Common use of Regulatory Responsibility Clause in Contracts

Regulatory Responsibility. (a) Licensee, its Affiliates, and Sublicensees shall be the legal and beneficial owner of all Regulatory Approvals and Regulatory Materials for Licensed Product in the Territory, and Regulatory Materials relating to such Regulatory Approvals in the Territory shall be submitted by, and in the name of, Licensee (or its Affiliates or Sublicensees, as the case may be). All INDs and CTAs for the Existing Study shall be transferred to Licensee within *** days following the completion of the Existing Study, and thereafter the Licensee will be the sponsor under all INDs and CTAs relating to the Licensed Product. As such, Licensee shall be responsible for reporting all adverse drug reactions related to Licensed Products to the appropriate Regulatory Authorities in the relevant countries in the Territory, in accordance with Applicable Law of such countries. Licensee shall also be responsible for all meetings with Regulatory Authorities and all post-Regulatory Approval commitments to Regulatory Authorities. (b) During the Term following the Effective Date, Licensee shall keep Company reasonably and regularly informed of the submission to Regulatory Authorities of all material Regulatory Materials, meetings with Regulatory Authorities, and receipt of, or any material changes to existing, Regulatory Approvals, in each case for the applicable Licensed Product in the Territory. During the Term following the Effective Date, Licensee will use commercially reasonable efforts to provide to Company any Regulatory Materials reasonably in advance of submission to Regulatory Authorities, to the extent practicable, so as to provide Company with an opportunity to review and provide its comments. (c) In the event Company assumes responsibility for any portion of the Territory, the Parties shall enter into a customary pharmacovigilance agreement. (d) Within ***days after the Effective Date or such longer time as may reasonably be necessary not to exceed ***days after the Effective Date, Company shall transfer and deliver all Regulatory Materials to Licensee in the manner and to locations reasonably selected by Licensee. Licensee shall also have the right to access any Company Know-How included or referenced therein and use such Company Know-How in connection with the performance of Licensee’s obligations and exercise of its rights under this Agreement, including inclusion of such information and Company Know-How in Regulatory Materials for any Licensed Products. (e) Licensee shall promptly provide copies of all material correspondence received from a Regulatory Authority relating to adverse effects and safe use of any Licensed Product, and all safety and adverse event reports submitted by Company to a Regulatory Authority relating to a Licensed Product, all of which will be the Confidential Information of Licensee.

Regulatory Responsibility. (a) LicenseeSLP shall be responsible for preparing, its Affiliatesobtaining, and Sublicensees shall be the legal maintaining all Regulatory Filings and beneficial owner of all Regulatory Approvals and conducting communications with the Regulatory Materials for Licensed Product Authorities in the Territory. Without limiting the foregoing, SLP shall have sole responsibility for seeking Regulatory Approval in Canada, and shall use Commercially Reasonable Efforts to obtain such Regulatory Materials relating Approval. For clarity, SLP shall have no obligation to such conduct any pre-clinical testing or clinical studies. All Regulatory Approvals in the Territory shall be submitted by, and held in the name ofof SLP, Licensee (or its Affiliates or Sublicensees, as the case may be). All INDs and CTAs for the Existing Study who shall be transferred the Marketing Authorization Holder (“MAH”) and the importer of record, and SLP shall maintain the right to Licensee within transfer the Regulatory Approvals to an Affiliate. SLP shall provide Sol-Gel with copies of all [*** days following *] (collectively, the completion “Key Regulatory Submissions”) prior to submission to a Regulatory Authority and Sol-Gel shall have [***], or a shorter time period if required by Law, from receipt of the Existing Studysuch Key Regulatory Submissions to provide comments. SLP shall reasonably consider and, and thereafter the Licensee will be the sponsor under all INDs and CTAs relating if