Material Evaluation Agreement

Note:  The TAACF Material Evaluation Agreement displayed below is for review purposes only.  An official copy will be forwarded to you upon request.  Please contact the TAACF at taacf@sri.org.

This Material Evaluation Agreement is made and entered into between the Division of Acquired Immunodeficiency Syndrome (“DAIDS”) of the National Institute of Allergy and Infectious Diseases (“NIAID”), located at 6700B Rockledge Drive, Bethesda, Maryland 20892, and <insert company>, having its principal place of business located at <insert company’s address> (“PROVIDER”). DAIDS funds a comprehensive portfolio of contracts to discover and develop novel agents for the prevention and treatment of infections caused by human immunodeficiency virus (“HIV”), opportunistic infections associated with AIDS, hepatitis C, and tuberculosis. PROVIDER requests to voluntarily participate in one or more of the evaluation programs (e.g., in vitro, animal model, drug development) funded by DAIDS and submits for evaluation patented or unpatented drugs, compounds, or other products (“Material”) to DAIDS. Without cost to the PROVIDER, DAIDS may evaluate the submitted Material through its Contractors.

DAIDS shall determine which protocols shall be utilized to evaluate PROVIDER’s Material and the extent of the evaluation. PROVIDER shall have the right to request limitations on the scope and extent of evaluation of the Material by DAIDS.  

DAIDS and PROVIDER therefore agree as follows:

1.      Definitions.

1.1              “Confidential Information” is scientific, business, or financial information the PROVIDER or DAIDS deem to be proprietary or confidential and which information is identified as “Confidential” in writing. Confidential written information shall be marked “Confidential.” Oral disclosures must be reduced to writing, marked “Confidential,” and sent to the other Party’s Point of Contact listed in Section 11 within 10 business days after disclosure to be considered Confidential Information.

1.2              “Contractors” are DAIDS approved non-profit and for-profit testing laboratories with contractual obligations to DAIDS. 

1.3              “DAIDS” is a division within NIAID, an institute of the National Institutes of Health (“NIH”), which is a component of the Department of Health and Human Services (“HHS”), an agency of the U.S. Government.  

1.4              “Evaluations” will include the testing of the Materials in the manner described below.

a.       <DAIDS to provide description of evaluations – use terms from “MEA examples list”>

1.5              “Invention” means any invention or discovery which is or may be patentable or otherwise protected under Title 35, United States Code (“U.S.C.”), or any novel variety or plant which is or may be protectable under the Plant Variety Protection Act (7 U.S.C. §§ 2321 et seq.).

1.6              “Material” means:

a.       <DAIDS & PROVIDER to negotiate Description of Material - use terms from “MEA examples list” >

1.7              “Results” means all recorded data, results, and technical information produced from the Evaluations of the Material under this Agreement and not previously disclosed by the PROVIDER.

2.      Submission and Evaluations of Material.

2.1              DAIDS represents that the contracts between DAIDS and the Contractors are consistent with the terms of this Agreement.

2.2              DAIDS has the right to decline to conduct Evaluations of any Material or to limit the scope of such Evaluations. PROVIDER understands that not all Evaluations offered by DAIDS are available at all times. Evaluations must be mutually agreed to by DAIDS and PROVIDER prior to commencement of Evaluations and are delineated in Section 1.4 above. After initiation of Evaluations listed in Section 1.4, PROVIDER and/or DAIDS may request additional Evaluations. Additional Evaluations are contingent upon meeting DAIDS criteria for such Evaluations and shall be mutually agreed upon in writing and attached hereto as an Amendment.

2.3              While PROVIDER may not select the Contractors, PROVIDER has the right to decline the use of particular Contractors conducting Evaluations prior to the communication of any Material to such Contractors.

2.4              Under the direction of DAIDS, PROVIDER shall forward to Contractors the Material to be tested together with a Material Safety Data sheet for each Material which contains pertinent available data as to chemical composition, purity, solubility, toxicity, and any precautions that need to be followed in handling, storing, and shipping the Material.

2.5              Material is to be used by Contractors for Evaluations under this Agreement only and for no other purpose. In addition, Material will not be chemically modified, replicated, derived, or reverse engineered unless specifically necessary for the performance of the Evaluations. Such modification would require PROVIDER’s written approval. Upon completion of Evaluations, DAIDS shall elect to either return to PROVIDER or destroy all unused Material.

2.6              DAIDS will use reasonable efforts to ensure rapid ongoing communication of Results to PROVIDER, and PROVIDER will in turn use reasonable efforts to keep DAIDS informed of PROVIDER’s own concurrent studies with the Material that may affect Evaluations or Results.

3.      Confidentiality.

3.1              PROVIDER may provide Confidential Information relevant to the Evaluation of the Material to DAIDS and the Contractors. DAIDS represents that the Contractors are required by their DAIDS contracts to protect such Confidential Information with reasonable efforts as specified in Section 3.3 below.

3.2        To the extent permitted by law, Confidential Information disclosed to DAIDS or the Contractors will remain confidential for five (5) years after the effective date of this Agreement unless the information:

a.       Is known by the public or becomes known by the public through no fault of DAIDS or the Contractors;

b.      Was obtained by DAIDS or the Contractors, without restriction, from a third party having no confidentiality obligation to the PROVIDER;

c.       Has been independently developed by DAIDS or the Contractors without reference to the PROVIDER’s Confidential information; or

d.      Is required to be disclosed by law, regulation, or court order provided that PROVIDER has been notified and DAIDS or the Contractors have taken reasonable efforts to minimize the extent of the required disclosure.

