Examples of Major EU Markets in a sentence
After receipt of Regulatory Approval in the US Territory for the first Collaboration Product for ADHD, Shire will commence Diligent Efforts to Develop a Collaboration Product for ADHD in the Major EU Markets.
The Development Plan for the Development by Shire of Collaboration Products for any indications in the Major EU Markets will be prepared by Shire and will be submitted to the JDC for review and approval.
The purposes of the JDC shall be (a) to determine the Development strategy for the Collaboration Products in the US Territory and Major EU Markets, (b) to facilitate the management and implementation of the Parties’ Development activities hereunder, and (c) to approve plans and budgets for the Development by New River of Collaboration Products for ADHD in the US Territory.
The Development of each Collaboration Product in the Major EU Markets under this Agreement shall be governed by a development plan (each, a “Development Plan”).
Shire will use Diligent Efforts in each of the Major EU Markets to launch a Collaboration Product in each such country after receiving all Regulatory Approvals for such Collaboration Product in such country, and thereafter will use Diligent Efforts to Commercialize the Collaboration Product in such country.
Notwithstanding the foregoing, Coya shall use Commercially Reasonable Efforts, either directly or through any Affiliates or Sublicensees, to Develop and obtain Regulatory Approval for at least one Product, in the United States, the Major EU Markets or Japan.
The purposes of the JDC shall be (a) to determine the Development strategy for the Collaboration Products in the US Territory and Major EU Markets (as defined in the ROW Agreement), (b) to facilitate the management and implementation of the Parties’ Development activities hereunder, and (c) to approve plans and budgets for the Development by New River of Collaboration Products for ADHD in the US Territory.
Each Development Plan shall describe the proposed overall program of Development for the Collaboration Product for each indication in each of the Major EU Markets, including preclinical studies, toxicology, formulation, process development, clinical studies, pediatric exclusivity plans and regulatory plans and other elements of obtaining Regulatory Approval in each applicable country, as well as timelines to key Governmental Authority meetings, Drug Approval Applications and Regulatory Approvals.
Notwithstanding the foregoing, Coya, either directly or through any Affiliates or Sublicensees, shall use Commercially Reasonable Efforts to Commercialize at least one Product, in the United States, the Major EU Markets or Japan following Regulatory Approval of such Product in each such country.
Shire covenants and agrees not to use any Third Parties to perform promotional activities for Collaboration Products in the Major EU Markets without the prior written approval of New River, such approval not to be unreasonably withheld, conditioned, or delayed.