Late Stage Development definition
Examples of Late Stage Development in a sentence
Each Party shall provide the Joint Development Committee with a good faith preliminary estimate of its pre-launch Commercialisation Costs of an Antibody Product on or about the date Amgen provides written notice to Celltech that it intends to proceed with Late Stage Development activities with respect to such Antibody Product.
The costs of manufacture, including scale-up and validation of Antibody Raw Material and Antibody Product in Finished Form, shall be deemed Research and Development Costs of Late Stage Development to the extent only that Antibody Raw Material and Antibody Product in Finished Form so produced is not used for Commercialisation and otherwise shall be a Cost of Goods.
The Development Lead shall be responsible for preparing clinical trial designs and protocols, sponsoring Clinical Studies, engaging Third Party Providers, and shall be primarily responsible for the conduct of any such Early Stage Development Activities or Late Stage Development Activities, as the case may be, consistent with the then-current Development Plan for such Collaboration Program.
Notwithstanding the initiation of Late Stage Development Activities for a particular Optioned Product within a Collaboration Program for an Indication, unless otherwise agreed, Denali will continue to be Development Lead for [***].
Verve will have the right but not the obligation, at its sole cost, to defend against any other declaratory judgment action or other action challenging any Acuitas Patent that, on the date of first notice of such action, are not necessary or useful for the research, development, manufacturing and commercialization of any lipid nanoparticle comprising product that is licensed or optioned by Acuitas to a Third-Party or is under Late Stage Development by Acuitas.
Reasonably in advance of the Initiation of Late Stage Development Activities for each Collaboration Program, the JPT will prepare a Transition Plan to be approved by the Parties for the transfer of the Development Lead with respect to such Optioned Product from Denali to Takeda.
Within [***] of Kiniksa’s receipt of a notice from Regeneron pursuant to this Section 5.7 (Regeneron Late Stage Development in the Regeneron Retained EEO Field), the Parties shall negotiate in good faith and enter into an amendment to this Agreement to allow Regeneron to independently Develop and Commercialize the Product in the Regeneron Retained EEO Field in the Territory and, at the same time, allow Kiniksa to independently Develop and Commercialize the Product in the Kiniksa Field in the Territory.
It is anticipated the J&J will be responsible for conducting all of the work under each such Late Stage Development Plan, subject to the assistance of Arena as contemplated in Section 3.2. J&J will be responsible for updating and amending each Late Stage Development Plan at least yearly, based on the progress and results of the applicable development program, and any relevant progress and results from development of Development Compounds, which shall be submitted to the Arena for review and comment.
For each Development Compound that has entered Phase IIb clinical trials, J&J shall prepare a Late Stage Development Plan for such Development Compound, which it shall submit to Arena for review and comment.
Upon completion of Early Stage Development, and only if GENE *****, Amgen shall promptly notify GENE in writing that Amgen intends to commence Late Stage Development for such Product, which notice shall include a Development Plan for Late Stage Development together with Amgen's non-binding, ***** estimate, in ***** detail, of the Development Costs of such Development Plan.