Event MA Clause Samples

Event MA. In addition to the [* *] MA -------- referred to in Section 9.1(a) hereof, in the event that (i) Catalytica shall receive a "Warning Letter" from the FDA, or any other regulatory agency inside or outside the United States, relating to the manufacture, packaging or labeling of the Product by Catalytica, (ii) Customer has rejected a shipment of Product for a failure to meet Specifications or (iii) Customer or Catalytica shall have received a series of complaints [* *] from Third Parties within any twelve (12) month period relating to the manufacturing process for the Product (individually or collectively, an "Event"), Customer ----- shall have the right to conduct an additional Manufacturing Audit or Audits according to the terms specified in Section 9.1 (c) hereof (such Event Manufacturing Audit or Audits to be hereinafter referred to as an "Event MA"). -------- It is understood and agreed, however, that with respect to any Contract Year, if Customer has not yet conducted a [* *] MA and Customer elects to exercise its rights with respect to an Event MA, then in such case, such Event MA and [* *] MA shall be conducted at
View SourceView Similar (3)
Event MA. In addition to the Annual MA, in the event that (i) JB Labs receives 483 Observations or a "Warning Letter" from the FDA or any foreign equivalent outside the USA relating to the Manufacture of the Product by JB Labs, (ii) JB Labs has received a DEA "Letter of Admonishment" or similar notice alleging non-compliance, (iii) Xanodyne has rejected a Batch of Product where it has been agreed or determined that such Product failed to meet Specifications or cGMP or (iv) Xanodyne or JR Labs shall have received a series of complaints (i.e. [**] complaints on at least [**] lots of Product determined to have been a result of operations at JB Labs) from Third Parties within any year relating to the Manufacture of a Product (individually or collectively, an "Event"); Xanodyne shall have the right to conduct additional Manufacturing Audits according to the terms specified in Section 9.13.4 below (such Manufacturing Audit or Audits to be hereinafter referred to as an "Event MA").
View Source
Event MA. In addition to the Periodic MA referred to in Section 8.1 hereof, in the event that: (i) the Regulatory Authorities schedule a regulatory inspection of the Facility in which API is Manufactured; (ii) HOVIONE receives a “Warning Letter” or Form 483 Observations from the FDA relating to the Manufacture of API by HOVIONE or compliance with cGMP’s at any facility where Manufacturing or other activities related to the API occurs; (iii) COMPANY has rejected a shipment of API for failure to meet Specifications; or (iv) COMPANY otherwise has reasonable concern regarding the quality or Manufacturing of API supplied by HOVIONE (individually or collectively, an “Event”), COMPANY shall have the right to conduct additional Manufacturing Audits in respect of the API according to the terms specified in Section 8.3 hereof (such Event Manufacturing Audit to be hereinafter referred to as an “Event MA”). [*****] shall bear [*****] costs and expenses incurred in connection with the conduct of such Event MA.
View Source
Event MA. In addition to the Annual MA, in the event that SUPPLIER shall receive a “483 Observation” or a “Warning Letter” from the Food and Drug Administration (FDA) or any foreign equivalent outside the USA relating to the manufacture, packaging, testing or labeling of the SUPERNUS PRODUCT by SUPPLIER; or similar notice alleging non-compliance; SUPERNUS has rejected a batch/lot of PRODUCT where it has been agreed or determined that such PRODUCT failed to meet Specifications or cGMP; or SUPERNUS or SUPPLIER have received a series of complaints which are judged to be major from Third Parties within any year relating to the manufacture (individually or collectively, an “Event”) SUPERNUS shall have the right to conduct additional Manufacturing Audits according to the terms specified below (such Event Manufacturing Audit(s) to be hereinafter referred to as an “Event MA(s)”.
View Source
Event MA. In addition to the Annual MA, in the event that (i) Patheon receives 483 Observations or a “Warning Letter” from the FDA or any foreign equivalent outside the USA relating to the Manufacture, packaging testing or labeling of the New River Product by Patheon, (ii) Patheon has received a DEA “Letter of Admonishment” or similar notice alleging non-compliance (iii) New River has rejected a Batch of Product where it has been agreed or determined that such Product failed to meet Specifications or cGMP or (iv) for circumstances where New River and Patheon reasonably believe and agree that significant quality and/or compliance issues exist or have been discovered, New River shall have the right to conduct additional Manufacturing Audits according to the terms specified in Section 9.13.3 below (such Event Manufacturing Audit or Audits to be hereinafter referred to as an “Event MA’).
View Source
Event MA. In addition to the Annual MA, in the event that: (i) SUPPLIER shall receive a FDA-483 Form or a warning or untitled letter from FDA or any foreign equivalent outside the USA relating to the manufacture, packaging, testing or labeling of the Product by SUPPLIER, (ii) STRYKER has rejected a production lot of Product where it has been agreed or determined that such Product failed to meet Product Specifications or the QSR/cGMPs, (iii) STRYKER or SUPPLIER has received an unusual trend of complaints or a trend of serious adverse events from any of its customers (including without limitation consumers, patients, doctors, pharmacies or wholesalers) at any time during the term of this Agreement (individually or collectively an “Event”), or (iv) SUPPLIER has otherwise breached the terms of this Agreement, (v) SUPPLIER moves to new facility, expands to additional facility or transfers part to third party, STRYKER shall have the right to conduct additional Manufacturing Audits according to the terms specified in Section 5.3.2.4 below (such Event Manufacturing Audit or Audits to be hereinafter referred to as an “Event MA”).
View Source

