Common use of Regulatory Inspections Clause in Contracts

Regulatory Inspections. In addition to the obligations set forth under Sections 5.2 and 5.3 of the License Agreement and Section 8.4 of the Supply Agreement, which are incorporated by reference, the provisions of this Section ‎3.2.4 shall apply: To the extent VIVUS receives advance notice, VIVUS shall notify Licensee *** in advance of any pending Governmental Authority inspections scheduled and relating to Product to be performed at any relevant facility (each, a “Facility”) and shall provide Licensee with copies of any notices or communications relating to the Services or the Product(s) within *** of receipt. Licensee representatives may be present when any Governmental Authority inspects VIVUS, provided such inspection directly relates to the Product(s), Services and/or common areas used in the provision of Services. Licensee representation shall be limited to two (2) individuals and *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Licensee’s direct participation in the audit shall be limited to questions directly related to the Product(s) and/or the Services. VIVUS shall provide Licensee with copies of any inspection reports from any Governmental Authorities that may impact the Product(s) within *** of receipt. VIVUS may redact proprietary and confidential information pertaining to other clients’ products at VIVUS’ discretion. VIVUS shall consult Licensee when preparing responses to Governmental Authorities, provided such responses are directly related to the Product(s) and/or Services, and shall obtain Licensee’s prior written consent (not to be unreasonably withheld, conditioned, or delayed) before submitting such responses. VIVUS will notify Licensee promptly, but in no event later than *** after VIVUS’ receipt of notice from any applicable CMO or other Third Party Subcontractor of, any action resulting in:

Regulatory Inspections. In addition APCETH will permit BBB or its designees to be present and participate in any visit or inspection by any regulatory authority of the obligations Facility which solely relates to any Product or the manufacturing process of the Product. For the avoidance of doubt, this shall not include any visit or inspection related to other products manufactured at APCETH or the general GMP inspection by the regulatory authority. APCETH shall notify BBB promptly if a regulatory authority requests permission to inspect any Clean Room made available to BBB as set forth in Section 3.2 and/or any of APCETH’s records or documents related to APCETH’s performance under Sections 5.2 and 5.3 this Agreement. Upon notification of an inspection, APCETH shall promptly notify BBB of the License Agreement date and Section 8.4 time of such inspection and allow BBB to assist in the Supply preparation for such inspection by a regulatory authority. APCETH will provide [***] notice to BBB, or as may be otherwise provided in the Quality Agreement, which are incorporated by referenceif the purpose of any such visit or inspection relates to or might affect the manufacture of Product, provided that the provisions of this Section ‎3.2.4 shall apply: To the extent VIVUS receives advance notice, VIVUS shall notify Licensee *** visit or inspection was announced to APCETH in advance of any pending Governmental Authority inspections scheduled and relating with sufficient notice. APCETH agrees to Product to be performed at any relevant facility (each, a “Facility”) and shall provide Licensee BBB with copies of all regulatory authority documentation including but not limited to correspondence, statements, warnings, enforcement actions, pleadings, summons, forms and records that APCETH receives as a result of or in anticipation of an inspection of the Clean Rooms. APCETH agrees to promptly notify BBB of any notices or communications findings resulting from any inspection by a regulatory authority relating to the Services or manufacture of Product, to take any necessary corrective action within the Product(s) timelines set by the relevant authority within [*** of receipt. Licensee representatives may be present when any Governmental Authority inspects VIVUS, provided such inspection directly relates *] and to the Product(s), Services and/or common areas used in the provision of Services. Licensee representation shall be limited to two (2) individuals and *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Licensee’s direct participation in the audit shall be limited to questions directly related to the Product(s) and/or the Services. VIVUS shall provide Licensee with copies of any inspection reports from any Governmental Authorities that may impact the Product(s) relevant correspondence to BBB within [*** of receipt. VIVUS may redact proprietary and confidential information pertaining to other clients’ products at VIVUS’ discretion. VIVUS shall consult Licensee when preparing responses to Governmental Authorities, provided such responses are directly related to the Product(s) and/or Services, and shall obtain Licensee’s prior written consent (not to be unreasonably withheld, conditioned*] after submission, or delayed) before submitting such responses. VIVUS will notify Licensee promptly, but as may be otherwise provided in no event later than *** after VIVUS’ receipt of notice from any applicable CMO or other Third Party Subcontractor of, any action resulting in:the Quality Agreement.

