Common use of Regulatory Assistance Clause in Contracts

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 will work in good faith together to develop a global safety data base containing such information relating to the Global Development Plan and the safety of the Compounds and the Program Products as the Parties may require to comply with applicable Law and otherwise monitor the safety of the Compounds and the Program Products. Each Party has the right to review any documents relating to the Global Development Plan in the possession of the other Party to ensure compliance with global regulatory standards, upon reasonable prior written notice to the other party. (b) 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 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 governmental or regulatory authorities concerning clinical investigation activities (including inquiries of investigators, clinical monitoring organizations and other related parties) relating to Compounds or Program Products; (iii) any communication from governmental or regulatory authorities pertaining to the manufacture, sale, promotion or distribution of Compounds or Program Products; (iv) any other governmental or regulatory authority reviews or inquiries relating to Compounds or Program Products; (v) receipt of a warning letter relating to any of the Compounds or Program Products; and (vi) an initiation of any governmental or regulatory authority investigation, detention, seizure or injunction concerning any Compound or Program Product.

Regulatory Assistance. (a) Each Party The Parties 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 will work in good faith together to develop a global safety data base containing such obtain any Regulatory Approvals for the use of PARI Products with RAPTOR Products. PARI shall provide or make available to Regulatory Authorities regulatory and technical information relating to the Global Development Plan PARI Products and/or components thereof as reasonably requested by 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. RAPTOR shall provide regulatory and technical information and data relating to the safety of the Compounds and the Program RAPTOR Products as reasonably requested by PARI to the extent required by a Regulatory Authority or that the Parties may require mutually agree will be helpful for a filing with a Regulatory Authority or in order for PARI to comply submit similar filings with applicable Law and otherwise monitor 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 safety PARI Products. RAPTOR shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to the Compounds and the Program RAPTOR Products. Each Party has shall notify the right to review other Party, as soon as reasonably practicable but in any documents event within 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 Global Development Plan in PARI Products and the possession of the other Party to ensure compliance with global regulatory standardsRAPTOR Products, upon reasonable prior written notice to the other partyas applicable. (b) Such assistance and actions It is currently anticipated by the Parties that, with respect to the United States, the Device regulatory path shall includenot include a [***]. Instead, 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 Parties currently anticipate proceeding with a potential material liability for either Party to Third Parties arising in connection with any Program Product, or [***]. (c) which is reasonably likely Notwithstanding anything to lead 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 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 then RAPTOR shall promptly reimburse PARI for Compounds or Program Products; (ii) inquiries the additional work performed and costs incurred by governmental or regulatory authorities concerning clinical investigation activities (including inquiries of investigators, clinical monitoring organizations and other related parties) relating to Compounds or Program Products; (iii) any communication from governmental or regulatory authorities pertaining PARI according to the manufacture, sale, promotion or distribution of Compounds or Program Products; (iv) any other governmental or regulatory authority reviews or inquiries relating to Compounds or Program Products; (v) receipt of a warning letter relating to any of Project Rate as defined in the Compounds or Program Products; and (vi) an initiation of any governmental or regulatory authority investigation, detention, seizure or injunction concerning any Compound or Program ProductDevelopment Agreement.

Regulatory Assistance. (a) Each Party The Parties 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 will work in good faith together to develop a global safety data base containing 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 Global Development Plan Manufacture and supply of PARI Products and/or components thereof as reasonably requested by INSMED to the safety 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 Compounds and 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 Program Products as PARI Products. INSMED shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to the Parties may require to comply with applicable Law and otherwise monitor the safety of the Compounds and the Program INSMED Products. Each Party has shall notify the right to review other Party, as soon as reasonably practicable but in any documents 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 Global Development Plan in PARI Products and the possession of the other Party to ensure compliance with global regulatory standardsINSMED Products, upon reasonable prior written notice to the other partyas applicable. (b) Such assistance 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 actions shall include, among other things, keeping INSMED Product) in the other Party informed, within an appropriate period form 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 Authoritya New Drug Application for the INSMED Product, which (a) raises any material concerns regarding the safety or efficacy of any Program Product, (b) which indicates or suggests single marketing application will contain a potential material liability for either Party to Third Parties arising Device module similar in connection with any Program Product, or (c) which is reasonably likely to lead format and content 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 (i510(k) governmental or regulatory inspections of manufacturing, distribution or other related facilities used for Compounds or Program Products; (ii) inquiries by governmental or regulatory authorities concerning clinical investigation activities (including inquiries of investigators, clinical monitoring organizations and other related parties) relating to Compounds or Program Products; (iii) any communication from governmental or regulatory authorities pertaining to the manufacture, sale, promotion or distribution of Compounds or Program Products; (iv) any other governmental or regulatory authority reviews or inquiries relating to Compounds or Program Products; (v) receipt of a warning letter relating to any of the Compounds or Program Products; and (vi) an initiation of any governmental or regulatory authority investigation, detention, seizure or injunction concerning any Compound or Program Productapplication.

