Throughout the following explanatory notes, “NPC” and “Institution” both mean a nonprofit corporation established under 38 U.S.C. §§ 7361 – 7368 and the term PI is used for Principal Investigator.

All explanatory notes are in italics. Suggested and alternative clauses as well as suggested letters are in regular type.

[NPC NAME & ADDRESS] (“Institution”) agrees to participate in a collaborative Clinical Research Agreement sponsored by [SPONSOR NAME & ADDRESS] (“Sponsor”) and conducted by [PI NAME] (“Principal Investigator”). This agreement is entered into as of the last date on the signature page hereof. The parties desire to combine their mutual interests and resources to search for new or improved methods of treating human afflictions.

Institution is a flexible funding mechanism established pursuant to 38 U.S.C. §§ 7361-7368 and as such facilitates research approved by the Department of Veterans Affairs (“VA”) and conducted by employees of [VAMC NAME] (VAMC) and Institution.

The parties agree as follows.

This Agreement (“Agreement”) is entered into as of the last date on the signature page hereof and sets forth the terms and conditions and establishes the relationship between [NPC NAME &ADDRESS] (“Institution), a nonprofit corporation affiliated with the Department of Veterans Affairs (VA), and [SPONSOR NAME & ADDRESS] (“Sponsor”) to facilitate research.

Sponsor and Institution desire to combine their mutual interests and resources to search for new or improved methods of treating human afflictions and to collaborate in the performance of a clinical investigation of [VERY BRIEF DESCRIPTION (e.g. – heart disease; diabetes; lung cancer.)]. This Study will be coordinated by [PI NAME] (hereinafter “Principal Investigator”).

The VA, the Institution, and the Principal Investigator possess valuable skills, knowledge, expertise and resources in relation to the field of research identified in the Protocol and desire to further serve the VA patients and the general public through medical research. Institution shall facilitate the conduct of this research, which has been approved by the VA in conjunction with the [VAMC NAME] and shall use all reasonable effort to ensure performance of this Agreement which shall provide maximum benefit to the VA, its veterans and the general public.

The parties agree as follows.

[NPC NAME] is a nonprofit research corporation established and authorized by sections 7361-7368 of Title 38, United States Code to provide a flexible funding mechanism for the conduct of VA approved research. Our corporation facilitates research conducted by VA and corporation employees at the [VAMC NAME], a Federal facility. Federal law and the relationship between the nonprofit research corporation and VA, necessitate some changes to this Agreement.

2.1 Inventions [Patent Law]

Inventions, Discoveries & Ownership of Results. Any information, invention or discovery, innovation, suggestion, idea, communication and report (whether patentable or not) (collectively “Invention”), conceived, reduced to practice, made or developed by Principal Investigator using resources provided by the Department of Veterans Affairs as a result of conducting the Study, are controlled by Federal law (35 U.S.C. §§ 102 & 200-212, 37 C.F.R. Part 501, and 38 C.F.R. §§ 1.650 - 1.663). Such invention resulting from this Study shall be disclosed to both VA and Sponsor, and may be subject to joint ownership by VA and Sponsor.

Notwithstanding any other language in this Agreement, any information, invention, discovery, or innovation arising from research conducted under this Study shall be governed by applicable Federal laws and regulations.

2.2 Data [Copyright Law]

All documents, protocols, data, know-how, methods, operations, formulas, confidential information and materials provided to the Investigator by Sponsor are and shall remain Sponsor’s property.

The Completed Case Reports, the Final Report and other documents resulting from the Study shall also be owned by the Sponsor. Copies of any documents referenced herein shall be returned to Sponsor upon Sponsor’s request within fourteen (14) days of such request. Investigator shall have the right to retain a copy for VA or its researchers as is appropriate, for clinical use of the results of the research contemplated in this Agreement.

Patient records are excluded from any discussion of sponsor ownership of reports, records, etc. generated by the Study.

