Royalty Report: Drugs, Cancer, Hormones – Collection: 282876

License Grant

Licensor grants sole responsibility to Licensee for the continued development of the antiestrogen compound in the territory.

License Property

Acolbifene shall mean the specific antiestrogen compound known as acolbifene (also referred to by the parties as EM-652 or SCH 57068) and having the chemical structure set forth.

Acolbifene is the chemical compound known as acolbifene hydrochloride, which has the following chemical structure
[2H-1-Benzopyran-7-ol, 3-( 4-hydroxyphenyl)-4-methyl-2-[ 4-[2-(lpiperidinyl)ethoxy]phenyl]-, hydrochloride, (2S)~]and may be alternatively described as
[ (2S)-3-( 4-Hydroxyphenyl)-4-methyl-2-[ 4-(2-piperidin-1-yl-ethoxy)phenyl]-2Hchromen-7-ol]

Acolbifene belongs to a class of compounds known as selective estrogen receptor modulators, or SERMs. SERMs inhibit the stimulatory effect that the female sex hormone estrogen has on the growth of breast and uterine cancer.

Field of Use

Licensee holds an option to manufacture, market and distribute acolbifene for the treatment and prevention of breast cancer and other indications.

Field means the therapeutic and/or prophylactic use of any Licensed Compound or Licensed Product for the treatment of any disease or condition in humans and/or animals.

License Grant

Licensor and its Affiliates hereby grant to Licensee an exclusive, worldwide royalty-bearing license, with the right to grant sublicenses, under any Licensor Patent Rights and to use any Licensor Know-How to make, have made, use and sell Licensed Products containing Acolbifene in the Field in the Territory (including Canada). The foregoing licenses shall be exclusive even as to Licensor. Licensor shall remain solely responsible (at its own expense) for the filing, prosecution, maintenance, enforcement and defense of the Licensor Patent Rights covering Licensed Products containing Acolbifene in the Territory which activities shall be governed by the terms of the Agreement.  This become effective as of the date on which Licensor’s licenses to Acolbifene are terminated pursuant to this agreement.

The Parties have been collaborating in the development of a certain antiestrogen compound as a Licensed Compound under the terms of the Agreement.

Licensee now desires to assume sole responsibility for the continued development of such antiestrogen compound.

License Property

Acolbifene shall mean the specific antiestrogen compound known as acolbifene (also referred to by the parties as EM-652 or SCH 57068) and having the chemical structure.

Licensed products means any pharmaceutical products in dosage form which contain one or more Licensed Compounds, including without limitation, Licensed Combinations.

Licensed Compounds means (i) any compounds existing on the effective date of this Agreement which were conceived of as antiestrogen or antiandrogen compounds by or on behalf of Licensee and (ii) any additional novel or existing compounds which are conceived of as compounds in the Field by or on behalf of Licensee while carrying out research in the program as that term is defined.

Field of Use

Acolbifene is a nonsteroidal selective estrogen receptor modulator which, as of 2015, is in phase III clinical trials for the treatment of breast cancer.

License Grant

Licensor grants to Licensee of the Cayman Islands an exclusive, right and license under the Fablyn Technology to make, have made, use, sell, have sold, import and export Products in the Field in the Territory.

License Property

Licensor owns or has rights under certain patent rights and know-how which relate to Fablyn.

Fablyn means lasofoxifene tartrate.  Fablyn (lasofoxifene tartrate) is a selective estrogen receptor modulator (SERM) intended for the treatment of osteoporosis in postmenopausal women.

Field of Use

Fablyn (lasofoxifene) is a selective estrogen receptor modulator (SERM) that was approved in the EU in 2009 for the treatment of osteoporosis in post-menopausal women at increased risk of fracture.

License Grant

Finnish Licensor grants Finnish Licensee an exclusive license subject to the terms and conditions hereof, to Licensors rights in the Invention and Patents. Licensor shall not for the term of this Agreement exercise the rights itself nor grant any of said rights to any third party.

Licensee shall have the right to sublicense the rights granted to it under this Agreement to any third party or parties.

