Royalty Report: Drugs, Disease, cardiac – Collection: 263955

License Grant

Licensor grants an exclusive right and license in the Licensee Territory, under the Licensor Technology, for all uses in the Field, with the right to grant sublicenses, to research, develop, modify and improve Compound and Product;  apply for and obtain Regulatory Approvals; and use, import/export, market, offer to sell and sell, Product and Compound; and make, or have made, the Compound and Product for use in the Field.

License Property

The Compound means the compound identified as LU 135252 (Darusentan) and its racemates, isomers, Prodrugs, active metabolites and any pharmaceutically acceptable salt or complex thereof, in its current and any other formulation.

Field of Use

The Field means all human and non-human diagnostic, prophylactic and therapeutic uses of the Compound and/or Product in any formulation or dosage form for any and all indications except therapeutic uses and indications in the Cancer Field.

Cancer Field means the prophylactic or therapeutic administration to humans or non-human animals as an agent, either alone or in combination with other agents, for the prevention, treatment or palliation of cancer including neoadjuvant, adjuvant or supportive care and/or as part of combination with radiotherapy, surgery, chemo-, biologic- or other therapy associated with cancer, including, but not limited to, pain and bone/skeletal complications or indications from bone metastasis.

License Grant

The German Licensor grants an exclusive right and license in the Territory, under Licensors Technology, for all Pharmaceutical Uses, with the right to grant sublicenses, to research, develop, modify and improve Compound and Product;  apply for and obtain Regulatory Approvals; and use, import/export, market, offer to sell and sell, Product and Compound.

License Property

The Compound means the endothelin receptor antagonist compound identified as BSF 208075 (ambrisentan) and the chemical name, (+)-(S)-2-(4,6-Dimethyl-pyrimidin-2-yloxy)-3-methoxy-3,3- diphenyl propionic acid, its racemates, isomers, Prodrugs, active metabolites and any pharmaceutically acceptable salt or complex thereof, in its current and any other formulation.

Field of Use

The license is for any pharmaceutical use.  The clinical study of the compound is for pulmonary arterial hypertension, Chronic Renal Failure and Chronic Heart Failure.

License Grant

Licensor grants an exclusive license, or sublicense, as the case may be, under the Licensor Patent Rights and Know-how, in each case with the right to grant sublicenses, to research, develop, make, have made, use, import, export, market, offer for sale, sell and have sold, Licensed Product in the Territory within the applicable Field.

License Property

The Compounds means SCH 619734 (Rolapitant) and SCH 900978.

The Licensed Product means any product comprising, incorporating or containing any Compound, or an alternate form of any Compound, including, but not limited to, a pharmaceutically acceptable salt, polymorph, crystal form, prodrug, or solvate of any Compound to the extent such alternate form is claimed in the Licensor Patent Rights.

Rolapitant, a Phase III-ready, oncology supportive-care product candidate, is a potent and selective neurokinin-1 (NK-1) receptor antagonist with an extended plasma half-life that has the potential to improve the management of nausea and vomiting experienced by cancer patients undergoing treatment with emetogenic chemotherapy. Phase II clinical testing of rolapitant for the prevention of nausea and vomiting in cancer patients treated with highly emetogenic chemotherapy demonstrated promising five-day activity following the administration of a single dose.

Field of Use

The Field means with respect to SCH 619734 (Rolapitant) all therapeutic, prophylactic, palliative and diagnostic uses in humans, and means, with respect to SCH 900978, treatment of nausea or vomiting of any cause; treatment of disease or treatment of symptoms or side effects of disease in oncology indications; treatment of side effects of oncology treatments or therapies; and (iv) any other supportive care indications in oncology.

License Grant

Licensor hereby grants to Licensee an exclusive (even as against Licensor and its Affiliates), nontransferable (except with respect to the assignment provision in Agreement) limited license during the Term under the Licensed Patents, solely to make, have made (pursuant to Agreement), use, sell, offer for sale and import the Licensed Products in the Territory in and for the Field. (No license, exclusive or nonexclusive, is granted hereunder under the Licensed Patents, except to so make, have made, use, sell, offer for sale and import the Licensed Products in the Territory in and for the Field.)

License Property

Patents
5,874,418 – Sulfoalkyl ether cyclodextrin based solid pharmaceutical formulations and their use
6,046,177 – Sulfoalkyl ether cyclodextrin based controlled release solid pharmaceutical formulations
6,133,248 – Polar drug of prodrug compositions with extended shelf-life storage and a method of making thereof

Licensed Product means (a) a Compound combined with or formulated using Captisol for ultimate use in humans in a dosage form/formulation, or (b) a pharmaceutical composition that includes a Compound and that is developed with the assistance of or incorporates any then-confidential component of the Captisol Data Package.

Compound means the proprietary Licensee isoflavone-based drug compound known as ME-143 (also known as NV-143) or the proprietary Licensee mitochondrial inhibitor drug compound known as ME-344, or any derivative, homolog, or analog of ME-143 or ME-344 or any isomer, salt, hydrate, solvate, amide, ester, metabolite, or prodrug of any of the foregoing.

Captisol Related Compound means Captisol or any derivative, homolog analog of Captisol or any isomer, salt, hydrate, solvate, amide, ester, metabolite or product of any of the foregoing, including without limitation sulfobutylether g(gamma) cyclodextrin sodium salt.

Licensed Product Family means one or more Licensed Products which are based on the same Compound(s) (or any isomers, salts, hydrates, solvates, amides, esters, metabolites, or prodrugs of the foregoing), irrespective of whether such Licensed Products contain different dosage forms, proportions or formulations of such Compound(s), utilize different inactive ingredients and/or are marketed for different indications. Notwithstanding the foregoing, a Licensed Product based on a Compound shall be deemed to be in a distinct Licensed Product Family from a Licensed Product based on the combination of the same relevant Compound with any other active pharmaceutical ingredient. As such, if Licensee develops one Licensed Product with ME-344 as the sole active ingredient with Captisol and also develops another Licensed Product with ME-344 in combination with another active ingredient with Captisol, then two distinct sets of milestone payments shall be potentially due under this Agreement, one for each of such two distinct Licensed Products.

Field of Use

Captisol® is a patent protected, uniquely modified cyclodextrin, whose chemical structure was rationally designed to enable the creation of new products by significantly improving solubility, stability, bioavailability and dosing of active pharmaceutical ingredients (APIs).

Captisol is  for use with the Licensee’s isoflavone-based drug compounds.

ME-344 is our isoflavone-derived mitochondrial inhibitor drug candidate. In preclinical studies, ME-344 has been shown to cause cell death in multiple human tumor cell lines, including ovarian cancer stem cells, by interfering with mitochondrial energy generation.

Field means the entire field of prevention, diagnosis and treatment of all human and animal diseases and disorders with the exceptions of (i) ocular treatment of any disease or condition with a formulation including a hormone; (ii) topical ocular treatment of inflammatory conditions; (iii) treatment and prophylaxis of fungal infections in humans; and (iv) any ocular treatment for retinal degeneration.