Contrave definition
Examples of Contrave in a sentence
Notwithstanding the exercise by Orexigen of its right to Co-Promote Contrave pursuant to Section 3.5, Takeda shall have the sole right and responsibility for handling all sales and distribution activities, including returns, order processing, invoicing and collection, distribution (including importing, exporting, transporting, customs clearance, warehousing, invoicing, handling and delivering Products to customers), and inventory and receivables for the Products in the Field in the Territory.
Orexigen submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave on March 31, 2010 and the Prescription Drug User Fee Act (PDUFA) action date has been set for January 31, 2011.
In clinical trials, Contrave was shown to help obese patients initiate and sustain significant weight loss, improve important markers of cardiometabolic risk and increase ability to control eating.
Contrave is a combination therapy believed to address both biological and behavioral drivers of obesity.
About Contrave Contrave is an investigational combination therapy believed to address both biological and behavioral drivers of obesity.
Takeda shall use Commercially Reasonable Efforts to Commercialize Products in the Field in the Territory in accordance with the Commercialization Plan and the terms of this Agreement, subject to Orexigen’s Commercialization of Contrave pursuant to Section 3.5 and the terms of any Co-Promote Agreement.
The initial Commercialization Plan for Contrave in the U.S. shall be agreed upon by the Parties within [***] ([***]) days after the Effective Date.
In addition, prior to making a Regulatory Filing relating to Contrave or responding to any such Regulatory Authority correspondence or interactions, except to the extent impracticable with respect to expedited safety reports, timelines imposed by Regulatory Authorities, Takeda SOPs and other similar time-sensitive issues, Takeda shall provide to the JDC and JSC a complete draft copy for its review and comment.
The Commercialization Plan for Contrave in countries outside the U.S., or for other Products in countries in the Territory, shall be mutually agreed upon by the Parties.
Assuming Contrave is commercialized, Takeda will pay tiered double-digit royalty payments on net sales in the Territory. Under the terms of the agreement, Orexigen and Takeda will work together on ongoing development of the product, with Orexigen leading pre-approval activities, and Takeda leading post-approval activities.