Development and Commercialization Activities. Arcus shall use Commercially Reasonable Efforts to Develop and Commercialize Patented Products in the Field. Notwithstanding the foregoing, Arcus is obligated to file an IND in the United States on a Patented Product no later than ​ months from the Effective Date; provided that Stage 2 Technology Transfer, as defined in Section 3.3.1 below, is completed no later than ​ days following the Effective Date. The deadline for Arcus to file an IND in the United States on a Patented Product shall be extended by one (1) day for each day that Abmuno is late in completing Stage 2 Technology Transfer. Any delay or postponement in the filing of an IND in the United States on a Patented Product beyond the deadline for such filing will be subject to approval by Abmuno, which approval shall not be unreasonably withheld, conditioned or delayed.

Regulatory, Manufacturing and Commercialization. After the Effective Date, # Zai Lab will be solely responsible for and control (at its own expense) all regulatory matters related to the Development and Commercialization of Compounds and/or Products in the Territory, including, without limitation, taking full responsibility for preparing and filing the relevant applications with the Regulatory Authorities for pre-clinical and clinical studies and for Regulatory Approval; and # Zai Lab will be solely responsible for and control (at its own expense) all aspects of Commercialization of Products and the Manufacturing and supply of Products (including, without limitation, the Manufacture and supply of related Compounds being Developed by Zai Lab) in the Territory and will have sole responsibility for all costs arising therefrom.

Development and Commercialization Plans. Licensee shall perform, and shall ensure that its Affiliates, sublicensees, and Third Party contractors perform, the activities described in any Development Plan for the Licensed Product in a professional manner and in compliance with, to the extent applicable, Good Laboratory Practices, Good Clinical Practices and/or Good Manufacturing Practices and in compliance with all other applicable laws, rules, and regulations.

Governance. Denali shall provide to ​ ​ written reports due every ​ following the Effective Date and continuing until receipt of the first Marketing Approval for a Licensed Product summarizing Denali’s research, development, manufacturing and commercialization activities for Licensed Product(s) (“Development Reports”) in the time since the last such ​ report was provided to ​. The foregoing Development Reports will also include a forecast of any anticipated Milestone Events. Each Development Report will be Denali’s Confidential Information.

review and discuss reports from the JDC and JCC and provide guidance thereto, direct the activities of such Committees, and approve each Research Plan, Early Clinical Development Plan, Late Clinical Development Plan and Joint Commercialization Plan and, in the case of all plans, amendments thereto;

Reporting. Commercializing Party shall keep Licensor reasonably informed of Commercializing Party’s and its sublicensees’ Commercialization activities concerning the Licensed Protocol, the Kaufmann Name and/or the Kaufmann Intellectual Property. Without limiting the foregoing, within thirty (30) days following the end of each calendar quarter (commencing for the calendar quarter ending December 31, 2021), Commercializing Party shall provide Licensor with a written report summarizing the significant Commercialization activities performed with respect to the Licensed Protocol, the Kaufmann Name and/or the Kaufmann Intellectual Property since the date of the last report. Such reports must be at a level of detail reasonably requested by Licensor.

Commercialization Pending Resolution of Disputes. In the event of a dispute relating to Commercialization in the Shared Territory with respect to a Product, and in an effort to avoid economic harm to such Product, the Lead Commercializing Party will be entitled to exercise tie-breaking decision authority pending the resolution of the applicable dispute in accordance with this Article 4; provided that # in exercising such authority the Lead Commercializing Party will take into consideration the temporary nature of such authority, # this [Section 4.8] will not apply to Pricing Matters, and # this [Section 4.8] will not apply if the dispute relates to any ACTR Matter.

Annual Reports; Etc. Promptly after the same are available, copies of each annual report, proxy or financial statement or other report or communication sent to the stockholders of the Borrower, and copies of all annual, regular, periodic and special reports and registration statements which the Borrower may file or be required to file with the SEC under Section 13 or 15(d) of the Securities Exchange Act of 1934, or with any national securities exchange, and in any case not otherwise required to be delivered to the Administrative Agent pursuant hereto;.

Records and Reports. Provider shall assist Manager and, where required by law or by legal process, provide access to records and information regarding the operation of the Biorepository. Consistent with all applicable federal, Utah and local statutes, rules and regulations and medical ethical standards, Provider shall give Manager full access to all of its biomedical and financial records during regular business hours and upon adequate notice as necessary for Manager to provide the Management Services. Manager shall maintain the confidentiality of all such information in accordance with applicable law. In the event that any regulation requires reports or disclosures of Provider or Manager and its contractors, upon request, Provider or Manager, as applicable, shall make, execute and deliver such reports, disclosures or other written information, certifications or assurances as may be reasonably required to assure timely compliance, subject to any confidentiality requirements imposed by law.

Monthly Status Reports. On or before the tenth (10th) day of each month, Service Provider shall submit monthly Project reports in a form including such information as reasonably requested by Owners.