Notification of Inspections. Arena agrees to notify Eisai within five calendar days of Arena’s receipt of any written or oral inquiries, notifications or inspection activity by any Regulatory Authority in regard to Product to be supplied to Eisai hereunder and immediately by telephone after learning of any unannounced visit or inspection, and shall permit one Eisai employee or agent, in each case approved by Arena, such approval not to be unreasonably conditioned, withheld or delayed, and subject to such agent’s executing a reasonable confidentiality agreement with Arena or, if applicable, any Third Party that manufactures any active pharmaceutical agent contained in Product, to be present at and participate in such visit or inspection, excluding any unannounced visit or inspection. Arena shall furnish to Eisai (i) within five calendar days after Arena’s receipt, any report or correspondence issued by any Regulatory Authority in connection with such inquiry, notification or inspection, including any FDA Form 483 (List of Inspectional Observations) or applicable portions of any FDA Warning Letters that pertain to any Product manufactured for Eisai hereunder (or any equivalent warning notice in another country or jurisdiction), and (ii) not later than two calendar days prior to the time Arena provides the same to any Regulatory Authority, copies of proposed draft responses or explanations relating to items set forth above (each, a “Proposed Response”), in each case redacted of trade secrets or other confidential information of Arena or its contract manufacturer that are unrelated to the obligations under this Agreement and the manufacture of any Product hereunder. Arena shall discuss with Eisai and consider in good faith any comments provided by Eisai on the Proposed Response. After the filing of the Proposed Response (so modified by comments provided by Eisai, as may be agreed) with the FDA or other Regulatory Authority, Arena shall notify Eisai of any further contacts with the FDA or such Regulatory Authority relating to the subject matter of the response.
Notification of Inspections. SteadyMed agrees to notify or to cause the applicable Contract Manufacturer to notify Cardiome within [*] of any written or oral inquiries, notifications or inspection activity by the FDA or the applicable Regulatory Authority in a Major Market specifically in regard to a Supplied Item and immediately by telephone after learning of any such unannounced visit or inspection. SteadyMed shall furnish to Cardiome (i) within [*] after receipt, any report or correspondence issued by the FDA or any such Regulatory Authority in a Major Market in connection with such inquiry, notification or inspection, including any FDA Form 483 (List of Inspectional Observations) or applicable portions of any FDA Warning Letters that pertain to a Supplied Item, and (ii) not later than [*] after submission to FDA or any such other Regulatory Authority, copies of responses or explanations relating to items set forth above, in each case redacted of trade secrets or other confidential information of SteadyMed or the applicable Contract Manufacturer that are unrelated to SteadyMed’s obligations under this Article 4 and the Manufacture of Supplied Items hereunder. After the filing of such response with the FDA or such other Regulatory Authority, SteadyMed shall promptly notify Cardiome of any further contacts with the FDA or such Regulatory Authority relating to the subject matter of the response.
Notification of Inspections. Each party agrees to notify the other within two (2) business days of its receipt of notification of any inquiries, notifications, or inspection activity by any Agency, regulatory authority or other authority in regard to ***TEXT OMITTED AND FILED SEPARATELY CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. SECTIONS 200.80(B)(4) 200.83 AND 204.24B-2 or affecting Product. The recipient party shall provide a reasonable description to the other party of any such governmental inquiries, notifications or inspections promptly (but in no event later than five (5) calendar days) after notification of completion of such visit or inquiry. The recipient party shall furnish to the other party, (i) within two (2) business days after receipt any report or correspondence issued by the Agency or regulatory authority in connection with such visit or inquiry, including but not limited to, any FDA Form 483, Establishment Inspection Reports or warning letters and (ii) at the same time it provides to any Agency or regulatory authority, copies of any and all documents, responses or explanations relating to items set forth above, in each case purged only of trade secrets of the recipient that are unrelated to the obligations under this Agreement or are unrelated to Product. In the event such governmental agency or authority requests or requires any action to be taken to address any citations, the recipient agrees, after consultation with the other party, to take such action as necessary to address such citations , and agrees to cooperate with the other party with respect to any such citation and/or action taken with respect thereto.
Notification of Inspections. FFFC agrees to notify Cempra in writing as soon as possible of any written or oral inquiries, notifications or inspection activity by any Regulatory Authority in regard to the API to be supplied to Cempra hereunder or to any Manufacturing activity related thereto. Cempra shall have the right to attend (or have any Affiliate thereof or licensee of Cempra or any Affiliate thereof attend) any such inspection that relates directly to Manufacturing (including testing) of API. FFFC shall provide a reasonable description of any such governmental or regulatory inquiries, notifications or inspections promptly, but in no event later than one (1) business day after such notification, inquiry or inspection. FFFC shall furnish to Cempra (i) as soon as possible and not to exceed within three (3) business days after receipt, any report or correspondence issued by any Regulatory Authority in connection with such notification, inquiry or inspection, including any List of Inspectional Observations, applicable portions of any Warning Letters, or any equivalent or similar form, letter, or notice in another country or jurisdiction which pertain to the API or any facility involved with the manufacture, handling, or storage thereof, and (ii) not later than ten (10) business days prior to the time it provides to any Regulatory Authority, copies of proposed responses or explanations relating to items set forth above (each, a “Proposed Response”), in each case redacted of trade secrets or other confidential or proprietary information of FFFC that are unrelated to the obligations under this Agreement or are unrelated to API or its manufacture. FFFC shall discuss with Cempra and consider in good faith any comments provided by Cempra on the Proposed Response. After the filing of a response with the Regulatory Authority, FFFC shall notify Cempra promptly in writing of any further contacts with such Regulatory Authority relating to the subject matter of the response until resolution and provide the final outcome (e.g. establishment inspection report (EIR)).
