Changes Required for Compliance Clause Samples

Changes Required for Compliance. If during the Term a Change is required to comply with changes in Agreed Standards made by Regulatory Authorities, Applicable Laws and/or other requirements of a Regulatory Authority, or if Miltenyi determines, in its reasonable judgment, that a Change is [***] in regard to the Miltenyi Product generally (in each case, a “Required Change”), Miltenyi shall use Commercially Reasonable Efforts to implement such Required Change [***]. However, in the event that a Required Change is specifically related to the use of Miltenyi Product for [***] (a “[***] Required Change”), then Miltenyi shall use Commercially Reasonable Efforts to implement such [***] Required Change only if and to the extent Autolus agrees to [***] as a result of any such [***] Required Change. Prior to implementing a Required Change in accordance with this Section 3.2(c), Miltenyi shall promptly advise Autolus as to any [***] which may result from any such Required Change, if any. Miltenyi and Autolus shall negotiate in good faith in an attempt to reach agreement on (i) the [***], if any, for any Miltenyi Product which embodies such Required Change, giving due consideration to the effect of such change on Miltenyi’s [***] associated with Miltenyi’s activities required to implement such Change, and (iii) any other amendments to this Agreement which may be necessitated by such Change (e.g., an adjustment to the [***]). For clarity, Miltenyi shall have no obligation to implement an [***] Required Change unless and until the Parties have reached agreement on all items as described in the preceding sentence.
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Changes Required for Compliance. If during the Term a Change is required to comply with changes in Agreed Standards made by Regulatory Authorities, Applicable Laws and/or other requirements of a Regulatory Authority, or if Miltenyi determines, in its reasonable judgment, that a Change is required to address safety and/or quality issues in regard to the Miltenyi Product generally (in each case, a “Required Change”), Miltenyi shall use [...***...] to implement such Required Change at its cost. However, in the event that a Required Change is specifically related to the use of Miltenyi Product for a Permitted Use in relation to a Bellicum Product (a “Bellicum-Specific Required Change”), then Miltenyi shall use [...***...] to implement such Bellicum-Specific Required Change only if and to the extent Bellicum agrees to reimburse Miltenyi for all documented costs and expenses reasonably incurred by Miltenyi as a result of any such Bellicum-Specific Required Change. Prior to implementing a Required Change in accordance with this Section 3.2(c), Miltenyi shall promptly advise Bellicum as to any scheduling and/or Product Price adjustments which may result from any such Required Change, if any. Miltenyi and Bellicum shall negotiate in good faith in an attempt to reach agreement on (i) the new Product Price, if any, for any Miltenyi Product which embodies such Required Change, giving due consideration to the effect of such change on Miltenyi’s manufacturing costs for the changed Miltenyi Product as well as any other relevant factors, (ii) the responsibility for any costs and expenses associated with Miltenyi’s activities required to implement such Change, and (iii) any other amendments to this Agreement which may be necessitated by such Change (e.g., an adjustment to the lead time for firm orders). For clarity, Miltenyi shall have no obligation to implement a Bellicum-Specific Required Change unless and until the Parties have reached agreement on all items as described in the preceding sentence.
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Changes Required for Compliance. If during the Term a [***] is required to [***], or if Miltenyi determines, in its reasonable judgment, that [***] generally (in each case, a “[***]”), Miltenyi shall use Commercially Reasonable Efforts to [***]. However, in the event that [***] is specifically related to [***], then Miltenyi shall use Commercially Reasonable Efforts to [***] only if and to the extent Autolus agrees [***] as a result of any such [***]. Prior to [***] in accordance with this Section 3.2(c), Miltenyi shall promptly advise Autolus as to any [***]. Miltenyi and Autolus shall negotiate in good faith in an attempt to reach agreement on (i) the [***] for any Miltenyi Product which embodies [***], giving due consideration to the effect of [***] as well as any other relevant factors, (ii) the responsibility for [***] associated with Miltenyi’s activities required to [***], and (iii) any other amendments to this Agreement which may be necessitated by [***] (e.g., an adjustment to [***]). For clarity, Miltenyi shall have no obligation to [***] unless and until the Parties have reached agreement on all items as described in the preceding sentence.
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Related to Changes Required for Compliance

  • Required Forms If subcontractors are used under the contract that has no stated HUB goal, Exhibits ▇-▇, ▇-▇, ▇-▇ and H-6 are required. Exhibits H-1 and H-6 are required if no subcontractors are being used to perform work under this contract.

