Changes to the Specifications or to the Manufacturing Process. If ARIAD US proposes (a) a change to the Specifications or the Raw Materials, equipment (other than changes for maintenance, repair, and like-for-like replacement) or process used to Manufacture the Product, or (b) a change to the procedures or facilities used to Manufacture the Product (collectively, the “Manufacturing Process”) that, in the case of (a) or (b) would require approval of any applicable Regulatory Authority in the Territory or would require an amendment of any Marketing Authorization application or Registration, the prior written approval of ARIAD SWISSCO is required before implementation of such change. If a change to the Specifications, Raw Materials, equipment or Manufacturing Process is required by one or more Regulatory Authorities or regulatory authorities outside the Territory or shall be applied globally, including for the manufacture of Products inside and outside the Territory, and if such change would require approval of any Regulatory Authority in the Territory or an amendment of any Marketing Authorization application or Registration, ARIAD US shall provide ARIAD SWISSCO with all information needed to amend the Marketing Authorization application or Registration and/or obtain the approval of the Regulatory Authority, as applicable, and the Parties shall cooperate with each other in obtaining any necessary modifications to any Registrations in the Territory to allow such change to be implemented. If the proposed change is required by a Regulatory Authority, then such notice shall include disclosure of the Regulatory Authority request and relevant correspondence. If any change to the Specifications, Raw Materials, equipment or Manufacturing Process is not required by any Regulatory Authority outside the Territory and shall not be applied globally and would require approval of any Regulatory Authority in the Territory or an amendment of any Marketing Authorization application or Registration, ARIAD US shall provide advanced written notice to ARIAD SWISSCO and shall consult with ARIAD SWISSCO regarding the implementation of such change. If the change is required by a Regulatory Authority inside the Territory but not in any other part of the world, [***] of implementing such change. If the change proposed by ARIAD US is required only by one or more regulatory authorities outside the Territory, or is not required by any Regulatory Authority, [***] of implementing such change. If the change is required by one or more Regulatory Authorities inside the Territory and by one or more regulatory authorities outside the Territory, [***]. For the avoidance of doubt, [***] of implementing a change to the Specifications, Raw Materials, equipment or Manufacturing Process if such change is mandated by a Regulatory Authority inside the Territory, and [***] of implementing such a change that is not mandated by any Regulatory Authority, including any such non-mandated change that ARIAD SWISSCO approves and that requires an amendment of a Marketing Authorization application or Registration or approval of a Regulatory Authority in the Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Appears in 1 contract
Changes to the Specifications or to the Manufacturing Process. If ARIAD US proposes (a) a change to the Specifications or the Raw Materials, equipment (other than changes for maintenance, repair, and like-for-like replacement) or process used to Manufacture the Product, or (b) a change to the procedures or facilities used to Manufacture the Product (collectively, the “Manufacturing Process”) that, in the case of (a) or (b) would require approval of any the applicable Regulatory Authority in the Territory or would require an amendment of any Marketing Authorization application or Registration, the prior ARIAD shall provide written approval of ARIAD SWISSCO is required before implementation of such changenotice to Otsuka. If a change to the Specifications, Raw Materials, equipment or Manufacturing Process is required by one or more Regulatory Authorities or regulatory authorities outside the Territory or shall be applied globally, including for the manufacture of Products inside and outside the Territory, and if such change would require approval of any Regulatory Authority in the Territory or an amendment of any Marketing Authorization application or Registration, ARIAD US shall provide ARIAD SWISSCO Otsuka with all information needed to amend the Marketing Authorization application or Registration and/or obtain the approval of the Regulatory Authority, as applicable, and the Parties shall cooperate with each other in obtaining any necessary modifications to any Registrations in the Territory to allow such change to be implemented. If the proposed change is required by a Regulatory Authority, then such notice shall include disclosure of the Regulatory Authority request and relevant correspondence. If any change to the Specifications, Raw Materials, equipment or Manufacturing Process is not required by any Regulatory Authority (or any regulatory authorities outside the Territory Territory) and shall not be applied globally and would require approval of any Regulatory Authority in the Territory or an amendment of any Marketing Authorization application or Registration, ARIAD US shall provide advanced not implement such change without the prior written notice to ARIAD SWISSCO and shall consult with ARIAD SWISSCO regarding the implementation approval of such changeOtsuka. If the change is required by a Regulatory Authority inside