Regulatory and Related Matters Sample Clauses

Regulatory and Related Matters. Except as disclosed on Schedule 7.15.3, since April 1, 2012, with respect to the Licensed Business and the Licensed Products, in the Designated Countries neither Spectrum nor any of its Affiliates (a) has received any written notice from any Person alleging any violation of any material Legal Requirement, or (b) been the subject of a written order or a written assessment of penalty by any Governmental Authority.
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Regulatory and Related Matters. (a) At all times during the Term, Coty shall maintain the Facilities, equipment and processes used in producing the Products in compliance with all Applicable Laws and Coty Standard Practices. (b) Coty shall maintain and make available to Ascendia upon reasonable notice (i) a retain of every batch of Product sold hereunder, (ii) batch records for every Product sold hereunder, and (iii) any additional documents required by Coty Standard Practices, in each case for a period of three (3) years or for the period specified by any Regulatory Authority, whichever is longer. (c) Coty shall maintain and make available to Ascendia upon reasonable notice all retained batches, batch records, stability analyses and data and any other information required by Applicable Law generated prior to or after the Effective Date with respect to any OTC Pharmaceutical Products. (d) Coty shall be responsible for taking the steps necessary to comply with the requirements of each Regulatory Authority in every country in which any Product has been sold in the twelve (12) months preceding the Effective Date necessary to permit the lawful manufacture, sale to Ascendia, and exportation and importation (if applicable) of the Products. (e) Ascendia shall be responsible for taking the steps necessary to comply with the requirements of each Regulatory Authority in any country in which Products have not been sold in the twelve months preceding the Effective Date, but in which or to which Ascendia sells such Products following the Effective Date. Ascendia and Coty shall use reasonable efforts to cooperate and Coty shall promptly provide to Ascendia all documents and information lawfully requested or required by such Regulatory Authorities.
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Regulatory and Related Matters. The Company represents and warrants that, to the best of its knowledge, neither it nor any of its affiliates nor any of its or their directors, officers, agents, employees, representatives or any other similar person associated with or acting for or on behalf of the foregoing in connection with the transactions contemplated in this Agreement, has offered, paid, promised to pay, or authorized the payment of any money, or offered, given a promise to give, or authorized the giving of anything of value, to any government official, political party or official thereof or to any candidate for political office (or to any person where the Company, any of its affiliates or any of its directors, officers, agents, employees, representatives of any other similar person knew or was aware of a high probability that all or a portion of such money or thing of value would be offered, given or promised, directly or indirectly, to any government official, political party, party official or candidate for political office) for the purpose of:
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Regulatory and Related Matters. (a) Each Parent Entity holds all Permits, variances, registrations, exemptions, Orders and other governmental authorizations, consents, approvals and clearances, including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, the Public Health Service Act of 1944, and the regulations of the FDA promulgated thereunder, from any Governmental Entity that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of Parent Products/Services and that in any such case is material to the conduct of their respective businesses as they are now being conducted (any such Governmental Entity, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of its Subsidiaries (the “Parent Permits”), and all such Parent Permits are valid, and in full force and effect. Since January 1, 2012, there has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Parent Permit. Parent and each of its Subsidiaries are in compliance in all material respects with the terms of all Parent Permits, and no event has occurred that would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any Parent Permit, except as would not be material to the conduct of Parent’s and each of its Subsidiaries’ respective businesses. (b) Since January 1, 2013, all applications, submissions, information and data utilized by Parent or Parent’s Subsidiaries as the basis for, or submitted by or, to the Knowledge of Parent, on behalf of Parent or Parent’s Subsidiaries in connection with, any and all requests for a Parent Permit relating to Parent or any of its Subsidiaries, and its respective business and Parent Products/Services, when submitted to the FDA or other Parent Regulatory Agency, were true and correct in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or other Parent Regulatory Agency. (c) Since January 1, 2012, neither Parent, nor any of its Subsidiaries, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Parent ...
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Regulatory and Related Matters. Except as disclosed on Schedule 7.13.3, since January 1, 2011, with respect to the Bayer Business and the Licensed Products, in the Designated Countries neither Bayer nor any of its Affiliates (a) has received any written notice from any Person alleging any violation of any material Legal Requirement, or (b) been the subject of a written order or a written assessment of penalty by any Governmental Authority .
