Royalty Report: Drugs, Delivery, Pharmaceuticals – Collection: 63694

License Grant

As part of the termination, the Company reacquired the rights to the intellectual property.  All obligations under the prior license agreement have been completed except for a perpetual royalty on net sales for LPCN 1021.

License Property

LPCN 1021: An Oral Product Candidate for Testosterone Replacement Therapy

LPCN 1021 is an oral formulation of the chemical testosterone undecanoate (TU), an eleven carbon side chain attached to testosterone. TU is an ester prodrug of testosterone. An ester is chemically formed by bonding an acid and an alcohol. Upon the cleavage, or breaking, of the ester bond, testosterone is formed. TU has been approved for use outside the United States for many years for delivery via intra-muscular injection and in oral dosage form and TU has received regulatory approval in the United States for delivery via intra-muscular injection. We are using our Lip’ral technology to facilitate steady gastrointestinal solubilization and absorption of TU for twice daily oral dosing of TU.

Field of Use

This agreement pertains to the drug industry relating to testosterone.

License Grant

The Licensor and Licensee have a license agreement for the Licensor's CPE-215 with Testosterone formulation – Testim.  Testim was was launched in the U.S. in early 2003. The Licensor recently obtained patents that cover the application of testosterone with CPE-215 in the U.S. and in foreign countries that continue through 2023.

License Property

The Licensor's platform drug delivery technology enhances permeation and absorption of pharmaceutical molecules across the skin, nasal mucosa and eye through development of proprietary formulations with molecules such as CPE-215.

Testim® is a gel for testosterone replacement therapy, which is a formulation of our technology with testosterone.

License Grant

Licensor grants an exclusive license in the Territory, and, the right to grant sub licenses, to rights under:
(a) the Licensor Patents and Technology; and
(b) Licensors rights in any Joint Developments in the Field;
in each case to develop, use, make, have made, sell or otherwise dispose of the Products in the Field; provided, however, that notwithstanding the foregoing, Licensee shall not have the right to make or have made the Products other than as expressly contemplated by or provided in the Manufacturing and Supply Agreement, or to modify in any way the structure or composition of the Products, without the prior written consent of Licensor.

License Property

The patents cover the T-Patch and/or the TE Patch.

Products means the TE Patch and the T-Patch. For the avoidance of doubt, Products does not include Intrinsa.

The Once A Week T Patch means the transdermal patch drug delivery system to be developed by Licensor that will contain testosterone as the single active ingredient at a dosage in vitro of testosterone to be determined, that is intended to be worn for seven consecutive days, which shall be evidenced by either an NDA or a supplement to the NDA for the T Patch or lntrinsa.

The T-Patch means the transdermal patch drug delivery system developed by Licensor that contains testosterone as the single active ingredient at an in vivo dosage bio-equivalent to Intrinsa which is worn for three to four consecutive days, which shall be evidenced by either an NDA, a supplement thereto, or a supplement to the NDA, for Intrinsa, and shall include any minor improvements or modifications to such product that do not require additional development work.

The TE Patch means the transdermal patch drug delivery system to be developed by Licensor that will contain as the active ingredients a combination of testosterone and estrogen at a single dosage in vivo of testosterone to be determined, which dosage shall be in the range of about 50 to about 600 meg/day and which shall he evidenced by an NDA or a supplement thereto.

Field of Use

The Field means transdermal patches that contain testosterone ( or androgen derivatives of testosterone or androgens that convert to testosterone in the body) as the single active ingredient, and transdermal patches that contain the combination of testosterone (or androgen derivatives of testosterone or androgens that convert to testosterone in the body) plus estrogen or other related hormones (e.g. progestin), in each case at dosages of testosterone, androgen derivatives of testosterone or androgens that convert to testosterone in the body (in vivo) in the range of about 50 to about 600 meg/day, for use by women for any indication.