the Territory but not in any other part of the world, [***] then Otsuka shall bear any expenses of implementing such change. If the change proposed by ARIAD US is required only by one or more regulatory authorities outside the Territory, or is not required by any Regulatory Authority, [***] of implementing such change. If the change is required by one or more Regulatory Authorities inside the Territory and by one or more regulatory authorities outside the Territory, [***]. For the avoidance of doubt, [***] of implementing a change to the Specifications, Raw Materials, equipment or Manufacturing Process if such change is mandated by a Regulatory Authority inside the Territory, and [***] of implementing such a change that is not mandated by any Regulatory Authority, including any such non-mandated change that ARIAD SWISSCO approves and that requires an amendment of a Marketing Authorization application or Registration or approval of a Regulatory Authority in the Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. by ARIAD is required only by one or more regulatory authorities outside the Territory, or is not required by any Regulatory Authority, then ARIAD shall bear any expenses of implementing such change. If the change is required by one or more Regulatory Authorities inside the Territory and by one or more regulatory authorities outside the Territory, the Parties shall share the expenses of implementing such change in proportion to the last calendar year’s Net Sales in the Territory as a percentage of the global net sales of the Product (calculated in the same manner as Net Sales) during the same time period, as may be reasonably estimated by ARIAD to the extent that complete global sales figures are not available. For the avoidance of doubt, Otsuka shall only be required to bear expenses of implementing a change to the Specifications, Raw Materials, equipment or Manufacturing Process if such change is mandated by a Regulatory Authority inside the Territory, and ARIAD shall solely bear the expenses of implementing such a change that is not mandated by any Regulatory Authority, including any such non-mandated change that Otsuka approves and that requires an amendment of a Marketing Authorization application or Registration or approval of a Regulatory Authority in the Territory. The Parties agree that the notification and approval procedures with respect to changes to the Specifications and the Manufacturing Process set forth in this Section 12.3 shall take effect commencing on filing of an application for Marketing Authorization of the applicable Product. For clarity, ARIAD shall have the right, at its sole cost, to change equipment for maintenance, repair, and like-for-like replacement, and to make other changes that ARIAD reasonably determines shall not require approval of any Regulatory Authority or affect the Marketing Authorization application(s) or Registration(s) in the Territory, without notice to or consent of Otsuka. Further for clarity, the Quality Agreements shall contain change control procedures, and any changes made to the Specifications, Raw Materials, equipment or Manufacturing Process shall be made in accordance with the Quality Agreements and in compliance with cGMP and Applicable Laws.
Appears in 1 contract
Samples: Collaboration Agreement (Ariad Pharmaceuticals Inc)
Changes to the Specifications or to the Manufacturing Process. If ARIAD US proposes (a) a change to the Specifications or the Raw Materials, equipment (other than changes for maintenance, repair, and like-for-like replacement) or process used to Manufacture the Product, or (b) a change to the procedures or facilities used to Manufacture the Product (collectively, the “Manufacturing Process”) that, in the case of (a) or (b) would require approval of any applicable Regulatory Authority in the Territory or would require an amendment of any Marketing Authorization application or Registration, the prior written approval of ARIAD SWISSCO is required before implementation of such change. If a change to the Specifications, Raw Materials, equipment or Manufacturing Process is required by one or more Regulatory Authorities or regulatory authorities outside the Territory or shall be applied globally, including for the manufacture of Products inside and outside the Territory, and if such change would require approval of any Regulatory Authority in the Territory or an amendment of any Marketing Authorization application or Registration, ARIAD US shall provide ARIAD SWISSCO with all information needed to amend the Marketing Authorization application or Registration and/or obtain the approval of the Regulatory Authority, as applicable, and the Parties shall cooperate with each other in obtaining any necessary modifications to any Registrations in the Territory to allow such change to be implemented. If the proposed change is required by a Regulatory Authority, then such notice shall include disclosure of the Regulatory Authority request and relevant correspondence. If any change to the Specifications, Raw Materials, equipment or Manufacturing Process is not required by any Regulatory Authority outside the Territory and shall not be applied globally and would require approval of any Regulatory Authority in the Territory or an amendment of any Marketing Authorization application or Registration, ARIAD US shall provide advanced written notice to ARIAD SWISSCO and shall consult with ARIAD SWISSCO regarding the implementation of such change. If the change is required by a Regulatory Authority inside the Territory but not in