Manufacturing Audit definition

Manufacturing Audit means an audit of Supplier’s Facility by no more than *** Medicis employees and/or agents for purposes of reviewing Supplier’s procedures and processes used in manufacturing and/or packaging the Products. Any such agents shall be qualified to conduct manufacturing audits, shall comply with all Supplier’s facility rules regarding safety and security notified by Supplier to Medicis and its employees and/or 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 Medicis subject to the terms hereof. Each Manufacturing Audit shall be conducted during Supplier’s normal business hours and upon at *** prior written notice to Supplier in the case of an Annual MA, or *** notice to Supplier in the case of an Incident MA. In no event shall a Manufacturing Audit exceed *** in duration, and in all cases Medicis shall ensure that its employees or agents will conduct each Manufacturing Audit, to the extent reasonably possible, so as not to interfere with the normal and ordinary operation of Supplier’s Facility. During a Manufacturing Audit, upon Medicis’s request, Supplier shall make available for Medicis’s review and inspection all equipment and facilities used in or in relation to the manufacture and/or packaging of the Products, records and support documents (i.e., manufacturing and analytical) with respect to each batch of the Products and other raw materials and packaging components used in the manufacture or packaging of the Products hereunder. At any such audit, Medicis shall have the right to obtain copies of such batch records with respect to the Product, provided that if this would involve Supplier incurring significant cost then the parties will discuss appropriate cost sharing of those expenses.

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Manufacturing Audit means Client’s planned, independent, documented, objective assessment of Cytovance and the portions of the Facility used for production of Client Product to verify that Cytovance’s systems and processes used to manufacture Client Product are in accordance with the agreed-upon quality expectations and applicable requirements from Regulatory Authorities. A Manufacturing Audit is not all inclusive and only includes review of systems, processes, procedures, and documentation related to Client Product.

Manufacturing Audit means an audit of the relevant Manufacturing Facility to be conducted by Customer and its Product Licensees or designees. Each Manufacturing Audit shall be conducted during Hovione’s normal business hours and upon reasonable prior written notice to Hovione (“reasonable”, for purposes of this provision, shall be at least [***] days, except that an Event MA shall occur as soon as reasonably practicable, and each Manufacturing Audit shall last no longer than [***], except that an Event MA may last longer as reasonably necessary. During a Manufacturing Audit, upon Customer’s request, Hovione shall make available for review and photocopying such documents as Customer and its auditors may reasonably request provided they relate to the Product and its Manufacture by Hovione.

Examples of Manufacturing Audit in a sentence

Receiving Party’s representative(s) or agent(s) conducting a Quality Audit will be qualified to conduct such audits, shall comply with Supplying Party’s safety and security rules, and will execute a commercially reasonable confidentiality agreement respecting the information obtained during the Manufacturing Audit.
Lush Manufacturing will provide a report of the Second Manufacturing Audit to the FWO in writing within 45 days of the due date referred to in paragraph 52 above.
Up to [***] Customer representatives shall have the right to conduct [***] Manufacturing Audit (as defined below) [***] during the term of this Agreement.(such Manufacturing Audit to be hereinafter referred to as a “Periodic 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.
In all cases New River 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 Patheon’s Plant.
Once every [***] during the Term, ACHAOGEN shall have the right to conduct one (1) Manufacturing Audit (as defined below) according to the terms specified in Section 11.4 hereof (such Manufacturing Audit to be hereinafter referred to as a “Periodic MA”).
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.
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.
In no event shall a Manufacturing Audit exceed [* *], and in all cases Customer shall ensure that its employees or agents will conduct each Manufacturing Audit so as not to interfere with the normal and ordinary operation of Catalytica's manufacturing facility.
Lush Manufacturing will notify the FWO in writing of the name of the professional services provider engaged to carry out the Second Manufacturing Audit by no later than seven days after the due date referred to in paragraph 52 above.