Regulatory Inspections. In addition Upon request by any properly authorized representative of any Regulatory Authority of appropriate jurisdiction to have access to or verify any record, report, documentation or data relating to a Project, Services, a Work Order, or otherwise relating to CymaBay in the possession, custody or control of CRO, CRO will promptly notify CymaBay and will arrange access by such Regulatory Authority to CRO to the obligations set forth under Sections 5.2 extent legally required for the purposes of verifying and/or copying any record, report, documentation or data pertaining to the a Study or Work Order. In the event that a Regulatory Authority conducts an inspection of CRO specifically related to a Study (and 5.3 such Study is not selected for audit as part of a routine inspection by a Regulatory Authority of CRO’s performance of contract research organization activities), CymaBay will reimburse CRO’s reasonable costs, on a time and materials basis, incurred in connection with hosting and responding to any such inspection (including any preparation, participation, follow-up and resolution of findings) up to a maximum amount of [*], except that CymaBay will not reimburse CRO for [*]. Upon notification of an impending inspection or audit by the License Agreement FDA or any other Regulatory Authority at CRO’s premises, CRO will promptly notify CymaBay and Section 8.4 will follow up with written notification of such inspection or audit. Unless prohibited by the Supply Agreementapplicable Regulatory Authority, which are incorporated by referenceand where appropriate, CymaBay will have the provisions right, but not the obligation, to be present at any such inspection or audit and to review and comment on any responses required. CRO will provide CymaBay with monthly updates and summaries of this Section ‎3.2.4 shall apply: To the extent VIVUS receives advance noticesuch inspection or audit, VIVUS shall notify Licensee *** in advance will forward CymaBay copies of correspondence from any Regulatory Authority, and will provide CymaBay with a copy of any pending Governmental written correspondence to such Regulatory Authority inspections scheduled and relating for CymaBay’s input prior to Product submitting it to be performed at any relevant facility (eachsuch Regulatory Authority, a “Facility”) and shall provide Licensee with copies of any notices or communications relating to the Services or the Product(s) within *** of receipt. Licensee representatives may be present when any Governmental Authority inspects VIVUS, provided such inspection directly relates to the Product(s), Services and/or common areas used in the provision of Services. Licensee representation shall be limited to two (2) individuals and *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Licensee’s direct participation in the audit shall be limited to questions directly related to the Product(s) and/or the Services. VIVUS shall provide Licensee with copies of any inspection reports from any Governmental Authorities except that may impact the Product(s) within *** of receipt. VIVUS CRO may redact proprietary and confidential from such copy any information pertaining therein that would, if disclosed, violate any of CRO’s confidentiality obligations to other clients’ products third parties. CRO will promptly take steps necessary to correct any deficiencies noted by a Regulatory Authority during an inspection or audit at VIVUS’ discretion. VIVUS shall consult Licensee when preparing responses no cost to Governmental AuthoritiesCymaBay, provided if such responses deficiencies are directly related to the Product(s) and/or Services, and shall obtain Licenseeresult of CRO’s prior written consent (not to be unreasonably withheld, conditioned, or delayed) before submitting such responses. VIVUS will notify Licensee promptly, but in no event later than *** after VIVUS’ receipt of notice from any applicable CMO or other Third Party Subcontractor of, any action resulting in:performance.