reasonable, in SLP’s sole judgment, incorporate such comments, prior to submission to the Licensed Product. As such, Licensee shall be responsible for reporting all adverse drug reactions related to Licensed Products to the appropriate Regulatory Authorities in the relevant countries in the Territory, in accordance with Applicable Law of such countries. Licensee shall also be responsible for all meetings with Regulatory Authorities and all post-Regulatory Approval commitments to Regulatory AuthoritiesAuthority. (b) During Sol-Gel shall provide timely support and consult SLP in its efforts to perform its obligations set forth in section 4.01(a) above. In support of SLP’s preparation of any Regulatory Filing with respect to the Term following Licensed Product in the Effective DateField in the Territory, Licensee to the extent required and upon SLP’s written request, Sol-Gel shall keep Company reasonably provide SLP access to a complete electronic copy of and regularly informed a right of reference to all current and as updated (i) Regulatory Documents Controlled by any Sol- Gel Entity (including those generated by any of Sol-Gel’s licensees that are Controlled by Sol- Gel) that are related to the Licensed Product in the Field, and (ii) any other information requested by Regulatory Authorities in the Territory in connection with SLP’s Regulatory Filings solely to the extent (A) Controlled by the Sol-Gel Entities, and (B) subject to Sol-Gel’s Commercially Reasonable Efforts to obtain, and Sol-Gel’s actual obtaining of the submission to Regulatory Authorities prior written consent of all material Regulatory Materials, meetings with Regulatory Authorities, and receipt of, or any material changes to existing, Regulatory ApprovalsSol-Gel Entities’ Third Party licensees, in each case ((i) through (ii)) to the extent permitted by applicable Law, and if applicable by the agreements entered between Sol-Gel Entities and its licensees. Without limiting the foregoing, Sol-Gel shall (i) provide SLP with the Key Regulatory Submissions filed for the applicable product in the United States that corresponds to the Licensed Product in both word and pdf format which are within its Control, and with respect to which it has the Territory. During contractual rights to share with SLP; (ii) perform Commercially Reasonable Efforts to assist SLP with causing the Term following manufacturers of the Effective Date, Licensee will use commercially reasonable efforts API for the Licensed Product to file electronic drug master files with the Regulatory Authority in the Territory in order to permit SLP to reference such information in the Licensed Product submission; and (iii) perform Commercially Reasonable Efforts to assist with SLP with causing the manufacturers of the API for the Licensed Product to provide SLP with any required documentation as requested by the Regulatory Authority in order to Company any Regulatory Materials reasonably in advance of submission to Regulatory Authorities, to the extent practicable, so as to provide Company comply with an opportunity to review and provide its commentsLaws. (c) In the event Company assumes responsibility for any portion of the Territory, the Parties shall enter into a customary pharmacovigilance agreement. (d) Within [***days after the Effective Date or such longer time as may reasonably be necessary not to exceed ] in conducting its regulatory responsibilities under this Section 4.01, and will [***days after the Effective Date, Company shall transfer ] [***]. All Third Party vendors and deliver all Regulatory Materials to Licensee in the manner and to locations reasonably selected by Licensee. Licensee shall also have the right to access any Company Know-How included or referenced therein and use such Company Know-How in connection with the performance of Licensee’s obligations and exercise of its rights under this Agreement, including inclusion of such information and Company Know-How in Regulatory Materials for any Licensed Productstheir activities require advance approval [***]. (e) Licensee shall promptly provide copies of all material correspondence received from a Regulatory Authority relating to adverse effects and safe use of any Licensed Product, and all safety and adverse event reports submitted by Company to a Regulatory Authority relating to a Licensed Product, all of which will be the Confidential Information of Licensee.

