Royalty Report: Drugs, Delivery, Pain – Collection: 289191

License Grant

Licensor grants the Licensee of China an exclusive license, without rights of sublicense, in the Field
under the Licensed Technology to market, advertise, promote, distribute for commercial sale, offer
for sale, sell, and import for commercial sale the Licensed Product in the Territory and Licensor
hereby grants a non-exclusive license, without rights of sublicense, under the Licensed Technology to develop in the Territory the Licensed Product for additional human therapeutic indications following Governmental Approval of such Licensed Product in the Territory for the Initial Indication.

License Property

Licensed Product means the 200mcg, 400mcg, 600mcg, 800mcg, and 1200mcg dosage strengths of that BEMA-based product which contains fentanyl as its sole API, is the subject of MAA DCP DE-H-1660-001-006-DC and NDA 022266 and, is supplied to Licensee by Licensor.

Product means the Licensed Product, Placebos, and Demonstration Samples.

The Drug Product is BEMA rM Fentanyl, Bucco/ Soluble Film

BEMA means the proprietary bioerodible, mucoadhesive multi-layer polymer film technology Controlled by Licensor.

Field of Use

A Competing Product means a pharmaceutical product that is labeled or marketed for the indication of breakthrough pain and incorporates fentanyl as an API.

The Field means the treatment of breakthrough cancer pain in patients tolerant to opioids, the Initial Indication, and, following Governmental Approval in the Territory of the Licensed Product for the Initial Indication, any additional human therapeutic indications for which Governmental Approval is obtained.

License Grant

The Licensor of Germany grants a non-exclusive, non-transferable, license to and under the patent to make, have made, use, have used, offer to sell, sell, have sold or import or have imported the Product.

The Parties wish to cooperate in the exclusive manufacturing of the Products and Placebos in the Territory.

License Property

The licensed property is EP O 949 925.

The Active Principle shall mean Fentanyl.

The Product shall mean Licensees transmucosal oral system containing Active Principle based on the Design of Licensee Technology.  

Licensee has bioerodable mucoadhesive transmucosal technology.

Licensor has technology and process for oral film form products and/or pharmaceutical preparations in general, their use, process development, including without limitation the mass preparation, coating, drying and compiling thereof, and, manufacturing, packaging, and labeling.

U.S. Patents Nos. 5,948,430, 6,177,096 and 6,284,264

Field of Use

Both Parties have experience with the oral film-form products industry.

The Licensee lead BEMAâ„¢ product under development is BEMAâ„¢ Fentanyl, a treatment for breakthrough cancer pain.

License Grant

The Company is granting the exclusive rights to develop and commercialize ONSOLIS® (fentanyl buccal soluble film) in the U.S. to Licensee.  The Company secured a new commercial partner for ONSOLIS® when a licensing agreement was completed.

License Property

ONSOLIS® a buprenorphine depot product for treatment of opioid dependence in the field of microencapsulation-based controlled/sustained release and drug delivery technologies.

Field of Use

Onsolis (fentanyl buccal soluble film) is an opioid analgesic indicated for the management of breakthrough pain in cancer.

Licensee will be responsible for the manufacturing, distribution, marketing and sales of ONSOLIS in the U.S.

License Grant

In connection with the Licensor's consent to our U.S. licensing transaction with Meda AB relating to ONSOLISâ„¢, we and the Licensor entered into a second Dispute Resolution Agreement pursuant to which we and the Licensor agreed to waive and dismiss with prejudice all current disputes between us, concerning each of the Clinical Development and Licensing Agreements and a securities purchase Agreement that we previously entered into which disputes had commenced during 2006.

License Property

BEMAâ„¢ (BioErodible MucoAdhesive) drug delivery system

The BEMA® drug delivery technology is a buccal soluble film consisting of a small, BioErodible polymer film for application to the mucosal membranes (inner lining of cheek). BEMA® films were designed to rapidly deliver a dose of drug across the mucous membranes for time sensitive conditions.

Field of Use

The rights apply to the healthcare industry.

License Grant

Licensor hereby grants to Licensee, subsidiary, a sole and exclusive, royalty-bearing license under the BEMA Technology to use, develop, market, advertise, promote, distribute, offer for sale, sell, export and import, manufacture, and have manufactured Products in the Territory, with the right to sublicense in accordance with this agreement. Subject to the terms of this Agreement, Licensee shall have the right to assign this Agreement, on the basis set forth in this agreement. During the term of this Agreement, Licensor shall not grant any right or license to any third party with respect to the BEMA Technology in the Territory.

Licensor hereby grants to Licensee a sole and exclusive, royalty-free license to use the Marks solely in connection with the use, promotion, marketing, distribution, offer for sale, and sale of the Products, on a Product-by-Product basis, in the Territory during the Royalty Term. Licensee may grant a sublicense to the Marks in accordance with this agreement.

License Property

BEMA means Licensor’s proprietary bioerodible, mucoadhesive multi-layer polymer film.

Marks means “BEMA” or any additional trademarks owned by Licensor with respect to the BEMA Technology, alone or accompanied by any logo or design and any non-English language equivalents in figure, sound or meaning, whether registered or not.

Product means individually and collectively any product which, but for the licenses granted under this Agreement, would infringe one or more valid claims of the BEMA Patent Rights.

Fentanyl Product means the first Product containing Fentanyl, used for the treatment of pain and sold in a Commercial Sale.

BEMA Patent Rights means all Patent Rights in the Territory related to the patents and patent applications listed, claiming BEMA or any Improvement, or which are necessary or appropriate to develop, manufacture and commercialize Products in the Territory, and that are under the Control of Licensor as of the Effective Date or that come under Licensors Control during the Term.
5,800,832 – Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces
6,159,498 – Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces

BEMA Technology means the BEMA Patent Rights and the BEMA Know How.

Patent Rights means all rights under patents and patent applications, and any and all patents issuing therefrom (including utility, model and design patents and certificates of invention), together with any and all substitutions, extensions (including supplemental protection certificates), registrations, confirmations, reissues, divisionals, continuations, continuations-in-part, re-examinations, renewals and foreign counterparts of the foregoing, and all improvements, supplements, modifications or additions.

Field of Use

BEMA(TM) is an acronym for “Bioerodible Mucoadhesive”, and consists of a patented oral BEMA™ disc, which delivers the drug through the mucosal surface (inner cheek) by placing the disc between the cheek and gum.

The BEMA(TM) technology allows for the delivery of drugs across the buccal (i.e., mouth) mucosa that provides a rapid onset of therapeutic effect and a competitive advantage in such areas as pain relief and sedation.