Restart Matters Sample Clauses

Restart Matters. In the event that any relevant Governmental Authority determines that Pfizer must cease manufacturing the Products as well as other products in the Fajardo Plant due to Pfizer's failure to adhere to cGMPs relating tx xxxxxacturing, handling or controlling of any product made in the Fajardo Plant, Pfizer shall use reasonable best efforts to obtain axxxxxxx from the relevant Governmental Authority to begin manufacturing the Products as soon as practicable thereafter. In the event of a Fajardo Plant shutdown described herein, should the relevant Governxxxxxx Authority allow Pfizer to begin manufacturing products in the Fajardo Plant on an incremental product-by-product basis, Pfizer shxxx xxx discriminate against the Products during Pfizer's efforts to obtain approval to restart manufacturing.
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Related to Restart Matters

  • FDA Matters (a) The Corporation has (i) complied in all material respects with all applicable laws, regulations and specifications with respect to the manufacture, design, sale, storing, labeling, testing, distribution, inspection, promotion and marketing of all of the Corporation’s products and product candidates and the operation of manufacturing facilities promulgated by the U.S. Food and Drug Administration (the “FDA”) or any corollary entity in any other jurisdiction and (ii) conducted, and in the case of any clinical trials conducted on its behalf, caused to be conducted, all of its clinical trials with reasonable care and in compliance in all material respects with all applicable laws and the stated protocols for such clinical trials. (b) All of the Corporation’s submissions to the FDA and any corollary entity in any other jurisdiction, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and remain true, accurate and complete in all material respects and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the statements therein not materially misleading. (c) The Corporation has not committed any act, made any statement or failed to make any statement that would breach the FDA’s policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar laws, rules or regulations, whether under the jurisdiction of the FDA or a corollary entity in any other jurisdiction, and any amendments or other modifications thereto. Neither the Corporation nor, to the Corporation’s Knowledge, any officer, employee or agent of the Corporation has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar state or foreign law or regulation or (ii) exclusion under 42 U.S.C. Section 1320a 7 or any similar state or foreign law or regulation, and neither the Corporation nor, to the Corporation’s Knowledge, any such person has been so debarred or excluded. (d) The Corporation has not sold or marketed any products prior to receiving any required or necessary approvals or consents from any federal or state governmental authority, including but not limited to the FDA under the Food, Drug & Cosmetics Act of 1976, as amended, and the regulations promulgated thereunder, or any corollary entity in any jurisdiction. The Corporation has not received any notice of, nor is the Corporation aware of any, actions, citations, warning letters or Section 305 notices from the FDA or any corollary entity.

