CLINICAL TRIAL AGREEMENT (SK#11731)

 

THIS AGREEMENT is made and entered into as of the 25th day of February, 2006 (hereinafter "Effective Date") by and between

 

SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH and its affiliate MEMORIAL HOSPITAL FOR CANCER AND ALLIED DISEASES both having a principal place of business at 1275 York Avenue, New York, New York 10021, membership corporations of the State of New York (hereinafter "SKI/MEMORIAL"), and

 

ACTINIUM PHARMACEUTICAL INC., a corporation having its principal place of business at 25b HANOVER Road, Florham Park, NJ 07932 (hereinafter "COMPANY").

 

 

WHEREAS, SKI/MEMORIAL will conduct a clinical trial entitled "Phase I Trial of Targeted Nano Generator (Actinium 225-Labeled Humanized Anti CD33 Monoclonal Ab HuM195" or "Study Drug") in Patients with Advanced Myeloid Malignancy" (IRB# 02-017, hereinafter "Study").

 

WHEREAS, COMPANY conducts business in the development, manufacture and sale of therapeutic products, and is interested in partial sponsorship of the Study in exchange for access to the data resulting from the Study.

 

NOW, THEREFORE intending to be legally bound and upon the terms, conditions and covenants hereinafter set forth, SKI/MEMORIAL and COMPANY agree as follows:

 

 

1.1         SKI/MEMORIAL has established and maintains a Leukemia Service, a Division of Hematologic Oncology, in the Department of Medicine and has acquired expertise in conducting research investigations, clinical trials and laboratory test evaluations.

 

1.2          The Study under this Agreement will be conducted under the protocol approved by SKI/MEMORIAL'S Human Subject Institutional Review Board (hereinafter "IRB"), based on the draft protocol annexed hereto as Exhibit A (hereinafter "Protocol"). SKI/MEMORIAL shall submit the Protocol for approval to the IRB and the United States Food and Drug Administration (hereinafter the "FDA"). COMPANY shall supply Actinium-225 and HuMI 95 after COMPANY has:

 

 

Promptly after SKI/MEMORIAL'S IRB has approved the final Protocol, SKI/MEMORIAL shall forward a copy to COMPANY. SKI/MEMORIAL shall also forward any subsequent change to the Protocol to COMPANY.

 

1.3         As part of this Agreement, SICEMEMOR1AL shall appoint Joseph G. Jurcic, M.D. and/or such other physicians as it may deem appropriate as investigators (hereinafter "Investigators") to oversee the Study. If Dr. Jurcic should become unable to complete the Study, SKI/MEMORIAL shall consult with COMPANY regarding the appointment of a new principal investigator.

 

1.4         The Investigators on behalf of SKI/MEMORIAL shall prepare and maintain records and case histories with all pertinent data documented as required by the Protocol on case report forms supplied by COMPANY. The parties shall hold all patient data confidential, and information provided to COMPANY shall not disclose patient health information, except to the extent that the patient consent form permits. COMPANY may disclose reports and other information to an independent data management company, provided the management company is bound to hold such information in confidence.

 

1.5         The Investigators shall also promptly notify COMPANY and the IRB of any adverse reaction in the course of the Study of which they become aware

 

1.6         SKI/MEMORIAL and COMPANY agree that in the performance and documentation of the Study they shall adhere to all applicable government laws, rules, regulations and guidelines, including but without limitation the Health Insurance Portability and Accountability Act of 1996 ("IIIPAA") and its regulations and official guidance promulgated thereunder, and those of the FDA, including among others the Generic Drug Enforcement Act of 1992 (21 USC §§ 305,306). Certifications and other documents required by these statutes and regulations, such as those relating to financial conflicts of interest and debarment from performing clinical trials, shall be provided as necessary.

 

1.7         COMPANY shall provide SKI/MEMORIAL with any investigational protocols, pre- clinical or background information which are germane to the Study.

 

1.8         Upon SKI/MEMORIAL'S request, COMPANY shall provide, without cost to SKI/MEMORIAL, sufficient amounts of Actinium 225 and HuM195 to conduct the Study.

