Conor Device definition
Examples of Conor Device in a sentence
Each such payment shall be accompanied by a statement setting forth in reasonable detail (i) the number and type of Conor Device incorporating Product sold in each country and the Net Sales applicable thereto, (ii) a breakdown of all the components of Net Sales set forth in clauses (i)—(iv) as set forth in Section 1.19, and (iii) such additional details as may be reasonably requested by Phytogen for the determination of payments due under Sections 7.1 and 7.
Each party shall provide to the other party all correspondence and reports that it receives from or sends to a governmental agency or Regulatory Authority in connection with the manufacture of the Product or the Conor Device, as applicable.
Unless earlier terminated as provided in this Section 10, the term of this Agreement shall commence on the Effective Date and shall expire on the tenth anniversary of the date of Commercial Launch of the Conor Device in the first country in the Territory.
If any Phytogen Proprietary Rights are infringed by a Third Party by reason of the manufacture, use, or sale of a product competitive with the Conor Device, the parties shall confer regarding whether to institute an action or proceeding with respect to such infringement.
Phytogen hereby grants to Conor and its Affiliates and licensees the right to access and to reference such DMFs for the purpose of preparing, filing, or maintaining applications for Regulatory Approval and other regulatory filings relating to the Conor Device incorporating Product in the Territory.
Each party Phytogen shall also provide to the other party, during the term of this Agreement, with such other regulatory support and information as the other party may reasonably request in connection with the Product and/or the Conor Device, including, without limitation, the preparation and maintenance of regulatory filings related to the Conor Device to the extent that such filings relate to the Product.
Each party shall maintain records as may be necessary to permit a recall, market withdrawal or a field correction of any of the Product or the Conor Device incorporating the Product delivered to Conor, Conor’s Affiliates, or to Conor Customers in the Territory that is effected either voluntarily or under a threat of, or a directive by, any governmental agency.
Conor shall provide Phytogen promptly with a copy of all Regulatory Approvals of the Conor Device, within the Field of Use in the Territory.
All decisions of the Regulatory Committee shall be made by a majority of the representatives of the Regulatory Committee provided such majority includes at least one appointee of each party; provided, however, that if the Regulatory Committee is unable to reach a majority decision with respect to regulatory recalls of the Conor Device only, then Conor shall make the final decision as to such matter, subject to the provisions of Section 6.4 hereof.
Conor shall retain samples of each shipment of the Conor Devices supplied pursuant to this Agreement in appropriate conditions of storage for each material retained per labeled conditions and GMP for a period of at least one (1) year after the expiration date of the Conor Device, or longer if required by applicable law.