  • Transitional Matters (a) Each of the parties acknowledges and agrees that the transition of the Business from the Selling Companies to Buyer will require that certain transactions and relationships will need to be entered into, restructured and reorganized in connection with the transition of the Business from the Selling Companies to Buyer. The parties agree that prior to the Closing Date, the parties shall cooperate with each other to identify all such transactions and relationships and negotiate in good faith to enter into a mutually acceptable Transitional Agreement effective as of the Closing Date, which agreement shall provide for all such transactions and relationships as are reasonably necessary to provide, (i) for (A) the operation of the Business and use of the Purchased Assets by Buyer, (B) the operation and use of the Excluded Assets by Sellers and the Selling Subsidiaries and (C) the separation of the Business, the Purchased Assets and the Assumed Liabilities from Parent and its Affiliates (including the Selling Companies), in each case during the period commencing on and after the Closing Date and ending no later than the one year anniversary of the Closing Date or such longer period as the parties may agree, including the following: (1) the transitioning of the financial systems, assets and hedging valuation systems, asset management systems, payroll and employee benefits systems and any other applicable business operating systems; (2) the provision of rights of access (provided that access to the ALSS Platform shall be governed and limited by the Intellectual Property Rights Agreement and the Services Agreement) to the Parent and its Affiliates to Intellectual Property currently owned (or licensed) by the Selling Companies (and included in the Purchased Assets) and used by Parent or the Selling Companies in the ordinary course of their business, or required by the Selling Companies for the operation and use of the Excluded Assets or Excluded Liabilities; provided, that access to the ALSS Platform and other Software shall be governed solely by the Intellectual Property Rights Agreement and the Services Agreement and, provided further, anything foregoing to the contrary notwithstanding, Buyer shall not be required to disclose or deliver trade secret or confidential information regarding the ALSS Platform, Software or Acquired Intellectual Property unless required by the Intellectual Property Rights Agreement, the Services Agreement or required by law or legal proceedings and under the type of protective provisions in the Intellectual Property Rights Agreement. (3) the provision of rights of access (to the extent not covered by the Intellectual Property Rights Agreement) to Buyer to Intellectual Property currently owned (or licensed) by Parent (or the Selling Companies) and used by the Selling Companies in connection with the Purchased Assets or Assumed Liabilities; (4) moving corporate records related to the Selling Companies; and (5) the provision of office space, computer equipment and supplies sufficient to enable the Selling Companies to complete any transition services; and (ii) for such services and facilities as Sellers and Selling Subsidiaries may require to monitor compliance with, and implementation of the Subservicing Agreement, during its term, including the provision of office space, computer equipment and supplies sufficient to enable Sellers to monitor compliance with the Retained Portfolio Subservicing Agreement throughout its term. (b) In addition to the matters to be identified pursuant to paragraph (a) of this Section 5.12, the Transition Agreement shall specifically provide for the transactions and matters outlined in Section 5.12 of Sellers' Disclosure Schedule. (c) For the purpose of facilitating the transition of the financial system, on or prior to the 15th day prior to the Closing Date, the Selling Companies shall create on their general ledger, a separate general ledger company ("GL Company"), as well as accounts for such GL Company ("Buyer GL Accounts"), which accounts shall be duplicative of the Selling Companies' own accounts ("Seller GL Accounts") and are intended to be used by the Buyer in the operation of the Business, the Purchased Assets and the Assumed Liabilities from and after the Closing Date. From and after the creation of the Buyer GL Accounts, until Closing, the Selling Companies shall maintain such accounts (as duplicate entries on the books of the Selling Companies in the name of the GL Company). From and after Closing until the completion of the transition of the financial system of the Selling Companies, the Buyer shall operate the Business by recording entries using the Buyer GL Accounts, and shall maintain on behalf of the Selling Companies, the Seller GL Accounts on its general ledger. (d) The party receiving service under the Transitional Agreement shall pay to the party providing service the costs incurred by such providing party. Services provided under the Transitional Agreement shall be performed at the same standard as the providing party performs such service for its own account.

