Common use of Conduct of Regulatory Activities Clause in Contracts

Conduct of Regulatory Activities. Licensee (itself and through its Affiliates and Sublicensees, as applicable) shall be solely responsible for the expenses and costs of all regulatory activities with respect to the Products in the Field in the Licensee Territory. Under the oversight of the JSC, Licensee shall implement the regulatory strategy formulated and adopted by the JSC and prepare, file, obtain and maintain Regulatory Approvals for the Products in the Field in the Licensee Territory, shall be the holder of all Regulatory Approvals for the Products in the Field in the Licensee Territory, and shall have responsibility for interactions with Regulatory Authorities with respect to the Products in the Field in the Licensee Territory; provided however that if 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 designee when allowed by Applicable Laws; provided that in the event and during any period that Allogene 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 on behalf of Allogene in holding or transferring such Regulatory Approval; and (iv) Licensee shall indemnify and hold Allogene Indemnitees (as defined herein) from and against all Losses to the extent arising from Allogene holding such Regulatory Approval in the Licensee Territory as set forth in Article 13. Notwithstanding anything in this Agreement to the contrary, Licensee may not modify the study protocol, use or indication of a Product without the JSC's prior written approval. The Parties acknowledge and agree that importation of final Products to the Licensee Territory would reduce cost and time to Regulatory Approvals. The Parties shall cooperate in good faith to explore importation of final Products to the Licensee Territory prior to Product approval. To fulfill the regulatory 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.

Conduct of Regulatory Activities. Licensee (itself and through its Affiliates and Sublicensees, as applicable) Pediatrix shall be solely responsible responsible, at its own cost and expense, for the expenses formulating regulatory strategy and costs of all regulatory activities with respect to the for preparing, filing, obtaining and maintaining Regulatory Approvals for Products in the Field in the Licensee Pediatrix Territory. Under the oversight of the JSC, Licensee shall implement the regulatory strategy formulated and adopted by the JSC and prepare, file, obtain and maintain Regulatory Approvals for the Products in the Field in the Licensee Territory, Pediatrix shall be the holder of all Regulatory Approvals for the Products in the Field in the Licensee Pediatrix Territory, and shall have responsibility for interactions with Regulatory Authorities with respect to the Products in the Field in the Licensee Territory; provided however that except if ARS is required by Applicable Laws in the Licensee Territory do not allow Licensee to hold Regulatory Approvals an Import Drug License or equivalent for any Product in the Licensee Pediatrix Territory, then during the Term Allogene in which case ARS shall (a) hold such Regulatory Approval for LicenseePediatrix’s benefit, shall (b) appoint Licensee Pediatrix (or one an Affiliate or Sublicensee of Pediatrix) as its Affiliates authorized exclusive legal agent of record to interact with NMPA and serve as its exclusive agent to handle all regulatory activities distributor for such the Product in the Licensee Pediatrix Territory, and 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 Licensee Pediatrix or its designee when allowed by Applicable Laws; provided that in the event and during any period that Allogene 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 on behalf of Allogene in holding or transferring such Regulatory Approval; and (iv) Licensee shall indemnify and hold Allogene Indemnitees (as defined herein) from and against all Losses to the extent arising from Allogene holding such Regulatory Approval in the Licensee Territory as set forth in Article 13. Notwithstanding anything in this Agreement to the contrary, Licensee may not modify the study protocol, use or indication of a Product without the JSC's prior written approval. The Parties acknowledge and agree that importation of final Products to the Licensee Territory would reduce cost and time to Regulatory Approvals. The Parties shall cooperate in good faith to explore importation of final Products to the Licensee Territory prior to Product approval. To fulfill the regulatory requirements for regulatory filings in the Licensee Territory, Allogene 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 Products in the Field in the Pediatrix Territory, and Pediatrix shall reimburse ARS for any third party costs incurred to provide the relevant certification documents or illustration statement such assistance that are agreed upon writing by both Parties. Parties shall conduct all such activities in accordance with notarization and/or legalization within a reasonable timelineApplicable Laws.

