Royalty Report: Drugs, Pain, Diagnostic – Collection: 31986

License Grant

The Company entered into a license, development and commercialization agreement with a major Korean pharmaceutical company.  The agreement grants the pharmaceutical company exclusive rights to market Zertane in South Korea for the treatment of premature ejaculation (“PE”) and for a combination drug to be developed, utilizing Zertane and an erectile dysfunction drug.

License Property

Our premature ejaculation product candidate, Zertane, is a specifically formulated orally disintegrating tablet, or ODT, of tramadol hydrochloride patented for the on-demand treatment of PE. Zertane is being developed utilizing a regulatory pathway pursuant to Section 505(b)(2) of the Food, Drug and Cosmetic Act, as amended, or the FDCA, as the active ingredient is already well characterized for the treatment of pain, and we are relying on the FDA’s finding of safety of tramadol hydrochloride to support its use in a new indication, PE, at a lower dose. If we receive marketing approval for Zertane, we believe it will be the first commercial product approved by the FDA for PE.

Field of Use

This agreement pertains to a drug for the treatment of premature ejaculation in the medical industry.

License Grant

Licensor grants to Irish Licensee an exclusive license to the Licensor IP in the Territory, as per the stipulations made in this Agreement, with the right to
(a)
market, promote, import into the Territory, offer for sale and sell the Product for use in the Field;
(b)
use the Trade Marks and reproduce the Licensor marketing materials in accordance with Agreement;
(c)
design its own packaging for the Product, and market the Product under its own trademark or any other trademark in the Territory; and
(d)
use the Licensor Know-How to exercise its rights and perform its obligations set out in this Agreement (the License); and provided that Licensor may continue to use the Licensor IP in the Territory for any purpose other than marketing, distributing and selling the Product in the Territory.

Licensor appoints Licensee as Licensor’s exclusive distributor for marketing and selling the Product in the Territory and Licensee accepts such appointment and agrees to use commercially reasonable efforts to market, distribute and sell the Product subject to the terms and conditions set out in this Agreement.

Licensee is entitled to grant sublicenses under the License that comply with this Agreement to its Affiliates and third parties.

License Property

Trade Marks means the trade marks as ZERTANE.

Product shall mean orally disintegrating tablets containing 89mg tramadol hydrochloride as the active ingredient, suitable for distribution in accordance with the Specifications in this Agreement and all Improvements thereto.

Licensor IP means all Intellectual Property Rights that subsist in
(a)
the Product, including methods and processes for its production and storage and its use in the life sciences;
(b)
Licensor’s marketing and informational materials;
(c)
the Improvements;
(d)
the Licensor Patents, the Licensor Know-How and the Trade Marks;
(e)
the colour scheme and the art work on the Pack (if not designed by Licensee);
and all other intellectual property rights that Licensor owns.

Canada Patent 2,440,920 – Use of Tramadol to Delay Ejaculation

Field of Use

Field means the treatment of premature ejaculation.

Zertane (tramadol HCl) is an oral drug in late-stage development as a proprietary treatment for premature ejaculation, a condition that has a major impact on the quality of life for men and their sexual partners and has demonstrated a favorable efficacy profile in clinical trials.

License Grant

Licensor hereby grants a Korean  pharmaceutical company an exclusive royalty-bearing license, with the right to sublicense directly or through multiple tiers under the Licensor Technology, to research, Develop, Finish, use, have used, sell, have sold, offer for sale, have offered for sale, distribute, have distributed, import, have imported, and otherwise Commercialize the Products in the Field in the Territory.  For clarity, the foregoing licenses exclude the right to Manufacture or have Manufactured the Product, except for the right to Finish the Product.

License Property

The Licensee has made or will make certain specified milestone payments to the Licensor upon the signing of the Agreement, a specified period of time following approval of ZertaneTM for sale in South Korea, a specified period of time following approval of a combination drug for sale in South Korea and specified periods of time following the end of the first calendar quarter where cumulative net sales of products including ZertaneTM (including combination drugs) in South Korea exceed specified thresholds.

Field of Use

The Agreement provides the Licensee with exclusive rights to market ZertaneTM in South Korea for the treatment of premature ejaculation and for a combination drug, utilizing ZertaneTM and another erectile dysfunction drug (PDE5 inhibitors and others), to simultaneously treat premature ejaculation and erectile dysfunction.

License Grant

The Licensor and Korean Licensee entered into an exclusive licensing agreement for the development and commercialization of Oliceridine in South Korea.

License Property

Oliceridine is a G protein biased ligand of the µ opioid receptor, for the management of moderate-to-severe acute pain where intravenous, or IV, administration is preferred.

Field of Use

This agreement pertains to the drug industry.