Notification of Inspections. Novasep agrees to notify Celladon within […***…] days of any written or oral inquiries, notifications or inspection activity by any Regulatory Authority in regard to Product supplied or to be supplied to Celladon hereunder. Novasep shall ***Confidential Treatment Requested
Notification of Inspections. Biocon agrees to notify Equillium within […***…] of any written or oral inquiries, notifications or inspection activity by any Regulatory Authority in regard to Clinical Material supplied or to be supplied to Equillium hereunder. Biocon shall provide a reasonable description of any such governmental inquiries, notifications or inspections promptly, but in no event later than […***…] after such notification, inquiry or inspection. Biocon shall furnish to Equillium (i) within […***…] after receipt, any report or correspondence issued by any Regulatory Authority in connection with such notification, inquiry or inspection, including any FDA Form 483 (List of Inspectional Observations) or applicable portions of any FDA warning letters (or any equivalent in another country or jurisdiction) which pertain to ITO or Product, and (ii) not later than […***…] prior to the time it provides to any Regulatory Authority (unless any such response is due to such Regulatory Authority within […***…], in which case Biocon shall furnish to Equillium as soon as reasonably practical, but in any event within […***…] prior to the time it provides to any Regulatory Authority), copies of proposed responses or explanations relating to items set forth above (each, a “Proposed Response”), in each case redacted of trade secrets or other confidential or proprietary information of Biocon that is unrelated to the obligations under this Agreement and is unrelated to Clinical Material or its Manufacture. Biocon shall discuss with Xxxxxxxxx and consider in good faith any comments provided by Xxxxxxxxx on the Proposed Response. Biocon shall provide a copy of the final response submitted to the FDA or other Regulatory Authority no later than […***…] after filing. After the filing of a response with the FDA or other Regulatory Authority, Biocon shall notify Equillium of any further contacts with such Regulatory Authority relating to the subject matter of the response.
Notification of Inspections. Each Party agrees to notify the other within [**CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] days of its receipt of notification of any inquiries, notifications, or inspection activity by any Regulatory Authority, governmental agency or authority in regard to or affecting the Ingredient. The recipient Party shall provide a reasonable description to the other Party of any such governmental inquiries, notifications or inspections promptly (but in no event later than [**CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] days) after notification of completion of such visit or inquiry. The recipient Party shall furnish to the other Party, (i) within [**CONFIDENTIAL TREATMENT REQUESTED; PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] days after receipt, any report or correspondence issued by the Regulatory Authority or governmental authority in connection with such visit or inquiry, including but not limited to, any FDA Form 483, Establishment Inspection Reports or warning letters and (ii) at the same time it provides to any Regulatory Authority or governmental authority, copies of any and all documents, responses or explanations relating to items set forth above, in each case purged only of trade secrets of the recipient that are unrelated to the obligations under this Agreement or the License Agreement or are unrelated to the Ingredient. In the event such governmental agency or authority requests or requires any action to be taken to address any citations, the recipient agrees, after consultation with the other Party, to take such action as necessary to address such citations, and agrees to cooperate with the other Party with respect to any such citation and/or action taken with respect thereto.
Notification of Inspections. OraSure agrees to notify Xxxxxx of any action by the FDA in regard to the Products or OraSure’s Manufacturing activities that could materially affect OraSure’s ability to perform its obligations hereunder.
Notification of Inspections. FAI also agrees to notify SYNOVICS within ten (10) business days xx any written or oral inquiries, notifications or inspection activity by any Regulatory Authority in regard to either the Compound or the Product to be supplied to SYNOVICS hereunder. FAI shall provide a reasonable description of any such governmental inquiries, notifications or inspections promptly (but in no event later than ten (10) business days) after such visit or inquiry. FAI shall furnish to SYNOVICS (i) within ten (10) business days after receipt, any report or correspondence issued by any Regulatory Authority in connection with such visit or inquiry, including but not limited to, any FDA Form 483 (List of Inspectional Observations) or applicable portions of any FDA Warning Letters that pertain to the Products in the Territory and (ii) not later than five (5) business days prior to the time it provides to any Regulatory Authority, copies of proposed responses or explanations relating to items set forth above (each, a "PROPOSED RESPONSE"), in each case redacted of trade secrets or other confidential or proprietary information of FAI that are unrelated to the obligations under this Agreement or are unrelated to any Products. FAI shall discuss with SYNOVICS and consider in good faith any comments provided by SYNOVICS on the Proposed Response. After the filing of a response with the FDA or other regulatory agency, FAI will notify SYNOVICS of any further contacts with such agency relating to the subject matter of the response.
Notification of Inspections. Lonza agrees to notify Altus within [***] any written or oral inquiries, notifications or inspection activity by any Regulatory Authority in regard to Bulk Product Component to be supplied to Altus hereunder. Lonza shall provide a reasonable description of any such governmental inquiries, Execution Original PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
