Provision Language
ARTICLE 5. REGULATORY MATTERS
5.1. SIIL Regulatory Responsibilities.
(a) SIIL shall own all Regulatory Filings, all pre-clinical data, clinical data generated from SIIL sponsored clinical trials and Regulatory Approvals for the Product in the Licensed Territory, and shall be solely responsible for preparing any and all Regulatory Filings for the Product in the Licensed Territory at its sole expense, provided that Visterra will provide SIIL with any Information or rights of reference in accordance with Section 2.3(a) as reasonably requested by SIIL in connection with the Licensed Antibody. The JSC shall review and comment on all such Regulatory Filings. SIIL shall keep Visterra informed of regulatory developments specific to the Product throughout the Licensed Territory and shall reasonably consider any input from Visterra with respect to SIIL’s interactions with Regulatory Authorities in the Licensed Territory.
(b) SIIL shall ensure, at its sole expense, that the Development, Manufacture and Commercialization of the Product in the Licensed Territory including any export or import of any Licensed Antibody or Product into or from the Licensed Territory is in compliance with all applicable Laws.
(c) To the extent permitted by the applicable Regulatory Authority and as requested by Visterra, SIIL shall allow representatives of Visterra to participate, at Visterra’s sole expense, in any scheduled conference calls and meetings between SIIL and any Regulatory Authority to the extent the call or meeting is specific to the Licensed Antibody. If Visterra elects not to participate in such calls or meetings, SIIL shall provide Visterra with written summaries to the extent available of such calls and meetings as soon as practicable after they become available.
(d) SIIL shall provide Visterra with copies of all final submissions and correspondence to and from all Regulatory Authorities relating to the Product in the Field within thirty (30) days of submission or receipt, as applicable, and shall provide Visterra a summary of each significant submission (such as application for approval for clinical trials, Regulatory Approval and fast track or orphan drug designation, the protocol for clinical trials and any modifications thereof) as soon as practicable but in any event within thirty (30) Business Days after such submission.
5.2. Adverse Events.
(a) Within [**], the Parties shall discuss in good faith and enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Product, such as safety data sharing, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such Pharmacovigilance Agreement shall govern the global pharmacovigilance procedures to be agreed upon by SIIL, Visterra and the commercial partners of each Party.
(b) Prior to the execution of such Pharmacovigilance Agreement, the Parties agree to coordinate the pharmacovigilance procedures in connection with the Development of the Product, SIIL shall submit to Visterra all SIIL safety information and reporting in a manner that, to the extent practicable, meets the reporting requirements in the Visterra Territory for such information and Visterra shall submit to SIIL all of Visterra’s (including its sublicensees’ and Affiliate’s) safety information and reporting in a manner that meets the reporting requirements in the Licensed Territory. SIIL shall own all the safety information, including any safety databases for the Product, generated by or on behalf of SIIL in the Licensed Territory. Each Party shall notify the other Party within twenty-four (24) hours of such Party’s learning of any Serious Adverse Events that is attributed to or potentially attributable to the use of the Product. Each Party shall also provide the other Party, on an annual basis and more frequently as reasonably requested by the other Party, a summary report of Adverse Events, as well as those Serious Adverse Events that are not attributable to the use of the Product.
(c) After the execution of the Pharmacovigilance Agreement, the Parties shall comply with the Pharmacovigilance Agreement with respect to all aspects of pharmacovigilance activities with respect to the Product, and Section 5.2(b) shall be of no further effect.
5.3. No Harmful Actions. If either Party believes that the other Party, as the case may be, is taking or intends to take any action with respect to the Product that could reasonably be expected to have a material adverse impact upon the regulatory status of the Product in the Visterra Territory or the Licensed Territory, such Party shall bring the matter to the attention of the other Party. Without limiting the foregoing, unless the Parties otherwise agree, a Party shall not communicate concerning the Product with any Regulatory Authority having jurisdiction in the other Party’s territory, unless so ordered by such Regulatory Authority or such communication is required by applicable Law. Such communications shall be promptly disclosed by the communicating Party to the other Party.
5.4. Notification of Threatened Action. Each Party shall notify the other Party as soon as practicable of any notice from a Regulatory Authority having jurisdiction in its territory, that relates to an impending action or inspection, and that would reasonably be expected to adversely affect the safety or efficacy claims of the Product or the continued marketing of the Product. Upon receipt of such information, the Parties shall consult with each other in an effort to agree an appropriate response.
5.5. Remedial Actions. Each Party shall, and shall ensure that its Affiliates shall, notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that the Product may be subject to any recall or withdrawal with respect to a Product taken by virtue of applicable Law in the Licensed Territory (a “Remedial Action”). The Parties shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action, provided that SIIL shall have sole and final decision-making authority as to the initiation and scope of any Remedial Action in the Licensed Territory. To the extent required by applicable Law, SIIL shall, and shall ensure that its Affiliates shall, maintain or have maintained adequate records to permit the Parties to trace the Manufacture of the Product and the distribution and, to the extent feasible, the use of the Product. If SIIL determines that any Remedial Action with respect to theProduct in the Field in the Licensed Territory should be commenced or Remedial Action is required by any Regulatory Authority having jurisdiction over the matter, SIIL shall control and coordinate all efforts necessary to conduct such Remedial Action. For clarity, as between the Parties, Visterra shall have sole discretion with respect to any matters relating to any Remedial Action in the Visterra Territory. The cost and expense of a Remedial Action arising from the Development, Manufacture or Commercialization of the Product in the Field in the Licensed Territory shall be borne solely by SIIL. Except as may be provided in a Supply Agreement, the cost and expense of both Parties in respect of a Remedial Action arising from the Development, Manufacture or Commercialization of the Product in the Visterra Territory shall be borne solely by Visterra.