Certificates of Manufacturing Compliance. The Manufacturing Party shall prepare, or cause its contract manufacturer(s) to prepare and deliver, and maintain for a period of not less than five (5) years and for so long as required under applicable requirements of the FDA or other applicable regulatory authority for each lot of Collaboration Products manufactured a certificate of manufacturing compliance containing the types of information which shall have been approved by the Program Management Team or required by the FDA or other applicable regulatory authority, which certificate will certify that the lot of Collaboration Products was manufactured in accordance with the Specifications and the Good Manufacturing Practices of the FDA or other applicable regulatory authority as the same may be amended from time to time. The Manufacturing Party shall advise the other Parties immediately if an authorized agent of the FDA or other regulatory authority visits any of the Manufacturing Party's manufacturing facilities, or the facilities where the Collaboration Products are being manufactured, for an inspection with respect to the Collaboration Products. The Manufacturing Party shall furnish to the other Parties the report by such agency of such visit, to the extent that such report relates to Collaboration Products, within ten (10) business days of the Manufacturing Party's receipt of such report, and the other Parties shall have the right to comment on any response by the Manufacturing Party to such inspecting agency.
Certificates of Manufacturing Compliance. HSL shall provide or cause to be provided for each Lot or Batch of Product purchased under this Agreement a certificate of manufacturing compliance, containing the type of information reasonably agreed upon by HSL and LMI, which will certify that the Lot or Batch of Product was manufactured in accordance with the Specifications and cGMP, including without limitation 21 CFR 210 and 211 and ICH Q7, as the same may be amended from time to time, and a copy of the fully executed batch record. HSL shall send such certificates and batch record to LMI concurrent with delivery of each Lot or Batch of Product. HSL agrees that it shall maintain all of the facilities used for the manufacture of the Product in material compliance with all applicable state, local, federal or international laws and regulations and shall permit the relevant governmental agencies to inspect the manufacturing facilities used for the manufacture of the Product whenever deemed necessary by such agencies. HSL shall advise LMI **** if an authorized agent of the FDA or other governmental agency visits any of HSL’s facilities where the Product is being manufactured, or where any component of the Product is manufactured, processed or controlled, or of any official contact concerning the Product; provided, however, that LMI shall have the right to be present for all scheduled inspections relating to the manufacture of Product. HSL shall furnish to LMI the report by such agency, appropriately redacted, that relates to such visit to the extent that such report relates to the Product, Facility or Quality system, within (i) **** of HSL’s receipt of such report if such report relates to urgent matters such as Product recall, facility shutdown or similar events (“Urgent Incident”) and (ii) **** after HSL’s receipt of such report for other matters. In addition to the observation rights set forth in the Proposals, upon reasonable advance notice to HSL, HSL shall allow LMI and its consultants (subject to entering into suitable confidentially agreements reasonably acceptable to HSL) reasonable access during normal business hours throughout the Term to any of HSL’s facilities where the Product is being manufactured, or where any component of the Product is manufactured, processed or controlled to verify compliance with HSL’s obligations under this Agreement; provided that such access shall be limited to **** during any consecutive ****, except in the event of an Urgent Incident, in which event HSL shall allow...
Certificates of Manufacturing Compliance. HMRI shall provide, or cause to be provided, for each lot of Product manufactured pursuant to this Agreement, a certificate of manufacturing compliance, containing the types of information which shall have been approved by mutual agreement of the parties, which will certify that the Product was manufactured in accordance with the Specifications and the GMP. HMRI shall advise Rugby promptly if an authorized agent of the FDA or other governmental regulatory agency visits any of HMRI's manufacturing facilities, or the facilities where the Products are being manufactured, concerning the Products. HMRI shall furnish to Rugby all material information supplied to, or supplied by, the FDA or other governmental regulatory agency, including the Form 483 observations and responses, to the extent that such report relates to Products (or the ability of HMRI to supply such Product), within five (5) business days of HMRI's receipt of such information or delivery of such information, as the case may be.
Certificates of Manufacturing Compliance. BioMarin shall prepare, or cause to be prepared and delivered, and maintain for a period of not less than five (5) years or for such longer period as required under applicable requirements of the FDA or other applicable regulatory authority for each Lot of Aldurazyme manufactured a certificate of manufacturing compliance containing the types of information typical for such reports or required by the FDA or other applicable regulatory authority, which certificate will certify that the Lot of Aldurazyme was manufactured in accordance with the Specifications and the cGMP Regulations as the same may be amended from time to time.
