COMPONENT CONTROL Sample Clauses

COMPONENT CONTROL. Bio-Techne and Sponsor shall mutually agree upon the specification of the Original Components and approved alternatives to the Components that can be substituted for an Original Component (the “Approved Alternative Components”) prior to the time of submission of applications for EUA, 510(k) clearance or de novo classification, or the submission to any other applicable Regulatory Authority. Bio-Techne shall have the authority on notice to but without any further approval of Sponsor to make changes to the Original Components to the extent such change is to an Approved Alternative Component. Any changes to the Original Components or Approved Alternative Components, and any changes to any Components that are substituted for Original Components through the following process (other than through the substitution of Approved Alternative Components), shall be determined as follows: (i) if Bio-Techne desires to propose changes to any Component or Approved Alternative Component, Bio-Techne shall provide Sponsor with a detailed description of such proposed changes, and no such changes to the Components or Approved Alternative Components, shall be introduced without Sponsor’s prior approval, (ii) if a Component or Approved Alternative Component becomes unavailable, Bio-Techne shall promptly provide Sponsor with a detailed description of a proposed replacement (and if Sponsor requests, alternative replacement approaches), and no such replacement shall be introduced without Sponsor’s prior approval, (iii) if Sponsor desires to change a Component or an Approved Alternative Component based on Sponsor’s belief that such change is required in order to comply with regulatory requirements for which Sponsor is responsible as a result of Sponsor’s position as manufacturer of record of the Co-Developed Test Kits, Sponsor and Bio-Techne shall consult together (if necessary with the support of a Working Group) to endeavor to achieve consensus on such change, however if consensus is not able to be achieved then Sponsor shall have the ultimate authority to require such change to be made, taking into consideration considerations of cost-effectiveness but ultimately prioritizing the need for regulatory compliance and quality, and (iv) if Sponsor desires to propose changes to any Component or Approved Alternative Component for reasons other than those described in clause (iii) of this sentence, then Sponsor shall provide Bio-Techne with a detailed description of such proposed changes, a...

COMPONENT CONTROL