CHANGES TO PRODUCTS / CHANGE CONTROL Clause Samples

CHANGES TO PRODUCTS / CHANGE CONTROL. 8.1 Changes to the Products (including the Raw Materials), the Manufacturing or the Facility may only be made in accordance with the Quality Agreement. For the purpose of clarity, changes to the Facility under this Section 8.1 and in the relevant sections included in the Quality Agreement only refers to changes directly relating to the Manufacturing of Product and/or impacting the Product. 8.2 Corden shall solely bear all of its actual and related costs resulting from: (a) Changes to the Facility (including but not limited to changes related to Facility safety reasons) requested by ▇▇▇▇▇▇ (on its own or on behalf of any approved subcontractor); and (b) Non-Product specific changes (i) required under Applicable Laws applicable in the country where the Facility is located; (ii) requested or required by the Government Authorities relating to the Facility and to the manufacture of pharmaceutical products; and/or (iii) related to the establishment and/or maintenance of cGMP; and (c) Changes in the materials or suppliers of the Raw Materials requested by ▇▇▇▇▇▇ and to the extent within ▇▇▇▇▇▇’s control. 8.3 Customer shall solely bear all actual and related costs resulting from: (a) Changes requested by ▇▇▇▇▇▇▇▇ (other than changes requested or required as set out in Section 8.18.1(b)); (b) Changes requested or required by the Regulatory Authorities relating to the Product, Manufacturing of Product and marketing of the pharmaceutical products containing the Product (except as set forth in Section (8.2(b)); and (c) Changes to the Product, Raw Materials and/or suppliers of Raw Materials for Product or the Manufacturing requested by Customer. 8.4 In the event that Applicable Laws change such that ▇▇▇▇▇▇’s expense for the Manufacture of the Product increases by more than [***] percent, Corden shall be entitled to add the additional, reasonable and documented expenses to the Product Price apportioned to Customer on a pro-rata share of the increase based on ▇▇▇▇▇▇’s apportioned utilization of the Facility. 8.5 In the event and solely to the extent that a change requested by Customer (or by Corden in accordance with Section 8.1(b)) may reasonably be expected to have an impact on the Manufacturing Process and/or the Manufacturer’s Release Specifications, the warranty obligation of CORDEN pursuant to Section 7.3(a)(i) shall be waived, but solely to the extent relating to such change and solely until such time that real-time stability data is available to reasonably suppor...