Clinical Trial Research Agreement

Exhibit 10.7


[ **** ] indicates confidential portions have been redacted and submitted separately pursuant to confidentiality request with the Commission


CLINICAL TRIAL RESEARCH AGREEMENT


This Agreement is entered into as of the last date on the signature page hereof (" Effective Date" ), by and between DUKE UNIVERSITY , a nonprofit educational and health care institution located at Office of Grants and Contracts, DUMC Box 3001, 107 Seeley G. Mudd Building, Durham, NC 27710, hereinafter called " Institution," and MEDAREX, INC. , a New Jersey corporation with its principal place of business located at 707 State Road, Suite 206, Princeton, New Jersey 08540-1437, hereinafter called " Medarex" .


RECITALS


WHEREAS, Medarex desires Institution to study the safety and/or efficacy of [ **** ] (the " Study Drug" ); and


WHEREAS, Institution is willing to perform certain clinical trial research with the Study Drug pursuant to the terms of this Agreement (the " Study" );


WHEREAS, the Study contemplated by this Agreement is of mutual interest and benefit to Institution and Medarex, and will further the instructional and research objectives of Institution in a manner consistent with its status as a nonprofit educational and health care institution,


NOW THEREFORE, based upon the promises and mutual covenants set forth herein, the parties hereto agree as follows:


AGREEMENT


1. SCOPE OF WORK Institution and Principal Investigator (defined in Article 2 below) agree to perform the Study under this Agreement strictly in accordance with the terms of the final protocol, including as it may be amended in accordance with the terms of this Agreement, for the Study entitled " A Phase I Open-Label, Dose-Escalation, Multi-Dose Study of [ **** ]" which is attached as Exhibit A (the " Protocol" ) and which is incorporated into this Agreement by reference. Institution represents and warrants that, to its best knowledge, its facilities and population are adequate to perform the Study contemplated by this Agreement and the Protocol. Institution and Principal Investigator agree that all aspects of the Study shall be conducted in conformity with all applicable supranational, national, state and other local laws and regulations, including any applicable requirements of the Health Insurance Portability and Accountability Act of 1996 and the United States Food and Drug Administration (" FDA" ) (collectively, " Applicable Law" ).


2. PRINCIPAL INVESTIGATOR


A. Appointment and Substitution of Principal Investigator. (i) Institution' s principal investigator is Michael Morse, M.D., (who with any sub-investigators shall be collectively referred to as " Principal Investigator" ). Principal Investigator shall direct and supervise the performance of the Study in accordance with applicable Institution policies, the Protocol and this Agreement. (ii) In the event that the Principal Investigator who signs either the Protocol and/or this Agreement leaves or is removed from the Institution or otherwise becomes unavailable to direct and supervise the performance of the Study, then Institution shall, within ten (10) days of such event, provide written notice thereof to Medarex and propose a replacement for the Principal Investigator with appropriate qualifications. Any successor to Principal Investigator must be approved, in writing, by Medarex and such successor shall be required to agree to all the terms and conditions of the Protocol and this Agreement and to sign each such document as evidence of such agreement (although failure to so sign shall not relieve such successor from abiding with all the terms and conditions of the Protocol and this Agreement). If Institution does not identify a qualified successor to Principal Investigator as provided above, or if the Medarex does not approve the successor proposed by the Institution, Medarex shall have the right to terminate this Agreement as provided in Section 6. A. B. No Debarment. (i) Institution and Principal Investigator represent that they shall not use in any capacity, in connection with any services to be performed under this Agreement, any individual who has been debarred pursuant to a7 306(a) or a7 306(b) of the Federal Food, Drug and Cosmetic Act, or excluded from a federal healthcare program (" Debarred" ). (ii) Institution and Principal Investigator agree to immediately inform Medarex in writing if any person who is performing services hereunder is Debarred or if any action, suit, claim, investigation or legal or administrative proceeding is pending, or, to the best of Institution' s knowledge, is threatened, that could result in Institution or any person performing services hereunder becoming Debarred. (iii) Principal Investigator represents that s/he is not Debarred and that no action, suit, claim investigation or legal or administrative proceeding is pending or threatened that could result in Principal Investigator becoming Debarred, and Principal Investigator agrees to immediately inform Medarex in writing if any such action, suit, claim, investigation or legal or administrative proceeding is threatened or commenced. C. Disclosure of Financial Interest. (i) Institution shall ensure that the Principal Investigator and other researchers engaged in a Study individually complete the form for the disclosure of financial interests and arrangements as attached at Appendix B as updated from time to time by Medarex to conform with applicable laws and regulations (the " Disclosure" ) and return it to Medarex. If circumstances change during the Study, and the Disclosure submitted by Principal Investigator is

2


no longer truthful and accurate, then Principal Investigator will promptly submit to Medarex an updated Disclosure reflecting the new circumstances.

