Third Indication Sample Clauses

The "Third Indication" clause defines the terms and conditions under which a third, additional use or application of a product, drug, or technology may be pursued or recognized within an agreement. Typically, this clause outlines the process for identifying, developing, and obtaining regulatory approval for a new indication beyond the initial two, specifying responsibilities, timelines, and any financial or intellectual property considerations. Its core practical function is to provide a clear framework for expanding the scope of the agreement to cover new therapeutic or commercial opportunities, thereby reducing ambiguity and facilitating future collaboration or commercialization efforts.
Third Indication. “Third Indication” means the initial indication (other than for the [***]) for which there has been a First Dose in a Registrational Trial for Aeroquin.
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Third Indication. 16.1 No initial milestone payment shall be due on acquisition by Nycomed of rights in respect of the Third Indication. 16.2 The Indications Committee shall meet within 60 days of completion of such studies (by KSB at its sole cost and expense) as the Development Committee considers to be required to be effected before the start of a Phase III Study in respect of the Third Indication Product (the “Initial Studies”) to consider and agree conduct of Market Research by an independent third party market research organisation (identified and agreed by the Indications Committee) to evaluate use of the Third Indication Product in the Territory using information obtained from such Phase I Study and the Phase II Study . The costs of such Market Research shall be borne in equal shares by the Parties. 16.3 Upon the delivery of the results of the Market Research the Indications Committee shall review the anticipated Market Potential for the Third Indication Product as determined in the Market Research. In the event that the anticipated Market Potential for the Third Indication Product in the Territory exceeds US$ 30,000,000 (thirty million); the Third Indication Product shall become an Agreed Indication and shall be developed by the Parties and licensed to Nycomed fully in accordance with the terms of this Clause 16 and this Agreement. 16.4 The parties shall as soon as reasonably practicable following the date of the Third Indication Product becoming an Agreed Indication, consult and collaborate in the determination of the Third Development Plan specifying the Phase III Study Clinical Trial program together with a timetable for all required actions for the completion of the Dossier, the anticipated Filing Date for the Third Indication Product and the Budget therefore. Each of Nycomed and KSB shall use best endeavours to agree the Third Development Plan. It is acknowledged that a Development Committee for the Third Indication Product shall be constituted and meet to discuss the Third Indication Product and the anticipated Third Development Plan, prior to it becoming an Agreed Indication, for the purposes of considering the nature and extent of the Initial Studies and to enable KSB to consult and take account of the views of Nycomed in the design and conduct of the Initial Studies. 16.5 The Third Development Plan shall be conducted in accordance with Clause 4 and the Budget for the Third Development Plan shall be as set out therein. 16.6 The costs of the conduct of the T...
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Third Indication. Upon first acceptance of a filing of an MAA for the Compound and/or Product for a third indication in Japan by or under authority of Astellas, Astellas shall pay XenoPort [... * ...
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Third Indication. Upon first acceptance of a filing of an MAA for the Compound and/or Product for a third indication in Japan by or under authority of Astellas, Astellas shall pay XenoPort [… * …]. Upon obtaining the first Marketing Approval of the Compound and/or Product for a third indication in Japan by or under authority of Astellas, Astellas shall pay XenoPort [… * …]. As used herein, a “third indication” shall mean any indication for which Marketing Approval is obtained, other than the indications triggering payment under Section 6.2.6 and 6.2.7(a) above.
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Third Indication. (a) […***…] […***…] (b) […***…] […***…]
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Related to Third Indication

  • For clarity the time allowances provided in clause 2.10 shall operate to reduce the maximum timetabled classroom teaching time specified in clause 4.2 of this agreement.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be or have been submitted to FDA or other comparable governmental entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, applicable Authorizations, and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and, for studies submitted to regulatory authorities for approval, in all material respects, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete and fairly present the data derived from such studies and trials in all material respects; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes materially call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.