JVC Products definition
Examples of JVC Products in a sentence
For purposes of the foregoing, the “Interim Transfer Price” shall mean [*] percent ([*]%) less than the average price quoted for the supply of the applicable JVC Product(s) quoted by three (3) independent Third Party manufacturers of international repute and having capabilities, to manufacture and supply such JVC Product(s) in accordance with GMP and other Applicable Laws (which Third Party manufacturers are chosen by the Board).
In the event this Agreement is terminated under Section 14.3 or Section 14.4 (and the Non-Defaulting Party has exercised the Call Option or Put Option) or the JVC is otherwise sold to a Third Party, the Parties shall fully cooperate with each other to facilitate a smooth, orderly and prompt transition of the development, manufacturing and/or commercialization of the JVC Products to the Party purchasing the JVC or the Third Party purchasing the JVC (the “JVC Successor”), at the JVC Successor’s expense.
Each Party may participate in any scheduled meetings between the JVC and Regulatory Authorities concerning material regulatory matters relating to the JVC Products (including via conference call or videoconference), and will have the right to receive copies of all material regulatory correspondence between the JVC and Regulatory Authorities regarding the JVC Products.
During the term of this Agreement, the JVC may request provision of certain services relating to the development and/or commercialization of one or more JVC Products from each Party on an as-needed basis.
Agila represents and warrants that prior to the Completion Date it will complete the construction and qualification of the [*] Facility (as defined in section 1.9 of the JDLA) with the capacity to supply all then-existing JVC Products in accordance with GMP and other Applicable Laws.
For clarity, the JVC shall own all the Regulatory Approvals (including Marketing Approvals), Regulatory Filings as well as all manufacturing and analytical records for the JVC Products, including all in-process and finished product records.
All Regulatory Filings and Regulatory Approvals (including Marketing Approvals) necessary to develop and commercialize the JVC Products throughout the Territory shall be filed and held in the name of the JVC.
The JVC’s business scope shall be the development and commercialization of JVC Products in the Territory.
In connection therewith, each Party shall grant the JVC Successor a license to such Party’s Background Technology and all intellectual property rights therein to the extent necessary for the JVC Successor to continue developing, manufacturing and commercializing the JVC Products in the same manner as the JVC would perform such activities under this Agreement.
Agila hereby grants to JVC an exclusive (with respect to the JVC Products), non-transferable, worldwide, fully-paid up, royalty-free license under Agila’s Background Technology, together with all intellectual property rights therein, solely to the extent necessary for JVC to develop and commercialize the JVC Products in accordance with this Agreement.