Regulatory and Quality Matters Sample Clauses

Regulatory and Quality Matters. 5.1 Regulatory Clearance or Approval of Company Product.
Sample 1
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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.
Sample 1
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.
Sample 1
Regulatory and Quality Matters 
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Related to Regulatory and Quality Matters

  • 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.

  • 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 Registration Rights Agreement shall be true and correct in all material respects as of the Closing Date, except for representations and warranties that speak as of a particular date, which shall be true and correct in all material 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 its assets 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, each Designated Portfolio has complied and will continue to comply with Section 817(h) of the Code and Treasury Regulation Section 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 Fund so as to achieve compliance within the grace period afforded by Regulation 1.817-5.

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