Provision Language
6. Manufacturing and Commercialization of Product
6.2 Manufacturing Requirements
(a) Appropriate Standards. Without prejudice to Licensee’s obligations to manufacture products to the standards required under this Agreement, Licensee shall at all times manufacture by the process and to quality standards at least as high as specified in the technology transfer package (“Appropriate Quality Standards”); and (ii) on a country-by-country basis, consistent with any applicable national, regional or local standards as may be required by the specific country where Product is sold. In addition, Licensee and its permitted Affiliate sublicensees and subcontractors shall meet the Appropriate Quality Standards prior to Licensee’s and its permitted Affiliate sublicensees’ sale of Product to any country within the Territory. Additionally, Licensee shall maintain quality systems, operations and facilities in compliance with cGMP standards and all applicable laws and regulations.
(b) Audit Right. Licensee hereby agrees to allow Gilead reasonable access to Licensee’s books and records, facilities and employees for the purpose and to the extent required for Gilead to audit Licensee’s compliance with the requirements of this Section 6.2. Gilead agrees that it shall limit its access to Licensee’s employees to the extent required to conduct the audit and that such employees shall not be required to disclose to Gilead information that is subject to obligations of confidentiality with third parties unless such third parties have provided consent for such disclosure. Gilead agrees to provide at least thirty (30) days prior notice of the proposed audit and agrees that such audits shall not be conducted more than once a year unless circumstances outside the ordinary course of business warrant such an audit (such as an investigation or other government action).
(c) Remedy for Failure. If Licensee fails at any time to meet the Appropriate Quality Standards with respect to the manufacture of Lenacapavir or Product, and after a ninety (90) day period, Licensee fails to cure any manufacturing deficiency sufficient to meet the Appropriate Quality Standards, Gilead may elect, in its sole discretion and notwithstanding Section 10.2 or 10.3 hereof, to suspend the effectiveness of the licenses granted hereunder until such time Gilead has determined that Licensee has corrected any such failure to Gilead’s reasonable satisfaction. During any such suspension, Gilead and Licensee shall coordinate with each other to provide for the supply of Lenacapavir or Product, as appropriate, to ensure that end-user patient requirements are not disrupted as a result of such suspension.
(d) Dose Requirements. All Product used or sold by Licensee shall consist of single dose concentrations of Lenacapavir that are the same as the dose concentration for Lenacapavir that has been approved by the FDA or EMA for the equivalent Gilead Lenacapavir Product. Licensee agrees that it shall manufacture and/or sell Product produced according to the standards as set forth in Section 6.2(a) and only as approved by the FDA or EMA for the Field and as approved for use in the Field by the appropriate regulatory authority having jurisdiction over Product in the country of sale.