3.3              No data about the Material, Evaluations, or Results will be kept in files open to the public either by DAIDS or the Contractors. Only personnel directly involved in the Evaluations will have access to the files containing Confidential Information.

3.4              PROVIDER acknowledges that Results are not Confidential Information as defined in Section 1.1, and may be disclosed by DAIDS and the Contractors only in accordance with Article 4 below.

4.      Disclosure of Results.

4.1              DAIDS and the Contractors may publish or otherwise publicly disclose Results after a period of six (6) months from the date of transfer of Results to PROVIDER. The six-month delay in disclosure is intended to allow PROVIDER time to file patent applications if desired.

4.2              Publication of Results earlier than the six (6) month period by DAIDS or Contractors will require PROVIDER’s prior written consent, which will not be unreasonably withheld.

4.3              PROVIDER is encouraged to pursue publication of Results in conjunction with or separately from DAIDS and the Contractors. Before PROVIDER or DAIDS submit a paper or abstract for publication or otherwise intend to publicly disclose information about Evaluations or Results related to PROVIDER’s Material, such as a press release, DAIDS and PROVIDER will provide the other Party fourteen (14) days to review and comment on the proposed disclosure. DAIDS will require the Contractors to consult with PROVIDER, whenever the Contractor intends to include Results in any publication or other public disclosure such as a press release.

4.4              PROVIDER will not be identified in DAIDS or Contractor publications as the source of Material without PROVIDER’s prior written approval.

4.5              PROVIDER will not construe the involvement of DAIDS in Evaluations as an endorsement of Material by the U.S. Government or any of its agencies, employees, or Contractors.

4.6              PROVIDER will include acknowledgement of DAIDS/NIAID/NIH and the contract number(s) providing support in any public disclosure (e.g., publication, press release, poster at a meeting).

5.      Intellectual Property.

5.1              Subject to applicable law, PROVIDER shall retain all of PROVIDER’s existing intellectual property rights to Material. DAIDS acknowledges that this Agreement may not be construed as a grant by the PROVIDER of a license or any other right or interest to the Material beyond those expressly set forth herein.

5.2              Declaration of Exceptional Circumstances> DAIDS represents that the contracts between DAIDS and the Contractors require the Contractors to assign to PROVIDER all right, title and interest in and to any new Invention(s) made during the Evaluations that contain in whole or in part the PROVIDER’s Material or relate to a new method of use of the Material beyond that intended by the PROVIDER under this agreement.. 

6.      Warranty and Limitation of Liability.

6.1              DAIDS acknowledges and agrees that the Material is experimental in nature. PROVIDER makes no representations and extends no warranty of any kind, either expressed or implied, including any warranty of merchantability or fitness for a particular purpose, or warranty that the use of Material will not infringe any patent, copyright, trademark, or other proprietary right.

6.2              PROVIDER disclaims all liability for any claims, damages, or liability resulting from its activities under this agreement, unless caused by PROVIDER’s gross negligence or willful misconduct. DAIDS shall be liable for any loss, claim, damage, or liability that DAIDS incurs as a result of its activities under this Agreement, except that DAIDS, as part of an agency of the United States, assumes liability only to the extent provided under the Federal Tort Claims Act, 28 U.S.C. §§ 2671 et seq.

6.3              No indemnification for any loss, claim, damage, or liability is intended or provided by DAIDS under this Agreement. DAIDS is prohibited under statute, the Anti-Deficiency Act 31 U.S.C. §1341, from indemnifying any party, absent other specific statutory authorization.

7.      Term and Termination.

7.1              This Agreement will be in effect for five (5) years from the date of the last signature below. 

7.2              DAIDS may terminate evaluations of Material based on demonstrated lack of efficacy, unanticipated toxicity, new information reported or published on drugs, compounds, or other products similar to Material, technical difficulties in performing Evaluations, lack of contract funds, or unavailability of resources. DAIDS shall notify PROVIDER in writing within five (5) business days of such a decision.

7.3              Either DAIDS or PROVIDER may terminate this Agreement at any time by giving written notice at least thirty (30) days prior to the desired termination date.

8.      Amendments.

8.1              If DAIDS or PROVIDER desires an extension of, or other modification to this Agreement they will, upon reasonable notice to the other, confer in good faith to determine the desirability of the modification. No modification is effective until a written Amendment is signed by authorized representatives of DAIDS and PROVIDER. 

8.2              If PROVIDER desires to add Material or Evaluations not originally agreed to, prior approval from DAIDS is required and an Amendment to this Agreement must be made. All terms and conditions of this Agreement will remain in full force and effect.

9.      Governing Law. 

The construction, validity, performance, and effect of this Agreement shall be governed by Federal law, as applied by the Federal Courts in the District of Columbia. Federal law and regulations will preempt any conflicting or inconsistent provisions in this Agreement. The illegality or invalidity of any provisions of this Agreement shall not impair, affect, or invalidate the other provisions of this Agreement.

10.  Survivability.

The provisions of Articles 3, 4, 5, 6, 9 and 10 will survive the termination or expiration of this Agreement.

11.  Points of Contact.

Accepted and agreed by the Parties through their duly authorized representatives as of the last date of signature below.

Note:  This web-based version of the TAACF Material Evaluation Agreement is for review puposes only.  An official copy will be forwarded to you immediately upon request.