Common use of Diligence and Resources Clause in Contracts

Diligence and Resources. 5.1.1.1. Without limiting the obligations of Insmed under this Agreement, Insmed shall, at its own expense, in respect of the Manufacturing Period: (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 5.1.1.1; (ii) subject to Article 18, provide to Therapure all Product Documentation and Product Information; (iii) if requested by Therapure, provide reasonable technical support to Therapure to the extent necessary for Therapure to Manufacture ARIKACE; and (iv) pursuant to and in accordance with a Request Order, deliver to Therapure DDP (Incoterms 2010) Therapure’s facilities in Mississauga, Ontario: (A) the Amikacin for the applicable calendar quarter (or such longer period of time to the extent required to release Batches for commercial Manufacturing), for further processing into ARIKACE; and (B) the Excipients, provided, however, that the Amikacin and Excipients so delivered: (A) shall be stored in a secure and appropriately segregated area within the Facility; (B) shall not be transferred to any third party (except as may be required by applicable Law) without the prior written consent of Insmed; and (C) shall only be used by Therapure for the Manufacture of ARIKACE. 5.1.1.2. Without limiting the obligations of Therapure under this Agreement, Therapure shall, in respect of the Manufacturing Period: (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 5.1.1.2; (ii) prepare executed Batch Production Records; (iii) manufacture and package Batches pursuant to Therapure’s Manufacturing Requirements; (iv) within [***] days prior to commencement of a calendar quarter send Request Orders to Insmed for quantities of Amikacin and Excipients derived from the quantity of ARIKACE forecasted in the Demand Forecast for such calendar quarter (or such longer period of time to the extent required to release Batches for commercial Manufacturing); (v) store all Amikacin and Excipients in a secure and appropriately segregated area within the Facility; (vi) take reasonable precautions to protect Amikacin and Excipients from damage; provided, that in the event of damage to the Amikacin or Excipients, to the extent attributable to the negligence or intentional act or omission of Therapure, Insmed’s exclusive remedy shall be the payment by Therapure of the costs associated with the replacement of such Amikacin or Excipients, which the parties agree shall be no greater than the Cost of Amikacin or the Cost of Excipients, as applicable; (vii) not transfer any Amikacin or Excipients to any third party (except as may be required by applicable Law) without the prior written consent of Insmed; (viii) only use Amikacin and Excipients for the Manufacture of ARIKACE; and (ix) maintain commercially reasonable levels of insurance for all Amikacin and Excipients stored within the Facility.

Diligence and Resources. 5.1.1.14.2.1. Without limiting the obligations of Insmed under this Agreement, Insmed shall, at its own expense, in respect of the Manufacturing PeriodTechnology 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 5.1.1.14.2.1; (ii) subject to Article 18, provide to Therapure all Product Documentation and Product Information; (iii) if requested by Therapure, provide reasonable technical support to Therapure to the extent necessary for Therapure to Manufacture ARIKACE; and (iv) pursuant to and in accordance with a Request Order, deliver Amikacin to Therapure DDP (Incoterms 2010) Therapure’s facilities in Mississauga, Ontario:; (Aiv) the Amikacin for the applicable calendar quarter 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 such longer period be deemed to approve the same within [***] Business Days of time 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 xxxx of materials; (ix) pay Therapure’s fees and charges relating to Technology Transfer and engineering and production of regulatory compliance batches required to release Batches for commercial Manufacturing)licensing of the Manufacturing operations, for further processing into ARIKACEas set out in Schedule A; and (Bx) promptly report to Therapure (and in no event later than [***] Business Days after the Excipients, provided, however, that the Amikacin occurrence of) any development which may materially and Excipients so delivered: (A) shall be stored in a secure and appropriately segregated area within the Facility; (B) shall not be transferred to any third party (except as may be required by applicable Law) without the prior written consent of Insmed; and (C) shall only be used by Therapure for the Manufacture of ARIKACEadversely affect Therapure’s performance under this Agreement. 5.1.1.24.2.2. Without limiting the obligations of Therapure under this Agreement, Therapure shall, in respect of the Manufacturing PeriodTechnology 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 5.1.1.24.2.2; (ii) prepare executed Batch Production Recordsemploy specialized technical resources reasonably necessary to execute the Technology Transfer; (iii) manufacture and package Batches pursuant following completion of the Workshop Construction Period, operate the Workshop to Therapure’s Manufacturing Requirementsallow for the Manufacture of ARIKACE; (iv) within 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 (and in no event later than [***] days prior to commencement of a calendar quarter send Request Orders to Insmed for quantities of Amikacin Business Days after the occurrence of) any development which may materially and Excipients derived from the quantity of ARIKACE forecasted in the Demand Forecast for such calendar quarter (or such longer period of time to the extent required to release Batches for commercial Manufacturing); (v) store all Amikacin and Excipients in a secure and appropriately segregated area within the Facilityadversely affect Insmed’s performance under this Agreement; (vi) take reasonable precautions reasonably assist Insmed, at a cost to protect Amikacin Insmed of $[***] per hour, with filing, seeking, prosecuting and Excipients maintaining all ARIKACE Permits, including the NDA and all other approvals from damageany applicable Governmental or Regulatory Authority; provided, that in the event of damage to the Amikacin or Excipients, to the extent attributable to the negligence or intentional act or omission of Therapure, Insmed’s exclusive remedy shall be the payment by Therapure of the costs associated with the replacement of such Amikacin or Excipients, which the parties agree shall be no greater than the Cost of Amikacin or the Cost of Excipients, as applicable;and (vii) not transfer any Amikacin or Excipients use reasonable commercial efforts to any third party (except as may be required by applicable Law) without carry out the prior written consent of Insmed; (viii) only use Amikacin and Excipients for the Manufacture of ARIKACE; and (ix) maintain commercially reasonable levels of insurance for all Amikacin and Excipients stored within the Facility.activities set out in Schedule A.