Manufacturing Compliance Clause Samples

Manufacturing Compliance. ▇▇▇▇▇▇ 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. The manufacturing facilities and operations of Company’s suppliers and manufacturers are not, to the Company’s knowledge, operated in violation of applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject.

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. 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. 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. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Applicable Regulatory Authorities.

Manufacturing Compliance. The drug product will be manufactured by Patheon according to the Supply Agreement at the facilities located at ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇ 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. Each Party shall be responsible for manufacturing VEGF Products in accordance with all applicable Laws, including applicable Good Manufacturing Practices. The Parties will enter into a separate quality agreements containing terms and provisions customary for that type of agreement in the pharmaceutical industry. One of the quality agreements may constitute an annex to the Supply Agreement. Both Parties shall use Commercially Reasonable Efforts to minimize Manufacturing Cost for each VEGF Product.

Manufacturing Compliance. ▇▇▇▇▇▇ shall advise Client immediately if an authorized agent of any Regulatory Authority schedules or visits (or gives notice that it intends to schedule or visit) Althea’s manufacturing facility and makes an inquiry regarding Althea’s Production of Client Product for Client. Client shall be entitled to be present during any such inspection or visit, and shall be further entitled to attend any end of visit wrap-up meeting with such regulatory agent, if feasible. [***] ▇▇▇▇▇▇ shall promptly provide Client with a copy of any report or findings of such Regulatory Authority relevant to Production or Client Product and of Althea’s intended response prior thereto to enable the parties to confer on such matter.