Assignment of Regulatory Filings. Subject to Section 4.6(b) below, at reasonable times to be mutually agreed by the Parties in order to maximize the efficiency of the Development of the Products in accordance with each Party’s responsibilities assigned to it under the Development Plan, Angioblast shall assign and deliver, or cause to be assigned and delivered, to Cephalon all Regulatory Materials (including INDs) obtained and maintained by Angioblast or its Affiliate or licensee for the Development of such Product for use in the Field in the Territory; provided, however, that, prior to the assignment of any such Regulatory Materials, Angioblast shall maintain such Regulatory Materials at its expense and shall take all reasonable actions to make available to Cephalon the benefits of such Regulatory Materials to the extent required by Cephalon in connection with its activities under this Agreement.
Assignment of Regulatory Filings. The Non-Developing Party promptly shall, as applicable, assign or make available by cross-reference to the Independent Development Party, at the Non-Developing Party’s sole cost, all registrations for such Independent Product (at the time of exercising its opt out rights) or Independent Indication (an assignment shall only occur after the expiration of the Non-Developing Party’s right to opt in; a cross reference right shall be available from the time of exercise of the Non-Developing Party’s opt out rights until the expiration of such party’s opt in rights or longer, as appropriate), as the case may be, and shall notify the appropriate Regulatory Authorities and take any other action reasonably necessary to effect such transfer of ownership or access to regulatory filings; provided, however, that a Non-Developing Party shall not have any obligation to assign to the Independent *Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portions. Development Party the Drug Master File for any Independent Product if and for so long as the Non-Developing Party is engaged in the Manufacture of such Independent Product on behalf of the Independent Development Party or with respect to Indications or territories for which such Non-Developing Party has retained rights.
Assignment of Regulatory Filings. (i) At a reasonable time [… * …], XenoPort shall assign or cause to be assigned to GSK all Regulatory Filings for the Compound in the Territory; provided, however, that, [… * …] XenoPort shall maintain [… * …]. Notwithstanding the foregoing, it is understood that XenoPort may [… * …] and/or [… * …] provided that, [… * …] For such purposes, [… * …] at which XenoPort [… * …].
Assignment of Regulatory Filings. Following the approval of the NDA for the Product, GelTex shall assign to Sankyo the NDA and IND for the Product. Sankyo will provide GelTex with at least two months written notice of the date following the approval of the NDA on which Sankyo desires for the assignment to be effective; provided, however that such date shall be no later than six (6) months following the approval of the NDA. Sankyo may give its notice as to the effective date of the assignment prior to the approval of the NDA, but in no event will the assignment be effective prior to the approval of the NDA. Prior to or upon assignment, GelTex shall transfer all information and material related to the regulatory filings related to Product to Sankyo. In connection with the assignment, the Parties shall agree on an orderly transfer of relevant information and materials, including, but not limited to, the safety data base collected in connection with the [*] Confidential information omitted and filed separately with the Commission. clinical development of the Product.
Assignment of Regulatory Filings. To the extent not already completed pursuant to Section 3.1.1(e), On a Collaboration Target-by-Collaboration Target basis, within [***] following Sanofi Participation Election Effective Date for a given Collaboration Target (if any), Kymera will transfer and assign to Sanofi Kymera’s entire right, title, and interest in and to all INDs, other Regulatory Filings, and other regulatory documentation in the Territory with respect to all Collaboration Candidates and Licensed Products Directed Against such Collaboration Target that is in the possession and control of Kymera, excluding any drug master files maintained by Kymera or a Third Party solely with respect thereto.
Assignment of Regulatory Filings. At any time upon Xxxxxxx’x request after the Effective Date, Licensor, on behalf of itself and its Affiliates, will and hereby does assign to Xxxxxxx all of Licensor’s and its Affiliates’ right, title and interest in, to and under all INDs/CTAs for the Licensed Products that are owned, controlled or otherwise held by Licensor or any of its Affiliates; provided, however, that Licensor will have no obligation to transfer to Xxxxxxx any [***] until the earliest of (a) the expiration of [***], (b) the expiration of [***] or (c) [***]. Licensor will deliver to Xxxxxxx full and complete copies of each of assigned IND/CTA and all related correspondence.
Assignment of Regulatory Filings. [ * ] the Effective Date, XenoPort shall provide DRL full copies of [ * ] XenoPort shall also assign or cause to be assigned to DRL such [ * ]; provided, however, that, prior to [ * ] in connection with its activities under this Agreement.
Assignment of Regulatory Filings. Promptly following the Effective Date, [***], OptiNose shall assign and cause to be assigned to Avanir IND No. [***] and all other Regulatory Material relating to the Product in the Licensed Territory. Prior to the assignment and transfer of such IND and other Regulatory Materials, OptiNose shall maintain (and/or cause to be maintained) such IND and other Regulatory Materials and shall take all reasonable actions to make available to Avanir and/or its designee the benefits of such IND and other Regulatory Materials in the Licensed Territory, to the extent required by Avanir in connection with its activities under this Agreement. The Out-Of-Pocket Expenses incurred by OptiNose in performing its obligations under this Section 5.2 shall be shared by the Parties to the extent and as provided in Section 4.5 above.
Assignment of Regulatory Filings. Within [***] after the effective date of termination of this Agreement (unless otherwise required by any applicable law or regulation), at Voronoi’s [***], ORIC shall assign (or cause to be assigned) to Voronoi or its designee (or to the extent not so assignable, ORIC shall take reasonable actions to make available to Voronoi or its designee the benefits of) all Regulatory Filings for a Licensed Product in the ORIC Territory owned and Controlled as of the effective date of termination by ORIC or any of its Affiliates.
Assignment of Regulatory Filings. At Licensee’s request, Kosan shall transfer and assign to Licensee, all Regulatory Filings owned by Kosan related to KOS-2187 (the “Transferred Regulatory Filings”), including but not limited to any CTA regarding KOS-2187, and copies of all written correspondence with Regulatory Agencies regarding KOS-2187. If requested by Licensee, Kosan agrees to perform within thirty (30) days of the Effective Date all such acts, and execute such further instruments, documents or certificates, as may be required for the Transferred Regulatory Filings to be transferred and assigned more effectively to Licensee. Effective upon such date that Kosan transfers to Licensee each Transferred Regulatory Filing officially with the applicable Regulatory Agency; Licensee shall and hereby does undertake all regulatory responsibilities, obligations and risks related to such Regulatory Filing. However, both Parties agree to work together to ensure a smooth transfer of Transferred Regulatory Filings and continuous dialog with FDA or foreign equivalent.
