Responsibility for Regulatory Filings. Each Party shall be responsible, [***], for filing, obtaining and maintaining approvals for those activities assigned to such Party hereunder in connection with the Development, manufacture and Commercialization of Products for the Field in the Territory. The Parties acknowledge that, as between the Parties, Cephalon shall have the sole right and responsibility for filing any MAA or Marketing Approval, as well as pricing or reimbursement approvals for the Products for the Field in the Territory and maintaining the same. All activities under this Section 4.6(b) shall be done subject to the oversight and in full consultation with the JSC. Prior to the filing any MAA for a Product in the Field in the Territory, Cephalon shall provide a copy thereof to the JSC for its review and approval (including any associated proposed labeling).
Responsibility for Regulatory Filings. Xanodyne shall be responsible, at its expense, for filing, obtaining and maintaining approvals for the development and commercialization of the Products for all Indications in the Territory, including any such IND, NDA or Marketing Approval by the FDA, as well as pricing or reimbursement approvals in the Territory. All such activity shall be reviewed by the JDC, [**]. All such filings will be in the name of Xanodyne.
Responsibility for Regulatory Filings. Apollo shall be responsible, at its expense, for filing, obtaining and maintaining approvals for the development and commercialization of each Product, alone or in combination with the Delivery Device, in the Territory, including any such IND, MAA or Marketing Approval, as well as pricing or reimbursement approvals in the Territory. All such activity shall be done in full consultation with the JSC. Apollo shall also obtain any export approvals required by the CFDA to import or export the Product to any country within the Territory. All such filings will be in the name of Apollo, except where otherwise required by local law.
Responsibility for Regulatory Filings. Except for [… * …] or [… * …], GSK shall be responsible, [… * …] for publishing, submitting, obtaining, and maintaining all Regulatory Filings (including any Other Indication NDAs for each Other Indication [… * …]) for the Compound and Products in the Territory. Notwithstanding the foregoing sentence, [… * …] for such Other Indication and with respect to any Regulatory Filings or activities [… * …]. XenoPort shall be responsible for [… * …] of each NDA for Other Indications (collectively, the “Other Indication NDAs”) in accordance with [… * …]. In addition, XenoPort shall be responsible for: [… * …]. It is understood that GSK shall have the right to [… * …], and to file in GSK’s name each Other Indication NDA. After such Other Indication NDA is filed, [… * …] with respect to such * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED Other Indication NDA and [… * …] Other Indication and [… * …] in the Territory. GSK [… * …]. [… * …].
Responsibility for Regulatory Filings. Subject to the remainder of this Article 4, (a) ILDONG shall have the sole right and responsibility, at its sole cost and expense, for preparing and filing all Regulatory Filings and Drug Approval Applications, Pricing Approval applications, or Reimbursement Approval applications required to Develop Compounds and Commercialize Products in the Territory in its own name; (b) all Regulatory Approvals for Products shall be solely owned by ILDONG; and (c) ILDONG shall have the sole right and responsibility for (i) maintaining all Regulatory Filings and/or Marketing Authorizations and (ii) reporting to any Regulatory Authority within the Territory all Adverse Events and Serious Adverse Events related to any Product if and to the extent required by Applicable Laws. To maximize market protection of Product, ILDONG may file for any orphan drug designations as appropriate within requisite timeframes prior to the submission of any Marketing Authorization Application. Firstly, within * (*) months following the QA approval of the Study Report of the last Clinical Trial as per the Development Program, ILDONG shall file, or cause to be filed, before the Regulatory Authority (KFDA) in South Korea, all authorization and registration applications required for the promotion, marketing, distribution and sale of Product in South Korea. ILDONG shall exercise Commercially Reasonable Efforts to obtain Marketing Authorizations with respect to the Product. Failure to meet this obligation will be considered a material breach of the Agreement and SUBLICENSOR shall have the right to terminate the Agreement for breach of ILDONG in accordance with Section 11.2.2. * Confidential material redacted and filed separately with the Commission.
Responsibility for Regulatory Filings. Except as otherwise expressly provided herein, each Party shall be responsible, at its expense, for filing, obtaining and maintaining Regulatory Approvals for those activities assigned to such Party hereunder in connection with the Development, Manufacture and Commercialization of and conduct of Medical Affairs Activities for Product within the Field in the Territory. All final and other material reports from non-clinical studies and clinical trials relating to the Product for the Field, as well all technical reports, shall be shared between the Parties as a basis for any such filing. All such final and other material reports and data analyses shall be prepared and delivered in the form in which they are available to the providing Party. The Parties acknowledge that unless the JSC designates otherwise, Grünenthal shall have the right and responsibility for preparing, filing and defending XXXx for Product within the Field in the Territory, provided that at Grünenthal’s reasonable request, MSB shall provide full support to Grünenthal with respect to such filings (including, if requested, assistance with analysing and understanding the Data Package and assistance with dossier preparation, including the provision of the integrated summaries of efficacy, the integrated summaries of safety, or other pooled analyses of the clinical data, as needed, and full access at any time (both before and after MAA) to the clinical database and data pooled therefrom and related metadata (e.g. CDISC compliant and assistance with preparing answers to questions from Regulatory Authorities, HTAs and/or national academic bodies). Where the Parties make any simultaneous filings in both the Territory and the United States, the Parties shall consult and coordinate in preparing such filings in order to avoid unnecessary duplication of efforts. All activities under this Section 7.1.1 shall be done subject to the oversight and in full consultation with the JDT. Without limiting the foregoing, prior to the filing any MAA for Product within the Field in the Territory, Grünenthal shall provide a copy thereof to MSB for its review and comment (including any associated proposed labeling) and MSB shall provide any comments in relation thereto within [***] of receipt. MSB shall provide Grünenthal with a copy of the Data Package and Dossier as soon as the same are available. Upon request, MSB shall use Commercially Reasonable Efforts to provide Grünenthal with a copy of a BLA or regulatory doss...