With the exception of patient records, and subject to the rights of publication described in this Agreement, all case report forms and other reports generated during the course of this Study are Sponsor’s property. All data may be used by Sponsor for any purpose without further financial obligation or restriction. Investigator shall have the right to obtain and use such data in order to publish the Study results, for continuing academic research purpose, and for the treatment and medical care of any Study subject.

The following equipment or funds to purchase it is furnished by Sponsor: _____________

Add “a” or “b” to the above:

a. At the completion of the Study, the equipment will be returned to the Sponsor at its expense.
b. At the completion of the Study the equipment will become the Institution’s property for use in other VA-approved research projects.

Sponsor shall not use the name of the Institution, VA or study subjects in any form of public information without the written consent of the entity or person involved. This in no way is intended to restrict free publication in scientific journals.

Neither party shall include the name of the other party in any advertising, sales promotion or other publicity release without the prior written approval of that party.

All advertising and/or endorsements are subject to 5 C.F.R. § 2635.702.

Sponsor may use the name of each party, title and purpose of the Study, protocol summary, basic eligibility criteria, study site locations and contact information for normal business purposes and may provide the same information to prospective or actual clinical study participants.

Each party agrees not to use the name of any other party, VA, or participant in the Study, in any advertising or news release or other publication without the prior written consent of the other parties.

All advertising and/or endorsements are subject to 5 C.F.R. § 2635.702.

In the event of a conflict between the terms of this Agreement and any other agreement entered into by the parties, the terms of this Agreement shall prevail. However, the current Protocol will continue to control all clinical and scientific aspects of the Study and will be followed until properly amended.

(Indemnity, Federal Tort Claims Act, Insurance, and Providing Treatment for Research-related Injuries)

Each of the parties shall retain all the rights and remedies available under applicable federal and state laws. Each of the parties shall be responsible and liable for the negligent acts, errors and omissions of its respective employees, agents and representatives.

Institution will be responsible for damages to the extent caused by the negligence of its officers, agents and employees arising from the performance of this Agreement. Sponsor will be responsible for all damages to the extent caused by the negligence of its officers, agents and employees arising from the performance of this Agreement.

Should the U.S. Government or a Federal employee be named as a party to a lawsuit, Sponsor acknowledges that the U.S. Government is represented by the U.S. Department of Justice in accordance with 28 U.S.C. § 516 and any decision to settle or compromise such a lawsuit will be made by the U.S. Government after consultation with the Sponsor.

The Department of Veterans Affairs (VA) is part of the executive branch of the United States. The Government is self-insured and does not maintain general liability insurance. In lieu of any insurance, VA’s liability for the negligence of its employees in performing their duties is governed exclusively by the provisions of the Federal Tort Claims Act, 28 U.S.C. §§ 1346(b) & 2671 – 2680 (FTCA). The individuals conducting the Study under this Agreement are employees or agents of the United States acting in furtherance of their duties. Pursuant to the extent provided for in the FTCA, the Government is financially liable and responsible for damages that result from the negligent or wrongful actions of federal employees acting within the scope of their employment. The FTCA generally provides that the Government will intervene in negligence claims brought against its employees and will defend, settle or pay them as appropriate.

Institution has medical malpractice insurance covering its employees performing the Study from [NAME OF INSURANCE COMPANY] in limits equal to or in excess of that required by Sponsor.

Sponsor agrees to provide reimbursement for:

(1) All reasonable and customary costs incurred and associated with the diagnosis of an adverse event involving the Study drug or a Study procedure; and

(2) All reasonable and customary costs incurred for treatment of physical injury to the subject if SPONSOR determines, after consulting with Investigator, that the adverse event was reasonably related to administration of the Study drug or Study; provided, however, that:

(a) the adverse event is not attributable to Investigator’s or any agents’ or employees’ negligence or misconduct;

(b) the adverse event is not attributable to any underlying illness, whether previously diagnosed or not; and

(c) the Study drug or Study procedure was administered in accordance with the Study.

