Regulatory and Quality Matters Sample Clauses
Regulatory and Quality Matters. 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.
Regulatory and Quality Matters. 5.1 Regulatory Clearance or Approval of Company Product.
(a) Regulatory Responsibility for Company Product. Company will be solely responsible for all regulatory matters and filings (including compilation and maintenance of required technical files) related to the Company Product, including without limitation all filings and applications, approvals, clearances, complaint-handling, quality assurance program, recordkeeping, and all other pre-marketing and post-marketing statutory and regulatory requirements applicable to the Company Product.
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