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. 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. 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. XXXXXX shall advise CLIENT immediately if it receives a Notice of Inspection from any regulatory authority or an authorized agent of any regulatory authority visits ALTHEA’s manufacturing facility and makes an inquiry regarding such facility or regarding or affecting ALTHEA’s Production of Drug Product for CLIENT. In addition, XXXXXX shall keep CLIENT informed of the progress of the inspection and provide to CLIENT a copy of any documents produced to the regulatory authority pursuant to such Notice of Inspection unless prohibited from doing so by the relevant regulatory authority.
Manufacturing Compliance. The Product will be manufactured by Abbott pursuant to the Manufacturing Agreement at the Abbott facility(s) located at 00 X. Xxxxxxxxx Road, Whippany, NJ 07981 (FDA facility registration #2211084) and at Xxxxxx GmbH & Co. KG, Xxxxx Xxxxxxx 00, Xxxxxxxxxxxx, Xxxxxxx 00000 (FDA facility registration #3002807401).
Manufacturing Compliance. AXXXXX shall advise CLIENT immediately if an authorized agent of any regulatory body visits ALTHEA’s manufacturing facility and makes an inquiry regarding ALTHEA’s Production of Company Plasmid DNA for CLIENT. Manufacturing deviations and investigations which occur during Production of Company Plasmid DNA and which do not cause the Production to be non-compliant with cGMP or with specifications, shall not be deemed to cause such Company Plasmid DNA to be non-conforming.
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.