More Definitions of Manufacturing Audit

Manufacturing Audit means an audit by no more than three individuals, reasonably acceptable by both parties, of that portion of Faulding's manufacturing facility where the Formulated Product is manufactured and of such documentation specifically relating to the manufacture of the Formulated Product, for purposes of confirming that Faulding's procedures and processes used in manufacturing the Formulated Product conform to GMP. Any such individuals shall be accompanied by Faulding personnel at all times, shall be qualified to conduct manufacturing audits, shall comply with Faulding's rules and regulations relating to facility security, health and safety, and shall execute a written agreement to maintain in confidence all information obtained during the course of any such audit except for disclosure to NaPro with respect to the Formulated Product for the purposes set forth in this Section 3.12.

Manufacturing Audit means 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 means an audit of that portion of Catalytica's ------------------- manufacturing facility where the Product is manufactured, packaged or tested (including analyzed or released) [* *] for purposes of reviewing Catalytica's procedures and processes used in manufacturing the Product. Any such employees and/or representative shall be accompanied by Catalytica personnel at all times, shall be qualified to conduct manufacturing audits, shall comply with Catalytica's rules and regulations relating to facility security, health and safety, and shall execute a written agreement with terms at least as restrictive as those in this Agreement to maintain in confidence all Confidential Information obtained during the course of any such audit except for disclosure to Customer. Each Manufacturing Audit shall be conducted during Catalytica's normal business hours and upon [* *] prior written notice to Catalytica in the case of a [* *] MA, or [* *] prior written notice to Catalytica in the case of an Event MA. The written notice shall identify any specific audit requests that Customer intends to make of Catalytica and Customer's contact person with regard to the Manufacturing Audit. In no event shall a Manufacturing Audit exceed [* *], and in all cases Customer shall ensure that its employees or agents will conduct each Manufacturing Audit so as not to interfere with the normal and ordinary operation of Catalytica's manufacturing facility.

Manufacturing Audit has the meaning set forth the Quality Assurance Agreement.

Manufacturing Audit means an audit by no more than two (2) employees and/or one (1) agent of ORPHAN of that portion of Catalytica’s manufacturing facility where the Product is manufactured for purposes of reviewing Catalytica’s procedures and processes used in manufacturing the Product. Any such employees and/or agent shall be accompanied by Catalytica personnel at all times, shall be qualified to conduct manufacturing audits, shall comply with Catalytica’s rules and regulations relating to facility security, health and safety, and shall execute a written agreement to maintain in confidence all information obtained during the course of any such audit except for disclosure to ORPHAN. Each Manufacturing Audit shall be conducted during Catalytica’s normal business hours and upon at least sixty (60) days’ prior written notice to Catalytica in the case of an Annual MA, or upon at least ten (10) days’ prior written notice to Catalytica in the case of an Event MA. The written notice shall identify any specific audit requests that ORPHAN intends to make of Catalytica and ORPHAN’S contact person with regard to the Manufacturing Audit. In no event shall a Manufacturing Audit exceed three (3) days in duration (ORPHAN will be billed at Catalytica’s standard full time equivalent rates for any Manufacturing Audit that, with Catalytica’s permission, exceeds three (3) days), and in all cases ORPHAN shall ensure that its employees or agents will conduct each Manufacturing Audit so as not to interfere with the normal and ordinary operation of Catalytica’s manufacturing facility. All Manufacturing Audits shall be at ORPHAN’S sole expense.

Manufacturing Audit means an audit of the relevant Manufacturing Facility to be conducted by ACHAOGEN or its designees. Each Manufacturing Audit shall be conducted during HOVIONE’s normal business hours and upon reasonable prior written notice to HOVIONE (“reasonable”, for purposes of this provision, shall be [***] for the Annual MA and [***] for the Event MA) and shall last no longer than [***]. During a Manufacturing Audit, upon ACHAOGEN’s request, HOVIONE shall make available for review and photocopying such documents as ACHAOGEN and its auditors may reasonably request provided they relate to the Product and its Manufacture by HOVIONE.