Common use of Regulatory Assistance Clause in Contracts

Regulatory Assistance. (a) The Parties shall cooperate in good faith to obtain any Regulatory Approvals for the use of PARI Products with INSMED Products; provided, however, that as to ROW PARI shall be provided with sufficient lead time and prior to requesting any such cooperation from PARI, INSMED shall be committed to use commercially reasonable efforts to launch the INSMED Products in the applicable country(ies). PARI shall provide regulatory and technical information relating to the Manufacture and supply of PARI Products and/or components thereof as reasonably requested by INSMED to the extent required by a Regulatory Authority or that the Parties mutually agree will be helpful for a filing with a Regulatory Authority. Alternatively, if PARI determines it is reasonably necessary to protect PARI Know-How related to eFlow or the Manufacture of PARI Products and if permitted by the applicable Regulatory Authority, PARI shall notify INSMED and make such information available to Regulatory Authorities directly (e.g. via a master file for devices or equivalent documents). INSMED shall provide regulatory and technical information and Data relating to the INSMED Products as reasonably requested by PARI to the extent required by a Regulatory Authority or that the Parties mutually agree will be helpful for a filing with a Regulatory Authority or in order for PARI to create its technical file of the CE documentation or similar documents. PARI shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to the PARI Products. INSMED shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to the INSMED Products. Each Party shall notify the other Party, as soon as reasonably practicable but in any event within [***] Business Days via telephone, followed by a notice in writing in the event any action is taken or threatened by a Regulatory Authority relating to the PARI Products and the INSMED Products, as applicable. (b) It is currently anticipated by the Parties that, with respect to the United States, the Device regulatory path shall not include a separate 510(k) submission to CDRH for clearance of the Device. Instead, the Parties currently anticipate proceeding with a single marketing application for the combination product (Device and INSMED Product) in the form of a New Drug Application for the INSMED Product, which single marketing application will contain a Device module similar in format and content to a 510(k) application.

Regulatory Assistance. (a) The Parties shall cooperate in good faith to obtain any Regulatory Approvals for the use of PARI Products with INSMED Products; provided, however, that as to ROW PARI shall be provided with sufficient lead time and prior to requesting any such cooperation from PARI, INSMED shall be committed to use commercially reasonable efforts to launch the INSMED Products in the applicable country(ies). PARI shall provide regulatory and technical information relating to the Manufacture and supply of PARI Products and/or components thereof as reasonably requested by INSMED to the extent required by a Regulatory Authority or that the Parties mutually agree will be helpful for a filing with a Regulatory Authority. Alternatively, if PARI determines it is reasonably necessary to protect PARI Know-How related to eFlow or the Manufacture of PARI Products and if permitted by the applicable Regulatory Authority, PARI shall notify INSMED and make such information available to Regulatory Authorities directly (e.g. via a master file for devices or equivalent documents). INSMED shall provide regulatory and technical information and Data relating to the INSMED Products as reasonably requested by PARI to the extent required by a Regulatory Authority or that the Parties mutually agree will be helpful for a filing with a Regulatory Authority or in order for PARI to create its technical file of the CE documentation or similar documents. PARI shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to the PARI Products. INSMED shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to the INSMED Products. Each Party shall notify the other Party, as soon as reasonably practicable but in any event within [*** (***] ) Business Days via telephone, followed by a notice in writing in the event any action is taken or threatened by a Regulatory Authority relating to the PARI Products and the INSMED Products, as applicable. (b) It is currently anticipated by the Parties that, with respect to the United States, the Device regulatory path shall not include a separate 510(k) submission to CDRH for clearance of the Device. Instead, the Parties currently anticipate proceeding with a single marketing application for the combination product (Device and INSMED Product) in the form of a New Drug Application for the INSMED Product, which single marketing application will contain a Device module similar in format and content to a 510(k) application.

