Xyrem definition
Examples of Xyrem in a sentence
The U.S. Borrower is seeking a permanent injunction to prevent Amneal from introducing a generic version of Xyrem that would infringe its patents.
Two additional patents, one covering a formulation of Xyrem and the other covering use of Xyrem for treatment of narcolepsy (Patent Nos.
On September 30, 2013, the U.S. Borrower received a Paragraph IV Certification from ▇▇▇▇▇▇ alleging that a tenth patent listed in the Orange Book for Xyrem would not be infringed by Roxane’s proposed generic product.
Jazz Pharmaceuticals requires certain Patient Confidential Information in connection with the Xyrem Success Program.
The Company has made available to Buyer a list of all correspondence between the FDA and the Company or its Subsidiaries with respect to Xyrem, and the dates of all FDA meetings held with respect to Xyrem since its approval on July 17, 2002, and the Company has provided Buyer with true and complete copies of the FDA minutes with respect to all such FDA meetings after such date.
In the event that (a) Xyrem or Xywav is damaged or destroyed after the product was dispensed and shipped to the Patient pursuant to Section 4.1(b) and (b) such damage or destruction [***], ESSDS shall replace the Xyrem or Xywav to the Patient free of charge once the damaged Xyrem or Xywav is returned to ESSDS.
The change to a CSA boundary shall become effective upon final approval of the new CSA boundary map by the School Board.
The U.S. Borrower is seeking a permanent injunction to prevent ▇▇▇▇▇▇ from introducing a generic version of Xyrem that would infringe its patents.
The Xyrem Success Program is a proprietary program to ensure the safe use of Xyrem and minimize the risk of abuse, misuse, and diversion of sodium oxybate.
With respect to all Xyrem or Xywav purchased by ESSDS from Jazz Pharmaceuticals pursuant to Section 4.1, ESSDS shall pay a purchase price to Jazz Pharmaceuticals [***].