Royalty Report: Drugs, Therapeutic, Pharmaceuticals – Collection: 4285

License Grant

Licensor hereby grant to Licensee a non-exclusive, royalty-bearing, non-transferable  and non-sublicensable license to the Licensed Patents to make, have made, import, use, sell, and offer for sale Licensee's Generic Product in the Territory solely during the License Term.

License Property

Licensed Patents means any and all patents now and in the future owned, controlled, assigned, or licensed to Licensor that are necessary for Licensee to make, have made, use, import, sell and offer for sale, Licensee's Generic Product in or for the Territory, including, but not limited to the '529 patent, '510 patent, '333 patent, '334 patent, '263 patent and '790 patent, and any current and future continuations, continuation-in-parts, divisionals, reexaminations, and/or reissues of such patents.  

Generic Product means (i) a generic equivalent of the Brand Product approved under an Abbreviated New Drug Application or pursuant to an application under 21 U.S.C. § 355(b)(2), including Licensee's Generic Product, or (ii) an AG Product.  

Brand Product means the product that is approved for distribution and sale under the Brand Product NDA and sold under the trademark Lidoderm® or any successor trademark.  

Brand Product NDA means New Drug Application No. 20-612 and any amendments or supplements thereto.

Licensee's Generic Product means Lidocaine Patch 5% that is the subject of Licensee's ANDA, and all amendments and supplements thereto, and which is intended to be AB-rated to the Brand Product.  

AG Product. The license granted pursuant to Section 2(a) shall be partially exclusive for a period of time in that Licensor and their respective Affiliates shall not market or sell a Generic Product, or authorize or license a Third Party to market or sell an AG Product at any time before the earlier of (i) seven and a half (7.5) months from the Start Date, and (ii) the Launch of any Third Party Generic Product in the Territory.

AG Product means a generic version of the Brand Product that is manufactured and sold under the Brand Product NDA without a trademark or using a trademark other than Lidoderm® or a successor trademark thereto.  

Sub-Licenses. Licensee shall have the right to sub-license the license granted to its Affiliates, but not to any Third Party, provided that any such sub-license shall be subject to Licensor's prior written consent, not to be unreasonably withheld or delayed.

Licensee seeks approval to manufacture, market and sell Licensee's Generic Product before the expiration of United States Patent No. 5,827,529 (the '529 patent), United States Patent No. 5,741,510 (the '510 patent), United States Patent No. 6,096,333 (the '333 patent), United States Patent No. 6,096,334 (the '334 patent), United States Patent No. 5,536,263 (the '263 patent), and United States Patent No. 6,361,790 (the '790 patent).

In response to the filing of Licensee's ANDA, Licensor filed suit against Licensee in the United States District Court for the District of Delaware alleging infringement of the '529 patent.

Licensor also filed suit against Licensee in the United States District Court for the District of Delaware alleging infringement of the '510 patent, the '333 patent, and the '334 patent.

No Party admits liability, but each desires to resolve, compromise and settle the Litigation on the terms and conditions set forth herein.

Field of Use

Licensee has filed Abbreviated New Drug Application (ANDA) No. 20-675 with the United States Food and Drug Administration (FDA) seeking approval to manufacture, market, and sell Licensee's Generic Product, which product is intended to be an AB-rated generic version of Licensor's drug product Lidoderm®.

License Grant

This Agreement settles the parties patent infringement litigation concerning Licensor's AVERSION® oxycodone product, previously marketed by Pfizer Inc. under its brand name Oxecta® (oxycodone HCI tablets).

In the suit, Licensor alleges that a generic AVERSION® oxycodone product for which Licensee is seeking approval to market in the U.S. pursuant to an Abbreviated New Drug Application filing with the U.S. Food and Drug Administration infringes a U.S. patent owned by Licensor .

Under the terms of the Settlement Agreement, Licensor will grant Licensee a non-exclusive, royalty-bearing license to the Licensor Patent and other current and future Orange Book listable patents to market, manufacture and sell a generic version of AVERSION® oxycodone in the United States. Licensee's license becomes effective 180 days following the first sale of a generic AVERSION® oxycodone

product in the United States by an entity that is entitled to the 180 day first-filer exclusivity provided in the Drug Price Competition.