  • Employment Matters (a) The Sellers have provided to the Buyer a complete and accurate list of the following information as of the date of this Agreement for each Business Employee: employer; job title; location; date of hiring; date of commencement of employment; and current compensation paid or payable. At least sixty (60) days prior to the applicable Closing, the Sellers will provide to the Buyer the following information as of immediately prior to such Closing (to the extent that such information can be generated at least sixty (60) days prior to such Closing and as early prior to such Closing as reasonably practicable to the extent such information cannot be generated at least sixty (60) days prior to such Closing) for each Business Employee whose services relate primarily to the portion of the Business being transferred at such Closing: service credit for purposes of vesting and eligibility to participate under any Employee Plan (including any vacation or other paid time off policy of the Sellers). The parties agree and acknowledge that, due to the timing of the deliveries contemplated by the preceding sentence, and as a result of ordinary course personnel turnover, certain individuals who are identified as Business Employees in connection with the deliveries contemplated by the preceding sentence may not be Business Employees at the applicable Closing, and certain individuals who are not identified as Business Employees in connection with the deliveries contemplated by the preceding sentence may be Business Employees at the applicable Closing, and in no event will any resulting inaccuracies in any information delivered pursuant to this Section 3.13(a) be considered a breach of any provision of this Agreement. Further, within ten (10) Business Days following the applicable Closing, the Sellers will provide to the Buyer, for each Business Employee whose services relate primarily to the portion of the Business being transferred at such Closing, data relating to the amount of sick and vacation leave that is accrued but unused as of such Closing. (b) Except as set forth on Section 3.13(b) of the Disclosure Schedule, (i) none of the Business Employees is, or during the past two (2) years has been, represented by a union, labor organization or group (collectively, a “Union”) that was either voluntarily recognized or certified by any labor relations board; (ii) none of the Business Employees is, or during the past two (2) years has been, a signatory to or bound by a Collective Agreement with any Union; (iii) to the Knowledge of the Sellers, there are no currently filed petitions for representation with respect to the formation of a collective bargaining unit involving any of the Business Employees and no such petitions for representation have been filed or, to the Knowledge of the Sellers, threatened in the past two (2) years; (iv) there is no unfair labor practice or labor arbitration proceeding brought by or on behalf of any of the Business Employees pending or, to the Knowledge of the Sellers, threatened against the Sellers and no such proceeding has been initiated or, to the Knowledge of the Sellers, threatened in the past two (2) years; and (v) no labor dispute, walk out, strike, slowdown, hand billing, picketing, or work stoppage involving the Business Employees has occurred, is in progress or, to the Knowledge of the Sellers, has been threatened in the past two (2) years.

  • Patent Matters 4.1 Licensor shall have the right, but not the obligation, to prosecute and maintain all Patents to be issued pertaining to the Patent applications licensed in Exhibit A at its cost and expense. Licensor shall keep licensee reasonably apprised of all relevant actions regarding the status of such patents. 4.2 Each Party shall notify the other Party of any infringement of any intellectual property rights with regard to the License IP or a Licensed Product by a third party in the Field which becomes known to such Party, and of any claim of infringement by a third party that the activities of a Party infringe patent rights of such third party. Licensor shall have has sole responsibility and control of legal action relating to claims of infringement with respect to the Licensed Technology. 4.3 Licensor shall have the first right, but not an obligation, to initiate, maintain and control, at Licensor’s expense, legal action against any infringement of intellectual property rights relating to the Licensed Technology by a third party in the Field. 4.4 In any suit, proceeding or dispute involving infringement of any intellectual property rights relating to the License IP in the Field, the Parties shall provide each other with reasonable cooperation shall make available to each other , at reasonable times and under appropriate conditions, all relevant personnel, records, papers, information, samples, specimens, and the like in its possession.

  • Operational Matters 7.1 The LGB shall comply with the obligations set out in Appendix 2 which deals with the day-to-day operation of, and delegation of responsibilities to, the LGB. 7.2 The LGB will adopt and will comply with all policies of the Trustees communicated to the LGB from time to time. 7.3 Both the Trustees and all members of the LGB have a duty to act with integrity, objectivity and honesty in the best interests of the Company and the Academy and shall be open about decisions and be prepared to justify those decisions except in so far as any matter may be considered confidential. 7.4 The LGB will review its policies and practices on a regular basis, having regard to recommendations made by the Trustees from time to time, in order to ensure that the governance of the Academy is best able to adapt to the changing political and legal environment. 7.5 The LGB shall provide such data and information regarding the business of the Academy and the pupils attending the Academy as the Trustees may require from time to time. 7.6 The LGB shall submit to any inspections by the Trustees, and any inspections pursuant to section 48 of the Education Act 2005 (Statutory Inspections of Anglican and Methodist Schools). 7.7 The LGB shall work closely with and shall promptly implement any advice or recommendations made by the Trustees in the event that intervention is either threatened or is carried out by the Secretary of State and the Trustees expressly reserve the unfettered right to review or remove any power or responsibility conferred on the LGB under this Scheme in such circumstances.

  • Scheduling Provisions The scheduling and premium provisions relating to consecutive weekends off in Article 16 do not apply to employees who accept positions under this provision.