SPONSOR shall have the option of paying the additional costs directly to the provider of the service or to the Institution.

AAHRPP COMPLIANT CLAUSE - highly recommended:

Human Subject Protection.  The research to be conducted under this CRADA involves Human Subjects or human tissues within the meaning of 38 C.F.R. Part 16 and all research to be performed under this CRADA will conform to applicable Federal laws and regulations and VHA policies and procedures.  Additional information is available from the HHS Office for Human Research Protections (http://www.hhs.gov/ohrp/). Collaborator and VA shall immediately notify each other upon identifying any aspect of the protocol, including information discovered during site monitoring visits, or the study results that may adversely affect  the safety,  well-being, or medical care of participants, or that may affect the willingness of participants to continue participation in the research, influence the conduct of the study, or that may alter the IRB’s approval to continue the study,  VA shall promptly notify the IRB of any such events.  When participant safety or medical care could be directly affected by study results, VA will send study participants a written communication about the results. 

Patient Safety – Reciprocal Notification: Sponsor and Institution shall immediately notify the other upon identifying any aspect of the protocol or the Study results that may adversely affect patient safety or well-being. Institution shall promptly notify IRB and VAMC officials.

Sponsor shall comply with the requirements of 21 C.F.R. § 312.32. Institution and/or Principal Investigator will report adverse events or findings (as defined in section 312.32) of which they become aware to Sponsor so that it may comply with that section’s reporting requirements. Sponsor shall furnish a copy of the IND safety report to Institution at the time it furnishes it to the FDA. Sponsor, Institution and Principal Investigator agree to notify each other of any events or concerns about the safety of the subjects that arise as the study progresses, even if these events or concerns do not meet the definition of an adverse event requiring notification.

During the term of this Agreement and thereafter, Institution and Principal Investigator shall use all reasonable efforts not to disclose without Sponsor’s written consent any information that Sponsor designates as confidential.

Institution and Principal Investigator will not disclose Sponsor’s confidential information to any person, except the Sub-investigators, members of the Institution Review Board and VA Research and Development Committee, or as required to the Food and Drug Administration, without the prior written consent of Sponsor. However, Institution may disclose Sponsor’s and Principal Investigator’s names, total grant amount, and a general non confidential title of the Study without Sponsor’s consent to VA and in any government report required of the Institution. Institution and Investigator further agree to take all reasonable precautions to prevent disclosure of Sponsor’s confidential information to a third party by the Principal Investigator, Sub‑investigators, the Institutional Review Board or the VA Research and Development Committee.

The provisions of this section do not apply to any information which:

(1) Was known to Institution or Principal Investigator prior to receiving that information either directly or indirectly from Sponsor, or

(2) Is generally known to the public or which becomes generally known to the public through no act or omission on the part of the Institution or Principal Investigator, or

(3) Is disclosed to Institution or the Principal Investigator at any time by a third party who had a legal right to disclose it, or

(4) Is needed for purposes of treating a patient who participated in the Study, or

(5) Is required by law, regulation, governmental or judicial order, or subpoena to be disclosed, provided Institution and/or Principal Investigator shall notify Sponsor immediately upon receiving notice of such required disclosure to permit Sponsor to oppose same by appropriate legal action.

(A) During the term of this Agreement, Principal Investigator and Institution may obtain Information from Sponsor that Sponsor identifies as Confidential Information.

(B) The parties agree: (i) that Confidential Information will be used only in connection with performance of this Agreement; (ii) to treat the Confidential Information as it would their own proprietary and confidential information; (iii) to disclose the Confidential Information only to employees or agents of the Institution that agree to be bound by these confidentiality obligations and who need to know such Confidential Information; and, (iv) to take all reasonable precautions to prevent the disclosure of the Confidential Information to any third-party without the prior written consent of Sponsor. However, Institution may disclose Sponsor’s and Principal Investigator’s names, total grant amount, and a general non confidential title of the Study without Sponsor’s consent to VA and in any required governmental report.

