Common use of Change in Specifications or Manufacturing Process Clause in Contracts

Change in Specifications or Manufacturing Process. (a) Each party shall notify the other in advance of any proposed changes in Specifications, release testing, stability testing, packaging, materials, equipment, facilities, processes or procedures used to manufacture Product under this Agreement. No changes in Specifications, release testing, stability testing, packaging or the materials, equipment, facilities, processes or procedures used to manufacture Product under this Agreement, except changes required by any applicable Regulatory Authority, will be made unless the parties have agreed to such changes in writing prior to adoption of such changes. Any such changes to the Product Specifications, release testing, stability testing, packaging, materials, equipment, facilities, processes or procedures used to manufacture Product shall be handled in accordance with the procedures established in the Quality Agreement, with costs paid as provided in Section 4.3(b), (c) or (d), as applicable. (b) In the event Company requests any such changes be made, other than changes described in Section 4.3(d), Manufacturer shall accommodate Company’s requested changes to the extent technologically feasible. If such changes would result in material change in the cost of manufacture, then in that event the product price may be suitably modified. If such changes require the purchase of capital equipment, such costs and any related installation and qualification costs will be to the account of the Company and such capital equipment shall be owned by the Company. (c) In the event Manufacturer requests any such changes be made, other than changes described in Section 4.3(d), and such changes would result in a material increase in Manufacturer’s cost of manufacture, all costs reasonably required in connection with such changes shall be paid as mutually agreed by the parties. (d) In the event changes are requested by a Regulatory Authority or required to bring either of the Facilities into compliance with Applicable Laws, or additional changes, activities, or manufacturing is required to bring the manufacturing process into compliance with Applicable Laws, Specifications or other Product Requirements, Manufacturer shall accommodate such changes to the extent technologically feasible, and all costs reasonably required in connection with such changes, activities, or manufacturing shall be borne by the Manufacturer. In such an event the product price may be suitably revised to accommodate such changes

Change in Specifications or Manufacturing Process. (a) Each party shall notify the other in advance of any proposed changes in Specifications, release testing, stability testing, packaging, materials, equipment, facilities, processes or procedures used to manufacture Product under this Agreement. No changes in Specifications, release testing, stability testing, packaging or the materials, equipment, facilities, processes or procedures used to manufacture Product under this Agreement, except changes required by any applicable Regulatory Authority, will be made unless the parties have agreed to such changes in writing prior to adoption of such changes. Any such changes to the Product Specifications, release testing, stability testing, packaging, materials, equipment, facilities, processes or procedures used to manufacture Product shall be handled in accordance with the procedures established in the Quality Agreement, with costs paid as provided in Section 4.3(b), (c) or (d), as applicable.. * Confidential Treatment Request(ed) (b) In the event Company requests any such changes be made, other than changes described in Section 4.3(d), Manufacturer shall accommodate Company’s requested changes to the extent technologically feasible. If such changes would result in material change in the cost of manufacture, then in that event the product price may be suitably modified. If such changes require the purchase of capital equipment, such costs and any related installation and qualification costs will be to the account of the Company and such capital equipment shall be owned by the Company. (c) In the event Manufacturer requests any such changes be made, other than changes described in Section 4.3(d), and such changes would result in a material increase in Manufacturer’s cost of manufacture, all costs reasonably required in connection with such changes shall be paid as mutually agreed by the parties. (d) In the event changes are requested by a Regulatory Authority or required to bring either of the Facilities into compliance with Applicable Laws, or additional changes, activities, or manufacturing is required to bring the manufacturing process into compliance with Applicable Laws, Specifications or other Product Requirements, Manufacturer shall accommodate such changes to the extent technologically feasible, and all costs reasonably required in connection with such changes, activities, or manufacturing shall be borne by the Manufacturer. In such an event the product price may be suitably revised to accommodate such changes