Regulatory Responsibility. (a) Licensee, its Affiliates, and Sublicensees and/or permitted sublicensees shall be the legal and beneficial owner of all Regulatory Approvals and Regulatory Materials for Licensed Product in the Territory, Field in the Territory and Regulatory Materials relating to such Regulatory Approvals in the Field in the Territory shall be submitted filed by, and in the name of, Licensee (or its Affiliates or Sublicenseespermitted sublicensees, as the case may be). All INDs ; provided that (i) the Parties shall use good faith efforts to cooperate to effectuate this Section 5.10, and CTAs (ii) in the event that after the Parties’ use of good faith efforts, Licensee, its Affiliate, and/or permitted sublicensee is unable to become the legal and beneficial owner of the Regulatory Approvals for Licensed Products in the Field in the Territory (or it is determined to be commercially infeasible for Licensee, its Affiliate, and/or permitted sublicensee to be the legal and beneficial owner of all Regulatory Approvals) in order to exercise its rights and perform its obligations under this Agreement, (A) Company shall be the legal and beneficial owner of the Regulatory Approvals for Licensed Product in the Field and in the Territory, (B) Company hereby designates Licensee, its Affiliates, and/or permitted sublicensees as Company’s regulatory agent and exclusive general distributor for the Existing Study shall be transferred to Licensee within *** days following Licensed Product in the completion of the Existing StudyTerritory, and thereafter (C) to the Licensee will extent later permitted by Applicable Law, Company shall promptly cooperate with Licensee, its Affiliates, and/or permitted sublicensees, including but not limited to transferring and assigning all Regulatory Approvals and Regulatory Materials to Licensee, its Affiliates, and/or permitted sublicensees, to allow Licensee, its Affiliates, and/or permitted sublicensees to be the sponsor under legal and beneficial owner of all INDs and CTAs relating to Regulatory Approvals for Licensed Products in the Licensed ProductField in the Territory. As such, Licensee Licensee, its Affiliates, and/or permitted sublicensees shall be solely responsible for reporting all adverse drug reactions related to Licensed Products to the appropriate Regulatory Authorities in the relevant countries in the Territory, in accordance with Applicable Law of such countries. Licensee Licensee, its Affiliates, and/or permitted sublicensees shall also be solely responsible for attending all meetings with Regulatory Authorities and fulfilling all post-Regulatory Approval commitments to Regulatory Authorities; provided that (y) in Licensee’s sole discretion, Licensee, its Affiliates, and/or permitted sublicensees may ask Third Party experts to attend any meetings with Regulatory Authorities, and (z) Company shall provide reasonable assistance to Licensee, its Affiliates, and/or permitted sublicensees, including but not limited to providing Company personnel to attend meetings with Regulatory Authorities with Licensee, its Affiliates, and/or permitted sublicensees, upon Licensee’s reasonable request and at Licensee’s cost and expense. (b) During the Term following the Effective DateTerm, Licensee shall keep Company reasonably and regularly informed of the submission to Regulatory Authorities of all material Regulatory Materials, meetings with Regulatory Authorities, and receipt of, or any material changes to existing, Regulatory Approvals, in each case for the applicable Licensed Product in the Territory. During the Term following the Effective Date, Licensee will use commercially reasonable efforts to provide to Company any Any new Regulatory Materials reasonably in advance of submission to Regulatory AuthoritiesMaterials, to the extent practicablecreated by Licensee, so as its Affiliates or its sublicensees, shall be provided to provide Company with an opportunity at least [***] calendar days prior to review the submission to Regulatory Authorities (or at a different time mutually agreed upon by the Parties) for the Company’s review, and provide its commentsLicensee shall consider in good faith any comments Company may have on such Regulatory Materials. (c) In Without limiting the event foregoing, Licensee shall keep Company assumes responsibility for reasonably informed, in a timely manner, of any portion Information that Licensee receives (directly or indirectly) that (i) raises any material concerns regarding the safety or efficacy of the Territory, Licensed Product; (ii) indicates or suggests a potential material liability of either Party to Third Parties in connection with the Parties shall enter into Licensed Product; (iii) is reasonably likely to lead to a customary pharmacovigilance agreementrecall or market withdrawal of the Licensed Product; or (iv) relates to the Licensed Product and is reasonably likely to have a material adverse impact on a Regulatory Approval or the Commercialization of the Licensed Product. (d) Within Company hereby grants to Licensee a right of reference to all Regulatory Materials Controlled by Company with respect to Licensed Products as of the Effective Date and during the Term solely for the purpose of obtaining or maintaining the Regulatory Approvals for the Licensed Product in the Territory. Licensee hereby grants to Company a right of reference to all Regulatory Materials Controlled by Licensee, its Affiliates, or its permitted sublicensees with respect to Licensed Products during the Term solely for the purpose of obtaining or maintaining the Regulatory Approvals for Licensed Product outside the Territory. (e) Details regarding the management of information of adverse events related to the clinical Development and the use of the Licensed Product in and outside the Territory shall be delineated in a separate pharmacovigilance agreement that shall be agreed to by the Parties within [***days after the Effective Date or such longer time as may reasonably be necessary not to exceed ***] calendar days after the Effective Date. Each Party shall be primarily responsible for filing of all required reports with respect to adverse events in its own territory as required under Applicable Law. (f) Notwithstanding