Regulatory Inspections. [[CoreRx:Organization]] agrees to promptly inform Client of any regulatory inquiry, communication or inspection, which directly relates to a Work Order or manufacture of the Products, and [[CoreRx:Organization]] shall make its relevant facilities and all records relating to such Work Order or the manufacture of the Products, available to the FDA or other regulatory authorities. All other aspect of interactions with Regulatory Authorities shall be governed by the Quality Agreement between parties.

Regulatory Inspections. Dynavax shall cooperate and cause its Affiliates and CMO to cooperate with any inspection of the Facility by any Government Authority or Regulatory Authority, including in connection with the Regulatory Approval process for the Product. Dynavax shall promptly notify Purchaser in writing if any Regulatory Authority notifies Dynavax that it intends to or (if no notice was provided, that does) visit the Facility for the purpose of reviewing the manufacture of CpG Material. To the extent practicable under the circumstances and not prohibited by such Regulatory Authority, Dynavax shall permit a reasonable number of Purchaser’s representatives to be present on site for such visit. Dynavax shall promptly provide Purchaser with a copy of # any reports or other correspondence issued by such Regulatory Authority following such visit, and # any material reports, comments, responses or other correspondence prepared by or on behalf of Dynavax, including its CMO, from or to (as applicable) any Regulatory Authority which relates specifically to or would reasonably be expected to affect the Products, including any comments, responses or notices received from the Regulatory Authority with respect thereto, in each of (i) and (ii), redacted as appropriate to protect any Confidential confidential information of Dynavax’s other customers. Purchaser acknowledges that it may not direct the manner in which Dynavax fulfills its obligations to permit such inspection by and to communicate with Regulatory Authorities; provided that Dynavax does so in accordance with Applicable Laws.

Regulatory Inspections. If any Regulatory Authority # contacts Everest, its Affiliates or their respective Sublicensees with respect to the alleged improper Development, Manufacture or Commercialization of any Licensed Product; # conducts, or gives notice of its intent to conduct, an inspection at Everest’s, its Affiliate’s or Sublicensee’s facilities used in the Development or Manufacturing of Licensed Products or # takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of Everest, its Affiliates or Sublicensees that could reasonably be expected to materially adversely affect any Development, Manufacture or Commercialization activities with respect to the Licensed Product, whether in or outside the Territory, then Everest will promptly notify NPLH of such contact, inspection or notice.

Regulatory Inspections. APCETH will permit [[Identifier]] or its designees to be present and participate in any visit or inspection by any regulatory authority of the 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 this Agreement. Upon notification of an inspection, APCETH shall promptly notify BBB of the date and time of such inspection and allow BBB to assist in the preparation for such inspection by a regulatory authority. APCETH will provide ​ notice to BBB, or as may be otherwise provided in the Quality Agreement, if the purpose of any such visit or inspection relates to or might affect the manufacture of Product, provided that the visit or inspection was announced to APCETH in advance with sufficient notice. APCETH agrees to provide 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 findings resulting from any inspection by a regulatory authority relating to the manufacture of Product, to take any necessary corrective action within the timelines set by the relevant authority within ​ and to provide copies of any relevant correspondence to BBB within ​ after submission, or as may be otherwise provided in the Quality Agreement.

Takeda shall allow any competent Regulatory Authority access to Takeda’s facilities to perform inspections of such facilities and cGMPs documents that are applicable to the Bulk Drug Product(s) or service(s) provided to the Company under this Agreement.

Regulatory Inspections. SBL shall facilitate on-site inspections of the Facility conducted by Regulatory Authorities. SBL shall notify Client according to the applicable QAA provisions of any contacts or inquiries by the Regulatory Authorities, including inspections, Pre-Approval Inspections, sample requests, and written correspondence and its result, related to the Product, as further defined in the applicable QAA. ​.

Regulatory Inspections. Licensee shall permit the Regulatory Authority(ies) in the Ovid Territory to conduct inspections of Licensee, its Affiliates, and its Sublicensees and subcontractors (including Clinical Trial sites) relating to the Development of the Product under the Development Plan, and shall ensure that such Affiliates and Sublicensees and subcontractors permit such inspections. In addition, Licensee shall promptly notify Ovid of any such inspection and shall supply Ovid with all information pertinent thereto. Ovid shall have the right to have a representative attend any such inspection. Ovid shall permit the Regulatory Authority(ies) in the Licensee Territory to conduct inspections of Licensee, its Affiliates, and its Sublicensees and subcontractors (including Clinical Trial sites) relating to the Development of the Product in the Licensee Territory under the Development Plan, and shall ensure that such Affiliates and Sublicensees and subcontractors permit such inspections. In addition, Ovid shall promptly notify the Licensee of any such inspection in the Licensee Territory and shall supply the Licensee with Certain identified information marked with ​ has been excluded from the exhibit because it is both not material and is the type that the registrant treats as private or confidential.

Regulatory Inspections. In the event the Facilities are the subject of an inspection by any Regulatory Authority or any other duly authorized agency of any national, state or local government directly relating to the manufacturing, packaging or warehousing of Product (including any Product complaint) , Alba shall notify Ortho as soon as possible but no later than within twenty-four (24) hours of learning of such inspection, and shall, if reasonably possible given the circumstances, afford Ortho the opportunity to be present at such inspection although Ortho shall have no obligation to attend. If any samples of Product are taken, Alba shall collect duplicate samples from the same lot and location. If documents related to Product are taken, Alba shall collect duplicate copies of such documents. These duplicate samples and copies of documents will be sent to Ortho as soon as possible but no later than within forty-eight (48) hours at Ortho’s expense. Alba shall supply Ortho with copies of any correspondence or portions of correspondence to the extent relating to the Products. In the event Alba receives any regulatory letter or written comments from any Regulatory Authority in connection with manufacturing and packaging of Products hereunder thereof, it shall provide Ortho with a copy of each such communication as soon as possible but no later than within forty-eight (48) hours. To the extent Alba is required to submit any correspondence to a Regulatory Authority that relates to the manufacture, packaging or warehousing of the Product, Alba shall provide Ortho with a copy of such correspondence as far in advance of its submission to such Regulatory Authority as possible and Ortho shall have the opportunity to review and comment upon such correspondence. Any written observation from a Regulatory Authority shall be shared with Ortho within one (1) day of receipt of the observation by Alba.

Regulatory Inspections. If FIS is notified that any API or Facility will be subject to an inspection, which involves any APIs manufactured for Purchaser, by any Governmental Authority, FIS shall promptly advise Purchaser of such investigation and fully cooperate with and allow any such inspection to the extent required by Laws. Purchaser shall have the right to have representatives present during any such inspection by a Governmental Authority.

Regulatory Inspections. Licensee shall permit the Regulatory Authority(ies) in the Ovid Territory to conduct inspections of Licensee, its Affiliates, and its Sublicensees and subcontractors (including Clinical Trial sites) relating to the Development of the Product under the Development Plan, and shall ensure that such Affiliates and Sublicensees and subcontractors permit such inspections. In addition, Licensee shall promptly notify Ovid of any such inspection and shall supply Ovid with all information pertinent thereto. Ovid shall have the right to have a representative attend any such inspection. Ovid shall permit the Regulatory Authority(ies) in the ​ = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both # not material and # would be competitively harmful if publicly disclosed.