Regulatory Obligations. Except as otherwise provided in Article 2.2, above, and this Article 6, Xxxxxxxxx shall be responsible for the regulatory strategy, including strategy for filings and label content, in consultation with Lilly, including commercial input. Xxxxxxxxx shall be solely responsible for all regulatory activities in connection with seeking Regulatory Approvals in the Territory, including communicating and preparing and filing all reports with the Regulatory Authorities. [**]
Regulatory Obligations. Licensee will own and maintain all regulatory filings and Marketing Approvals in the Territory for POZEN Products, including all INDs and NDAs for the Initial POZEN Product. As between the Parties, but subject to [...***...], Licensee will be solely responsible for all activities in connection with maintaining Marketing Approvals required for the Commercialization and manufacture of POZEN Products in the Territory, including communicating and preparing and filing all reports (including Adverse Event reports) with the applicable Regulatory Authorities in the Territory.
Regulatory Obligations. All obligations relating to the Product NDA shall, at all times during the Term, remain with LMI, including without limitation (a) the obligation to prepare and make any updates or amendments to the Product NDA or CMC, (b) to pay any fees or other costs associated with such filings, or (c) to collect, investigate and report to the FDA and other appropriate regulatory authorities any Product-related adverse experience reports, quality reports, and complaint reports. HSL shall provide LMI with access to any such information reasonably required to enable LMI to comply with its obligations under this Section 4.1. HSL shall remain solely responsible, at its expense, for compliance with (A) cGMPs (including any comparable requirements imposed by foreign authorities), but limited to those jurisdictions that are within the Territory as set forth in any amendment to this Agreement for which it has been qualified to produce Product; (B) obtaining or maintaining establishment registrations and all other required permits and licenses for all relevant facilities; and (C) the preparation and submission of all records and reports required by FDA and other appropriate regulatory authorities in connection with the manufacture and sale to LMI of the Product, including, without limitation, updating the DMF in countries or regions within the Territory and providing LMI with the necessary DMF Authorization Letters, if applicable at additional cost to LMI, unless the Proposal includes such activities. All information, documents and updates with regard to the manufacture of Product which are required by any governmental agency shall be provided by HSL in a timely manner, and HSL shall submit to all inquiries and inspections by any such agencies. All documents directly related to the Product and a summary of all information provided by HSL to any such agency shall be provided to LMI in advance of submission to such agency. LMI shall not file any documents relating to HSL with regulatory authorities without HSL’s prior written consent, which shall not be unreasonably withheld or delayed. HSL shall provide comments on proposed submissions within five business days of receipt and in the absence of delivery of such comments LMI may proceed with its filing. Notwithstanding the foregoing, LMI and HSL acknowledge that the regulatory support described in Proposal No. 973-5-11 sets forth the costs for filings in the Territory and the scope of HSL’s responsibility for such filings. Any cos...
Regulatory Obligations. Nothing in this Agreement shall require either Party or any of its Subsidiaries to violate or breach any applicable law, including any regulatory obligations binding on such person.
Regulatory Obligations. The Product Party shall be solely responsible for all activities in connection with the Regulatory Approvals for its Products in the Territory, including without limitation communicating and preparing and filing all reports (including without limitation adverse drug experience reports) with the FDA. The non-Product Party agrees to cooperate with the Product Party as requested, at the Product Party’s expense, in preparing and filing all such reports. The Product Party shall pay all fees associated with obtaining and maintaining the Regulatory Approvals including, without limitation, any establishment license fees of such Product Party or Third Parties which must be paid with respect to facilities used in the manufacture of its Products.
Regulatory Obligations. 10.1 Either party will notify the other immediately it becomes aware of any disciplinary action or investigation planned, requested or conducted by any Regulator, relating in any way to itself or any of its representatives, except where such notification would place the notifying party in breach of any applicable law, or where the notifying party would be acting contrary to any Regulatory Rules.
Regulatory Obligations. Customer is responsible for compiling the registration dossiers (with reasonable and necessary assistance from Lonza), filing the marketing applications with the regulatory authorities in the Territory, and maintaining marketing authorizations for the Product and the costs associated with the same. Lonza shall reasonably assist Customer in obtaining and maintaining marketing authorizations for the Product. Customer is responsible for (a) the formulation, use, packaging, labeling, distribution and disposal of Product, including compliance with all Laws related to the same; (b) communicating with any governmental authority concerning the Product (for the avoidance of doubt, Lonza may interact with governmental authorities for the purpose of fulfilling legal obligations); and (c) storing and handling Product in appropriate conditions following its delivery; and (d) determining that the Product is permitted for human use. Customer is responsible for developing all Product labeling, and for labeling content.
Regulatory Obligations. A Party may bring an action to enforce any Regulatory Obligation, once approved as proposed under this Agreement, only to the extent otherwise provided by Applicable Law. Nothing in this Agreement establishes a right to enforce a Regulatory Obligation, or jurisdiction for such enforcement, against a Party if such right or jurisdiction does not otherwise exist under Applicable Law.
Regulatory Obligations. Animas and Debiotech shall cooperate in the preparation of, and shall execute, as part of the Development Program, a Quality Agreement in order to meet the requirements of ISO13485, European MDD and FDA QSR (21 CFR 820) requirements for medical devices, to the extent applicable.
Regulatory Obligations. Pfizer and Pfizer Affiliates shall be solely responsible for preparation and submission of applications to Regulatory Authorities regarding Product. Pfizer and Pfizer’s Affiliates will advise Codexis of document requirements in support of such applications by Pfizer or its Affiliates. Codexis will use commercially reasonable efforts to provide documents and additional information needed for such applications, and to cooperate with and assist Pfizer and its Affiliates in preparation and submission of such applications to the FDA (and other Regulatory Authorities, as appropriate). All such applications to Regulatory Authorities and related filings by Pfizer and its Affiliates shall be the sole and exclusive property of Pfizer and its Affiliates. Pfizer and its Affiliates shall be solely responsible for all contacts and communications with any Regulatory Authority with respect to all matters relating to Product and services provided under this Agreement. At the request of Pfizer or its Affiliates, Codexis shall make appropriate personnel reasonably available for meetings with Regulatory Authorities related to manufacturing of Codexis Enzyme and the related processing of Product.
