Manufacturing Audit Clause Samples

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. Seller shall permit not more frequently than [***], one or more qualified technical specialists from Buyer (or its sublicensee), upon reasonable prior notice and during normal business hours, to conduct audits (including quality, safety and environmental) of the portion of any its facilities or other facilities (to the extent Seller has audit or observation rights over other facilities) used to Manufacture, store, handle or distribute Supplied Product; provided, however, that Seller may refuse access to portions of such facilities where products other than the Supplied Product are Manufactured, stored, handled or distributed and; provided, further, that Seller shall allow and support such additional audits as reasonably requested by Buyer to address specific quality problems relating to the Supplied Product or in response to any applicable Governmental Authority requirements. Subject to compliance with the terms and conditions of the Seller Supply Agreements, one or more qualified technical specialists of Buyer shall be permitted to accompany Seller on Seller’s audits or observation visits of its Sources of Supply to the extent any such audit or observation relates to the Supplied Product; provided that, if Seller has the right to conduct such an audit but decides not to conduct such audit, Seller shall notify Buyer of its decision not to exercise such right and Buyer may then request Seller to exercise such right accompanied by one or more qualified technical specialists of Buyer, and Seller shall reasonably cooperate with such request including with respect to scheduling, scope and duration of the audit. Observations and conclusions of any such audits will be issued to Seller and Seller shall provide a written response within [***] of receipt of such observations and conclusions. The Parties shall discuss such response and agree on corrective action to be implemented. Seller shall ensure that agreed corrective action shall be implemented by the audited party, at the audited party’s expense.

Manufacturing Audit. ▇▇▇▇, 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 ▇▇▇▇’▇ 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. 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. The term “Manufacturing Audit” shall mean an audit of the Facility by agents of STRYKER for purposes of reviewing SUPPLIER’s procedures and processes used in manufacturing the Product and SUPPLIER’s compliance with this Agreement. Any STRYKER employees or agents conducting a Manufacturing Audit, Event MA and observational visits, shall be qualified to conduct such audits or visits, shall comply with all SUPPLIER’s facility rules regarding safety and security notified by SUPPLIER to STRYKER and its employees and agents and shall execute a written agreement to maintain in confidence all information obtained during the course of any such audit except for disclosure to STRYKER, such agreement to be negotiated between the Parties. Each Manufacturing Audit shall be conducted during SUPPLIER’s normal business hours and upon at least fifteen (15) business days’ prior written notice to SUPPLIER in the case of an Annual MA, or within two business days prior written notice to SUPPLIER in the case of an Event MA. In all cases STRYKER shall ensure that its employees or agents will conduct each Manufacturing Audit as is reasonably practicable not to interfere with the normal and ordinary operation of the Facility. During a Manufacturing Audit, upon STRYKER’s request, SUPPLIER shall make available for STRYKER’s review and inspection all equipment and facilities used in or in relation to the manufacture, packaging, testing, labeling or storing of the Product, records and supporting documents (e.g., manufacturing, analytical, and testing documentation) with respect to each production lot of the Product and other materials used in the manufacture of the Product. At any such audit, STRYKER shall have the right to obtain copies of records concerning the Product; provided however, that STRYKER pays SUPPLIER for its reasonable costs associated with making such copies. STRYKER or its Affiliates’ employees or agents will be escorted at all times by SUPPLIER personnel. All audits will be conducted in accordance to all regulations STRYKER must comply to, including but not limited to: Q▇▇, ▇▇▇▇▇▇▇▇, Medical Device Directive (“MDD”), MHLW Ordinance No. 169 and the CMDR.

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.