(ii) Medarex will hold any Disclosures in confidence and will only use such Disclosure in meeting FDA regulatory requirements under 21 C.F.R. Part 54. By completing the Disclosure, Principal Investigator certifies that the Disclosure supplied is truthful and accurate. Failure to return a completed Disclosure to Medarex shall be a material breach of this Agreement that may result in Medarex terminating this Agreement. 3. PROJECT MONITOR AND INSPECTION RIGHTS A. Medarex may designate from time to time certain of its employees, consultants or contractors as project monitors (" Project Monitor(s)" ). During the Study and for a reasonable time after completion or early termination of the Study, the Project Monitor(s) may, with reasonable advance notice and during regular business hours: (i) examine and inspect Institution facilities used in the performance of the Study; and (ii) inspect, audit, and copy or have copied, all data and work product generated in the performance of the Study conducted under this Agreement, and all other data necessary for Medarex to confirm that the Study is being conducted in conformance with the Protocol and in compliance with all Applicable Law. B. Institution agrees to cooperate with and assist Medarex, to the extent deemed reasonable by Medarex, in order to facilitate the Project Monitor' s examination, inspection, auditing and copying of materials relating to the Study and in order to enforce the rights granted to Medarex in this Article 3. C. Principal Investigator and Institution agree to take any action necessary, as reasonably requested by Medarex, to properly correct or address any deficiencies noted by the Project Monitors during any audit and agree to cooperate with Medarex with respect to any action taken to address any such deficiencies. 4. CLINICAL TRIAL APPROVALS A. Institution shall be responsible for obtaining the following: (i) approval of the Protocol, any informed consent relating to the Study and advertisement, if any, pertaining to the enrollment of subjects in the Study by the appropriate Institutional Review Board (" IRB" ) prior to beginning any Study on human subjects; and (ii) an informed consent which complies with all Applicable Law signed by or on behalf of each human subject prior to the subject' s participating in the Study. B. In the event the IRB requires changes in the Protocol or form of informed consent, Institution shall advise Medarex in advance of such changes and all modifications to the Protocol, and Medarex must approve all such changes in advance. Institution and Principal

3


Investigator shall not modify the Protocol or the informed consent as approved by the IRB without the prior written approval of Medarex. 5. TERM OF AGREEMENT A . The term of this Agreement shall commence on the Effective Date and shall expire upon the completion of the Study and the receipt and acceptance by Medarex of the final Study documentation required to be provided under the Protocol. B. It is anticipated that the Study shall begin on March 2004, and shall be completed on March 2005. If at any time Institution or Principal Investigator have reason to believe that the Study shall not be initiated or completed as per the above schedule, they shall advise Medarex in writing of the reason(s) and length of additional time required to commence or complete work, and if such delay is due to the negligence or willful misconduct of Institution or Principal Investigator, then Medarex may terminate this Agreement as provided in Article 6. 6. TERMINATION AND ENROLLMENT CAP A. Medarex may terminate this Agreement by giving thirty (30) days written notice to Institution. In the event thirty (30) days is determined by Institution to be insufficient notice based upon evaluation of risks to enrolled research subject(s) then receiving the Study Drug, the parties shall cooperate to safely withdraw subjects from drug treatment as soon as reasonably possible. Notwithstanding the foregoing, in the event Medarex believes that immediate termination is necessary due to its evaluation of risks to enrolled research subject(s), Medarex may terminate this Agreement immediately. B. Notwithstanding any other provision hereof, Medarex shall be entitled to terminate this Agreement for any Material Breach which shall be defined as Institution' s failure to comply with (a) its obligations and responsibilities hereunder and the terms and conditions of this Agreement (b) the Protocol; or (c) Applicable Law relevant to the Study. C. In the event of any termination: (i) Institution and Principal Investigator shall return to Medarex all unused materials, including but not limited to, Study Drug and clinical supplies (unless written authorization to retain or destroy them is given by Medarex, in which case Institution and Principal Investigator shall comply with the applicable provisions of Article 12 hereof); (ii) except in the event of termination because of a Material Breach by Institution or Principal Investigator, and unless otherwise specified in writing between the parties, the total sums payable by Medarex pursuant to this Agreement shall be pro-rated for actual work performed and non-cancelable expenses incurred in accordance with the Protocol to date of termination with any unexpended portion of funds previously paid by Medarex to Institution being refunded to Medarex; (iii) in the event of termination as a result of a Material Breach, the parties agree to make a good faith effort to reach agreement to compensate Institution for actual work performed and non-cancelable expenses incurred in accordance with the Protocol to date of