Regulatory Assistance. a. PCT and Client shall permit Regulatory Agencies to conduct inspections of the Facility(ies) where Services are performed as may reasonably be requested during normal business hours and PCT shall cooperate, at Client’s cost, with such Regulatory Agencies (a) The Parties shall cooperate in good faith to obtain any Regulatory Approvals for the use of PARI Products with INSMED Products; provided, however, that as to ROW PARI shall be provided with sufficient lead time and prior to requesting any such cooperation from PARI, INSMED shall be committed to use commercially reasonable efforts to launch the INSMED Products in the applicable country(ies). PARI shall provide regulatory and technical information relating to the Manufacture and supply of PARI Products and/or components thereof as reasonably requested by INSMED to the extent required by a Regulatory Authority such inspections or that the Parties mutually agree will be helpful for a filing with a Regulatory Authority. Alternatively, if PARI determines it is reasonably necessary audits relate primarily to protect PARI Know-How related to eFlow Product or the Manufacture of PARI Products and if permitted by the applicable Regulatory Authority, PARI shall notify INSMED and make such information available to Regulatory Authorities directly (e.g. via a master file for devices or equivalent documentsServices set forth in this Agreement). INSMED shall provide regulatory and technical information and Data relating to the INSMED Products as reasonably requested by PARI to the extent required by a Regulatory Authority or that the Parties mutually agree will be helpful for a filing with a Regulatory Authority or in order for PARI to create its technical file of the CE documentation or similar documents. PARI shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to the PARI Products. INSMED shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to the INSMED Products. Each Party shall notify give the other Partyprior written notice, as soon as reasonably practicable but in any event to the extent practicable, of such inspections and keep the other Party informed about the progress, results and conclusions of each regulatory inspection. If prior notice is not possible, PCT shall, within [***] * Business Days via telephoneof said inspections, followed by inform Client of a notice in writing in regulatory inspection relating to or that may reasonably affect Services under the Agreement. In the event any action is taken or threatened that an inspection/audit by a Regulatory Authority Agency of a Facility where Services are being performed relates solely to the Product or Services provided to Client in this Agreement, and such inspection/audit is not the result of the negligence or willful misconduct of PCT, then Client agrees that PCT may charge Client the standard hourly rates for the PCT staff involved (in accordance with the table of hourly rates set forth in Section 17(m) below, as such rates may be adjusted from time to time) with such audit/inspection. b. PCT shall, within *** Business Days, promptly provide to Client copies of correspondence received from any Regulatory Agencies in connection with such inspections or relating to any Product, the PARI Products Facility (if it relates to or affects the Services and/or Product) or the Manufacturing Process, including, but not limited to, FDA Form 483 notices or warning letters. PCT will consult with, and obtain approval from, Client (which approval will not be unreasonably withheld or delayed) before responding to each such communication from a Regulatory Agency that relates to the INSMED ProductsProduct or the Manufacturing Process. Client will be given the opportunity to have a representative, at Client’s cost and expense, present during an FDA or other Regulatory Agency inspection relating to or that may reasonably affect Services under the Agreement. In the event that an inspection/audit by the Regulatory Agency of the Facility solely relates to the Product or Services provided to Client in the Agreement, and such inspection/audit is not the result of the negligence or willful misconduct of PCT, then Client agrees that PCT may charge Client the standard hourly rates for the PCT staff involved (in accordance with the table of hourly rates set forth in Section 17(m) below, as applicablesuch rates may be adjusted from time to time) with such audit/inspection. (b) It is currently anticipated by the Parties that, with respect to the United States, the Device regulatory path shall not include a separate 510(k) submission to CDRH for clearance of the Device. Instead, the Parties currently anticipate proceeding with a single marketing application for the combination product (Device and INSMED Product) in the form of a New Drug Application for the INSMED Product, which single marketing application will contain a Device module similar in format and content to a 510(k) application.