The Settlement Agreement will remain in effect until the expiration of the term of the license granted by tbe Licensor to the Licensee.

License Property

AVERSION® oxycodone is a Schedule II narcotic indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

License Grant

Licensor, for itself and its Affiliates, grants to Licensee and its Affiliates in accordance with the terms and conditions of this Agreement, the exclusive right (even as to Licensor and its Affiliates), under all of the existing or future Product Know-How owned or controlled by Licensor or its Affiliates, to register, make or have made, develop, import/export or have imported/exported, use or have used, Market, offer for sale or have sold, and otherwise exploit the Product on a sole and exclusive basis (even as to Licensor and its Affiliates) in or for the Territory.

License Property

The Product 1% testosterone gel AB-rated to AndroGel®; male testosterone gel as an AB-rated equivalent to AndroGel.

AB-rated drugs are drugs that meet the necessary bio-equivalence standards established by the Food and Drug Administration (FDA).

The Licensee will make certain upfront and milestone payments to the company.

The stated royalty rate will increase during the period of time if the Licensee markets the licensed product and is the sole marketer of a generic 1% testosterone gel that is AB-rated to AndroGel® in the United States.

The Licensee is a generic drug manufacturer.

Field of Use

AndroGel® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone.

License Grant

Licensor, for itself and its Affiliates, grants to Licensee and its Affiliates in accordance with the terms and conditions of this Agreement, the exclusive right (even as to Licensor and its Affiliates), under all of the existing or future Product Know-How owned or controlled by Licensor or its Affiliates, to register, make or have made, develop, import/export or have imported/exported, use or have used, Market, offer for sale or have sold, and otherwise exploit the Product on a sole and exclusive basis (even as to Licensor and its Affiliates) in or for the Territory.

License Property

The Product 1% testosterone gel AB-rated to AndroGel®; male testosterone gel as an AB-rated equivalent to AndroGel.

AB-rated drugs are drugs that meet the necessary bio-equivalence standards established by the Food and Drug Administration (FDA).

The Licensee will make certain upfront and milestone payments to the company.

The stated royalty rate will increase during the period of time if the Licensee markets the licensed product and is the sole marketer of a generic 1% testosterone gel that is AB-rated to AndroGel® in the United States.

The Licensee is a generic drug manufacturer.

Field of Use

AndroGel® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone.

License Grant

Licensor, for itself and its Affiliates, hereby grants India Licensee and its Affiliates, on and from the Entry Date through the expiration of the last-to-expire of the OMIDRIA Patents Family, a royalty-bearing, non-exclusive, non-sublicensable, non-transferable right and license under their respective rights in and to the OMIDRIA Patents Family to make, have made, use, sell, offer to sell, import, and distribute the ANDA Product in or for the Territory.

After the date of signature for this Settlement Agreement, the Parties shall execute a “Consent Judgment” providing for the terms of a consent judgment and stipulated dismissal of the Action, in the form attached hereto, and shall file it in the United States District Court for the District of Delaware in the Action.

License Property

OMIDRIA®, a pharmaceutical product containing the active ingredients phenylephrine hydrochloride and ketorolac tromethamine, in and for the United States.

The term OMIDRIA Patents shall mean United States Patent Numbers 8,173,707; 8,586,633; 9,066,856; 9,278,101; 9,399,040; 9,486,406; and 9,855,246.
8,173,707 – Ophthalmologic irrigation solutions and method
8,586,633 – Ophthalmologic irrigation solutions and method
9,066,856 – Stable preservative-free mydriatic and anti-inflammatory solutions for injection

The term OMIDRIA Patents Family shall mean the OMIDRIA Patents and any United States patents issued from a patent application that is a divisional of, continuation of, continuation-in-part of, or otherwise shares common priority with, an application from which one or more of the OMIDRIA Patents issued, or any amendment, reissue or reexamination thereof.

