Regulatory Support Clause Samples
The Regulatory Support clause outlines the obligations of one or both parties to assist each other in complying with relevant laws, regulations, or government requirements related to the agreement. This may involve providing necessary documentation, responding to regulatory inquiries, or updating procedures to meet new legal standards. Its core function is to ensure that both parties can effectively navigate regulatory environments, reducing the risk of non-compliance and associated penalties.
POPULAR SAMPLE Copied 5 times
Regulatory Support. (a) POLYPEPTIDE agrees to use commercially reasonable efforts to assist CUSTOMER, in seeking approval of its NDA(s) with respect to PRODUCT. In furtherance of (and without limiting) the foregoing, POLPYPEPTIDE agrees to use commercially reasonable efforts to address feedback from the FDA (whether provided to POLYPEPTIDE or CUSTOMER) regarding the comparability of registration batches of PRODUCT manufactured by POLYPEPTIDE (before or after the Effective Date) that are submitted to the FDA in connection with the NDA filing for the PRODUCT.
(b) POLYPEPTIDE agrees to cooperate with any inspection by the FDA or other Regulatory Authority, including, but not limited to any inspection prior to approval of a PRODUCT NDA.
(c) POLYPEPTIDE agrees to (i) establish and maintain a separate DMF for each manufacturing site for the PRODUCT in accordance with POLYPEPTIDE’s SOP and the requirements of applicable Regulatory Authorities; and (ii) provide [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. CUSTOMER and their respective licensees in the Territory, with letters of access to, and rights to reference, each such DMF and any other comparable files. POLYPEPTIDE shall obtain CUSTOMER’S prior written approval of the Specifications filed in any DMF.
(d) At CUSTOMER’s request, POLYPEPTIDE agrees to provide such documentation and data as CUSTOMER reasonably requires to complete and maintain the CMC section of CUSTOMER’s NDA filings, in addition to, the filing and maintenance of the DMFs. POLYPEPTIDE shall establish each DMF in a timely manner to support CUSTOMER’s NDA filings, and shall provide to CUSTOMER such documentation, data and other information relating to the PRODUCT as CUSTOMER may require for submission to Regulatory Authorities.
(e) POLYPEPTIDE agrees to provide CUSTOMER with written copies of any proposed changes to a DMF at least [**] days prior to filing the changes, which changes shall not be implemented without CUSTOMER’s written consent except to the extent required to comply with the requirements of a Regulatory Authority which are indentified to CUSTOMER and implemented in a mutually agreed manner.
Regulatory Support. Bioverativ may request regulatory support that is related to the Manufacture of Drug Substance. Biogen shall use commercially reasonable efforts to provide the following support services and shall be reimbursed by Bioverativ for reasonable costs incurred in connection therewith and in accordance with Schedule 6 attached hereto: (a) providing regulatory information, drafts and filings that Biogen already has in its possession and (b) answering questions reasonably necessary for the preparation of regulatory filings for the products. For purposes of clarity, Biogen shall not be required to hire and/or transfer from other projects any regulatory full-time equivalents in order to meet the regulatory support needs described in this Section 12.1. In any event, Biogen will provide to Bioverativ free of charge copies of any regulatory filings prepared by Biogen relating to changes to Regulatory Approvals that arise from CMC-related changes for the products.
Regulatory Support. In the event that LICENSEE engages in clinical and regulatory activities directed towards obtaining regulatory approval of a LICENSEE PRODUCT and desires additional assistance or information from LICENSOR with respect to the cell lineage history, testing results or any other cell line documentation relating to the CELLS, then LICENSOR shall, at the expense of LICENSEE, use commercially reasonable efforts to provide such assistance or information.
Regulatory Support. In the event customer receives a direct request from a regulatory body with supervisory authority over Customer or Customer’s Affiliates (“Regulator”) to provide specific information related to its use of the Covered Service or such Regulator formally requires a direct right to audit Workday, Workday will use commercially reasonable efforts to support the Customer in responding to such Regulatory Support request, and prioritize any such request. For the avoidance of doubt, the scope of Regulatory Support assistance will be limited to the controls applicable to the Covered Service. If Customer requests an audit scope other than the specific requirement from the Regulator, Customer must acquire the Annual Audit and pay the Annual Audit Fee. The following topics are excluded from the Regulatory Support offering: • Subprocessor physical and environmental safeguards for data centers; • Subprocessor operational management of infrastructure platforms; and • Subprocessor data center tours.