 

1.9         SKI/MEMORIAL shall permit COMPANY to monitor the progress of the Study through site visits and review of Study reports and related documentation. The parties agree that COMPANY may engage a third party of COMPANY's choosing to conduct the Study monitoring.

2.1         SKI/MEMORIAL shall keep COMPANY advised of the status of the Study via periodic reports. The frequency of reports shall be mutually agreed to by both parties. There shall also be a final report of the Study presented to COMPANY within sixty (60) days of the Study completion.

 

2.2         All reports submitted to COMPANY shall become the property of COMPANY and may be used by COMPANY for its internal uses. If COMPANY desires to release the reports or any contents in the reports to the public domain by any means or methods such as press releases, publications, meeting presentations, COMPANY must first obtain written_ consent from SKI/MEMORIAL.

3.1         Notwithstanding anything contained herein to the contrary including without limitation Article IV, SKI/MEMORIAL may freely publish the results of its investigative findings hereunder. The authorship and contents (including scientific conclusions and professional judgments) of any paper submitted shall be determined by SK /MEMORIAL. SKI/MEMORIAL shall provide COMPANY with a copy of the papers prepared for publication prior to their submission to a scientific journal or presentation at scientific meetings. COMPANY shall have thirty (30) days to review the papers. COMPANY shall not make any editorial changes in the papers, but may delete any of its Confidential Information (as defined in Article V) contained therein. COMPANY personnel shall be acknowledged With customary scientific practice.

4.1         In order to effectively complete the Study, it may be necessary or desirable for the parties to disclose proprietary, trade secret and/or information relating to patients (hereinafter "Confidential Information") to one another.

4.1.1 All medical records (or other patient information) not transcribed into the case report forms are Confidential Information of SKI/MEMORIAL, and do not need to be marked "Confidential". There shall be no time limit on the parties' obligation to maintain the confidentiality of patient identifiable health information, including information whose identifiers may be ascertained by the exercise of reasonable effort through investigation. Patient identifiable health information shall be protected in compliance with all applicable regulations, rules and statutes. COMPANY agrees to refrain from publishing or disclosing any part of such confidential medical records or from using it except as necessary to discuss and analyze the results of the Study, to ensure research integrity, to communicate with the FDA and other regulatory authorities, and other wise as required by law or specifically permitted by authorizations or consents signed by Study subjects, or waivers of authorization granted by an IRB overseeing the Study ("Permitted Activities"). COMPANY also agrees to restrict the use and disclosure of any individually identifiable health information gained through the Permitted Activities to its workforce, contractors, subcontractors, Study collaborators and agents who must have access to that information in order directly to support or facilitate the Permitted Activities, and to use the necessary means to bind those parties to these restrictions and requirements, as though these restrictions and requirements applied to these entities directly.

 

 

4.1.2 Any other Confidential Information shall be marked as "Confidential" or, if provided to the other party orally, shall be reduced to writing marked as "Confidential" and sent to the other party within ten (10) days of the oral disclosure, except that this requirement shall not apply to patient information, which is always Confidential Information. Each party agrees that such other Confidential Information of the other party disclosed to it or to its employees or an independent data management company shall for three (3) years after disclosure:

(a) be used only in connection with the legitimate purposes of this Agreement;

(b) be disclosed only to those who have a need to know it; and

(c) be safeguarded with the same care normally afforded confidential information in the possession, custody or control of the party holding the Confidential Information.

 

Under this Agreement the maximum compensation for which COMPANY is responsible is three hundred and twenty eight thousand U.S. Dollars ($328,000), which is based on SKI/MEMORIAL enrolling a maximum of 30 qualified subjects, a maximum of 10 incomplete and pharmacy fee.

5.4          SKI/MEMORIAL shall discuss if COMPANY so requests, budgetary matters with COMPANY, but reserves the right to be the final control on budgetary categories and expenditures.

