Manufacturing Regulatory Matters. The Company and its Subsidiaries have complied in all material respects with all statutes and regulations related to the research, manufacture and sale of its products to the extent applicable to the Company’s and its Subsidiaries’ activities. Items manufactured or under investigation by the Company and its Subsidiaries comply with all applicable manufacturing practices regulations and other requirements established by government regulators in the jurisdictions in which the Company or its Subsidiaries manufacture their products. Except as disclosed in the SEC Reports, the Company is not and its Subsidiaries are not the subject of any investigation by any competent authority with respect to the development, testing, manufacturing and distribution of their products, nor has any investigation, prosecution, or other enforcement action been threatened by any regulatory agency. Except as disclosed in the SEC Reports, neither the Company nor any of its Subsidiaries has received from any regulatory agency any letter or other document asserting that the Company or any Subsidiary has violated any statute or regulation enforced by that agency with respect to the development, testing, manufacturing and distribution of their products. To the Company’s knowledge, research conducted by or for the Company and its Subsidiaries has complied in all material respects with all applicable legal requirements.
Manufacturing Regulatory Matters. Notwithstanding the provisions of Section 8.3, Orion will be responsible for any reporting of matters regarding the manufacturing of Product to USL, and USL will notify the FDA in accordance with pertinent laws and regulations. Orion shall immediately notify USL of any such matter if significant or serious and promptly furnish to USL complete copies of such reports submitted by Orion to the FDA. Orion shall also advise USL of any occurrence or information which arise out of Orion’s manufacturing activities, which have or could reasonably be expected to have adverse regulatory compliance and/or reporting consequences or adverse impact on the Development or commercialization of Product. Orion shall be responsible for handling and responding to any appropriate governmental agency inspections with respect to manufacturing of Product, and shall provide information related thereto to USL in accordance with the provisions of Section 8.10. In addition, Orion must immediately communicate to USL any quality issues or failures of audits of the FDA that affect USL’s ability to obtain, promote or sell Product in the Territory. Orion will furnish USL with copies of all investigation reports directly relating to or impacting the Product. Without limiting the generality of the foregoing, Orion shall supply USL with the following information in a timely manner for USL’s annual regulatory filing: copies of all exception reports; copies of all complaint reports; analytical results for all lots manufactured; an inspection report of all house samples; stability data for all lots for which stability testing is ongoing; reports regarding any formulation changes, manufacturing or packaging process changes and production batch record alterations (including a complete description and rationale for all such changes); and any data involving recalls or field corrections. No changes shall be made without following the change control process as described in the Quality Assurance Agreement.
Manufacturing Regulatory Matters. (a) Supplier will be responsible for any reporting of matters regarding the manufacture of Components, as applicable, to the FDA and other relevant regulatory authorities, in accordance with pertinent laws and regulations. Supplier shall notify Purchaser of any such matter if significant or serious and promptly furnish complete copies of such reports to Purchaser in the English language. Supplier also shall advise Purchaser of any occurrence or information which arises out of Supplier's manufacturing activities which has adverse regulatory compliance and/or reporting consequences concerning a Component.
(b) Supplier shall be responsible for handling and responding to any appropriate governmental agency inspections with respect to manufacturing of Components during the term of this Agreement. Supplier shall provide to Purchaser any information requested by any governmental agency in connection with any governmental inspection related to Components. Supplier shall use reasonable efforts to promptly advise Purchaser of any requests by any governmental agency for such inspections with respect to manufacturing of Components.
(c) Any changes by Supplier to the manufacturing process for Components that may require approval by the FDA or other authorities or amendment of existing Regulatory Approvals shall require the prior written approval of Purchaser, not to be unreasonably withheld or delayed.
(d) Supplier certifies it did not and will not use in any capacity the services of any person, including any firm or individual, debarred or subject to debarment under the Generic Drug Enforcement Act of 1992, amending the Food Drug and Cosmetic Act at 21 USC 335a. Supplier agrees to notify Purchaser immediately in the event any person providing services to Supplier under the scope of the work of this Agreement is debarred or becomes subject to debarment.
(e) For the limited purpose of permitting a quality and compliance audit, Supplier shall grant to authorized representatives of Purchaser upon reasonable notice and not more than once per year, unless a substantial and reasonable need for an additional audit can be shown, access to areas of Supplier's plants and each of Supplier's Third Party supply contractor's plants, and to those technical records made by Supplier that only relate solely to Quality Assurance testing and regulatory compliance monitoring for manufacturing of Components, at such times as Components are being manufactured, solely for the purpose of Purch...
Manufacturing Regulatory Matters. (a) Each Party shall use Commercially Reasonable Efforts to ensure that its Product Suppliers (i) maintain all regulatory and governmental permits, licenses and approvals that may be necessary to manufacture and ship API Compound or Collaboration Products and (ii) conform to the specifications for API Compound and Collaboration Products and agree in the case of a nonconformity identified within ** (**) days after receipt thereof, to replace, at no additional expense to either Party, such API Compound or Collaboration Product within ** (**) days after receipt of notification of nonconformity.
(b) In accordance with Article 9, each Party shall advise the other Party of any information which arises out of such Party's Product Suppliers' manufacturing activities of which it is aware or such Party's or its Affiliates' manufacturing hereunder, whether relating to Collaboration Products or API Compound, which have adverse regulatory compliance and/or reporting consequences concerning Collaboration Products or API Compound.
(c) In accordance with Article 9, each Party shall provide to the other Party any information reasonably requested by such other Party and shall consult the other Party before providing any information to any Governmental Authority in connection with manufacture of Collaboration Products or API Compound. Each Party shall immediately advise the other Party of any requests by any Governmental Authority for inspections at the premises of such Party's Product Suppliers, or such Party or any of its Affiliates, with respect to Collaboration Products or API Compound. ** = 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.
