Existing IND Transfer Sample Clauses

Existing IND Transfer. Pursuant to the Original CDOA, KKC transferred and assigned to Aevi all of KKC’s and its Affiliates’ rights in and to IND #(***) and IND #(***) (the “Existing INDs”) and delivered to the United States Food and Drug Administration or a successor agency in the United States with responsibilities comparable to those of the United States Food and Drug Administration (“FDA”) the letter required by 21 CFR Part 314.72 notifying FDA of the transfer of the Existing INDs to Aevi. If this Agreement expires or terminates prior to the exercise or expiration of the Plan A/B Option, Aevi will transfer and

Existing IND Transfer. KHK hereby transfers and assigns, and will cause its Affiliates (including Kyowa Kirin Pharmaceutical Development, Inc.) to transfer and assign, to Medgenics all of KHK’s and its Affiliates’ rights in and to IND #***** and IND #***** (the “Existing INDs”). No later than ***** after the CDOA Effective Date, KHK will deliver to the United States Food and Drug Administration or a successor agency in the United States with responsibilities comparable to those of the United States Food and Drug Administration (“FDA”) the letter required by 21 CFR Part 314.72 notifying FDA of the transfer of the Existing INDs to Medgenics. If this Agreement expires or terminates other than as a result of the exercise of the Option prior to the expiration of the Option Period, Medgenics will transfer and assign to KHK or KHK’s designee the Existing INDs and all amendments or supplements thereto submitted to FDA by or on behalf of Medgenics within ***** after such expiration or termination of this Agreement. If this Agreement expires pursuant to Section 7.1(b) as a result of Medgenics’ exercise of the Option during the Option Period, Medgenics will retain title to the Existing INDs and all amendments or supplements thereto submitted to FDA by or on behalf of Medgenics pursuant to the License Agreement (as defined below). In this Agreement, a Party’s “Affiliate” means, with respect to any person or entity, any other person or entity which controls, is controlled by, or is under common control with such person or entity. A person or entity will be regarded as in control of another entity if it owns or controls more than fifty percent (50%) of the equity securities of the subject entity entitled to vote in the election of directors (or, in the case of an entity that is not a corporation, for the election of the corresponding managing authority). ***** Confidential Information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to this omitted information.