Healthcare and Regulatory Matters. Except, in each case, as may be disclosed on Schedule 3.07(b): (A) The Pacira Entities, and to the knowledge of the Borrower, each of their respective employees, agents, clinical investigators, and contractors solely with respect to the exercise of their respective duties on behalf of the Borrower or its Subsidiaries, are in compliance in all material respects with all applicable Health Care Laws. Neither the Borrower nor any of the other Pacira Entities has received written notice of any pending or, to the knowledge of the Borrower or any Subsidiary, threatened claim, suit, proceeding, hearing, enforcement, audit, inspection, investigation, seizure, shutdown, field action, recall, untitled letter or warning letter, notice of suspension or cancellation of a Drug Establishment License, medical device establishment registration or other license, U.S. Food and Drug Administration (“FDA”) Form 483, arbitration or other similar correspondence or action from the DEA, the U.S. Department of Health and Human Services, the U.S. Department of Health and Human Services Office of Inspector General or any applicable Governmental Authority with jurisdiction over the safety, efficacy, development, manufacture, ownership, testing, storage, transportation, distribution, supply, packaging, processing, use, marketing, labeling, promotion, holding, import or export, disposal or sale or offer for sale of any product, service, operation or activity of the Loan Parties (each a “Regulatory Authority”), alleging that any service, operation or activity of the any Pacira Entity, or any of the products, is in material violation of any applicable Health Care Law. (B) Except as would not reasonably be expected to have a Material Adverse Effect, the Borrower and each of its Subsidiaries, and to the knowledge of the Borrower, each of their respective employees, agents or clinical investigators solely with respect to the exercise of their respective duties on behalf of the Borrower or its Subsidiaries, are in compliance in all material respects with all applicable Health Care Laws. Neither the Borrower nor any of the Subsidiaries has received written notice of any pending or, to the Borrower’s or any Subsidiaries’ knowledge, threatened claim, suit, proceeding, hearing, enforcement, audit, inspection, investigation, seizure, shutdown, field action, recall, untitled letter or warning letter, notice of suspension or cancellation of a Drug Establishment License, medical device establishment r...

Healthcare and Regulatory Matters. (a) (i) CGHC currently conducts, and has at all times since the Look-Back Date conducted, its respective business in all material respects in compliance with all Health Care Laws applicable to their respective operations, activities or services, any agreements executed with any Governmental Authorities as they relate to any Health Care Program and any Orders to which they are a party or are subject, including any settlement agreements or corporate integrity agreements, (ii) since the Look-Back Date, neither CGHC, nor any officer, manager or director of CGHC or, to CGHC’s Knowledge, any independent contractor of CGHC, has received any written notice, citation, suspension, revocation, limitation, warning, or request for production of information or repayment or refund issued by a Governmental Authority that alleges or asserts that CGHC or any officer, manager, director or independent contractor thereof has violated any Health Care Laws or which requires or seeks to adjust, modify or alter CGHC’s operations, activities, services or financial condition that has not been fully and finally resolved to the Governmental Authority’s satisfaction without further liability to CGHC, (iii) CGHC is not a party to any corporate integrity agreement, monitoring agreement, consent decree, deferred prosecution agreement, settlement order or similar agreement with any Governmental Authority with respect to any actual or alleged violation in any material respect of any applicable Health Care Law with material obligations (other than confidentiality obligations) remaining to be performed, (iv) CGHC has not made a voluntary disclosure pursuant to any Governmental Authority self-disclosure protocol or similar procedure, including, but not limited to, the U.S. Department of Health and Human Services Office of Inspector General’s Health Care Fraud Self- Disclosure Protocol or the Centers for Medicare and Medicaid Services’ Self-Referral Disclosure Protocol, and any similar state self-disclosure protocols, or has made a material disclosure to a Governmental Authority regarding potential repayment obligations arising from actual or potential violations of any Health Care Law and (v) there are no restrictions imposed by any Governmental Authority upon CGHC’s business, activities or services that would restrict or prevent in any material respect CGHC from operating as it currently operates. (a) Since the Look-Back Date, no Governmental Authority or Health Care Program has imposed a mat...

