AACF
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NIAID's Antimicrobial Acquisition and
Coordinating Facility AACF |
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Submission Info Screening Assays |
NIAID Official Screening Agreement
<Insert Submitter’s name>, referred to in this Agreement as “Submitter” has requested to participate in one or more of the anti-infective or other non-clinical evaluation programs funded by the Division of Acquired Immunodeficiency Syndrome (DAIDS), the Division of Allergy, Immunology and Transplantation (DAIT), and the Division of Microbiology and Infectious Diseases (DMID), all part of the National Institute of Allergy and Infectious Diseases (“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. Submitter may request to submit without charge patented or unpatented drugs, compounds or other products (“Material”) to NIAID. Through its contract testing laboratories or contract coordinating facilities (“Contractors”) and according to the terms and conditions below NIAID may evaluate Material for possible activity against infectious organisms or perform other non-clinical evaluations (“Evaluations”). NIAID and Submitter therefore agree as follows:
1. Submission of Material 1.1 NIAID represents that the contracts between NIAID and its Contractors are consistent with the terms of this Agreement. 1.2 While Submitter may not select the Contractors to be used, Submitter has the right to decline the use of particular Contractors conducting Evaluations. NIAID has the right to decline to conduct Evaluations of any Material. Submitter understands that not all Evaluations offered by NIAID are available at all times. 1.3 With respect to each of the proposed Evaluations, Submitter must complete Appendix A attached to this Agreement which must be mutually agreed to by NIAID and Submitter before such agreed Evaluations will be conducted. Appendix A must include a description of Material to be submitted to NIAID and the specific Evaluations requested by Submitter. 1.4 Following concurrence by NIAID, Submitter will forward to Contractors, in accordance with NIAID’s directions, Material for Evaluations as listed in Appendix A. In addition Submitter will forward data sheets for each Material which will contain pertinent data as to chemical composition, purity, solubility, toxicity, previous biological efficacy and any precautions that need to be followed in the handling, storing, or shipping of Material. 1.5 At Submitter’s request and with the prior approval of NIAID, Material to be evaluated may be submitted to Contractors under code. NIAID must be provided with the key to the code and the chemical structures of the encoded material to prevent duplication of evaluations.
2. Evaluations of Material 2.1 Protocols used for Evaluations will be approved jointly by NIAID and Submitter. 2.2 NIAID will work in conjunction with Contractors to ensure rapid ongoing communication of data and results generated from the Evaluations (“Results”) to Submitter, and Submitter will in turn use reasonable efforts to keep NIAID informed of Submitter’s own concurrent studies with Material including, but not limited to those that may affect Evaluations, Results or duplication of efforts. 2.3 Material will be used by Contractors only for Evaluations as mutually agreed to by Submitter and NIAID and for no other purpose. In addition, the Material will not be chemically modified, replicated, derived or reverse engineered. Upon completion of Evaluations all unused Material will be returned to Submitter, destroyed or otherwise disposed of as directed by Submitter.
3. Confidentiality 3.1 Submitter may provide to NIAID or Contractors scientific, business or financial information relevant to Material that Submitter deems to be its proprietary and confidential information (“Confidential Information”). Submitter must identify Confidential Information in writing as confidential. NIAID represents that Contractors are required by the NIAID contracts to protect such Confidential Information in accordance with this Section 3. 3.2 To the extent permitted by law, Confidential Information disclosed to NIAID or Contractors will remain confidential for three (3) years from 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 the recipient; b) Was obtained by the recipient, without restriction, from a third party having no confidentiality obligation to Submitter; c) Was made available to the recipient by Submitter without a confidentiality obligation, or with prior written authorization for its disclosure; d) Has been independently developed by the recipient without reference to Submitter’s information; or e) Is required to be disclosed by law, regulation or court order provided that Submitter has been notified and the recipient has taken reasonable efforts to minimize the extent of the required disclosure. 3.3 NIAID will ensure that Confidential Information is kept in restricted-access files. Only personnel directly involved in the Evaluations will have access to the files containing Confidential Information. Submitter acknowledges that Results are not Submitter’s Confidential Information and may be disclosed by NIAID and Contractors in accordance with Section 4 below.
4. Publications 4.1 NIAID and the Contractors may publish or otherwise publicly disclose Results after a period of four (4) months from the date of transfer of Results to Submitter. This delay in disclosure is intended to allow Submitter time to file patent applications if desired. 4.2 Publication of Results earlier than the four (4) month period by NIAID or Contractors will require Submitter’s prior written consent, which will not be unreasonably withheld. 4.3 Before Submitter or NIAID submit a paper or abstract for publication or otherwise intend to publicly disclose information about Evaluations or Results related to Submitter’s Material, such as a press release, NIAID and Submitter will provide the other Party fourteen (14) days to review and comment on the proposed disclosure. 4.4 Submitter will not be identified in NIAID or Contractor’s publications as the source of Material without Submitter’s prior written approval. 4.5 Submitter will not construe the involvement of NIAID in Evaluations as an endorsement of Material by the U.S. Government or any of its agencies, employees or Contractors. Submitter will give appropriate credit for the Evaluations to NIAID, and/or the Contractors.
