Quality Control; Change in Specifications or Supplier. (a) BMS shall conduct all quality control testing of the Product prior to shipment in accordance with the Product Registration and applicable Laws. BMS shall retain records and samples of the Product relating to such testing as required by applicable Law and shall provide the Company with reasonable access during normal business hours to such records during any Audit in accordance with the procedures set forth in Section 7.04; provided, however, that such access does not unreasonably disrupt the normal operations of BMS. If the Company conducts quality control testing of the Product after delivery thereof to the Company, the Company shall use a laboratory qualified by BMS to ensure consistency of testing with the BMS results. If reasonably required by the Company, BMS shall promptly after the Effective Date (and in no event later than *** days provide all analytical methodology used by BMS for quality control testing of the Product.
(b) The Company shall have the right: (i) subject to BMS’ prior written consent not to be unreasonably withheld, to change the Specifications with respect to the Product from time to time; (ii) subject to BMS’ prior written consent not to be unreasonably withheld, to change the tubes used for the Product; (iii) to change the Specifications with respect to the Product without prior written consent, from time to time, as may be required by any Governmental Entity having jurisdiction over the Product; or (iv) to change the Specifications with respect to the Product by mutual agreement of the Parties and in each case, on not less than *** calendar days prior written notice to BMS (or such shorter period as required by any Governmental Entity or mutually agreed by the Parties). In such event, upon the reasonable request of the Company and at the Company’s sole expense, BMS shall assist with all analytical or experimental work to be performed in connection with making such change, but the Company shall be responsible, at the Company’s expense, for filing all changes proposed by the Company to any Product Registration, and for seeking approval of any such change required by each applicable Governmental Entity. The Company shall reimburse BMS or its Affiliates for *** in implementing any changes to the Specifications in accordance with this Section 2.06(b) requested by the Company in BMS’ or its Affiliates’ Facility, and for filing, amending or supplementing any Manufacturing Facility Registration required thereby and shall not hold BM...