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Regulatory and Related Matters. (a) The Company Entities are and have been since July 1, 2012 in compliance in all material respects with (i) all Laws (including all rules, regulations, policies and guidance) of FDA, Drug Enforcement Administration (“DEA”), Health Canada, the European Medicines Agency (“EMA”) and other Healthcare Regulatory Authorities, including by way of example only, the Food, Drug, and Cosmetic Act, the Public Health Service Act, the Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health (HITECH) Act, the Social Security Act, the Patient Protection and Affordable Care Act, Pub. L. No. 110-148 and the Health Care Education Reconciliation Act of 2010, Pub. L. No. 110-152, all as amended, and all implementing regulations, and (ii) all Healthcare Regulatory Authorizations, including all requirements of FDA, DEA, Health Canada, EMA and all other Healthcare Regulatory Authorities, that are applicable to the Company Entities, or by which any property, product, service or other Asset of a Company Entity (including, without limitation, any Company Product Candidates) is bound or affected. (b) Since July 1, 2012, no Company Entity has received any written notification of any pending or, to the Knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation or revocation of any certificate of accreditation issued by an FDA or CMS recognized accrediting organization, revocation of any State, Provincial or Federal license or permit, suspension, exclusion, suspension of payments, imposition of prepayment review, corrective action plan, civil money penalties, arbitration or other action from any Healthcare Regulatory Authority. (c) Since July 1, 2012, the Company Entities have held all Healthcare Regulatory Authorizations required for the conduct of their respective businesses, and all such Healthcare Regulatory Authorizations are in full force and effect. No event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder of any such Healthcare Regulatory Authorization. (d) Section 2.16(d) of the Company Disclosure Schedule contains a complete and accurate list of all of the Company Product Candidates of the Company Entities, listing, where applicable, those Company Product Candidates for which the Company Entities have applied for or have authorization or cl...
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Regulatory and Related Matters. (a) Except as disclosed on Schedule 6.11.3, and except with respect to claims made in promotional or advertising materials that have been either withdrawn or are no longer used and for which Genzyme and its Affiliates will not be responsible, neither Bayer nor any of its Affiliates has, since January 1, 2008 and with respect to the Bayer Business, in the Major Market Countries and Other Key Countries, and to Bayer’s Knowledge, in all other countries, received any (i) written notice from the FDA or any other Governmental Authority, including the Office of Inspector General, any United States Attorney, the Department of Justice or any attorney general of any jurisdiction, alleging any violation of any Drug Law, The False Claims Act (31 U.S.C. § 3729—3733) or false claims acts under state Legal Requirements, commencing or indicating an intention to conduct an investigation, audit, or review; (ii) notice of inspectional observation (including those recorded on form FDA 483), establishment inspection report, warning letter, penalty, fine, sanction, request for recall or other remedial action; or (iii) other written documents issued by the FDA or any other Governmental Authority alleging lack of compliance with any Drug Law by Bayer, any of its Affiliates, or Persons who are otherwise performing services for the benefit of Bayer or any of its Affiliates. (b) Bayer has, with respect to the Bayer Business, delivered or made available to Genzyme all material correspondence and meeting minutes received from or sent to the FDA and any other similar foreign Governmental Authorities in Major Market Countries and Other Key Countries since January 1, 2008, with respect to the Bayer Business, including any and all notices of inspectional observations, establishment inspection reports and any other material documents received by Bayer or any of its Affiliates since January 1, 2008 from the FDA or similar foreign Governmental Authorities which relate to Bayer’s compliance in any material respect with regulatory requirements of the FDA or similar foreign Governmental Authorities. (c) Except with respect to claims made in promotional or advertising materials or statements made by sales representatives to physicians or other customers, that have been either withdrawn, resolved or are no longer used, and for which Genzyme and its Affiliates will not be responsible, neither Bayer nor any of its Affiliates, nor to Bayer’s Knowledge, agent of Bayer or its Affiliates, has, with res...
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Regulatory and Related Matters. (a) Each SSI Party has all Registrations required to conduct its business as currently conducted, and Section 3.18(a) of the SSI - DE Disclosure Schedule sets forth a true, complete and correct list as of the date of this Agreement of such Registrations. Each of such Registrations is valid and subsisting in full force and effect. To the knowledge of the SSI Parties, no Regulatory Authority or Governmental Entity is considering limiting, suspending or revoking any such Registration or changing the marketing classification or labeling of the products of any SSI Party. To the knowledge of the SSI Parties, there is no false or misleading information or material omission in any product application or other submission to any Regulatory Authority or Governmental Entity. Each SSI Party has fulfilled and performed in all material respects its obligations under each Registration, and no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration. Any third party that is a manufacturer or contractor for any SSI Party is in compliance with all Registrations insofar as they pertain to the manufacture of product components or products for such SSI Party. (b) All products developed, tested, investigated, manufactured, distributed, marketed or sold by or on behalf of any SSI Party that are subject to the jurisdiction of any Regulatory Authority or Governmental Entity have been and are being developed, tested, investigated, manufactured, distributed, marketed and sold in all material respects in compliance with Laws enforced by any Regulatory Authority or Governmental Entity that has jurisdiction over the operations of such SSI Party, or any other applicable Law, including those regarding non-clinical research, clinical research, establishment registration, device listing, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, device importation and exportation, adverse event reporting and reporting of corrections and removals. To the knowledge of the SSI Parties, except as would not be material to the SSI Parties, any third party that is a manufacturer or contractor for any SSI Party is in compliance with all Laws insofar as they pertain to the manufacture of product components or products for SSI Parties. (c) There are no enforcement actions (including any administrative proceeding, prosecution, injunction, seizure, civil penalt...
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Regulatory and Related Matters 
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Related to Regulatory and Related Matters