Regulatory Assistance. (a) The Parties shall cooperate in good faith to obtain any Regulatory Approvals for the use of PARI Products with INSMED RAPTOR Products; provided, however, that as to ROW PARI shall be provided with sufficient lead time and prior to requesting any such cooperation from PARI, INSMED shall be committed to use commercially reasonable efforts to launch the INSMED Products in the applicable country(ies). PARI shall provide or make available to Regulatory Authorities regulatory and technical information relating to the Manufacture and supply of PARI Products and/or components thereof as reasonably requested by INSMED RAPTOR to the extent required by a Regulatory Authority or that the Parties mutually agree will be helpful for a filing with a Regulatory Authority. Alternatively, if PARI determines it is reasonably necessary to protect PARI Know-How related to eFlow or the Manufacture of PARI Products and if permitted by the applicable Regulatory Authority, PARI shall notify INSMED and make such information available to Regulatory Authorities directly (e.g. via a master file for devices or equivalent documents). INSMED RAPTOR shall provide regulatory and technical information and Data data relating to the INSMED RAPTOR Products as reasonably requested by PARI to the extent required by a Regulatory Authority or that the Parties mutually agree will be helpful for a filing with a Regulatory Authority or in order for PARI to create its technical file of the CE documentation or submit similar documentsfilings with any appropriate Regulatory Authority. PARI shall cooperate with any inspection of its facilities, (including facilities of its Affiliates) by any Regulatory Authority relating to the PARI Products. RAPTOR shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to the PARI Products. INSMED shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to the INSMED RAPTOR Products. Each Party shall notify the other Party, as soon as reasonably practicable but in any event within [***] Business Days forty-eight (48) hours via telephone, followed by a notice in writing in the event any action is taken or threatened by a Regulatory Authority relating to the PARI Products and the INSMED RAPTOR Products, as applicable. (b) It is currently anticipated by the Parties that, with respect to the United States, the Device regulatory path shall not include a separate 510(k) submission to CDRH for clearance of the Device[***]. Instead, the Parties currently anticipate proceeding with a single marketing application [***]. (c) Notwithstanding anything to the contrary in this Agreement, in the event that the Regulatory Requirements to obtain a Regulatory Approval in any country in the Territory exceeds the amount of work or time involved or required from PARI compared to a [***], then RAPTOR shall promptly reimburse PARI for the combination product (Device additional work performed and INSMED Product) costs incurred by PARI according to the Project Rate as defined in the form of a New Drug Application for the INSMED Product, which single marketing application will contain a Device module similar in format and content to a 510(k) applicationDevelopment Agreement.

Regulatory Assistance. A. Regulatory Actions. PCT shall permit the FDA and other Regulatory Agencies to conduct inspections of PCT's Mountain View, California Facility (athe "MV Facility") The Parties as they may request, including pre-approval inspections, and shall cooperate with such Regulatory Agencies with respect to the inspections related to the Services or the Product. PCT shall give MICROISLET prior notice, to the extent practicable, of any such inspections, and keep MICROISLET informed about the results and conclusions of each regulatory inspection, including actions taken by PCT to remedy any conditions cited in good faith the inspections. If prior notice is not possible, PCT shall promptly (i.e., within one day of the said inspection) inform MICROISLET in the event that a regulatory inspection affects work carried out at PCT's facilities on behalf of MICROISLET. In addition, PCT shall permit MICROISLET or its representative to obtain assist in the preparation for and be present at inspections relating to the Services or the Product. Within five (5) days of receipt by PCT, PCT shall provide MICROISLET with copies of any written inspection reports issued by the Regulatory Approvals for Agency and all correspondence between PCT and the use Regulatory Agency which relate to the Services or the Product, including FDA Form 483, "Notice of PARI Products with INSMED ProductsObservation," and all related correspondence, in each case relating to the Services or the Product; provided, however, that as PCT may exclude from such copies any references to ROW PARI shall be provided with sufficient lead time the name and prior any identifying information specific to requesting other non-MICROISLET products. Similarly, PCT agrees to promptly (i.e., within five (5) days of receipt by PCT) notify and provide MICROISLET copies of any such cooperation from PARIrequest, INSMED shall be committed to use commercially reasonable efforts to launch directive or other communication of the INSMED Products in the applicable country(ies). PARI shall provide regulatory and technical information FDA or other Regulatory Agency relating to the Manufacture and supply of PARI Products and/or components thereof as reasonably requested by INSMED to the extent required by a Regulatory Authority or that the Parties mutually agree will be helpful for a filing with a Regulatory Authority. Alternatively, if PARI determines it is reasonably necessary to protect PARI Know-How related to eFlow Services or the Manufacture of PARI Products Product and if permitted by the applicable Regulatory Authority, PARI shall notify INSMED and make such information available to Regulatory Authorities directly (e.g. via a master file for devices or equivalent documents). INSMED shall provide regulatory and technical information and Data relating to the INSMED Products as reasonably requested by PARI to the extent required by a Regulatory Authority or that the Parties mutually agree will be helpful for a filing with a Regulatory Authority or in order for PARI to create its technical file of the CE documentation or similar documents. PARI shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating MICROISLET in responding to the PARI Products. INSMED shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to the INSMED Products. Each Party shall notify the other Partysuch requests, as soon as reasonably practicable but in any event within [***] Business Days via telephone, followed by a notice in writing in the event any action is taken or threatened by a Regulatory Authority relating to the PARI Products directives and the INSMED Products, as applicablecommunications. (b) It is currently anticipated by the Parties that, with respect to the United States, the Device regulatory path shall not include a separate 510(k) submission to CDRH for clearance of the Device. Instead, the Parties currently anticipate proceeding with a single marketing application for the combination product (Device and INSMED Product) in the form of a New Drug Application for the INSMED Product, which single marketing application will contain a Device module similar in format and content to a 510(k) application.