Related to Event MA

  • Servicer Termination Events For purposes of this Agreement, the occurrence and continuance of any of the following shall constitute a “Servicer Termination Event”: (a) Any failure by the Servicer to deposit into any Account any proceeds or payment required to be so delivered or to direct the Indenture Trustee to make the required payment from any Account under the terms of this Agreement that continues unremedied for a period of five Business days after written notice is received by the Servicer or after discovery of such failure by a Responsible Officer of the Servicer; (b) Failure on the part of the Servicer duly to observe or perform, in any material respect, any covenants or agreements of the Servicer set forth in this Agreement, which failure (i) materially and adversely affects the rights of the Securityholders and (ii) continues unremedied for a period of 60 days after discovery of such failure by a Responsible Officer of the Servicer or after the date on which written notice of such failure requiring the same to be remedied shall have been given to the Servicer by any of the Owner Trustee, the Indenture Trustee or Noteholders evidencing not less than 50% of the Outstanding Amount of the Controlling Class of Notes; (c) If any representation or warranty of the Servicer, in its capacity as Servicer, made in this Agreement shall prove to be incorrect in any material respect as of the time when the same shall have been made and the incorrectness of such representation or warranty has a material adverse effect on the Issuer or the Noteholders and such failure continues unremedied for 90 days after discovery thereof by a Responsible Officer of the Servicer or receipt by the Servicer of written notice thereof from the Indenture Trustee or the Noteholders representing not less than 50% of the Outstanding Amounts of the Notes; or (d) The occurrence of an Insolvency Event with respect to the Servicer; provided, however, that a delay or failure of performance referred to under clause (a) above for a period of 10 days or clause (b) or (c) above for a period of 30 days will not constitute a Servicer Termination Event if such delay or failure was caused by force majeure or other similar occurrence.

  • Servicer Termination Event For purposes of this Agreement, each of the following shall constitute a “Servicer Termination Event”:

  • Consequences of a Servicer Termination Event If a Servicer Termination Event shall occur and be continuing, the Trust Collateral Agent may, or at the direction of the Majority Noteholders shall, by notice given in writing to the Servicer (and to the Trust Collateral Agent if given by the Noteholders) terminate all of the rights and obligations of the Servicer under this Agreement. On or after the receipt by the Servicer of such written notice or upon termination of the term of the Servicer, all authority, power, obligations and responsibilities of the Servicer under this Agreement, whether with respect to the Notes, the Certificate or the Other Conveyed Property or otherwise, shall pass to, be vested in and become obligations and responsibilities of the successor Servicer appointed by the Majority Noteholders; provided, however, that the successor Servicer shall have no liability with respect to any obligation which was required to be performed by the terminated Servicer prior to the date that the successor Servicer becomes the Servicer or any claim of a third party based on any alleged action or inaction of the terminated Servicer. The successor Servicer is authorized and empowered by this Agreement to execute and deliver, on behalf of the terminated Servicer, as attorney-in-fact or otherwise, any and all documents and other instruments and to do or accomplish all other acts or things necessary or appropriate to effect the purposes of such notice of termination, whether to complete the transfer and endorsement of the Receivables and the Other Conveyed Property and related documents to show the Trust as lienholder or secured party on the related Lien Certificates, or otherwise. The terminated Servicer agrees to cooperate with the successor Servicer in effecting the termination of the responsibilities and rights of the terminated Servicer under this Agreement, including, without limitation, the transfer to the successor Servicer for administration by it of all cash amounts that shall at the time be held by the terminated Servicer for deposit, or have been deposited by the terminated Servicer, in the Collection Account or thereafter received with respect to the Receivables and the delivery to the successor Servicer of all Receivable Files, Monthly Records and Collection Records and a computer tape in readable form as of the most recent Business Day containing all information necessary to enable the successor Servicer to service the Receivables and the Other Conveyed Property. The terminated Servicer shall grant the Trust Collateral Agent, the successor Servicer and the Majority Noteholders reasonable access to the terminated Servicer’s premises at the terminated Servicer’s expense.

