Complera definition

Complera means the fixed-dose co-formulated product in oral dosage form containing, as its only APIs per single daily dose, TDF, FTC and RPV, which product is either (a) a solid form that contains a dosage form of TDF equivalent to three hundred (300) milligrams Tenofovir Disoproxil Fumarate, FTC equivalent to two hundred (200) milligrams Emtricitabine and RPV equivalent to twenty-five (25) milligrams Rilpivirine; or (b) an age-appropriate pediatric formulation and dosage consistent with the Pediatric Investigation/Study Plan for a product that corresponds to the product described in clause (a) above, which plan is developed by Gilead and approved by ▇▇▇▇▇▇▇ in accordance with this Agreement.
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Examples of Complera in a sentence

  • All other changes to the Territory Combination Product Specifications for Major Market Complera, Branded Region B/C Complera, Major Market R/F/TAF Product or Branded Region B/C R/F/TAF Product shall be subject to the provisions of this JDA.

  • The “RPV Supply Agreement” shall mean (a) with respect to Supplied RPV for Territory Complera and, if and only to the extent mutually agreed by the Parties in writing, the Territory R/F/TAF Product, unless and until the Parties execute such new supply agreement and such new agreement becomes effective, that certain TMC278 (Rilpivirine (RPV)) Commercial Supply Agreement, dated as of June 1, 2010 and amended as of June 18, 2014, and (b) thereafter such new agreement as amended from time to time.

  • Before the First Commercial Sale of the Territory R/F/TAF Product in a Major Market Country, Gilead shall develop and propose to ▇▇▇▇▇▇▇ a set of core messages with respect to the Territory R/F/TAF Product, which core messages shall serve as a basis for the promotion of the Territory R/F/TAF Product in such countries to physicians (as updated from time to time, the “R/F/TAF Product Key Selling Messages” and, together with the Complera Key Selling Messages, the “Key Selling Messages”).

  • An initial plan of activities for obtaining and maintaining a first Marketing Approval for the Territory R/F/TAF Product in the Field in each of the Major Market Countries is attached hereto as Annex JJ (such plan, together with the plan existing as of the Restatement Effective Date for obtaining and maintaining first Marketing Approvals for Territory Complera in the Field in each of certain countries in the Territory, the “Registration Plan”).

  • The quantity of Major Market Complera set forth in a given Forecast for each of the first (1st) through the fourth (4th) months shall be binding.

  • Each such invoice shall state the quantity of Major Market Complera, Branded Region B/C Complera, Major Market R/F/TAF Product or Branded Region B/C R/F/TAF Product, as applicable, covered by such invoice and specify all amounts due in United States Dollars.

  • Neither Party nor any of its Affiliates, Sublicensees or Third Party Distributors shall Distribute any Combination Product in Region C other than Branded Region B/C Complera or Branded Region B/C R/F/TAF Product.

  • The Parties acknowledge and agree that Gilead obtained a first Marketing Approval of Territory Complera in each of the United States, [*] and by the European Commission prior to the Restatement Effective Date.

  • No copy of any Quote, Master Services Agreement, Service Attachment, discussions, negotiations, terms, or conditions relating to any Quote, Master Services Agreement, or any Service Attachment may be disclosed to any third party, except by reason of legal, accounting or regulatory requirements, without the prior written consent of the parties hereto.

  • For clarity, such Rights of Reference granted to Gilead under this Section 9.2.1 shall be to the entire item of ▇▇▇▇▇▇▇ Regulatory Documentation (not portions thereof) and shall include those listed as items 1 through 3 (in the case of Territory Complera) or 4 through 6 (in the case of the Territory R/F/TAF Product) in Annex II.

Related to Complera

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • Power production activities means any business operation that involves a project commissioned by the government of Iran whose purpose is to facilitate power generation and delivery, including, but not limited to, establishing power-generating plants or hydroelectric dams, selling or installing components for the project, providing service contracts related to the installation or maintenance of the project, as well as facilitating such activities, including by providing supplies or services in support of such activities.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.