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.
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...
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 [... * ...
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.
Third Indication. (a) […***…] […***…]
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