Conduct of Regulatory Activities. Licensee (itself and through its Affiliates and Sublicensees, as applicable) ALFRESA shall be solely responsible for the expenses formulating regulatory strategy and costs of all regulatory activities with respect to the for preparing, filing, obtaining and maintaining Regulatory Approvals for Products in the Field in the Licensee ALFRESA Territory. Under If the oversight of the JSC, Licensee shall implement the regulatory strategy formulated and adopted by the JSC and prepare, file, obtain and maintain Regulatory Approvals for the Products Authority in the Field ALFRESA Territory requires reanalysis of any Product used in the Licensee Territorya clinical trial, 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 Licensee Territory, ALFRESA Territory and shall have responsibility for interactions with Regulatory Authorities with respect to the Products in the Field in the Licensee ALFRESA Territory; provided however that if 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 designee when allowed by Applicable Laws; provided that in the event and during any period that Allogene 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 on behalf of Allogene in holding or transferring such Regulatory Approval; and (iv) Licensee shall indemnify and hold Allogene Indemnitees (as defined herein) from and against all Losses to the extent arising from Allogene holding such Regulatory Approval in the Licensee Territory as set forth in Article 13. Notwithstanding anything in this Agreement to the contrary, Licensee may not modify the study protocol, use or indication of a Product without the JSC's prior written approval. The Parties acknowledge and agree that importation of final Products to the Licensee Territory would reduce cost and time to Regulatory Approvals. The Parties shall cooperate in good faith to explore importation of final Products to the Licensee Territory prior to Product approval. To fulfill the regulatory requirements for regulatory filings in the Licensee Territory, Allogene ALFRESA shall use Commercially Reasonable Efforts to file XXXx and, as applicable, seek Pricing and Reimbursement Approval for and seek and maintain Regulatory Approval for Products in the Field 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 keep ARS regularly informed of, the preparation, Regulatory Authority review and approval 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 relevant certification documents or illustration statement with notarization and/or legalization within a reasonable timelineParties under Section 4.3, ALFRESA shall bear all expenses it incurs to conduct all regulatory activities in the ALFRESA Territory under this Agreement.

Conduct of Regulatory Activities. (a) Subject to Article 3, unless otherwise agreed by the Parties, Licensee (itself and through its Affiliates and Sublicensees, as applicable) shall be solely responsible responsible, at its own expense, for the expenses and costs of 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 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 [*]. [*] Each Party shall consider the other Party’s comments [*] and make decisions in accordance with Section 7.3. (b) Notwithstanding the foregoing, if Licensee, its Affiliates or Sublicensees are unable to become the legal and beneficial owner of the Regulatory Filings for the Products in the Licensee Territory in order to exercise its rights and perform its obligations under this Agreement, (a) C4T will be the legal and beneficial owner of the Regulatory Filings for the Products in the Licensee Territory (such Regulatory Filings will be included in the C4T Know-How and licensed to Licensee), (b) C4T will designate Licensee, its Affiliates or Sublicensees as C4T’s regulatory agent and exclusive general distributor for the Products in the Licensee Territory, and (c) to the extent later permitted by Applicable Laws, C4T will cooperate with Licensee to allow Licensee, its Affiliates or Sublicensees to be the legal and beneficial owner of the Regulatory Filings for the Products in the Licensee Territory. Under Licensee will conduct the oversight regulatory activities in the Licensee Territory under this Agreement (i) in its own name, if Licensee (or its Affiliates or Sublicensees) is the legal and beneficial owner of the JSC, Licensee shall implement the regulatory strategy formulated and adopted by the JSC and prepare, file, obtain and maintain Regulatory Approvals for the Products in the Field Licensee Territory or (ii) as the express and authorized regulatory agent of record for C4T in the Licensee Territory, shall be if C4T is the holder legal and beneficial owner of all the Regulatory Approvals Filings for the Products in the Field Licensee Territory, under which situation ACTIVE/119414966.70 such actions will be taken on behalf of C4T and for the benefit of Licensee in the Licensee Territory. (c) Unless otherwise agreed by the Parties, and shall have responsibility for interactions with Regulatory Authorities 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 Field in the circumstances under Section 3.3(b)(i) where Licensee Territory; provided however that if 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 do not allow 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 hold Regulatory Approvals for any Product in the Licensee Territorythis Agreement, then during the Term Allogene C4T shall, and shall hold such Regulatory Approval for Licensee’s benefitensure that its relevant Affiliates and sublicensees will, shall appoint Licensee or one of its Affiliates as its exclusive agent to handle conduct all regulatory activities for such Product in the Licensee Territory, and shall promptly transfer such Regulatory Approval to Licensee or its designee when allowed by Applicable Laws; provided that in the event and during any period that Allogene 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 on behalf of Allogene in holding or transferring such Regulatory Approval; and (iv) Licensee shall indemnify and hold Allogene Indemnitees (as defined herein) from and against all Losses to the extent arising from Allogene holding such Regulatory Approval in the Licensee Territory as set forth in Article 13compliance with Licensee’s instructions and final decisions. Notwithstanding anything in this Agreement to the contraryFor clarity, Licensee may not modify the study protocol, use or indication of a Product without the JSC's prior written approval. The Parties acknowledge and agree that importation of C4T shall have final Products to the Licensee Territory would reduce cost and time to Regulatory Approvals. The Parties shall cooperate in good faith to explore importation of final Products to the Licensee Territory prior to Product approval. To fulfill the regulatory 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 timelinedecision-making authority regarding [*].