any other part of the world, [***] of implementing such change. If the change proposed by ARIAD US is required only by one or more regulatory authorities outside the Territory, or is not required by any Regulatory Authority, [***] of implementing such change. If the change is required by one or more Regulatory Authorities inside the Territory and by one or more regulatory authorities outside the Territory, [***]. For the avoidance of doubt, [***] of implementing a change to the Specifications, Raw Materials, equipment or Manufacturing Process if such change is mandated by a Regulatory Authority inside the Territory, and [***] of implementing such a change that is not mandated by any Regulatory Authority, including any such non-mandated change that ARIAD SWISSCO approves and that requires an amendment of a Marketing Authorization application or Registration or approval of a Regulatory Authority in the Territory. For clarity, ARIAD US shall have the right, [**], to change equipment for maintenance, repair, and like-for-like replacement, and to make other changes that ARIAD US reasonably determines shall not require approval of any Regulatory Authority or affect the Marketing Authorization application(s) or Registration(s) in the Territory, without notice to or consent of ARIAD SWISSCO. Further for clarity, the Quality Agreements shall contain change control procedures, and any changes made to the [**] = Portions of this Exhibit, indicated by the xxxx “[***],” were exhibit have been omitted and have pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amendedCommission.
Appears in 1 contract
Samples: License Agreement (Incyte Corp)
Changes to the Specifications or to the Manufacturing Process. If ARIAD US proposes (a) a change to the Specifications or the Raw Materials, equipment (other than changes for maintenance, repair, and like-for-like replacement) or process used to Manufacture the Product, or (b) a change to the procedures or facilities used to Manufacture the Product (collectively, the “Manufacturing Process”) that, in the case of (a) or (b) would require approval of any applicable Regulatory Authority in the Territory or would require an amendment of any Marketing Authorization application or Registration, the prior written approval of ARIAD SWISSCO is required before implementation of such change. If a change to the Specifications, Raw Materials, equipment or Manufacturing Process is required by one or more Regulatory Authorities or regulatory authorities outside the Territory or shall be applied globally, including for the manufacture of Products inside and outside the Territory, and if such change would require approval of any Regulatory Authority in the Territory or an amendment of any Marketing Authorization application or Registration, ARIAD US shall provide ARIAD SWISSCO with all information needed to amend the Marketing Authorization application or Registration and/or obtain the approval of the Regulatory Authority, as applicable, and the Parties shall cooperate with each other in obtaining any necessary modifications to any Registrations in the Territory to allow such change to be implemented. If the proposed change is required by a Regulatory Authority, then such notice shall include disclosure of the Regulatory Authority request and relevant correspondence. If any change to the Specifications, Raw Materials, equipment or Manufacturing Process is not required by any Regulatory Authority outside the Territory and shall not be applied globally and would require approval of any Regulatory Authority in the Territory or an amendment of any Marketing Authorization application or Registration, ARIAD US shall provide advanced written notice to ARIAD SWISSCO and shall consult with ARIAD SWISSCO regarding the implementation of such change. If the change is required by a Regulatory Authority inside the Territory but not in any other part of the world, [***] of implementing such change. If the change proposed by ARIAD US is required only by one or more regulatory authorities outside the Territory, or is not required by any Regulatory Authority, [***] of implementing such change. If the change is required by one or more Regulatory Authorities inside the Territory and by one or more regulatory authorities outside the Territory, [***]. For the avoidance of doubt, [***] of implementing a change to the Specifications, Raw Materials, equipment or Manufacturing Process if such change is mandated by a Regulatory Authority inside the Territory, and [***] of implementing such a change that is not mandated by any Regulatory Authority, including any such non-mandated change that ARIAD SWISSCO approves and that requires an amendment of a Marketing Authorization application or Registration or approval of a Regulatory Authority in the Territory. For clarity, ARIAD US shall have the right, [***], to change equipment for maintenance, repair, and like-for-like replacement, and to make other changes that ARIAD US reasonably determines shall not require approval of any Regulatory Portions of this Exhibit, indicated by the xxxx mxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Authority or affect the Marketing Authorization application(s) or Registration(s) in the Territory, without notice to or consent of ARIAD SWISSCO. Further for clarity, the Quality Agreements shall contain change control procedures, and any changes made to the Specifications, Raw Materials, equipment or Manufacturing Process shall be made in accordance with the Quality Agreements and in compliance with cGMP and Applicable Laws.
