Changes Requested by VIVUS Sample Clauses
Changes Requested by VIVUS. VIVUS will provide Purchaser with advance notice of any material changes to procedures, Specifications, methods (including testing methods) or standard operating procedures relating to the manufacture or supply of the Product and VIVUS will not make or permit any such changes without the prior written consent of Purchaser if such change is (i) inconsistent with the then-current approved NDA for the Product, (ii) reasonably likely to have a material adverse effect on VIVUS’ ability to comply with the terms of this Agreement, including any Product delivery timelines hereunder, or (iii) otherwise reasonably likely to have an adverse impact on the Commercialization of the Product in the Purchaser Territory.
Changes Requested by VIVUS. Vivus shall have the right, in its sole discretion, to change any procedures, Specifications, methods (including testing methods) or standard operating procedures relating to the manufacture or supply of the Product. Notwithstanding the foregoing, Vivus shall not implement any such change that is (i) inconsistent with the then-current MAA or NDA for the Product or (ii) reasonably likely to have a material adverse effect on Vivus’ ability to comply with the terms of this Agreement, including any Product delivery timelines hereunder.
Changes Requested by VIVUS. VIVUS shall have the right, in its sole discretion, to change to any procedures, Specifications, methods (including testing methods) or standard operating procedures relating to the manufacture or supply of the Product. Notwithstanding the foregoing, VIVUS shall not implement any such change that is (i) inconsistent with the then-current MAA for the Product or (ii) reasonably likely to have a material adverse effect on VIVUS’s ability to comply with the terms of this Agreement, including any Product delivery timelines hereunder.