Manufacturing Authorization. Notwithstanding the other provisions of this [Section 7.8], Manufacturer will be responsible for obtaining and maintaining, at all times during the Term, all approvals, permits, licenses, registrations, DUNS number, authorizations, or qualifications required from any Authority (including any Pharmaceutical Regulatory Authority) required in order for it to operate in all respects the Manufacturing Site in order to conduct the Manufacturing Services as contemplated herein. Without limiting the foregoing, Manufacturer shall at all times during the Term have and maintain a manufacturing authorization from the FDA in respect of the Manufacturing Site in order to conduct the Manufacturing Services as contemplated herein. The Parties will coordinate as needed to ensure that Manufacturer has such approvals, permits, licenses, registrations, authorizations and qualifications in place as of the Closing. Manufacturer will be responsible for

Manufacturing Responsibility. Promptly following the Effective Date, the Parties shall mutually agree on a Manufacturing technology transfer plan to timely provide for the orderly transition of Manufacturing activities and technology, and related Know-How and Third Party contracts for the Licensed Product to Licensee (the “Manufacturing Tech Transfer Plan”). After the successful completion of the Manufacturing Tech Transfer Plan and associated success criteria therein, Licensee shall itself, or through its Affiliates or Sublicensees, be responsible for all commercial supply of the Licensed Product in the Territory. Licensee will undertake such activities at its sole expense.

Manufacturing Approvals. [[NanoTx:Organization]] shall remain responsible for the drug master files until the completion of the Manufacturing Tech Transfer Plan. Thereafter, PLUS shall be responsible for the filing and maintenance of the drug master files with the FDA and the equivalent thereof in the other countries in the Territory as part of obtaining Regulatory Approval for the Manufacture of the Licensed Products.

Patheon will perform the Manufacturing Services as set out in this Agreement for the Price and in accordance with the Quality Agreement. Subject to the preceding sentence, Patheon will convert API and Components into Product, and provide supportive Manufacturing Services such as quality assurance (for example quality controls, analytical testing, quality inspection, and stability programs), primary and secondary packaging, and any other related Manufacturing Services as agreed between the parties.

Manufacturing Documentation. SBL shall maintain the Manufacturing Documentation to be true and accurate, and shall keep the Manufacturing Documentation in strict confidence and shall not use the Manufacturing Documentation for any purposes other than providing or performing the Services or other obligations hereunder. SBL shall maintain all Manufacturing Documentation for at least that period specified in the applicable QAA. Upon written request of Client and at mutually agreeable times, Client shall have the right to review ​ Manufacturing Documentation, including the executed Batch Records ​ as further defined in the applicable QAA. Client may also ​ copies of such Manufacturing Documentation, ​. SBL shall record and maintain such records, data, documentation and other information in the language required in the applicable QAA or as so required by a Regulatory Authority and in compliance with Applicable Laws. To the extent necessary, SBL may redact or withhold Manufacturing Documentation provided pursuant this MSA or any applicable PSA solely to the extent necessary to protect the confidential information of its other clients or third parties. The form and style of Batch documents, including, but not limited to, Batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of SBL. Notwithstanding anything to the contrary, SBL SOPs not specific to the Client’s Products may be provided to Client for on-site review and/or through electronic data room if deemed reasonably necessary by both SBL and Client. Such SOPs cannot be removed from the SBL premises, copied, photographed or otherwise replicated.

Manufacturing Facility. In manufacturing any Products, Supplier shall maintain an organization and facilities, including, without limitation, suitable equipment and tools, in accordance with standards generally accepted in the industry, and employ adequately trained and competent personnel in all functions. Supplier will keep complete and accurate records in all material respects with respect to Products it manufactures pursuant to this Agreement. Supplier shall, upon S&W’s request from time to time by providing at least 7 days prior notice, allow S&W or its representatives access to Supplier’s facilities to inspect the manufacture and assembly of the Products during reasonable hours, and provide S&W with such records in the possession of Supplier, as S&W may reasonably request, relating to the manufacture of Products and the source of any raw materials and components used in the Products; provided, however, in no event shall such inspection interfere with the business of Supplier.

Manufacturing Plans. With respect to a Co-Funding Product, the Lead Party, in consultation with the JMC, will develop and update as necessary, for each Co-Funding Product, a Manufacturing Plan, which shall be reviewed and approved by the JSC. ​. Each Manufacturing Plan shall set forth the ​. The Manufacturing Plan (including each annual update thereto) for a Co-Funding Product shall be prepared by the Lead Party in consultation with the Participating Party, reviewed by the JMC, presented to the JSC for approval, and reviewed and approved by the JSC at least ​. The Lead Party shall use Commercially Reasonable Efforts to perform its responsibilities in accordance with the approved Manufacturing Plans. Upon the Participating Party’s written request, the Lead Party shall provide the Participating Party with complete and accurate copies of material Manufacturing-related records.

“Manufacturing Know-How and Materials” has the meaning set forth in Section 3.2.2

Subject to the remainder of this Section 3.2.2, as promptly as possible and in any event in accordance with the timing set forth in the Technology Transfer Plan, Relay will initiate and complete (and if applicable, use Commercially Reasonable Efforts to cause its CMO to initiate and complete) a technology transfer to Licensee, or to its CMO of the Phase Ia Product, such CMO to be selected by Licensee and reasonably acceptable to Relay, of Relay Know-How, documentation and other Materials that relate to the Manufacture of the Lead Candidate or Lead Product (such Know-How, documentation and Materials, the “Manufacturing Know-How and Materials”) and that are listed on the Technology Transfer Plan (such transfer, the “Manufacturing Transfer”). To the extent any copies of documents or materials within the Manufacturing Know-How and Materials are in possession of a Third Party, Relay is solely responsible, at its own cost and expense, to procure and provide to Licensee all such Manufacturing Know-How and Materials, together with all rights to access and use any such Development Know-How and Materials in accordance with this Agreement (which may be procured or provided by letters of authorization or comparable instruments where approved by Licensee). Relay will make available its personnel and use Commercially Reasonable Efforts to cause its CMO and other Third Party Subcontractors with relevant subject matter expertise to be available on a reasonable basis to consult with Licensee or Licensee’s CMO with respect to the Manufacturing Know-How and Materials and the Manufacturing Transfer. Relay will not be required to perform a Manufacturing Transfer to more than one CMO of Licensee. Subject to the completion of the Manufacturing Transfer, Licensee will be solely responsible for contracting with its CMO for the supply of the Licensed Candidates or Licensed Products, and Relay will have no obligations under such agreement between Licensee and such CMO.

Manufacturing Agreement. As consideration for the dismissal, license, release, covenant no to sue and other benefits under this Agreement relating to the Patent Claims and the Licensed Patents, [[CAO:Organization]] and Biolase agree to negotiate in good faith to finalize and execute a definitive Manufacturing Agreement.