CoDev Product definition
Examples of CoDev Product in a sentence
For avoidance of doubt, upon PIRS CoDev Option Exercise Effective Date the applicable Collaboration Product shall be considered a CoDev Product and the exclusive license under Section 2.1 with respect to such CoDev Product shall terminate.
On a CoDev Product-by-CoDev Product basis, PIRS shall have the right to discontinue co-Development and co-Commercialization (including all cost-sharing and other obligations therein) with respect to such CoDev Product (“CoDev Product Opt-Out”) by providing one [***] days’ prior written notice to SGEN, with the CoDev Product Opt-Out being effective upon the end of such [***]-day notice period.
For avoidance of doubt, this technology access fee shall not be [***] to SGEN even if a Compound is later is designated a CoDev Product.
Subject Section 4.4.5 and Section 4.5, and subject to the activities allocated to each Party under a CoDev Product Plan, PIRS shall be primarily responsible for obtaining Regulatory Approvals for a CoDev Product in the PIRS Territory, and SGEN shall be primarily responsible for obtaining Regulatory Approvals for a CoDev Product in the SGEN Territory.
PIRS shall have—and SGEN hereby grants to PIRS as of the Effective Date—the exclusive option (exercisable in PIRS’ sole discretion) to opt into [***] global co-Development and co-Commercialization as set forth in the CoDev Product Plan of [***] Collaboration Product, which would then become a CoDev Product and would no longer be an Exclusive Product, in accordance with the selection procedure set forth below (the “PIRS CoDev Option”).
After the Effective Date, the Parties shall mutually agree on a reasonably practicable date to enter into an agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to a CoDev Product (the “Pharmacovigilance Agreement”).
Unless otherwise set forth in an approved CoDev Product Plan or Global Commercialization Strategy, with respect to the CoDev Products, each Party shall select one or more product trademarks (including backup trademarks) for the CoDev Products for use by such Party in its Respective Territory (including backup trademarks) (the “Product Trademarks”) in line with the agreed upon Global Branding Strategy.
Following such assumption, SGEN and PIRS shall no longer be responsible or liable to each other for any of their respective obligations (including diligence) and liabilities applicable to the further Research, Development, Manufacture, and Commercialization of such CoDev Product (including, without limitation, that PIRS shall no longer have any governance or reporting obligations to SGEN with respect to the applicable CoDev Product).
SGEN will own all IND/IMPDs, ▇▇▇▇, Regulatory Approvals and related regulatory documentation submitted to any Competent Authority in the SGEN Territory with respect to a CoDev Product as well as any drug master files maintained by or on behalf of SGEN anywhere in the world with respect to a CoDev Product.
PIRS shall have the full and unrestricted right, but not the obligation, to bring and control an appropriate suit or other action against any person or entity under any Joint Patent or CoDev Product Compound Specific Patent directly relating to a CoDev Product in the Field in the PIRS Territory (“PIRS Infringement Action”), in its own name and entirely under its own direction and control.