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. 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. 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. 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. (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.
(b) Beginning on the first anniversary of the completion of the Initial Transfer, and on each anniversary thereafter during the Term, VBI shall: (i) at least on an annual basis, provide Brii Bio with a description of any new Regulatory Documentation and new VBI Know-How, including any significant manufacturing process changes, developed since the last such summary that is necessary or reasonably useful for Brii Bio’s development, manufacture, and commercialization of Licensed Products during the Term, in the event that Brii Bio has elected to effect a Technology Transfer under 7.3; (ii) transfer any such Regulatory Documentation or Know-How to Brii Bio upon request; and (iii) provide Brii Bio with reasonable access to technical assistance regarding the Regulatory Documentation, at Brii Bio’s reasonable expense.
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.
Transfer of Regulatory Documentation. Within [***], Coya shall and hereby does assign to DRL all Regulatory Approvals (to the extent such Regulatory Approval is not issued directly to DRL or its Affiliate) and other Regulatory Documentation owned or otherwise Controlled by Coya and necessary or useful to Commercialize Final Product in such indication(s) in such country. DRL and Cxxx shall enter into and execute any documents necessary to effectuate the foregoing assignment. DRL shall own all Regulatory Documentation for the Final Product in the DRL Field in a given country in the DRL Transferred Territory following the Regulatory Approval of the Final Product in such country.
Transfer of Regulatory Documentation. Promptly (and in no event later than sixty (60) days) following the Effective Date, Mereo shall transfer and assign to UGNX or its designee the Transferred Regulatory Documentation (“Regulatory Transfer”). Prior to completion of the Regulatory Transfer, Mereo shall maintain or cause to be maintained using its current agent (or another agent designated by UGNX) all Transferred Regulatory Documentation in its name, in accordance with applicable Laws and shall consult with UGNX with respect thereto. Mereo will provide and hereby grants UGNX the right to access, reference, use, and update the Specified EMA Documentation in connection with seeking the first Marketing Approval of the Licensed Product in the Mereo Territory. Upon completion of the Regulatory Transfer, all Transferred Regulatory Documentation shall be the sole property and held in the name of, UGNX or its designee. The Parties shall coordinate to complete such Regulatory Transfer, and Mereo shall provide, and shall cause its Affiliates to provide, any assistance as may be reasonably requested by UGNX to complete such Regulatory Transfer. As between the Parties, Mereo shall be solely responsible for reasonable Costs incurred in connection with the Regulatory Transfer.
Transfer of Regulatory Documentation. Licensee shall, and shall cause its Sublicensees and its and their respective Affiliates to, cooperate with Licensor or its designee (at Licensee's own expense) to effect the assignment set forth in Section 14.7.1(a), if applicable, and shall provide to Licensor or its designee any copies of relevant documents Controlled by Licensee, its Sublicensees and its and their respective Affiliates and rights of reference or access necessary to allow Licensor or its designee to exercise its rights under this ARTICLE 14. (d) THIRD PARTY AGREEMENTS, CLINICAL STUDIES, PHASE IIIB CLINICAL STUDIES, PHASE IV CLINICAL STUDIES AND POST-APPROVAL COMMITMENTS. To the extent requested by Licensor in writing and permitted under the applicable agreement, Licensee shall, and does hereby automatically, and shall cause its Sublicensees and its and their respective Affiliates to, transfer and assign to Licensor or its designee, and Licensor or its designee hereby accepts, all right, title and interest in and to any agreements with any Third Parties to the extent such agreements relate to the Licensed Products in the Field in the Territory (including agreements with contract research organizations, clinical sites and investigators). In addition, with respect to any Clinical Studies, Phase IIIB Clinical Studies, Phase IV Clinical Studies and Post-Approval Commitments for the Licensed Products being conducted by or on behalf of Licensee or any of its Affiliates or Sublicensees as of the effective date of termination, at Licensor's option, Licensee shall, and shall cause such Affiliates and Sublicensees to, either (i) end each of such Clinical Studies, Phase IIIB Clinical Studies, Phase IV Clinical Studies and Post-Approval Commitment with respect to enrolled subjects in an orderly and prompt manner in accordance with Applicable Law and consistent with ethical norms, including by providing any required follow up treatment with previously enrolled subjects, or (ii) transfer control to Licensor or its designee of each of such Clinical Studies, Phase IIIB Clinical Studies, Phase IV Clinical Studies and Post-Approval Commitments and cooperate with Licensor or its designee to ensure a smooth and orderly transition thereof that will not involve any disruption of each of such Clinical Studies, Phase IIIB Clinical Studies, Phase IV Clinical Studies and Post-Approval Commitments.
