Common use of Manufacture by Shire; Commercial Supply by Shire Clause in Contracts

Manufacture by Shire; Commercial Supply by Shire. Shire will have the right to act as, or to appoint a Third Party to act as, a second source for Collaboration Products under terms and conditions to be established by the Parties and subject to reasonable commercial qualification by New River and applicable regulatory requirements. In connection with such right, and based on the specifications provided by New River under Section 6.2, Shire will prepare all specifications required for any facility at which Shire intends to Manufacture, or have Manufactured, Collaboration Products, including cGMP qualification guidelines, and any QA approved procedures to be followed during the qualification of such facility, all consistent with the specifications and procedures approved in any existing Regulatory Approval, in each case at Shire’s sole expense. Following validation of such facility, the JSC will task Shire with the production of quantities of Collaboration Products at least sufficient for Shire to maintain such validation as a second source and such quantities shall be available for distribution by Shire. For purposes of determining the Allowable Expenses for sales of Collaboration Products to Third Parties, the [*] on such sales shall be equal to [*] for the quantity of such Collaboration Products actually sold, as determined in accordance with Exhibit A. In the event that [*] any agreement with a Third Party Manufacturer for the Manufacture of Compound or otherwise [*] such that there is a reasonable likelihood of insufficient quantities of Compound to satisfy the need thereof for the Manufacture of Collaboration Products, then Shire shall be entitled, but not be required, to assume in whole or in part New River’s rights and related obligations under such agreement (to the extent permissible thereunder) or otherwise direct the exercise of rights and performance of obligations by New River under such agreement, including the establishment of additional Third Party Manufacturers or Manufacture by Shire, in each case upon the mutual agreement of the Parties, such agreement not to be unreasonably withheld, delayed or conditioned. In such event the Parties shall meet and confer to devise the most effective supply plan for the bulk Compound and/or Collaboration Products and to consider amendments to this or other agreements, as necessary.

Manufacture by Shire; Commercial Supply by Shire. Shire will have the right to act as, or to appoint a Third Party to act as, a second source for Collaboration Products under terms and conditions to be established by the Parties and subject to reasonable commercial qualification by New River and applicable regulatory requirements. In connection with such right, and based on the specifications provided by New River under Section 6.2, Shire will prepare all specifications required for any facility at which Shire intends to Manufacture, or have Manufactured, Collaboration Products, including cGMP qualification guidelines, and any QA approved procedures to be followed during the qualification of such facility, all consistent with the specifications and procedures approved in any existing Regulatory Approval, in each case at Shire’s sole expense. Following validation of such facility, the JSC will task Shire with the production of quantities of Collaboration Products at least sufficient for Shire to maintain such validation as a second source and such quantities shall be available for distribution by Shire. For purposes of determining the Allowable Expenses for sales of Collaboration Products to Third Parties, the [*] on such sales shall be equal to [*] for the quantity of such Collaboration Products actually sold, as determined in accordance with Exhibit A. In the event that [*] any agreement with a Third Party Manufacturer for the Manufacture of Compound or otherwise [*] such that there is a reasonable likelihood of insufficient quantities of Compound to satisfy the need thereof for the Manufacture of Collaboration Products, then Shire shall be entitled, but not be required, to assume in whole or in part New River’s rights and related obligations under such agreement (to the extent permissible thereunder) or otherwise direct the exercise of rights and performance of obligations by New River under such agreement, including the establishment of additional Third Party Manufacturers or Manufacture by Shire, in each case upon the mutual agreement of the Parties, such agreement not to be unreasonably withheld, delayed or conditioned. In such event the Parties shall meet and confer to devise the most effective supply plan for the bulk Compound and/or Collaboration Products and to consider amendments to this or other agreements, as necessary.