Royalty Report: Drugs, Cancer, Disease – Collection: 4747

License Grant

This is an exclusive License to use a proprietary cell line to develop and potentially commercialize recombinant human papillomavirus (HPV) virus-like particle (VLP) vaccines.

Pursuant to the License Agreement, Licensee has an exclusive worldwide License to develop, manufacture and market HPV-16 VLP vaccines for the prevention and/or treatment of HPV infection, except that Licensor retained the right to co-market the product in the United States, including Puerto Rico.

Field of Use

The parties are currently working together on manufacturing HPV-16 VLP vaccines being evaluated by the National Cancer Institute in clinical trials. The vaccines are designed to prevent and/or treat HPV-16 infection and associated cervical cancer.

License Grant

The Licensor entered into a License Agreement with the Korean Licensee, to develop, manufacture and commercialize influenza vaccines using the Licensee's proprietary VLP technology.

License Property

The Licensor is a clinical-stage biopharmaceutical company focused on developing novel and effective recombinant vaccines. These vaccines leverage the Licensor's platform technology coupled with a single-use bioprocessing production system to develop virus-like particle (VLP) vaccines, as well as recombinant nanoparticle vaccines.

VLPs are genetically engineered three-dimensional nanostructures that incorporate immunologically important recombinant proteins. The Company’s VLPs resemble the virus they were engineered to mimic, but lack the genetic material to replicate the virus and its single-use bioprocessing production technology uses insect cells rather than chicken eggs or mammalian cells.

The Licensor’s current product targets include VLP vaccines against seasonal and pandemic (including H5N1) influenza and a recombinant nanoparticle vaccine against Respiratory Syncytial Virus (RSV).

The upfront payment has been deferred and will be recognized as revenue when certain obligations in the agreement are satisfied.

Field of Use

At its own cost, the Licensee is responsible for funding its clinical development of the influenza VLP vaccines and completing a manufacturing facility in South Korea.

License Grant

Pursuant to the Agreement, Licensee obtained an exclusive license under Licensor patent rights and know-how to develop, make, have made, use and sell Licensed Products in the Territory.

With this amendment the parties wish to amend the Agreement to provide for the reversion of rights to Licensor under the Licensor patent rights and know-how for Influenza vaccine, HPV vaccine and HSV vaccine.

As of the Amendment Effective Date, the license granted to Licensee, and the rights and obligations of Licensee and Licensor arising therefrom, shall no longer apply to Influenza vaccine, HPV Vaccine and HSV Vaccine, and these vaccines shall no longer be deemed to be Licensed Products under the Agreement.

Hereby amended Licensor grants to Licensee an exclusive license, even as to Licensor, under Licensor know-how and patent rights to develop, make, have made, use and sell Licensed products in the Territory with the right to grant sub licenses to Affiliates of Licensee and those persons or entities through whom Licensee, in the normal course of its business collaborates in the manufacture and sale of its products; provided however, that nothing in this Agreement shall prohibit Licensor from utilizing the Licensor know-how and/or patent rights, exclusive of Licensee know-how, to develop, make, have made, use and sell, either by itself or with one or more third parties, products for the treatment of infectious diseases: provided, further, notwithstanding the preceding proviso, that Licensor shall not have any right to develop, make, have made, use, or sell, either by itself or with one or more third parties, Treatment Vaccines.

Licensor grants an option to obtain a license under theLicensor patent rights and know-how to make, have made, use, sell, offer to sell and import Cancer Vaccines in the Territory for up to three (3) Cancer targets. Such Cancer target license shall be exclusive, even as to Licensor, for each Cancer Target so licensed, and shall be sublicenseable by Licensee pursuant to the terms applicable to Licensed Products.

License Property

This amendment includes Amended Definitions Relating to Cancer targets, and, Licensed Product means a bulk or finished AIDS Vaccine, or other vaccine for the prevention of human infectious disease if licensed hereunder, which utilizes the Technology or technology which is developed by Licensor during and as a result of the research collaboration program; and upon the exercise of an Option for a Cancer vaccine, such bulk or finished Cancer vaccine for the prevention of Cancer Indications, provided, however, that if any vaccine is also capable of being used for treatment of the same human infectious disease or Cancer indication, then such therapeutic use of such vaccine shall also be considered a Licensed Product for purposes of the license being granted by Licensor to Licensee under this Agreement; and Treatment vaccines.

Treatment vaccines means a bulk or finished vaccine.

Field of Use

The field of use is for the treatment of Human Immunodeficiency Virus (HIV-1) and/or diseases caused by infection with HIV-1 in humans;  Hepatitis Virus (HBV) and or diseases caused by infection with HBV in humans; and Cancer vaccines for the treatment, but not prevention or prevention and treatment, of Cancer Indications.