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. 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 92 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. 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. During the term of this Agreement, each ------------------------ party shall advise the other party of any government visits to, or written or oral inquiries about, any facilities or procedures for the manufacture, storage, and/or handling of the Product, and/or the marketing, selling, promotion or distribution of the Product within two (2) business days after notice of such visit or inquiry (or if no advance notice is given to AAI, then within one (1) business day after occurrence of such visit or inquiry). Each party shall furnish to the other party, within three (3) business days after receipt of any such inquiries, any report or correspondence issued by or provided to the governmental authority in connection with such visit or inquiry, excluding any trade secrets of such party that are unrelated to the activities under this Agreement and any information that is unrelated to the Product. Each party shall permit the relevant governmental authorities to inspect its facilities and records in connection with the activities contemplated by this Agreement.
Governmental Inspections. For a period of nine (9) months 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, Product) or procedures for the manufacture, storage or handling of 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). 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. Tenant shall endeavor to cause any governmental authority required to have issued a Governmental Approval to perform inspections of the Tenant Work, and Tenant shall make available to Landlord copies of all written inspection reports issued relative to the Tenant Work upon request from Landlord.
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.
