Common use of Manufacture of Products Clause in Contracts

Manufacture of Products. Ironwood will be responsible for Manufacture of Development Materials and for API Manufacturing; provided, however, that nothing in this Agreement will prevent Ironwood from contracting with any Third Parties to Manufacture Development Materials or to conduct API Manufacturing, provided that such Third Parties shall comply with all requirements pursuant to this Agreement and the Manufacturing and Supply Agreement and that Ironwood shall be fully responsible for such Third Party’s compliance with such requirements. Ironwood will perform all such Manufacturing activities in accordance with GCP, GLP and GMP. Ironwood will supply Development Material and Licensed Compound for Commercial supply to Astellas in bulk form ready for formulation, packaging and labeling. Ironwood will be responsible for shipping the bulk Development Material and other Licensed Compound to the locations designated by Astellas. Development Material and Licensed Compound for Commercial supply will be shipped to Astellas F.O.B. [**], and title to such Development Material and other Licensed Compound will pass to Astellas upon placement by Ironwood with a carrier for delivery to Astellas. Astellas will be responsible, at its sole cost and expense, to complete the drug product manufacturing, packaging, and labeling of the Licensed Compound. In furtherance of the foregoing, the Parties will execute a manufacturing and supply agreement promptly following the Effective Date, (a) under which Astellas will pay Ironwood [**] for supplying Development Material and Commercial supply of the Licensed Compound for the Product to Astellas, [**], and (b) which will contain, at a minimum, such terms and conditions as are described in Schedule 3.4 hereto and the last sentence of Section 4.10 (“Manufacturing and Supply Agreement”). Notwithstanding anything else contained herein, Astellas may not exercise its right to Manufacture Development Materials or Licensed Compound pursuant to the grant of rights under Section 2.1 unless (i) Ironwood has failed to supply Development Materials or Licensed Compound for Commercialization to Astellas under circumstances which, under the Manufacturing and Supply Agreement, would permit Astellas to Manufacture Development Materials or [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Licensed Compound for Commercialization, (“Failure To Supply”) in which event, Astellas shall consult with Ironwood on the appointment of one or more Third Parties as manufacturer of Licensed Compound and shall reasonably consider Ironwood’s comments regarding such appointment, (ii) the expiration of the last­to­expire of all, or the absence of any (including because Valid Claims never issued or were otherwise invalidated), Valid Claims in the Ironwood Patent Rights in Japan that cover the Licensed Compound (“Patent Expiration”), (iii) Ironwood notifies Astellas that it intends to cease Manufacture of Development Material or Licensed Compound for Commercialization (“Cessation of Manufacture”), or (iv) an Insolvency Event affecting Ironwood.

Manufacture of Products. Ironwood will be responsible for Manufacture of Development Materials and for API Manufacturing; provided, however, that nothing in this Agreement will prevent Ironwood Xxxxxxxx from contracting with any Third Parties to Manufacture Development Materials or to conduct API Manufacturing, provided that such Third Parties shall comply with all requirements pursuant to this Agreement and the Manufacturing and Supply Agreement and that Ironwood shall be fully responsible for such Third Party’s compliance with such requirements. Ironwood will perform all such Manufacturing activities in accordance with GCP, GLP and GMP. Ironwood will supply Development Material and Licensed Compound for Commercial supply to Astellas in bulk form ready for formulation, packaging and labeling. Ironwood will be responsible for shipping the bulk Development Material and other Licensed Compound to the locations designated by Astellas. Development Material and Licensed Compound for Commercial supply will be shipped to Astellas F.O.B. [**], and title to such Development Material and other Licensed Compound will pass to Astellas upon placement by Ironwood with a carrier for delivery to Astellas. Astellas will be responsible, at its sole cost and expense, to complete the drug product manufacturing, packaging, and labeling of the Licensed Compound. In furtherance of the foregoing, the Parties will execute a manufacturing and supply agreement promptly following the Effective Date, (a) under which Astellas will pay Ironwood [**] for supplying Development Material and Commercial supply of the Licensed Compound for the Product to Astellas, [**], and (b) which will contain, at a minimum, such terms and conditions as are described in Schedule 3.4 hereto and the last sentence of Section 4.10 (“Manufacturing and Supply Agreement”). Notwithstanding anything else contained herein, Astellas may not exercise its right to Manufacture Development Materials or Licensed Compound pursuant to the grant of rights under Section 2.1 unless (i) Ironwood has failed to supply Development Materials or Licensed Compound for Commercialization to Astellas under circumstances which, under the Manufacturing and Supply Agreement, would permit Astellas to Manufacture Development Materials or [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Licensed Compound for Commercialization, (“Failure To Supply”) in which event, Astellas shall consult with Ironwood on the appointment of one or more Third Parties as manufacturer of Licensed Compound and shall reasonably consider IronwoodXxxxxxxx’s comments regarding such appointment, (ii) the expiration of the last­to­expire of all, or the absence of any (including because Valid Claims never issued or were otherwise invalidated), Valid Claims in the Ironwood Patent Rights in Japan that cover the Licensed Compound (“Patent Expiration”), (iii) Ironwood notifies Astellas that it intends to cease Manufacture of Development Material or Licensed Compound for Commercialization (“Cessation of Manufacture”), or (iv) an Insolvency Event affecting Ironwood.

