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Screening Agreement

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

The organization providing compounds for evaluation (SUPPLIER), may supply products, patented or unpatented, to the Division of AIDS (DIVISION), which may then screen and test them for possible treatment of mycobacterial infections including tuberculosis. If agreed to in writing by the SUPPLIER and the DIVISION, but not unless such written agreement is obtained, these products may also be entered into screening and testing as antiviral, antibacterial, antifungal, antiparasitic, immunomodulating, and biological modifying agents with potential for treatment of AIDS and associated opportunistic infections.

Using protocols evaluated and approved mutually by the DIVISION and the SUPPLIER, the products will be screened by one or more of the DIVISION's contract testing laboratories (SCREENING CONTRACTORS), but will not be placed in the laboratories of any company in or affiliated with the pharmaceutical or chemical industries without the SUPPLIER's written permission.

In order to facilitate record keeping and handling of confidential materials, the following procedures will be used by the DIVISION:

  1. The SUPPLIER shall forward to the acquisition contractor (Southern Research Institute, hereafter referred to as SOUTHERN) the products to be tested together with data sheets in duplicate for each product, giving pertinent available data as to chemical constitution, stability, solubility, toxicity, previous biological efficacy and any precautions that need to be followed in handling, storing, shipping and/or testing.
  2. It is clearly understood that no data about the products, whether provided by the SUPPLIER or generated by the DIVISION or SOUTHERN, and the results of the testing will be kept in any files open to the public either by the DIVISION, SCREENING CONTRACTORS, or SOUTHERN. Only those employees directly engaged in the operation of the DIVISION will have access to the files of information regarding source and nature of confidential materials and results of testing, except as required pursuant to the Freedom of Information Act, 5 U.S.C. 552. In no case will information properly designated as proprietary or confidential by the SUPPLIER need to be released under this Act.
  3. Whenever possible, the SUPPLIER will be given the choice of the DIVISION's SCREENING CONTRACTORS, although at present there is no preference; and, it is understood that the DIVISION reserves the right to send the SUPPLIER's products to other SCREENING CONTRACTORS if the need arises. It is furthermore understood that the contracts between the DIVISION and the SCREENING CONTRACTORS will contain provisions to safeguard the

    4. SUPPLIER's rights under this Agreement.

  4. Because the DIVISION's screening effort will be accomplished in collaboration with the DIVISION's scientific staff and SOUTHERN's project team, as well as the SUPPLIER's own staff, the DIVISION will use its best efforts to facilitate rapid ongoing communications of screening data to the SUPPLIER.

Although the SUPPLIER recognizes that the interchange of information is generally desirable in the field of treatment for mycobacterial infections including tuberculosis, it is mutually understood that the SUPPLIER, in voluntarily supplying appropriately marked information deemed proprietary, including product and information regarding this product hereunder, is entitled to protection for any such technical information it may furnish.

  1. It is understood and agreed to, subject to applicable law, that the SUPPLIER shall retain all rights to those products in which the SUPPLIER has a proprietary interest. To clarify, the finding of activity in the designated screens does not result in any intellectual property rights for SOUTHERN or the SCREENING CONTRACTORS. The DIVISION agrees to notify the SUPPLIER of the names of the SCREENING CONTRACTORS prior to submitting SUPPLIER’s products to them. Subject notwithstanding, to the provision that, with respect only to those products determined by means of the various screening and testing processes to possess such significant activity (strong potential to be scheduled for clinical trial by the DIVISION, using mutually approved protocols), the U. S. Government shall have a royalty-free irrevocable, nonexclusive license for clinical trials under any patent that the SUPPLIER may have or obtain on such product or on a process for use of such product, to manufacture and/or use by or for the U. S. Government the invention(s) claimed by the patent(s) only for medical research purposes related to the treatment of mycobacterial infections including tuberculosis.
  2. The DIVISION and SUPPLIER agree that publication of screening results is worthwhile and should be governed by the following. Specifically:
    1. With regard to screening results on compounds in which the SUPPLIER has a proprietary interest, and that the DIVISION deems significant for research on mycobacterial infections including tuberculosis, the SUPPLIER agrees that the DIVISION may publish or otherwise disclose such results only with the written permission of the SUPPLIER, and that the SUPPLIER will not unreasonably withhold such permission. SUPPLIER in that regard agrees to pursue appropriate patent coverage in a timely manner, or to allow the U. S. Government to do so.
    2. The SUPPLIER will inform the DIVISION prior to publishing screening data along with the available biological and physical data; appropriate credit shall be given to the U. S. Public Health Service.
    3. In no case will the DIVISION publish information identifying the SUPPLIER as the source of a product without written approval from the SUPPLIER; appropriate credit shall be given to the SUPPLIER.
  3. Following the receipt of complete test results by the DIVISION, the SUPPLIER will receive in a timely manner a full report including all screening data. The products scheduled for clinical trial, referred to herein under paragraph 3a, shall be designated by the DIVISION, and the aforementioned report will specify the products so selected. The SUPPLIER has the right to proceed with clinical trials in a timely manner at its own expense. The DIVISION agrees to assist the SUPPLIER with assessing the clinical potential of candidate compounds.

 

The DIVISION is confident that this agreement will lay the basis for mutually satisfactory cooperation in the field and in the treatment of mycobacterial infections including tuberculosis.

In agreeing to the above, the SUPPLIER signs below, as well as the attached duplicate of this agreement, and returns both to the DIVISION for countersignature. One original will be returned for the SUPPLIER's files.

 

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