Independent Development Work Data Sample Clauses

Independent Development Work Data. Each Party shall provide access to the other Party and its sublicensee(s), without any additional consideration required, to any and all safety and pharmacovigilance Data resulting from its and, for Versartis, its Affiliates’ and Third Party Partners’ and for Teijin, its Affiliate’s and other Sublicensee’s Independent Development Work, and the Party receiving such Data shall have the right (i) to use such Data only to the extent reasonably necessary for the receiving Party to comply with its regulatory reporting and compliance obligations, including safety reporting obligations, in its territory, and (ii) of reference to all Regulatory Filing in the Territory or in the Versartis Territory, as the case may be, but shall not have the right to use such Data to apply for a Regulatory Approval, or any Commercialization activities. However, in the event the Non-Proposing Party reimburses the Proposing Party for [ * ] percent ([ * ]%) of the costs of its Independent Development Work as provided in Section 4.6.2.2, upon the Non-Proposing Party reimbursing the Proposing Party as provided in Section 4.6.2.2, the Non-Proposing Party shall have the right to use and reference any and all Data (including efficacy Data) resulting from the other Party’s Independent Development Work, in order to obtain and maintain Regulatory Approval for the Licensed Products in such Non-Proposing Party’s territory and otherwise Commercialize the Licensed Products in its respective territory in accordance with the terms of this Agreement. In addition, each Party shall provide the other Party, at no cost, all and any Data generated from its Independent Development Work to be submitted to the Regulatory Authorities in its territory solely for reference purposes, which shall mean, in the case of the Territory, submission of such Data as “Sankou Siryou,” but not as “Hyouka Siryou.” As used in this Section 4.14, the term “Sankou Siryou” means any data or other information used as a supplement to, and specified as such in, a Regulatory Filing in the Territory, and the term “Hyouka Siryou” means any data or other information that is intended to serve as evidence of the efficacy and the safety of the drug, and specified as such, in a Regulatory Filing in the Territory. For the avoidance of doubt, Versartis may provide, at no cost, such Independent Development Work Data it receives from Teijin (and sublicense the foregoing rights in this Section 4.14) to its Third Party Partners, and Teijin may pr...