Regulatory and Quality Matters Sample Clauses

Regulatory and Quality Matters. 4.0 The Parties shall enter into the Quality Agreement within thirty (30) days of the Effective Date and such agreement shall be incorporated herein and made a part hereof. ARISTOS shall also enter into a Quality Agreement with the Manufacturer and SOVEREIGN shall use reasonable efforts to assist ARISTOS in obtaining one. If ARISTOS cannot obtain executed Quality Agreements within thirty (30) days of the Effective Date, ARISTOS, in its sole discretion, may elect to terminate this Agreement.
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Regulatory and Quality Matters. Mainbridge Regulatory Approvals. Mainbridge shall be solely responsible for identifying, obtaining and maintaining at its sole cost and expense all FDA and other clearances and/or approvals which are required for the marketing and sale in the Territory of the Pumps and related Consumables. Mainbridge shall submit a 510(k) clearance application to the FDA for the Pumps within [***] of the execution of this Agreement and will use reasonable commercial efforts to obtain 510(k) clearance for the Pumps. Regulatory Approvals for Treprostinil. Mainbridge shall have no responsibility for identifying, obtaining, and maintaining all FDA and other approvals which are required for the marketing and sale of Treprostinil in the Territory.
Regulatory and Quality Matters. 5.1 Regulatory Clearance or Approval of Company Product.
Regulatory and Quality Matters 

Related to Regulatory and Quality Matters

  • SMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment.

  • EMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment.

  • NMHS Governance, Safety and Quality Requirements 3.1 Participates in the maintenance of a safe work environment.

  • Existence and Qualification; Power; Compliance With Laws Borrower is a corporation duly formed, validly existing and in good standing under the Laws of the State of California. Borrower is duly qualified or registered to transact business and is in good standing in the State of California, and each other jurisdiction in which the conduct of its business or the ownership or leasing of its Properties makes such qualification or registration necessary, except where the failure so to qualify or register and to be in good standing could not reasonably be expected to have a Material Adverse Effect. Borrower has all requisite power and authority to conduct its business, to own and lease its Properties and to execute and deliver each Loan Document to which it is a Party and to perform its Obligations. The chief executive offices of Borrower are located in San Dimas, California. All outstanding capital stock of Borrower is duly authorized, validly issued, fully paid and non-assessable, and no holder thereof has any enforceable right of rescission under any applicable state or federal securities or other Laws. Borrower is in compliance with all Laws and other legal requirements applicable to its business, has obtained all authorizations, consents, approvals, orders, licenses and permits from, and has accomplished all filings, registrations and qualifications with, or obtained exemptions from any of the foregoing from, any Governmental Agency that are necessary for the transaction of its business, except where the failure so to comply with Laws and other legal requirements applicable to its business, obtain authorizations, etc., file, register, qualify or obtain exemptions could not reasonably be expected to have a Material Adverse Effect.

  • Maintenance of Existence and Qualifications Each Restricted Person will maintain and preserve its existence and its rights and franchises in full force and effect and will qualify to do business in all states or jurisdictions where required by applicable Law, except where the failure so to qualify will not cause a Material Adverse Change.

  • Organization and Qualifications Customer and each of its Subsidiaries (i) is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation, (ii) has the power and authority to own its properties and assets and to transact the businesses in which it presently is engaged and (iii) is duly qualified and is authorized to do business and is in good standing in each jurisdiction where it presently is engaged in business and is required to be so qualified.

  • Accuracy of the Company’s Representations and Warranties; Performance by the Company The Company shall have delivered the certificate required to be delivered pursuant to Section 4(o) on or before the date on which delivery of such certificate is required pursuant to Section 4(o). The Company shall have performed, satisfied and complied with all covenants, agreements and conditions required by this Agreement to be performed, satisfied or complied with by the Company at or prior to such date, including, but not limited to, the covenants contained in Section 4(p), Section 4(q) and Section 4(r).

  • Accuracy of the Company’s Representations and Warranties Each of the representations and warranties of the Company in this Agreement and the other Transaction Documents that are qualified by materiality or by reference to any Material Adverse Effect shall be true and correct in all respects, and all other representations and warranties shall be true and correct in all material respects, as of the date when made and as of the Closing Date as though made at that time, except for representations and warranties that are expressly made as of a particular date, which shall be true and correct in all respects as of such date.

  • Organization and Qualification of Seller Seller is a corporation and has all necessary power and authority to own, operate or lease the properties and assets now owned, operated or leased by it and to carry on the Business as currently conducted. Seller is duly licensed or qualified to do business and is in good standing in each jurisdiction in which the ownership of the Purchased Assets or the operation of the Business as currently conducted makes such licensing or qualification necessary.

  • Diversification and Qualification 6.1. The Fund will invest the assets of each Designated Portfolio in such a manner as to ensure that the Contracts will be treated as annuity or life insurance contracts, whichever is appropriate, under the Code and the regulations issued thereunder (or any successor provisions). Without limiting the scope of the foregoing, the Fund will, with respect to each Designated Portfolio, comply with Section 817(h) of the Code and Treasury Regulation §1.817-5, and any Treasury interpretations thereof, relating to the diversification requirements for variable annuity, endowment, or life insurance contracts, and any amendments or other modifications or successor provisions to such Section or Regulations. In the event of a breach of this Article VI by the Fund, it will take all reasonable steps (a) to notify the Company of such breach and (b) to adequately diversify the affected Designated Portfolio so as to achieve compliance within the grace period afforded by Treasury Regulation §1.817-5.

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