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. 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. (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 [… * …].
(ii) Notwithstanding Section 4.6(a)(i) above, at a reasonable time after the Restatement Effective Date, but in any case no later than [… * …], GSK shall assign (or cause to be assigned) any and all INDs and/or other Regulatory Filings pertaining to the Product for any Other Indication filed by GSK, or any of its Affiliates or Sublicensees in the Territory (together with any Regulatory Filings filed, or authorized to be filed, by XenoPort in the Territory with respect to Other Indications collectively, the “Other Indication Regulatory Filings”); provided, however, [… * …]; and provided further, that [… * …]. Further, it is understood that, following the Restatement Effective Date: (A) XenoPort may file (or authorize the filing of) additional INDs and other Regulatory Filings to conduct the clinical trials and other activities pertaining to the Product for any Other Indication set out in the then-current Development Plan, or that XenoPort is otherwise permitted to conduct pursuant to Section 4.4(b) or 2.1(a); and (B) without limiting the last sentence of this Section 4.6(a)(ii), Section 4.6(b) or Section 4.9 below, GSK shall not be obligated to file (or authorize the filing of) additional INDs or other Regulatory Filings to support the clinical trials and other activities described in the preceding clause (A). Notwithstanding the foregoing and without limiting Section 4.9 below, GSK shall cooperate with and assist XenoPort (or its designee) and shall take those actions reasonably necessary to allow XenoPort to conduct clinical trials and other activities in the Territory [… * …].
(iii) Except to the extent required or, if agreed to by the Parties [… * …] useful, for XenoPort to continue to conduct development activities for Other Indications [… * …], upon GSK’s written request, XenoPort shall assign (or cause to be assigned) to GSK the Regulatory Filings with respect to an Other Indication in the Territory in connection with the filing of an NDA for the Product for such Other Indication in the Territory in accordance with Section 4.6(b) below.
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 Xxxxxx Xxxxxx’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. (including Marketing Approvals). At Nativis’ option, which will be exercised by written notice to Teijin, to the extent permitted under Applicable Laws, Teijin will assign or cause to be assigned to Nativis or its designee (or to the extent not assignable, Teijin will take all reasonable actions to make available to Nativis or its designee the benefits of) all Regulatory Filings (including INDs, NDAs, and Marketing Approvals) for the Licensed Product in the Territory, including all such Regulatory Filings made or owned by its Affiliates or Sublicensees. Nativis will notify Teijin before the effective date of termination whether the Regulatory Filings should be assigned to Nativis or its designee, and if the latter, identify the designee, and provide Teijin with all necessary details to enable Teijin to effect the assignment (or availability). If Nativis fails to provide such notification prior to the effective date of termination, Teijin has no obligation to assign the Regulatory Filings to Nativis.
Assignment of Regulatory Filings. Unless otherwise agreed by the Parties, with respect to each Regulatory Filing (including any applicable IND) that (a) relates solely to the Licensed Compound or any Licensed Product, (b) is not already held in the name of GSK or any of its Affiliates or Sublicensees and (c) with respect to which Mersana is no longer the Regulatory Responsible Party, Mersana will assign to GSK all rights, title, and interests in and to each such Regulatory Filing, and provide GSK a copy of each such Regulatory Filing, on a reasonably prompt timeline as agreed by the Parties.
Assignment of Regulatory Filings. On a Collaboration Target-by-Collaboration Target basis, within [***], 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. Unless otherwise agreed by the Parties, no later than [***], if ITEOS holds, in its name, any Regulatory Filings (including INDs) with respect to any Licensed Products as of such date, unless otherwise agreed by the Parties, ITEOS will assign to GSK all rights, title, and interests in and to each such Regulatory Filing (including INDs) filed in the Territory, and will transfer to GSK copies (in electronic or other format) of those Regulatory Filings owned by ITEOS or its Affiliates that are necessary to assign such INDs to GSK, provided, however, that ITEOS will not assign Regulatory Filings (including INDs) to GSK regarding Additional Development Activities being conducted by ITEOS in accordance with Section 3.4 (Additional Development) until (a) such Additional Development Activities are added to the Global Development Plan pursuant to Section 3.4.3(b) (Proof of Concept Data) or (b) the applicable Regulatory Approval is obtained in connection with such Additional Development Activities, as described in Section 3.4.3(c) (Receipt of Regulatory Approval), in each case, which assignment of Regulatory Filings shall be in a manner and on the timelines to be agreed by the Parties.
