Royalty Report: Drugs, Cancer, Disease – Collection: 315284

License Grant

Licensor grants to Licensee an exclusive (even as to Licensor and its Affiliates), royalty-bearing right and license, including the right to sublicense, under the Licensor Intellectual Property and Licensor’s interest in the Joint Intellectual Property, to Develop, Manufacture, use and Commercialize, including filing for, obtaining and maintaining Regulatory Approval for, Products in the Field in the Territory.

License Property

Licensor Patent Rights means all Patent Rights in the Territory that are Controlled by Licensor or any of its Affiliates as of the Effective Date or thereafter during the Term (other than Joint Patent Rights) that Cover any Compound or Product.

US Patent #8,658,618 – Methods for preventing or reducing neurotoxicity associated with administering DPD inhibitors in combination with 5-FU and 5-FU prodrugs

US Patent #8,318,756 – Methods for administering DPD inhibitors in combination with 5-FU and 5-FU prodrugs

Compound means Eniluracil together with all analogs, derivatives, metabolites, stereoisomers, polymorphs, formulations, mixtures or compositions thereof, and any existing or future improved or modified versions of the foregoing developed by or on behalf of Licensee, its Affiliates or Sublicensees (or their respective Affiliates or assignees).

Combination Product means (a) any pharmaceutical product that is a single formulation consisting of a Compound and one or more other active compounds or active ingredients, which other active compounds or active ingredients are not Compounds (“Other API”) or (b) any combination of a Compound sold together with any separately formulated Other API for a single invoiced price.

Eniluracil (EU) is an oral irreversibledihydropyrimidine dehydrogenase (DPD) inhibitor, the enzyme responsible for rapidly breaking down 5-FU.

Field of Use

The Field of Use is for medical uses in the treatment of patients with Hepatocellular Carcinoma, a type of Liver Cancer.

License Grant

Licensor shall, and hereby does, grant to Licensee an exclusive (even as to Licensor and its Affiliates), royalty-bearing right and license, including the right to sublicense in accordance with this Agreement(b), under the Licensor Intellectual Property and Licensor’s interest in the Joint Intellectual Property, to Develop, Manufacture, use and Commercialize, including filing for, obtaining and maintaining Regulatory Approval for, Products in the Field in the Territory.

License Property

Product means any pharmaceutical preparation containing one or more Compounds either as an active ingredient(s) or any Combination Product. For the avoidance of doubt, nothing in this Agreement grants to Licensee any right or license under any Patent Rights or Know-How Controlled by Licensor with respect to any Other API.

Compound means RX-3117 (fluorocyclopentenylcytosine or also known as roducitabine) [which is a cytidine analog, similar to gemcitabine,][with a sequence of 4-amino-1-[(1S,4R,5S)-2-fluoro-4,5-dihydroxy-3-(hydroxymethyl)cyclopent-2-en-1-yl] pyrimidin-2-one] together with all analogs, derivatives, metabolites, stereoisomers, polymorphs, formulations, mixtures or compositions thereof covered by Licensor Intellectual Property, and any existing or future improved or modified versions of the foregoing developed by or on behalf of Licensee, its Affiliates or Sublicensees.

Patent
7,405,214 – Nucleoside derivatives and therapeutic use thereof
9,782,410 – Fluorocyclopentenylcytosine methods of use

Field of Use

RX-3117 is an oral, anticancer agent with an improved pharmacological profile relative to gemcitabine and other nucleoside analogs. Rx-3117 has a family of patents extending into 2036 as well as U.S. Food and Drug Administration (FDA) Orphan Designation for the treatment of Pancreatic Cancer. Licensee will evaluate the potential benefit of RX-3117 for patients with such cancers as pancreatic or non-small cell lung cancer.

License Grant

With this amendment, the Canadian Licensor adds Eniluracil to the scope of the agreement with the Licensee of the United Kingdom

Following completion by Licensor of both the Preclinical Studies and the Eniluracil Phase I Clinical Trials, Licensee shall have the right, for a limited period, to terminate Licensor’s license to the Product and be granted an exclusive license by Licensor to research, Develop, make, have made, use, and Commercialize Eniluracil and Products for all indications in all dosage forms and combinations, formulations, presentations, line extensions and package configurations in all countries of the Territory in which there is a Valid Claim of the Licensee Patents, Licensor Patents, or any Joint Invention Patents.

License Property

The product is Eniluracil.  Preclinical Studies means those in-vitro and human ex-vivo studies on Eniluracil conducted by Licensor.

Eniluracil is an irreversible inhibitor of DPD, the enzyme primarily responsible for the rapid breakdown of 5-FU in the body. Eniluracil is being developed to improve the therapeutic value of 5-FU by making it effective in cancers and reducing the debilitating side effects. We believe that eniluracil might enhance and expand the therapeutic spectrum of activity of 5-FU, reduce the occurrence of a disabling side effect known as hand foot syndrome and allow 5-FU to be given orally

Field of Use

Licensor is a biopharmaceutical company dedicated to the discovery and development of novel cancer therapeutics.  Eniluracil is being evaluated for use in breast cancer therapy.

License Grant

The Canadian Licensee licensed eniluracil from the English Licensor. Under the original terms of the agreement, the Licensee received an exclusive license for eniluracil for all indications, and the Licensor retained options to buy back the compound at various points in time during its development in return for milestone payments and sales royalties to the Licensee.

License Property

Eniluracil is an irreversible inhibitor of DPD, the enzyme primarily responsible for the rapid breakdown of 5-FU in the body. Eniluracil is being developed to improve the therapeutic value of 5-FU by making it effective in cancers and reducing the debilitating side effects. We believe that eniluracil might enhance and expand the therapeutic spectrum of activity of 5-FU, reduce the occurrence of a disabling side effect known as hand foot syndrome and allow 5-FU to be given orally.

