Catalent Obligations. Catalent Pharma Solutions, LLC (“Catalent”) represents and warrants that it will perform the work defined in this quotation (the “Project”) in accordance with written specifications agreed to by the parties (“Specifications”), applicable master batch records, protocols, standard operating procedures, all applicable laws, rules and regulations, including without limitation cGMP (as defined below)), and other written instructions agreed to by the parties (the “Project Instructions”). As used herein “cGMP” means current Good Manufacturing Practices pursuant to (a) the U.S. Federal Food, Drug and Cosmetics Act as amended (21 USC 301 et seq.), (b) relevant U.S. regulations found in Title 21 of the U.S. Code of Federal Regulations (including but not limited to Xxxxx 00, 000, 000, 000 xxx 000), (x) XXX Directive 00/000/XXX xx 00 Xxxx 0000, (x) the Canadian Food and Drugs Act, Part C (drugs) and Good Manufacturing Practice Guidelines and (e) the EC Guide to Good Manufacturing Practice for Medicinal Drug Products, including respective guidance documents and any comparable laws, rules or regulations of any agreed upon foreign jurisdiction, as each may be amended from time to time. cGMP also includes adherence to any applicable Product license requirements, relevant current International Conference on Harmonization (ICH) guidance documents, and other relevant guidance documents.
Catalent Obligations. Catalent hereby agrees to use commercially reasonable efforts to progress the Capital Project according to the scope and timelines set forth in Schedule A, [***] Catalent shall be responsible for all Facility-related regulatory obligations and approvals where the Products are manufactured. Iroko shall be responsible for all regulatory obligations and approvals relating to the Products’ filings and approvals (excluding Catalent’s Facility related obligations as set forth above) as required to market the Products in the United States and any other jurisdictions. Catalent’s regulatory obligations relate solely to Facility renovation and utility qualification specific for supporting Iroko’s intended commercial manufacturing process and equipment train. Catalent will be responsible for Catalent Equipment (as defined herein) installation/operational qualifications. Catalent shall, at Iroko’s request, Iroko’s *** Portions of this page have been omitted pursuant to a request for confidential treatment and filed separately with the Securities and Exchange Commission. cost, and with Iroko’s reasonable assistance, be responsible for Iroko Equipment (as defined herein) installation/operational qualifications. In addition, the parties acknowledge and agree that process validation necessary to establish a robust commercial manufacturing process will need to be established and agreed between the parties as soon as practicable. As described is United States Food and Drug Administration “Guidance for Industry, Process Validation: General Principles and Practices,” conclusions about a commercial manufacturing process can only be made after the process validation protocol (“PPQ”) is fully executed and the data are fully evaluated. If process qualification is not successful (i.e., does not demonstrate that the process as designed is capable of reproducible performance at commercial scale), then it is understood by Iroko that additional design studies and qualification may be necessary. Catalent shall not be liable to Iroko nor be deemed to have breached this Agreement for errors, delays or other consequences arising from Iroko’s failure to provide necessary documents, materials or information as agreed and/or in a timely manner. Nor will Catalent be liable to Iroko if Iroko fails to otherwise reasonably cooperate in order for Catalent to perform its obligations and any such failure by the Iroko will automatically extend any timelines affected by a time period that reasonably ...
