Governmental Inspections. During the Exclusive Period, each Party shall advise and provide a reasonable description to the other Party of any governmental visits to, or written or oral inquiries about, any facilities or procedures for the manufacture, storage or handling of Product, promptly (but in no event later than five (5) calendar days) after such visit or inquiry. Each Party shall furnish to the other Party, (a) within two (2) days after receipt, any report or correspondence issued by the governmental authority in connection with such visit or inquiry, including but not limited to, any FDA Form 483 Establishment Inspection Reports, warning letters, and (b) at the same it provides to a governmental authority, copies of any and all responses or explanations relating to items set forth in Section 3.5(a), in each case purged only of trade secrets of the receiving Party that are unrelated to the other Party's activities under this Agreement and any information that is unrelated to the Product.
Governmental Inspections. For a period of [****]* following the Closing Date each party shall advise the other party of any governmental visits to, or written or oral inquiries about, any facilities (to the extent such visit relates to, or the results thereof could affect the manufacture or supply of, the CV Products) or procedures for the manufacture, storage or handling of the CV Products, or the marketing, selling, promotion or distribution of any of the CV Products, promptly after any such visit or inquiry (or in advance, for any scheduled visits). During this period, each party shall promptly furnish to the other party any report or correspondence issued by or provided to a Governmental Entity in connection with such visit or inquiry, purged only of Confidential Information of such party wholly unrelated to the other party’s activities under this Agreement and any information that is unrelated to the CV Products. Each party shall permit the relevant Governmental Entity to inspect its facilities in connection with the activities contemplated by this Agreement.
Governmental Inspections. Each party shall advise the other party of any governmental visits to, or written or oral inquires about, any facilities or procedures for the manufacture, storage, or handling of the Licensed Product, or the marketing, selling, promotion or distribution of the Licensed Product, promptly (but in no event later than [*] after notice of such visit or inquiry. Each party shall, within [*] of receipt or submission, furnish to the other party any report or correspondence issued by or provided to the governmental authority in connection with such visit or inquiry.
Governmental Inspections. For a period of [**] years following the Closing Date, each party shall advise the other party of any governmental visits to, or written or oral inquiries about, any facilities (to the extent such visit relates to, or the results thereof could affect the manufacture or supply of, the Product) or procedures for the manufacture, storage or handling of the Product, or the marketing, selling, promotion or distribution of the Product, promptly after any such visit or inquiry (or in advance, for any scheduled visits). During this period, each party shall promptly furnish to the other party any report or correspondence issued by or provided to a Governmental Entity in connection with such visit or inquiry, purged only of Confidential Information of such party wholly unrelated to the other party’s activities under this Agreement and any information that is unrelated to the Product. Each party shall permit the relevant Governmental Entity to inspect its facilities in connection with the activities contemplated by this Agreement.
Governmental Inspections. Each party shall advise the other party of any governmental visits to, or written or oral inquiries about, any facilities (to the extent such visit relates to, or the results thereof could affect the manufacture or supply of, a Product) or procedures for the manufacture, storage or handling of a Product, or the marketing, selling, promotion or distribution of any Product, promptly after any such visit or inquiry (or in advance, for any scheduled visits). Each party shall promptly furnish to the other party any report or correspondence issued by or provided to the governmental authority in connection with such visit or inquiry, purged only of confidential information of such party wholly unrelated to the other party's activities under this Agreement and any information that is unrelated to the Products. Each party shall permit the relevant governmental authorities to inspect its facilities in connection with the activities contemplated by this Agreement.