  • Litigation and Related Matters The commencement of, or any material development in, any action, suit, proceeding or investigation affecting the Borrower or any of its Subsidiaries or any of their respective properties before any arbitrator or Governmental Authority, (i) in which the amount involved that the Borrower reasonably determines is not covered by insurance or other indemnity arrangement is $50,000,000 or more, (ii) with respect to any Document or any material Indebtedness or preferred stock of the Borrower or any of its Subsidiaries or (iii) which, if determined adversely to the Borrower or any of its Subsidiaries, could reasonably be expected to have a Material Adverse Effect.

  • Organization and Related Matters Buyer is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware.

  • TRAINING AND RELATED MATTERS The parties recognise that in order to increase the efficiency and productivity of the company a significant commitment to structured training and skill development is required. Accordingly the parties commit themselves to: a) The parties to this Agreement recognise the importance of the apprenticeship system to the construction industry. It is agreed that every employer party to this Agreement who employs five (5) or more tradespersons in any one classification shall undertake to employ at least one (1) apprentice or make arrangements to host an apprentice from an agreed group apprenticeship scheme. Where an employer does not currently have an apprentice as per this provision, reasonable time shall be allowed to enable the employer to comply with this clause. Further, the parties are committed to a strong ratio of apprentices in the industry. Apprenticeship levels on a specific project may be discussed at the Project Pre-Commencement Conference (refer Clause 16). b) Providing employees with the opportunity to acquire additional skills within relevant career path structures through appropriate structured training based on nationally endorsed (i.e. Construction Training Australia endorsed) competency standards and curriculum; c) Actively encouraging employees to seek formal recognition of their skills (i.e. recognition of prior learning); and d) Using training providers accredited and acceptable to the parties. The CFMEU, MBAV and other employer associations are legitimately engaged in providing training to industry and it is hereby agreed that all parties will properly recognise and accept the validity of nationally accredited training as provided by the other parties. e) The parties will consult on the development of training programs which are consistent with the following: • Training provided will be consistent with the company’s business requirements, relevant to the work of the employees, consistent with the skills development of each employee and with applicable national competency standards. • Training may be taken either on or off the job with all reasonable steps being taken to conduct training in normal working hours. • If an approved training activity is undertaken during ordinary working hours, the employee/s concerned shall not suffer any loss of pay. • Approved training activities undertaken outside of ordinary hours will be paid at single time or will, at the employee’s option, be taken as time off in lieu of payment. Provided that the scheduling of time off must be consistent with the needs of the business and be by agreement with the company. • Training costs of courses approved by the company will be met by the company. • The company will not be asked to meet the costs of training undertaken by employees which was not approved by the company. • Leave of absence granted pursuant to this clause shall count as service for all purposes of the award and this agreement. • Accredited members of the union will be allowed up to 5 days per year, without loss of pay, to attend trade union educational courses conducted or approved by the union. (see appendix H) f) The parties to this Agreement recognise the importance of the role that Apprentices/Trainees fulfill within the industry and, more importantly, a role that they will fulfill as trades persons following the conclusion of the indentures. To this end the Victorian Building Industry Consultative Committee will investigate ways of enhancing employment prospects for Apprentice/Trainees. In addition it is agreed that, where appropriate, employers will use their best endeavours to employ Apprentices/Trainees in order to ensure appropriate trade persons levels for the future.