License Grant

Licensor grants a sole and exclusive license, under the Licensor Patent Rights and Licensor Know-How, to develop, use, sell, offer for sale, and import Licensed Products in the Territory, and make and have made Licensed Products in the Territory for such development, use, sale, offering for sale, and importation.

Licensor also grants to Licensee, its Affiliates and sublicensees immunity from suit from Licensor and its Affiliates under any Patent owned or controlled by Licensor or its Affiliates on the Effective Date, and any other Patent that claims priority from or the benefit of the filing date of any of the foregoing Patents, with respect to making, using, selling, offering for sale or importing of Licensed Product in a formulation in existence as of the Effective Date.

License Property

The patents and know-how relate to certain patent rights, know-how and regulatory filings with respect to various orally active cell cycle inhibitors (CCI), including the CCI compounds.

Compound means the compound known as Licensors 31 7453,  270431 and/or  27 4006, or any compound that is a salt, ester or polymorph of  31 7153,  27 0431 and/or 27 4006.

Field of Use

Field means all therapeutic, prophylactic, and other pharmaceutical uses, applications and indications.

MKC-1, is an orally-active, novel, small molecule, cell cycle inhibitor with a unique mechanism of action. Specifically, MKC-1 arrests cellular mitosis by inhibiting a novel intracellular target important in cellular trafficking that has been shown to be involved in cell division. MKC-1 will begin Phase 2 studies in metastatic breast cancer in early 2006. A second Phase 2 trial with MKC-1 in non-small cell lung cancer is anticipated in the second half of 2006.

License Grant

Israeli Licensor will grant Licensee an exclusive, royalty-bearing right and license, including the right to sublicense for the patent rights and the know-how to develop and commercialize their next generation irinotecan cancer drug, ATT-11T.

License Property

ATT-11T is a novel lipophilic anti-cancer pro-drug that is being developed for the treatment of the same solid tumors as prescribed for irinotecan. This pro-drug is a conjugate of a specific proprietary Licensor molecule connected to SN-38, the active metabolite of irinotecan. The proprietary Licensor molecule on ATT-11T allows ATT-11T to bind to cell membranes to form an inactive pro-drug depot on the cell with SN-38 preferentially accumulating in the membrane of tumors cells and the tumor core. This unique characteristic is expected to make the therapeutic window of ATT-11T wider than irinotecan such that the anti-tumor effect of ATT-11T will occur at a much lower dose than irinotecan with a milder adverse effect profile than irinotecan. The wider therapeutic window will likely lead to more patients responding with less side effects when on ATT-11T compared to irinotecan.

Compound means ATT-11T together with all analogs, derivatives, metabolites, stereoisomers, polymorphs, formulations, mixtures, or compositions thereof, and any existing or future improved or modified versions of the foregoing developed by or on behalf of Licensee, its affiliates or sublicensees.

Field of Use

The product is used in the treatment of tumors.

License Grant

Licensor hereby grants to Licensee a royalty-bearing, non-transferable license, with the right to grant sublicenses as provided in Agreement, under the Licensor Technology and Licensor Trademarks, which license shall be non-exclusive with respect to the Merck Know-How and exclusive (even as to Licensor, except to the extent necessary for Licensor to perform its obligations under this Agreement with respect to any Licensor Technology (other than the Merck Know-How) and the Licensor Trademarks, to Exploit the Compounds and Products in the Licensee Field in the Licensee Territory.  The foregoing license grant by Licensor does not include any grant of rights under the Licensor Technology or Licensor Trademarks to Exploit any active pharmaceutical compound that is not a Compound, other than, to the extent applicable, any API(s) Controlled by Licensor (if any) that are included in a Product that is deemed to be a Single Agent Product pursuant to this Agreement.

License Property

Product means any pharmaceutical product, including all forms, presentations, strengths, doses and formulations (including any method of delivery), containing a Compound alone or in combination with other APIs.  For the sake of clarity, all forms, presentations, doses and formulations of a pharmaceutical product containing a Compound shall be considered the same Product for purposes of this Agreement, so long as each form, presentation, dose and formulation contains the same Compound and same other APIs (and no other Compounds or other APIs).

Compound means (a) the Initial Compound; (b) the compound licensed to Licensor under the Merck License Agreement and known as MK-2512; or (c) with respect to both (a) and (b), any pharmaceutically acceptable salt, polymorph, crystal form, prodrug or solvate thereof.

Licensor Patents means all Patents Controlled by Licensor during the Term that are necessary or useful to Exploit the Compounds or Products in the Licensee Field in the Licensee Territory.  Licensor Patents include, as of the Effective Date, those Patents set forth in Exhibit 1.117, the Merck Patents and AstraZeneca Patents.    
US #8071623 – Amide substituted indazoles as poly(ADP-ribose)polymerase(PARP) inhibitors
US #8436185 – Pharmaceutically acceptable salts of 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide
US #8188084 – Pyridinone and pyridazinone derivatives as inhibitors of poly (ADP-ribose) polymerase (PARP)

Trademark means any word, name, symbol, colour, designation, slogan, catch phrase or device or any combination thereof used or intended to be used in commerce and indicating the source for a product or service, including any domain name, trademark, trade dress, brand mark, trade name, brand name, logo or business symbol, any registrations of any of the foregoing or any pending applications therefor.

Field of Use

The collaboration and license agreement focused on the development and commercialization of niraparib specifically for the treatment of prostate cancer. Niraparib is an oral, once daily, potent, and highly selective PARP inhibitor that is currently being evaluated in Phase 3 clinical trials for ovarian and breast cancer.