Second Generation Compound definition

Second Generation Compound means Compounds that when compared to the [***] interact with a [***] and which have distinct pharmacophore properties and improved profile with an acceptable safety profile.
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Second Generation Compound has the meaning set forth in Section 1.206 of the License Agreement.
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Second Generation Compound means compounds synthesized [* **************************************************************** *********************************************]
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Examples of Second Generation Compound in a sentence

  • Unless this Agreement is sooner terminated in accordance with the provisions of this Article 13, the Research Phase with respect to a particular compound shall expire upon the designation of such compound as a Second Generation Compound in accordance with Section 4.1.4 hereof.

  • At such time, such compound will become part of the Development Program and the Joint Steering Committee will amend the Annual Development Plan then in effect as appropriate to cover such Second Generation Compound including new product objectives for each of the Parties.

  • In the event that the Development Phase is terminated with respect to any compound pursuant to Section 13.1.2, then such compound may not be designated as a Second Generation Compound or a Replacement Compound by the Joint Steering Committee.

  • If the Joint Steering Committee determines that any Metasyn or MKG Blood Pool Magnetic Resonance Agent has been shown to have significant performance advantages (with respect to marketing, technical or other requirements) over any compound then in development (including, without limitation, the Licensed Compound) then the Joint Steering Committee may designate such compound a Second Generation Compound.

  • In the event that the Research Program is terminated with respect to any compound pursuant to Section 13.2.2, then such compound may not be designated as a Second Generation Compound or a Replacement Compound by the Joint Steering Committee.

  • The Joint Steering Committee shall determine which of the Parties shall be responsible for performing the obligations described in clauses (i) and (ii) of the immediately preceding sentence with respect to any Second Generation Compound, the Replacement Compound(s) and any Outside Compounds and the corresponding Licensed Products.

  • The Development Option provided to HMR under Section 3.1 shall be deemed to have been exercised with respect to that Second Generation Compound.

  • If Genentech determines to develop such Second Generation Compound in the Field in the Territory outside the United States, it shall establish a Genentech Development Plan and Genentech Development Budget therefor.

  • If the foregoing 120-day period is not sufficient to enable HMR to conduct at least sixty (60) days of IN VIVO or IN VITRO tests as it deems appropriate with respect to a Second Generation Compound, HMR will so notify VERTEX within sixty (60) days after commencement of the 120-day period, and additional time will be provided as may be reasonably agreed by the parties to facilitate the testing.

  • A Second Generation Compound as to which the Second Generation Option has been validly exercised shall be considered a Compound hereunder and no longer subject to the provisions of Section 2.3 hereof.


More Definitions of Second Generation Compound

Second Generation Compound means any compound or agent which is a Second Generation Candidate and which the Parties agree in writing to develop in collaboration pursuant to Section 3.3 of this Agreement, or that Genentech elects to develop pursuant to Section 3.6 of this Agreement.
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Second Generation Compound means (a) any Second Generation Clinical Candidate to which Roche has exercised its Option Right pursuant to Section 3.13, (b) [***], (c) [***], and (d) [***].
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Second Generation Compound means compounds synthesized [*
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Second Generation Compound means any improved nucleotide 5'-triphosphate, 5'-diphosphate or 5'-monophosphate compound related to the Compound which has utility as a product for use in the Field and which Inspire owns or to which Inspire has exclusive rights.
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Related to Second Generation 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)).

  • 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.

  • 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.

  • Licensed Compound means [***].

  • 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”).

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

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

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

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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.

  • 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.

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

  • 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.

  • 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.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • 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.

  • 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:

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.