Regulatory Inspections. In addition Antares shall permit the FDA and other Regulatory Authorities to conduct inspections of each Manufacturing Site as they may request, including pre-approval inspections, and shall cooperate with such Regulatory Authorities with respect to the obligations set forth under Sections 5.2 inspections and 5.3 of any related matters, in each case which is related to the License Agreement and Section 8.4 of the Supply AgreementDevice, which are incorporated by reference, the provisions of this Section ‎3.2.4 Product or sample Product. Antares shall apply: To the extent VIVUS receives advance notice, VIVUS shall notify Licensee give AMAG notice within [*** in advance *] of becoming aware of any pending Governmental Authority inspections scheduled such inspections, and relating keep AMAG reasonably informed about the results and conclusions of each regulatory inspection, including actions taken by Antares or its Subcontractor to Product to be performed at any relevant facility (each, a “Facility”) and shall provide Licensee with copies of any notices or communications relating to the Services or the Product(s) within [*** of receipt. Licensee representatives may be present when any Governmental Authority inspects VIVUS, provided such inspection directly relates to the Product(s), Services and/or common areas used in the provision of Services. Licensee representation shall be limited to two (2) individuals and *** ] INDICATES MATERIAL THAT WAS HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL WAS HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Licensee’s direct participation AMENDED remedy conditions cited in the audit shall be limited to questions directly related inspections, to the Product(s) and/or extent such results and conclusions relate to the ServicesDevice, Product or sample Product. VIVUS shall In addition, Antares will promptly provide Licensee AMAG with copies of any written inspection reports from any Governmental issued by Regulatory Authorities that may impact the Product(s) within *** of receipt. VIVUS may redact proprietary and confidential information pertaining to other clients’ products at VIVUS’ discretion. VIVUS shall consult Licensee when preparing responses to Governmental all correspondence between Antares and Regulatory Authorities, provided such responses are directly including, but not limited to, FDA Form 483, Notice of Observation, and all related correspondence, in each case only to the extent relating to the Device, Product or sample Product or general manufacturing concerns related to the Product(s) and/or ServicesDevice, Product or sample Product, which in all cases may be reasonably redacted by Antares to protect confidential information of Antares or its partners, licensees or licensors. Antares agrees to promptly notify and shall obtain Licensee’s prior written consent (not to be unreasonably withheldprovide AMAG copies of any request, conditioned, or delayed) before submitting such responses. VIVUS will notify Licensee promptly, but in no event later than *** after VIVUS’ receipt of notice from any applicable CMO directive or other Third Party Subcontractor ofcommunication of the FDA or other Regulatory Authority relating to the Device, any action resulting in:Product or sample Product and to reasonably cooperate with AMAG in responding to such requests, directives and communications.

Regulatory Inspections. In addition APCETH will permit BBB or its designees to be present and participate in any visit or inspection by any regulatory authority of the obligations Facility which solely relates to any Product or the manufacturing process of the Product. For the avoidance of doubt, this shall not include any visit or inspection related to other products manufactured at APCETH or the general GMP inspection by the regulatory authority. APCETH shall notify BBB promptly if a regulatory authority requests permission to inspect any Clean Room made available to BBB as set forth in Section 3.2 and/or any of APCETH’s records or documents related to APCETH’s performance under Sections 5.2 and 5.3 this Agreement. Upon notification of an inspection, APCETH shall promptly notify BBB of the License Agreement date and Section 8.4 time of such inspection and allow BBB to assist in the Supply preparation for such inspection by a regulatory authority. APCETH will provide [***] notice to BBB, or as may be otherwise provided in the Quality Agreement, which are incorporated by referenceif the purpose of any such visit or inspection relates to or might affect the manufacture of Product, provided that the provisions of this Section ‎3.2.4 shall apply: To the extent VIVUS receives advance notice, VIVUS shall notify Licensee *** visit or inspection was announced to APCETH in advance of any pending Governmental Authority inspections scheduled and relating with sufficient notice. APCETH agrees to Product to be performed at any relevant facility (each, a “Facility”) and shall provide Licensee BBB with copies of all regulatory authority documentation including but not limited to correspondence, statements, warnings, enforcement actions, pleadings, summons, forms and records that APCETH receives as a result of or in anticipation of an inspection of the Clean Rooms. APCETH agrees to promptly notify BBB of any notices or communications findings resulting from any inspection by a regulatory authority relating to the Services or manufacture of Product, to take any necessary corrective action within the Product(s) timelines set by the relevant authority within [*** *] and to provide copies of receipt. Licensee representatives any relevant correspondence to BBB within [***] after submission, or as may be present when any Governmental Authority inspects VIVUS, otherwise provided such inspection directly relates to the Product(s), Services and/or common areas used in the provision of ServicesQuality Agreement. Licensee representation shall be limited to two (2) individuals and [*** *] INDICATES MATERIAL THAT WAS HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL, AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Licensee’s direct participation in the audit shall be limited to questions directly related to the Product(s) and/or the Services. VIVUS shall provide Licensee with copies of any inspection reports from any Governmental Authorities that may impact the Product(s) within *** of receipt. VIVUS may redact proprietary and confidential information pertaining to other clients’ products at VIVUS’ discretion. VIVUS shall consult Licensee when preparing responses to Governmental Authorities, provided such responses are directly related to the Product(s) and/or Services, and shall obtain Licensee’s prior written consent (not to be unreasonably withheld, conditioned, or delayed) before submitting such responses. VIVUS will notify Licensee promptly, but in no event later than *** after VIVUS’ receipt of notice from any applicable CMO or other Third Party Subcontractor of, any action resulting in:COMPANY IF PUBLICLY DISCLOSED.

