Royalty Report: Drugs, Pharmaceuticals, Disease – Collection: 5948

License Grant

Licensor hereby grants to Licensee an exclusive, even as to Licensor, license under the Licensed Assets to make, have made, sell, offer to sell, have sold, market, promote, distribute, import and otherwise transfer, dispose, provide and place the Products in the Territory.

License Property

“Product Trademarks” means any trademarks related to the Products, including the Levall Trademark.

“Products” shall mean the following
(i) Levall 5.0 – Phenylephrine HCl 15mg, Guaifenesin 100mg, Hydrocodone Bitartrate 5mg;
(ii) Levall G – Pseudoephedrine HCl/90mg, Guaifenesin 400mg;

(iii) Levall 12 – Carbetapentane Tannate 30mg, Phenylephrine Tannate 30 mg; (iv) Levall Liquid – Phenylephrine HCl 15mg, Carbetapentane Citrate 25 mg, Guaifenesin 100mg;
(v) Lev/Pse/GG – Pseudoephedrine HCl/90mg, Guaifenesin 400mg (Levall G Generic);
(vi) Carb/Phenyl-12 – Carbetapentane Tannate 30 mg, Phenylephrine Tannate 30mg (Levall 12 Generic); and (vii) Any future product using the Product Intellectual Property, including, but not limited to, NDAs, product line extensions, ANDAs, 505(b)(2) applications or the like.

The Levall® product line consists of various pharmaceutical products that provide relief from coughing, congestion and rhinitis associated with respiratory infections such as the common cold, influenza, bronchitis and sinusitis. The Levall® License permits us to make, sell, market, distribute, import and otherwise transfer the Levall® products on a worldwide basis.  Our Levall® product line currently consists of four products Levall® 12, Levall® Liquid, Levall® 5.0 and Levall® G. Our Levall® product line offers different combinations of antihistamines, expectorants, decongestants and anti-tussives that are designed to provide symptomatic relief for several patient types with respiratory infections.

Field of Use

The rights granted apply to the healthcare market.

License Grant

The Parties have entered into that certain Amended and Restated License Agreement dated August 19, 2006 regarding the Levall brand of cough and cold medication, including without limitation Levall 12, Levall 5 and Levall-G and other products defined as Products in this Agreement.
Licensee and Licensor desire to settle fully and finally any and all disputes and claims currently between them, in accordance with the terms and conditions of this Settlement Agreement.

License Property

The Levall® product line consists of various pharmaceutical products that provide relief from coughing, congestion and rhinitis associated with respiratory infections such as the common cold, influenza, bronchitis and sinusitis. The Levall® License permits us to make, sell, market, distribute, import and otherwise transfer the Levall® products on a worldwide basis.

Field of Use

Our Levall® product line currently consists of four products Levall® 12, Levall® Liquid, Levall® 5.0 and Levall® G. Our Levall® product line offers different combinations of antihistamines, expectorants, decongestants and anti-tussives that are designed to provide symptomatic relief for several patient types with respiratory infections.

License Grant

The Licensor grants the Licensee an exclusive, world-wide, perpetual license, including the right to grant sublicenses, to use the Licensed Rights, and the goodwill associated therewith, in connection with the sale, marketing, and promotion of Products, subject to the terms and conditions.

License Property

Licensed Rights means the Licensor’s trademark rights in Extendryl and any Licensor-owned proprietary information relating to formulations, the testing of formulations, sales and marketing information, historical financial data and regulatory information that relate directly to Fleming’s products sold under the Extendryl mark.

Products means any product marketed and sold by the Licensee or its Affiliate or sublicensee under the Extendryl mark or that is substantially similar in formulation to any of the Extendryl products sold by Fleming, including any product line extensions.

Extendryl family of products are prescription respiratory medications indicated for the relief of respiratory congestion, allergic rhinitis, and vasomotor rhinitis.

Field of Use

Extendryl is an antihistamine, decongestant, and anticholinergic combination used to relieve congestion, sneezing, and watery eyes due to colds, flu, or hay fever.

License Grant

To the extent that Licensee purchases tablets of Licensor’s Guaifenesin Product pursuant to the Supply Agreement, Licensor grants Licensee a non-exclusive, perpetual and irrevocable right to sell and offer for sale to the Retail Trade such tablets supplied by Licensor under the Licensed Patents in the Territory and agrees, in a timely manner, to take all steps with respect to the New Drug Applications and/or other marketing authorizations for such Licensor’s Guaifenesin Product that are necessary in order to manufacture and supply such Licensor’s Guaifeneisin Product tablets to Licensee hereunder and under the Supply Agreement and to ensure that Licensee and its Affiliates or its single Sublicensee, as the case may be, is authorized to sell such Licensor’s Guaifenesin Product. Only Licensee and its Affiliates, on the one hand, or a single Sublicensee, on the other hand, may sell to the Retail Trade pursuant to this paragraph.