  • Labour Matters No material work stoppage, strike, lock-out, labour disruption, dispute grievance, arbitration, proceeding or other conflict with the employees of the Corporation or the Subsidiaries currently exists or, to the knowledge of the Corporation, is imminent or pending and the Corporation and the Subsidiaries are in material compliance with all provisions of all federal, national, regional, provincial and local laws and regulations respecting employment and employment practices, terms and conditions of employment and wages and hours.

  • Year 2000 Matters Any reprogramming required to permit the proper functioning (but only to the extent that such proper functioning would otherwise be impaired by the occurrence of the year 2000) in and following the year 2000 of computer systems and other equipment containing embedded microchips, in either case owned or operated by the Borrower or any of its Subsidiaries or used or relied upon in the conduct of their business (including any such systems and other equipment supplied by others or with which the computer systems of the Borrower or any of its Subsidiaries interface), and the testing of all such systems and other equipment as so reprogrammed, will be completed by March 31, 1999. The costs to the Borrower and its Subsidiaries that have not been incurred as of the date hereof for such reprogramming and testing and for the other reasonably foreseeable consequences to them of any improper functioning of other computer systems and equipment containing embedded microchips due to the occurrence of the year 2000 could not reasonably be expected to result in a Default or Event of Default or to have a Material Adverse Effect. Except for any reprogramming referred to above, the computer systems of the Borrower and its Subsidiaries are and, with ordinary course upgrading and maintenance, will continue for the term of this Agreement to be, sufficient for the conduct of their business as currently conducted.

  • Additional Matters (a) Any claim on account of a Liability that does not result from a Third-Party Claim shall be timely asserted by written notice given by the Indemnitee to the related Indemnifying Party. Such Indemnifying Party shall have a period of 30 days after the receipt of such notice within which to respond thereto. If such Indemnifying Party does not respond within such 30-day period, such Indemnifying Party shall be deemed to have refused to accept responsibility to make payment. If such Indemnifying Party does not respond within such 30-day period or rejects such claim in whole or in part, such Indemnitee shall be free to pursue remedies as specified by this Agreement and the Ancillary Agreements. (b) In the event of payment by or on behalf of any Indemnifying Party to any Indemnitee in connection with any Third-Party Claim, such Indemnifying Party shall be subrogated to and shall stand in the place of such Indemnitee as to any events or circumstances in respect of which such Indemnitee may have any right, defense or claim relating to such Third-Party Claim against any claimant or plaintiff asserting such Third-Party Claim or against any other Person. Such Indemnitee shall cooperate with such Indemnifying Party in a reasonable manner, and at the cost and expense of such Indemnifying Party, in prosecuting any subrogated right, defense or claim. (c) In the event of an Action in which the Indemnifying Party is not a named defendant, if either the Indemnitee or the Indemnifying Party shall so request, the parties shall endeavor to substitute the Indemnifying Party for the named defendant, if reasonably practicable. If such substitution or addition cannot be achieved or is not requested, the named defendant shall allow the Indemnifying Party to manage the Action as set forth in this Agreement and the Indemnifying Party shall fully indemnify the named defendant against all costs of defending the Action (including court costs, sanctions imposed by a court, attorneys’ fees, experts’ fees and all other external expenses, and the allocated costs of in-house counsel and other personnel), the costs of any judgment or settlement, and the cost of any interest or penalties relating to any judgment or settlement.

