Transfer of Regulatory Documentation. Vividion shall transfer, as soon as practicable (but in the case of any IND(s) in no event later than [***] days after the Effective Date unless otherwise agreed by the Parties), to Celgene any and all Regulatory Approvals and Regulatory Documentation (including the IND and any foreign counterparts thereof) for all Licensed Products and Companion Diagnostics in the Territory, and thereafter Celgene (or its designee) shall file and hold title to all Regulatory Documentation and Regulatory Approvals and supplements thereto relating to Licensed Products and Companion Diagnostics in the Territory.
Transfer of Regulatory Documentation. Upon Lilly’s request after payment of the license fee in accordance with Section 7.1, Incyte shall transfer ownership to Lilly of any Regulatory Documentation Controlled by Incyte and existing as of the Effective Date.
Transfer of Regulatory Documentation. Jounce shall promptly transfer copies of and provide rights of reference to Celgene for any and all Regulatory Approvals and Regulatory Documentation (including the IND and any foreign counterparts thereof) necessary for Celgene to perform the activities set forth in Article 2.
Transfer of Regulatory Documentation. Novartis shall transfer, within sixty (60) days after the Effective Date, to OV for its use the Regulatory Documentation for the Compound in the Territory.
Transfer of Regulatory Documentation. No later than 30 days after the receipt of Approval for a Product in a country, unless otherwise agreed by the Parties, Ionis will assign to Akcea all rights, title, and interests in and to each IND and NDA for such Product filed in such country. The date of such transfer will be the “NDA Transfer Date.” After the NDA Transfer Date for a Product in a country, Ionis will transfer to Akcea in accordance with the regulatory plan to be established by the Regulatory Sub-Committee copies (in electronic or other format) of other Regulatory Documentation (including drafts) Controlled by Ionis as of the NDA Transfer Date related to such Product (collectively, with the Regulatory Documentation transferred to Akcea pursuant to this Section 3.5.2 the “Assigned Regulatory Documentation”). Ionis will execute all letters, attestations, forms, confirmatory assignments, and other documentation reasonably requested by Akcea to give effect to the assignment and transfer of INDs, NDAs, and Assigned Regulatory Documentation contemplated by this Section 3.5.2. If any Approval for a Product in a country cannot be transferred to Akcea within such 30 day period, then, to the extent it would be helpful to hasten the Commercialization of such Product in such country, at Akcea’s request, Ionis will appoint Akcea as its exclusive distributor of the applicable Product in such country and grant Akcea the right to appoint sub-distributors until such time as such Approval in such country has been transferred to Akcea, and the Parties will enter into a distribution agreement on reasonable and customary terms to memorialize such appointment.
Transfer of Regulatory Documentation. (a) As soon as practical after the Effective Date, VBI shall (at no additional cost to Brii Bio) commence disclosing and making available to Brii Bio the Regulatory Documentation for the Licensed Product and the relevant VBI Know-How and additional materials that are reasonably required and available in connection with Brii Bio’s development, and commercialization, of Licensed Products (the “Initial Transfer”). VBI shall complete such Initial Transfer no later than thirty (30) days after the Effective Date.
Transfer of Regulatory Documentation. (a) Gilead shall provide Galapagos or its designated Affiliate with a copy of the Transferred Regulatory Documentation for each Registered Country promptly following the Effective Date. On or prior to the date determined by the JTT or, if applicable, the TSC, Gilead will, and will cause its Affiliate(s) to, assign and transfer to Galapagos, or its Affiliate(s), all of the Transferred Regulatory Documentation as specified in the Transition Plan to the extent that such Transferred Regulatory Documentation is not otherwise and would no longer be required to be used or held for use in connection with the Licensed Products in the Gilead Territory or for Clinical Trials being conducted by Gilead or its Affiliate(s) that are not Transferred Clinical Trials. Each Party, or its Affiliate(s), as applicable, will submit all filings, letters and other documentation necessary to effect such assignments and transfers to the applicable Regulatory Authority.
Transfer of Regulatory Documentation. No later than twenty (20) days after the Effective Date, IGF shall (A) grant a right of reference to LIRUM to Regulatory Approvals, (B) assign and transfer to LIRUM all Regulatory Documentation that are Controlled by IGF, including those under the IND#116840 for IGF-MTX and IND#131518 for CPE54, for any Compounds or Licensed Products; and (C) deliver to LIRUM copies of such Regulatory Documentation. Upon termination of this Agreement in whole by either party, LIRUM will be obligated to and will assign and transfer to IGF within twenty (20) days all Regulatory Documentation (including all INDs for IGF-MTX and CPE54 and any Regulatory Documentation for any l Compounds and Licensed Products under this Agreement) and LIRUM’s rights of reference to Regulatory Approvals will automatically terminate. Upon termination of this Agreement partially as to one or more Compounds or Licensed Products, LIRUM will be obligated to and will assign and transfer within twenty (20) days all Regulatory Documentation and all INDs pertaining to only the terminated Compounds or Licensed Products and LIRUM’s rights of reference to Regulatory Approvals related to the applicable Compounds or Licensed Products will automatically terminate.
Transfer of Regulatory Documentation. No later than [***] ([***]) [***] after the Effective Date, IGF shall (A) grant a right of reference to LIRUM to Regulatory Approvals, (B) assign and transfer to LIRUM all Regulatory Documentation that are Controlled by IGF, including those under the [***] for IGF-MTX and IND#131518 for CPE54, for any Compounds or Licensed Products; and (C) deliver to LIRUM copies of such Regulatory Documentation. Upon termination of this Agreement in whole by either party, LIRUM will be obligated to and will assign and transfer to IGF within [***] ([***]) [***] all Regulatory Documentation (including all INDs for IGF-MTX and CPE-54 and any Regulatory Documentation for any l Compounds and Licensed Products under this Agreement) and LIRUM’s rights of reference to Regulatory Approvals will automatically terminate. Upon termination of this Agreement partially as to one or more Compounds or Licensed Products, LIRUM will be obligated to and will assign and transfer within ([***]) [***] all Regulatory Documentation and all INDs pertaining to only the terminated Compounds or Licensed Products and LIRUM’s rights of reference to Regulatory Approvals related to the applicable Compounds or Licensed Products will automatically terminate.
Transfer of Regulatory Documentation. Within the time period set forth in the Transitional Services Agreement, AstraZeneca shall provide Licensee with an electronic copy of the AstraZeneca Regulatory Documentation existing as of the Execution Date. For the avoidance of doubt, all Information contained in the AstraZeneca Regulatory Documentation constitutes AstraZeneca Know-How and AstraZeneca’s Confidential Information and shall remain as such notwithstanding the transfer of the Existing Approvals to Licensee.
