Diligence and Resources Clause Samples
Diligence and Resources. 4.2.1. Without limiting the obligations of Insmed under this Agreement, Insmed shall, at its own expense, in respect of the Technology Transfer Program:
(i) work diligently in a professional manner and with all reasonable commercial efforts in fulfilling any and all of its obligations, including under this Section 4.2.1;
(ii) subject to Article 18, provide to Therapure all Product Documentation and Product Information;
(iii) pursuant to and in accordance with a Request Order, deliver Amikacin to Therapure DDP (Incoterms 2010) Therapure’s facilities in Mississauga, Ontario;
(iv) assist Therapure in process implementation and validation;
(v) approve or object to engineering and process designs within [***] Business Days of receipt thereof by Insmed from Therapure (or be deemed to approve the same within [***] Business Days of receipt by Insmed from Therapure of a second notice thereof);
(vi) in Insmed’s sole discretion, file, seek, prosecute and maintain all ARIKACE Permits, including the NDA and all other approvals from any applicable Governmental or Regulatory Authority;
(vii) provide reasonable technical advice and resources to Therapure to the extent necessary for Therapure to undertake the Technology Transfer;
(viii) provide to Therapure SOPs and manufacturing ▇▇▇▇ of materials;
(ix) pay Therapure’s fees and charges relating to Technology Transfer and engineering and production of regulatory compliance batches required for licensing of the Manufacturing operations, as set out in Schedule A; and
(x) promptly report to Therapure (and in no event later than [***] Business Days after the occurrence of) any development which may materially and adversely affect Therapure’s performance under this Agreement.
4.2.2. Without limiting the obligations of Therapure under this Agreement, Therapure shall, in respect of the Technology Transfer Program:
(i) work diligently in a professional manner and with all reasonable commercial efforts in fulfilling any and all of its obligations, including under this Section 4.2.2;
(ii) employ specialized technical resources reasonably necessary to execute the Technology Transfer;
(iii) following completion of the Workshop Construction Period, operate the Workshop to allow for the Manufacture of ARIKACE;
(iv) retain suitably qualified personnel and maintain appropriate quality systems and other infrastructure to support Manufacture of ARIKACE and the continued operation and maintenance of the Workshop;
(v) promptly report to Insmed...
