Common use of Governmental Inspections and Requests Clause in Contracts

Governmental Inspections and Requests. Catalent shall promptly advise Palatin if an authorized agent of any Regulatory Authority (A) notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the Processing or (B) takes any regulatory action with respect to the Product or the Processing. Catalent shall promptly provide to Palatin a report of the result of any such inspection by any Regulatory Authority to the extent directly related to the Processing of the Product and furnish to Palatin a copy of all written information provided by such Regulatory Authority to the extent specifically and directly related to the Processing of the Product, if any, within 10 days of Catalent’s receipt of such information, in each case redacted as appropriate to protect any Confidential Information of Catalent and/or confidential information Catalent’s other customers. Palatin acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities. Notwithstanding the foregoing, Catalent shall not initiate or participate in any communications with any Regulatory Authority concerning the Product or the Processing thereof without prior consultation with Palatin, unless Catalent (i) reasonably believes it is required by Applicable Law to make the communication under conditions that make such prior consultation impossible or impractical, in which case Catalent shall promptly thereafter notify Palatin in writing of the nature and content of the communication, or (ii) is requested to do so by Palatin. If any inspection by Regulatory Authorities is related to the Processing of the Product, Palatin shall reimburse Catalent for all reasonable and documented costs associated with such inspection attributable to the Processing of the Product. If deficiencies are identified in connection with any inspection by Regulatory Authorities related to or otherwise affecting the Processing of the Product, Catalent shall use commercially reasonable efforts to correct all such deficiencies in a timely manner. Catalent shall advise Palatin periodically of progress being made with respect to such deficiencies and notify Palatin, in writing, upon completion of any corrective action taken.

Governmental Inspections and Requests. Catalent AAC shall promptly advise Palatin Xxxxxx within three (3) Business Days if an authorized agent of any Regulatory Authority (A) notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the Processing or (B) takes any regulatory action visits a facility where manufacturing activity with respect to CoSeal Devices or CoSeal Units takes place, where the Product or the Processing. Catalent shall promptly provide to Palatin a report interest of the result of any such inspection by any Regulatory Authority to the extent directly is specifically related to manufacturing activity with respect to CoSeal Devices or CoSeal Units (and shall require any Third Party manufacturers to do the Processing of the Product same within five (5) Business Days with respect to their facilities). In such circumstance, AAC shall furnish (and furnish shall require any Third Party manufacturer to Palatin furnish) to Xxxxxx a copy of all written information provided sections of the report by such Regulatory Authority to the extent which are specifically and directly related to the Processing of the Product, if any, CoSeal Devices or CoSeal Units within 10 ten (10) days of Catalent’s receipt of such informationreport. Further, in each case redacted as appropriate to protect any Confidential Information upon receipt of Catalent and/or confidential information Catalent’s other customers. Palatin acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities. Notwithstanding the foregoing, Catalent shall not initiate or participate in any communications with any a Regulatory Authority concerning the Product written request to inspect a manufacturing facility or the Processing thereof without prior consultation with Palatin, unless Catalent (i) reasonably believes it is required by Applicable Law to make the communication under conditions that make such prior consultation impossible or impractical, in which case Catalent shall promptly thereafter notify Palatin in writing manufacturing facilities of the nature and content of the communicationa Third Party manufacturer, or to audit AAC’s (iior its Third Party manufacturer’s) is requested to do so by Palatin. If any inspection by Regulatory Authorities is related to the Processing of the Product, Palatin shall reimburse Catalent for all reasonable books and documented costs associated with such inspection attributable to the Processing of the Product. If deficiencies are identified in connection with any inspection by Regulatory Authorities related to or otherwise affecting the Processing of the Product, Catalent shall use commercially reasonable efforts to correct all such deficiencies in a timely manner. Catalent shall advise Palatin periodically of progress being made records with respect to such deficiencies manufacturing of CoSeal Devices or CoSeal Units under this Manufacturing Agreement, AAC shall notify Xxxxxx thereof within three (3) Business Days (and require any Third Party manufacturer to notify PalatinXxxxxx within five (5) Business Days thereof), in writing, upon completion and shall provide (and require any Third Party manufacturer to provide) Xxxxxx with a copy of any corrective written document received from such Regulatory Authority. AAC shall provide Xxxxxx with notice of any such non-written inspection request from a Regulatory Authority which specifically relates to the CoSeal Devices or CoSeal Units as promptly as reasonably practicable under the circumstances. AAC shall also provide to Xxxxxx such notice as is reasonably practicable under the circumstances of any action takenby a Regulatory Authority, resulting from an inspection of a facility where manufacturing activity with respect to CoSeal Devices or CoSeal Units takes place, which is reasonably anticipated to materially affect AAC’s ability to perform its obligations under this Manufacturing Agreement. Nothing in this Section 5.3 shall require AAC to submit to Xxxxxx any books, records, data or information relating to the manufacture or distribution of any products not covered under this Manufacturing Agreement or the Distribution and License Agreement.