(d) In the event any Party or its Product Supplier is inspected by the FDA or any similar or related Governmental Authority relating to Collaboration Products or Compound, such Party will use its Commercially Reasonable Efforts to ensure that the **. Each Party shall promptly notify the other Party of any alleged violations or deficiencies relating to a manufacturing facility at which Collaboration Products or API Compound is manufactured, packaged or stored, and shall promptly disclose to the other Party all relevant portions of any notice of observations or potential violations as well as a copy of its or its Product Suppliers' response thereto.
(e) Each Party will use Commercially Reasonable Efforts not to use, ...
Manufacturing Regulatory Matters. = 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. ** ** = 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. **
Manufacturing Regulatory Matters. 19.1 West shall maintain all applicable regulatory and governmental permits, licenses and approvals required to manufacture and ship Products to BD.
19.2 West will be responsible for any reporting of matters regarding the manufacture of Products to the US Food and Drug Administration (“FDA”) and other relevant regulatory authorities, in accordance with applicable laws and regulations. West shall within two (2) business days (unless applicable regulations or law require more expedient notification) notify BD of any such matter and promptly furnish complete copies of such reports to BD. West shall also advise BD of any occurrence or information that arises out of West’s manufacturing activities, whether or not occurring with Products, which has adverse regulatory compliance and/or reporting consequences concerning Products.
19.3 West shall be responsible for handling and responding to any appropriate governmental agency inspections with respect to Products during the Term. West shall provide to BD any information reasonably requested by BD in connection with any governmental inspection related to Products. West shall within two (2) business days (unless applicable regulations or law require more expedient notification) advise BD of any requests by any governmental agency for such inspections with respect to Products.
19.4 In the event West is inspected by the FDA, or any similar or health authority, West shall promptly notify BD of any alleged violations or deficiencies relating to the manufacturing facility at which Products are manufactured, packaged or stored, and shall promptly disclose to BD all relevant portions of any notice of observations or potential violations (e.g. FDA Form-483) as well as a copy of West’s response thereto.
19.5 West certifies it has not and will not use in any capacity the services of any person, including any firm or individual, debarred or subject to debarment under the Generic Drug Enforcement Act of 1992, amending the Food Drug and Cosmetic Act at 21 USC 335a. West agrees to notify BD immediately in the event any person providing services to West under the scope of the work of this Agreement is debarred or becomes subject to debarment. West further certifies that it: (i) is not currently excluded, debarred, or otherwise ineligible to participate in the federal health care programs as defined in 42 U.S.C. § 1320a-7b(f) (the “Federal Health Care Programs”) or generally from federal procurement and non-procurement programs; (ii...
Manufacturing Regulatory Matters. (a) Xxxx shall maintain the ANDAs and any other regulatory approvals necessary for Xxxx to supply Finished Product hereunder. Xxxx shall promptly advise Xxxxx in writing of any information arising out of its manufacturing activities that may have adverse regulatory compliance and/or reporting consequences concerning the Finished Product.
(b) Where Xxxx may lawfully do so, Xxxx shall provide Xxxxx with access to copies of all filings submitted by Xxxx to any Governmental Authority for each Licensed Product. Xxxx shall have the final decision-making authority in every case on whether and how to maintain the ANDAs and any other regulatory approvals necessary for Xxxx to supply Finished Product hereunder and any other issues in connection with such approvals and on whether and how to communicate with any Governmental Authority; provided, that Xxxx will not, except where required by, or to fulfill obligations under, Applicable Law or except where required by a Governmental Authority within the scope of its authority, supplement, amend or otherwise alter the ANDAs or any other such regulatory approval so as to breach this Agreement or to adversely alter the rights granted to Xxxxx hereunder or under the License Agreement.
Manufacturing Regulatory Matters. 13 4.3 Product Recall Procedures........................... 14 4.4 Documentation....................................... 15
Manufacturing Regulatory Matters. (a) Supplier will be responsible for any reporting of matters regarding the manufacture of Components, as applicable, to the FDA and other relevant regulatory authorities, in accordance with pertinent laws and regulations. Supplier shall notify Purchaser of any such matter if significant or serious and promptly furnish complete copies of such reports to Purchaser in the English language. Supplier also shall advise Purchaser of any occurrence or information which arises out of Supplier's manufacturing activities which has adverse regulatory compliance and/or reporting consequences concerning a Component.
(b) Supplier shall be responsible for handling and responding to any appropriate governmental agency inspections with respect to manufacturing of Components
Manufacturing Regulatory Matters. (a) TBC shall use its best efforts to maintain all regulatory and governmental permits, licenses and approvals that may be necessary to manufacture and ship PRODUCT to SB.
(b) TBC will be responsible for any reporting of matters regarding the manufacture of PRODUCT to the FDA and other relevant regulatory authorities, in accordance with pertinent laws and regulations. TBC shall immediately notify SB of any such matter and promptly furnish complete copies of such reports to SB. SB shall advise TBC of any occurrence or information which arise out of manufacturing activities of PRODUCT by SB or on SB's behalf which have or could reasonably be expected to have adverse regulatory compliance and/or reporting consequences concerning PRODUCT.
(c) In the event TBC should become aware of information that may require a recall, field alert, product withdrawal or field correction arising from any defect in any PRODUCT provided under this AGREEMENT, TBC shall immediately notify SB in Writing. In the event that SB decides that a recall, field alert, product withdrawal, or field correction is necessary due to any defect in any PRODUCT, SB will notify TBC.