Appears in 1 contract
Changes to the Specifications or to the Manufacturing Process. If ARIAD US proposes (a) a change to the Specifications or the Raw Materials, equipment (other than changes for maintenance, repair, and like-for-like replacement) or process used to Manufacture the Product, or (b) a change to the procedures or facilities used to Manufacture the Product (collectively, the “Manufacturing Process”) that, in the case of (a) or (b) would require approval of any applicable Regulatory Authority in the Territory or would require an amendment of any Marketing Authorization application or Registration, the prior written approval of ARIAD SWISSCO is required before implementation of such change. If a change to the Specifications, Raw Materials, equipment or Manufacturing Process is required by one or more Regulatory Authorities or regulatory authorities outside the Territory or shall be applied globally, including for the manufacture of Products inside and outside the Territory, and if such change would require approval of any Regulatory Authority in the Territory or an amendment of any Marketing Authorization application or Registration, ARIAD US shall provide ARIAD SWISSCO with all information needed to amend the Marketing Authorization application or Registration and/or obtain the approval of the Regulatory Authority, as applicable, and the Parties shall cooperate with each other in obtaining any necessary modifications to any Registrations in the Territory to allow such change to be implemented. If the proposed change is required by a Regulatory Authority, then such notice shall include disclosure of the Regulatory Authority request and relevant correspondence. If any change to the Specifications, Raw Materials, equipment or Manufacturing Process is not required by any Regulatory Authority outside the Territory and shall not be applied globally and would require approval of any Regulatory Authority in the Territory or an amendment of any Marketing Authorization application or Registration, ARIAD US shall provide advanced written notice to ARIAD SWISSCO and shall consult with ARIAD SWISSCO regarding the implementation of such change. If the change is required by a Regulatory Authority inside the Territory but not in any other part of the world, [***] of implementing such change. If the change proposed by ARIAD US is required only by one or more regulatory authorities outside the Territory, or is not required by any Regulatory Authority, [***] of implementing such change. If the change is required by one or more Regulatory Authorities inside the Territory and by one or more regulatory authorities outside the Territory, [***]. For the avoidance of doubt, [***] of implementing a change to the Specifications, Raw Materials, equipment or Manufacturing Process if such change is mandated by a Regulatory Authority inside the Territory, and [***] of implementing such a change that is not mandated by any Regulatory Authority, including any such non-mandated change that ARIAD SWISSCO approves and that requires an amendment of a Marketing Authorization application or Registration or approval of a Regulatory Authority in the Territory. For [**] = Portions of this Exhibit, indicated by the xxxx “[***],” were exhibit have been omitted and have pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities Commission. clarity, ARIAD US shall have the right, [**], to change equipment for maintenance, repair, and Exchange Commission pursuant like-for-like replacement, and to make other changes that ARIAD US reasonably determines shall not require approval of any Regulatory Authority or affect the Marketing Authorization application(s) or Registration(s) in the Territory, without notice to or consent of ARIAD SWISSCO. Further for clarity, the Quality Agreements shall contain change control procedures, and any changes made to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of Specifications, Raw Materials, equipment or Manufacturing Process shall be made in accordance with the Securities Exchange Act of 1934, as amendedQuality Agreements and in compliance with cGMP and Applicable Laws.
Appears in 1 contract
Samples: License Agreement (Incyte Corp)