Governmental Inspections and Requests. Catalent Cardinal Health shall promptly immediately advise Palatin Cubist if an authorized agent of any Regulatory Authority (A) notifies Catalent that it intends to or does visit visits the Facility for the purpose of reviewing Facilities concerning the Processing of the Product. Further, upon receipt of a Regulatory Authority request to inspect the Facilities or (B) takes any regulatory action audit Cardinal Health’s books and records with respect to Processing under this Agreement, Cardinal Health shall immediately notify Cubist, and shall provide Cubist with a copy of any written document received from such Regulatory Authority relating to the Product or no later than [ ]* hours after Cardinal Health’s receipt thereof. Cubist shall have a right to have up to [ ]* representatives attend any inspection described in the Processing. Catalent first two sentences of this Section 9.4 or, in the alternative, Cardinal Health shall promptly provide to Palatin a report of daily reports generally summarizing the result of inspectional process and any such inspection findings communicated by any the Regulatory Authority to a designated Cubist representative. Cardinal Health shall furnish to Cubist a copy of the extent report by such Regulatory Authority, if any, within [ ]* of Cardinal Health’s receipt of such report. In addition, Cardinal Health shall immediately notify Cubist of other Regulatory Authority inspections of the Facilities that are not directly related to the Processing of the Product and furnish if Cardinal Health has a reasonable basis to Palatin a copy of all written information provided by believe that the subject of, or issues identified during, such Regulatory Authority inspection are likely to the extent specifically and directly related to impact the Processing of the Product, if any, within 10 days . Cardinal Health shall furnish to Cubist a copy of Catalent’s receipt of the report by such information, in each case redacted as appropriate to protect any Confidential Information of Catalent and/or confidential information Catalent’s other customers. Palatin acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities. Notwithstanding the foregoing, Catalent shall not initiate or participate in any communications with any Regulatory Authority concerning the Product or the Processing thereof without prior consultation with Palatin, unless Catalent (i) reasonably believes it is required by Applicable Law to make the communication under conditions that make regarding any such prior consultation impossible or impractical, in which case Catalent shall promptly thereafter notify Palatin in writing of the nature and content of the communication, or (ii) is requested to do so by Palatin. If any inspection by Regulatory Authorities is related to the Processing of extent that the Product, Palatin shall reimburse Catalent for all reasonable and documented costs associated with such inspection attributable report relates to the Processing of the Product. If deficiencies are identified Cubist shall notify Cardinal Health of any visits by Regulatory Authorities to facilities manufacturing the API, performing testing on the Product, or performing other services in connection with any the Product if Cubist reasonably believes that such visit may result in an inspection by Regulatory Authorities related to or otherwise affecting the Processing of the Product, Catalent shall use commercially reasonable efforts to correct all such deficiencies in a timely manner. Catalent shall advise Palatin periodically of progress being made with respect to such deficiencies and notify Palatin, in writing, upon completion of any corrective action takenFacilities.