(C) Institution and Principal Investigator shall be relieved of all obligations under this Section regarding Confidential Information which: (i) was known to Principal Investigator or Institution prior to receipt hereunder as set forth in written records; or (ii) at the time of disclosure to Institution or Principal Investigator was generally available to the public, or which after disclosure hereunder, becomes generally available to the public, through no fault of the Institution or Principal Investigator; or (iii) is hereafter made available to Institution or Principal Investigator from any third-party having a right to do so; or (iv) is needed for purposes of treating a patient who participated in the Study; or (v) is required by law, regulation, governmental or judicial order ,or subpoena to be disclosed, provided Institution and/or Principal Investigator shall notify Sponsor prior to any such disclosure to permit Sponsor to oppose same by appropriate legal action.

[All Confidentiality & Disclosure Laws Except FOIA]

Upon reasonable notice and at reasonable times during the term of this Agreement, the Principal Investigator and each Sub‑investigator shall permit representatives of Sponsor to examine their respective facilities, to validate case reports against original data in their files, to make copies of relevant records and monitor the work performed hereunder, to determine the adequacy of the facilities and to determine whether the Study is being conducted in compliance with this Agreement, the Protocol, and relevant government requirements. Access to patient health information shall be in compliance with all Federal statutes and regulations relating to privacy.

Publications and Presentations. Institution or Principal Investigator may freely publish and disseminate 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 the Principal Investigator. Principal Investigator shall provide Sponsor with a copy of the paper(s) prepared for publication at the earliest practicable time, but in any event not less than thirty (30) days prior to their submission to a scientific journal or presentation at scientific meetings and a reasonably detailed summary or abstract of any other oral or written publication not less than thirty (30) days prior to their submission or presentation. Sponsor may comment upon, but may not make any editorial changes to the results and conclusions set forth in the papers. Sponsor personnel shall be acknowledged in accordance with customary scientific practice.

If a multi-center project add:

As this Study is part of a multi-center trial, publications derived from this Study should include input from Principal Investigator, his/her colleagues, other investigators in this trial and Sponsor personnel. Such input should be reflected in publication authorship, and agreement regarding order of authors should be established before writing a manuscript. Investigators interested in participating in writing the manuscript should contact Sponsor. Selection of authors will depend, in part, on their level of enrollment of eligible patients. The authors selected shall have access to all data necessary for publication. VA and its researchers shall be acknowledged in accordance with customary scientific practice in any publication or presentation. Subsequent to the multi-center publication or one year after completion of the Study, whichever occurs first, Principal Investigator and/or his/her colleagues may publish the results of Investigator's part of the Study independently. (Federal Copyright Act of 1976, as amended, 17 U.S.C. § 101, et seq.)

Publications and Presentations.

(A)(1) If the Study has been designed as a single-center Study, Principal Investigator shall have the right, consistent with academic standards, to publish or present the results of his/her work performed pursuant to the Study, provided that any proposed publication or presentation (collectively, "Proposed Publication") is first reviewed by Sponsor and in accordance with Section (B).

(A)(2) If the Study has been designed as a multi-center Study, Principal Investigator acknowledges that, due to the limited patient population in its treatment group, the data generated from its individual participation in the Study and evaluation of its individual results, may not be sufficient from which to draw any meaningful scientific conclusions. For these reasons, except as provided below, Principal Investigator will not individually publish or present the results obtained from Principal Investigator’s participation in the multi-center Study. Principal Investigator may, however, upon written notice to Sponsor participate in a joint, multi-center publication of the Study results with other third party principal investigators and/or institutions, provided that the Proposed Publication is first reviewed by Sponsor in accordance with Section (B). The authors of this multi-center publication shall have access to all necessary data. VA and its researchers shall be acknowledged in accordance with customary scientific practice in any publication or presentation. In the event that the multi-center publication has not been completed within one (1) year from the date of the completion or termination of the Study, then notwithstanding the foregoing, Principal Investigator may individually publish a Proposed Publication regarding individual results from the Study, provided that the Proposed Publication is first reviewed by Sponsor in accordance with Section (B).

