HIV Product definition

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 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 the product applicable to the treatment, prevention and/or amelioration of HIV developed pursuant to the HIV Program.
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Examples of HIV Product in a sentence

  • Selfcare agrees that it will not sell or distribute the HIV Product or clinical data relating to the HIV Product without complying with all applicable regulations.

  • To the extent required under applicable European Union regulations, Selfcare shall charge the same price for HIV Product in countries in the Territory that are members of the European Union.

  • Selfcare hereby acknowledges that the ChemTrak Technology, particularly ChemTrak's proprietary Software and the data and regulatory strategy reflected in ChemTrak's filings with the U.S. FDA regarding the HIV Product, has been maintained by ChemTrak as highly confidential and constitutes ChemTrak's proprietary and extremely valuable trade secret information.

  • 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.

  • Selfcare shall have sole responsibility for diligently pursuing Regulatory Approval of the HIV Product throughout the Territory as soon as practicable, and for bearing all costs associated therewith.

  • 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.

  • 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.

  • ChemTrak will provide Selfcare with a copy of all documentation required by the U.S. FDA in connection with its review of the HIV Product, including a right to reference all applications, registrations, and supporting documents submitted and received by ChemTrak, and will provide assistance in connection with the pursuit of Regulatory Approvals in the Territory according to a plan to be mutually agreed upon.

  • Within thirty (30) days after the receipt of the first Regulatory Approval for HIV Product in a country in the Territory, Selfcare shall submit to ChemTrak an initial purchase order for a mutually agreed upon number of Sample Collection Kits based on the predicted number necessary to launch the product.

  • 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.

Related to HIV Product

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Licensed Compound means [***].

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • Bundled Product means Product sold together with any other product(s) or service(s) at a single unit price, whether packaged together or separately, and which other product(s) or service(s) have material independent value from Product itself.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • Competing Product means [***].

  • Licensed producer means a person or entity licensed to produce medical cannabis.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Hemp products means all products made from industrial hemp,