Common use of Access to Regulatory Filings Clause in Contracts

Access to Regulatory Filings. (a) Licensee shall promptly provide to Verrica true and complete copies of all INDs and ▇▇▇▇ for Product filed by or on behalf of Licensee or its Affiliates or Sublicensees with Regulatory Authorities in the Territory and all Regulatory Approvals received for Product from Regulatory Authorities in the Territory. Licensee hereby grants to Verrica Rights of Reference to all such Product Filings for the purposes of: (i) obtaining and maintaining Regulatory Approvals for Compound and Product in the Verrica Territory; (ii) obtaining and maintaining Regulatory Approvals for any product incorporating the Compound (other than Product) in the Territory; (iii) the manufacture of Compound or Product for use or distribution anywhere in the world; and (iv) complying with applicable pharmacovigilance and other regulatory requirements with respect to the Product and activities described in the preceding clauses (i) through (iii). Without limiting the foregoing, if an English translation of any IND or MAA filed by or on behalf of Licensee in the Territory for the Product or Compound is reasonably necessary for Verrica’s regulatory purposes, then on Verrica’s written request, Licensee will, as soon as practicable seek and obtain such English translation (to the extent newly generated by or on behalf of Licensee or its Affiliates or Sublicensees), and provide such English translation to Verrica, provided that Verrica will reimburse Licensee for [***] of the external costs reasonably incurred by Licensee in connection with obtaining such English translation, which amounts shall be paid by Verrica within [***] following Verrica’s receipt of an invoice for any such undisputed amounts. (b) Verrica shall promptly provide to Licensee true and complete copies of all Product Filings for Product filed by or on behalf of Verrica or its Affiliates in the United States or with the European Medicines Agency (or any successor agency). Verrica hereby grants to Licensee the Rights of Reference to all such Product Filings for the purposes of: (i) obtaining and maintaining Regulatory Approvals for Product in the Field in the Territory; (ii) manufacturing the Product for use and distribution in the Field in the Territory under the Manufacturing License, if applicable; and (iii) complying with applicable pharmacovigilance and other regulatory requirements with respect to Product in the Territory. (c) Each Party shall, promptly upon request of the other Party, file with applicable Regulatory Authorities such letters of authorization, access or cross-reference as may be necessary to accomplish the intent of this Section 5.2.

Access to Regulatory Filings. (a) Licensee Mundipharma shall promptly provide to Verrica Cidara true and complete copies (including English translations if required) of all INDs ReCoRDs, summaries of product characteristics (SmPCs) and/or national prescribing information for Licensed Product (including Pediatric Licensed Product) as approved by each Regulatory Authority in the Major Markets, and copies of all INDs, master ▇▇▇▇ and Regulatory Approvals for Licensed Product filed by or on behalf of Licensee or its Affiliates or Sublicensees with Regulatory Authorities (including Pediatric Licensed Product) in the Territory and all Regulatory Approvals received for Product from Regulatory Authorities in the Mundipharma Territory. Licensee Mundipharma hereby grants to Verrica Cidara Rights of Reference to all such Product Filings (excluding Expanded Licensed Product Clinical Efficacy Data generated by or on behalf of Mundipharma as an Independent Development Party unless the parties have executed an Expanded Licensed Product Amendment with respect to the applicable Expanded Licensed Product) for the purposes of: (i) obtaining and maintaining Regulatory Approvals for Compound and Licensed Product (including Pediatric Licensed Product) in the Verrica Cidara Territory, subject to Section 2.3; (ii) obtaining and maintaining Regulatory Approvals for to the extent Mundipharma or any product incorporating the of its Affiliates is manufacturing, or having its CMO manufacture, Compound or Licensed Product, conducting or having conducted CMC activities in relation to Compound or Licensed Product (other than including Pediatric Licensed Product) in the Territory); (iii) to the extent Mundipharma or any of its Affiliates is manufacturing, or having its CMO manufacture, Compound or Licensed Product, the manufacture of Compound or Licensed Product (including Pediatric Licensed Product) for use or distribution anywhere in the world, subject to Section 2.7; and (iv) complying with applicable pharmacovigilance and other regulatory requirements with respect to the Product and activities described in the preceding clauses (i) through (iii)Cidara Territory. Without limiting the foregoingFor clarity, if an English translation Cidara shall not have Rights of any IND or MAA filed by or on behalf of Licensee in the Territory Reference to such Product Filings for Licensed Product for the purposes of obtaining or maintaining Regulatory Approvals for Product that is not Licensed Product, except that Cidara shall have such Rights of Reference to Data regarding Pediatric Licensed Product that is contained in such Product Filings for the purposes of obtaining or Compound maintaining Regulatory Approvals for Product that is reasonably necessary for Verrica’s regulatory purposes, then on Verrica’s written request, Licensee will, as soon as practicable seek and obtain such English translation (to the extent newly generated by or on behalf of Licensee or its Affiliates or Sublicensees), and provide such English translation to Verrica, provided that Verrica will reimburse Licensee for [***] of the external costs reasonably incurred by Licensee in connection with obtaining such English translation, which amounts shall be paid by Verrica within [***] following Verrica’s receipt of an invoice for any such undisputed amountsnot Licensed Product. (b) Verrica Cidara shall promptly provide to Licensee Mundipharma true and complete copies of all Product Filings for Licensed Product filed by or on behalf of Verrica or its Affiliates (including Pediatric Licensed Product) in the United States or with the European Medicines Agency (or any successor agency)Cidara Territory. Verrica Subject to Section 5.3, Cidara hereby grants to Licensee Mundipharma the Rights of Reference to all such Product Filings (excluding Expanded Licensed Product Clinical Efficacy Data generated by or on behalf of Cidara unless the parties have executed an Expanded Licensed Product Amendment with respect to the applicable Expanded Licensed Product) for the purposes of: (i) obtaining and maintaining Regulatory Approvals for Licensed Product (including Pediatric Licensed Product) in the Field in the Mundipharma Territory, subject to Section 2.5; (ii) manufacturing the conducting or having conducted CMC activities in relation to Licensed Product for use and distribution in the Field in the Territory under the Manufacturing License, if applicable(including Pediatric Licensed Product); and (iii) complying with applicable pharmacovigilance and other regulatory requirements with respect to Licensed Product (including Pediatric Licensed Product) in the Mundipharma Territory. (c) Each Party party shall, promptly upon request of the other Partyparty, file with applicable Regulatory Authorities such letters of authorization, access or cross-reference as may be necessary to accomplish the intent of this Section 5.24.11, which cooperation shall include the provision to Mundipharma by Cidara of the necessary certificates of pharmaceutical product, ancillary documents and supporting information (e.g., on reference pricing) required or requested by a Regulatory Authority in the Mundipharma Territory.