(B) Sponsor shall complete its review within sixty (60) days after receipt of any Proposed Publication (individual or multi-center) from Principal Investigator. If Sponsor believes that any Proposed Publication contains any information relating to patentable items, the disclosure of such Proposed Publication to any third party shall be delayed for up to ninety (90) days (beyond the review period) to permit the filing of a patent application. Should Sponsor request such a delay, then upon the written request of Principal Investigator, Sponsor shall use its best efforts consistent with reasonable business and scientific practice to expedite the filing of such patent application. However, if at the end of such ninety day period, despite the use of diligent efforts on the part of Sponsor, additional time is necessary or required in order to complete the filing of a patent application, Sponsor may request, and Principal Investigator shall grant, an extension of the period of time within which to file the patent application not to exceed an additional sixty (60) days.

Institution and Principal Investigator shall comply with all applicable federal, state and local laws, regulations and guidelines.

Institution and Principal Investigator shall comply with all applicable federal, state and local laws, regulations and guidelines, including but not limited to (i) the Federal Food Drug and Cosmetics Act, as amended and regulations promulgated thereunder, and (ii) VA regulations relating to the protection of human subjects. Additionally, Institution and Principal Investigator (a) shall comply with generally accepted professional clinical and research standards of care, and (b) will follow Good Clinical Practices to the extent required by the FDA.

Study records are managed in accordance with the Privacy Act records system notice, currently identified as 34 VA 12, which provides, in part, that records will be retained for five (5) years after the completion of the research project and/or publication of a final report. Study records may be destroyed thereafter in accordance with Privacy Act guidelines.

Study records are managed in accordance with the Privacy Act records system notice, currently identified as 34 VA 12, which provides, in part, that records will be retained for five (5) years after the completion of the research project and/or publication of a final report. Study records may be destroyed thereafter in accordance with Privacy Act guidelines.

However, if Sponsor requires or is required to maintain the study records for a longer period, it shall contact the Institution at least three months prior to the expiration of the five-year period and arrange for transfer and storage of the records by Sponsor. Said transfer and storage shall be at Sponsor’s expense and in compliance with all Federal statutes and regulations relating to privacy.

(A) Termination of this Agreement

(1) Either party may terminate this Agreement if the other party breaches any of its obligations or provisions of this Agreement, provided however, that the defaulting party shall be given not less than thirty (30) days prior written notice of such default and the opportunity to cure the default during such period.

(2) Either party may terminate this Agreement for cause or convenience upon ninety (90) days written notice.

(3) In the event this Agreement is terminated by either party, then Sponsor may specify in writing which activities and Studies should be completed at the expense of Sponsor by Investigator and the effective date of termination shall be extended only with respect to those activities and Studies until they are completed.

(B) Termination of the Study

(1) Sponsor may immediately terminate a Study being performed under the terms of this Agreement or Investigator's participation in such Study (a) in the event the Investigator does not enroll the specified minimum evaluable patients per calendar quarter, or (b) for safety reasons relating to the use of the Compound, or (c) in the event Sponsor terminates its development program relative to the Compound or the indication for the Compound specified in the Protocol, or (d) if the FDA requests that the Study be terminated.

(2) Either party or the Principal Investigator may immediately suspend or terminate performance of the Study if there is a reasonable basis to believe that the safety of the Study subjects is at risk. Whoever suspends or terminates shall immediately notify the others of the action and its basis.