Change in Specifications or Manufacturing Process. (a) Each party AMAG shall notify not make any material changes to the other in advance of any proposed changes in Specifications, release testing, stability testing, packaging, Specifications or to the materials, equipment, facilities, processes process or procedures used to manufacture Product under this Agreementfor the Licensed Territory (“Process Changes”) without Takeda’s prior written consent, which consent shall not be unreasonably withheld or delayed. No changes in SpecificationsFor clarity, release testing, stability testing, packaging or the materials, equipment, facilities, processes or procedures used to manufacture Product under this Agreement, except changes required a material change shall be any change that must be approved by any applicable a Regulatory Authority, will be made unless as described in the parties have agreed to such changes Restated Quality Agreement. AMAG shall manage all Process Changes in writing prior to adoption accordance with its Change Control System and the applicable Quality Agreement and shall keep Takeda informed of the progress of such changes. Any such changes Upon any change to the Product Specifications, release testingthe Parties shall amend the Restated Quality Agreement accordingly. (a) If, stability testingafter the Supply Agreement Effective Date, packaging, materials, equipment, facilities, processes a Regulatory Authority requires a Process Change as a condition for obtaining or procedures used to manufacture maintaining Regulatory Approval for the Product shall be handled in accordance with the procedures established in the Quality Licensed Territory (“Regulatory required Process Change”), Takeda shall promptly notify AMAG, and the Parties shall meet and discuss how to implement such requirement. AMAG shall use Commercially Reasonable Efforts to accommodate such Process Change and, if AMAG implements such Process Change, shall use Commercially Reasonable [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Efforts to do so in a cost-effective manner. If, as a result of such change, the Fully Burdened Manufacturing Cost exceeds the applicable Cap or Adjusted Cap, then [***], notwithstanding anything to the contrary in this Agreement, . With respect to any expenses incurred by AMAG in connection with costs paid such Process Change that are not included in the Fully Burdened Manufacturing Cost: (i) Capital Equipment expenditures will be shared as provided in Section 4.3(b)2.6 and (ii) Takeda shall [***]. In addition, (c) or (d), as applicableTakeda shall [***]. (b) In If, after the event Company Supply Agreement Effective Date, AMAG requests any such changes be made, a Process Change that is not required to obtain or maintain Regulatory Approval for the Product in the Licensed Territory and other than changes described Process Changes addressed in Section 4.3(d)3.6(d) of this Agreement, Manufacturer promptly, and in any event within thirty (30) Days, following AMAG’s written notice of a proposed Process Change, the Parties shall accommodate Company’s requested changes to the extent technologically feasiblemeet and discuss such proposal in good faith. If Takeda determines that it will not grant such changes consent to a Process Change, Takeda shall promptly notify AMAG following such determination, provide an explanation of its concerns and use Commercially Reasonable Efforts to cooperate with AMAG on an implementation of such Process Change that would result be acceptable to Takeda, not later than forty-five (45) Days after receipt of written notice from AMAG of the proposed Process Change, however Takeda shall not be deemed to have given its consent to such requested Process Change if Takeda shall fail to provide its concerns within the forty-five Days period. If the Parties agree to make such Process Change, then AMAG shall use Commercially Reasonable Efforts to implement such Process Change in material change a cost-effective manner. With respect to any expenses incurred by AMAG in connection with such Process Change that are not included in the cost of manufactureFully Burdened Manufacturing Cost, then in that event the product price may be suitably modified. If such changes require the purchase of capital equipment, such costs and any related installation and qualification costs will be to the account of the Company and such capital equipment shall be owned by the Company[***]. (c) In If, after the event Manufacturer Supply Agreement Effective Date, Takeda requests any a Process Change that is not required to obtain or maintain Regulatory Approval for the Product in the Licensed Territory, the Parties shall meet and discuss such changes be madeproposal in good faith. AMAG shall use Commercially Reasonable Efforts to accommodate such Process Change and, other than changes described in Section 4.3(d)if AMAG implements such Process Change, and such changes would result shall use Commercially Reasonable Efforts to do so in a material increase cost-effective manner. If as a result of such change, the Fully Burdened Manufacturing Cost exceeds the applicable Cap or Adjusted Cap, [***], notwithstanding anything to the contrary in Manufacturer’s cost of manufacture, all costs reasonably required this Agreement. With respect to any expenses incurred by AMAG in connection with such changes Process Change that are not included in the Fully Burdened Manufacturing Cost: (i) Capital Equipment expenditures will be shared as provided in Section 2.6 and (ii) Takeda shall be paid as mutually agreed by the parties[***]. (d) In If, after the event changes are requested by Supply Agreement Effective Date, either Party proposes a Regulatory Authority or Process Change that is not required to bring either obtain or maintain Regulatory Approval for the Product in the Licensed Territory, but which is in the view of the Facilities into compliance with Applicable Lawsproposing Party to be deemed to create any economical advantages for both Parties (including, but not limited to, reducing the Fully Burdened Manufacturing Cost, improving reliability of supply, or additional changesreducing lead time for manufacturing) , activities, or manufacturing is required to bring the manufacturing process into compliance with Applicable Laws, Specifications or other Product Requirements, Manufacturer Parties shall accommodate meet and discuss such changes to the extent technologically feasible, and all costs reasonably required proposal in connection with such changes, activities, or manufacturing good faith. AMAG shall be borne by the Manufacturer. In such an event the product price may be suitably revised use Commercially Reasonable Efforts to accommodate such changesProcess Change and, if AMAG implements such Process Change, shall use Commercially Reasonable Efforts to do so in a cost- [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. effective manner. If as a result of such change, the Fully Burdened Manufacturing Cost exceeds the applicable Cap or Adjusted Cap, then such excess costs will [***].

Change in Specifications or Manufacturing Process. (a) Each party shall notify the other in advance of any proposed changes in Specifications, release testing, stability testing, packaging, materialsMaterials, equipment, facilities, processes or procedures used to manufacture Product under this Agreement. No changes in Specifications, release testing, stability testing, packaging or the materialsMaterials, equipment, facilities, processes or procedures used to manufacture Product under this Agreement, except changes required by any applicable Regulatory Authority, will be made unless the parties have agreed to such changes in writing prior to adoption of such changes. Any such changes to the Product Specifications, release testing, stability testing, packaging, materialsMaterials, equipment, facilities, processes or procedures used to manufacture Product shall be handled in accordance with the procedures established in the Quality Agreement, with costs paid as provided in Section 4.3(b), (c) or (d), as applicable. (b) In the event Company requests any such changes be made, other than changes described in Section 4.3(d), Manufacturer shall accommodate Company’s requested changes to the extent technologically feasible. If such changes would result in material change in the cost of manufacture, then in that event the product price Product Price may be suitably modified. If such changes require the purchase of capital equipment, such costs and any related installation and qualification costs will be to the account of the Company and such capital equipment shall be owned by the Company. (c) In the event Manufacturer requests any such changes be made, other than changes described in Section 4.3(d), and such changes would result in a material increase in Manufacturer’s cost of manufacture, all costs reasonably required in connection with such changes shall be paid as mutually agreed by the parties. (d) In the event changes are requested by a Regulatory Authority or required to bring either of the Facilities into compliance with Applicable Laws, or additional changes, activities, or manufacturing is required to bring the manufacturing process Manufacturing Process into compliance with Applicable Laws, Specifications or other Product Requirements, Manufacturer shall accommodate such changes to the extent technologically feasible, and all costs reasonably required in connection with such changes, activities, or manufacturing shall be borne by the Manufacturer. In such an event the product price Product Price may be suitably revised to accommodate such changes.