Manufacturing Audit. Xxxx, either itself or through or with its representatives, shall have the right, twice each calendar year, or more often if a reasonable basis exists therefore (such as, by way of example and not limitation, a change in, or material noncompliance with, applicable laws, regulations and governmental guidelines), upon reasonable notice and during normal business hours, to subject the manufacturing facilities where Corium manufactures, or has manufactured, Product to a cGMP audit or inspection at Xxxx’x expense. This inspection shall be conducted to ensure compliance with all requirements of applicable laws and regulations, including cGMPs, and all guidelines promulgated by the FDA as well as evolving standards required by the FDA. Such inspection and auditing shall be permitted upon reasonable notice and during normal business hours, taking into account Corium’s manufacturing cycle of Product.
Manufacturing Audit. Agile, either itself or through or with its representatives, shall have the right, once each calendar year, or more often if there is a legitimate basis for unusual concern (such as a change in, or material noncompliance with, applicable laws, regulations and governmental guidelines), upon reasonable notice and during normal business hours, to subject the manufacturing facilities where Corium manufactures, or has manufactured, Product to a cGMP audit or inspection at Agile’s expense. This inspection shall be conducted to ensure compliance with all requirements of applicable laws and regulations, including cGMPs, and all applicable guidelines promulgated by the FDA and other relevant regulatory agencies, as well as applicable evolving standards required by the FDA and other relevant regulatory agencies. Such inspection and auditing shall be permitted upon reasonable notice and during normal business hours, taking into account Corium’s manufacturing cycle of Product.
Manufacturing Audit. For purposes of this Agreement, the term "Manufacturing Audit" shall mean an audit of JB Labs' Plant for the Product by no more than [**] employees and/or [**]agents of Xanodyne for purposes of reviewing JB Labs' procedures and processes used in Manufacturing the Products, unless otherwise agreed. Any such agents shall be qualified to conduct manufacturing audits, shall comply with all JB Labs' facility rules regarding safety and security notified by JB Labs to Xanodyne and its employees and agents. Each Manufacturing Audit shall be conducted during JB Labs' normal business hours and upon at least fifteen (15) days' prior written notice to JB Labs in the case of an Annual MA, or with prior notice to JB Labs in the case of an Event MA. In all cases Xanodyne shall ensure that its employees or agents will conduct each Manufacturing Audit so as not, insofar as is reasonably practicable, to interfere with the normal and ordinary operation of JB Labs' Plant. During a Manufacturing Audit, upon Xanodyne's request, JB Labs shall make available for Xanodyne's review and inspection all equipment and facilities used in or in relation to the Manufacture of a Product, records and support documents (i.e. manufacturing and analytical) with respect to each Batch of the Product and other Raw Materials and packaging components used in the Manufacture or packaging of the Product hereunder. At any such audit, Xanodyne shall have the right to obtain copies of such batch records with respect to the Product(s), provided however, that Xanodyne pays JB Labs for its reasonable costs associated with making such copies. All costs of an Event MA shall be borne by Xanodyne unless the requirement for audit arises as a result of the negligence of JB Labs or the breach of the terms of this Agreement or the Manufacturing Agreement by JB Labs, in which case JB Labs shall absorb all costs associated with the audit.
Manufacturing Audit. Kamada shall, as reasonably deemed necessary by Chiesi, but no more frequently than once in any [*****] period and upon not less than [*****] prior written notice from Chiesi and in a manner calculated not to unreasonably interfere with Kamada’ or its Third Party manufacturers’ conduct of business, allow Chiesi employees or Representatives reasonable access to its and/or its Third Party manufacturers’ manufacturing, packaging, testing, stability, and quality control facilities, as the case may be, that relate to the Product, including the actual process of manufacture and packaging of the Product, at Chiesi's expense. The audit shall be conducted by Chiesi's personnel and any of its designated Representatives each of whom shall, in connection with their participation in such audit, agree to execute a confidentiality agreement in favor of Kamada. Such audits will be conducted during Kamada’s normal business hours and at times mutually agreeable to the Parties.
Manufacturing Audit. ONXEO will permit DARA’s representatives to examine or audit the manufacturing services and documentation for the Product performed hereunder at the manufacturing premises at which the work is conducted: (i) once every two (2) calendar years, upon reasonable advance written notice and not less than thirty (30) working days, during regular business hours, solely to determine that the manufacturing services are being performed in accordance with the Specifications, the FDA Rules and the Quality Agreement and this Supply Agreement (“Audit”), and (ii) without limitation of frequency, during regular business hours, in the event a serious issue arises with the performance of the manufacturing services or a negative finding results from any inspection pursuant to Section 6.7 below (“Audit for Cause”). DARA shall bear all costs and expenses for its own representatives during each Audit on manufacturing site, except for Audits for Cause, the costs of which shall be borne by ONXEO.
Manufacturing Audit. ACY shall have the right to inspect at reasonable intervals and during normal business hours, and on reasonable prior notice, the operations (including without limitation, all such aforesaid records, processes, and other facets of the manufacturing operations) and facilities of APOLLON wherein PRODUCT is manufactured, packaged, inspected, tested, labelled, stored or shipped, and to analyze any tangible material relevant thereto.
