Api Specification Changes. (a) Amarin Requested Changes. During the Term, except as set forth in Section 5.2(c), Amarin shall not be entitled to change the API Specifications related to Chemport’s performance of its obligations hereunder related to API unless it receives the Consent of Chemport, which Consent shall not be unreasonably withheld or delayed. If Amarin requests, and Chemport approves, a discretionary change to the API Specifications, Chemport shall make all revisions to the API Specifications requested by Amarin. Amarin retains the right and responsibility for final approval of the API Specifications. Amarin shall pay Chemport all documented reasonable amounts incurred in implementing a change to the API Specifications requested by Amarin under this Section 5.2(a). For all changes to the API Specifications requested by Amarin pursuant to this Section 5.2, Amarin shall, in its discretion, following consultation with Chemport, if reasonably practicable, either (i) perform, or arrange for the performance of, all development work in connection therewith or (ii) have Chemport perform such development work at the Facility at Amarin’s expense. For the avoidance of doubt, Section 5.2(a)(i) does not give Amarin any right to use or disclose (A) any Chemport Intellectual Property (except as may be permitted by any express license from Chemport), or (B) any Chemport Confidential Information (except as may be permitted under Article XIII hereof). Chemport agrees to use commercially reasonable efforts to minimize its costs associated with any API Specification change. At the request of Amarin, Chemport shall evaluate the estimated costs and timing of potential revisions to the API Specifications. (b) Chemport Changes. Chemport shall not make any revisions to the API Specifications, the manufacturing process or Material Third Party Suppliers, without prior written Consent of Amarin, which Consent shall not be unreasonably withheld or delayed. If the Parties implement a change in the API Specifications or the manufacturing process under this Section 5.2, they shall negotiate any changes in any affected Purchase Order to provide reasonable accommodation for changed circumstances. The costs of revisions requested by Chemport under this Section 5.2(b) shall be borne by Chemport without any increase in the API Price.
Appears in 1 contract
Sources: Api Commercial Supply Agreement
Api Specification Changes. (a) Amarin Requested Changes. During the Term, except as set forth in Section 5.2(c), Amarin shall not be entitled to change the API Specifications related from time to Chemport’s performance time and, upon consent of its obligations hereunder related to API unless it receives the Consent of ChemportEquateq, which Consent shall not be unreasonably withheld or delayed. If Amarin requests, and Chemport approves, a discretionary change to the API Specifications, Chemport Equateq shall make all revisions to the API Specifications requested by Amarin, but reserves the right to adjust the API Price to the extent the changes to the API Specifications cause an increase or decrease in Equateq’s cost of purchase of goods, manufacture, testing, packaging, storing, handling, releasing and shipping of API; provided, however, that the Parties shall endeavour to agree to any adjustment in API Price using good faith efforts prior to the implementation of revision to the API Specification and in the absence of such agreement Amarin may either accept the price adjustment as notified by Equateq or retract the request for a revision to the API Specifications. Amarin retains the right and responsibility for final approval of the API SpecificationsSpecifications prior to implementation. Except to the extent Amarin-requested changes are generally applicable to the Facility or Equateq’s manufacture of other products or as otherwise provided in Section 5.2(c) below, Amarin shall pay Chemport all Equateq the documented reasonable amounts incurred in implementing a change to the API Specifications requested by Amarin under this Section 5.2(a). For all changes to the API Specifications requested by Amarin pursuant to this Section 5.2, Amarin shall, in its discretion, following consultation with Chemport, if reasonably practicable, either (i) perform, or arrange for the performance of, all development work in connection therewith therewith, or (ii) have Chemport Equateq perform such development work at the Facility at Amarin’s expenseFacility. For clarity, Amarin shall not have the avoidance of doubt, Section 5.2(a)(i) does not give Amarin any right to use or disclose (A) any Chemport access Equateq Intellectual Property or the Facility for purposes of performing development work pursuant to (except as may be permitted by any express license from Chemport)i) in the immediately preceding sentence. At the request of Amarin, or (B) any Chemport Confidential Information (except as may be permitted under Article XIII hereof)Equateq shall evaluate the estimated costs and timing of potential revisions to the API Specifications. Chemport Equateq agrees to use commercially reasonable efforts to minimize its costs associated with any API Specification change. At the request of Amarin, Chemport shall evaluate the estimated costs and timing of potential revisions to the API Specifications.
(b) Chemport Equateq Changes. Chemport Equateq shall not make any revisions to (i) the API Specifications, (ii) the manufacturing process which are likely to impact the process validation or Material cause a required change to the DMF, or (iii) Third Party SuppliersSuppliers not approved by Amarin, in each case, without prior written Consent consent of Amarin, which Consent shall such consent not to be unreasonably withheld or delayed. With respect to revisions to the manufacturing process which are not likely to impact the process validation or cause a required change to the DMF and to Third Party Suppliers that are approved by Amarin, Equateq shall provide advance written notice. If the Parties implement a change in the API Specifications or the manufacturing process under this Section 5.2, they shall negotiate any changes in any affected Purchase Order to provide reasonable accommodation for changed circumstances. The costs of revisions requested by Chemport Equateq under this Section 5.2(b) shall be borne by Chemport Equateq without any increase in the API Price.
Appears in 1 contract
Sources: Api Supply Agreement