Regulatory Inspections. In addition The ACCEPTOR shall allow foreign and local governmental authorities to inspect and review their facilities, operations and quality systems as necessary in order to facilitate, obtain or maintain the required registration in those countries where CONTRACT GIVER and ACCEPTOR desire to sell PRODUCT(s). Each party acknowledges that the other party may respond independently to any correspondence or inquiry from any Regulatory Authority. The ACCEPTOR shall however agree to the obligations set forth under Sections 5.2 and 5.3 following: • To notify the CONTRACT GIVER promptly of any inspection or inquiry by any Regulatory Authority concerning one or more of the License Agreement and Section 8.4 of PRODUCT(s). The responsible contact persons are listed in Enclosure B. • To forward to the Supply Agreement, which are incorporated by reference, the provisions of this Section ‎3.2.4 shall apply: To the extent VIVUS receives advance notice, VIVUS shall notify Licensee *** in advance of any pending Governmental Authority inspections scheduled and relating to Product to be performed at any relevant facility (each, a “Facility”) and shall provide Licensee with CONTRACT GIVER copies of any notices or communications correspondence from any Regulatory Authority relating to one or more of the Services PRODUCT(s). The ACCEPTOR agrees that, during an inspection by a Regulatory Authority concerning one or more of the Product(sPRODUCT(s) within *** that it will not disclose information and materials that are not required to be disclosed to such a Regulatory Authority, without the prior consent of receipt. Licensee representatives may be present when any Governmental Authority inspects VIVUSthe CONTRACT GIVER, provided such inspection directly relates to the Product(s), Services and/or common areas used in the provision of Services. Licensee representation which shall be limited to two (2) individuals and *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Licensee’s direct participation in the audit shall be limited to questions directly related to the Product(s) and/or the Services. VIVUS shall provide Licensee with copies of any inspection reports from any Governmental Authorities that may impact the Product(s) within *** of receipt. VIVUS may redact proprietary and confidential information pertaining to other clients’ products at VIVUS’ discretion. VIVUS shall consult Licensee when preparing responses to Governmental Authorities, provided such responses are directly related to the Product(s) and/or Services, and shall obtain Licensee’s prior written consent (not to be unreasonably withheld. The ACCEPTOR will immediately inform the responsible contact persons of the CONTRACT GIVER as listed in Enclosure B concerning any critical or major issues encountered during any Regulatory Authority inspection that might adversely affect the quality of one or more of the PRODUCT(s). The ACCEPTOR shall submit to CONTRACT GIVER, conditioned, or delayed) before submitting such responses. VIVUS will notify Licensee promptly, but in no event later than *** after VIVUS’ within 5 business days of receipt of notice from the official report, a copy of the relevant parts of the report issued by the authorities and the proposed corrective actions that the ACCEPTOR will undertake. The report and the proposed corrective actions should be in English if requested by CONTRACT GIVER. CONTRACT PROVIDER should provide the ACCEPTOR with all the necessary information to carry out the contracted operations correctly in accordance with the pharmaceutical registration and any applicable CMO other legal requirements. The Contract Giver should ensure that the Contract Acceptor is fully aware of any problems associated with the product or the work which might pose a hazard to his premises, equipment, personnel, other materials or other Third Party Subcontractor of, any action resulting in:products. ACCEPTOR shall have a procedure in place to ensure that the qualified person releasing every batch ensures that each batch has been manufactured and checked in compliance with the requirements of pharmaceutical registration.