The checks shall be made payable to Sloan-Kettering Institute for Cancer Research (Sloan-Kettering Institute Tax I.D. No. 13-1624182) and shall be forwarded to:

COMPANY should note on its check stub or in its transmittal letter that the payment relates to a Clinical Trial Agreement, SK#I1731, under the direction of Dr. Jurcic.

Both parties shall, at all times during the performance of this Agreement, remain as independent contractors and the Agreement shall not make the parties partners, joint venturers, or agents of one another. No party to this Agreement shall have the power to bind or obligate the other party

7.1          This Agreement shall commence on the Effective Date of this Agreement and shall continue until completion as provided in the Protocol, which is estimated to occur twenty four (24) months from the Effective Date hereof.

 

7.2          This Agreement can be terminated by either SKI/MEMORIAL or COMPANY with or without cause upon thirty (30) days prior written notice without penalty to either party. Notwithstanding any notice period SKI/MEMORIAL may immediately cease provision of services pursuant to the Protocol if either the Principal Investigator or the IRB determines that immediate cessation is appropriate for patient safety.

 

7.3          In the event that this Agreement is terminated prior to completion of the Study, the amount due to SKI/MEMORIAL from COMPANY shall be $ 10,000 for each patient who was enrolled in the Study any time between the Effective Date and the date of termination of this Agreement. For purposes of this Agreement enrollment shall mean a patient that has signed the IRB-approved patient Informed Consent Form for the Study and successfully passed any pretreatment screening that is required.

 

7.4          If COMPANY terminates the Agreement prior to completion of the Study, COMPANY shall, if permitted by law and requested by SKI/MEMORIAL, supply SKI/MEMORIAL, free of charge, with sufficient Study Material to allow SKI/MEMORIAL to complete the treatment of those patients participating in the Study on the date of SKI/MEMORIAL'S receipt of COMPANY'S termination notice.

 

7.5          Sections 1.5, 7.4, 7.5, 11.1-3, and 11.5 and Articles II, III, IV, VIII, IX, and X shall all survive the termination of this Agreement.

8.2          COMPANY represents and warrants to SKI/MEMORIAL that it is authorized to enter into this Agreement, to provide HuM195 under this agreement and that its execution, delivery and performance of this Agreement will not conflict with or constitute a default under any other agreement to which it is a party or by which its assets are bound.

8.3          COMPANY represents and warrants that it obtained the Hu_Ml 95 from Protein Design Labs, Inc. (hereinafter "PDL ") who has been made aware of and authorized the present Study.

9.1          Preservation of Data. Notwithstanding anything else in this Agreement to the contrary, unless specifically instructed otherwise in writing by COMPANY, SKI/MEMORTAL shall retain and preserve one (1) copy of all records relating to the Study for two (2) years after the last marketing authorization for the Study Drug has been approved or COMPANY has discontinued its research with respect to the Study Drug and the FDA has been notified, or such longer period as shall be required by law (such period being referred to herein as the "Retention Period"). At the end of such period, SKI/MEMORIAL may destroy all such material upon giving COMPANY written notice of its intent to do so at least sixty (60) days prior to destruction.

9.2          Inventions. "Inventions" shall mean any invention that is conceived, developed and reduced to practice during or as a result of the performance of the Study. Inventions conceived or reduced to practice solely by SKI/MEMORIAL or its faculty, staff, employees, or students shall be the sole property of SKI/MEMORIAL. Inventions conceived and reduced to practice solely by COMPANY or its employees or subcontractors or agents shall be the sole property of COMPANY. Inventions conceived and reduced to practice jointly by SKI/MEMORIAL or its faculty, staff, employees, or students, together with one or more employees, subcontractors or agents of COMPANY, shall be owned jointly by SKI/MEMORIAL and COMPANY.

 

9.3          To the extent SKI may legally do so, SKI/MEMORIAL grants to COMPANY a right of first refusal to obtain an exclusive license to SKI's interest in any jointly owned Inventions, through good faith negotiations and on commercially reasonable terms. The option shall extend for a period of six (6) months following disclosure of the Invention to the COMPANY. In the event the parties, acting in good faith, fail to reach a mutually acceptable agreement within three (3) months after commencing negotiations, SKI/MEMORIAL shall be entitled to negotiate a license with a third party for such patent applications.

