Specified Studies definition

Specified Studies means, with respect to a Licensed Product, (i) all clinical trials currently underway in the Territory for such Licensed Product in the applicable Development Plan and (ii) all clinical trials in the applicable Development Plan to be Initiated after the Effective Date which are global in nature, including Phase 3b Clinical Trials.
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Specified Studies is defined in Section 2.2.1.
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Specified Studies has the meaning set forth in Section 4.2.2. 1.164 “Subcommittee” has the meaning set forth in Section 2.2.
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Examples of Specified Studies in a sentence

  • As of the Execution Date, the IND for the Specified Studies is held by IDEA and ALPHARMA hereby authorizes IDEA, until ALPHARMA instructs it otherwise, to continue to be the owner of such IND and, until IDEA no longer holds such IND, to communicate with the FDA regarding such regulatory issues, subject to the prior approval of ALPHARMA in relation to each communication, which will not be unreasonably withheld or delayed.

  • Recognizes certain Institutions for Specified Studies / Specialized Studies and Research – by its Statute 2008.2..

  • ALPHARMA shall assist IDEA, as reasonably requested by IDEA, in connection with any regulatory approval application filings or other regulatory matters or submissions relating to the Specified Studies outside the Territory at IDEA's cost (other than internal personnel costs of ALPHARMA).

  • IDEA shall use commercially reasonable efforts to complete the Specified Studies within the timeframes set forth in Schedule I (which timeframes shall start as to the Phase 3 clinical trials included in the Specified Studies on the date on which milestone 2 (as defined in Section 3.2) is achieved).

  • In the event the Parties amend the Research Plan for the initial Research Program with respect to the Specified Studies, then notwithstanding Section 2.1.5(a), the Parties shall mutually agree on [***].

  • All such reports and other data and information resulting from or related to the Specified Studies shall belong to ALPHARMA and constitute Confidential Information of ALPHARMA for purposes of this Agreement and IDEA hereby assigns all of its right, title and interest therein to ALPHARMA.

  • IDEA shall cooperate, at its own expense, with the exercise of ALPHARMA's step-in right (including without limitation procuring the cooperation of its employees and contractors and providing all relevant information), and all costs and expenses of conducting the Specified Studies will remain IDEA's sole responsibility.

  • If IDEA is in breach of any of its obligations under this Section 5.1 and such breach remains uncured for [**] days after ALPHARMA gives written notice to IDEA of such breach, ALPHARMA shall have the right to step-in and take over the management and direction of the Specified Studies (including without limitation the right to manage and direct the activities of all third party contractors engaged to perform any aspects of the Specified Studies).

  • IDEA shall assist ALPHARMA, as reasonably requested by ALPHARMA, in connection with any NDA filings or other regulatory matters or submissions relating to the Specified Studies in the Territory at ALPHARMA's cost (other than internal personnel costs of IDEA).

  • IDEA shall not be required to accept any change proposed by ALPHARMA that materially increases the scope of any of the Specified Studies.


More Definitions of Specified Studies

Specified Studies means the preclinical and clinical studies, the details of which are set forth in Schedule F.
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Related to Specified Studies

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • 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.

  • Pivotal Clinical Trial means a Phase 3 Clinical Trial, or a Phase 2b Clinical Trial for which the applicable Regulatory Authority has determined that the data generated in such Phase 2b Clinical Trial would be sufficient, depending on its outcome, to support the Regulatory Approval for the applicable Licensed Product.

  • 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.

  • 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 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.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • 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)).

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • 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).

  • Regulatory Filings means any and all regulatory applications, filings, approvals and associated correspondence required to Develop, manufacture, market, sell and import Products in, or into, each country or jurisdiction in the Territory.

  • Compound of Concern means a contaminant that, based on generally available information, may be emitted to the atmosphere in a quantity from any source at the Facility that is significant either in comparison to the relevant Ministry Point of Impingement Limit or if a Ministry Point of Impingement Limit is not available for the compound then, based on generally available toxicological information, the compound has the potential to cause an adverse effect as defined by the EPA at a Point of Impingement.

  • 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 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.

  • Acquisition Target means any Person becoming a Subsidiary of the Company after the date hereof; any Person that is merged into or consolidated with the Company or any Subsidiary of the Company after the date hereof; or any Person with respect to which all or a substantial part of that Person’s assets are acquired by the Company or any Subsidiary of the Company after the date hereof.

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

  • Development Period means the period from the date of this Agreement until the Appointed Date;

  • 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.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • 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).

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.