Governmental Inspections and Requests. Catalent shall promptly advise Palatin Client if an authorized agent of any Regulatory Authority (A) notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the Processing or (B) takes any regulatory action audit Catalent’s books and records with respect to the Product or the Processing. Catalent shall promptly provide to Palatin Client with a report of the result copy of any written document received from such inspection by Regulatory Authority relating to such notification, as well as any other request, directive or other communication of any Regulatory Authority relating to the Product or its Processing. Catalent shall permit authorized officials of any Regulatory Authority to inspect the extent directly related Facility, including the equipment used for the Processing, shipping or receiving of Product and Client-supplied Materials and Raw Materials, as may be required or necessary for the granting or maintaining of any government approvals necessary and/or required to be granted by such Regulatory Authority for the manufacture, import, marketing, distribution and sale of the Product, as well as any documents relevant to the Processing of Product under this Agreement. Catalent shall permit representatives of Client and any Client Licensee to assist in the Product preparation for and furnish to Palatin be present at any such inspection of the Facility. Upon request, Catalent shall promptly provide Client with a copy of all written information provided any report issued by such Regulatory Authority to received by Confidential materials omitted and filed separately with the extent specifically Securities and directly related to the Processing of the ProductExchange Commission. Asterisks denote omissions. Catalent following such visit, if any, within 10 days of Catalent’s receipt of such information, in each case redacted as appropriate to protect any Confidential Information confidential information of Catalent and/or confidential information and Catalent’s other customers, and notify Client of any actions taken by Catalent to remedy conditions cited in any such report. Palatin Prior to responding to any such report, Catalent shall provide Client a copy of its proposed response for Client’s and any Client Licensee’s review and comments and Catalent shall take under careful consideration and use good faith efforts to implement any comments or recommendations provided by Client or any Client Licensee with respect thereto directed towards the Product or its Processing prior to submitting such response to the applicable Regulatory Authority. Client acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities. Notwithstanding the foregoing, Catalent Client shall not initiate or participate in any communications with any Regulatory Authority concerning the Product or the Processing thereof without prior consultation with Palatin, unless Catalent (i) reasonably believes it is required by Applicable Law to make the communication under conditions that make such prior consultation impossible or impractical, in which case Catalent shall promptly thereafter notify Palatin in writing of the nature and content of the communication, or (ii) is requested to do so by Palatin. If any inspection by Regulatory Authorities is related to the Processing of the Product, Palatin shall reimburse Catalent for all reasonable and documented costs associated with such inspection attributable to the Processing of the Product. If deficiencies are identified in connection with any inspection by Regulatory Authorities related to or otherwise affecting the Processing of the Product, Catalent shall use commercially reasonable efforts to correct all such deficiencies in a timely manner. Catalent shall advise Palatin periodically of progress being made with respect to such deficiencies and notify Palatin, in writing, upon completion of any corrective action taken[**].

Governmental Inspections and Requests. Catalent shall permit any Regulatory Authority to conduct inspections of any Facility as such Regulatory Authority may request, including pre-approval inspections, and shall cooperate with such Regulatory Authority with respect to such inspections and any related matters, in each case that is related to the Product or its Processing. Catalent shall promptly (but not later than [***] after notification) advise Palatin Client if an authorized agent of any Regulatory Authority (A) notifies Catalent that it intends to or does will visit the Facility for the purpose of reviewing the Processing Processing, or of any written or oral inquiries or communications (Bincluding Form 483 letters) takes from any regulatory action Regulatory Authority concerning or relating to, or that reasonably could be expected to impact, the Product, including Catalent’s quality systems used in connection with respect to the Product or the such Processing, including during any pre-approval inspection. Catalent shall promptly provide permit Client or its Representative to Palatin a report of be present at the result of Facility during any such inspection by any Regulatory Authority concerning EXECUTION VERSION or relating to, or that reasonably could be expected to impact, the Product to the extent directly related to not prohibited by Applicable Laws or the Processing applicable Regulatory Authority. Within [***] of the Product and furnish to Palatin its receipt, Catalent shall provide Client with a copy of all written information any applicable report or correspondence issued by or provided by to such Regulatory Authority to the extent specifically and directly related to the Processing of the Productin connection with such visit or inquiry, if any, within 