 

9.4          Retention of Non-Exclusive License by SKI/MEMORIAL. SKI/MEMORIAL shall retain an irrevocable, non-assignable, royalty free license to use for non-commercial research purposes any Inventions licensed to COMPANY pursuant to Section 9.3.

 

9.5          -U.S. Government's Rights. It is understood that the -U.S. government partially sponsors this Study and, therefore, has certain rights to Inventions made under the Study.

10.2       SKI/MEMORIAL shall indemnify, defend or hold COMPANY harmless from and against all claims, causes of action, suits, damages and costs arising directly from a failure by SKI/MEMORIAL, its staff or agents to: (1) comply with any applicable FDA or other governmental requirement; (ii) adhere to the terms of the Protocol, except to the extend that such claims arise out of COMPANY'S gross negligence or willful misconduct.

 

10.3        As a condition to a party's right to indemnification hereunder, the claiming party must inform the other party of a claim as soon as is practical after it receives notice of the claim, permit the indemnifying party to control the defense of such claim, to select and engage counsel of its own choice to defend against such claims and to settle any claims or suits at its discretion, and otherwise cooperate fully with the indemnifying party in the defense of such claim. In no event shall the indemnifying party have any obligation hereunder with respect to claims or suits settled or compromised without its prior written consent.

11.1        No right or license is granted under this Agreement by either party to the other either expressly or by implication, except those specifically set forth herein.

 

11.2        Unless otherwise specified in this Agreement, nothing contained in this Agreement shall impose an obligation of exclusivity on one party by the other. Both parties reserve the right to enter into and participate in other activities (either alone or with a third party) including, but not limited to, clinical trials and sponsored research projects.

 

11.3        All matters affecting the interpretation, validity and performance of this Agreement shall be governed by the laws of the State of New York applicable to agreements made and to be performed wholly within the State of New York. This Agreement, including the Protocol, sets forth the entire understanding between the parties herein, and cannot be changed or amended except by written agreement executed by the parties. In the event of any inconsistency in this Agreement, the inconsistency shall be resolved by giving precedence first, to the Articles of this Agreement, and then, to the Protocol. Notwithstanding the above, in the event of a conflict between the text of this Agreement and the text of the final, IRB-approved Protocol, the anal Protocol shall control with respect to any matter for which the United States Food and Drug Administration (hereinafter "FDA") has promulgated regulations addressing the requirement set forth in the Protocol; this Agreement shall govern for all other matters. This Agreement may not be assigned by either party without the prior written consent of the other party.

11.4       All notices to be given by either party to the other shall be made in writing, delivered by any means providing proof of delivery, at the following addresses respectively:

All notices to be given by either party to the other shall be made in writing, delivered by any means providing proof of delivery, at the following addresses respectively:

11.5        Except as set forth in Articles 3 and 4, as requifed by law and/or as may be required in order to maintain a party's status as an exempt organization under Section 501(c)(3) of the Internal Revenue Code and regulations thereunder, neither SICINEMORIAL nor COMPANY shall release any information., publicity, news releases or other public announcement, written or oral, with regard to the Agreement or any amendment thereto or to performance hereunder, to newspapers or any other mass communication media without the prior written approval of the other parry. COMPANY shall not use the name of SKI/MEMORIAL and their affiliate corporation Memorial Sloan-Kettering Cancer Center, or a variant of any of the foregoing in any advertising, packaging or other promotional material in connection with the Study Drug except as may be required by law.

11.6        If anyone or more of the provisions of this Agreement is held to be invalid or unenforceable from which no appeal can be or is taken, the provision shall be considered severed from this Agreement, and shall not serve to invalidate the remaining provisions hereof, so long as the essential benefits of this Agreement will still be realized. The parties shall make a good faith effort to replace the invalid or unenforceable provision with a valid one that, in its economic effect, is most consistent with the invalid or unenforceable provision.