Payment for Certain Changes Sample Clauses

Payment for Certain Changes. Either Party may request a Specification change intended to maintain compliance with Laws or to bring the Specifications into compliance with Laws. Payment for Specification changes required for compliance with Laws will be made per the following standards: (i) The costs of revisions requested by either Party in order to maintain the Specifications in conformity with that Product’s Regulatory Approval in the Licensed Territory, cGMPs, or Laws (including with respect to any of the Materials used in that Product), and not generally applicable to the manufacture of pharmaceutical products or types of dosage forms (e.g., sterile vials or blister packs) generally, shall be borne by GSK. (ii) The costs of revisions requested by either Party to maintain the Specifications in conformity with cGMPs, or Laws that are generally applicable to the manufacture of pharmaceutical products or applicable dosage form (e.g., sterile vials or tablets in blister packs), shall be borne by Impax and reasonably allocated between the Product supplied to GSK (which allocation shall be included in the Transfer Price) and other pharmaceutical products that benefit from such revision.

Payment for Certain Changes. Either Party may request a Specifications change intended to maintain high standards or compliance with Regulatory Acts and Legal Requirements or to bring the Specifications into compliance with high standards or Regulatory Acts and Legal Requirements. Subject to Section 4.2(d), payment for changes required for compliance with Regulatory Acts or Legal Requirements will be made per the following standards: (i) Subject to (iii) below, the costs of revisions requested by either Party in order to maintain the Specifications in conformity with that Product’s Drug Application, applicable cGMPs, applicable Regulatory Acts or Legal Requirements (including with respect to any of the materials used in that Product), and not to the manufacture of pharmaceutical products or types of dosage forms (e.g., sterile vials or blister packs) generally, shall be borne by GSK. (ii) Subject to (iii) below, the costs of revisions (including any capital expenditure incurred to implement any revision, costs of additional materials and one-time expenditures) requested by either Party to maintain the Specifications in conformity with cGMPs, laws Regulatory Acts or Legal Requirements applicable to the manufacture of pharmaceutical products or applicable dosage form (e.g., sterile vials or tablets in blister packs), shall be borne by Draxis without any increase in the price of that Product if subsequently sold to GSK; provided, however, that the costs related to information technology systems enabling improved EDI, shall be borne by GSK. (iii) Notwithstanding the individual financial obligations in (i) and (ii) above, if at any time during the Term of the Agreements, GSK interprets and applies cGMPs in a manner that is materially more burdensome to Draxis than the interpretation and application followed by Draxis’ other pharmaceutical customers, then the Parties will negotiate in good faith to settle the proportion of the incremental cost to be borne by each of the Parties to implement GSK’s interpretation and application of cGMPs.