anything in this Agreement or the Development Plan to the contrary, Licensee must (i) (w) apply to the NMPA for the applicable Clinical Trial approval or Regulatory Approval for mTNBC cancer in PRC within [***] months of Marketing Approval by the FDA of the Drug Approval Application for the mTNBC indication (provided that all documents for U.S. approval reasonably necessary for Licensee to file for Clinical Trial approval or Regulatory Approval (as applicable) have been transferred to Licensee), and (x) if needed, perform an add-on Clinical Trial for the mTNBC Indication, and (ii) apply to the NMPA for the Regulatory Approval for each other Priority Indication (y) within [***] months of the filing of a Drug Approval Application for the Licensed Product for the same Priority Indication by Company in the U.S. if the PRC is included in the Global Study for such Priority Indication or (z) within [***] months of any Regulatory Approval of the Licensed Product for the same Priority Indication in the U.S. if (A) the PRC is not included in the Global Study for such Priority Indication and (B) nonetheless the data from the Global Study for such Priority Indication is deemed sufficient for a Drug Approval Application by the NMPA and no additional Clinical Trial is needed; provided, however, that (1) Licensee may request Company’s consent for a reasonable extension to any time period set forth in clauses (i)-(ii) to the extent it has been reasonably diligent and actively pursuing Development for such, such consent not to be unreasonably withheld, conditioned or delayed; and (2) Company shall transfer provide all relevant data Controlled by Company or its Affiliates to the extent necessary or reasonably useful for such filing pursuant to the terms and deliver all Regulatory Materials conditions hereunder at least, to Licensee in the manner and extent feasible, [***] months prior to locations reasonably selected any anticipated filing date of any filing to the NMPA by Licensee. Licensee The Parties shall also have mutually agree upon filing timelines for Regulatory Approval related to any indications in addition to the right to access any Company Know-How included or referenced therein and use such Company Know-How in connection with the performance of Licensee’s obligations and exercise of its rights under this Agreement, including inclusion of such information and Company Know-How in Regulatory Materials for any Licensed ProductsPriority Indications. (eg) Licensee shall promptly provide copies of all material correspondence received from a Regulatory Authority relating to adverse effects and safe use of any Licensed Productbe responsible for, and all safety and adverse event reports submitted by Company to a Regulatory Authority relating to a Licensed Productbear the costs of, all of which will be regulatory activities with respect to the Confidential Information of LicenseeLicensed Product in the Territory.

Regulatory Responsibility. (a) Licensee, its Affiliates, AMIDE shall remain responsible for maintaining and Sublicensees shall be fulfilling all regulatory requirements with respect only to the legal and beneficial owner Manufacture of all Regulatory Approvals and Regulatory Materials for Licensed Product in the Territory, and Regulatory Materials relating to such Regulatory Approvals in the Territory shall be submitted by, and in the name of, Licensee (or its Affiliates or Sublicensees, Products that are imposed by Law upon AMIDE as the case may be). All INDs and CTAs for the Existing Study shall be transferred to Licensee within *** days following the completion manufacturer of the Existing Study, and thereafter the Licensee will be the sponsor under all INDs and CTAs relating to the Licensed Product. As such, Licensee shall be responsible for reporting all adverse drug reactions related to Licensed Products to the appropriate Regulatory Authorities in the relevant countries in the Territory, in accordance with Applicable Law of such countries. Licensee shall also be responsible for all meetings with Regulatory Authorities and all post-Regulatory Approval commitments to Regulatory AuthoritiesProducts. (b) During SIRIUS shall perform all necessary regulatory filings and will obtain all necessary registrations in the Term following United States, with the Effective DateFDA or other relevant government agencies, Licensee shall keep Company reasonably and regularly informed as required by law, for Manufacture of the submission to Regulatory Authorities of Product. SIRIUS shall be solely and exclusively responsible for obtaining, maintaining and fulfilling all material Regulatory Materials, meetings regulatory requirements with Regulatory Authorities, and receipt of, or any material changes to existing, Regulatory Approvals, in each case for the applicable Licensed Product in the Territory. During the Term following the Effective Date, Licensee will use commercially reasonable efforts to provide to Company any Regulatory Materials reasonably in advance of submission to Regulatory Authorities, respect to the extent practicableProducts that are imposed by Law upon SIRIUS in connection with SIRIUS's Commercialization and sale of the Products. SIRIUS shall, so as on a timely basis, provide AMIDE with all information that is reasonably necessary and relevant to provide Company with an opportunity to review and provide assist AMIDE in fulfilling all of its commentsregulatory obligations. (c) In the event Company assumes responsibility for any portion AMIDE shall advise SIRIUS orally or in writing within [c.i.] days if an authorized agent of the Territory, FDA or other governmental agency visits AMIDE's manufacturing facility and requests or requires information or changes which directly pertain to the Parties Product or which may negatively impact AMIDE's ability to continue to manufacture SIRIUS's Product under this Agreement. FDA audit time specific to Product [c.i.]