Common use of Conduct of Regulatory Activities Clause in Contracts

Conduct of Regulatory Activities. JW (itself and through its Affiliates and Sublicensees, as applicable) will be solely responsible, at its own expense, for all regulatory activities with respect to the Products in the Field in the JW Territory, including formulating regulatory strategy and preparing, filing, obtaining and maintaining Regulatory Approvals for the Products in the Field in the JW Territory, will be the holder of all Regulatory Approvals for the Products in the Field in the JW Territory, and will have responsibility for interactions with Regulatory Authorities with respect to the Products in the Field in the JW Territory; provided that TSVT may elect, in its sole discretion, to submit CMC Information directly to the concerned Regulatory Authority. Notwithstanding the foregoing, in the event that JW, its Affiliates or Sublicensees are unable to become the legal and beneficial owner of the Regulatory Documents for the Products in the JW Territory in order to exercise its rights and perform its obligations under this Agreement, (a) TSVT will be the legal and beneficial owner of the Regulatory Documents for in the JW Territory and such Regulatory Documents will be included in TSVT Know-How, (b) TSVT hereby designates JW, its Affiliates or Sublicensees as TSVT’s regulatory agent and exclusive general distributor for the Products in the JW Territory, and (c) to the extent later permitted by Applicable Laws, TSVT will cooperate with JW to allow JW, its Affiliates or Sublicensees to be the legal and beneficial owner of the Regulatory Documents for the Products in the JW Territory. ▇▇ will conduct the regulatory activities in the JW Territory under this Agreement (i) in its own name, if JW (or its Affiliates or Sublicensees) is the legal and beneficial owner of the Regulatory Approvals for the Products in the JW Territory or (ii) as the express and authorized regulatory agent of record for TSVT in the JW Territory, if TSVT is the legal and beneficial owner of the Regulatory Documents for the Products in the JW Territory, under which situation such actions will be taken on behalf of TSVT and for the benefit of JW in the JW Territory. If any regulatory activities in the JW Territory are conducted in TSVT’s name, TSVT will have final decision-making authority regarding all such regulatory activities, including the content of regulatory submissions for Products in the JW Territory and JW will, and will ensure that its relevant Affiliates and Sublicensees will, conduct all regulatory activities in compliance with TSVT’s final decisions. Notwithstanding the foregoing, in the event any regulatory activities in the JW Territory are conducted in TSVT’s name, TSVT shall consult with and reasonably consider all suggestions from JW in good faith prior to exercising the aforementioned final decision rights.

Conduct of Regulatory Activities. JW (itself and through its Affiliates and Sublicensees, as applicable) will ALFRESA shall be solely responsible, at its own expense, responsible for all regulatory activities with respect to the Products in the Field in the JW Territory, including formulating regulatory strategy and for preparing, filing, obtaining and maintaining Regulatory Approvals for the Products in the Field in the JW ALFRESA Territory. If the Regulatory Authority in the ALFRESA Territory requires reanalysis of any Product used in a clinical trial, will ARS shall assist with such reanalysis subject to reimbursement by ALFRESA of costs incurred by ARS for such reanalysis. ALFRESA shall be the holder of all Regulatory Approvals for the Products in the Field in the JW Territory, ALFRESA Territory and will shall have responsibility for interactions with Regulatory Authorities with respect to the Products in the Field in the JW Territory; provided that TSVT may elect, in its sole discretion, to submit CMC Information directly to the concerned Regulatory Authority. Notwithstanding the foregoing, in the event that JW, its Affiliates or Sublicensees are unable to become the legal and beneficial owner of the Regulatory Documents for the Products in the JW Territory in order to exercise its rights and perform its obligations under this Agreement, (a) TSVT will be the legal and beneficial owner of the Regulatory Documents for in the JW Territory and such Regulatory Documents will be included in TSVT Know-How, (b) TSVT hereby designates JW, its Affiliates or Sublicensees as TSVT’s regulatory agent and exclusive general distributor for the Products in the JW Territory, and (c) to the extent later permitted by Applicable Laws, TSVT will cooperate with JW to allow JW, its Affiliates or Sublicensees to be the legal and beneficial owner of the Regulatory Documents for the Products in the JW ALFRESA Territory. ALFRESA shall use Commercially Reasonable Efforts to file ▇▇▇▇ will conduct the regulatory activities in the JW Territory under this Agreement (i) in its own nameand, if JW (or its Affiliates or Sublicensees) is the legal as applicable, seek Pricing and beneficial owner of the Reimbursement Approval for and seek and maintain Regulatory Approvals for the Products in the JW Territory or (ii) as the express and authorized regulatory agent of record for TSVT in the JW Territory, if TSVT is the legal and beneficial owner of the Regulatory Documents for the Products in the JW Territory, under which situation such actions will be taken on behalf of TSVT and for the benefit of JW in the JW Territory. If any regulatory activities in the JW Territory are conducted in TSVT’s name, TSVT will have final decision-making authority regarding all such regulatory activities, including the content of regulatory submissions Approval for Products in the JW Territory and JW willField throughout the ALFRESA Territory. ALFRESA shall conduct all such activities in accordance with Applicable Laws. ALFRESA shall consult