Examples of SMA Licensed Product in a sentence
The Development of the SMA Licensed Program and the Development and Commercialization of each SMA Licensed Product pursuant to the Collaboration will be conducted under the oversight of the SMAC, which shall be comprised of [***] members, with each Party contributing [***] representatives who are employees of such Party.
With respect to any SMA Licensed Product, Genzyme shall be responsible for one-hundred percent (100%) of all Global Development Costs that occur after the Option Exercise Date for such SMA Licensed Product.
Voyager’s sole and exclusive remedy for any breach by Genzyme of this Section 7.2.1 with respect to any SMA Licensed Product shall be [***].
Following the Transition Period with respect to an SMA Licensed Product, once every Calendar Quarter Genzyme shall provide to Voyager, through the SMAC, an update regarding Development activities conducted by or on behalf of Genzyme with respect to such SMA Licensed Product, as well as any Clinical Studies with respect to such SMA Licensed Product conducted by Genzyme.
Voyager shall be responsible for one-hundred percent (100%) of Global Development Costs for such SMA Licensed Product that occur prior to the Option Exercise Date for the SMA Licensed Product for goods and services to be performed prior to the Option Exercise Date.
Genzyme shall use Commercially Reasonable Efforts to Develop the SMA Licensed Product and obtain Regulatory Approval therefor in each Genzyme Territory MMC; provided, however, that Voyager’s sole and exclusive remedy for any breach by Genzyme of such obligation to use such Commercially Reasonable Efforts shall be [***].
Genzyme shall use Commercially Reasonable Efforts to Commercialize the SMA Licensed Product in each Genzyme Territory MMC where Genzyme has obtained Regulatory Approval and Reimbursement Approval.
The classification of such Split Territory Licensed Program (and Split Territory Licensed Products) as an additional SMA Licensed Program (and additional SMA Licensed Program) shall have no effect on any other SMA Licensed Program or SMA Licensed Product.
If the SMAC fails to approve a Transition Plan for an SMA Licensed Product within [***] following the Option Exercise Date with respect to such SMA Licensed Product, then the matter shall be submitted to the AJSC for resolution pursuant to Section 9.1.6 (Decision Making).
For clarity, Global Development Costs to be paid by Genzyme pursuant to this Section 5.3.4 (Global Development Costs) shall exclude any amounts paid after the Option Exercise Date forthe SMA Licensed Product to Third Parties with respect to services rendered or services procured in connection with the conduct of any Clinical Study or Development activity that, in either case, is completed or performed prior to the Option Exercise Date for the SMA Licensed Product.