Governmental Inspections. Seller shall notify Company (i) sufficiently in advance of any known upcoming significant inspections by any Governmental Authority relating to the Facility, to allow Company the opportunity to attend, and (ii) promptly after any unscheduled or impromptu inspection with a description of the nature and outcome of such inspection. Commercial Operation. Seller shall cause COD to occur no later than [_______, 20__] (the “Target COD”). Company shall not be obligated to accept and establish a Commercial Operation Date earlier than [_______, 20__] (insert date that is 90 days prior to Target COD). Seller shall notify Company of the date on which Seller believes the Facility has achieved Commercial Operation (a “COD Notice”). A COD Notice shall include all necessary supporting documentation of the satisfaction or occurrence of all COD Conditions. Company shall have 10 Business Days to review a COD Notice and raise any Commercially Reasonable objection to Seller’s satisfaction of any of the COD Conditions, provided, however, that Seller’s COD Notice shall be deemed accepted by Company if Company fails to object within such time period. Seller may notify Company of completion of one or more COD Conditions on an individual and incremental basis prior to COD, provided, however, that Company shall in all cases have up to 10 Business Days to review and object to each such notice. For purposes hereof:
Governmental Inspections. Aventis shall advise Purchaser immediately upon receiving a notice that an authorized agent of a Governmental Authority will visit or inspect its facilities where the Product is being manufactured, processed, packaged, labeled, tested or stored. Aventis shall furnish to Purchaser all material information supplied to, or supplied by, any Governmental Authority, including, without limitation, any Notice of Inspection, Form 483 observations and warning letters, untitled letters, to the extent that such reports or letters relate to Product, or the ability of Aventis to supply such Product, within five (5) Business Days of their receipt of such information or delivery of such information, as the case may be. Aventis shall be [*] Confidential treatment requested. responsible for responding to all such notices, forms or letters, except that Aventis shall provide such responses to Purchaser, to the extent feasible, at least three (3) Business Days prior to submission to any Governmental Authority and shall incorporate such reasonable and timely revisions as suggested by Purchaser.
Governmental Inspections. If JULPHAR is notified that the Active Ingredient or the Production Site will be subject to an inspection related to the Active Ingredient, by any Governmental Authority, JULPHAR shall promptly inform DANCE of such inspection and shall cooperate with and allow such inspection to the extent required by Applicable Laws. Subject to being excluded due to restrictions under confidentiality obligations of JULPHAR to Third Parties, and to JULPHAR’s determination that particular information and/or documentation is confidential in nature, JULPHAR shall provide information related to inspection outcomes to DANCE resulting from such inspection to the extent relevant to the Active Ingredient. JULPHAR will promptly inform DANCE whether any Form FDA 483 (or its equivalent) or warning letters or citations (collectively a “483 Notice”) are issued to JULPHAR (by the FDA or any other Governmental Authority) which are related to or impact the supply of the Active Ingredient to DANCE, and if the 483 Notice relates directly to the Active Ingredient, then JULPHAR shall use commercially reasonable effort to resolve it as quickly as practical.
Governmental Inspections. If any governmental authority notifies CRO, or CRO becomes aware, that any such regulatory authority intends to inspect, audit, or investigate CRO or take any regulatory action in connection with a Site or the Project or its obligations hereunder, CRO shall notify Sponsor within twenty-four (24) hours of receipt of such notice or becoming so aware. If not prohibited by any Applicable Laws, Sponsor may be present during, and witness, any such inspection, audit, investigation or regulatory action. CRO will cooperate with the applicable governmental authority in such inspections, audits, and investigations and will maintain the records related to the Project and this Agreement in a way that facilitates such activities.
Governmental Inspections. Seller shall give Buyer or its affected Affiliate prompt notice of any impending inspections by a governmental agency of the facility used for or processes involved in the manufacture of the Systems, and shall provide Buyer and its Affiliate an opportunity to observe such inspection. Seller shall provide Buyer with copies of inspection reports, correspondence and other documents relating to government inspections. Each party shall promptly notify the other of new instructions, regulations or specifications of which it becomes aware which are relevant to the manufacture of the Systems under this Contract and which are required by the Food and Drug Administration or other U.S. federal agency, equivalent foreign regulatory agencies, or other applicable laws or governmental regulations and shall confer with each other with respect to the best means to comply with such requirements. Seller shall be responsible for obtaining and maintaining all necessary plan inspection standards and plant licenses, registrations or permits to enable the manufacture and sale of the Systems. Each party will promptly notify the other party of any comments, responses or notices that a party receives from any governmental authorities which relate to the regulatory status of the Systems in any applications or fields other than the irradiation of food, flowers or animal hides.