4


termination to the extent that such work can be used in the further development of the Study Drug, but in no event more than the pro-rated amounts as provided in subsection (ii) above; and

(iv) Institution and Principal Investigator shall return to Medarex all Confidential Information provided by Medarex (as defined in Article 9 hereof) in the possession of Institution and Principal Investigator. D. The termination of this Agreement shall not relieve either party of its obligation to the other in respect of: (i) retaining in confidence all Confidential Information (as defined in Article 9 hereof); (ii) complying with record keeping and reporting obligations (as set forth in Article 7 hereof); (iii) providing prior review for any publications (as set forth in Article II hereof) and obtaining written approval and consents for publicity and promotional purposes (as set forth in Article 18 hereof); (iv) compensation by Medarex for services performed by Institution to date of termination, except as set forth in Article 6.C(iii) hereof; (v) complying with obligations relating to clinical supplies (as set forth in Article 12 hereof); (vi) indemnification and insurance (as set forth in Article 13 hereof); (vii) inspection rights (as set forth in Article 3 hereof); and (viii) obligation to assist in obtaining patent protection (as set forth in Article 14 hereof), if applicable all of which obligations are binding on the appropriate party and shall survive any termination and remain in full force and effect as set forth in this Agreement.


E. Institution and Principal Investigator agree that during the term of this Agreement and for a period of six (6) months thereafter, they shall neither directly nor indirectly solicit for employment, or otherwise retain employees of Medarex, whom Institution and Principal Investigator have encountered as a result of performance of the Study(ies) for Medarex. F. Institution shall neither disclose to Medarex nor induce Medarex to use any secret or confidential information or material belonging to third parties, including other sponsors of other clinical trials. G. Medarex reserves the right to limit enrollment in the Study by giving written notice, or by giving notice by telephone followed by written notice, to Institution and Principal Investigator to cease further enrollment in the Study beyond the number of patients set forth in

5


such notice (the " Enrollment Cap" ). Upon receipt of such notice, Institution and Principal Investigator agree to enroll no further patients in the Study. Unless otherwise specified in writing between the parties, in the event of such a notice to cease further enrollment, the total sums payable by Medarex pursuant to this Agreement shall be pro-rated for the number of patients enrolled to the date of such notice, with any funds for patients beyond the Enrollment Cap previously paid by Medarex to Institution being refunded to Medarex.

7. RECORDS AND REPORTS A. Principal Investigator and Institution shall have the following record keeping and reporting obligations: (i) preparation and maintenance of complete, accurate written records, accounts, notes, reports and data relating to the Study under this Agreement; and (ii) preparation of and submission to Medarex (in a periodic and timely manner during the term of this Agreement) all raw data and other material as required in the Protocol in the form of properly completed patient case report forms (" Case Report Forms" ) or into an electronic database (i.e., remote data entry) made available by Medarex for each patient as provided in the Protocol. Case Report Forms and the electronic database shall be the exclusive property of Medarex. B. Principal Investigator and Institution agree to notify Medarex within twenty-four (24) hours after learning of any serious and/or unexpected adverse drug reaction affecting any patient in the Study. Principal Investigator and Institution further agree to follow up such notification of adverse drug reaction with appropriate reports to Medarex and, as appropriate, regulatory authorities in compliance with the Protocol and Applicable Law. C. Principal Investigator and Institution further agree to maintain records and data during and after the term or early termination of this Agreement in compliance with Applicable Law. D. Principal Investigator and Institution agree to notify Medarex within twenty-four (24) hours in the event that the FDA or any other regulatory authority notifies the Study site of a pending inspection/audit. In addition, Principal Investigator and Institution shall forward to Medarex any written communication received as a result of the inspection/audit within twenty-four (24) hours of receipt of such communication and Institution agrees to allow Medarex to assist in responding to any such communication that requires a response. Such responses by Institution shall be made within two (2) weeks of issuance of any such communication or within any earlier deadline set by the issuing regulatory authority or Applicable Law. Principal Investigator and Institution shall also provide to Medarex copies of any documents related to the Study provided to any inspector or auditor. If the FDA or other regulatory authority requests or requires any action to be taken to address any such communication, Principal Investigator and Institution agree, after consultation with Medarex, to take such action as necessary to address such communication, and agree to cooperate with Medarex with respect to any such communication and/or action taken with respect thereto.

6


8. COST AND PAYMENT


Medarex shall pay Institution for the performance of the Study as provided in the budget for the Study that is attached as Exhibit C (the " Budget" ) and which is incorporated into this Agreement by reference. The parties acknowledge that the payment(s) set forth in the Budget are adequate consideration for the work undertaken hereunder. Unless otherwise agreed in writing by a duly authorized officer of Medarex, Medarex shall have no obligation to make any payments to Institution or Principal Investigator in addition to those contained in the Budget.


