Combination Product means a product (a) containing a Licensed Product together with one or more other active ingredients, or (b) with one or more products, devices, pieces of equipment or components, but sold for an integrated price (e.g., with the purchase of one product the customer gets a coupon for the other) or for a single price.
Combination Products means COBI Combination Products, EVG Combination Products, TDF Combination Products, TAF Combination Products and Quad Product.
Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.
Alternative nicotine product means any noncombustible product containing nicotine that is intended 766 for human consumption, whether chewed, absorbed, dissolved, or ingested by any other means. 767 "Alternative nicotine product" does not include any nicotine vapor product, tobacco product, or product 768 regulated as a drug or device by the U.S. Food and Drug Administration (FDA) under Chapter V (21 769 U.S.C. § 351 et seq.) of the Federal Food, Drug, and Cosmetic Act.
Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.