Access to Regulatory Filings. (a) Licensee shall promptly provide to Verrica Dermavant true and complete copies accurate English translations of all INDs and ▇▇▇▇ (to the extent newly generated by or on behalf of Licensee or its Affiliates or Sublicensees) for Product filed by or on behalf of Licensee or its Affiliates or Sublicensees with Regulatory Authorities in the Territory and all Regulatory Approvals received for Product from Regulatory Authorities in the Territory. Licensee hereby grants to Verrica Dermavant Rights of Reference to all such Product Filings for the purposes of: (i) obtaining and maintaining Regulatory Approvals for Compound and Product in the Verrica Dermavant Territory; (ii) obtaining and maintaining Regulatory Approvals for any product incorporating the Compound (other than Product) in the Territory; (iii) the manufacture of Compound or Product for use or distribution anywhere in the world; and (iv) complying with applicable pharmacovigilance and other regulatory requirements with respect to the Product and activities described in the preceding clauses (i) through (iii). Without limiting the foregoing, if an a certified English translation of any IND or MAA filed by or on behalf of Licensee in the Territory for the Product or Compound is reasonably necessary for VerricaDermavant’s regulatory purposes, then on VerricaDermavant’s written request, Licensee will, as soon as practicable seek and obtain such certified English translation (to the extent newly generated by or on behalf of Licensee or its Affiliates or Sublicensees)translation, and provide such certified English translation to VerricaDermavant, provided that Verrica Dermavant will reimburse be responsible for reimbursing Licensee for [***] of the external costs reasonably incurred by Licensee in connection with obtaining such certified English translationtranslations, which amounts shall be paid by Verrica Dermavant within [***] following VerricaDermavant’s receipt of an invoice for any such undisputed amounts. (b) Verrica Dermavant shall promptly provide to Licensee true and complete copies of all Product Filings for Product filed by or on behalf of Verrica Dermavant or its Affiliates or Sublicensees in the United States U.S. or with the European Medicines Agency (or any successor agency). Verrica Dermavant hereby grants to Licensee the Rights of Reference to all such Product Filings for the purposes of: (i) obtaining and maintaining Regulatory Approvals for Product in the Field in the Territory; (ii) manufacturing the Product for use and or distribution in the Field in the Territory under the Manufacturing License, following the grant of such Manufacturing License, if applicable; , and (iii) complying with applicable pharmacovigilance and other regulatory requirements with respect to Product in the Territory. (c) Each Party party shall, promptly upon request of the other Partyparty, file with applicable Regulatory Authorities such letters of authorization, access or cross-reference as may be necessary to accomplish the intent of this Section 5.24.9.