Examples of Split Territory Licensed Product in a sentence
Voyager shall provide Genzyme with reasonable advance notice of all formal meetings and teleconferences with Regulatory Authorities in the Voyager Territory pertaining to any Split Territory Licensed Product, or with as much advance notice as practicable under the circumstances.
In addition, each Party shall promptly share with the other Party all material developments and information that it comes to possess relating to the Development of any Split Territory Licensed Products, including Safety Concerns and study reports and data generated from Clinical Studies of such Split Territory Licensed Product.
Voyager shall use Commercially Reasonable Efforts to (a) Develop each Split Territory Licensed Product and obtain Regulatory Approval therefor by the FDA in the United States; and (b) perform the Development activities allocated to it under each applicable Split Territory Global Development Plan, as each such Split Territory Global Development Plan may be amended in accordance with this Agreement.
Voyager’s sole and exclusive remedy for any breach by Genzyme of this Section 7.1.1.4 with respect to any Split Territory Licensed Product shall be [***].
Each Party shall calculate and maintain records of Global Development Costs incurred by it and its Affiliates with respect to a Split Territory Licensed Product and, within [***] following the end of each Calendar Quarter, each Party shall submit to the other a report detailing the Global Development Costs incurred by it and its Affiliates during such Calendar Quarter, and, if requested, shall provide reasonable supporting documentation to the other Party (an “Global Development Costs Report”).
Each Party, in consultation with the other Party, shall decide whether to conduct a recall of a Split Territory Licensed Product in its own Territory and the manner in which any such recall shall be conducted (except in the case of a government mandated recall, when such Party may act without such advance notice but shall notify the other Party as soon as possible).
Each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order to effect a recall of a Split Territory Licensed Product in the other Party’s Territory.
In addition, notwithstanding anything to the contrary in this Agreement, Voyager shall not conduct any Clinical Study for a Split Territory Licensed Product in a country in the Genzyme Territory without Genzyme’s prior written consent.
Genzyme will submit the Global Branding Strategy for a Split Territory Licensed Product to the PSC responsible for such Split Territory Licensed Product at least annually.
Each Split Territory Global Development Budget shall be updated annually by the PSC responsible for the applicable Split Territory Licensed Product in accordance with Section 5.2.4 (Updates and Amendments Split Territory Global Development Plans and Split Territory Global Development Budgets).