5. Intellectual Property 5.1 Subject to applicable law, Submitter will retain all of Submitter’s existing intellectual property rights to Material. 5.2 Submitter understands that Contractors have the right to elect to retain title to inventions made under Government-supported contracts [37 CFR 401.14(b)]. However, Contractors have agreed to an “Intellectual Property Option” as part of their contracts. Under the Intellectual Property Option Contractors are required to: a) Promptly notify NIAID and Submitter of any invention made by Contractors in the performance of work under the contract using Submitter’s Material; b) Grant Submitter a paid-up, nonexclusive, nontransferable, royalty-free, world-wide license to all such inventions for research purposes only; and c) Grant Submitter a time-limited first option to negotiate an exclusive, world-wide royalty-bearing license in such inventions for all commercial purposes, including the right to grant sub-licenses, on terms to be negotiated in good faith by Submitter and Contractor.
6. No Warranty Material is experimental in nature. Submitter 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.
7. Liability and Indemnification 7.1 Submitter disclaims all liability for claims, damages, or liability resulting from its activities under this agreement, unless caused by Submitter’s gross negligence or willful misconduct. 7.2 No indemnification is provided by either Party under this Agreement. NIAID is prohibited under statute, the Anti-Deficiency Act, 31 U.S.C. § 1341, from indemnifying any party, absent other specific statutory authorization.
8. Governing Law The construction, validity, performance and effect of this Agreement will 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 will not impair, affect, or invalidate the other provisions of this Agreement.
9. Duration of Agreement This Agreement will be in effect for three (3) years from the date of the last signature below.
10. Amendments. 10.1 If NIAID or Submitter 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 NIAID and Submitter. 10.2 If Submitter desires to add Material or Evaluations not originally listed in Appendix A, prior written approval from NIAID is required. All other terms and conditions of this Agreement will remain in full force and effect.
11. Termination Either NIAID or Submitter may terminate this Agreement at any time by giving written notice at least thirty (30) days prior to the desired termination date.
12. Survivability The provisions of Articles 3, 4, 5, 6, 7, 8 and 12 will survive the termination or expiration of this Agreement.
SIGNATURES BEGIN ON NEXT PAGE Accepted and agreed by the Parties through their duly authorized representatives as of the last date of signature below.
FOR NIAID: ____________________________ Carole Heilman, Ph.D. Director Division of Microbiology & Infectious Diseases, NIAID, NIH Room 6111, 6610 Rockledge Dr Bethesda, MD 20892-6603 Ph: (301) 496-1884 Fax: (301) 480-4528 Date: _______________________
FOR SUBMITTER: ____________________________ Name: Title: Organization: Address: Phone/Fax: Date: _______________________
SUBMITTER POINTS OF CONTACT:
Submitter Agreement POCName: Title: Organization: Street/Bldg: City: State: Zip: Phone: Fax: Email:
Submitter Scientific POCName: Title: Organization: Street/Bldg: City: State: Zip: Phone: Fax: Email: Appendix A
1. SUBMITTER REQUESTED EVALUATIONS
PLEASE NOTE: While every attempt is made to accommodate all evaluations and models selected, all evaluations are not available at all times.
