Gilead Combination Product definition

Gilead Combination Product means a pharmaceutical product containing a Galapagos Molecule or Optioned Molecule In Combination with one or more other active pharmaceutical ingredients that are owned or controlled by Gilead or any of its Affiliates, in any and all finished forms, presentations, delivery systems, strength, dosages, and formulations.
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Gilead Combination Product means a pharmaceutical product containing the Licensed Compound in combination with at least one active pharmaceutical ingredient other than the Licensed Compound, which active pharmaceutical ingredient is Controlled by Gilead or its Affiliates. The term “in combination,” covers instances where the Licensed Compound and at least one active pharmaceutical ingredient Controlled by Gilead or its Affiliates are administered in a single formulation and where the Licensed Compound and at least one active pharmaceutical ingredient Controlled by Gilead or its Affiliates are sold either as a fixed dose combination or with separate doses in a single package. * Confidential Information, indicated by […***…], has been omitted from this filing and filed separately with the Securities and Exchange Commission.
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Gilead Combination Product means a pharmaceutical product containing the Licensed Compound in combination with at least one active pharmaceutical ingredient other than the Licensed Compound, which active pharmaceutical ingredient is Controlled by Gilead or its Affiliates. The term “in combination,” covers instances where the Licensed Compound and at least one active pharmaceutical ingredient Controlled by Gilead or its Affiliates are administered in a single formulation and where the Licensed Compound and at least one active pharmaceutical ingredient Controlled by Gilead or its Affiliates are sold either as a fixed dose combination or with separate doses in a single package.* Confidential Information, indicated by […***…], has been omitted from this filing and filed separately with the Securities and Exchange Commission.
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Examples of Gilead Combination Product in a sentence

  • For purposes of this Section 8.4, […***…] for a Gilead Combination Product shall mean […***…].

  • If a Compulsory License is granted to a Third Party with respect to a Licensed Product or Gilead Combination Product, as applicable in any country in the Licensed Territory, and such Third Party actually sells such Licensed Product or Gilead Combination Product in the country under such Compulsory License, with a royalty rate lower than the royalty rate provided by this Section 8.3, then the Parties shall […***…].

  • Gilead will own all INDs, applications for Regulatory Approval and related regulatory documentation in the Territory with respect to any Licensed Product or Gilead Combination Product.

  • Royalties under Section 8.3(a) and Section 8.3(b) shall be payable, on a country-by-country basis, on the Net Sales of Licensed Products or Gilead Combination Products, as applicable, beginning on the First Commercial Sale of the first Licensed Product or Gilead Combination Product to launch in such country until […***…] (the “Royalty Term”).

  • Following the Regulatory Transition Date, Gilead will be solely responsible for all regulatory matters relating to any Licensed Product or Gilead Combination Product in the Territory, and shall use Commercially Reasonable Efforts with respect to such regulatory matters for the first Licensed Product in each Major Market in each Target Indication, and Galapagos shall use Commercially Reasonable Efforts as requested by Gilead to assist Gilead with such regulatory matters.

  • The rights and obligations of both Parties with respect to any Patents that disclose the use of any active pharmaceutical ingredient that is owned or controlled by Gilead or any of its Affiliates with any Galapagos Molecule, Galapagos Product, Optioned Molecule or Optioned Product (including, for clarity, any Gilead Combination Product) shall be governed by the applicable Combination Product Activities Agreement.

  • For a Compulsory License regarding a Gilead Combination Product, the Parties’ respective share of Net Receipts will be adjustied according to the […***…] of such Gilead Combination Product.

  • To the extent […***…] the […***…] of such Gilead Combination Product for such country shall be added to the Net Sales of Licensed Products for purposes of calculating the sales milestones, royalty rates and royalties pursuant to Sections 8.2(c) and 8.3(a) and such Net Sales corresponding to such […***…] shall not be counted as Net Sales of Gilead Combination Products for purposes of Section 8.3(b).

  • For a Compulsory License regarding a Gilead Combination Product, the Parties’ respective share of Net Receipts will be adjusted according to the […***…] of such Gilead Combination Product.

  • For a Gilead Combination Product sold for Veterinary Use, the Parties’ respective share of revenues will be adjustied according to the […***…] of such Gilead Combination Product.


More Definitions of Gilead Combination Product

Gilead Combination Product means a pharmaceutical product containing the Licensed Compound in combination with […***…]. The term “in combination,” covers instances where the Licensed Compound and at least […***…].” (j) Section 1.97 of the A&R Collaboration Agreement shall be deleted in its entirety as of the Effective Date and replaced with the following:
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Related to Gilead Combination Product

  • Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Combination Products means COBI Combination Products, EVG Combination Products, TDF Combination Products, TAF Combination Products and Quad Product.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Licensed Compound means [***].

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

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

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

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

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

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

  • Competing Product means [***].

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • 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.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • 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.

  • 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.

  • Companion Diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:

  • Royalty Product means, either (a) an Alnylam Royalty Product, or (b) an Inex Royalty Product.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.