Royalty Report: Drugs, Disease, Therapeutic – Collection: 6935


Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 3


This collection of transactions and supporting information was developed using our AI algorithm to curate similar royalty reports into a cohesive collection to support your licensing, transfer pricing or other transaction scenarios where documented royalty rates and/or deal terms are important.
Category: Technology Licenses
Created On: 2022-04-28
Record Count: 3

Primary Industries

  • Drugs
  • Disease
  • Therapeutic
  • Pharmaceuticals
  • cardiac

IPSCIO Report Record List

Below you will find the records curated into this collection.  This summary includes the complete licensed property description so that you can review and determine if this collection covers the topics, technology or transaction type that is relevant for your needs.  The full report will include all relevant deal data such as the royalty base, agreement date, term description, royalty rates and other deal terms.  For reference, here is a sample of a full IPSCIO curated royalty rate report: Sample Report

IPSCIO Record ID: 6935

License Grant
The Canadian Licensor entered into a collaboration and License Agreement with the Licensee, a U.S. affiliate of a leading pharmaceutical company headquartered in Japan.

The Licensor granted the Licensee an exclusive License to vernakalant (iv) and its related technology to develop, make and sell intravenous or injectable formulations of vernakalant (iv) in North America for any and all indications including the treatment of atrial fibrillation and atrial flutter, including a right to subLicense to third parties.

License Property
In July 2006, the Licensor amended the collaboration and License Agreement. The Licensee agreed to fund all of the costs associated with the re-submission of the NDA for vernakalant (iv), including the engagement of external consultants, and paid to the Licensor a milestone payment on the re-submission of the NDA for vernakalant (iv) to the FDA. In addition, a milestone payment is payable on approval of vernakalant (iv) by the FDA. The Licensee is also responsible for 75% of all the remaining development costs related to seeking regulatory approval in North American markets, and all marketing and commercialization costs for vernakalant (iv) in North America. Licensee has also agreed to make additional milestone payments with respect to any subsequent drugs developed under the Agreement. Licensor also has the right, without payment, to use the clinical data package which makes up the NDA for vernakalant (iv) to seek approval for the drug outside of North America. Our Agreement has an indefinite term but can be terminated entirely, or on a country by country basis, by either party if certain development or commercialization milestones are not met. All development activities related to regulatory approval in North American markets are jointly managed by both parties until the termination of our Agreement. Licensee is responsible for the development plan, NDA application and registration for vernakalant (iv), along with the sales, marketing and distribution of vernakalant (iv). The Licensor managed the completed ACT 1 and ACT 2 clinical studies, while Licensor managed ACT 3 and ACT 4 clinical studies. The ACT 5 trial is being managed by Licensee who is also responsible for the commercial manufacturing of vernakalant (iv), while the Licensor is responsible for manufacturing clinical supplies of the compound, which we are undertaking through the use of contract manufacturers.
Field of Use
The rights granted apply to the pharmaceutical industry relating to drug products.

Vernakalant (INN; codenamed RSD1235, proposed tradenames Kynapid and Brinavess) is an investigational drug under regulatory review for the acute conversion of atrial fibrillation.

IPSCIO Record ID: 209524

License Grant
The Canadian Licensor grants an exclusive, even as to Licensor, license under the Licensors Technology to  (a) develop and manufacture Products for use in the Territory in the Field; and  (b) use, promote, market, distribute, offer for sale, sell, export and import Products in the Territory for use in the Field; with the right to sublicense.
License Property
The proprietary compound is known as RSD1235 or (1R,2R)-2-[(3R)-Hydroxypyrrolidinyl]-l-(3,4-dimethoxyphenethoxy)-cyclohexane monohydrochloride] .  The Product means finished pharmaceutical preparations for human use in all injectable or intravenous dosage forms containing RSD1235 as an active ingredient.  The patents relate to Aminocyclohexyl Ether Compounds and Uses Thereof.

RSD1235 is an investigational drug for the acute conversion of atrial fibrillation.  RSD1235 has been demonstrated in a second phase 3 clinical trial; the acute-use intravenous antiarrhythmic agent has been shown to safely convert more patients to normal sinus rhythm than placebo.

Field of Use
The Field means the use of the Product in an injectable or intravenous formulation for any and all indications, including the Indication.  The Indication means Atrial Fibrillation and Atrial Flutter.

Atrial fibrillation is an abnormal heart rhythm characterized by rapid and irregular beating of the atria.
Atrial flutter is a common abnormal heart rhythm that starts in the atrial chambers of the heart.

IPSCIO Record ID: 728

License Grant
Licensor hereby assigns to Licensee of Canada rights and interest in the Regulatory Approvals that Licensor has or may have had, including the NDA, and Licensee will be responsible for the costs associated therewith.
License Property
Pursuant to the Project Transfer Agreement, the Parties have agreed to terminate the Collaborative Agreement entered into in November 2007 and the Parties further agreed that the CPI-300 project will be transferred and assigned to the Company. In addition, the Licensor has assigned to the Company all rights and interest in the regulatory approvals that Licensor has or may have had, including the New Drug Application, and the Company will be responsible for the costs associated therewith. The Company will have full and complete authority with respect to the prosecution and/or amendment of the NDA and the commercialization of the product and/or the technology encompassed in the CPI-300 project.

The Company will also assume all obligations to, and responsibility for, the Biovail litigation, including the costs thereof. On August 18, 2009 Licensor was sued by Biovail in the U.S. District Court of Delaware for patent infringement, under provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), with respect to Biovail's U.S. Patent No. 6,096,341.

Product means tablets that contain 450 mg of bupropion hydrochloride extended release as described in the NDA.

Field of Use
The rights granted apply to pharmaceutical products relating to CPI-300 which is a higher strength of the antidepressant bupropion HCl, the active ingredient in Wellbutrin XL® in the healthcare industry.
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