Regulatory Assistance. (a) Each Party The Parties 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 will work in good faith together to develop a global safety data base containing 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 Global Development Plan Manufacture and supply of PARI Products and/or components thereof as reasonably requested by INSMED to the safety 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 Compounds and 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 Program Products as PARI Products. INSMED shall cooperate with any inspection of its facilities (including facilities of its Affiliates) by any Regulatory Authority relating to the Parties may require to comply with applicable Law and otherwise monitor the safety of the Compounds and the Program INSMED Products. Each Party has shall notify the right to review other Party, as soon as reasonably practicable but in any documents 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 Global Development Plan in PARI Products and the possession of the other Party to ensure compliance with global regulatory standardsINSMED Products, upon reasonable prior written notice to the other partyas applicable. (b) Such assistance 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 actions shall include, among other things, keeping INSMED Product) in the other Party informed, within an appropriate period form 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 Authoritya New Drug Application for the INSMED Product, which (a) raises any material concerns regarding the safety or efficacy of any Program Product, (b) which indicates or suggests single marketing application will contain a potential material liability for either Party to Third Parties arising Device module similar in connection with any Program Product, or (c) which is reasonably likely to lead format and content 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 (i510(k) governmental or regulatory inspections of manufacturing, distribution or other related facilities used for Compounds or Program Products; (ii) inquiries by governmental or regulatory authorities concerning clinical investigation activities (including inquiries of investigators, clinical monitoring organizations and other related parties) relating to Compounds or Program Products; (iii) any communication from governmental or regulatory authorities pertaining to the manufacture, sale, promotion or distribution of Compounds or Program Products; (iv) any other governmental or regulatory authority reviews or inquiries relating to Compounds or Program Products; (v) receipt of a warning letter relating to any of the Compounds or Program Products; and (vi) an initiation of any governmental or regulatory authority investigation, detention, seizure or injunction concerning any Compound or Program Productapplication.

Regulatory Assistance. All Regulatory Approvals with respect to Licensed Products in the Field in the Territory shall be in the name of Licensee or its Sublicensee. Licensee shall have exclusive control and authority over, and responsibility for, the regulatory strategies relating to the development and commercialization of all Licensed Products in the Field in the Territory, including, without limitation: (a) Each Party the preparation of all documents submitted to Regulatory Authorities and the filing of all submissions relating to Regulatory Approval of Licensed Products in the Field in the Territory (including each IND); and (b) all regulatory actions, communications and meetings with any governmental authority with respect to any Licensed Product in the Field in the Territory. Upon the request of Licensee, SGI shall use Commercially Reasonable Efforts to provide to Licensee on a timely basis such information as may be required or useful for the foregoing regulatory activities, and otherwise provide reasonable assistance to Licensee in complying with all regulatory obligations, including certifications and product approvals. Licensee shall be responsible for interfacing, corresponding and meeting with all Regulatory Authorities with respect to any Licensed Product in the Field in the Territory. Except as required by applicable law or in response to a request of Licensee, SGI shall not communicate directly with the FDA or any other governmental authority relating to any Licensed Product without the prior written consent of Licensee. In furtherance thereof, SGI shall refer all FDA communications relating to any Licensed Product to Licensee. SGI shall cooperate with the other Party Licensee to provide all reasonable assistance and take all actions reasonably requested by the other Party Licensee that are necessary or desirable to enable the other Party to comply with any Law law in the Territory applicable to any Compound or Program ProductLicensed Product in the Field. SGI hereby [*] required to support the filing of all submissions relating to Regulatory Approval of a Licensed Product in the Field in the Territory, includingsolely for purposes of allowing Licensee to obtain and maintain submissions relating to Regulatory Approvals for Licensed Products in the Field in the Territory. In furtherance of the foregoing, but not limited toSGI shall, report adverse drug experience reports (and serious adverse drug experience reports) promptly upon request of Licensee, deliver a letter to the relevant Regulatory Authority FDA, in form and submit substance reasonably acceptable to Licensee, authorizing Licensee to reference the drug master files of SGI. SGI will inform Licensee of all changes to drug master files that will or file promotional materials with the relevant Regulatory Authority. The Parties will work in good faith together to develop a global safety data base containing such information relating to the Global Development Plan and the safety of the Compounds and the Program Products as the Parties may require to comply with applicable Law and otherwise monitor the safety of the Compounds and the Program Products. Each Party has the right to review any documents relating to the Global Development Plan in the possession of the other Party to ensure compliance with global regulatory standards, upon reasonable prior written notice to the other party. (b) 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 might be reasonably likely to lead affect the regulatory filings of Licensee. Licensee shall reimburse SGI for any out of pocket costs incurred by SGI in providing any such information plus an amount equal to a recall or market withdrawal of any Program ProductSGI’s then current Personnel Fee for SGI’s personnel engaged in such activities, provided that neither Party shall be obliged to disclose information as set forth 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 governmental or regulatory authorities concerning clinical investigation activities (including inquiries of investigators, clinical monitoring organizations and other related parties) relating to Compounds or Program Products; (iii) any communication from governmental or regulatory authorities pertaining to the manufacture, sale, promotion or distribution of Compounds or Program Products; (iv) any other governmental or regulatory authority reviews or inquiries relating to Compounds or Program Products; (v) receipt of a warning letter relating to any of the Compounds or Program Products; and (vi) an initiation of any governmental or regulatory authority investigation, detention, seizure or injunction concerning any Compound or Program Product6.1.2.

