HCM2 definition
Examples of HCM2 in a sentence
Notwithstanding MyoKardia’s final decision making authority under Section 2.9 for the Registration Programs for HCM1 Products and HCM2 Products, unless Sanofi otherwise agrees in writing, each such Registration Program will support Regulatory Approval from at least the FDA and the EMA.
Sanofi shall own all Marketing Authorization Applications and Marketing Approvals with respect to (i) DCM1 Products worldwide and (ii) HCM1 Products and HCM2 Products outside the United States.
If the GDC decides, as reflected through a Development Plan for a Product or an amendment thereto, to research, develop and/or commercialize a Combination Product containing both (a) one or more HCM1 Compounds and/or one or more HCM2 Compounds; and (b) one or more DCM1 Compounds, the Parties shall negotiate in good faith an amendment to this Agreement which shall address the Parties’ rights and obligations with respect to such Combination Product.
With respect to HCM1 Products and HCM2 Products, the Parties shall coordinate regarding whether to use the same Product Marks in both Parties’ respective territories.
Each Party shall pay its share of the Registration Program Costs for the HCM1 Products and the HCM2 Products (including the Expanded Use Products, subject to such an alternate cost sharing arrangement and/or [***] option) in accordance with Section 9.5.
Unless otherwise agreed by the Parties in writing, MyoKardia shall have the primary responsibility to assemble the EOP2 Package for the HCM1 Products and the HCM2 Products, and Sanofi shall have the primary responsibility to assemble the EOP2 Package for the DCM1 Products, with assistance from MyoKardia.
In the event there is Product Infringement relating to an HCM1 Product or HCM2 Product both inside and outside the United States, the Parties shall coordinate in good faith regarding enforcement strategy.
In the event that a royalty is not due under this clause (b)(ii) with respect to a given HCM1 Product or HCM2 Product, then the royalties described in Section 12.3(b)(iii) shall apply to the Retained Territory with respect to such Product.
MyoKardia shall provide Sanofi with reasonable assistance and cooperation with respect to obtaining pricing and reimbursement approvals for the HCM1 Products and the HCM2 Products in the Licensed Territory, at Sanofi’s request and expense.
The licenses and other rights granted to MyoKardia under the Sanofi Licensed Technology and Joint Program Technology shall expand to include the HCM1 Products and the HCM2 Products in the Licensed Territory and the DCM1 Products worldwide.