License Property

Invention shall mean the invention described in the appendix to the invention notification 'Uudet trifenyylibutaani ja-buteenijohdannaiset' dated July 29 1997 provided by the inventors to Licensor, including without limitation the therein identified compounds.  The Invention and Patents relate to triphenylalkene derivatives and their use as selective estrogen receptor modulators (Serms). Estrogens have been known as female sex hormones. However, lately many tissue-specific properties for estrogens have been described in organs, which are not classically considered to be estrogen-sensitive or estrogen- 20 responsive. During the menopause the secretion of estrogens
is dramatically decreased. Subsequently elderly women develop commonly climacteric symptoms including hot flushes, sweating, insomnia, depression, headache, vaginal dryness, cardiovascular symptoms, urinary incontinence, swelling feeling, breast tenderness and fatigue. In long-term estrogen deficiency induces cardiovascular disorders and osteoporosis which increase the risk of bone fractures and  hospitalizations.

Patents shall mean granted US patent No 6,576,645 and its divisional allowed US patent application No 10/408,303, both titled 'Triphenylalkene derivatives and their use as selective estrogen receptor modulators' and any corresponding issued patent or filed patent application based on the inventions described in US patent 6,576,645 or the US patent application 10/408,303 that are filed or granted in any country of the world including any corresponding patent applications filed in any country or territory, or based on any divisionals, continuations, continuations-in-part, reissues, re-examinations, and extensions of any of the foregoing (including any 'patent term restoration' period or supplementary protection certificate granted under applicable laws in a given country).
Patent #6,576,645 – Triphenylalkene derivatives and their use as selective estrogen receptor modulators

Product(s) shall mean any pharmaceutical product containing i) any of the compounds identified in the Invention as its active ingredient alone or in combination of other active ingredients; ii) any molecule that has similar pharmacological properties with such compounds and falls within the claims of the Patents.

Field of Use

The Field of Use is for the use of novel selective estrogen receptor modulators (SERMs) and their pharmaceutical preparations in men and women for the treatment of degenerative diseases and symptoms due to estrogen deficiency. Estrogens have been known as female sex hormones.

Licensee a pharmaceutical company focused on discovering, licensing, developing and commercializing compounds in the endocrine, metabolic and cardiovascular therapeutic areas relating to the treatment of hormone deficiencies that result from aging in men and women.

License Grant

The Parties have previously entered into several Material Transfer Agreement(s) (MTA) to evaluate certain Licensor compounds under the following three catagories Selective Estrogen Receptor Modulators (SERMs), Hedgehog (HH) Antagonists, and Glucocorticoid Receptor (GR) Agonists, herein referred to as the Compounds. This Agreement shall replace any prior MTAs, as they relate to these Compounds.  Provided however that, SERM Tool Compounds referred to in the SERM MTA shall remain covered under the existing SERM MTA. In addition, the Parties may mutually agree, from time to time, to add additional compounds.

Licensor grants an exclusive license to the Licensed Compounds under the Licensed Patents and Licensed Know-How to research, develop, have developed, make, have made, use, have used, manufacture, have manufactured, register, have registered, offer for sale, sell, have sold, import and export, distribute, and market Licensed Products in the Field within the Territory.  Licensee shall have the right to sublicense.

Licensee shall have an exclusive option to license exclusively the rights related to such Compound in the Field under a separate, definitive license agreement.

License Property

The compounds relate to Selective Estrogen Receptor Modulators (SERMs); Hedgehog (HH) Antagonists; and, Glucocorticoid Receptor (GR) Agonists.

The Licensors Compounds considered and/or evaluated by Licensee under the Agreement and are selected by Licensee to be licensed, the Licensed Compounds.

An Early Preclinical Compound shall be defined as a Compound for which there is less than 4-week GLP toxicology studies in at least two animal species, including at least one rodent species and one  non-rodent species.

A Late Preclinical Compound shall be defined as a Compound for which there is at least 4-week GLP toxicology studies in at least two animal species, including at least one rodent species and one non-rodent species, but no human clinical data.

A Clinical Compound shall be defined as a Compound for which there is at least 4-week GLP toxicology studies in at least two animal species, including at least one rodent species and one non-rodent species, and at least one human clinical study conducted under a US IND or equivalent, and covering at least twenty-eight days of daily dosing.

The licensed patents are all existing and future patents and patent applications relating to the Licensed Compounds.

The licensed products are any pharmaceutical formulation which contains a Licensed Compound for use in the Field, including any metabolites, salts, isomers, or pro-drugs of a Licensed Compound.

Field of Use

The Collaboration agreement and  is to develop and commercialize preclinical compounds discovered by Licensor for dermatologic therapeutics.

The field of use is Diagnostic uses, topical treatments for cosmetic uses and topical treatments for the prevention, amelioration, or cure of dermatological diseases, including without limitation, skin cancers, and conditions in humans and animals.