Regulatory Inspections. In addition If any Regulatory Authority (i) contacts Licensee or any of its Affiliates or any Sublicensee with respect to the obligations set forth under Sections 5.2 and 5.3 alleged improper Development, Manufacture or Commercialization of any Licensed Product, (ii) conducts, or gives notice of its intent to conduct, an inspection at Licensee’s or its Affiliate’s or a Sublicensee’s facilities used in the Development or Manufacturing of Licensed Products, or (iii) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of Licensee or its Affiliates or a Sublicensee that could reasonably be expected to adversely affect any Development, Manufacture or Commercialization activities with respect to the Licensed Product in or outside of the License Territory, then Licensee will promptly notify Nabriva of such contact, inspection or notice. If any Regulatory Authority (I) contacts Nabriva or any of its Affiliates with respect to the alleged improper Manufacture of any Licensed Product that is provided by or on behalf of Nabriva to Licensee under this Agreement and Section 8.4 of the or any Supply Agreement, which are incorporated by reference(II) conducts, the provisions or gives notice of this Section ‎3.2.4 shall apply: To the extent VIVUS receives advance noticeits intent to conduct, VIVUS shall notify Licensee *** in advance of any pending Governmental Authority inspections scheduled and relating to Product to be performed an inspection at any relevant facility (each, a “Facility”) and shall provide Licensee with copies of any notices Nabriva’s or communications relating to the Services or the Product(s) within *** of receipt. Licensee representatives may be present when any Governmental Authority inspects VIVUS, provided such inspection directly relates to the Product(s), Services and/or common areas its Affiliate’s facilities used in the provision Manufacturing of Services. Licensed Products provided by or on behalf of Nabriva to Licensee representation shall under this Agreement or any Supply Agreement, (III) contacts Nabriva or any of its Affiliates with respect to a material issue concerning the alleged improper Development or Commercialization of any Licensed Product that could reasonably be limited expected to two (2) individuals and *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Licensee’s direct participation materially adversely affect any Development or Commercialization activities with respect to the Licensed Product in the audit shall Field in the Territory, or (IV) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of Nabriva or its Affiliates that could reasonably be limited expected to questions directly related materially adversely affect any Development or Commercialization activities with respect to the Product(s) and/or Licensed Product in the Services. VIVUS shall provide Licensee with copies of any inspection reports from any Governmental Authorities that may impact Field in the Product(s) within *** of receipt. VIVUS may redact proprietary and confidential information pertaining to other clients’ products at VIVUS’ discretion. VIVUS shall consult Licensee when preparing responses to Governmental AuthoritiesTerritory, provided such responses are directly related to the Product(s) and/or Services, and shall obtain Licensee’s prior written consent (not to be unreasonably withheld, conditioned, or delayed) before submitting such responses. VIVUS then Nabriva will promptly notify Licensee promptlyof such contact, but in no event later than *** after VIVUS’ receipt of notice from any applicable CMO inspection or other Third Party Subcontractor of, any action resulting in:notice.

Regulatory Inspections. In addition Cognate agrees, in each case, to the extent not prohibited by Applicable Law or the applicable Authority, to advise Asterias by telephone and email as soon as reasonably possible of any proposed or announced visit or inspection, and as soon as possible but in any case [***] any unannounced visit or inspection, by the FDA or other Authority of any Facility used to Manufacture Products under this Agreement. Subject to Cognate’s obligations set forth under Sections 5.2 of confidentiality to any third parties, to the extent practicable and 5.3 if not prohibited by Applicable Laws, Cognate will permit Asterias to be present and participate in any FDA or other Authority visit or inspection of the License Agreement and Section 8.4 of the Supply Agreement, which are incorporated by reference, the provisions of this Section ‎3.2.4 shall apply: To Facility to the extent VIVUS receives advance notice, VIVUS shall notify Licensee *** in advance such visit or inspection relates directly to the Product Manufactured for Asterias by Cognate pursuant to this Agreement. Cognate will (unless prohibited by Applicable Law from doing so) provide Asterias with a copy of any pending Governmental report, notice or other written communication received from the FDA or other Authority inspections scheduled and relating to Product to be performed at any relevant facility (each, a “Facility”) and shall provide Licensee in connection with copies of any notices such visit or communications inspection relating to the Services Product or the Product(s) within *** Facility (if it relates directly to or directly affects the Development and/or Manufacture of receiptProduct), which report, notice or other communication will be redacted to remove information directly pertaining to or directly affecting any other third party. Licensee representatives may be present when any Governmental Authority inspects VIVUSCognate will provide, provided such inspection directly relates to the Product(s)extent not prohibited by Applicable Law or the applicable Authority, Services and/or common areas used in the provision Asterias with a copy of Services. Licensee representation shall be limited to two (2) individuals and *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Licensee’s direct participation in the audit shall be limited to questions directly related that portion of any written response or filing Cognate submits to the Product(s) and/or FDA or other Authority addressing the ServicesManufacture of Product or the Manufacturing Process reasonably prior to submission of such response or filing so that Asterias may comment thereon (which comments Cognate shall reasonably consider but shall not be obligated to include). VIVUS shall provide Licensee with copies of any inspection reports from any Governmental Authorities that may impact Notwithstanding the Product(s) within *** of receipt. VIVUS may redact proprietary and confidential information pertaining to other clients’ products at VIVUS’ discretion. VIVUS shall consult Licensee when preparing responses to Governmental Authoritiespreceding sentence, provided such responses are directly related to the Product(s) and/or Services, and shall obtain Licensee’s prior written consent (not to be unreasonably withheld, conditioned, or delayed) before submitting such responses. VIVUS will notify Licensee promptly, but in no event later than *** after VIVUS’ receipt of notice from will Asterias require Cognate to delay or otherwise impair Cognate’s ability to timely respond to or submit any applicable CMO filing to FDA or any other Third Party Subcontractor of, any action resulting in:Authority.