  • Franchise Matters (a) Since June 30, 2003, the Company and its Subsidiaries (i) have maintained records of all franchise activities in which full, true, and complete entries have been made of all material dealings and transactions in relation to their franchise activities, including all offering circulars, Franchise Agreements (as defined below), correspondence with franchisees, written complaints by franchisees, and government audits, (ii) have complied in all material respects with all applicable Laws regarding franchise activities and other franchise-related matters, (iii) have complied with all franchise agreements and other agreements by which the Company or its Subsidiaries directly or indirectly grant any third party franchise rights (whether not such agreement was entered into before or after June 30, 2002, each, a “Franchise Agreement”), (iv) have obtained and maintained in place franchisee agreements which contain provisions requiring the franchisee to (A) indemnify the Company or any Subsidiary, as applicable, with respect to claims relating to the franchisee’s business and (B) to obtain insurance from financially sound and respectable insurers to cover such indemnity, naming the Company as additional insured and loss payee, (v) have timely filed with the applicable Governmental Entities all Uniform Franchise Offering Circulars and other required filings, (vi) each Uniform Franchise Offering Circular delivered to any franchisee, prospective franchisee, or Governmental Entity by the Company or any Subsidiary complied in all material respects as of the date delivered with all requirements of applicable Law, and, when delivered, did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading, and (vii) the Company and its Subsidiaries have accounted for and administered in accordance with the Franchise Agreements and applicable franchise laws all advertising and marketing funds and cooperatives, if any, which the Company and its Subsidiaries administer and into which monies are paid by their franchisees. Section 3.25(a) of the Company Disclosure Letter sets forth a complete and accurate list, as of the date hereof, of all currently effective Franchise Agreements, including the name of the franchisee and the date and expiration date of the applicable Franchise Agreement. The Company has provided the Buyer with true, complete and correct copies of all currently effective Franchise Agreements, including any amendments or modifications thereto, as of the date hereof, and there are no oral agreements, promises or understandings with respect to any currently effective Franchise Agreements. (b) Except as set forth in Section 3.25(b) of the Company Disclosure Letter: (i) the royalty rates and required advertising contributions specified in each currently effective Franchise Agreement remain in effect, are being paid when due and have not been reduced, modified, waived, or otherwise affected by any Franchise Agreement “side letter,” modification, amendment, waiver, or suspension, in whole or in part and each currently effective Franchise Agreement is in full force and effect; (ii) all franchise registrations remain in full force and effect and are not the subject of any existing or threatened action by a Governmental Entity or otherwise intended, in whole or in part, to result in the termination, revocation, modification, suspension, conditioning, or dissolution of any such franchise registration and/or any other circumstance which might or would impair, impede or preclude the Company’s ability routinely to renew or amend (as the case may be) any such franchise registration and/or enter into Franchise Agreements in any jurisdiction; (iii) there are no written, or to the Knowledge of the Company, threatened, franchisee complaints, threats to initiate litigation or arbitration, or threats to file complaints with a Governmental Entity, whether such threats have been filed either with the Company or any Subsidiary and/or any third party (including any Governmental Entity); (iv) there exists no extant formal or, to the Knowledge of the Company, informal, complaint, inquiry, investigation, or judicial or administrative action or proceeding, communicated or commenced (as the case may be) by any Governmental Entity, to or against the Company or any Subsidiary regarding its offer and sale of franchises; the administration of its franchise network; advancing or referring to any complaint received from any franchisee; inquiring of or contesting any element of the Company’s franchise program or franchise relationships (including antitrust issues such as predatory pricing or monopolization); and/or, otherwise related to the Company’s or any Subsidiary’s compliance with any franchise Law; (v) there exists no litigation or other claims asserted by any third party against any of the Company’s franchisees in which the Company or any Subsidiary is a party thereto under any theory, including negligence or “vicarious liability”; (vi) no supply Contract to which the Company or any Subsidiary is a party may be unilaterally terminated by the subject supplier as a result of this Agreement, the Offer, the Merger or any of the other transactions contemplated by this Agreement, if that supply contract is material to the operation of the Company’s network of franchisees, taken as a whole; (vii) since December 31, 2004, neither the Company, nor any of its Subsidiaries has refused to renew any Franchise Agreement; (viii) to the Company’s Knowledge, no franchisee of the Company or any of its Subsidiaries is currently in default in any material respect under any Franchise Agreement; (ix) since December 31, 2004, neither the Company nor any of its Subsidiaries has terminated any Franchise Agreement; and (x) the Company may enter into this Agreement and consummate the transactions contemplated hereby without the consent of any Franchisee.

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