PMA Letter definition

PMA Letter means a letter issued by the United States Food and Drug Administration (“FDA”) which grants clearance or premarket approval for the sale of the Pipeline device in the United States with an indication to treat any subset of intracranial aneurysms, provided that such letter does not impose material restrictions that severely diminish the long term commercial viability of the Pipeline device in the United States, it being understood that none of the following conditions contained in the letter will be deemed to severely diminish the long term commercial viability of the Pipeline device in the United States: (a) the standard conditions (Conditions of Approval) found in all medical device premarket approval and 510(k) clearance letters, as the case may be, issued by the FDA, (b) warnings, cautions, precautions and contraindications that are customary or reasonable given the nature and purpose of the Pipeline device that don’t otherwise, individually or in the aggregate, severely diminish the long term commercial viability of the Pipeline device in the United States, (c) a requirement that a post approval study be conducted on the Pipeline device, (d) a requirement that physicians who will be working with the Pipeline device receive reasonable training with respect to the device, or (e) a requirement that only physicians with expertise in neurovascular procedures use the device. In the event that the FDA issues a letter which does not satisfy the definition of PMA Letter above, then the obligations of the parties under this Agreement to continue to attempt to obtain the PMA Letter shall continue in accordance with the terms of this Agreement.
Sample 1

Examples of PMA Letter in a sentence

  • From and after the Effective Time, the Surviving Corporation will manage its overall ongoing business as it determines reasonably necessary to pursue and obtain the issuance of the PMA Letter.

Related to PMA Letter

  • Post Closing Letter is that certain Post Closing Letter dated as of the Effective Date by and between Collateral Agent and Borrower.

  • Confirmation Letter means a letter issued by any applicable Rating Agency to the effect that neither (a) the resignation of Provident as Servicer under the Servicing Agreement and appointment of Litton as successor Servicer thereunder, nor (b) the amendments exxxxxxated by this Agreement, will adversely affect the then current ratings on the Certificates then being rated.

  • Mandate Letter has the meaning ascribed to it in the Memorandum of Understanding between MOHLTC and the LHIN, and means a letter from the Minister to the LHIN establishing priorities in accordance with the Premier’s mandate letter to the Minister.

  • Investment Letter shall have the meaning specified in subsection 9.07(a).

  • Advisory letter means a nondisciplinary letter to notify a

  • Undertaking Letter The letter in substantially the form set forth in Exhibit C of the Trust Agreement.

  • Disbursement Letter means an instructional letter executed and delivered by Borrower to Agent regarding the extensions of credit to be made on the Closing Date, the form and substance of which is satisfactory to Agent.

  • Welcome Letter means the document entitled “welcome letter” containing important details about this group policy;

  • Private Letter Ruling shall have the meaning set forth in the Recitals.

  • Investor Letter means that certain Investor Letter, substantially in the form attached hereto as Exhibit B.

  • Escrow Agreement means the escrow agreement entered into prior to the date hereof, by and among the Company, the Escrow Agent and the Placement Agent pursuant to which the Purchasers shall deposit Subscription Amounts with the Escrow Agent to be applied to the transactions contemplated hereunder.

  • Master Separation Agreement has the meaning set forth in the recitals.

  • Sponsor Letter Agreement has the meaning set forth in the recitals to this Agreement.

  • Closing Escrow Agreement means the Closing Escrow Agreement, dated as of the date hereof, between the Company, Xxxx Capital Partners, LLC and the escrow agent (the “Escrow Agent”) identified therein, in the form of Exhibit B hereto.

  • Control Letter means a letter agreement between Agent and (i) the issuer of uncertificated securities with respect to uncertificated securities in the name of any Credit Party, (ii) a securities intermediary with respect to securities, whether certificated or uncertificated, securities entitlements and other financial assets held in a securities account in the name of any Credit Party, (iii) a futures commission merchant or clearing house, as applicable, with respect to commodity accounts and commodity contracts held by any Credit Party, whereby, among other things, the issuer, securities intermediary or futures commission merchant disclaims any security interest in the applicable financial assets, acknowledges the Lien of Agent, on behalf of itself and Lenders, on such financial assets, and agrees to follow the instructions or entitlement orders of Agent without further consent by the affected Credit Party.

  • Xxxxxx Agreement means that certain Contingent Stock Agreement, effective as of January 1, 1996, by The Xxxxx Company in favor of and for the benefit of the Holders (named in Schedule I thereto) and the Representatives (therein defined), as amended.

  • Transition Agreement has the meaning set forth in Section 12.8.1.

  • Commitment Letter has the meaning set forth in Section 5.7.

  • Estoppel Letter A document executed by the Cooperative Corporation certifying, with respect to a Cooperative Unit, (i) the appurtenant Proprietary Lease will be in full force and effect as of the date of issuance thereof, (ii) the related stock certificate was registered in the Mortgagor's name and the Cooperative Corporation has not been notified of any lien upon, pledge of, levy of execution on or disposition of such stock certificate, and (iii) the Mortgagor is not in default under the appurtenant Proprietary Lease and all charges due the Cooperative Corporation have been paid.

  • Engagement Letter means that certain Engagement Letter, dated as of June 18, 2015, by and among the Borrower and the Arrangers.

  • Representation Letter Letters to, or agreements with, the Depository to effectuate a book entry system with respect to the Class A Certificates registered in the Register under the nominee name of the Depository.

  • Post-Closing Agreement shall have the meaning set forth in Section 8.9.

  • Disbursement Agreement means, on any date, the Disbursement Agreement, as originally in effect on the Closing Date, among the Borrower, Holdings, the Administrative Agent, the Discount Note Indenture Trustee, the Disbursement Agent, the Servicing Agent and the Securities Intermediary and as thereafter from time to time amended, supplemented, amended and restated or otherwise modified.

  • Termination Letter has the meaning specified in Section 2.17(b).