Royalty Report: Drugs, Biotechnology, Therapeutic – Collection: 29037

License Grant

The University hereby grants to Licensee and Licensee hereby accepts, the following license during the Term in the Territory.

License Property

Licensed Product Any product made, made for, used, sold or imported by Licensee or any Sublicensees that (a) in the absence of this Agreement, the manufacture, use, sale, offering for sale, or importation thereof would infringe at least one Valid Claim, or (b) uses a process covered by a Valid Claim. Licensed Products exclude all forms and derivatives of proteins with the biological activity of follicle-stimulating hormone (FSH), luteinizing hormone (LH), thyrotropin or thyroid-stimulating hormone (TSH), and human chorionic gonadotropin (HCG) that have been modified according to any Valid Claim.

The License relate to three CTP (Carboxyl Terminal Peptide) patents and expanded the field of use to all natural and non-natural therapeutic proteins and peptides (other than LH, FSH and hCG). Under the License Agreement, the Licensor has the right to sub-License the Licensed patents. The License Agreement terminates in 2018 when the last of the patents Licensed to us under the License Agreement expires, unless terminated earlier. Pursuant to our License Agreement with the University, we have obtained an exclusive License to the key CTP patents that have been issued by the U.S. Patent and Trademark Office – U.S. #5,712,122, U.S. #5,759,818 and U.S. #6,225,449.

Field of Use

Any and all human therapeutics, excluding any and all diagnostic applications and veterinary therapeutics.

License Grant

Licensor is willing to grant limited rights to Licensee under the terms and conditions herein to purify gonadotropins to appropriate clinical specifications  and generate crude gonadotropin containing mixtures from cell cultures for use as such or in further purification to appropriate specifications for the treatment of infertility.

Subject to the provisions of this Agreement, Licensor hereby grants to Licensee, for the Term, an exclusive, sub-licensable license to use the Licensed Patents and Technical Information to manufacture clinical grade gonadotropin hormones including FSH in the Manufacturing Territory for sale within the Sales Territory in the Field of Use.

License Property

Licensor owns certain intellectual property related to treatment of infertility and know-how relating to the commercial production and cellular generation of the hormone, follicle-stimulating hormone (FSH) and related gonadotropin hormones for use in the treatment of infertility in both humans and animals.

Licensed Patents as used herein means any and all patents, patent applications or utility models owned by Licensor during the Term of this Agreement, which are either pending or in force during the Term and relate to any Licensed Product, or any item of Technical Information. Below is a current list of Licensed Patents. Licensed Products as used herein means manufacturing methods for purification of gonadotropins &/or methods to generate crude mixtures of gonadotropins for further purification by use of licensed methods and all components and related products which are designed or developed by or for Licensee utilizing Technical Information and Licensed Patents as identified is this Agreement.

Sublicense.  Subject to the provisions of this Agreement, Licensor hereby grants to Licensee the right to sublicense the rights granted in Article 2.1.  Licensee may sublicense the manufacturing rights licensed to it under Section 2.1 upon the prior written consent of the Licensor.

Licensed Patents
1. United States Patent Number 5,990,288, Method for Purifying FSH.
2. United States Patent Number 6,458,593 B1, Immortalized Cell Lines and Methods of Making The Same.

Licensed Products
1. FSH produced through use of US Patent no. 5,990,288.
2. FSH, LH and/or hCG produced through use of US Patent no. 6,458,593 B1.
3. FSH, LH and/or hCG produced through use of US Patent no. 6,458,593 B1 and subsequently purified through use of US Patent no. 5,990,288.
4. FSH, LH and/or hCG produced through technology and know-how transferred from the Licensor to the Licensee/Sub-licensee.
5. Formulations of fertility drugs used to treat infertility produced through technology and know-how transferred from the Licensor to the Licensee/Sub-licensee.
6. Licensed Products described in Nos. 4 & 5 above, are to be mutually agreed as such by both Licensor and Licensee.

Field of Use

Field of Use as used herein shall mean treatment of infertility.

Licensee desires to manufacture, or have manufactured by a third party contract manufacturing organization, gonadotropin hormones for use in the treatment of infertility using Licensed Patents, and Technical Information of Licensor relating to the manufacture of gonadotropin hormones.   Licensee desires to obtain rights to use Licensor's US Patents, and an option to a pending patent application for  the commercial production of clinical grade gonadotropin hormones and, in addition, the Licensor's intellectual property related to generation of crude materials containing gonadotropin hormones from certain cellular sources.

License Grant

The University hereby grants to the Licensee a license with the right to sublicense others, under Licensed Patents and Licensed Know How to develop, test, manufacture, export, import, sell and use Subject Products and Subject Services in the Field of Use, which license, except insofar as otherwise provided herein.

License Property

Licensed Product, Licensed Vaccine and Licensed Service are Subject Product, Subject Vaccine and Subject Service, respectively, insofar as covered by the within License.

Field of Use

Field of Use shall be the use of Subject Products and Subject Service in the case of the non-hormonal antigens for the treatment, detection, diagnosis and/or prevention of cancer and in the case of hCG, for any other application except cancer (which is covered in the agreement of March 12, 1996), and except for fertility control.

License Grant

The Licensor, an University, granted a worldwide, exclusive license to the Licensee for patents and technology in the field.

License Property

License Patents European Patent No. 0636171 issued 6/7/00,  Patent No.6,403,326 issued 6/11/02 and its continuation, U.S. Patent number 6,339,143 issued January 15, 2002 and certain Antibodies and Cell Lines.

Field of Use

Therapeutic Subfield of cancer therapy (active and passive immunotherapy) in humans and non-humans and fertility control in non-humans.

The Animal Subfield shall include all therapeutic treatment in non-humans.

The Diagnostic Subfield shall include all diagnostics in humans and non-humans.

License Grant

The Company hereby grants a non-exclusive, non-transferable right and license under the Licensed Patents, without the right to sublicense, to make, have made for its own use and sale, use, offer for sale, sell, and import Product and to practice the methods claimed in the Licensed Patents in connection with such Product, and to extend to its customers purchasing Product the right to use and sell the Product purchased and to practice the methods claimed in the Licensed Patents in connection with such Product, all of the foregoing limited expressly to the field of human in vitro manually formatted immunodiagnostic assays.

License Property

Product shall mean immunodiagnostic assays.

Licensed Patent(s) shall mean United States Letters Patent No. 5,591,645. Patents relate to Rapid Manual Tests for hCG and LH analytes.  Human chorionic gonadotropin or human chorionic gonadotropin (hCG) is a glycoprotein hormone produced in pregnancy that is made by the developing embryo after conception and later by the syncytiotrophoblast (part of the placenta).

Field of Use

Field of Use shall mean human.