Regulatory Matters (a) VFL and Purchaser shall cooperate and use commercially reasonable efforts to obtain all consents, approvals and agreements of, and to give and make all notices and filings with, any Governmental Entity necessary to authorize, approve or permit the consummation of the transactions contemplated by this Agreement, the Related Agreements and any other agreements contemplated hereby or thereby, including, without limitation, as set forth on Schedule 3.04 and Schedule 4.04. Purchaser and VFL will provide each other and their counsel the opportunity to review in advance and comment on all such filings with any Governmental Entity. Purchaser and VFL will keep each other informed of the status of matters relating to obtaining the regulatory approvals specified in Schedule 3.04 and Schedule 4.04. It is expressly understood by the parties hereto that each party hereto shall use commercially reasonable efforts to ensure that representatives of both Purchaser and VFL shall have the right to attend and participate in any hearing, proceeding, meeting, conference or similar event before or with a Governmental Entity or other organization relating to this Agreement or a Related Agreement. In furtherance of the foregoing, Purchaser and VFL shall provide each other reasonable advance notice of any such hearing, proceeding, meeting, conference or similar event. The notice required to be given under this Section 5.04 shall be given to representatives of VFL or Purchaser entitled to receive notices hereunder.
(b) VFL and Purchaser shall cooperate and use commercially reasonable efforts to obtain all other approvals and consents to the transactions contemplated by this Agreement and the Related Agreements, including the consents of third parties under Assigned Contracts. In the event and to the extent that VFL is unable to obtain any required approval or consent of non-governmental authorities to any agreement to be assigned to Purchaser hereunder, (i) VFL shall use commercially reasonable efforts in cooperation with Purchaser to (A) provide or cause to be provided to Purchaser the benefits of any such agreement, (B) cooperate in any arrangement, reasonable and lawful as to VFL and Purchaser, designed to provide such benefits to Purchaser and (C) enforce for the account of Purchaser any rights of VFL arising from such agreements, including the right to elect to terminate in accordance with the terms thereof on the advice of Purchaser and (ii) Purchaser shall use commercially reasonable efforts to perform the obligations of VFL arising under such agreements and licenses, to the extent that, by reason of the transactions consummated pursuant to this Agreement or otherwise, Purchaser has control over the resources necessary to perform such obligations. If and when any such approval or consent shall be obtained or such agreement or license shall otherwise become assignable, VFL shall promptly assign all of its rights and obligations thereunder to Purchaser without the payment of further consideration and Purchaser shall, without the payment of any further consideration therefor, assume such rights and obligations and VFL shall be relieved of any and all obligation or liability hereunder.
RIGHT OF ALLOTTEE TO USE COMMON AREAS AND FACILITIES SUBJECT TO PAYMENT OF TOTAL MAINTENANCE CHARGES
Veto rights 6.3.4.1 A Member which can show that its own work, time for performance, costs, liabilities, intellectual property rights or other legitimate interests would be severely affected by a decision of the Steering Committee may exercise a veto with respect to the corresponding decision or relevant part of the decision.
6.3.4.2 When the decision is foreseen on the original agenda, a Member may veto such a decision during the meeting only.
6.3.4.3 When a decision has been taken on a new item added to the agenda before or during the meeting, a Member may veto such decision during the meeting and within 15 days after the draft minutes of the meeting are sent.
6.3.4.4 In case of exercise of veto, the Members shall make every effort to resolve the matter which occasioned the veto to the general satisfaction of all Members.
6.3.4.5 A Party may not veto decisions relating to its identification as a Defaulting Party. The Defaulting Party may not veto decisions relating to its participation and termination in the Partnership or the consequences of them.
6.3.4.6 A Party requesting to leave the Partnership may not veto decisions relating thereto.
Data Subjects Rights 5.1. Where a data subject asserts claims for rectification, erasure or access to Us, and where We are able to correlate the data subject to You, based on the information provided by the data subject, We shall refer such data subject to You without undue delay. We shall support You, where possible, and based upon Your instruction insofar as agreed upon. We shall not be liable in cases where You fail to respond to the data subject’s request completely, correctly, or in a timely manner. Notwithstanding the foregoing, if Your employee submits a data subject request in relation to Online Training Cloud, You agree that we can fulfill such request without Your further approval.
5.2. We shall support You, insofar as is agreed upon by the parties, and where possible for Us, in fulfilling data subjects’ requests and claims, as detailed in chapter III of the GDPR and in fulfilling the obligations enumerated in Articles 33 to 36 GDPR.
Regulatory References A reference in this Agreement to a section in the HIPAA Rules means the section as in effect or as amended.
Certain Regulatory Matters Except as set forth on Section 2.24 of the Disclosure Schedules:
(a) No member of the Seller Group is in receipt of notice of, or is subject to any investigation, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”), in each case relating to the Business Products or to the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member of the Seller Group, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulterated.
(b) No member of the Seller Group has made any false statements on, or material omissions from, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business Products.
(c) No member of the Seller Group: (i) has made an untrue statement of material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) or any other Governmental Authority with respect to any product produced sold by any member of the Seller Group, or (ii) has failed to disclose a material fact required to be disclosed to the FDA, USDA or any other Governmental Authority.
(d) No member of the Seller Group: (i) has made or offered any payment, gratuity or other thing of value that is prohibited by any Law to personnel of the FDA, USDA or any other Governmental Authority or any other Person; (ii) has been convicted of any crime under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption Law.
(e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall.
(f) No member of the Seller Group is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.
Limitation on Out-of-State Litigation - Texas Business and Commerce Code § 272 This is a requirement of the TIPS Contract and is non-negotiable. Texas Business and Commerce Code § 272 prohibits a construction contract, or an agreement collateral to or affecting the construction contract, from containing a provision making the contract or agreement, or any conflict arising under the contract or agreement, subject to another state’s law, litigation in the courts of another state, or arbitration in another state. If included in Texas construction contracts, such provisions are voidable by a party obligated by the contract or agreement to perform the work. By submission of this proposal, Vendor acknowledges this law and if Vendor enters into a construction contract with a Texas TIPS Member under this procurement, Vendor certifies compliance.
Product References a. “Or Equal” In all Solicitations or Bid Specifications, the words “or equal” are understood to apply where a copyrighted, brand name, trade name, catalog reference, or patented Product is referenced. References to such specific Product are intended as descriptive, not restrictive, unless otherwise stated. Comparable Product will be considered if proof of compatibility is provided, including appropriate catalog excerpts, descriptive literature, specifications and test data, etc. The Commissioner’s decision as to acceptance of the Product as equal shall be final.
b. Discrepancies in References In the event of a discrepancy between the model number referenced in the Solicitation or Bid Specifications and the written description of the Products that cannot be reconciled, then the written description shall prevail.
Contracts (Rights of Third Parties) Xxx 0000 No term of this Agreement is enforceable under the Contracts (Rights of Third Parties) Xxx 0000 by a person who is not a party to this Agreement.
No Rights to Service Nothing contained in this Agreement shall be construed as giving Participant any right to be retained, in any position, as an employee, consultant or director of the Company or its Affiliates or shall interfere with or restrict in any way the right of the Company or its Affiliates, which is hereby expressly reserved, to remove, terminate or discharge Participant at any time for any reason whatsoever.
