Royalty Report: Drugs, Skin care, Delivery – Collection: 29032

License Grant

The Licensor granted the Licensee an exclusive, worldwide, royalty bearing License and subLicense to certain drug delivery technology, including the exclusive worldwide marketing and intellectual property rights to the Initial Products and any Potential Products that may be developed for it by the Licensor; where the Licensor is to be the exclusive manufacturer of the Initial Products and Potential Products that the Licensor may develop for the Licensee.

License Property

'Initial Products' shall mean five products not requiring FDA approval, (A) four (4) Salicylic Acid formulations with strengths between two (2%) percent and ten (10%) percent solution for therapeutic use in the treatment of (i) acne, (ii) seborrheic dermatitis, (iii) psoriasis, or (iv) tinea versicolor; and (B) one (1) Benzoyl Peroxide formulation for therapeutic use in the treatment of acne ('BPO Acne Product').

Salicylic acid is a beta-hydroxy acid and acts in a similar manner to alpha-hydroxy acids on the skin, softening the stratum corneum, increasing cell turnover in the epidermis, and increasing hydration of the epidermal layer. The beta-hydroxy acids are believed to have some superior properties over the alpha-hydroxy acids. Salicylic acid has poor solubility in water, but very good solubility in alcohol, therefore many of the earliest preparations containing salicylic acid were alcohol-based, leading to undesirable drying of the skin. More recently several companies have utilized liposomes, phospholipid vesicles, to deliver salicylic acid in cosmetic preparations. Liposomes have the disadvantages that they are expensive and difficult to prepare.

License Grant

For good and valuable consideration, the adequacy of which is hereby acknowledged, the parties, intending to be legally bound, hereby agree to amend certain sections of the original agreement.  Royalty payments in consideration for the license granted has been amended.

License Property

The amended sections include but not limited to

Channel of Trade with respect to products containing glycolic acid shall mean the mail order, multi level, and direct door-to-door markets and to products containing gluconolactone shall mean any market or channel of distribution.

Licensed Products shall include any cosmetic and/or dermatologic preparation covered by the Licensed Patent Rights (a) containing glycolic acid and/or its salts (1) for the treatment of human skin wrinkles and/or fine lines on the human skin; (2) the treatment of dry skin; (3) as a skin cleanser; (4) as a hair conditioner; (5) as a shampoo; or (b) cosmetic and dermatologic preparations containing glycolic acid and/or its salts, in combination with salicylic acid for the treatment of acne; or (c) cosmetic and dermatologic preparations containing glycolic acid and/or its salts in combination with two percent (2%) or less of hydroquinone for the treatment of pigmented spots on human skin; or (d) cosmetic and dermatological preparations containing gluconolactone for alleviating or improving the signs of dermatological aging of the human skin, including the reduction of human skin wrinkles.

Licensed Patent Rights shall mean, subject to the specific exclusions set forth  (as amended herein), and all divisions, continuations, continuations-in-part, reissues, reexaminations and extensions thereof (a) covering only cosmetic and dermatologic preparations containing glycolic acid and/or its salts for (1) the treatment of human skin wrinkles and/or fine lines on the human skin; (2) the treatment of dry skin; (3) as a skin cleanser; (4) as a hair conditioner; (5) as a shampoo; (b) covering only cosmetic and dermatologic preparations containing glycolic acid and/or its salts, in combination with salicylic acid for the treatment of acne; (c) covering only cosmetic and dermatologic preparations containing glycolic acid and/or its salts in combination with two percent (2%) or less of hydroquinone for the treatment of pigmented spots on human skin; and (d) covering only cosmetic and dermatological preparations containing gluconolactone for alleviating or improving the signs of dermatological aging of the human skin, including the reduction of human skin wrinkles.

Field of Use

This agreement pertains to skin care.

License Grant

Licensor hereby grants to Licensee an exclusive royalty-bearing license under the Licensor Technology to use, develop, market, advertise, promote, distribute, offer for sale, sell, export and import, but not Manufacture, the Product in the Territory for use in the Field, without the right to sublicense; provided Licensee shall have the right to grant a sublicense or otherwise enter into a marketing agreement with respect to the Product for Mexico and/or Canada.

License Property

Product means, individually or collectively, as the context requires, the formulation comprised of Dapsone in an SMP(TM) delivery system, including the Acne Product and any other current and future indication(s) (including indications for burn itch, acne rosacea, psoriasis and atopic dermatitis as determined by the JDMC) for all concentrations, sizes of volume, configurations and combinations of Dapsone in an SMP(TM) delivery system for use in the Field.

Dapsone means 4,4 diaminodiphenylsulfone and all salts, polymorphs and isomers thereof.