with ARS either directly or through the JDC regarding, and will ensure that its relevant Affiliates keep ARS regularly informed of, the preparation, Regulatory Authority review and Sublicensees willapproval of submissions and communications with Regulatory Authorities with respect to Products in the Field in the ALFRESA Territory. In addition, ALFRESA shall promptly provide ARS with copies of any material documents, information and correspondence received from a Regulatory Authority with an English translation thereof and, upon reasonable request by ARS, with copies of any other documents, reports and communications from or to any Regulatory Authority relating to Compositions, Products or activities under this Agreement. Except as agreed otherwise by the Parties under Section 4.3, ALFRESA shall bear all expenses it incurs to conduct all regulatory activities in compliance with TSVT’s final decisions. Notwithstanding the foregoing, in the event any regulatory activities in the JW ALFRESA Territory are conducted in TSVT’s name, TSVT shall consult with and reasonably consider all suggestions from JW in good faith prior to exercising the aforementioned final decision rightsunder this Agreement.

Conduct of Regulatory Activities. JW (a) Subject to Article 3, unless otherwise agreed by the Parties, Licensee (itself and through its Affiliates and Sublicensees, as applicable) will shall be solely responsible, at its own expense, for all regulatory activities with respect to the Products (excluding the [*] or any other Global Trials that Licensee is participating in as C4T’s agent, but including the circumstances under Section 3.3(b)(i) where Licensee is not permitted by Applicable Laws to be the sole applicant of the IND application or NDA application for the Product in the Field in the JW Territory, including formulating regulatory strategy Licensee Territory and preparing, filing, obtaining and maintaining Regulatory Approvals for the Products in the Field in the JW Territory, will be the holder of all Regulatory Approvals for the Products in the Field in the JW Territory, and will have responsibility for interactions with Regulatory Authorities with respect submits to the Products NMPA an IND application or NDA application for such Product as C4T’s agent, provided that, for clarity, C4T shall have final decision-making authority on [*]. [*] Each Party shall consider the other Party’s comments [*] and make decisions in the Field in the JW Territory; provided that TSVT may elect, in its sole discretion, to submit CMC Information directly to the concerned Regulatory Authority. accordance with Section 7.3. (b) Notwithstanding the foregoing, in the event that JWif Licensee, its Affiliates or Sublicensees are unable to become the legal and beneficial owner of the Regulatory Documents Filings for the Products in the JW Licensee Territory in order to exercise its rights and perform its obligations under this Agreement, (a) TSVT C4T will be the legal and beneficial owner of the Regulatory Documents Filings for the Products in the JW Licensee Territory and (such Regulatory Documents Filings will be included in TSVT the C4T Know-HowHow and licensed to Licensee), (b) TSVT hereby designates JWC4T will designate Licensee, its Affiliates or Sublicensees as TSVTC4T’s regulatory agent and exclusive general distributor for the Products in the JW Licensee Territory, and (c) to the extent later permitted by Applicable Laws, TSVT C4T will cooperate with JW Licensee to allow JWLicensee, its Affiliates or Sublicensees to be the legal and beneficial owner of the Regulatory Documents Filings for the Products in the JW Licensee Territory. ▇▇ Licensee will conduct the regulatory activities in the JW Licensee Territory under this Agreement (i) in its own name, if JW Licensee (or its Affiliates or Sublicensees) is the legal and beneficial owner of the Regulatory Approvals for the Products in the JW Licensee Territory or (ii) as the express and authorized regulatory agent of record for TSVT C4T in the JW Licensee Territory, if TSVT C4T is the legal and beneficial owner of the Regulatory Documents Filings for the Products in the JW Licensee Territory, under which situation ACTIVE/119414966.70 such actions will be taken on behalf of TSVT C4T and for the benefit of JW Licensee in the JW Licensee Territory. If . (c) Unless otherwise agreed by the Parties, for any regulatory activities with respect to the Products (excluding the [*] or other Global Trials that Licensee is participating in as C4T’s agent, but including the circumstances under Section 3.3(b)(i) where Licensee is not permitted by Applicable Laws to be the sole applicant of the IND application or NDA application for the Product in the Licensee Territory and submits to the NMPA an IND application or NDA application for such Product as C4T’s agent, provided that, for clarity, C4T shall have final decision-making authority on [*], Licensee will have the final decision-making authority regarding [*]. (d) For any clinical trial where Licensee has decision-making authority pursuant to this Agreement, C4T shall, and shall ensure that its relevant Affiliates and sublicensees will, conduct all regulatory activities in the JW Licensee Territory are conducted in TSVTcompliance with Licensee’s nameinstructions and final decisions. For clarity, TSVT will C4T shall have final decision-making authority regarding all such regulatory activities, including the content of regulatory submissions for Products in the JW Territory and JW will, and will ensure that its relevant Affiliates and Sublicensees will, conduct all regulatory activities in compliance with TSVT’s final decisions. Notwithstanding the foregoing, in the event any regulatory activities in the JW Territory are conducted in TSVT’s name, TSVT shall consult with and reasonably consider all suggestions from JW in good faith prior to exercising the aforementioned final decision rights[*].