Healthcare and Regulatory Matters. Except, in each case, as may be disclosed on Schedule 3.07(b): (i) (A) As of the Effective Date, (B), the Borrower and its Subsidiaries, and to the knowledge of the Borrower, each of their respective employees, agents, clinical investigators, and contractors solely with respect to the exercise of their respective duties on behalf of the Borrower or its Subsidiaries, are in compliance in all material respects with all applicable Health Care Laws, and (C) neither the Borrower nor any of its Subsidiaries has received written notice of any pending or, to the knowledge of the Borrower or any Subsidiary, threatened claim, suit, proceeding, hearing, enforcement, audit, inspection, investigation, seizure, shutdown, field action, recall, untitled letter or warning letter, notice of suspension or cancellation of a drug establishment license, medical device establishment registration or other license, U.S. Food and Drug Administration (“FDA”) Form 483, arbitration or other similar correspondence or action from the DEA, the U.S. Department of Health and Human Services, the U.S. Department of Health and Human Services Office of Inspector General or any applicable Governmental Authority with jurisdiction over the safety, efficacy, development, manufacture, ownership, testing, storage, transportation, distribution, supply, packaging, processing, use, marketing, labeling, promotion, holding, import or export, disposal or sale or offer for sale of any material product, service, operation or activity of the Loan Parties (each a “Regulatory Authority”), alleging that any such service, operation or activity of the Borrower or any of its Subsidiaries, or any of such products, is in material violation of any applicable Health Care Law.

Healthcare and Regulatory Matters. (a) Except as set forth on S chedule 3.27(a), the Company is materially in compliance with Health Care Laws. (b) Except as set forth on S chedule 3.27(b) the Company is not currently a party to or the subject of any Action nor has it received in the past five (5) years written notice from any Governmental Authority that alleges any material noncompliance (or that the Company is or has been under investigation or the subject of an inquiry by any such Governmental Authority for such alleged material noncompliance) with respect to any applicable Health Care Law with respect to the Company. (c) Neither the Company nor any of its officers, directors, employees or agents is or has been the subject of any Action regarding any actual or alleged violation of any anti-bribery, anti- corruption or anti-fraud Legal Requirements that would reasonably be expected to give rise to civil or criminal penalties or potential exclusion from a Government Health Care Program. No such Action has been threatened in writing, and, the Company is not aware of any event that has occurred or circumstance exists that is likely to give rise to any such Action. (d) Except as set forth on Schedule 3.27(d), the Company has not entered into any written agreement or settlement with any Governmental Authority with respect to any Action or its material non-compliance with, or material violation of, any applicable Health Care Law with respect to the Company nor does the Company have on-going obligations from any such written agreement or set of circumstances that would give rise to such material noncompliance by the Company (or that would subject the Company to such an Action, investigation or inquiry by any such Governmental Authority for such alleged material noncompliance). (e) Neither the Company nor any of its officers, directors, employees or agents is or has been (i) excluded from participation in any federal, state or territorial health care programs, (ii) Federal Acquisition Regulation, relating to debarment and suspension applicable to federal Governmental Authorities generally (48 C.F.R. Subpart 9.4), or other applicable Legal Requirement, or (iii) made a party to any other Action by any Governmental Authority that may prohibit such Person from selling products to any governmental or other purchaser pursuant to any federal, state or local Legal Requirement. (f) No employee or other representative of the Company has in furtherance of or in connection with the Business: (i) offered, pro...

Healthcare and Regulatory Matters. Without limiting the generality of any other representation or warranty made in this Agreement, Borrower hereby represents and warrants that the following statements are true, complete and correct, and Borrower hereby covenants and agrees to notify Collateral Agent and Lenders within three (3) Business Days following the occurrence of any facts, events or circumstances, whether threatened, existing or pending, that would make any of the following representations and warranties untrue, incomplete or incorrect (together with such supporting data and information as shall be necessary to fully explain to Collateral Agent and Lenders the scope and nature of the fact, event or circumstance), and shall provide to Collateral Agent and Lenders within two (2) Business Days of Collateral Agent’s or Lender’s request, such additional information as Collateral Agent or Lenders shall request regarding such disclosure:

Healthcare and Regulatory Matters. Without limiting the generality of any other representation or warranty made in this Agreement, Borrower hereby represents and warrants that the following statements are true, complete and correct, and Borrower hereby covenants and agrees to notify Bank within three (3) Business Days following the occurrence of any facts, events or circumstances, whether threatened, existing or pending, that would make any of the following representations and warranties untrue, incomplete or incorrect (together with such supporting data and information as shall be necessary to fully explain to Bank the scope and nature of the fact, event or circumstance), and shall provide to Bank within two (2) Business Days of Bank’s request, such additional information as Bank shall request regarding such disclosure:

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Tax and Regulatory Matters No Buyer Entity or, to the Knowledge of Buyer, any Affiliate thereof has taken or agreed to take any action, and Buyer does not have any Knowledge of any agreement, plan or other circumstance, that is reasonably likely to (i) prevent the Merger from qualifying as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code, or (ii) materially impede or delay receipt of any of the Requisite Regulatory Approvals.
Healthcare Matters Except where the failure to comply with any applicable Health Care Law could not reasonably be expected to have a Material Adverse Effect, Parent and each of its Subsidiaries is, and at all times since the Closing Date has been, in compliance with all Health Care Laws applicable to it, its assets, business or operations. No circumstance exists or event has occurred with respect to a violation of any Health Care Law that could reasonably be expected to have a Material Adverse Effect. Neither Parent nor any Subsidiary thereof has received any notice of communication from any Governmental Authority alleging noncompliance with any applicable Health Care Law that could reasonably be expected to have a Material Adverse Effect. For the avoidance of doubt, no notice or any information provided by any Governmental Authority pursuant to this Section 7.01(cc) shall need to be provided to the Administrative Agent or any of the Lenders if such action would be prohibited by Applicable Law. Notwithstanding any other provision of this Agreement or any other Transaction Document, the representations and warranties contained in this Section shall be continuing, and remain in full force and effect until the Final Payout Date.
Accounting, Tax and Regulatory Matters Each Owner and the Company, -------------------------------------- jointly and severally, represents and warrants to Premiere that neither the Company, any Owner nor any Affiliate thereof has taken or agreed to take any action or has any knowledge of any fact or circumstance that is reasonably likely to (i) prevent the Merger from qualifying for pooling-of-interests accounting treatment or as a reorganization within the meaning of Section 368(a) of the Code, or (ii) materially impede or delay receipt of any consents referred to in Section 5.6 of the Uniform Terms or result in the imposition of a condition or restriction of the type referred to in the last sentence of such Section.
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.
Litigation and Regulatory Cooperation During and after the Executive’s employment, the Executive shall cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while the Executive was employed by the Company. The Executive’s full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times. During and after the Executive’s employment, the Executive also shall cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while the Executive was employed by the Company. The Company shall reimburse the Executive for any reasonable out-of-pocket expenses incurred in connection with the Executive’s performance of obligations pursuant to this Section 7(f).
Reporting Obligations and Regulatory Approvals Applicable laws and regulations may require holders and beneficial owners of Shares, including the Holders and Beneficial Owners of ADSs, to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. Holders and Beneficial Owners of ADSs are solely responsible for determining and complying with such reporting requirements and obtaining such approvals. Each Holder and each Beneficial Owner hereby agrees to make such determination, file such reports, and obtain such approvals to the extent and in the form required by applicable laws and regulations as in effect from time to time. Neither the Depositary, the Custodian, the Company or any of their respective agents or affiliates shall be required to take any actions whatsoever on behalf of Holders or Beneficial Owners to determine or satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.
Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.
COVERED HEALTHCARE SERVICES This section describes covered healthcare services. This plan covers services only if they meet all of the following requirements: • Listed as a covered healthcare service in this section. The fact that a provider has prescribed or recommended a service, or that it is the only available treatment for an illness or injury does not mean it is a covered healthcare service under this plan. • Medically necessary, consistent with our medical policies and related guidelines at the time the services are provided. • Not listed in Exclusions Section. • Received while a member is enrolled in the plan. • Consistent with applicable state or federal law. We review medical necessity in accordance with our medical policies and related guidelines. Our medical policies can be found on our website. Our medical policies are written to help administer benefits for the purpose of claims payment. They are made available to you for informational purposes and are subject to change. Medical policies are not meant to be used as a guide for your medical treatment. Your medical treatment remains a decision made by you with your physician. If you have questions about our medical policies, please call Customer Service. When a new service or drug becomes available, when possible, we will review it within six (6) months of one of the events described below to determine whether the new service or drug will be covered: • the assignment of an American Medical Association (AMA) Current Procedural Terminology (CPT) code in the annual CPT publication; • final Food and Drug Administration (FDA) approval; • the assignment of processing codes other than CPT codes or approval by governing or regulatory bodies other than the FDA; • submission to us of a claim meeting the criteria above; and • generally, the first date an FDA approved prescription drug is available in pharmacies (for prescription drug coverage only). During the review period, new services and drugs are not covered. For all covered healthcare services, please see the Summary of Medical Benefits and the Summary of Pharmacy Benefits to determine the amount that you pay and any benefit limits.