(3) Upon receipt of notice of termination of a Study from Sponsor, Investigator shall immediately stop entering patients into the Study and, to the extent medically permissible, cease administering the Compound and conducting procedure on patients already entered into the Study.

(4) Investigator shall use all reasonable efforts, upon the request of Sponsor, to (i) complete reports for all patients that have been entered into the Study as of the termination date of this Agreement and/or (ii) write a final report for that portion of the Study that has been completed as of the termination date.

(5) Upon termination of a Study, Sponsor's sole obligation shall be to pay Institution for any non-cancelable obligations and a pro-rated amount for actual work performed pursuant to the Study. In the event Sponsor has overpaid Institution for work actually performed up to the date of the termination of the Study, as soon as reasonably practicable Institution shall refund to Sponsor any amounts already paid by Sponsor to Institution that are in excess of what Institution is due under this Agreement for the Study which has been terminated.

(C) Termination of this Agreement or any individual Study being performed under the terms of this Agreement shall not affect any rights or remedies of either party at law or in equity.

Either party or the Principal Investigator may immediately suspend or terminate performance of the Study if there is a reasonable basis to believe the safety or welfare of the Study subjects is at risk. Whoever suspends or terminates the Study shall immediately notify the others of the action and its basis.

Institution may terminate the Agreement for the same reasons and on the same terms as granted the Sponsor in this Agreement.

Upon termination of a Study, Sponsor's sole obligation shall be to pay Institution for any non-cancelable obligations and a pro-rated amount for actual work performed pursuant to the Study. In the event Sponsor has overpaid Institution for work actually performed up to the date of the termination of the Study, as soon as reasonably practicable Institution shall refund to Sponsor any amounts already paid by Sponsor to Institution that are in excess of what Institution is due under this Agreement for the Study which has been terminated.

This agreement shall be construed, interpreted and enforced under Federal law and, when not inconsistent, the laws of the Institution’s state of incorporation. Nothing herein shall supersede federal law.

Should any dispute arise between the parties to this Agreement, appropriate senior level personnel of the Sponsor and Institution shall first confer in person or by conference call and attempt to resolve the dispute. This conference shall occur within thirty (30) days of the time the dispute arises.

If no resolution is reached, within forty-five (45) days of the first conference, Sponsor and Institution shall attempt to settle the dispute by formal mediation. If the parties cannot agree upon a mediator and the place of the mediation, the mediation shall be administered by the American Arbitration Association in [CITY WHERE INSTITUTION IS LOCATED].

If no resolution is reached in mediation, the dispute may be resolved by arbitration before a three-arbitrator panel, administered by the American Arbitration Association, with limited discovery. To the extent not inconsistent with Federal law, the venue and the governing law shall be in and that of the State of [WHERE THE INSTITUTION IS LOCATED].

In no event shall punitive or exemplary damages or attorneys’ fees be awardable. Each party shall be responsible for its costs and fees.

RECOMMENDED (VAMC)

Referenced in, but not a party to this agreement:

[VAMC NAME & ADDRESS]

ALTERNATIVE:

This Agreement is between Sponsor and Institute, and VA is not a party.  The signature below of the Associate Chief of Staff for Research and Development at the [NAME OF VAMC] (VAMC) attests to the fact that this Study has been approved for conduct at the VAMC and that the Institution is authorized to use VAMC facilities to conduct this proposed Study.

______________________________________________
[NAME]

Associate Chief of Staff for Research and Development

RECOMMENDED (PI):

I have read the foregoing and, while not a party to this agreement, I understand the obligations of the principal investigator as stated therein.

_______________________________________________________
            [HERE TYPE IN NAME AND DEGREE OF PI]

ALTERNATIVE:

I understand and agree to the obligations of Principal Investigator in this Agreement.

_______________________________________________________
            [HERE TYPE IN NAME AND DEGREE OF PI]

This Agreement is the complete Agreement between Sponsor and Institution pertaining to this Study. Any modification is effective only when it is signed by both parties.