Conduct of Regulatory Activities. JW (itself and through its Affiliates and Sublicensees, as applicable) will Pediatrix shall be solely responsible, at its own cost and expense, for all regulatory activities with respect to the Products in the Field in the JW Territory, including formulating regulatory strategy and for preparing, filing, obtaining and maintaining Regulatory Approvals for the Products in the Field in the JW Pediatrix Territory, will . Pediatrix shall be the holder of all Regulatory Approvals for the Products in the Field in the JW Pediatrix Territory, except if ARS is required by Applicable Laws to hold an Import Drug License or equivalent for any Product in the Pediatrix Territory, in which case ARS shall (a) hold such Regulatory Approval for Pediatrix’s benefit, (b) appoint Pediatrix (or an Affiliate or Sublicensee of Pediatrix) as its authorized exclusive legal agent of record to interact with NMPA and serve as its exclusive distributor for the Product in the Pediatrix Territory, and will have responsibility Pediatrix shall reimburse ARS for all cost and expense incurred in connection therewith, (c) shall provide access to and copies of such Regulatory Filings, Regulatory Approvals and any Pricing and Reimbursement approvals to Pediatrix promptly upon Pediatrix’s request, and (d) shall promptly transfer such Regulatory Approval to Pediatrix or its designee when allowed by Applicable Laws. Pediatrix shall use Commercially Reasonable Efforts to file NDAs and, as applicable, seek Pricing and Reimbursement Approval for and seek and maintain Regulatory Approval for Products in the Field in all regions throughout the Pediatrix Territory. Pediatrix shall keep ARS regularly informed of, the preparation, Regulatory Authority review and approval of substantive submissions and material communications with Regulatory Authorities with respect to Products in the Field in the Pediatrix Territory. ARS shall use Commercially Reasonable Efforts to assist with Pediatrix with interactions with Regulatory Authorities with respect to the Products in the Field in the JW Territory; provided that TSVT may elect, in its sole discretion, to submit CMC Information directly to the concerned Regulatory Authority. Notwithstanding the foregoing, in the event that JW, its Affiliates or Sublicensees are unable to become the legal and beneficial owner of the Regulatory Documents for the Products in the JW Territory in order to exercise its rights and perform its obligations under this Agreement, (a) TSVT will be the legal and beneficial owner of the Regulatory Documents for in the JW Territory and such Regulatory Documents will be included in TSVT Know-How, (b) TSVT hereby designates JW, its Affiliates or Sublicensees as TSVT’s regulatory agent and exclusive general distributor for the Products in the JW Pediatrix Territory, and (c) Pediatrix shall reimburse ARS for any third party costs incurred to the extent later permitted provide such assistance that are agreed upon writing by both Parties. Parties shall conduct all such activities in accordance with Applicable Laws, TSVT will cooperate with JW to allow JW, its Affiliates or Sublicensees to be the legal and beneficial owner of the Regulatory Documents for the Products in the JW Territory. ▇▇ will conduct the regulatory activities in the JW Territory under this Agreement (i) in its own name, if JW (or its Affiliates or Sublicensees) is the legal and beneficial owner of the Regulatory Approvals for the Products in the JW Territory or (ii) as the express and authorized regulatory agent of record for TSVT in the JW Territory, if TSVT is the legal and beneficial owner of the Regulatory Documents for the Products in the JW Territory, under which situation such actions will be taken on behalf of TSVT and for the benefit of JW in the JW Territory. If any regulatory activities in the JW Territory are conducted in TSVT’s name, TSVT will have final decision-making authority regarding all such regulatory activities, including the content of regulatory submissions for Products in the JW Territory and JW will, and will ensure that its relevant Affiliates and Sublicensees will, conduct all regulatory activities in compliance with TSVT’s final decisions. Notwithstanding the foregoing, in the event any regulatory activities in the JW Territory are conducted in TSVT’s name, TSVT shall consult with and reasonably consider all suggestions from JW in good faith prior to exercising the aforementioned final decision rights.