Responsibility for Regulatory Filings. Except as otherwise contemplated by this Section 7.8 or Section 9.3(b), Acorda will have the sole responsibility and authority for filing all documents with all Pharmaceutical Regulatory Authorities and taking any other actions that may be required for the receipt and/or maintenance of Pharmaceutical Regulatory Authority approval for the incorporation into Marketed Product to be marketed, distributed and sold in the Territory of Supplied Product to be Manufactured hereunder. Acorda will be responsible for ensuring the accuracy of the documents provided to the Pharmaceutical Regulatory Authorities by Acorda for Supplied Product and Marketed Product, and shall ensure through use of the change control process that Manufacturer is provided with the currently filed, active Specifications for Supplied Product and the information needed to enable Manufacturer to comply with the EXECUTION COPY Manufacturing Services Agreement requirements of applicable Marketing Authorizations for Marketed Product applicable to the Manufacturing Services. Notwithstanding anything to the contrary in this Agreement, Acorda shall provide Manufacturer with a draft of any document that Acorda proposes to file with any Authority describing operations to be performed within the Manufacturing Site on such a schedule as will afford Manufacturer not less than two Business Days to respond with comments to Acorda, which comments Acorda shall consider in good faith for incorporation in the document it proposes to file with the relevant Authority. Without limiting Manufacturer’s obligations under this ARTICLE 7, Acorda may request from Manufacturer additional regulatory support services as listed and for the prices set forth in Schedule 4.
Responsibility for Regulatory Filings. Except as provided in Section 4.6(a) above, DRL shall be responsible [ * ] for filing, obtaining and maintaining approvals for the development and commercialization of the Compound and each Product in the Territory, including any such IND, NDA or Marketing Approval, as well as pricing or reimbursement approvals in the Territory and for any regulatory filings required in connection with clinical trials for Products conducted by or under the authority of DRL in the ROW Territory in accordance within this Agreement.
Responsibility for Regulatory Filings. Xxxxx shall have the exclusive right and responsibility for (a) preparing, filing and maintaining all Regulatory Filings for each Product in its own name, (b) to the extent required by Applicable Laws, reporting to Regulatory Authorities any Adverse Events related to a Product that it is reasonably aware of, and (c) otherwise communicating and interacting with Regulatory Authorities with respect to Products prior and subsequent to Regulatory Approval.
Responsibility for Regulatory Filings. Subject to the Regulatory Transition Plan and Section 3.10.6, *. In addition, DS shall be obligated to prepare and file a Drug Approval Application based on data from Phase 2 Clinical Trials and/or Phase 3 Clinical Trials if the JSC determines, as a Joint Decision, that (i) the primary endpoints for efficacy and safety of such Clinical Trials have been met in all material respects, and (ii) there is a reasonable likelihood of approval with a label substantially equivalent to the label that will be requested in the Drug Approval Application, unless the JSC determines as a Joint Decision to delay the preparation and filing of such Drug Approval Application in order to conduct additional Clinical Trials to obtain data to maximize the likelihood of obtaining Commercialization Regulatory Approval or optimize the label. ARQULE (i) shall, at DS’s request, provide to DS, and DS shall have the right to provide to its Sublicensees or Affiliates, copies of a drug approval application filed by Kyowa with the Regulatory Authorities in the Field outside the Territory, and grants to DS and its Sublicensees or Affiliates the right to access, reference, use and incorporate such drug approval application in the Territory; and (ii) agrees that ARQULE shall, at DS’s request, provide to DS, and that DS shall have the right to provide to its Sublicensees or Affiliates, copies of any additional information or data with respect to the Licensed Product generated by, or on behalf of, Kyowa and owned or otherwise controlled by Kyowa and necessary or useful for DS and its Sublicensees or Affiliates to obtain any Regulatory Approvals or perform such other Regulatory Activities under this Agreement, and to Develop, Manufacture and Commercialize Licensed Products. For the avoidance of doubt, DS’s obligations under this Section 3.1.4(b) shall apply to Regulatory Filings and Drug Approval Applications for Licensed Products in New Cancer Indications (as defined in Section 3.14 below).
