Voyager Territory definition
Examples of Voyager Territory in a sentence
Voyager will submit representative samples of its Voyager Territory Promotional Materials developed by it for use in the Voyager Territory to the PSC annually.
In addition, notwithstanding anything to the contrary in this Agreement, Genzyme shall not conduct any Clinical Study for a Split Territory Licensed Product in the Voyager Territory without Voyager’s prior written consent.
Other than Split Territory Global Development Activities, all Development activities to be undertaken with respect to each Split Territory Licensed Product by or on behalf of Voyager with respect to the Voyager Territory, including Secondary Indication Studies, shall be set forth in a written work plan and time table (each, a “Voyager Territory Development Plan”).
In addition, upon request of either Party (on behalf of itself or a Sublicensee), the other Party shall obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Split Territory Licensed Products in the Genzyme Territory or the Voyager Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments).
Voyager shall have sole responsibility for the Voyager Territory Development Plans, as described below.
Voyager will own all INDs, BLAs and related regulatory documentation submitted to any Regulatory Authority in the Voyager Territory with respect to any Split Territory Licensed Product.
Voyager shall be solely responsible, at its expense, for all Commercialization activities relating to Split Territory Licensed Products in the Voyager Territory.
Each Voyager Territory Development Plan shall subsequently be updated by Voyager from time-to-time at least once each Calendar Year not later than September 1 until such time as no further Development or Secondary Indication Studies are occurring or expected to occur with respect to the applicable Split Territory Licensed Product.
All such Voyager Territory Promotional Materials will be compliant with applicable Law and, if applicable, consistent in all material respects with the Global Branding Strategy for such Split Territory Licensed Product.
The Voyager Territory Commercialization Plan for a Split Territory Licensed Product shall subsequently be updated and modified by Voyager, from time to time at its discretion and no less frequently than once per Calendar Year, based upon, among other things, Voyager’s Commercialization activities with respect to such Split Territory Licensed Product in the Voyager Territory, a copy of which updated plan Voyager will provide to the PSC responsible for such Split Territory Licensed Product.