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 THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 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) 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.
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.
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.
Manufacturing Regulatory Matters. (a) MPI 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.
Manufacturing Regulatory Matters. (a) Aradigm will be responsible for any reporting of matters regarding the manufacture of AERx DEVICES, DRUG PRODUCTS and ACCESSORIES to the FDA and other relevant regulatory authorities, in accordance with pertinent laws and regulations. Aradigm shall notify SB of any such matter if significant or serious and promptly furnish complete copies of such reports to SB. Aradigm shall also advise SB of any occurrence or information which arise out of Aradigm's manufacturing activities, whether or not occurring with an AERx DEVICE, DRUG PRODUCT or ACCESSORY, which have or could reasonably be expected to have adverse regulatory compliance and/or reporting consequences concerning an AERx DEVICE, DRUG PRODUCT or ACCESSORY.
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.
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.