Regulatory Inspections. In addition Hospira also agrees to allow the FDA, the EMA or any other EU national Regulatory Authority (e.g., the UK Medicines and Healthcare Products Regulatory Agency - “MHRA” [†]) to conduct any pre-Regulatory Approval (“PAI”) or for cause inspection of the Facility related to the obligations set forth under Sections 5.2 Processing of Product which the FDA, the EMA or other relevant Regulatory Authority requests or requires and 5.3 Hospira agrees to reasonably cooperate with such Regulatory Authority in connection with such inspection. Omeros agrees to offset Hospira’s costs for each PAI inspection at the rate of [†] per PAI. Hospira shall advise Omeros no later than the next day that is not a Saturday, Sunday or federal or state holiday if an authorized agent of any Regulatory Authority or any other regulatory body plans to visit the Facility for a PAI or for any other reason after approval, and makes an inquiry regarding Hospira’s Processing of Product or performance of other Services regarding any part of the License Agreement and Section 8.4 Facility that is used in Processing of Product or performance of other Services. Omeros shall have the Supply Agreement, which are incorporated by reference, the provisions of this Section ‎3.2.4 shall apply: To the extent VIVUS receives advance notice, VIVUS shall notify Licensee *** in advance of any pending Governmental Authority inspections scheduled and relating to Product right to be performed present at any relevant facility (each, a “Facility”) and shall provide Licensee with copies of any notices or communications visit directly relating to the Services Product or the Product(s) within *** of receipt. Licensee representatives may otherwise with Hospira’s approval, which approval shall not be present when unreasonably withheld, and to review in advance and comment on any Governmental Authority inspects VIVUS, provided such inspection directly relates response to the Product(s), Services and/or common areas used in the provision of Services. Licensee representation shall be limited to two communication or investigation submitted by Hospira (2) individuals and *** INDICATES MATERIAL but no † DESIGNATES PORTIONS OF THIS DOCUMENT THAT WAS HAVE BEEN OMITTED AND PURSUANT TO A REQUEST FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Licensee’s direct participation in the audit more than [†] Omeros personnel shall be limited to questions directly related to present during any such visit). Hospira shall cooperate fully with Omeros in providing the Product(s) and/or the Servicesinformation needed for any such communication. VIVUS Hospira shall provide Licensee with to Omeros copies of any inspection reports from any Governmental Authorities that may impact the Product(s) within *** Form 483s or equivalent documents delivered by such Regulatory Authority or regulatory body as a result of receipt. VIVUS may redact proprietary and confidential information pertaining to other clients’ products at VIVUS’ discretion. VIVUS shall consult Licensee when preparing responses to Governmental Authoritiessuch visit, provided such responses are directly related to the Product(s) and/or Services, and shall obtain Licensee’s prior written consent (not to be unreasonably withheld, conditioned, or delayed) before submitting such responses. VIVUS will notify Licensee promptly, but in no event later than *** after VIVUS’ receipt of notice from any applicable CMO extent that the 483 or other Third Party Subcontractor of, any action resulting in:document specifically mentions Product. Portions of the 483 or other document not relating to Product will be redacted.