Conduct of Regulatory Activities. JW Licensee (itself and through its Affiliates and Sublicensees, as applicable) will shall be solely responsible, at its own expense, responsible for the expenses and costs of all regulatory activities with respect to the Products in the Field in the JW Licensee Territory. Under the oversight of the JSC, including formulating Licensee shall implement the regulatory strategy formulated and preparingadopted by the JSC and prepare, filingfile, obtaining obtain and maintaining maintain Regulatory Approvals for the Products in the Field in the JW Licensee Territory, will shall be the holder of all Regulatory Approvals for the Products in the Field in the JW Licensee Territory, and will shall have responsibility for interactions with Regulatory Authorities with respect to the Products in the Field in the JW Licensee Territory; provided however that TSVT may electif Applicable Laws in the Licensee Territory do not allow Licensee to hold Regulatory Approvals for any Product in the Licensee Territory, then during the Term Allogene shall hold such Regulatory Approval for Licensee’s benefit, shall appoint Licensee or one of its Affiliates as its exclusive agent to handle all regulatory activities for such Product in the Licensee Territory, and shall promptly transfer such Regulatory Approval to Licensee or its sole discretion, to submit CMC Information directly to the concerned Regulatory Authority. Notwithstanding the foregoing, designee when allowed by Applicable Laws; provided that in the event and during any period that JWAllogene holds such Regulatory Approval for Licensee’s benefit, (i) Allogene shall not be obligated to perform any activities, bear any obligations, or bear any costs, in each case, in addition to the activities set forth in this Agreement due to Allogene or its Affiliate holding such Regulatory Approval; (ii) Allogene shall not assume any liability in connection with Allogene holding such Regulatory Approval; (iii) should Allogene incur any costs or expenses related to holding or transferring any such Regulatory Approval, Licensee shall reimburse Allogene or its Affiliates for any and all costs and expenses incurred by or Sublicensees are unable to become the legal and beneficial owner on behalf of the Regulatory Documents for the Products Allogene in the JW Territory in order to exercise its rights and perform its obligations under this Agreement, (a) TSVT will be the legal and beneficial owner of the Regulatory Documents for in the JW Territory and holding or transferring such Regulatory Documents will be included in TSVT Know-How, (b) TSVT hereby designates JW, its Affiliates or Sublicensees as TSVT’s regulatory agent and exclusive general distributor for the Products in the JW Territory, Approval; and (civ) Licensee shall indemnify and hold Allogene Indemnitees (as defined herein) from and against all Losses to the extent later permitted by Applicable Laws, TSVT will cooperate with JW to allow JW, its Affiliates or Sublicensees to be the legal and beneficial owner of the arising from Allogene holding such Regulatory Documents for the Products Approval in the JW TerritoryLicensee Territory as set forth in Article 13. ▇▇ will conduct the regulatory activities Notwithstanding anything in the JW Territory under this Agreement (i) in its own nameto the contrary, if JW (Licensee may not modify the study protocol, use or its Affiliates or Sublicensees) is indication of a Product without the legal JSC's prior written approval. The Parties acknowledge and beneficial owner agree that importation of final Products to the Licensee Territory would reduce cost and time to Regulatory Approvals for the Products in the JW Territory or (ii) as the express and authorized regulatory agent of record for TSVT in the JW Territory, if TSVT is the legal and beneficial owner of the Regulatory Documents for the Products in the JW Territory, under which situation such actions will be taken on behalf of TSVT and for the benefit of JW in the JW TerritoryApprovals. If any regulatory activities in the JW Territory are conducted in TSVT’s name, TSVT will have final decision-making authority regarding all such regulatory activities, including the content of regulatory submissions for Products in the JW Territory and JW will, and will ensure that its relevant Affiliates and Sublicensees will, conduct all regulatory activities in compliance with TSVT’s final decisions. Notwithstanding the foregoing, in the event any regulatory activities in the JW Territory are conducted in TSVT’s name, TSVT The Parties shall consult with and reasonably consider all suggestions from JW cooperate in good faith to explore importation of final Products to the Licensee Territory prior to exercising Product approval. To fulfill the aforementioned final decision rightsregulatory requirements for regulatory filings in the Licensee Territory, Allogene shall use Commercially Reasonable Efforts to provide the relevant certification documents or illustration statement with notarization and/or legalization within a reasonable timeline.