. AMIDE shall enter into a customary pharmacovigilance agreementnotify SIRIUS of any FDA determination regarding failure to comply with CGMP. (d) Within ***days after the Effective Date or such longer time AMIDE shall report adverse drug experience information within [c.i.] hours of receipt by AMIDE. AMIDE shall provide other post Commercialization reports as may reasonably are required to be necessary not to exceed ***days after the Effective Date, Company shall transfer and deliver all Regulatory Materials to Licensee in the manner and to locations reasonably selected by Licensee. Licensee shall also have the right to access any Company Know-How included or referenced therein and use such Company Know-How in connection filed with the performance of Licensee’s obligations FDA or its equivalent. All telephone calls received by AMIDE relating to the Product shall be referred to SIRIUS. SIRIUS shall be responsible for fulfilling any and exercise of its rights under this Agreementall regulatory requirements with respect to such events, including inclusion but not limited to the filing of such information all required forms, contact and Company Knowfollow-How in Regulatory Materials for up with the patient or reporter of the event, and will make any Licensed Productsnecessary contact with the FDA regarding the subject matter of same. (e) Licensee SIRIUS, in performing its obligations hereunder, shall promptly materially comply with all applicable Laws. If SIRIUS receives notice of an inspection or other notification by a governmental entity, including FDA, relating to Products, promotional materials or other matters, SIRIUS shall notify AMIDE on the same day such notice or notification is received, and provide to AMIDE, within [c.i.] hours, copies of all material relevant documents, warning letters and other correspondence received from a Regulatory Authority and notifications relating to adverse effects Products. SIRIUS agrees to cooperate with AMIDE during any inspection, investigation or other inquiry by FDA or any other governmental entity, including providing information and/or documentation, as requested by FDA or other governmental entity. SIRIUS also agrees to discuss any response to observations or notifications received and safe use to give AMIDE an opportunity to comment on any proposed response before it is made. In the event of disagreement concerning the form or content of such response, however, AMIDE shall be responsible for deciding the appropriate form and content of any Licensed Product, response with respect to any of its cited activities and all safety SIRIUS shall be responsible for deciding the appropriate form and adverse event reports submitted by Company content of any response with respect to a Regulatory Authority relating to a Licensed Product, all any of which will be the Confidential Information of Licenseeits cited activities.

Regulatory Responsibility. (a) Licensee, its Affiliates, and Sublicensees shall be the legal and beneficial owner of all Regulatory Approvals and Regulatory Materials for Licensed Product in the Territory, and Regulatory Materials relating to such Regulatory Approvals in the Territory shall be submitted by, and in the name of, Licensee (or its Affiliates or Sublicensees, as the case may be). All INDs and CTAs for the Existing Study shall be transferred to Licensee within [*** ] days following the completion of the Existing Study, and thereafter the Licensee will be the sponsor under all INDs and CTAs relating to the Licensed Product. As such, Licensee shall be responsible for reporting all adverse drug reactions related to Licensed Products to the appropriate Regulatory Authorities in the relevant countries in the Territory, in accordance with Applicable Law of such countries. Licensee shall also be responsible for all meetings with Regulatory Authorities and all post-Regulatory Approval commitments to Regulatory Authorities. (b) During the Term following the Effective Date, Licensee shall keep Company reasonably and regularly informed of the submission to Regulatory Authorities of all material Regulatory Materials, meetings with Regulatory Authorities, and receipt of, or any material changes to existing, Regulatory Approvals, in each case for the applicable Licensed Product in the Territory. During the Term following the Effective Date, Licensee will use commercially reasonable efforts to provide to Company any Regulatory Materials reasonably in advance of submission to Regulatory Authorities, to the extent practicable, so as to provide Company with an opportunity to review and provide its comments. (c) In the event Company assumes responsibility for any portion of the Territory, the Parties shall enter into a customary pharmacovigilance agreement. (d) Within [***] days after the Effective Date or such longer time as may reasonably be necessary not to exceed [***] days after the Effective Date, Company shall transfer and deliver all Regulatory Materials to Licensee in the manner and to locations reasonably selected by Licensee. Licensee shall also have the right to access any Company Know-How included or referenced therein and use such Company Know-How in connection with the performance of Licensee’s obligations and exercise of its rights under this Agreement, including inclusion of such information and Company Know-How in Regulatory Materials for any Licensed Products. (e) Licensee shall promptly provide copies of all material correspondence received from a Regulatory Authority relating to adverse effects and safe use of any Licensed Product, and all safety and adverse event reports submitted by Company to a Regulatory Authority relating to a Licensed Product, all of which will be the Confidential Information of Licensee. (f) Without limiting Section 5.9(a), Company, on behalf of itself and its Affiliates, hereby grants to Licensee a right of reference to all INDs and CTAs for the Existing Study and any other Regulatory Materials Controlled by Company or its Affiliates with respect to Licensed Products for the purpose of submitting additional INDs and CTAs and obtaining or maintaining the Regulatory Approvals for Licensed Product in the Territory. (g) Licensee shall have the exclusive right to seek and attempt to obtain pricing and reimbursement approvals for the Licensed Products in the Territory. (h) Company shall cooperate in good faith with Licensee in obtaining the Regulatory Approvals for IMMU-132 in the indications contemplated by the Development Plan, subject to reimbursement at the applicable FTE Rate for such activities.

