Description
Category: Technology Licenses
Created On: 2022-04-28
Record Count: 8
Primary Industries
- Drugs
- Therapeutic
- Pharmaceuticals
- Disease
- Pain
- Cancer
IPSCIO Report Record List
Below you will find the records curated into this collection. This summary includes the complete licensed property description so that you can review and determine if this collection covers the topics, technology or transaction type that is relevant for your needs. The full report will include all relevant deal data such as the royalty base, agreement date, term description, royalty rates and other deal terms. For reference, here is a sample of a full IPSCIO curated royalty rate report: Sample Report
IPSCIO Record ID: 4285
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.
IPSCIO Record ID: 3297
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.
IPSCIO Record ID: 7311
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.
IPSCIO Record ID: 27699
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.
IPSCIO Record ID: 236808
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.
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).
IPSCIO Record ID: 210224
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.
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
IPSCIO Record ID: 3091
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®.
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.
IPSCIO Record ID: 7499
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 Productsâ€);
Licensor asserts that Licensee’s versions of Mucinex® and Humibid® infringe Adams’ U.S. Patent No. 6,372,252 (the “Adams Patentâ€).