HIF Compound definition

HIF Compound means any compound that stabilizes hypoxia-inducible factor (“HIF”) or that modulates HIF prolyl hydroxylase activity.
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HIF Compound means any molecule that stabilizes HIF through modulation of prolyl hydroxylase and/or asparaginyl hydroxylase. 25. “IND” shall mean an Investigational New Drug application, as defined in the U.S. Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or comparable filing in a foreign jurisdiction, in each case with respect to a Product for use within the Field. 26. “Indication” shall mean any given indication within the Field. 27. “Initiate” or “Initiation” shall mean with respect to a particular clinical trial for a Product, the initial dosing of the first patient in such trial in accordance with the protocol therefor. 28. “JDCA” shall mean the Japanese Definitive Collaboration Agreement between FibroGen and Astellas effective June 1, 2005. 29. “Marketing Approval” shall mean, with respect to each Product, approval in the Territory by the appropriate regulatory agency to market such Product for an Indication within the Field. It is understood that pricing or reimbursement approval shall constitute a part of the Marketing Approval. For purposes of the Milestone Payments triggered by Marketing Approval set forth below, the First Commercial Sale of a Product (excluding permitted sales for compassionate use — also referred to as named patient supply in Europe — pending diligent efforts to obtain Marketing Approval) shall trigger such [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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HIF Compound means any molecule that stabilizes HIF through modulation of prolyl hydroxylase and/or asparaginyl hydroxylase.
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Examples of HIF Compound in a sentence

  • Effective upon such written notice, the identified HIF Compound shall be deemed a Collaboration Compound, provided that AstraZeneca shall not have any obligations with respect to such Collaboration Compound (or Product) under this Agreement unless and until AstraZeneca’s acceptance thereof through written notice to FibroGen.

  • FibroGen shall have the sole right and authority to initiate and/or pursue at its sole expense any patent office proceeding, pre- or post-grant or issuance, including reissue, reexamination, limitation, or invalidation proceedings, or any opposition- or interference-type proceeding or challenge against any Third Party Patent that relates or that may potentially relate to the manufacture, use, or sale of a HIF Compound, a Product, or a Designated Product.

  • At any time during the Term, FibroGen may upon written notice to AstraZeneca include any HIF Compound in the definition of Collaboration Compound (and Product).

  • AstraZeneca hereby covenants that during the Term and the term of the U.S. and RoW Agreement, except pursuant to this Agreement or the U.S. and RoW Agreement, neither it nor its Affiliates will, directly or indirectly, by itself or with a Third Party, research, manufacture, develop, sell, market or otherwise commercialize any HIF Compound in the Territory, and neither it nor its Affiliates will license or authorize a Third Party to conduct any such activity in the Territory.

  • FibroGen China shall have the sole right and authority to initiate and/or pursue at its sole expense any patent office proceedings, pre- or post-grant or issuance, including reissue, reexamination, limitation, or invalidation proceedings, or any opposition- or interference-type proceeding or challenge against any Third Party Patent that relates or that may potentially relate to the manufacture, use, or sale of a HIF Compound or a Product.

  • For the avoidance of doubt, a given HIF Compound shall be deemed designated as a Product (and written notice thereof provided to Astellas) once FibroGen (directly or indirectly, including by a licensee) Initiates a Phase III clinical trial with such HIF Compound in patients for an Anemia Indication prior to the Final Development Termination Date.

  • FibroGen shall provide notice to Astellas of any such designation, identifying the HIF Compound subject thereto.

  • Designation of Products: In addition to FG-2216 and FG-4592, a HIF Compound shall become a Product hereunder when any such HIF Compound owned or Controlled by FibroGen is so designated by FibroGen (by notice to Astellas as described below) prior to the Final Development Termination Date.

Related to HIF Compound

  • 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 [***].

  • 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.

  • Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.

  • Compound means the taking of two or more ingredients and fabricating them into a single

  • 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”).

  • 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.

  • 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.

  • 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.

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

  • Compounds means any or all of the following chemicals, as the context requires:

  • 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.

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

  • Exempt compound means the same as defined in Rule 2.

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

  • Antibody means a molecule comprising or containing one or more immunoglobulin variable domains or any fragments, derivatives, variants or modifications thereof that bind to the same antigen.

  • 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.

  • 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 [***].

  • 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.

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

  • Alternative nicotine product means any noncombustible product containing nicotine that is intended for human consumption, whether chewed, absorbed, dissolved, or ingested by any other means. "Alternative nicotine product" does not include any nicotine vapor product, tobacco product, or product regulated as a drug or device by the U.S. Food and Drug Administration (FDA) under Chapter V (21

  • Opioid antagonist means a drug that binds to opioid

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • 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.