Event MA. In addition to the [ * ] MA referred to in Section 8.2(a) hereof, in the event that (i) Catalytica shall receive a “Warning Letter” from the FDA relating to the manufacture, packaging or labeling of the Product by Catalytica, (ii) ORPHAN has rejected a shipment of Product for a mutually agreed upon failure to meet Specifications or (iii) ORPHAN or Catalytica shall have received a series of complaints (i.e., 3 or more complaints on at least 2 Production Batches) from Third Parties within any Contract Year relating to the manufacturing process for the Product (individually or collectively, an “Event”), ORPHAN shall have the right to conduct an additional Manufacturing Audit or Audits according to the terms specified in Section 8.2(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 ORPHAN has not yet conducted an [ * ] MA and ORPHAN elects to exercise its rights with respect to an Event MA, then in such case, such Event MA and [ * ] MA shall be conducted at the same time; provided, however, an [ * ] MA shall not be conducted within [ * ] of the immediately preceding [ * ] MA.
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”).
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 CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. SECTIONS 200.80(b)(4) AND 240.24b-2. [*****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION. 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.
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’).
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)”.
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").
