Royalty Report: Drugs, Disease, Therapeutic – Collection: 3196

License Grant

Licensor hereby grant to Licensee, and Licensee hereby accepts in respect of the Licensed Technology and the Licensors’ interest in the Joint Technology:  (a) the exclusive license, even as to the Licensor and their Affiliates, with the right to grant Sublicenses (i) to Develop the Compound and Products in the Territory for use and Commercialization in the Field in the Territory and (ii) to Commercialize Products in the Field in the Territory; and (b) a non-exclusive license, with the right to grant Sublicenses to Manufacture or have Manufactured in the Territory (i) Products for use or Commercialization by Licensee and its Sublicensees under the license granted and (ii) Compound for incorporation into such Products.

The Licensor granted License of relevant know-how, patent rights and technology,for Relistor® (methylnaltrexone bromide) subcutaneous injection, to the Licensee, a leading gastrointestinal disease specialty company.

License Property

Relistor (methylnaltrexone bromide) subcutaneous injection is a first-in-class therapy for opioid-induced constipation (OIC).

OIC is the constipation that often arises when patients take opioids for pain relief.

License Grant

The Licensor's lead product is Relistorâ„¢ (methylnaltrexone bromide). On April 24, 2008, Relistor subcutaneous injection was approved by the U.S. Food and Drug Administration for sale in the United States for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Our collaboration partner, the Licensee, commenced sales of Relistor subcutaneous injection in the U.S. in June 2008.

Field of Use

The rights granted apply in the medical industry.

License Grant

The Licensor and the Licensee entered in to a worldwide exclusive Agreement for the development and commercialization of Relistor.

License Property

Relistor is for the treatment of opioid induced constipation, specifically designed to block the constipating effects of opioid pain medications in the gastrointestinal tract.

Field of Use

The Licensee will further developing and commercializing Rlistor, including completing clinical development necessary to support regulatory marketing approvals for potential new indications and formulations of the drug, such as oral methylnaltrexone.

License Grant

Licensor hereby grants to the Puerto Rico Licensee in the Field an exclusive (even as to Licensor, other than as set forth in this agreement (Retained Rights)) license under the Licensor Technology and Joint Technology, with the right to sublicense as set forth in this agreement (Sublicenses), to make, have made, use, Develop, sell, offer to sell, have sold, import, export, and otherwise exploit and Commercialize the Compound and Products in the Territory. Licensee acknowledges that with respect to those Licensor Patent Rights that are Controlled by Licensor pursuant to the Third Party Agreements, the foregoing license is subject to the rights of the Third Party licensors under such Third Party Agreements.

License Property

Product means a product containing the Compound as an active ingredient, including without limitation a Combination Product.

Combination Product means any Product that contains the Compound as an active ingredient together with one or more other active ingredients and is sold for a single invoiced price, e.g., where the Compound is packaged for sale together with a second compound or biologic as an active ingredient (either as a single fixed dose or as separate doses).

Compound means R-methyinaltrexoun (R-MNTX) which is chemically defined as morphinanium, 17R, 17-(cyclopropylmethyl)-4, 5-epoxy-3,14-dihydroxy-17-methyl-6-oxo-, bromide, (5a)-(9C1), and its pharmacologically acceptable salts, together with their solvates, hydrates, hemihydrates, metabolites, pro-drugs, esters, and if applicable, any isomers or racemates thereof, but excluding any of the foregoing olecules whose primary mechanism of action is as an opioid agonist. The “Compound” does not include the Excluded Molecules.

Licensor Patent Rights means any Patent Right Controlled by Licensor or its Affiliates as of the Effective Date or at any time during the Term that relates to, claims, or if issued, would be infringed by an unlicensed Third Party’s manufacture, use, sale, importation, Development or Commercialization of the Compound, or any Product; provided, however, that if a Third Party becomes an Affiliate of Licensor pursuant to a transaction or series of related transactions as a result of which such Third Party is able to elect a majority of the members of the board of directors of Licensor (or its successor company) or any of its “controlling Affiliates” (as defined in this agreement) (Licensor Change of Control), “Licensor Patent Rights” will not include any Patent Rights that were Controlled by such Third Party prior to the completion of such transaction or series of related transactions. Licensor Patent Rights are identified as:
4,719,215 – Quaternary derivatives of noroxymorphone which relieve nausea and emesis
4,861,781 – Quaternary derivatives of noroxymorphone which relieve nausea and emesis
5,102,887 – Method for reducing emesis and nausea induced by the administration of an emesis causing agent

Joint Patent Rights means any Patent Rights related to any invention, development or discovery made or created in the course of the Collaboration jointly by (i) employees or agents of Licensor or any of its Affiliates, and (ii) employees or agents of Licensee or any of its Affiliates, as determined in accordance with this agreement (Inventorship).

Licensor Technology means the Licensor Know-How and the Licensor Patent Rights.

Joint Technology means the Joint Know-How and the Joint Patent Rights.

To relieve pain, narcotic medications such as morphine activate specific opioid receptors located in the central nervous system – the brain and spinal cord. Opioids, however, also interact with these receptors outside of the central nervous system, resulting in side effects, which can be debilitating, including constipation, urinary retention and severe itching. MNTX is designed to block peripheral opioid receptors whose activation causes these side effects. As MNTX does not cross the blood-brain barrier, it does not interfere with brain-centered pain relief.

Field of Use

The agreement is for the joint development and commercialization of methylnaltrexone (MNTX) for the treatment of opioid-induced side effects, including constipation and post-operative bowel dysfunction. These medical conditions are major therapeutic challenges in the management of gastrointestinal function in individuals treated with opioids for pain or in patients following serious or prolonged surgeries.