  • Capitalization and Related Matters (a) The Company has an authorized capital consisting of 230,000,000,000 shares of Common Stock and 25,000,000 shares in total of Series A-2 Convertible Preferred Stock, Series D Convertible Preferred Stock, Series C Preferred Stock and collectively with the Series E Preferred Stock, “Preferred Stock”, of which 13,489,918,237 shares of Common Stock and 3,000 shares of Preferred Stock are issued and outstanding as of the date hereof (after giving effect to the transactions contemplated hereby) as set forth on Schedule 3.2(a) hereto. All of the outstanding shares of the Company’s capital stock are, and immediately after the Closing will be, validly issued and outstanding, fully paid and non-assessable. No such stock (i) was issued in violation of the preemptive rights of any shareholder or (ii) is held as treasury stock. All of the outstanding capital stock of the Company was issued in compliance with all applicable federal and state securities or “blue sky” laws and regulations. (b) Except as set forth on Schedule 3.2(b) hereto, there are no outstanding securities convertible into Common Stock or any other capital stock of the Company nor any rights to subscribe for or to purchase, or any options for the purchase of, or any agreements providing for the issuance (contingent or otherwise) of, or any calls, commitments or claims of any character relating to, such capital stock or securities convertible into such capital stock (collectively, “Securities Rights”). Except as set forth on Schedule 3.2 hereto the Company (i) is not subject to any obligation (contingent or otherwise) to repurchase or otherwise acquire or retire any of its capital stock; or (ii) has no liability for dividends or other distributions declared or accrued, but unpaid, with respect to any capital stock. (c) Except as set forth on Schedule 3.2(c) hereto, the Company is not a party to any agreement, understanding or arrangement, direct or indirect, relating to any class or series of the Company’s capital stock, including, without limitation, any voting agreement, restriction on resale, shareholder agreement or registration rights agreement.

  • Related Matters Notwithstanding anything herein to the contrary, additional conditions or restrictions related to such Options may be contained in the Plan or the resolutions of the Plan Committee authorizing such grant of Options.

  • Indemnification and Related Matters Section 8.01

  • Compensation and Related Matters During the Term of the Executive’s employment, as compensation and consideration for the performance by the Executive of the Executive’s duties, responsibilities and covenants pursuant to this Agreement, the Company shall pay the Executive and the Executive agrees to accept in full payment for such performance the amounts and benefits set forth below.

  • Press Releases and Related Matters Each Credit Party executing this Agreement agrees that neither it nor its Affiliates will in the future issue any press releases or other public disclosure using the name of GE Capital or its affiliates or referring to this Agreement, the other Loan Documents or the Related Transactions Documents without at least 2 Business Days' prior notice to GE Capital and without the prior written consent of GE Capital unless (and only to the extent that) such Credit Party or Affiliate is required to do so under law and then, in any event, such Credit Party or Affiliate will consult with GE Capital before issuing such press release or other public disclosure. Each Credit Party consents to the publication by Agent or any Lender of a tombstone or similar advertising material relating to the financing transactions contemplated by this Agreement. Agent reserves the right to provide to industry trade organizations information necessary and customary for inclusion in league table measurements.

  • The Merger and Related Matters 4 Section 2.01. Certificate of Merger.................................................4 Section 2.02. The Effective Time....................................................4 Section 2.03. Certain Effects of the Merger.........................................4 Section 2.04. Effect of the Merger on Capital Stock.................................5 Section 2.05. Delivery, Exchange and Payment........................................6 Section 2.06. Merger Consideration Calculation......................................7 Section 2.07. Fractional Shares.....................................................7

  • Definitions and Related Matters For purposes of this Agreement, the capitalized terms used herein shall have the meanings assigned to them herein or in the attached Exhibit 1 and, for purposes of this Agreement and all other documents executed in connection herewith, the rules of construction set forth in Exhibit 1 shall govern.

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