10 days of Catalent’s receipt of such information, in each case redacted as appropriate to protect any Confidential Information confidential information of Catalent and/or confidential information and Catalent’s other customers. Palatin Client acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities. Notwithstanding the foregoing, Catalent shall not initiate permit, and shall cause its Affiliates and Representatives to permit, the relevant Regulatory Authority to inspect its facilities in connection with the Product, provided that Client has provided advanced written notification to Catalent that Client has filed with a new Territory. [***]. Catalent shall, prior to any correspondence or participate submission delivered to such Regulatory Authority (bearing in mind any time period limitations in responding to any such Regulatory Authority), permit Client to review and provide comments thereto, to the extent concerning or relating to, or that reasonably could be expected to impact, the Product or its Processing, and, prior to responding to any reports, requests, directive or other communications with issued by any Regulatory Authority concerning or relating to, or that reasonably could be expected to impact, the Product or its Processing, Catalent shall take under consideration and use good faith efforts to implement any comments or recommendations provided by Client with respect thereto direct towards the Product or its Processing thereof without prior consultation with Palatinto submitting such response to the applicable Regulatory Authority. In addition, unless Catalent (i) reasonably believes it is required by Applicable Law to make the communication under conditions that make such prior consultation impossible or impractical, in which case Catalent shall promptly thereafter notify Palatin in writing and, at Client’s written request, provide Client copies of the nature and content any request, directive or other communication of the communicationany Regulatory Authority concerning or relating to, or (ii) is requested that reasonably could be expected to do so by Palatin. If any inspection by Regulatory Authorities is related to impact, the Processing of the Product, Palatin shall reimburse Catalent for all reasonable and documented costs associated with such inspection attributable to the Processing of the Product. If deficiencies are identified in connection with any inspection by Regulatory Authorities related to Product or otherwise affecting the Processing of the Product, Catalent shall use commercially reasonable efforts to correct all such deficiencies in a timely manner. Catalent shall advise Palatin periodically of progress being made with respect to such deficiencies and notify Palatin, in writing, upon completion of any corrective action takenits Processing.

Governmental Inspections and Requests. Catalent AAC shall promptly advise Palatin Xxxxxx within three (3) Business Days if an authorized agent of any Regulatory Authority (A) notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the Processing or (B) takes any regulatory action visits a facility where manufacturing activity with respect to CoSeal Devices or CoSeal Units takes place, where the Product or the Processing. Catalent shall promptly provide to Palatin a report CONFIDENTIAL interest of the result of any such inspection by any Regulatory Authority to the extent directly is specifically related to manufacturing activity with respect to CoSeal Devices or CoSeal Units (and shall require any Third Party manufacturers to do the Processing of the Product same within five (5) Business Days with respect to their facilities). In such circumstance, AAC shall furnish (and furnish shall require any Third Party manufacturer to Palatin furnish) to Xxxxxx a copy of all written information provided sections of the report by such Regulatory Authority to the extent which are specifically and directly related to the Processing of the Product, if any, CoSeal Devices or CoSeal Units within 10 ten (10) days of Catalent’s receipt of such informationreport. Further, in each case redacted as appropriate to protect any Confidential Information upon receipt of Catalent and/or confidential information Catalent’s other customers. Palatin acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities. Notwithstanding the foregoing, Catalent shall not initiate or participate in any communications with any a Regulatory Authority concerning the Product written request to inspect a manufacturing facility or the Processing thereof without prior consultation with Palatin, unless Catalent (i) reasonably believes it is required by Applicable Law to make the communication under conditions that make such prior consultation impossible or impractical, in which case Catalent shall promptly thereafter notify Palatin in writing manufacturing facilities of the nature and content of the communicationa Third Party manufacturer, or to audit AAC’s (iior its Third Party manufacturer’s) is requested to do so by Palatin. If any inspection by Regulatory Authorities is related to the Processing of the Product, Palatin shall reimburse Catalent for all reasonable books and documented costs associated with such inspection attributable to the Processing of the Product. If deficiencies are identified in connection with any inspection by Regulatory Authorities related to or otherwise affecting the Processing of the Product, Catalent shall use commercially reasonable efforts to correct all such deficiencies in a timely manner. Catalent shall advise Palatin periodically of progress being made records with respect to such deficiencies manufacturing of CoSeal Devices or CoSeal Units under this Manufacturing Agreement, AAC