Common use of Cordis Changes Clause in Contracts

Cordis Changes. Notwithstanding Section 6.2(c) of the License Agreement, (i) Cordis may make changes to the Specification and/or manufacture of the Product, without SRM’s approval (including without limitation the manufacturing processes and raw materials contained therein or otherwise used to manufacture the Product), provided that such changes are within the ranges set forth in the Specification and Cordis (a) provides advance written notice to SRM of such changes, and (b) provides to SRM, pursuant to the criteria set forth in Form 12364266 (attached as Exhibit 7 to this Agreement), as may be amended by Cordis, and Form 12553603, (attached as Exhibit 8 to this Agreement), as may be amended by Cordis, a regulatory assessment of the changes to the specification and/or manufacture of the PRECISE® Carotid Stent System, such assessment is provided “as is,” without any representations or warranties, and shall be treated as Cordis Confidential Information, and (c) provides timely confirmation to SRM that the regulatory assessment in 233 (i)(b) did not require approval of a Regulatory Authority for the changes to the specification and/or manufacture of the PRECISE® Carotid Stent System, such confirmation is provided “as is,” without representations or warranties, and shall be treated as Cordis Confidential Information. hi the event that any change by Cordis within the ranges set forth in the Specification requires Cordis receive approval of a Regulatory Authority for the PRECISE® Carotid Stent System, and therefore SRM receive approval of a Regulatory Authority for the Product, SRM may within fifteen (15) days of the date of delivery of the regulatory assessment, submit to Cordis one (1) purchase order for up to six (6) months of forecast (the forecast as described in Exhibit 5, Section 1) Product, manufactured according to the pre-change Specification and manufacturing process, such six (6) month period shall begin the next immediate month following the date of notice and continue for the next five (5) months, and such Product to be delivered by Cordis to SRM upon mutually agreed to delivery dates in writing; except that if after using commercially reasonable efforts to obtain raw materials, such materials are not available, Cordis shall have no obligation to supply Product pursuant to this sentence. In the case of a change pursuant to Section 2.3.1(1), except as set forth in this Section 2.3.1(i), Cordis shall have no obligation to supply Product according to the pre-change Specification or manufacturing process. (ii) Cordis may make changes to the Specification and/or manufacture of the Product, outside the ranges set forth in the Specification, provided that (a) Cordis provides advance written notice to SRM of such changes, (b) Cordis provides a regulatory assessment of the changes to the specification and/or manufacture of the PRECISE® Carotid Stent System, such assessment is provided “as is,” without representations or warranties, and shall be treated as Cordis Confidential Information, and (c) Cordis provides SRM copies of engineering studies of the changes to the Specification and/or manufacture of the Product. In the case of a Cordis change pursuant to Section 2.3.1(ii) upon such written notice, SRM may within fifteen (15) days of the date of delivery of such notice, submit one (1) purchase order for up to six (6) months of forecast (the forecast as described in Exhibit 5, Section 1) Product, manufactured according to the pre-change Specification and manufacturing process, such six (6) month period shall begin the next immediate month following the date of notice and continue for the next five (5) months, and such Product to be delivered by Cordis to SRM upon mutually agreed to delivery dates; except that if after using commercially reasonable efforts to obtain raw materials, such raw materials are not available, Cordis shall have no obligation to supply Product pursuant to this sentence. In the event that the change pursuant to this Section 2.3.1(0) relates to a change in the Facility, SRM may within fifteen (15) days of the date of delivery of such notice, submit one (1) purchase order for Product to be manufactured according to the pre-change Specification and manufacturing process, such amount not to exceed up to six (6) months of forecast (the forecast as described in Exhibit 5, Section 1) Product, such six (6) month period shall begin the next immediate month following the date of notice and continue for the next five (5) months, and such Product to be delivered by Cordis to SRM upon mutually agreed to delivery dates. In the case of a change pursuant to Section 2.3.1(0), except as set forth in this Section 2.3.1(0, Cordis shall have no obligation to supply Product according to the pre-change Specification or manufacturing process. (iii) Cordis shall provide advance notice to SRM of any proposed changes to Cordis’ methodology of conducting such regulatory assessments under Section 2.3.1(i) pursuant to Form 12364266 and Form 12553603, to permit SRM to timely evaluate any potential or actual impact of such changes on the Parties agreed-to procedure under this Section 2.3.1.