Clinical Requirements definition

Clinical Requirements means the amount of BC Parenteral Meloxicam or Finished Meloxicam to be provided by Alkermes to Recro and its Sublicensees in accordance with Section 3.4 of this Agreement for the conduct of clinical studies of Finished Meloxicam.
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Clinical Requirements means those quantities of a Product reasonably required by a Party for the conduct of preclinical and clinical studies of such Product in that Party's Territory. The term Clinical Requirements as used herein with respect to a Party shall also include the Clinical Requirements of that Party's licensees, if any.
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Clinical Requirements means such quantities of any Anti-IgE Product as are required by Novartis, Genentech and/or Tanox for the conduct of preclinical and clinical studies in order to obtain Approval of that Anti-IgE Product with respect to a particular Regulatory Jurisdiction, quantities of any Anti-IgE Product which are required by Novartis, Genentech or Tanox for submission to a Public Authority in accordance with this Agreement (or any Ancillary Agreement) in connection with any Approval Application or Approval in any Regulatory Jurisdiction and quantities of any Anti-IgE Product which are required by Novartis, Genentech or Tanox for any post-marketing clinical trial or Phase IV clinical trial intended to support expanded labeling or required to satisfy requirements of a Public Authority in connection with any Approval or Pricing Approval.
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Examples of Clinical Requirements in a sentence

  • CONTRACTOR accepts such engagement, on the General Terms and Conditions hereinafter specified in this Agreement, the Additional Provisions attached hereto, and the following described exhibits, all of which are incorporated into this Agreement by this reference: Exhibit A: Scope of Services and Clinical Requirements Exhibit A, Attachment 1: Y.

  • All of the forecasts provided under this Agreement shall specify Placebo Requirements by the number of units and shall break down Product Requirements covered by such forecast by Clinical Requirements and * CONFIDENTIAL TREATMENT REQUESTED Commercial Requirements, and by the number of units and Dosage Units of the Product.

  • GENENTECH shall not be obligated to supply Clinical Requirements to ROCHE other than in accordance with the quantities mutually agreed to and at the approximate dates of delivery mutually agreed to.

  • If ROCHE exercises its option for a license for a Product under Section 2 of Article II of this Agreement and if such Product is a Small Molecule Product, ROCHE shall be responsible for the manufacture and supply of GENENTECH's Clinical Requirements and Commercial Requirements of such Small Molecule Product.

  • The Parties agree that irreparable damage, for which monetary damages (even if available) would not be an adequate remedy, may occur in the event that Alkermes does not perform any provision of this Agreement with respect to supply of Clinical Requirements in accordance with its specified terms or otherwise breach such provisions.

  • Unless Recro directs otherwise, the provision of the CMC Development Services, and the supply of the Clinical Requirements and the Requirements will continue until such time as the Parties reach agreement on any issue subject to resolution pursuant to Section 2.1(e); provided, however, that neither Party will have any obligation to incur any costs, or to perform any related activities, if such costs would be in dispute if incurred.

  • Alkermes agrees that it will use commercially reasonable efforts to prevent an interruption of supply hereunder and shall immediately notify Recro of any problems or unusual production situations which may adversely affect the supply of the Clinical Requirements or the Requirements, or quality or timely delivery of BC Parenteral Meloxicam or Finished Meloxicam.

  • Alkermes shall cooperate with Recro, in accordance with the Quality Agreement, in investigating any potential non-conforming Batch of BC Parenteral Meloxicam, or the Finished Meloxicam derived therefrom, provided to Recro in connection with the Clinical Requirements and/or the Requirements.

  • Prior to increasing the maximum amount of Clinical Requirements, the Parties shall consider updates to Recro’s development plan for Finished Meloxicam, clinical trial results related to Finished Meloxicam, the implications of such results, and feedback from Regulatory Authorities.

  • Alkermes and Recro shall discuss in good faith forecasting and ordering requirements for supply of the Clinical Requirements.


More Definitions of Clinical Requirements

Clinical Requirements means the quantities of the Product, Placebo and Diluent required for the conduct of pre-clinical studies and/or Clinical Studies of Product in the Field pursuant to a Development Plan.
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Clinical Requirements means the quantities of Finished Product and Placebo needed for the conduct of pre-clinical and/or clinical studies (including any post-marketing clinical studies, regardless of how they are accounted for in Exhibit B to the Collaboration Agreement) of the Licensed Product in the Territory.
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Clinical Requirements means all quantities of SCH 619734 (Rolapitant) as are required by the Acquirer of the Rolapitant Product Assets for the conduct of preclinical, clinical studies, and/or Clinical Trials for the purposes of obtaining any and all Applications and/or Product Approvals in the United States for the use of Products containing SCH 619734 (Rolapitant) for CINV and/or PONV.
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Clinical Requirements means the quantities of Kits which are needed by SCHERING and its sublicensees (if any) for the conduct of preclinical and clinical studies of Licensed Product throughout the Licensed Territory.
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Clinical Requirements means the amount of Polymer Product needed by Amylin, Amylin Parent and Collaboration Partner for the conduct of clinical studies of Exenatide LAR pursuant to the Development and License Agreement.
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Clinical Requirements means the quantities of a Drug Candidate or Product which are required by a Party for the conduct of preclinical and clinical studies of that Drug Candidate or Product by that Party. The term Clinical Requirements as used herein with respect to a Party shall also include the Clinical Requirements of that Party's permitted licensees, if any.
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Related to Clinical Requirements

  • Technical Requirements means the Technical Requirements in Section VII of the tendering documents.

  • Applicable Technical Requirements and Standards means those certain technical requirements and standards applicable to interconnections of generation and/or transmission facilities with the facilities of an Interconnected Transmission Owner or, as the case may be and to the extent applicable, of an Electric Distributor, as published by Transmission Provider in a PJM Manual provided, however, that, with respect to any generation facilities with maximum generating capacity of 2 MW or less (synchronous) or 5 MW or less (inverter-based) for which the Interconnection Customer executes a Construction Service Agreement or Interconnection Service Agreement on or after March 19, 2005, “Applicable Technical Requirements and Standards” shall refer to the “PJM Small Generator Interconnection Applicable Technical Requirements and Standards.” All Applicable Technical Requirements and Standards shall be publicly available through postings on Transmission Provider’s internet website.

  • MREL Requirements means the laws, regulations, requirements, guidelines, rules, standards and policies relating to minimum requirements for own funds and eligible liabilities applicable to the Issuer and/or the Group, from time to time, (including any applicable transitional or grandfathering provisions), including, without limitation to the generality of the foregoing, any delegated or implementing acts (such as regulatory technical standards) adopted by the European Commission and any regulations, requirements, guidelines, rules, standards and policies relating to minimum requirements for own funds and eligible liabilities adopted by the Federal Republic of Germany or the Republic of Italy, a relevant resolution authority or the European Banking Authority from time to time (whether or not such requirements, guidelines or policies are applied generally or specifically to the Issuer and/or the Group), as any of the preceding laws, regulations, requirements, guidelines, rules, standards, policies or interpretations may be amended, supplemented, superseded or replaced from time to time.

  • Operational requirements means the need to ensure that the Agency is to be operated as effectively, efficiently and economically as possible.

  • MREL Requirement means the minimum requirement for own funds and eligible liabilities which is or, as the case may be, will be applicable to the Issuer;