shall notify Xxxxxx thereof within three (3) Business Days (and require any Third Party manufacturer to notify PalatinXxxxxx within five (5) Business Days thereof), in writing, upon completion and shall provide (and require any Third Party manufacturer to provide) Xxxxxx with a copy of any corrective written document received from such Regulatory Authority. AAC shall provide Xxxxxx with notice of any such non-written inspection request from a Regulatory Authority which specifically relates to the CoSeal Devices or CoSeal Units as promptly as reasonably practicable under the circumstances. AAC shall also provide to Xxxxxx such notice as is reasonably practicable under the circumstances of any action takenby a Regulatory Authority, resulting from an inspection of a facility where manufacturing activity with respect to CoSeal Devices or CoSeal Units takes place, which is reasonably anticipated to materially affect AAC’s ability to perform its obligations under this Manufacturing Agreement. Nothing in this Section 5.3 shall require AAC to submit to Xxxxxx any books, records, data or information relating to the manufacture or distribution of any products not covered under this Manufacturing Agreement or the Distribution and License Agreement.

Governmental Inspections and Requests. Catalent Kevelt and/or Pharmsynthez shall promptly advise Palatin Xenetic within three (3) Business Days if an authorized agent of any Regulatory Authority (A) notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the Processing or (B) takes any regulatory action authority visits a facility where manufacturing activity with respect to Virexxa takes place, where the Product or the Processing. Catalent shall promptly provide to Palatin a report interest of the result regulatory authority is specifically related to manufacturing activity with respect to Virexxa. In such circumstance, Kevelt and/or Pharmsynthez shall furnish to Xenetic a copy of sections of the report by such regulatory authority, which are specifically related to Virexxa within five (5) days of receipt of such report if such report is received in English by Kevelt and/or Pharmsynthez. If the sections of the report by such regulatory authority are not in English, the receiving Party shall translate the sections of the report into English and shall provide such translated sections of the report to Xenetic within ten (10) days of receipt of such report. Further, upon receipt of a regulatory authority written request to inspect a Kevelt and/or Pharmsynthez manufacturing facility, or to audit Kevelt’s and/or Pharmsynthez’s books and records with respect to manufacturing of Virexxa under this Transition and Resupply Agreement, Kevelt and/or Pharmsynthez shall notify Xenetic thereof within three (3) days, and shall provide Xenetic with a copy of any written document received from such regulatory authority if the document is written in English. If the document is not written in English, Pharmsynthez and/or Kevelt shall provide Xenetic with an English translation within ten (10) days of the receipt of the document. Kevelt and/or Pharmsynthez shall provide Xenetic with notice of any such non-written inspection request from a regulatory authority which specifically relates to Virexxa as promptly as reasonably practicable under the circumstances. Kevelt and/or Pharmsynthez shall also provide to Xenetic such notice as is reasonably practicable under the circumstances of any action by any Regulatory Authority to the extent directly related to the Processing a regulatory authority, resulting from an inspection of the Product and furnish to Palatin a copy of all written information provided by such Regulatory Authority to the extent specifically and directly related to the Processing of the Product, if any, within 10 days of Catalent’s receipt of such information, in each case redacted as appropriate to protect any Confidential Information of Catalent and/or confidential information Catalent’s other customers. Palatin acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities. Notwithstanding the foregoing, Catalent shall not initiate or participate in any communications with any Regulatory Authority concerning the Product or the Processing thereof without prior consultation with Palatin, unless Catalent (i) reasonably believes it is required by Applicable Law to make the communication under conditions that make such prior consultation impossible or impractical, in which case Catalent shall promptly thereafter notify Palatin in writing of the nature and content of the communication, or (ii) is requested to do so by Palatin. If any inspection by Regulatory Authorities is related to the Processing of the Product, Palatin shall reimburse Catalent for all reasonable and documented costs associated with such inspection attributable to the Processing of the Product. If deficiencies are identified in connection with any inspection by Regulatory Authorities related to or otherwise affecting the Processing of the Product, Catalent shall use commercially reasonable efforts to correct all such deficiencies in a timely manner. Catalent shall advise Palatin periodically of progress being made facility where manufacturing activity with respect to such deficiencies Virexxa takes place, which is reasonably anticipated to materially affect Kevelt’s and/or Pharmsynthez’s ability to perform its obligations under this Transition and notify PalatinResupply Agreement. Nothing in this Section 4.03 shall require Kevelt and/or Pharmsynthez to submit to Xenetic any books, in writingrecords, upon completion data or information relating to the manufacture or distribution of any corrective action takenproducts other than Virexxa.