The term ANDA Product shall mean a Generic OMIDRIA Product sold, offered for sale or distributed pursuant to ANDA No. 210183, including supplements or amendments to ANDA No. 210183, but excluding any such supplements or amendments after the original filing date of ANDA No. 210183 that change the mode of administration or active ingredient(s).

Field of Use

OMIDRIA is added to ophthalmic irrigation solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain.

License Grant

The counsel for the Parties shall execute a Consent Judgment providing for the terms of a consent judgment and stipulated dismissal of the Action and shall file it in the United States District Court for the District of Delaware (the District Court) in the Action.

Plaintiffs and Defendants, the parties in the above-captioned action, have agreed to terms and conditions representing a negotiated settlement of this action and have set forth those terms and conditions in a Settlement Agreement.

License Property

As used in this Consent Judgment, (i) the term “ANDA Product” shall mean a drug product sold, offered for sale or distributed pursuant to Abbreviated New Drug Application No. 208417.  The term “ANDA Product” shall mean a Generic OMIDRIA Product sold, offered for sale or distributed pursuant to ANDA No. 208417, including supplements or amendments to ANDA No. 208417, but excluding any such supplements or amendments after the original filing date of ANDA No. 208417 that change the mode of administration or active ingredient(s).

The term “Approved OMIDRIA Product” shall mean any product sold, offered for sale or distributed pursuant to NDA No. 205388, including any supplements or amendments to NDA No. 205388, but excluding any such supplements or amendments after the original filing date of NDA No. 205388 that change the mode of administration or active ingredient(s).

The term “Generic OMIDRIA Product” shall mean a drug product that is sold, offered for sale or distributed under an ANDA or application pursuant to 21 U.S.C. § 355(b)(2) that refers to the Approved OMIDRIA Product as the reference-listed drug.

OMIDRIA Patents shall mean United States Patent Numbers 8,173,707, 8,586,633, 9,066,856, 9,278,101, 9,399,040, and 9,486,406.

8,173,707 – Ophthalmologic irrigation solutions and method
8,586,633 – Ophthalmologic irrigation solutions and method
9,066,856 – Stable preservative-free mydriatic and anti-inflammatory solutions for injection
9,278,101 – Ophthalmologic irrigation solutions and method
9,399,040 – Ophthalmologic irrigation solutions and method
9,486,406 – Stable preservative-free mydriatic and anti-inflammatory solutions for injection

Field of Use

This agreement pertains to the drug industry.

License Grant

The parties entered into a settlement and License Agreement whereby all claims were resolved and the Company obtained the rights to certain patents in and related to the litigation including rights to U.S. Reissue Patent REI 41,884, as well as all foreign counterparts, all of which expire in 2016.

With the settlement, Licensee will pay Licensor a one-time fee and the Licensor will not receive any additional payments for sales of Abraxane®, or any other nab®-Paclitaxel product in the United States or globally. Licensee will acquire a fully-paid up, exclusive, world-wide license to select Licensor's U.S. and foreign patents for Abraxane®.

License Property

Prior to the settlement, on July 19, 2006, Licensor filed a lawsuit against the predecessor entity of Licensee in the U.S. District Court for the District of Delaware alleging that Licensee willfully infringed two of its patents by making, using and selling the Abraxane® brand drug. Licensor sought unspecified damages and an injunction. In response, Licensee contended that it did not infringe the Licensor patents and that the Licensor patents are invalid and unenforceable. Before trial, Licensor dropped its claim that Licensee infringed one of the two asserted patents. Licensor also dropped its request for an injunction as to the remaining patent. On June 13, 2008, after a trial with respect to the remaining patent, a jury ruled that Licensee had infringed that patent, that Licensee’s infringement was not willful, and that the patent was valid and enforceable.

At issue was Licensee’s alleged infringement of Licensor’s patent for the nanoparticulate formulation of the breast cancer drug Abraxane.

A federal jury in the U.S. District Court for the District of Delaware agreed with that contention, and ordered the Company Licensee to pay an upfront fee and ongoing royalty.

Field of Use

Abraxane® for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) was approved by the U.S. Food and Drug Administration, or FDA, in January 2005, for the treatment of metastatic breast cancer and, as of December 2010, was approved for marketing in 42 countries.

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.