Novartis Audits Sample Clauses
The "Novartis Audits" clause grants Novartis the right to review and examine the records, processes, or facilities of its contractual partner to ensure compliance with the terms of their agreement. Typically, this clause outlines the scope of audits, the notice period required before an audit, and the types of information or documentation that Novartis may access, such as financial records or quality control data. Its core practical function is to provide Novartis with oversight and assurance that contractual obligations are being met, thereby mitigating risks related to non-compliance or mismanagement.
Novartis Audits. (i) For the purpose of ensuring Legend’s compliance with this Agreement, Legend agrees and will ensure that its employees, directors, officers, [***] (to the extent Legend or its Affiliates has the right) and agents agree (where necessary) that Novartis or one of its designated Affiliates or a Third Party auditor [***] shall have the right, [***] upon reasonable prior notice (of no less than [***]) from Novartis, [***], but no more than [***] (inclusive of any initial qualification audit conducted pursuant to Section 7.2(d)(vi)), for a period of up to [***], to audit and have access to: (A) [***]; (B) [***]; and (C) [***], in each case ((A)–(C)), to the extent necessary to confirm Legend’s compliance with Article 4 of this Agreement. The audit and access rights referenced under this Section 7.2(d), include without limitation the right to conduct face to face or on-line interviews with Legend’s employees, directors, officers, [***] and agents, the right to access and review (in both soft and hard copy) any and all internal policies, internal audit reports, standard operating procedures, procedures, guidelines, or other internal documentation of Legend (including non-confidential documentation with Third Parties relating to the audit scope and Legend’s corporate structure), respective evidence and proof and all written explanations provided by Legend reasonably necessary to [***]. Any audit (and related data collection activities) shall be carried out in compliance with Applicable Laws.
(ii) Each Party shall, subject to Section 4.3, [***] of any audit conducted pursuant to this Section 7.2(d).
(iii) Following any such audit, Novartis may provide Legend with an audit report, which shall enable Legend to, [***], prepare a corrective action plan (including a timetable to implement and complete the plan) to address any major or critical deviations or deficiencies identified in the audit for Novartis’ review. [***] shall review and approve ([***]) the corrective action plan, and Legend shall [***] implement any reasonable corrections in accordance with such mutually agreed corrective action plans. Notwithstanding any recommendations provided by Novartis to Legend, [***]. Legend will conduct its obligations with respect to a corrective action plan, subject to Section 4.3, [***].
(iv) Nothing in this Section 7.2(d) requires Legend to provide information on profits, margins, overheads or costs of capital [***] for the purposes of an audit, or to provide any confiden...
Novartis Audits. (i) For the purpose of ensuring Licensor’s compliance with this Agreement, Licensor agrees and will ensure that its Affiliates and its and their respective employees, directors, officers and agents agree, and will use commercially reasonable efforts to ensure that its subcontractors agree, (where necessary) that Novartis or [***] of its designated Affiliates or a Third Party acting on Novartis’ behalf shall have the right, at any time upon reasonable prior notice from Novartis, during [***] (except as otherwise specified in this Agreement) to audit and have access to: [***]. The audit and access rights referenced under this Section 7.2(d) (Novartis Audits) include the right to conduct reasonable face-to-face or on-line interviews with Licensor’s and its Affiliates’ and their respective employees, directors, officers, agents and, where permissible, subcontractors, the right to access and review any and all internal policies, internal audit reports, standard operating procedures, procedures, guidelines, or other internal documentation of Licensor its Affiliates and its and their respective subcontractors (where permissible), respective evidence and proof and all written explanations provided by Licensor to confirm its compliance with the provisions of this Agreement (other than Licensor’s payment obligations). Any audit (and related data collection activities) shall be carried out in compliance with Applicable Laws.
(ii) Each Party shall bear its own costs and expenses of any audit conducted pursuant to this Section 7.2(d) (Novartis Audits).
(iii) Following any such audit, Novartis may provide Licensor with an audit report, which shall enable Licensor to, acting reasonably and without undue delay, prepare a corrective action plan (including a timetable to implement and complete the plan) to address any deviations or deficiencies identified in the audit for Novartis’ review. Novartis shall review and the Parties shall mutually approve (with neither Party having final decision-making authority) the corrective action plan, and Licensor shall, and shall cause its Affiliates and its and their respective subcontractors or CMOs to, implement any reasonable corrections in accordance with such corrective action plan. Notwithstanding any recommendations provided by Novartis to Licensor, Licensor will remain responsible for the implementation of such corrective action plan and acknowledges and agrees that it places reliance on such recommendations at its own risk and a...
Novartis Audits. Arvinas agrees and will ensure that its Affiliates and its and their respective employees, directors, officers, subcontractors and agents agree (where necessary) that Novartis or one of its designated Affiliates or a Third Party acting on Novartis’ behalf and reasonably acceptable to Arvinas shall have the right, [**] during the period in which Arvinas is supplying the Licensed Compound and Licensed Product or conducting any Arvinas Clinical Trial Activities, as applicable, [**], to audit and have access to: (1) all Records relating to [**], in the possession or Control of Arvinas, its Affiliates and its and their respective subcontractors; and (2) Arvinas’ compliance/anti-corruption program. The audit and access rights referenced under this Section 7.2(c) include the right to conduct reasonable face to face or on-line interviews with Arvinas’ and its Affiliates’ and their respective employees, directors, officers, subcontractors and agents and the right to access and review (in both soft and hard copy) any and all Records, internal audit reports, standard operating procedures, procedures, and guidelines of Arvinas, its Affiliates and its and their respective subcontractors within the audit scope (including documentation with Third Parties relating to the audit scope). Any audit (and related data collection activities) shall be carried out in compliance with Applicable Laws.
Novartis Audits