Common use of Event MA Clause in Contracts

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

Event MA. In addition to the [* *] Annual MA -------- referred to in Section 9.1(a8.2(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, FDA relating to the manufacture, packaging or labeling of the Product by Catalytica, (ii) Customer ORPHAN has rejected a shipment of Product for a mutually agreed upon failure to meet Specifications or (iii) Customer 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 twelve (12) month period Contract Year relating to the manufacturing process for the Product (individually or collectively, an "“Event"”), Customer ----- ORPHAN shall have the right to conduct an additional Manufacturing Audit or Audits according to the terms specified in Section 9.1 (c8.2(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 Customer ORPHAN has not yet conducted a [* *] an Annual MA and Customer ORPHAN elects to exercise its rights with respect to an Event MA, then in such case, such Event MA and [* *] Annual MA shall be conducted atat the same time; provided, however, an Annual MA shall not be conducted within six (6) months of the immediately preceding Annual MA.

Event MA. In addition to the [[ * *] MA -------- referred to in Section 9.1(a8.2(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, FDA relating to the manufacture, packaging or labeling of the Product by Catalytica, (ii) Customer ORPHAN has rejected a shipment of Product for a mutually agreed upon failure to meet Specifications or (iii) Customer 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 twelve (12) month period Contract Year relating to the manufacturing process for the Product (individually or collectively, an "“Event"”), Customer ----- ORPHAN shall have the right to conduct an additional Manufacturing Audit or Audits according to the terms specified in Section 9.1 (c8.2(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 Customer ORPHAN has not yet conducted a [an [ * *] MA and Customer ORPHAN elects to exercise its rights with respect to an Event MA, then in such case, such Event MA and [[ * *] MA shall be conducted atat the same time; provided, however, an [ * ] MA shall not be conducted within [ * ] of the immediately preceding [ * ] MA.