Royalty Report: Drugs, Therapeutic, Ophthalmological – Collection: 25218

License Grant

Parties entered into a license agreement, under which Licensor licensed to Licensee exclusive development and commercialization rights, under Licensor’s AzaSite™ patent rights and certain know-how, for topical anti-infective products containing azithromycin as the sole active ingredient for human ocular or ophthalmic indications (each a “Subject Product”) in the United States and Canada and their respective territories (the “Territory”).

License Property

AzaSite (azithromycin ophthalmic solution) is a 1% sterile aqueous topical ophthalmic solution of azithromycin formulated in DuraSite® (polycarbophil, edetate disodium, sodium chloride).

Field of Use

AzaSite is an eye ointment containing azithromycin, a macrolide antibiotic that fights bacteria. Azithromycin is used to treat eye infections caused by bacteria;  bacterial conjunctivitis; commonly referred to as pink eye. AzaSite may also be used for purposes not listed in this medication guide.

License Grant

The Licensee signed an exclusive licensing Agreement with the Licensor for the U.S. and Canadian commercialization of AzaSite (1.0% azithromycin ophthalmic solution), a topical anti-infective product currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of bacterial conjunctivitis. Under the terms of the Agreement, the Licensee has acquired from Licensor exclusive rights to commercialize AzaSite for ocular infections in the United States and Canada.

License Property

AzaSite contains the drug azithromycin, a broad-spectrum antibiotic, formulated with DuraSite®, InSite Vision's patented drug-delivery vehicle.

License Grant

Under the License Agreement, the Licensor exclusively licensed to Licensee certain intellectual property in connection with the development and commercialization of topical anti-infective products containing azithromycin as the sole active ingredient for human ocular or ophthalmic indications in the United States and Canada and their respective territories and possessions.

License Property

This Agreement provides for commercialization of AzaSite (1.0% azithromycin ophthalmic solution), a topical anti-infective product for the treatment of bacterial conjunctivitis. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic, formulated with DuraSite®, Licensor's patented drug-delivery vehicle.

License Grant

Licensor grants Licensee an exclusive license under the Licensed Patents to make, have made, use, sell, offer for sale, import and make regulatory filings with respect to Licensed Products in the Territory and export components of Licensed Products from any country in the Territory for the purpose of making Licensed Products outside that country, but not to the extent that such components are covered by Licensor patents other than Licensed Patents, together with the right to grant sublicenses.

License Property

Licensed Patents shall mean United States Patent No. 6,861,411 and EP-B-0 925 789 and the foreign counterpart patents and patent applications thereof for Method of Treating Eye Infections with Azithromycin.

Licensed Products shall mean the ocular anti-infective product candidate known as AzaSiteTM or ISV-401, containing azithromycin as its sole active ingredient, and AzaSiteTM Plus or ISV-502, an ocular anti-infective product candidate containing azithromycin and dexamethasone as its sole active ingredients or other ophthalmic products agreed to by both parties.

Field of Use

This agreement is for products treating eye infections.

License Grant

Mexican Licensor hereby grants by way of a license to Licensee, and Licensee hereby accepts, a sole and exclusive, running royalty-bearing license under the Patent Rights and using the Technical Information & Know-How to make or have the Product made, develop, manufacture, use, market, offer to sell, and sell the Product, in the Territory. This license shall not include the right for Licensee to sell the Product from the Territory to any party outside of the Territory. The license granted to Licensee herein shall not include the right to grant further licenses or sub-licenses to any third party without the prior written consent of Licensor, such con not to be unreasonably withheld. Nothing in this Agreement shall affect, and Licensor shall retain the right to grant, other sub-licenses to the Product outside of the Territory.

License Property

Product shall mean a the topical ophthalmic solution containing the Compound as an active ingredient at 0.1% and 0.05%, for the treatment of ophthalmic diseases and a ophthalmic carrier solution referenced in US Patent # 6,071,958 known as “Sophisen”. The Product is already commercialized in Mexico under the trademark of “Modusik-A”.

6,071,958 – Ophthalmic carrier solution

Patent Rights shall mean granted under U.S. Patents No.6,071,958 issued June 6, 2000 for “Sophisen” as well as any and all reissues, re-examinations, and patent term extensions thereof.

Compound shall mean a certain chemical substance having the chemical structure of Cyclo[[(E)-(2S,3R,4R)-3- hydroxy-4-methy-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl]. This Compound is also referred to as Cyclosporin A.

Field of Use

Sophisen, a new ophthalmic drug carrier, was characterized using physicochemical and morphological criteria.  

Sophisen®” is a novel system for transporting ophthalmic drugs for ophthalmic application), which, in addition to improving the active ingredients’ delivery and effectiveness, has the particular feature of minimizing burning sensation when applying ophthalmic solutions to the eye.