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CLINICAL STUDY AGREEMENT

Clinical Trial Agreement

CLINICAL STUDY AGREEMENT | Document Parties: NORTHWEST BIOTHERAPEUTICS INC You are currently viewing:
This Clinical Trial Agreement involves

NORTHWEST BIOTHERAPEUTICS INC

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Title: CLINICAL STUDY AGREEMENT
Date: 4/18/2006
Industry: BIOTRX    

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EXHIBIT 10.35

CLINICAL STUDY AGREEMENT

      THE REGENTS OF THE UNIVERSITY OF CALIFORNIA , on behalf of its Los Angeles Campus (hereinafter “University”), and Northwest Biotherapeutics Inc., (hereinafter “Company”), agree that University will perform for a clinical study (hereinafter “the Study”) in accordance with the protocol entitled “Phase 1 Clinical Trial Evaluating Booster Vaccinations of DCVax ® -Brain for Treatment of Glioblastoma” (attached as Exhibit A) on the following terms and conditions:

1. INVESTIGATOR; INVESTIGATOR OBLIGATIONS :

A. Linda Liau, M.D., Ph.D., is the named principal investigator (“Investigator”) and will be responsible for conducting the Study; Company is not a “Sponsor”, as that term is defined by the Food and Drug Administration (“FDA”) Federal Code of Regulations 21 CFR 312.3(b), of the Study. Investigator will not represent in the informed consent or elsewhere that Company is the Study Sponsor.

B. Company acknowledges that Investigator is the author of the Study protocol and research design. The Study protocol and design shall be the property of the University, but Company shall have certain rights of access to and use of Study data in accordance with this Agreement. The Investigator will inform the Company of any changes in the Protocol that significantly affect the Study objectives or Study subject safety and any other material changes.

C. The Study will be conducted in accordance with the Protocol, FDA defined Good Clinical Practice Guidelines (GCPs) and all applicable laws and regulations. Investigator, to the extent required to do so by applicable law, will obtain and maintain: (a) an Investigational New Drug application (“IND”) pursuant to FDA regulations, (b) University’s institutional review board (“IRB”) review and approval or exemption, and/or (c) written patient informed consent (“Informed Consent”) approved by the IRB and signed by the Study patient or Study patient legal representative as required. The University and Investigator are fully responsible for the adequacy of the Informed Consent and Company has no liability related to nor obligation to review or comment on that document.

D. University through Investigator shall provide Company with a final report of the research efforts under this Agreement as described in Exhibit B.

E. As Study Sponsor, INSTITUTION and INVESTIGATOR are solely responsible for reporting any adverse events or safety reports in connection with the Study that may be required by applicable law to be made to the FDA or other regulatory authority. INSTITUTION and INVESTIGATOR shall provide Company with a copy of any such reports simultaneously with submission to the FDA or other agency.

F. The Investigator shall limit the use and evaluation of Study Drug, as defined herein, to activities directly related to the Protocol and shall not transfer any Company Study Drug to any third party, without the prior written consent of Company.

2. COMPANY OBLIGATIONS:

A. Company will not provide DCVax-Brain (“Study Drug”) for use in this Study. Such Study Drug will continue to be prepared by Investigator.

B. Payment. The cost to Company for the Study is $215,829.00 USD (inclusive of University’s applicable overhead rate for investigator initiated studies), to be paid in accordance with the schedule attached as Exhibit C. The total amount will be adjusted if needed, according to actual patient visits as outlined in Exhibit C. Additional testing, treatment or other procedures not specifically authorized by Company or set forth in this Agreement, will not be reimbursed by the Company unless prior approval by the parties is made in writing.

 


 

3. TERM: This Agreement shall become effective as of the last date of signing by the last party to sign and shall continue until completion of the Study or until termination pursuant to Article 13.

4. PAYMENTS:

All payments will be made payable to:

 

 

 

 

 

 

 

The Regents of the University of California

 

 

Tax I.D. Number: 95-6006143

 

 

 

 

 

 

 

 

 

All payments will be mailed to:

 

UCLA Remittance Center

 

 

 

 

10920 Wilshire Boulevard

 

 

 

 

Suite 107

 

 

 

 

Los Angeles, California 90024-1406

 

 

 

 

 

 

 

Payments shall reference:

 

Investigator Name and Study Title

5.  CONFIDENTIALITY : Company will not disclose its confidential information unless it is necessary to the Study. Any information Company discloses to University and considers confidential will be clearly marked in writing, as “Confidential”, or if orally disclosed to University, will be clearly identified as “Confidential”. Except as required by law, University will not disclose such Company confidential information for a period of five (5) years from the expiration or termination of this Agreement. This obligation to maintain confidentiality does not apply to information that: (a) was known to University prior to its receipt from Company, (b) the University independently develops, (c) is now public knowledge or subsequently becomes such through no breach of this Agreement, (d) is rightfully disclosed by third parties to University, or (e) University is required by law to disclose. University will use reasonable efforts to protect the confidentiality of such information while in its possession.

6.  PUBLICATION : University may publish Study results or present Study results at meetings, seminars, or the like, but will not disclose confidential information received from Company. University agrees to submit a copy of all manuscripts, abstracts, and /or presentation materials which report results of the Study, to Company for review and comment forty-five (45) days prior to its publication. Company will have said forty-five days to review publication. Company will have no editorial rights over manuscripts, but may comment on and request redaction of confidential or proprietary information.

7.  UNIVERSITY AND COMPANY NAMES : California Education Code section 92000 prohibits use of University’s names to suggest that University endorses a product or service. Company will not use University’s names, including “UCLA,” without the express prior written approval, except to identify University as the Study site when required to do so by law. University will not use Company’s names without the express prior written approval of Company, except when required to do so by law.

8. INVENTIONS :

A. Inventorship of developments or discoveries first conceived and reduced to practice under this Agreement (“Subject Inventions”) will be determined in accordance with U.S. Patent Law. All rights to Subject Inventions made solely by employees of University will belong solely to University. All rights to Subject Inventions made solely by employees of Company will belong solely to Company. All rights to Subject Inventions made jointly by employees of University and employees of Company will belong jointly to Univer


 
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