License Property

The agreement relates to the patent infringement lawsuit filed by Licensor in the U.S. District Court for the Eastern District of Pennsylvania on Oct. 4, 2006, against Licensee for infringement of Licensor's U.S. Patent No. 6,372,252 (‘252 patent), which expires in 2020.

Licensed Products” shall mean the collective reference to (I) the Mutual 600 mg Guaifenesin Product, (ii) the Mutual 1200 mg Guaifenesin Product, and (ii) the Mutual Combination Guaifenesin Products, defined herein, as well as (iv) any other product containing guaifenesin that is made with the formulation set forth in the Mutual ANDA; and a “Licensed Product” shall mean each of them.

“Mutual 600 mg Guaifenesin Product” shall mean (I) a formulation as defined in the Mutual ANDA containing a total of 600 mg of guaifenesin as its sole active ingredient, (ii) any similar formulation that does not require a new bioequivalence clinical study for FDA approval, or (iii) or any formulation for which Licensee provides Licensor with a certification letter pursuant to 21 U.S.C. § 355(j)(2)(B) representing that said formulation is subject to this Agreement as a Licensed Product, but excluding in each case any Bilayered Products.

“Mutual 1200 mg Guaifenesin Product” shall mean (I) a formulation as defined in the Mutual ANDA containing a total of 1200 mg of guaifenesin as its sole active ingredient, (ii) any similar formulation that does not require a new bioequivalence clinical study for FDA approval, or (iii) any formulation for which Licensee provides Licensor with a certification letter pursuant to 21 U.S.C. § 355(j)(2)(B) representing that said formulation is subject to this Agreement as a Licensed Product, but excluding in each case any Bilayered Products.

“Mutual ANDA” shall mean the Abbreviated New Drug Application No. 78-333.

“Licensed Patents” shall mean the (I) the Adams Patent and U.S. Patent Application No. 09/559,542 filed April 28, 2000, and any claims that issue from the Reexamination, and (ii) any U.S. reissue, reexamination, continuation, divisional or continuation-in-part thereof.

“Adams Patent” shall mean U.S. Patent No. 6,372,252.

Licensor manufactures, markets and sells the pharmaceutical formulations containing 600 and 1200 mg of guaifenesin alone and in combination with other active ingredients under the brand names Mucinex® (guaifenesin 600 mg ER tablets), Mucinex® DM (guaifenesin 600 mg/pseudoephedrine 60 mg ER tablets), Mucinex® D (guaifenesin 600 mg/dextromethorphan 30 mg ER tablets) and Humibid® (guaifenesin 1200 mg ER tablets) and plans to manufacture, market and sell future extended-release products containing guaifenesin (collectively “Adams Guaifenesin Products”);

Licensor asserts that Licensee’s versions of Mucinex® and Humibid® infringe Adams’ U.S. Patent No. 6,372,252 (the “Adams Patent”).

Field of Use

Licensee is in the process of developing versions of Mucinex® D and Mucinex® DM.

License Grant

Licensor grants to Licensee under the Licensed Patents the exclusive right and license to use, sell and distribute Finished Dosage Products containing Chlorpheniramine Tannate covered by the Licensed Patents in the Territory, except only as to the license rights of Unisource, Inc., a Colorado corporation and or Carter Wallace Inc. pertaining to products that contain Chlorpheniramine Tannate and are covered by the Licensed Patents.

License Property

The patents cover phenylephrine tannate compositions, and, processes for producing tannate products.

Finished Dosage Products means products that contain active pharmaceutical ingredients and are in a form ready for sale to a final consumer, including, without limitation, a liquid suspension or tablet.

Licensor is the owner of the entire right, title and interest in, to and under Letters Patent of the United States [No. 5,599,846 granted February 4, 1997], directed to phenylephrine tannate compositions and Letters of Patent of the United States No. 5,663,415 granted September 2, 1997, directed to processes for producing tannate products (said patents collectively referred to as the Licensed Patents).

Field of Use

The licensed patent covers the manufacturing process of an active ingredient used in Tanafed.
Tanafed is a liquid cold and allergy product primarily for children.

The compound has a general use as an antihistamine.