Governmental Inspections and Requests. Catalent shall permit any Regulatory Authority to conduct inspections of any Facility as such Regulatory Authority may request, including pre-approval inspections, and shall cooperate with such Regulatory Authority with respect to such inspections and any related matters, in each case that is related to the Product or its Processing or Packaging. Catalent shall promptly advise Palatin Client if an authorized agent of any Regulatory *** 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. Authority (A) notifies Catalent that it intends visits or schedules a visit to or does visit the any Facility for the purpose of reviewing the Processing or (B) takes any regulatory action with respect to concerning the Product or the Processingits Processing or Packaging. Catalent shall promptly provide permit Client or its representative to Palatin a report of assist in the result of any preparation for and be present on site for such inspections; provided that Client shall not participate in such inspection unless requested to do so by any Regulatory Authority to the extent directly related to the Processing of the Product and Catalent. Catalent shall furnish to Palatin Client a copy of all written information provided the report by such Regulatory Authority to the extent specifically and directly related to the Processing of the ProductAuthority, if any, within 10 days *** of Catalent’s receipt of such informationreport and notify Client of any actions taken by Catalent to remedy conditions cited in any such report. Further, in each case redacted as appropriate upon receipt of a Regulatory Authority request to protect inspect any Confidential Information of Catalent and/or confidential information Facility or audit Catalent’s other customers. Palatin acknowledges that it may not direct the manner in which Catalent fulfills its obligations books and records with respect to permit inspection by and to communicate with Regulatory Authorities. Notwithstanding the foregoingProcessing or Packaging, Catalent shall not initiate promptly notify Client, and shall provide Client with a copy of any written document received from such Regulatory Authority. In addition, Catalent agrees to promptly notify and provide Client copies of any request, directive or participate in any communications with other communication of any Regulatory Authority concerning relating to the Product or the its Processing thereof without prior consultation with Palatinor Packaging. Prior to responding to any reports, unless Catalent (i) reasonably believes it is required requests, directive or other communications issued by Applicable Law to make the communication under conditions that make such prior consultation impossible or impractical, in which case Catalent shall promptly thereafter notify Palatin in writing of the nature and content of the communication, or (ii) is requested to do so by Palatin. If any inspection by Regulatory Authorities is related Authority relating to the Product or its Processing of the Product, Palatin shall reimburse Catalent for all reasonable and documented costs associated with such inspection attributable to the or Packaging or general Processing of the Product. If deficiencies are identified in connection with any inspection by Regulatory Authorities related to or otherwise affecting the Processing of the ProductPackaging issues, Catalent shall provide Client a copy of its proposed response for Client’s review and comments and Catalent shall take under careful consideration and use commercially reasonable good faith efforts to correct all such deficiencies in a timely manner. Catalent shall advise Palatin periodically of progress being made implement any comments or recommendations provided by Client with respect thereto direct towards the Product or its Processing or Packaging prior to submitting such deficiencies and notify Palatin, in writing, upon completion of any corrective action takenresponse to the applicable Regulatory Authority.