Regulatory Cooperation. Each Party is responsible concerning adverse drug reactions, safety information and compliance with regulatory requirements. XPH is responsible for providing any such data to Kinex that is required by the United States Regulatory Authority. Kinex is also responsible for providing any such data to XPH that is required by the Regulatory Authority in the Territory. The Parties hereby agree that they will each make Commercially Reasonable Efforts in coordinating their respective regulatory, Development and Commercialization efforts.

Regulatory Cooperation. Each Party shall use Commercially Reasonable Efforts to provide the other Party with all reasonable assistance and take all actions reasonably requested by such other Party, without changing the allocation of responsibilities set forth in this Article 5, that are necessary or desirable to enable: # Licensee to obtain and maintain Regulatory Approvals for Product in the Field in the Territory; and # Verrica to obtain and maintain Regulatory Approvals for Product in the Verrica Territory or outside the Field in the Territory. Each Party shall cooperate with any inspection by any Regulatory Authority relating to Product, including any inspection prior to approval of an application for Regulatory Approval for Product.

Litigation and Regulatory Cooperation. During and after the Executive’s employment, the Executive shall cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while the Executive was employed by the Company. The Executive’s full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times. During and after the Executive’s employment, the Executive also shall cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while the Executive was employed by the Company. The Company shall reimburse the Executive for any reasonable out-of-pocket expenses incurred in connection with the Executive’s performance of obligations pursuant to this [Section 11(k)].

GEMA agrees to provide promptly to SAVARA, as requested, all information and data in GEMA’s possession or control necessary or useful for SAVARA and/or its designees to apply for, obtain and maintain Regulatory Filings (and approvals therefor) for API and Products in any country, including information relating to the Manufacturing Facility and all information required to be submitted in the CMC section of a Regulatory Filing or required or requested to be provided to the FDA or other Regulatory Authorities. Except as provided in [Section 8.3.2] below: # any such information and data shall be provided by GEMA at no additional cost to SAVARA.

Each Party shall use Commercially Reasonable Efforts to provide the other Party with all reasonable assistance and take all actions reasonably requested by such other Party, without changing the allocation of responsibilities set forth in this Article 5, that are necessary or desirable to enable: # Verrica to seek, obtain, and maintain Regulatory Approvals for Product in the Licensed Field in the Territory; and # Lytix to seek, obtain, and maintain Regulatory Approvals for Product in the Retained Field in the Territory. Each Party shall cooperate with any inspection by any Regulatory Authority relating to Product, including any inspection prior to approval of an application for Regulatory Approval for Product.

Litigation and Regulatory Cooperation. During and after the Executive’s employment, the Executive shall cooperate fully with the Company in # the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while the Executive was employed by the Company, and # the investigation, whether internal or external, of any matters about which the Company believes the Executive may have knowledge or information. The Executive’s full cooperation in connection with such claims, actions or investigations shall include, but not be limited to, being available to meet with counsel to answer questions or to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times. During and after the Executive’s employment, the Executive also shall cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while the Executive was employed by the Company. The Company shall reimburse the Executive for any reasonable out-of-pocket expenses incurred in connection with such cooperation (not to include attorneys’ fees), and will compensate the Executive at an hourly rate for all time spent on such matters based on the Executive’s Base Salary on the Date of Termination.

Regulatory Cooperation. Supplier shall cooperate, at Buyer's cost, with any reasonable requests for assistance from Buyer with respect to obtaining and maintaining any and all Regulatory Approvals for the Products.

Regulatory Cooperation. Without limiting [Section 4.1.3] (Development Cooperation), the Parties shall, each at their own expense, provide the other Party with reasonable access to and copies of any documents or other materials Controlled by such Party that are useful for regulatory filings and correspondence and maintenance of Regulatory Approvals for Products in the Field in such other Party’s territory and will otherwise cooperate with the other Party’s efforts to obtain and maintain Regulatory Approvals for Products in the applicable field and territory. Viela shall keep MTPC reasonably (but at least on a quarterly basis) informed regarding the status and progress of all regulatory matters relating to Products outside of the Territory by providing MTPC with a copy and English abstract of any Regulatory Submission made to a Regulatory Authority and all written correspondence and abstracts of all material oral correspondence involved in such Regulatory Submission, in each case to the extent Controlled by Viela. Viela shall provide MTPC with any data that is # Controlled by Viela or its Affiliate, and # useful or necessary to comply with requirements from Regulatory Authorities in the Territory, with respect to Viela Compound or a Product in the Field. In the event of an urgent request from the Regulatory Authorities, MTPC may directly contact Viela, its Affiliate or relevant Third Party under contract with Viela with respect to Viela Compound or Product including but not limited to contract research organizations.

Regulatory Cooperation. As reasonably requested by the Regulatory Responsible Party from time to time during the Term, the other Party shall promptly provide reasonable assistance to the Regulatory Responsible Party with respect to filings and other interactions with Regulatory Authorities regarding Licensed Antibodies and Licensed Products.

Regulatory Cooperation. The JSC shall review the overall regulatory strategy and positioning for the Product in the Licensee Territory and the Non-Encumbered Territory. In connection with such review, each Party shall provide to the JSC such information regarding a proposed filing as either Party may reasonably request. Each Party shall provide to the JSC, copies of all material submissions it makes to, and all material correspondence it receives from the EMA or the FDA pertaining to the Product, and the other Party may provide comments regarding such documents and correspondence prior to their submission, which comments shall be considered in good faith.