Royalty Report: Drugs, Cancer, Therapeutic – Collection: 383112

License Grant

Licensor (or its designated Affiliates) shall sell, assign, transfer, convey and deliver (or, where relevant, shall procure the same) to Licensee (or its designated Affiliates) free and clear of all encumbrances (other than Assumed Liabilities) and Licensee (or its designated Affiliates) shall purchase, acquire and accept, all right, title and interest of Licensor in, to and under the Assets. For the avoidance of doubt, the Assets shall not include the NDA until the NDA Transfer Date, as set forth in Agreement, the Excluded Assets as defined in Agreement, and copies of Product Records, Product Regulatory Materials and Marketing and Promotional Material retained by Licensor to comply with its legal obligations.

License Property

Product means Sancuso® a medicine containing granisetron, a serotonin-3 (5-HT3) receptor antagonist sold under the NDA and including any supplements thereto, in all FDA approved forms and indications.

Sancuso® is the only skin patch approved by the U.S. Food and Drug Administration for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy. When applied 24 to 48 hours before receiving chemotherapy, the Sancuso® patch slowly and continuously releases the medicine contained in the adhesive through clean and intact skin areas into the patient’s bloodstream. It can be worn for up to seven days in a row for chemotherapy regimens of up to five consecutive days.

Field of Use

The rights purchased are for a pharmaceutical product used for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment.

License Grant

Licensor grants an exclusive license in the Territory under the Patent Rights and Know How to develop, have developed, apply for and obtain Regulatory Approval, use, Market and import Licensed Product, with the right to grant sublicenses.

Licensor grants the right to use the Clinical Information and Data generated by or on behalf of Licensor and its Affiliates for the purpose of obtaining Regulatory Approval of the Licensed Product in the Territory.

License Property

Active Ingredient shall mean the chemical compound known as granisetron.

Licensed Product shall mean a formulation of the Active Ingredient with the Biochronomer formulation, including the formulation designated by APP as APF530.

Granisetron is a serotonin 5-HT3 receptor antagonist used as an antiemetic to treat nausea and vomiting following chemotherapy and Radiotherapy.

Field of Use

The product is for the treatment of patients undergoing moderately or highly emetogenic chemotherapy.

The Field shall mean any and all human applications.

APF530 is currently in Phase 3 trials in the U.S. for the prevention of acute and delayed chemotherapy-induced nausea and vomiting.

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 a non-transferable sublicenseable royalty-bearing, exclusive right and license under the Licensed Technology to Exploit the Licensed Product in the Territory, to the full end of the Term for which the Licensed Technology is licensed, unless sooner terminated as herein after provided.

Technology licensed by a U.S. company to a U.S. company is an Oral Spray, which aims to prevent nausea and vomiting associated with chemotherapy and radiotherapy, as well as postoperative-induced nausea and vomiting.  FDA recently agreed to review application for the spray.  Note that the lower range of the royalty rate is estimated.

License Property

Licensor has certain proprietary rights and intellectual property (including to certain patents) with respect to lingual sprays for the metered delivery of pharmaceutical products to humans (the 'Technology').

'Licensed Technology' shall mean the Licensor's Patents, the Licensor Know-How and the Drug Master File, collectively, but only with respect to the Exploitation of the Licensed Product.

'Licensed Product(s)' shall mean any dosage of pharmaceutical composition or preparation in finished form labeled and packaged for sale by prescription, overthe-counter or any other method for human application only that contains ondansetron delivered by means of the Licensed Process.

Ondansetron lingual spray , or “OLS,” our most recently-acquired product candidate,is a novel delivery system that utilizes the vast and highly-absorptive surfaces of the oral cavity (including the area under the tongue) to deliver the drug ondansetron, the most widely used drug to prevent chemotherapy-induced nausea and vomiting , directly into the bloodstream. Administration of ondansetron lingual spray (i.e., spraying on the tongue) will potentially decrease the time necessary to ahcive effective concentrations in the bloodstream, which we believe will more rapidly alleviate nausea and vomiting than conventional oral tablet dosage forms of ondansetron currently available.

Field of Use

Ondansetron is a medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, or surgery.