Regulatory Support. If requested by CUMBERLAND, and at CUMBERLAND’S cost at reasonable fees to be agreed by the parties, FAULDING shall provide CUMBERLAND with reasonable assistance in relation to the Development of, and applications for regulatory approval for, pharmaceutical products other than the Drug Product which are identified by CUMBERLAND, including but not limited to the preparation of development reports, stability reports, manufacturing documentation and instructions for use necessary to support applications for regulatory approval.
Regulatory Support. 5.3.1 TEKMIRA will be responsible for (a) designing and implementing stability study protocols for the testing of Investigational Medicinal Product and reporting out-of-specification results, if any, to OXFORD during the duration of the Clinical Trial; and (b) updating TEKMIRA’s regulatory filings for the Investigational Medicinal Product with all results generated in the performance of the stability studies. Parameters for the stability study design are set forth in Exhibit 5.3.1 attached hereto.
Regulatory Support. Upon request, Supplier shall provide information necessary for ▇▇▇▇ to obtain regulatory approval for the marketing, sale, and distribution of ▇▇▇▇ products into which Supplier's Products are incorporated. Such information may include specific details relating to raw materials, composition, ingredients, and other items.
Regulatory Support. Except as otherwise expressly set forth herein, Senti shall be responsible for all filings necessary for approval to conduct clinical trials of and market Products. Provider will provide to Senti such Services as stated in the applicable SoW for cooperation with reporting obligations and/or the provision of information relating to the Product or the Manufacture, including the Manufacturing Process, thereof as may be necessary or useful for Senti to apply for, obtain and maintain Regulatory Approvals for each Product in any country or regulatory jurisdiction, including, without limitation, information relating to the Facilities, or the process, methodology, raw materials and intermediates used in the Manufacture of each Product and all information required to be submitted in the CMC section of an IND or a BLA or other regulatory filings, or required or requested to be provided to any Regulatory Authority. No later than six (6) months or such shorter period as may be required under relevant regulations following completion or permanent cessation of the Services at the applicable Facility, Senti shall: (a) file an update to any applicable regulatory filings relating to the Product to indicate a change in manufacturer; and (b) provide to Provider written confirmation of its compliance with this sentence.
Regulatory Support. 2.2.1.1 BI RCV agrees to co-operate with VIDARA in obtaining and maintaining all US governmental approvals and registrations relevant to the CMC section of the registration dossier (and their foreign equivalents) as requested by VIDARA.
2.2.1.2 The Parties shall consult with each other concerning the scope and content of all regulatory filings, and shall jointly define the requirements for the necessary PRODUCT registration with the FDA so that BI RCV shall be able to fulfill its obligations under this AGREEMENT with respect to the CMC portion of such PRODUCT registration. With respect to any part of the CMC portion which contains BI RCV and/or BI Pharma KG INFORMATION, BI RCV shall be provided an opportunity to review and comment on such parts prior to submission to a HEALTH AUTHORITY as set forth in the QUALITY AGREEMENT.
Regulatory Support. To the extent practicable, Eagle shall notify MDCO within ten (10) business days prior to any inspection (of which Eagle is aware) by the FDA or other regulatory agency relating to Product or any Product-related facility that is involved in the supply of Product to MDCO hereunder and, within twenty-four (24) hours after such inspection, shall furnish MDCO with a copy of all documentation, including any Form 483 and the Third Party Manufacturer’s response thereto, relating to such inspection. In addition, Eagle shall notify MDCO within five (5) business days after its receipt of any other written regulatory actions or communications (other than ministerial, non-substantive communications) relating to the Product or any Product-related facility that is involved in the supply of Product to MDCO hereunder. The Parties shall confer with each other with respect to any response regarding such action or communication and the best means to comply with such action or communication, but the final response shall be within Eagle’s final decision-making authority.