Healthcare Section 1. Bargaining unit employees with one (1) year or more of service will be provided coverage for the duration of this contract through the “Full Coverage” Team Care Plan (“Team Care MM200”), which includes dental, vision, life, short term disability, medical and prescription drug benefits. Prior to January 1, 2020, bargaining unit employees with less than one (1) year of service will be provided coverage through the “Medical Only” plan. On January 1, 2020, all bargaining unit employees enrolled in the Medical Only plan shall be enrolled in the Full Coverage plan, and the Medical Only plan will eliminated. The rates for 2019 and a further description of the plan and rates are referenced
Reports; Regulatory Matters (a) Each of the Companies and their Subsidiaries have timely filed or furnished, as applicable, all reports, registrations, statements and certifications, together with any amendments required to be made with respect thereto, that they were required to file or furnish, as applicable, since January 1, 2006 with (i) any state regulatory authority, (ii) the SEC, (iii) any foreign regulatory authority, and (iv) any self-regulatory authority, (collectively, “Regulatory Agencies”) and with each other applicable Governmental Entity, and all other reports and statements required to be filed or furnished by them since January 1, 2006, including any report or statement required to be filed pursuant to the laws, rules or regulations of the United States, any state, any foreign entity, or any Regulatory Agency or other Governmental Entity, and have paid all fees and assessments due and payable in connection therewith. Except as set forth in Section 3.5 of the Company Disclosure Schedule, no Regulatory Agency or other Governmental Entity has initiated since January 1, 2006 or has pending any proceeding, enforcement action or, to the knowledge of Seller, investigation into the business, disclosures or operations of any of the Companies or any of its Subsidiaries. Since January 1, 2006, no Regulatory Agency or other Governmental Entity has resolved any proceeding, enforcement action or, to the knowledge of Seller, investigation into the business, disclosures or operations of any of the Companies or any of its Subsidiaries. There is no unresolved, or, to Seller’s knowledge, threatened criticism, comment, exception or stop order by any Regulatory Agency or other Governmental Entity with respect to any report or statement relating to any examinations or inspections of any of the Companies or any of its Subsidiaries. Since January 1, 2006, there have been no formal or informal inquiries by, or disagreements or disputes with, any Regulatory Agency or other Governmental Entity with respect to the business, operations, policies or procedures of any of the Companies or any of its Subsidiaries (other than normal inquiries made by a Regulatory Agency or other Governmental Entity in the Companies’ ordinary course of business). (b) No Company nor any of its Subsidiaries is subject to any cease-and-desist or other order or enforcement action issued by, or is a party to any written agreement, consent agreement or memorandum of understanding with, or is a party to any commitment letter or similar undertaking to, or is subject to any order or directive by, or has been ordered to pay any civil money penalty by, or has been since January 1, 2006 a recipient of any supervisory letter from, or since January 1, 2006 has adopted any policies, procedures or board resolutions at the request or suggestion of, any Regulatory Agency or other Governmental Entity that currently restricts or affects in any material respect the conduct of its business (or to Seller’s knowledge that, upon consummation of the transactions contemplated hereby, would restrict in any material respect the conduct of the business of either Buyer or any of its Subsidiaries), or that in any material manner relates to its capital adequacy, its ability to pay dividends, its credit, risk management or compliance policies, its internal controls, its management or its business, other than those of general application that apply to similarly situated companies or their Subsidiaries (each item in this sentence, a “Company Regulatory Agreement”), nor has any of the Companies or any of their Subsidiaries been advised since January 1, 2006 by any Regulatory Agency or other Governmental Entity that it is considering issuing, initiating, ordering, or requesting any such Company Regulatory Agreement. (c) Seller has previously made available to Buyers an accurate and complete copy of each (i) final registration statement, prospectus, report, schedule and definitive proxy statement filed with the SEC by Seller pursuant to the Securities Act or the Securities Exchange Act of 1934, as amended (the “Exchange Act”) since January 1, 2006 (the “Seller SEC Reports”) and prior to the date of this Agreement and (ii) communication mailed by Seller to its shareholders since January 1, 2006 and prior to the date of this Agreement. No such Seller SEC Report or communication, at the time filed or communicated (or, if amended prior to the date hereof, as of the date of such amendment), with respect to the Companies and their Subsidiaries only, contained any untrue statement of a material fact or omitted to state any material fact required to be stated therein or necessary in order to make the statements made therein, in light of the circumstances in which they were made, not misleading. To the knowledge of Seller, other than as set forth in Section 3.5 of the Company Disclosure Schedule, none of the Seller SEC Reports is the subject of any ongoing review or investigation by the SEC or any other Governmental Entity and there are no unresolved SEC comments with respect to any of such documents.

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