  • Compliance with Accessibility Standards All parties to this Agreement shall ensure that the plans for and the construction of all projects subject to this Agreement are in compliance with standards issued or approved by the Texas Department of Licensing and Regulation (TDLR) as meeting or consistent with minimum accessibility requirements of the Americans with Disabilities Act (P.L. 101-336) (ADA).

  • COMPLIANCE WITH Governing Law This Agreement will be subject to termination or modification at any time to the extent its performance may conflict with any federal or state law or any rule, regulation or order of a federal or state regulatory body having jurisdiction. This Agreement shall be subject to approval of any federal or state regulatory body whose approval is a legal prerequisite to its execution and performance. Cost allocations and the methods of allocation provided herein may also be subject to the jurisdiction of the Federal Energy Regulatory Commission (“FERC”) under Section 1275 of the Energy Policy Act of 2005 and the rules promulgated thereunder and, to the extent applicable, FERC determinations regarding the allocation of costs shall be dispositive. Any number of counterparts of this Agreement may be executed, and each shall have the same force and effect as an original instrument, as if all parties to all counterparts had signed the same instrument.

  • Securities Law Compliance Notwithstanding anything to the contrary contained herein, you may not exercise your option unless the shares of Common Stock issuable upon such exercise are then registered under the Securities Act or, if such shares of Common Stock are not then so registered, the Company has determined that such exercise and issuance would be exempt from the registration requirements of the Securities Act. The exercise of your option also must comply with other applicable laws and regulations governing your option, and you may not exercise your option if the Company determines that such exercise would not be in material compliance with such laws and regulations.

  • DECLARATION OF COMPLIANCE WITH APPLICABLE STANDARDS 1. Does the Work report experiments involving human subjects? [ ] YES [ ] NO  If Yes, were the reported experiments in accordance with the ethical standards of the committee responsible for human experimentation (institutional and national), and with the Helsinki Declaration of 1975, as revised in 2013 (▇▇▇▇://▇▇▇▇▇▇.▇▇▇.▇▇▇/ecodes/node/3931 )? [ ] YES [ ] NO (If Yes, the Assignor must submit a copy of the approval and consent-to-disclose form to ▇▇▇▇▇▇▇ Science Publishers by fax or email.) Please state whether Ethical Approval was given, by whom and the relevant Judgement’s reference number. (If No, the Assignor must mention an institutional or regional guideline.) 2. Does the Work report experiments involving animals? [ ] YES [ ] NO  If Yes, were the reported experiments in accordance with the standards set forth in one of below national guidelines and regulations: o The US National Research Council's "Guide for the Care and Use of Laboratory Animals," o The US Public Health Service's "Policy on Humane Care and Use of Laboratory Animals," and "Guide for the Care and Use of Laboratory Animals." o UK : the Animals (Scientific Procedures) Act 1986 Amendment Regulations (SI 2012/3039). [ ] YES [ ] NO 6 [v.122016] Conflicts of interest arise when authors, reviewers, or editors have interests (such as financial or personal interests) that are not made clear and that may influence their judgment on the content of their work. Authors and editors who submit work for publication with ▇▇▇▇▇▇▇ Science are required to disclose and acknowledge all forms of financial support relating to the work to be published, all commercial or financial involvement that might present an appearance of a conflict of interest in respect of the work, and all agreements relating to sponsorship of any research upon which the work is based. Are there any actual, or potential, conflicts of interest? [ ] YES [ ] NO If Yes, details of the actual or potential conflicts of interest must be set-out in the spaces provided below. Does Assignor require assistance in having the English grammar and style of the Work checked and improved by ▇▇▇▇▇▇▇ Science? [ ] YES [ ] NO If Yes, ▇▇▇▇▇▇▇ Science will provide a quote in respect of the same.