Regulatory Assistance. (a) Each Party shall cooperate with the other Party to provide all reasonable assistance and take all actions reasonably requested by the other Party that are necessary or desirable to enable the other Party to comply with any Law applicable to any Compound or Program Product, including, but not limited to, report adverse drug experience reports (and serious adverse drug experience reports) to the relevant Regulatory Authority and submit or file promotional materials with the relevant Regulatory Authority. The Parties shall cooperate will work in good faith together to obtain any Regulatory Approvals for the use of PARI Products with INSMED Products; provided, however, that as to ROW PARI shall be provided with sufficient lead time and prior to requesting any develop a global safety data base containing such cooperation from PARI, INSMED shall be committed to use commercially reasonable efforts to launch the INSMED Products in the applicable country(ies). PARI shall provide regulatory and technical information relating to the Manufacture Global Development Plan and supply the safety of PARI the Compounds and the Program Products and/or components thereof as reasonably requested by INSMED to the extent required by a Regulatory Authority or that the Parties mutually agree will be helpful for a filing may require to comply with a Regulatory Authority. Alternatively, if PARI determines it is reasonably necessary to protect PARI Know-How related to eFlow or applicable Law and otherwise monitor the Manufacture of PARI Products and if permitted by the applicable Regulatory Authority, PARI shall notify INSMED and make such information available to Regulatory Authorities directly (e.g. via a master file for devices or equivalent documents). INSMED shall provide regulatory and technical information and Data relating to the INSMED Products as reasonably requested by PARI to the extent required by a Regulatory Authority or that the Parties mutually agree will be helpful for a filing with a Regulatory Authority or in order for PARI to create its technical file safety of the CE documentation or similar documents. PARI shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to Compounds and the PARI Products. INSMED shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to the INSMED Program Products. Each Party shall notify has the other Party, as soon as reasonably practicable but in right to review any event within [***] Business Days via telephone, followed by a notice in writing in the event any action is taken or threatened by a Regulatory Authority documents relating to the PARI Products and Global Development Plan in the INSMED Productspossession of the other Party to ensure compliance with global regulatory standards, as applicableupon reasonable prior written notice to the other party. (b) It Such assistance and actions shall include, among other things, keeping the other Party informed, within an appropriate period of time relevant to any Regulatory Authority requirements applicable to such other Party or otherwise reasonable period of time, of notification of any action by, or notification or other information which it receives (directly or indirectly) from, any Regulatory Authority, which (a) raises any material concerns regarding the safety or efficacy of any Program Product, (b) which indicates or suggests a potential material liability for either Party to Third Parties arising in connection with any Program Product, or (c) which is currently anticipated reasonably likely to lead to a recall or market withdrawal of any Program Product, provided that neither Party shall be obliged to disclose information in breach of any contractual restriction which it could not reasonably have avoided. Information that shall be disclosed pursuant to this Section 4.3.4 shall include, but not be limited to: ***Confidential Treatment Requested (i) governmental or regulatory inspections of manufacturing, distribution or other related facilities used for Compounds or Program Products; (ii) inquiries by the Parties thatgovernmental or regulatory authorities concerning clinical investigation activities (including inquiries of investigators, with respect clinical monitoring organizations and other related parties) relating to Compounds or Program Products; (iii) any communication from governmental or regulatory authorities pertaining to the United Statesmanufacture, the Device sale, promotion or distribution of Compounds or Program Products; (iv) any other governmental or regulatory path shall not include authority reviews or inquiries relating to Compounds or Program Products; (v) receipt of a separate 510(k) submission warning letter relating to CDRH for clearance any of the Device. InsteadCompounds or Program Products; and (vi) an initiation of any governmental or regulatory authority investigation, the Parties currently anticipate proceeding with a single marketing application for the combination product (Device and INSMED detention, seizure or injunction concerning any Compound or Program Product) in the form of a New Drug Application for the INSMED Product, which single marketing application will contain a Device module similar in format and content to a 510(k) application.