9. CONFIDENTIAL INFORMATION A. " Confidential Information" shall mean any and all confidential or proprietary information obtained from Medarex, or generated, created or learned by Institution or Principal Investigator as a result of performing the Study under this Agreement, including without limitation commercial, scientific, medical and technical information and data relating to Medarex, the Study Drug or any Study, any information derived therefrom, the Protocol, the investigator' s brochure, interim results and any other information or material disclosed under secrecy agreements previously entered into between the parties. During and for a period of five (5) years after the term or early termination of this Agreement, Institution and Principal Investigator shall retain in confidence all Confidential Information. Confidential Information shall not include information: (i) which is or becomes public knowledge through no fault of Institution or Principal Investigator; or (ii) which is lawfully made available to Institution or Principal Investigator by an independent third party owing no obligation of confidentiality to Medarex with regard thereto (and such lawful right can be properly demonstrated by Institution or Principal Investigator); or (iii) which is already in Institution' s or Principal Investigator' s possession at the time of receipt from Medarex (and such prior possession can be properly demonstrated by contemporaneous written records belonging to Institution or Principal Investigator); or (iv) which is independently developed by Institution personnel without access to or reliance upon Confidential Information provided by Medarex hereunder (and such independent development can be properly demonstrated by contemporaneous written records belonging to Institution or Principal Investigator). B. Subject to applicable federal, state or local legal and regulatory requirements, Institution and Principal Investigator agree to promptly return to Medarex, upon its request, all Confidential Information obtained from Medarex pursuant to this Agreement; provided, however, that Institution' s legal counsel may retain one copy of such Confidential Information in a secure location for purposes of identifying Institution' s obligations under these confidentiality provisions, and provided further, that Principal Investigator may retain a copy of the Study results for use in accordance with the terms of this Agreement. C. Institution and Principal Investigator shall not use Confidential Information for any purpose other than performance in accordance with this Agreement. Institution and Principal Investigator shall limit disclosure of Confidential Information received hereunder to only those of their representatives, agents, officers and employees (collectively, " Agents" ) who are directly

7


involved with the Study and only if such Agents are subject to binding obligations of confidentiality at least as protective as those agreed upon in this Agreement. Institution and Principal Investigator shall protect the confidentiality of Confidential Information using at least the same level of effort as it uses to protect their own confidential or proprietary information, but in no event shall Institution and Principal Investigator use less than commercially reasonable efforts. D. Institution and Principal Investigator acknowledge and expressly agree that any disclosure of Confidential Information in violation of this Agreement may be detrimental to Medarex' s business and may cause it irreparable harm and damage. In accordance with Applicable Law and in addition to any other rights and remedies provided herein, Medarex shall be entitled to seek equitable relief by way of injunction or otherwise. 10. PERMITTED DISCLOSURES Notwithstanding anything to the contrary in this Agreement, Institution may disclose Confidential Information to the extent, and to the persons and/or entities, required by governmental law, rule, regulation or order; provided, however, that if possible, Institution both (i) gives prompt notice to Medarex of the disclosure requirement in order to allow to Medarex to obtain any available limitation on or exemptions from such disclosure requirement, and (ii) reasonably cooperates in such efforts by Medarex.


11. DATA, PUBLICATIONS AND OTHER RIGHTS In recognition of the importance of disseminating information relating to any novel or important observations or results arising from the Study and understanding that such need must be balanced with Medarex' s obligations to maintain control over Confidential Information as well as to comply with appropriate rules and regulations of the FDA, the parties hereby agree to the following:

A. All research data and results generated during the course of the Study shall be the property of Medarex, and Medarex shall have the right to use such data and results for any purpose in accordance with applicable law; provided, however that Medarex agrees to collect, use and disclose data from the Study with respect to any Study subject only in accordance with the authorization contained in the informed consent(s) obtained from such Study subject as part of the Study, unless otherwise required by law. Institution shall be free to use the results of the Study for its own internal, non-commercial research, educational, clinical and publication purposes without the payment of royalties or other fees. Principal Investigator and Institution further agree to execute any documents or under take any further actions if requested by Medarex to assign and transfer title to such data. B. Subject to the terms and conditions of this Agreement, Institution and. Principal Investigator have the right to publish or publicly present the results of the Study. Principal Investigator and Institution agree not to publish or publicly present any interim results of the Study without the prior written consent of Medarex, as provided below. Principal Investigator and Institution further agree to provide thirty (30) days written notice to Medarex prior to submission for publication or presentation to permit Medare ...