Xyrem Success Program definition

Xyrem Success Program means the program for patients taking Xyrem for which CuraScript and ESSDS shall perform the Covered Services hereunder, and which, as between the parties, is Jazz Pharmaceuticals’ property and proprietary information. The Xyrem Success Program was created for the purpose of complying with FDA-mandated requirements relating to Product.
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Examples of Xyrem Success Program in a sentence

  • Accordingly, we may face pressure to license or share the Xyrem Success Program with generic competitors in the future.

  • Upon termination or expiration of this 2011 Master Services Agreement, for whatever reason, Jazz Pharmaceuticals shall have the right to transfer all Xyrem Success Program SOPs and Business Rules and the toll free Xyrem telephone number to another specialty pharmacy and/or distributor of its choice, and CuraScript and ESSDS shall cooperate with Jazz Pharmaceuticals in the transfer of such items to another qualified specialty pharmacy and/or distributor.

  • Thus, ANDAs referencing Xyrem must, in order to be acceptable for review, contain information demonstrating that the proposed ANDA drug product would have the same labeling and conditions of use as Xyrem—including those aspects of Xyrem’s labeling and conditions of use that are incorporated within the Xyrem Success Program.

  • Furthermore, in the event that Jazz Pharmaceuticals chooses to engage another distributor for commercial, non- clinical Product in addition to ESSDS (other than an Affiliate of ESSDS or CuraScript), CuraScript and ESSDS shall maintain the right to continue to provide Covered Services to any Patients enrolled in the Xyrem Success Program as of the date that CuraScript and ESSDS no longer maintain its exclusive pharmacy/distributor status.

  • Limitations of UseXyrem may only be dispensed to patients enrolled in the Xyrem Success Program [see Warnings and Precautions (5.3)].1.1 Cataplexy in Narcolepsy‌Xyrem (sodium oxybate) oral solution is indicated for the treatment of cataplexy in narcolepsy [see Clinical Studies (14.1)].1.2 Excessive Daytime Sleepiness in Narcolepsy‌Xyrem (sodium oxybate) oral solution is indicated for the treatment of excessive daytime sleepiness (EDS) in narcolepsy [see Clinical Studies (14.2)].

  • The Xyrem Success Program was created to permit Xyrem’s approval consistent with the conditions that the FDA placed on the use of Xyrem.

  • Rightscorp, Inc., et al, Case No. 2:14-cv-9032-DSF-JCG (C.D. Cal.) (“Blaha”) pending in the Central District of California.the former case); see also Harris v.

  • Specifically at issue is whether ANDAs referencing Xyrem must contain such information regarding those aspects of the Xyrem Success Program that constitute labeling and/or conditions of use.

  • The current goal of LOTUS is to gain a comprehensive understanding of ozone trends, including their relationship to altitude and latitude, by thoroughly evaluating uncertainties in trend studies and considering the impact of errors related to the sam-55 pling and stability of data sets.

  • Because the elements of the Xyrem Success Program are “conditions of use” of Xyrem, any ANDA referencing Xyrem must contain, when filed, sufficient information to demonstrate that 70 Roxane’s Jan.

Related to Xyrem Success Program

  • Pilot program means a program using a representative sample of residential and small commercial customers to assist in developing and offering customer choice of electricity supply for all residential and commercial customers.

  • Training program means a standardized medication

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Non-Administrator Ambulatory Surgical Facility means an Ambulatory Surgical Facility which does not meet the definition of an Administrator Ambulatory Surgical Facility.

  • Educational program means a program for educating and preparing physician assistants which is approved by the board.

  • Number of Students Who Began Program means the number of students who began the program who are scheduled to complete the program within the reporting calendar year.

  • Development Program means the implementation of the development plan.

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Virginia Stormwater Management Program or “VSMP” means a program approved by the State Board after September 13, 2011, that has been established by a locality to manage the quality and quantity of runoff resulting from land-disturbing activities and shall include such items as local ordinances, rules, permit requirements, annual standards and specifications, policies and guidelines, technical materials, and requirements for plan review, inspection, enforcement, where authorized in this article, and evaluation consistent with the requirements of this article and associated regulations.

  • Program Staff means an employee or individual who by contract with the program provides a service and has the applicable competencies, qualifications, or certification required to provide the service.

  • (3) PROGRAM.—The term program’ means

  • E-Verify Program above means the employment verification program administered by the United States Department of Homeland Security, the Social Security Administration, or any successor program.

  • Basic Comprehensive User Guide means the Ministry document titled Basic Comprehensive Certificates of Approval (Air) User Guide” dated April 2004 as amended.

  • Municipal Separate Storm Sewer System Management Program means a management program covering the duration of a state permit for a municipal separate storm sewer system that includes a comprehensive planning process that involves public participation and intergovernmental coordination, to reduce the discharge of pollutants to the maximum extent practicable, to protect water quality, and to satisfy the appropriate water quality requirements of the CWA and regulations, and this article and its attendant regulations, using management practices, control techniques, and system, design, and engineering methods, and such other provisions that are appropriate.

  • PRIMARY PLAN (PRIMARY means a plan whose benefits for a person's healthcare coverage must be determined without taking the existence of any other plan into consideration.

  • Child day program means a regularly operating service arrangement for children where, during the absence of a parent or guardian, a person or organization has agreed to assume responsibility for the supervision, protection, and well-being of a child under the age of 13 for less than a 24-hour period.

  • Development Plans has the meaning set forth in Section 3.2.

  • Nursing program means a series of courses leading to an LPN certificate or an ADN degree provided through a Wyoming community college; or a BSN degree or a Master’s degree provided through the University of Wyoming; or, in the case of a candidate for a doctoral degree, provided through an institution offering the required nursing education courses under contract with the WICHE, or in a distance nursing education program provided through a university that is regionally accredited.

  • Bug and tar remover means a product labeled to remove either or both of the following from painted motor vehicle surfaces without causing damage to the finish:

  • Education program means any program that is principally engaged in the provision of education, including, but not limited to, early childhood education, elementary and secondary education, postsecondary education, special education, job training, career and technical education, and adult education, and any program that is administered by an educational agency or institution.

  • System for Award Management (SAM) database means the primary Government repository for contractor information required for the conduct of business with the Government.

  • Switching and Tagging Rules means the switching and tagging procedures of Interconnected Transmission Owners and Interconnection Customer as they may be amended from time to time.

  • SECONDARY PLAN (SECONDARY means a plan that is not a primary plan.

  • Non-Administrator Dialysis Facility means a Dialysis Facility which does not have an agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan but has been certified in accordance with the guidelines established by Medicare.

  • Non-Administrator Substance Use Disorder Treatment Facility means a Substance Use Disorder Treatment Facility that does not meet the definition of an Administrator Substance Use Disorder Treatment Facility.

  • Approved abuse education training program means a training program using a curriculum approved by the abuse education review panel of the department of public health or a training program offered by a hospital, a professional organization for physicians, or the department of human services, the department of education, an area education agency, a school district, the Iowa law enforcement academy, an Iowa college or university, or a similar state agency.