Manufacturing Compliance. Each Party will use diligent efforts to Manufacture the Formulated Bulk Product and Finished Product supplied under this Article VIII or, as applicable, to ensure that the same is Manufactured by Third Parties in conformity with Good Practices and applicable Laws. Each Party will timely notify and seek the approval of the other Party, which approval shall not be unreasonably withheld or delayed, for any Manufacturing changes for the Formulated Bulk Product or Finished Product that are reasonably likely to have an adverse impact on (a) the quality of the Licensed Products supplied under this Agreement or (b) the regulatory status of the Licensed Products in the Territory, including requirements to support or maintain any Approvals. Each Party shall have the right to conduct inspections and audits of the other Party's facilities involved in the Manufacture of Licensed Products in the Field pursuant to this Agreement at reasonable times and on reasonable prior notice on terms to be agreed upon by the Parties. Moreover, each Party will use diligent efforts to negotiate agreements that would allow the other Party to audit the facilities of Third Party contractors (including Sanofi, if applicable) involved in the Manufacture of Licensed Products for use in the Field under this Agreement.
Manufacturing Compliance. FAULDING shall advise CUMBERLAND immediately if an authorized agent of any regulatory body visits FAULDING’s manufacturing facility and makes an inquiry regarding FAULDING’s method of manufacture of the Drug Product for CUMBERLAND. Upon receipt of any Form 483 Notice of Inspectional Observations issued by the FDA or notice of deficit from any other regulatory inspection after a visit to FAULDING’s manufacturing facility, FAULDING shall immediately send CUMBERLAND a copy thereof; provided that it may redact any language that is subject to a legally enforceable confidentiality agreement between FAULDING and a third party.
Manufacturing Compliance. The drug product will be manufactured by Patheon according to the Supply Agreement at the facilities located at 0000 X. Xxxxxxxxx Rd., Cincinnati, OH. The FDA facility number for this location is 1510437. The drug product shall be manufactured according to cGMP’s (21 CFR Part 210-211) as well as all additional requirements detailed in the batch records or approved Supplement. All computer systems used to control manufacturing processes shall be validated, and shall comply with 21 CFR Part 11.
Manufacturing Compliance. All Clinical Development Candidates and Cell Therapy Products supplied hereunder shall be manufactured by or on behalf of Athersys in compliance with current good manufacturing practices, other applicable requirements of relevant regulatory authorities, and other applicable laws and regulations, including applicable laws and regulations relating to the transportation, storage, use, handling and disposal of waste materials and hazardous materials used to manufacture Clinical Development Candidates and/or Cell Therapy Products. Athersys, at its expense, shall obtain and maintain, and/or shall require that its Third-Party manufacturers obtain and maintain, for so long as Athersys is supplying Clinical Development Candidates and/or Cell Therapy Products hereunder, all facility licenses and government permits necessary to manufacture and supply the Clinical Development Candidates and Cell Therapy Products.
Manufacturing Compliance. BIONICHE shall advise CUMBERLAND immediately if an authorized agent of any regulatory body visits the Facility and makes an inquiry regarding BIONICHE’s method of manufacture of the Drug Product for CUMBERLAND. Upon receipt of any Form 483 Notice of Inspectional Observations issued by the FDA or notice of deficit from any other regulatory inspection after a visit to the Facility, BIONICHE shall immediately send CUMBERLAND a copy thereof; provided that it may redact any language that is subject to a written confidentiality agreement between BIONICHE and a third party.
Manufacturing Compliance. Xxxxxx shall advise Client immediately if an authorized agent of any Regulatory Authority visits the Facility and makes an inquiry regarding Althea’s Production of Client Product.
Manufacturing Compliance. Supplier will comply and ensure that all authorized Subcontractors and Approved Vendors comply with all laws and regulations applicable to the Supplier and manufacturing of the Products, including but not limited to, governmental regulations, labor laws, and environmental standards. Eargo will have no liability for any aspect of Supplier’ supply chain or operations, including any and all Approved Vendors.
Manufacturing Compliance. Nisso shall manufacture the Drug Substance, including all samples thereof, in accordance with the Specifications, the Drug Master File, cGMPs and applicable registrations of and approvals for the Drug Substance. Nisso shall promptly notify Replidyne of any out-of-specification manufacturing events, shall investigate such events, and shall provide Replidyne with a report with full supporting data of such investigation and corrective actions, which Replidyne may comment upon and dispute. As requested from time to time, Nisso shall provide Replidyne with a letter certifying that the manufacture of Drug Substance is in compliance with cGMPs, including without limitation, as required by the CFR.
Manufacturing Compliance. Xxxxxx shall advise Client immediately if an authorized agent of any regulatory body visits Xxxxxx’x manufacturing facility and makes an inquiry specifically regarding Xxxxxx’x Production of Product for Client. Client shall advise Xxxxxx immediately if an authorized agent of any regulatory body plans to visit or accompany Client on a visit to Client’s facility or Xxxxxx’x manufacturing facility.
Manufacturing Compliance. All Products delivered to Purchaser (or shipped to a third party at the direction of Purchaser) under this Agreement shall be free of defects in material and workmanship and meet the Specifications, and applicable Regulatory Standards. Seller represents and warrants that it has the necessary expertise, personnel, facilities and equipment to perform its obligations in accordance with this Agreement and that it shall operate and maintain its manufacturing facility in compliance with Regulatory Standards.