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") Each Party as they may request, including pre-approval inspections, and 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 such Regulatory Agencies 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) respect to the relevant Regulatory Authority inspections related to the Services or the Product. PCT shall give MICROISLET prior notice, to the extent practicable, of any such inspections, and submit keep MICROISLET informed about the results and conclusions of each regulatory inspection, including actions taken by PCT to remedy any conditions cited in 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 file promotional materials with its representative to assist in the relevant Regulatory Authority. The Parties will work in good faith together to develop a global safety data base containing such information preparation for and be present at inspections relating to the Global Development Plan 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 Agency and all correspondence between PCT and the safety Regulatory Agency which relate to the Services or the Product, including FDA Form 483, "Notice of the Compounds Observation," and the Program Products as the Parties may require to comply with applicable Law and otherwise monitor the safety of the Compounds and the Program Products. Each Party has the right to review any documents all related correspondence, in each case relating to the Global Development Plan in Services or the possession Product; provided, however, PCT may exclude from such copies any references to the name and any identifying information specific to 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 request, directive or other communication of the FDA or other Party to ensure compliance with global regulatory standards, upon reasonable prior written notice Regulatory Agency relating to the other party. (b) Such assistance Services or the Product 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 cooperate with MICROISLET in responding to such other Party or otherwise reasonable period of timerequests, 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 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 governmental or regulatory authorities concerning clinical investigation activities (including inquiries of investigators, clinical monitoring organizations directives and other related parties) relating to Compounds or Program Products; (iii) any communication from governmental or regulatory authorities pertaining to the manufacture, sale, promotion or distribution of Compounds or Program Products; (iv) any other governmental or regulatory authority reviews or inquiries relating to Compounds or Program Products; (v) receipt of a warning letter relating to any of the Compounds or Program Products; and (vi) an initiation of any governmental or regulatory authority investigation, detention, seizure or injunction concerning any Compound or Program Productcommunications.

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) to the extent such inspections or audits relate primarily to Product or Services set forth in this Agreement). Each Party shall cooperate with give the other prior written notice, 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 of said inspections, inform Client of a regulatory inspection relating to or that may reasonably affect Services under the Agreement. In the event that an inspection/audit by a Regulatory 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 all reasonable assistance and take all actions reasonably requested by the other Party that are necessary to Client copies of correspondence received from any Regulatory Agencies in connection with such inspections or desirable to enable the other Party to comply with any Law applicable relating to any Compound Product, the Facility (if it relates to or Program affects the Services and/or Product) or the Manufacturing Process, including, but not limited to, report adverse drug experience reports FDA Form 483 notices or warning letters. PCT will consult with, and obtain approval from, Client (and serious adverse drug experience reportswhich approval will not be unreasonably withheld or delayed) before responding to each such communication from a Regulatory Agency that relates to the relevant Product 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 Authority 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 submit such inspection/audit is not the result of the negligence or file promotional materials 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 relevant Regulatory Authority. The Parties will work table of hourly rates set forth in good faith together Section 17(m) below, as such rates may be adjusted from time to develop a global safety data base containing time) with such information relating to the Global Development Plan and the safety of the Compounds and the Program Products as the Parties may require to comply with applicable Law and otherwise monitor the safety of the Compounds and the Program Products. Each Party has the right to review any documents relating to the Global Development Plan in the possession of the other Party to ensure compliance with global regulatory standards, upon reasonable prior written notice to the other partyaudit/inspection. (b) 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 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 governmental or regulatory authorities concerning clinical investigation activities (including inquiries of investigators, clinical monitoring organizations and other related parties) relating to Compounds or Program Products; (iii) any communication from governmental or regulatory authorities pertaining to the manufacture, sale, promotion or distribution of Compounds or Program Products; (iv) any other governmental or regulatory authority reviews or inquiries relating to Compounds or Program Products; (v) receipt of a warning letter relating to any of the Compounds or Program Products; and (vi) an initiation of any governmental or regulatory authority investigation, detention, seizure or injunction concerning any Compound or Program Product.