Royalty Report: Therapeutic, Drugs, Medical – Collection: 241274

License Grant

The Parties entered a License Agreement for the commercialization of the one-year vaginal system for contraception in the territory.

License Property

The product is the investigational segesterone acetate/ethinyl estradiol one-year vaginal system for contraception.  The one-year vaginal contraceptive system is in the shape of a ring and combines a novel progestin, segesterone acetate (Nestorone®), with a widely used estrogen (ethinyl estradiol) to prevent ovulation for an entire year (13 cycles).

Field of Use

The field of use is contraception.

License Grant

Licensor shall grant to Licensee a non-exclusive license to make, have made, use, sell and have sold such CombiPatch Product under Confidential Information relating to the CombiPatch Product, including Licensors  Technology, Licensors Patent Rights and any other patents, know-how, improvements, development studies and other information, and any trademarks related to the CombiPatch Product and owned by Licensor, for a royalty of Licensees Net Revenues from sales of the CombiPatch Product so manufactured, in addition to other terms and condition as reasonably agreed between the parties.

Licensor shall supply to Licensee, and Licensee shall purchase from Licensor all of Licensees requirements for the CombiPatch Product for sale in the Territory subject to the terms and conditions set forth herein.  Licensor shall also exclusively supply Licensee, and Licensee shall purchase from Licensor all of Licensees requirements for Licensed Products other than the CombiPatch Product for sale in the Territory.

License Property

The term CombiPatch Product shall mean the transdermal estrogen/progestin patch product which has and is being developed by Licensor solely or jointly with another party and its Affiliates and is marketed under the trademark CombiPatch(TM) in the Territory.

CombiPatch Product, at Licensees option, shall be supplied in finished, packaged and labeled form or in bulk rolls.

The term Licensed Product shall have the meaning set forth in the Licensor License Agreement, as amended. The term Licensed Product or shall mean individually and collectively any Estrogen Transdermal Drug Delivery System or any Combination Estrogen/Progestin Drug Delivery System. A Licensed Product relating to the Estrogen Transdermal Drug Delivery System shall be referred to as an 'Estrogen Product' and a Licensed Product relating to the Combination Estrogen/Progestin Drug Delivery System shall be referred to as a 'Combination Product.'

The term Licensors Technology' shall have the meaning set forth in the Licensor License Agreement in so far as it relates to any combination estrogen/progestin in a polymer adapted for transdermal delivery by application to the epidermis, other than combinations indicated for contraceptive use.

CombiPatch(TM) is a transdermal combination estrogen/progestin delivery system.

Field of Use

This agreement pertains to the drug industry relating to any combination estrogen/progestin in a polymer adapted for transdermal delivery by application to the epidermis, other than combinations indicated for contraceptive use.

CombiPatch (estradiol, norethindrone acetate transdermal system) is a combination of female hormones used to treat the symptoms of menopause such as feelings of warmth in the face, neck and chest, or sudden intense spells of heat and sweating ('hot flashes' or 'hot flushes'); to treat vulvar and vaginal changes.

License Grant

Licensor grants to an exclusive license, subject to Licensors right to use Licensed Products for research activities, under the Licensed Technical Information, with the right to grant sublicenses to Sublicensees, to manufacture, market, use, sell and distribute the Licensed Products throughout the Territory and the non-exclusive right, with the right to grant sublicenses to Sublicensees, to use any Compound Trademark in connection with the manufacture, marketing, use, sale and distribution of Licensed Products only, in each case subject to, and in accordance with, the terms of this Agreement.

License Property

The Licensed Product means any and all transdermal patches for the administration of the Compound, either alone or in combination with other compounds, for use in the Field.

Licensor has developed, and owns the right to use, certain data and information pertaining to the synthetic steroid Nestorone(R) (17-acetoxy-16-methylene-19-norprogesterone).

Licensor and the manufacturer of Nestorone(R) have entered into an agreement for, among, other things, the supply of Nestorone(R), to manufacturers of products incorporating Nestorone(R), including products for use in the field of human reproductive health.

Nestorone and Elcometrine, is a progestin of the 19-norprogesterone group which is used as a hormonal contraceptive and in the treatment of endometriosis.

Endometriosis is a condition in which the layer of tissue that normally covers the inside of the uterus grows outside of it. Most often this is on the ovaries, fallopian tubes, and tissue around the uterus and ovaries; however, in rare cases it may also occur in other parts of the body.

The tradename registered is Nestorone(R).

Field of Use

The Field means human hormone replacement therapy or contraception.