Common use of Manufacturing Audit Clause in Contracts

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. For purposes of this Agreement, the The term "“Manufacturing Audit" ” shall mean an audit of JB Labs' Plant for the Product Facility by no more than [**] employees and/or [**]agents of Xanodyne STRYKER for purposes of reviewing JB Labs' SUPPLIER’s procedures and processes used in Manufacturing manufacturing the Products, unless otherwise agreedProduct and SUPPLIER’s compliance with this Agreement. Any such STRYKER employees or agents conducting a Manufacturing Audit, Event MA and observational visits, shall be qualified to conduct manufacturing auditssuch audits or visits, shall comply with all JB Labs' SUPPLIER’s facility rules regarding safety and security notified by JB Labs SUPPLIER to Xanodyne STRYKER and its employees and agentsagents 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 JB Labs' SUPPLIER’s normal business hours and upon at least fifteen (15) business days' ’ prior written notice to JB Labs SUPPLIER in the case of an Annual MA, or with within two business days prior written notice to JB Labs SUPPLIER in the case of an Event MA. In all cases Xanodyne STRYKER shall ensure that its employees or agents will conduct each Manufacturing Audit so as not, insofar as is reasonably practicable, practicable not to interfere with the normal and ordinary operation of JB Labs' Plantthe Facility. During a Manufacturing Audit, upon Xanodyne's STRYKER’s request, JB Labs SUPPLIER shall make available for Xanodyne's STRYKER’s review and inspection all equipment and facilities used in or in relation to the Manufacture manufacture, packaging, testing, labeling or storing of a the Product, records and support supporting documents (i.e. manufacturing e.g., manufacturing, analytical, and analyticaltesting documentation) with respect to each Batch production lot of the Product and other Raw Materials and packaging components materials used in the Manufacture or packaging manufacture of the Product hereunderProduct. At any such audit, Xanodyne STRYKER shall have the right to obtain copies of such batch records with respect to concerning the Product(s), Product; provided however, that Xanodyne STRYKER pays JB Labs 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 costs of an Event MA shall audits will be borne by Xanodyne unless conducted in accordance to all regulations STRYKER must comply to, including but not limited to: QXX, XXX00000, Medical Device Directive (“MDD”), MHLW Ordinance No. 169 and 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 auditCMDR.

Manufacturing Audit. For purposes of this Agreement, the term "“Manufacturing Audit" ” shall mean an audit of JB Labs' Patheon’s Plant for the Product by no more than [**] employees and/or [**]agents of Xanodyne New River for purposes of reviewing JB Labs' Patheon’s procedures and processes used in Manufacturing manufacturing the New River Products, unless otherwise agreed. Any such agents shall be qualified to conduct manufacturing audits, shall comply with all JB Labs' Patheon’s facility rules regarding safety and security notified by JB Labs Patheon to Xanodyne New River and its employees and agentsagents and shall execute a written agreement to maintain in confidence all information obtained during the count of any such audit except for disclosure to New River subject to the terms hereof. Each Manufacturing Audit shall be conducted during JB Labs' Patheon’s normal business hours and upon at least fifteen (15) days' prior written notice [***] to JB Labs Patheon in the case of an Annual MA, or with prior at least 3 working days notice to JB Labs Patheon in the case of an Event MA. The dates of the audit will be mutually agreed upon by the Parties. In all cases Xanodyne New River shall ensure that its employees or agents will conduct each Manufacturing Audit so as not, insofar as is reasonably practicable, practicable to interfere with the normal and ordinary operation of JB Labs' Patheon’s Plant. During a Manufacturing Audit, upon Xanodyne's New River’s request, JB Labs Patheon shall make available for Xanodyne's New River’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 New River shall have the right to obtain copies of such batch records with respect to the Product(sNew River product(s), provided however, that Xanodyne New River pays JB Labs Patheon for its reasonable costs associated with making such copies. All costs of an Event MA shall be borne by Xanodyne New River unless the requirement for audit arises as a result of the negligence of JB Labs Patheon or the breach of the terms of this Agreement or the Manufacturing Agreement by JB LabsPatheon, in which case JB Labs Patheon shall absorb all costs associated with the audit.

Manufacturing Audit. For purposes of this Agreement, the term "Manufacturing Audit" Seller shall mean an audit of JB Labs' Plant for the Product by no permit not more frequently than [**] employees and/or *], 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 [**]agents *] of Xanodyne for purposes receipt of reviewing JB Labs' procedures such observations and processes used in Manufacturing the Products, unless otherwise agreedconclusions. Any The Parties shall discuss such agents shall response and agree on corrective action to 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 agentsimplemented. 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 Seller 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 agreed corrective action shall be borne implemented by Xanodyne unless the requirement for audit arises as a result of audited party, at 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 auditaudited party’s expense.