Certificates of Manufacturing Compliance. The Manufacturing Party shall prepare and maintain for a period of not less than five (5) years and for so long as required under applicable requirements of the FDA for each lot of Collaboration
Certificates of Manufacturing Compliance. At the request of BIOMEDICA and at BIOMEDICA’s expense, MIP shall provide or cause to be provided for such Compounds or Products purchased, a certificate of manufacturing compliance, containing the types of information reasonably agreed upon by BIOMEDICA and MIP. Such certificate shall certify that the Compounds or Products were manufactured in accordance with the specifications provided by BIOMEDICA and in compliance with all local laws in the country of manufacture.
Certificates of Manufacturing Compliance. RenaGel LLC shall prepare, or cause its contract manufacturer(s) to prepare and deliver to RenaGel LLC, and maintain for a period of not less than five (5) years and for so long as required under applicable requirements of the FDA or other applicable regulatory agency for each lot of Collaboration Products manufactured a certificate of manufacturing compliance containing the types of information that shall have been approved by the Program Management Team or required by the FDA or other applicable regulatory agency, which certificate will certify that the lot of Collaboration Products was manufactured in accordance with the Specifications and the Good Manufacturing Practices of the FDA or other applicable governmental regulatory agency as the same may be amended from time to time. RenaGel LLC shall advise the other Parties immediately if an authorized agent of the FDA or other governmental regulatory agency visits any facilities where the Collaboration Products are being manufactured for an inspection with respect to the Collaboration Products. RenaGel LLC shall furnish to the other Parties the report by such agency of such visit, to the extent that such report relates to Collaboration Products, within ten (10) business days of RenaGel LLC's receipt of such report.
Certificates of Manufacturing Compliance. DSM shall provide or cause to be provided, for each lot of Product purchased pursuant to this Agreement, a certificate of manufacturing compliance, containing the types of information which shall have been agreed between the parties, which will certify that the lot of Product was manufactured in accordance with the Specifications and the current Good Manufacturing Practices of the FDA, as the same may be amended from time to time, including without limitation the requirements listed on Exhibit F (collectively, GMPS). In the event the FDA or other governmental regulatory agency notifies DSM that it intends to visit or inspect the Facility, DSM shall immediately provide notice of such visit or inspection to Cubist and Cubist shall have the right to participate in such visit or inspection. DSM shall advise Cubist immediately If an authorized agent of the FDA or other governmental regulatory agency visits the Facility without prior notice, DSM shall furnish to Cubist the report by such agency of such visit within [ ]* of DSM’s receipt of such report. In the event DSM fails to meet the GMPs, as a consequence of the non-, late- or misperformance of its obligations hereunder except for reasons of Force Majeure DSM will be responsible, at DSM’s expense, for (a) conducting an investigation to define the probable causes for the failure, (b) providing an acceptable GMP investigation report to Cubist for review and written approval and (c) achieving compliance with GMP.
Certificates of Manufacturing Compliance. Manufacturer shall provide or cause to be provided a certificate of manufacturing compliance or manufacturing lot record that will certify that the lot of Product was manufactured in accordance with the Specifications and applicable cGMPs.
Certificates of Manufacturing Compliance. Pursuant to the Manufacturing Agreement, Cyberkinetics shall prepare and maintain (or shall cause the Third Party manufacturer to prepare and maintain) for a period of not less than five (5) years and for so long as required under applicable requirements of the FDA for each Collaboration Product manufactured a certificate of manufacturing compliance containing the types of information which shall have been approved by the Program Management Team or required by the FDA, which certificate will certify that the Collaboration Products were manufactured in accordance with the applicable specifications and the Good Manufacturing Practices of the FDA or other applicable governmental regulatory agency as the same may be amended from time to time. Cyberkinetics shall advise the other Parties immediately if an authorized agent of the FDA or other governmental regulatory agency visits any of Cyberkinetics' manufacturing facilities, or the facilities where the Collaboration Products are being manufactured, for an inspection with respect to the Collaboration Products. Cyberkinetics shall furnish to the other Parties the report by such agency of such visit, and any correspondence with such agency, to the extent relating to Collaboration Products, or that might reasonably impair the manufacture of the Collaboration Product in accordance with this Agreement or the Manufacturing Agreement, within three (3) days of Cyberkinetics' receipt of such report.
