have failed to remedy such breach within such 60 day period. Any notice served by DPC pursuant to this Section 5.2 shall specify the nature of the breach and the required remedy by LICENSEE.
5.3 Termination by LICENSEE. Subject to Section 5.4, LICENSEE shall have the right to terminate the license granted hereunder upon written notice to DPC.
5.4 Effect of Termination.
5.4.1 Upon termination or expiration of this Agreement for any reason all rights and licenses granted to LICENSEE hereunder shall terminate.
5.4.2 Survival. The termination of this Agreement shall not affect any rights or obligations of either party that have accrued or matured prior to termination and which are intended by the parties to survive termination.
6. OTHER PROVISIONS
6.1 Assignment. This Agreement may not be assigned or otherwise transferred by LICENSEE without the prior written consent of DPC. DPC may, without LICENSEE's consent, assign all or any portion of its rights and obligations hereunder in connection with the transfer of the Licensed Patents to a third party assignee or successor in interest, provided that such assignee or successor in interest agrees to be bound by the, terms of this Agreement.
6.2 Applicable Law; Jurisdiction. This Agreement is acknowledged to have been made in and shall be construed in accordance with the laws of the State of Delaware, without regard to conflict of laws principles which would dictate the application of the law of a different jurisdiction, provided, that, all questions concerning the construction or effect of patent applications and patents shall be decided in accordance with the laws of the country in which the particular patent application or patent concerned has been filed or granted, as the case may be.
6.3 Notices. Any notice or other communication pursuant to this Agreement shall be sufficiently made or given on the date of mailing if sent to such party by facsimile on such date, with paper copy being sent by certified first class mail, postage prepaid, or by next day express delivery service, addressed to it at its address below (or such address as it shall designate by written notice given to the other party).
If to DPC: [contact information; now to BMS]
If to LICENSEE: [contact information]
6.4 Relationship of the Parties. It is expressly agreed that the relationship between LICENSEE and DPC shall not constitute a partnership, joint venture or agency. Neither LICENSEE nor DPC shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other, without the prior consent of the other party to do so.
6.5 Severability. In performing this Agreement, the parties shall comply with all applicable laws. Wherever there is any conflict between any provision of this Agreement and any law, the law shall prevail, but in such event the affected provision of this Agreement shall be limited or eliminated only to the extent necessary, and the remainder of this Agreement shall remain in full force and effect. In the event the terms of this Agreement are materially altered as a result of the foregoing, the parties shall re-negotiate in good faith the terms of this Agreement to resolve any inequities.
6.6 Counterparts. This Agreement may be executed in counterparts with the same effect as if both parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument.
6.7 Entire Agreement. This Agreement, including the Attachments hereto, constitutes the entire agreement between the parties with respect to the subject matter hereof, and supersedes any and all oral and/or written communications or understandings relating to the subject matter hereof.
IN WITNESS WHEREOF, the parties have caused their duly authorized officers to execute and deliver this License Agreement as of the Effective Date.
[Signature for DuPont Pharmaceuticals Company]
[Signature for Harvard University]
ATTACHMENT A
| Country | Application Serial No. | Patent No. | Issue Date | Expiry Date |
| USA | 4,959,317 | 9/25/1990 | 9/25/2007 | |
| Canada | 1,293,460 | 12/24/1991 | 12/24/2008 | |
| Ireland | 60421 | 7/8/1994 | 10/6/2006 | |
| Japan | 86/236385 | N/A | N/A | N/A |
| EPO | 0 220 009 | 2/10/1993 | 10/6/2006 | |
| Austria | E0085649 | 2/10/1993 | 10/6/2006 | |
| Belgium | 0 220 009 | 2/10/1993 | 10/6/2006 | |
| France | 0 220 009 | 2/10/1993 | 10/6/2006 | |
| Great Britain | 0 220 009 | 2/10/1993 | 10/6/2006 | |
| Germany | 3687734 | 2/10/1993 | 10/6/2006 | |
| Greece | 3007809 | 2/10/1993 | 10/6/2006 | |
| Italy | 0 220 009 | 2/10/1993 | 10/6/2006 | |
| Luxembourg | 0 220 009 | 2/10/1993 | 10/6/2006 | |
| Netherlands | 0 220 009 | 2/10/1993 | 10/6/2006 | |
| Sweden | 0 220 009 | 2/10/1993 | 10/6/2006 | |
| Switzerland | 0 220 009 | 2/10/1993 | 10/6/2006 |
ATTACHMENT B
(Attachment B contains the template of the Cre-Lox MTA. See the MTA for Cre-Lox Materials.)