Licensor Patent Rights or Licensor Patent means
5,863,560 – Compositions and Methods for Topical Application of Therapeutic Agents
6,060,085 – Compositions and Methods for Topical Application of Therapeutic Agents
09/236,909 (*pending application)

SMP(TM) technology or SMP(TM) delivery system means a technology and delivery system consisting of a combination of a dissolved drug with a microparticle suspension of the drug to allow a controlled amount of the dissolved drug to permeate the epidermal layer of the skin. The SMP(TM) technology includes, but is not limited to, topical formulations containing Dapsone.

Acne Product means the 3% Acne Product or the 5% Acne Product and any other concentrations of the Product that may be used for the treatment of acne vulgaris, depending on the decision of the JDMC.

Field of Use

Field means the topical treatment of skin in humans.

License Grant

Licensor grants to Licensee and Affiliates of Licensee under the Licensed Patent Rights a non-exclusive license to make, have made, use, sell, and distribute in the Territory Licensed Products except through the Excluded Channel of Trade.

License Property

Licensed Products shall include any cosmetic and/or dermatologic preparation covered by the Licensed Patent Rights (a) containing glycolic acid and/or its salts (1) for the treatment of human skin wrinkles and/or fine lines on the human skin; (2) the treatment of dry skin; (3) as a skin cleanser; (4) as a hair conditioner; (5) as a shampoo; or (b) cosmetic and dermatologic preparations containing glycolic acid and/or its salts, in combination with salicylic acid for the treatment of acne; or (c) cosmetic and dermatologic preparations containing glycolic acid and/or its salts in combination with two percent (2%) or less of hydroquinone for the treatment of pigmented spots on human skin.

Licensed Patent Rights shall mean, those portions of the patents and patent applications, and all divisions, continuations, continuations-in-part, reissues, reexaminations and extensions thereof; (a) covering only cosmetic and dermatologic preparations containing glycolic acid and/or its salts for (1) the treatment of human skin wrinkles and/or fine lines on the human skin; (2) the treatment of dry skin; (3) as a skin cleanser; (4) as a hair conditioner; (5) as a shampoo; (b) covering only cosmetic and dermatologic preparations containing glycolic acid and/or its salts, in combination with salicylic acid for the treatment of acne; and (c) covering only cosmetic and dermatologic preparations containing glycolic acid and/or its salts in combination with two percent (2%) or less of hydroquinone for the treatment of pigmented spots on human skin.

Excluded Channel of Trade shall mean the mail order, multi-level and direct door-to-door markets. Notwithstanding the Excluded Channel of Trade herein, Licensee may process orders made by customers of Licensee as a result of 800 telephone, toll-free telephone or telephone orders, provided that Licensee and its Affiliates shall not employ television, including without limitation, television infomercials, to advertise any 800 telephone, toll-free telephone or any telephone numbers to take, process or receive sales orders.

Field of Use

Patent rights were for products containing glycolic acids and its salts for the treatment of wrinkles and fine lines, dry skin, in combination with salicylic acid for the treatment of acne and in combination with hydroquinone 2% or less for the treatment of skin pigmentation, and as a skin cleanser, hair conditioner and shampoo.

License Grant

Supplier/Licensor shall supply, or cause to be supplied, and Licensee shall purchase all of Licensees requirements of the Finished Product, for use in the Field in the Territory on the terms, and subject to the conditions, of this agreement.  Licensor agrees that, during the Term of this Agreement, Licensee shall have the exclusive right to purchase the Product from Licensor and its Affiliates for resale in the Field and the Territory.

Licensor grants a non-exclusive license under the trademark to affix trademark to the Product except where Licensor determines that there is a risk of infringement and so informs Licensee.

License Property

Licensor owns or has rights to certain intellectual property trade marked as Novasome® and has know-how to develop and manufacture formulations using such technology.

Licensor has developed one 2% Salicylic Acid lotion Product utilizing the Technology, hereinafter referred as the Product, determined by Licensee to be suitable for the treatment of acne.

The Product is 2% w/w Salicylic Acid Novasome® Lotion.

Licensors U.S. trademark is Novasome ® Technology.

Novasome® Technology shall mean certain proprietary technology involving the use of amphiphiles to prepare bi-layer membrane structures.

Field of Use

The agreement is for a specialty dermatological company, for a unique therapeutic moisturizing product using the Novasome® encapsulation technology.  Licensee has a right of first refusal for development of additional formulations of the product for the treatment of psoriasis and seborrheic dermatitis.  Psoriasis is a skin disease that causes red, itchy scaly patches, most commonly on the knees, elbows, trunk and scalp.  Seborrheic dermatitis is a common skin condition that mainly affects your scalp. It causes scaly patches, red skin and stubborn dandruff. Seborrheic dermatitis can also affect oily areas of the body, such as the face, sides of the nose, eyebrows, ears, eyelids and chest.

The Field means any Product recognized in the trade as a pharmaceutical, cosmetic or personal care Product.