Check box to indicate desired screens:
DMID Virology Branch (VB) In Vitro Screens Herpesviruses: HSV-1, HSV-2, VZV, EBV, CMV, HHV-6, HHV-8 Respiratory viruses: Flu A & B, RSV, PIV, Measles, Rhino, Adeno, SARS Orthopoxviruses: Vaccinia, Cowpox Biodefense: VEE, Punta Toro, Pichinde, Yellow fever, West Nile, Dengue Hepatitis B virus, Hepatitis C virus Papillomavirus, BK virus
Other in vitro model: __________________________________________
DMID Virology Branch Animal Models Herpesviruses (HSV-1, HSV-2, MCMV, GPCMV, HCMVSCID-hu) Respiratory viruses (Flu A & B, RSV, PIV-3, MV, Human Metapneumovirus) Orthopoxviruses (Vaccinia, Cowpox, Ectromelia, Monkeypox) Papillomaviruses (Shope, HPVSCID-hu) Hamster scrapie Special Pathogens: Punta Toro, Pichinde, Banzi, Semliki Forest, West Nile, Venezuelan Equine Encephalitis, Yellow Fever SARS Other animal model: __________________________________________
VB Agreement POCDenise Cinquegrana, MPH Health Specialist Virology Branch, DMID, NIAID, NIH 6610 Rockledge Dr., Room 4048, MSC 6604 Bethesda, MD 20892 Phone: (301) 451-3503 Fax: (301) 480-1594 Email: cinquegranad@niaid.nih.gov
VB Scientific POCChristopher Tseng Ph.D. Program Officer Virology Branch, DMID, NIAID 6610 Rockledge Drive, Rm 4105 Bethesda, MD 20817-6604 Phone: (301) 496-7453 Fax: (301) 480-1594 Email: ctseng@niaid.nih.gov DMID Office of Biodefense Research Affairs (OBRA) - In Vitro Tests Bacterial Species: Bacillus anthracis Yersinia pestis Francisella tularensis Brucella spp. Burkholderia mallei Burkholderia pseudomallei Coxiella burnetii
Assay: Broth Micro-dilution Agar Dilution E Test
Other: __________________________________________
DMID Office of Biodefense Research Affairs - In Vivo Tests Specify below: Pathogen: Strain/Isolate: Animal Model: Other: ______________________________________
OBRA Agreement POCJeff Hildesheim Technology Development Associate Office of Technology Development NIAID, NIH 6610 Rockledge Drive, Rm 4028 Bethesda, MD 20817-6606 Phone: 301-451-3524 Fax: 301-402-7123 Email: jh30h@nih.gov
OBRA Scientific POCKristin DeBord, PhD Program Officer OBRA, NIAID, NIH 6610 Rockledge Drive, Rm 5025 Bethesda, MD 20892-6604 Phone: 310-402-8554 Fax: 301-480-1263 Email: debordk@niaid.nih.gov
DMID Enteric and Hepatic Disease Branch (EHDB) - Hepatitis Animal ModelsHBV--woodchuck infection modelHBV--transgenic mouse model and hydrodynamic injection modelHCV--SCID-hu mouse modelOther animal model: _____________________________________
EHDB Agreement POCDiana S. Berard Program Officer EHDB, DMID, NIAID 6610 Rockledge Drive/4003 Bethesda, MD 20892-6604 Phone: (301) 402-8617 Fax: (301) 402-1456 Email: dberard@niaid.nih.gov
EHDB Scientific POCDiana S. Berard Program Officer EHDB, DMID, NIAID 6610 Rockledge Drive/4003 Bethesda, MD 20892-6604 Phone: (301) 402-8617 Fax: (301) 402-1456 Email: dberard@niaid.nih.gov
DMID Sexually Transmitted Infections Branch (STIB) Evaluations
Evaluations in the pig-tailed macaque model for activity against STD pathogens.
Note that for this test Submitter agrees that: (1) Submitter will supply NIAID with 500 ml of each Material and its placebo vehicle. All Material will be prepared under GMP conditions. (2) The placebo vehicle must contain no microbicidal agent. (3) The Material must have a reasonable consistency for vaginal application. (4) The shelf life of the Material should be determined by the Submitter to be stable for at least 6 months from date of shipment. (5) The Material must be formulated in a vehicle that is not expected to interfere with the anti-microbial effects of the active agent.
Other evaluation: __________________________________________
STIB Agreement POCAnna Z. Amar Technology Development Associate Office of Technology Development NIAID, NIH 6610 Rockledge Drive, Rm 4043 Bethesda, MD 20817-6606 Phone: 301-451-3525 Fax: 301-402-7123 Email: aa54d@nih.gov
STIB Scientific POCCarolyn Deal, PhD Chief STIB, NIAID, NIH 6610 Rockledge Drive, Rm 5039 Bethesda, MD 20892-6604 Phone: 301-402-0443 Fax: 301-480-3617 Email: aa54d@nih.gov
2. DESCRIPTION OF MATERIAL AND INFORMATION TO BE PROVIDED BY SUBMITTER
Please include here all pertinent available data as to purity, solubility, stability, toxicity, chemical composition and structure, previous biological efficacy, and any precautions that should be followed in handling, storing and shipping for each Material being submitted.
For Sexually Transmitted Diseases (STDB) tests: Submitter will forward to the Sexually Transmitted Diseases (STDB) of the DMID or to the testing site, as directed by the STDB, the additional data sheets on the Material to be Evaluated, marked confidential. Data sheets are to be in duplicate for each product, giving pertinent available data as to: (1) In vitro data* showing active ingredient(s) and/or formulation’s activity against STD pathogens (e.g. Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, HIV, HSV) made available by the Submitter. (2) In vitro data* showing effects of active ingredient(s) and/or formulation on Lactobacillus crispatus and other members of vaginal flora. (3) The toxicity data for the Material will, at a minimum, include Rabbit Vaginal Irritation studies, and comments on cell associated toxicity observed in in vitro assays (item 1).
List of Submitter’s Material:
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