Licensed GT Product definition
Examples of Licensed GT Product in a sentence
The JPT’s purpose will be to facilitate the exchange of information with respect to (a) the commercialization, including reimbursement strategies, regarding the Licensed GT Product and Licensed Treatment and Dimension’s gene therapy products, in particular, in the field of Hemophilia B, and (b) the continued clinical development of the Licensed GT Product post Regulatory Approval.
Promptly after completion of the POC Trial, Dimension shall, […***…], conduct all necessary technology transfer (including Materials) to Bayer as reasonably necessary for Bayer to practice the licenses granted under Section 5.1 with respect to such Licensed GT Product.
Each milestone payment is payable […***…], regardless of the number of times the corresponding event is achieved by a Licensed GT Product and/or Licensed Treatment and regardless of the number of Licensed GT Products and/or Licensed Treatments to achieve such event.
The Parties intend that during the Research Term and under the Research Plan, Dimension will discover and develop […***…] GT Produc[…***…] and complete a POC Trial for […***…] GT Product, which […***…] GT Product, upon completion (successful or not) of such POC Trial, shall be deemed a “Licensed GT Product” after which point, Bayer’s licenses set forth in Section 5.1 shall apply, and Bayer shall have sole responsibility for further development, manufacture and Commercialization of such Licensed GT Product.
Following the conduct of the POC Trial and a GT Product becoming a Licensed GT Product, Dimension shall assign and transfer to Bayer, at Bayer’s expense, any and all such INDs. Any orphan designation for the Licensed GT Product and/or the Field for which Dimension has filed or intends to file an IND will be in the name of Bayer or one of its Affiliates.
The Parties acknowledge that pursuant to the ReGenX Agreement, Dimension is required to provide ReGenX with a development plan and budget covering the […***…] of development activities with respect to the Licensed GT Product and Licensed Treatment, and to provide […***…] updates to such development plan and budget.
Bayer will use Commercially Reasonable Efforts to develop, Commercialize, market, promote, and sell at least one Licensed GT Product or Licensed Treatment in the Field in the US and the Major Market Countries.
In the event […***…] Licensed GT Product is the subject of a POC Trial, but fails to achieve Demonstration of Clinical POC (as determined pursuant to Section 2.11.4), at Bayer’s discretion and request, the Parties shall amend the Research Plan and Research Budget to add activities to identify and develop […***…] GT Product and conduct a POC Trial for such […***…] GT Product (the “Backup Product”) and as needed, extend the then-current Research Term to conduct such activities.
Within […***…] of […***…] during the term of this Agreement, Bayer shall provide Dimension with written progress reports through the JSC and JPT, setting forth in reasonable detail the progress of the development, evaluation, testing, and commercialization of each Licensed GT Product and Licensed Treatment.
In the event that, following the POC Trial, Bayer makes a good faith determination in accordance with its standard practices and procedures for such determinations that there is a material safety issue with respect to the Licensed GT Product in the Field in the Territory Bayer may terminate this Agreement upon […***…] notice.