Regulatory Responsibility. (a) Licensee, its Affiliates, and Sublicensees shall be the legal and beneficial owner of all Regulatory Approvals and Regulatory Materials for Licensed Product in the Territory, and Regulatory Materials relating to such Regulatory Approvals in the Territory shall be submitted by, and in the name of, Licensee (or its Affiliates or Sublicensees, as the case may be). All INDs and CTAs for the Existing Study shall be transferred to Licensee within **[ * ] days following the completion of the Existing Study, and thereafter the Licensee will be the sponsor under all INDs and CTAs relating to the Licensed Product. As such, Licensee shall be responsible for reporting all adverse drug reactions related to Licensed Products to the appropriate Regulatory Authorities in the relevant countries in the Territory, in accordance with Applicable Law of such countries. Licensee shall also be responsible for all meetings with Regulatory Authorities and all post-Regulatory Approval commitments to Regulatory Authorities. (b) During the Term following the Effective Date, Licensee shall keep Company reasonably and regularly informed of the submission to Regulatory Authorities of all material Regulatory Materials, meetings with Regulatory Authorities, and receipt of, or any material changes to existing, Regulatory Approvals, in each case for the applicable Licensed Product in the Territory. During the Term following the Effective Date, Licensee will use commercially reasonable efforts to provide to Company any Regulatory Materials reasonably in advance of submission to Regulatory Authorities, to the extent practicable, so as to provide Company with an opportunity to review and provide its comments. (c) In the event Company assumes responsibility for any portion of the Territory, the Parties shall enter into a customary pharmacovigilance agreement. (d) Within ***[ * ] days after the Effective Date or such longer time as may reasonably be necessary not to exceed ***[ * ] days after the Effective Date, Company shall transfer and deliver all Regulatory Materials to Licensee in the manner and to locations reasonably selected by Licensee. Licensee shall also have the right to access any Company Know-How included or referenced therein and use such Company Know-How in connection with the performance of Licensee’s obligations and exercise of its rights under this Agreement, including inclusion of such information and Company Know-How in Regulatory Materials for any Licensed Products. (e) Licensee shall promptly provide copies of all material correspondence received from a Regulatory Authority relating to adverse effects and safe use of any Licensed Product, and all safety and adverse event reports submitted by Company to a Regulatory Authority relating to a Licensed Product, all of which will be the Confidential Information of Licensee. (f) Without limiting Section 5.9(a), Company, on behalf of itself and its Affiliates, hereby grants to Licensee a right of reference to all INDs and CTAs for the Existing Study and any other Regulatory Materials Controlled by Company or its Affiliates with respect to Licensed Products for the purpose of submitting additional INDs and CTAs and obtaining or maintaining the Regulatory Approvals for Licensed Product in the Territory. (g) Licensee shall have the exclusive right to seek and attempt to obtain pricing and reimbursement approvals for the Licensed Products in the Territory. (h) Company shall cooperate in good faith with Licensee in obtaining the Regulatory Approvals for IMMU-132 in the indications contemplated by the Development Plan, subject to reimbursement at the applicable FTE Rate for such activities.