  • Servicer Default Any one of the following events shall constitute a default by the Servicer (a “Servicer Default”): (a) any failure by the Servicer to deliver to the Indenture Trustee for deposit in any of the Trust Accounts or distribution to the Certificateholders any required payment or to direct the Indenture Trustee to make any required distributions therefrom, which failure continues unremedied for a period of five Business Days after written notice of such failure is received by the Servicer from the Owner Trustee or the Indenture Trustee or after discovery of such failure by an officer of the Servicer; or (b) failure by the Servicer or, if the Servicer is an affiliate of the Depositor, the Depositor, as the case may be, duly to observe or to perform in any material respect any other covenants or agreements of the Servicer or the Depositor (as the case may be) set forth in this Agreement or any other Basic Document, which failure shall (i) materially and adversely affect the rights of Certificateholders or Noteholders and (ii) continue unremedied for a period of 60 days after the date on which written notice of such failure, requiring the same to be remedied, shall have been given (A) to the Servicer or the Depositor (as the case may be) by the Owner Trustee or the Indenture Trustee or (B) to the Servicer or the Depositor (as the case may be), and to the Owner Trustee and the Indenture Trustee by the Holders of the Notes evidencing at least a majority of the Outstanding Amount of the Controlling Securities and the Holders (as defined in the Trust Agreement) of Certificates evidencing at least a majority of the percentage interest of the Certificates; or (c) the occurrence of an Insolvency Event with respect to the Servicer or, if the Servicer is an affiliate of the Depositor, the Depositor. Notwithstanding the foregoing, a delay in or failure of performance referred to under clause (a) above for a period of ten Business Days or referred to under clause (b) for a period of 90 Business Days, shall not constitute a Servicer Default if such delay or failure could not be prevented by the exercise of reasonable diligence by the Servicer and was caused by an act of God or other similar occurrence. Upon the occurrence of any such event, the Servicer shall not be relieved from using its best efforts to perform its obligations in a timely manner in accordance with the terms of this Agreement and the Servicer shall provide the Indenture Trustee, the Owner Trustee, the Noteholders and the Certificateholders prompt notice of such failure or delay by it, together with a description of its efforts to so perform its obligations. So long as the Servicer Default shall not have been remedied or stayed by the application of the above paragraph, either the Indenture Trustee or the Holders of the Notes evidencing at least a majority of the Outstanding Amount of the Controlling Securities, by notice then given in writing to the Servicer (and to the Indenture Trustee and the Owner Trustee if given by the Noteholders) may terminate all the rights and obligations (other than the obligations set forth in Section 7.02 hereof) of the Servicer under this Agreement. On or after the receipt by the Servicer of such written notice, all authority and power of the Servicer under this Agreement, whether with respect to the Notes, the Certificates or the Receivables or otherwise, shall, without further action, pass to and be vested in the Indenture Trustee or such successor Servicer as may be appointed under Section 8.02; and, without limitation, the Indenture Trustee and the Owner Trustee are hereby authorized and empowered to execute and deliver, for the benefit of the predecessor Servicer, as attorney-in-fact or otherwise, any and all documents and other instruments, and to do or accomplish all other acts or things necessary or appropriate to effect the purposes of such notice of termination, whether to complete the transfer and endorsement of the Receivables and related documents, or otherwise. The predecessor Servicer shall cooperate with the successor Servicer, the Indenture Trustee and the Owner Trustee in effecting the termination of the responsibilities and rights of the predecessor Servicer under this Agreement, including the transfer to the successor Servicer for administration by it of all cash amounts that shall at the time be held by the predecessor Servicer for deposit, or shall thereafter be received by it with respect to any Receivable. Further, in such event, the Servicer shall use commercially reasonable efforts to effect the orderly and efficient transfer of the servicing of the Receivables to the successor Servicer, and as promptly as practicable, the Servicer shall provide to the successor Servicer a current computer tape containing all information from the Receivables Files required for the proper servicing of the Receivables, together with the documentation containing any and all information necessary for the use of the tape. All reasonable and documented costs and expenses (including attorneys’ fees) incurred in connection with transferring the Receivable Files to the successor Servicer and amending this Agreement to reflect such succession as Servicer pursuant to this section shall be paid by the predecessor Servicer upon presentation of reasonable documentation of such costs and expenses. Upon receipt of notice of the occurrence of a Servicer Default, the Owner Trustee shall give notice thereof to the Depositor who promptly shall provide such notice to the Rating Agencies.

  • Termination Event; Notice The Purchase Contracts and all obligations and rights of the Company and the Holders thereunder, including, without limitation, the rights of the Holders to receive and the obligation of the Company to pay any Contract Adjustment Payments or any Deferred Contract Adjustment Payments, and the rights and obligations of the Holders to purchase shares of Common Stock, will immediately and automatically terminate, without the necessity of any notice or action by any Holder, the Purchase Contract Agent or the Company, if, on or prior to the Purchase Contract Settlement Date, a Termination Event shall have occurred. Upon the occurrence of a Termination Event, the Company shall promptly but in no event later than two Business Days thereafter give written notice thereof to the Purchase Contract Agent, the Collateral Agent, and to the Holders at their addresses as they appear in the Security Register. Upon and after the occurrence of a Termination Event, the Units shall thereafter represent the right to receive the Debentures underlying the Applicable Ownership Interest in Debentures or the Applicable Ownership Interest in the Treasury Portfolio, as the case may be, forming a part of such Units in the case of Corporate Units, or Treasury Securities in the case of Treasury Units, in accordance with the provisions of Section 4.3 of the Pledge Agreement.