HIV Product definition

HIV Product shall also include any future modification, line extension or improved version of such product developed by ChemTrak during the term of this Agreement, but excluding any mail-in HIV urine or saliva test, and any True Home HIV Test.
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HIV Product means that Aware(TM) brand mail-in HIV test which has been developed by ChemTrak, consisting of a blood sample home preparation kit (the "SAMPLE COLLECTION KIT"), procedures for analysis of the blood sample at a mail-in central laboratory (a "TESTING FACILITY," as further described in Section 3.2) and reporting of results to customers, and a counseling service (the "COUNSELING SERVICE," as further described in Section 3.2) for discussion of results with customers, as further described in regulatory materials submitted by ChemTrak to the U.S. Food and Drug Administration ("FDA") prior to the Effective Date. "HIV Product" shall also include any future modification, line extension or improved version of such product developed by ChemTrak during the term of this Agreement, but excluding any mail-in HIV urine or saliva test, and any True Home HIV Test.
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HIV Product means any product containing, incorporating, or otherwise including an HIV Vaccine, in any dosage strength, formulation, or method of administration. For clarity, “HIV Product” shall include any HB-500 Program Candidate and HB-500 Program Product (each as defined under the Collaboration Agreement).
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Examples of HIV Product in a sentence

  • Selfcare represents that it is familiar with and agrees to comply with all such regulations, including any future modifications thereof, in connection with the distribution of the HIV Product.

  • ChemTrak shall have the right, but not the obligation, to repurchase from Selfcare all of the HIV Product (to the extent that the same are in new and original condition) then in Selfcare's inventory, F.O.

  • All reports, forecasts and plans generated by or for Selfcare with respect to the HIV Product and provided to ChemTrak under this Article 6 (collectively, the "Marketing Data") shall constitute Confidential Information of Selfcare, as defined under Article 8 hereof.

  • ChemTrak shall have the right to review and comment on such plan before Selfcare makes any contact with any regulatory agency pertaining to the HIV Product in the Territory.

  • Prior to First Commercial Sale and at the beginning of each calendar year thereafter, Selfcare shall submit to ChemTrak in writing whatever annual marketing plan detailing Selfcare's proposed marketing and pricing strategy and tactics for the HIV Product during the following year has been developed by Selfcare for its internal use.

  • If Selfcare assumes the defense pursuant to Section 9.2, Selfcare shall not enter into any settlement that may adversely affect the HIV Product outside the Territory, or require ChemTrak to make any payment to a third party or Selfcare, without the prior written consent of ChemTrak.

  • The parties agree to cooperate in all respects, including providing all information and documents in each party's possession, to assure compliance with adverse event reporting requirements and similar regulations applicable to the HIV Product, on a worldwide basis, including but not limited post-approval requirements imposed by the U.S. FDA by PMA approval order or regulation pursuant to 21 CFR Part 814, Subpart E, and medical device reporting obligations under 21 CFR Part 803.

  • ChemTrak wishes to designate Selfcare, and Selfcare wishes to be designated, as ChemTrak's exclusive distributor for the HIV Product in the Territory, on the terms and conditions set forth in this Agreement.

  • All expenses incurred by Selfcare in connection with its obligations under this Agreement will be borne solely by Selfcare, subject to recovery of certain expenses out of Net Sales of HIV Product as provided in Section 7.4. Selfcare will be responsible for appointing its own employees, agents and representatives, who will be compensated by Selfcare.

  • The Parties intend that this Agreement set forth all of the terms and conditions applicable to the sale of the HIV Product and accordingly agree that all provisions, terms and conditions of any purchase order, sales or order acknowledgment, invoice or other business form or document (a "Form"), unless an amendment to this Agreement in accordance with Section 13.5 hereof, shall be superseded hereby and therefore shall be disregarded and have no force and effect.


More Definitions of HIV Product

HIV Product means the product applicable to the treatment, prevention and/or amelioration of HIV developed pursuant to the HIV Program.
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