Manufacture of Products. Ironwood will be responsible for Manufacture of Development Materials and for API Manufacturing; Manufacturing; provided, however, that nothing in this Agreement will prevent Ironwood from contracting with any Third Parties to Manufacture Development Materials or to conduct API Manufacturing, provided that such Third Parties shall comply with all requirements pursuant to this Agreement and the Manufacturing and Supply Agreement and that Ironwood shall be fully responsible for such Third Party’s compliance with such requirements. Ironwood will perform all such Manufacturing activities in accordance with GCP, GLP and GMP. Ironwood will supply Development Material and Licensed Compound for Commercial supply to Astellas in bulk form ready for formulation, packaging and labeling. Ironwood will be responsible for shipping the bulk Development Material and other Licensed Compound to the locations designated by Astellas. Development Material and Licensed Compound for Commercial supply will be shipped to Astellas F.O.B. [**], and title to such Development Material and other Licensed Compound will pass to Astellas upon placement by Ironwood with a carrier for delivery to Astellas. Astellas will be responsible, at its sole cost and expense, to complete the drug product manufacturing, packaging, and labeling of the Licensed Compound. In furtherance of the foregoing, the Parties will execute a manufacturing and supply agreement promptly following the Effective Date, (a) under which Astellas will pay Ironwood [**] for supplying Development Material and Commercial supply of the Licensed Compound for the Product to Astellas, [**], and (b) which will contain, at a minimum, such terms and conditions as are described in Schedule 3.4 hereto and the last sentence of Section 4.10 (“Manufacturing and Supply Agreement”). Notwithstanding anything else contained herein, Astellas may not exercise its right to Manufacture Development Materials or Licensed Compound pursuant to the grant of rights under Section 2.1 unless (i) Ironwood has failed to supply Development Materials or Licensed Compound for Commercialization to Astellas under circumstances which, under the Manufacturing and Supply Agreement, would permit Astellas to Manufacture Development Materials or [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Licensed Compound for Commercialization, (“Failure To Supply”) in which event, Astellas shall consult with Ironwood on the appointment of one or more Third Parties as manufacturer of Licensed Compound and shall reasonably consider Ironwood’s comments regarding such appointment, (ii) the expiration of the last­to­expire last-to-expire of all, or the absence of any (including because Valid Claims never issued or were otherwise invalidated), Valid Claims in the Ironwood Patent Rights in Japan that cover the Licensed Compound (“Patent Expiration”), (iii) Ironwood notifies Astellas that it intends to cease Manufacture of Development Material or Licensed Compound for Commercialization (“Cessation of Manufacture”), or (iv) an Insolvency Event affecting Ironwood.

Manufacture of Products. Ironwood will be responsible for Manufacture of Development Materials and for API Manufacturing; Manufacturing; provided, however, that nothing in this Agreement will prevent Ironwood from contracting with any Third Parties to Manufacture Development Materials or to conduct API Manufacturing, provided that such Third Parties shall comply with all requirements pursuant to this Agreement and the Manufacturing and Supply Agreement and that Ironwood shall be fully responsible for such Third Party’s compliance with such requirements. Ironwood will perform all such Manufacturing activities in accordance with GCP, GLP and GMP. Ironwood will supply Development Material and Licensed Compound for Commercial supply to Astellas in bulk form ready for formulation, packaging and labeling. Ironwood will be responsible for shipping the bulk Development Material and other Licensed Compound to the locations designated by Astellas. Development Material and Licensed Compound for Commercial supply will be shipped to Astellas F.O.B. [**], and title to such Development Material and other Licensed Compound will pass to Astellas upon placement by Ironwood with a carrier for delivery to Astellas. Astellas will be responsible, at its sole cost and expense, to complete the drug product manufacturing, packaging, and labeling of the Licensed Compound. In furtherance of the foregoing, the Parties will execute a manufacturing and supply agreement promptly following the Effective Date, (a) under which Astellas will pay Ironwood [**] for supplying Development Material and Commercial supply of the Licensed Compound for the Product to Astellas, [**], and (b) which will contain, at a minimum, such terms and conditions as are described in Schedule 3.4 hereto and the last sentence of Section 4.10 (“Manufacturing and Supply Agreement”). Notwithstanding anything else contained herein, Astellas may not exercise its right to Manufacture Development Materials or Licensed Compound pursuant to the grant of rights under Section 2.1 unless (i) Ironwood has failed to supply Development Materials or Licensed Compound for Commercialization to Astellas under circumstances which, under the Manufacturing and Supply Agreement, would permit Astellas to Manufacture Development Materials or [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Licensed Compound for Commercialization, (“Failure To Supply”) in which event, Astellas shall consult with Ironwood on the appointment of one or more Third Parties as manufacturer of Licensed Compound and shall reasonably consider Ironwood’s comments regarding such appointment, (ii) the expiration of the last­to­expire last-to-expire of all, or the absence of any (including because Valid Claims never issued or were otherwise invalidated), Valid Claims in the Ironwood Patent Rights in Japan that cover the Licensed Compound (“Patent Expiration”), (iii) Ironwood notifies Astellas that it intends to cease Manufacture of Development Material or Licensed Compound for Commercialization (“Cessation of Manufacture”), or (iv) an Insolvency Event affecting Ironwood.