Royalty Report: Drugs, Diagnostic, Disease – Collection: 2180

License Grant

The Company, through its subsidiary, entered into an exclusive contract to license its tuberculosis diagnostics test (rapid diagnostic test for the detection of tuberculosis).

License Property

The test utilizes a combination of three highly specialized Mycobacterium tuberculosis antigens that react with serum from persons having active TB, in just three minutes.  This ability of the test to distinguish TB infection from active disease makes it ideal for helping medical professionals select the appropriate therapy.  The indications for the use of the test for tuberculosis are living in or travel from most third world countries, and certain developed countries, a known exposure to the disease and high risk physical conditions.

Field of Use

The rights granted apply to the medical field.

License Grant

During fiscal year ending June 30, 2000, the Company, through its subsidiary, entered into an agreement to license its tuberculosis diagnostics test (the TB Test).

License Grant

The Licensor of the United Kingdom grants to the Licensee of the United Kingdom a license under the Licensed Technology to
–  undertake research with a view to Developing Licensed Products and Combination Products for use in the Field;
–  Develop and have Developed Licensed Products and Combination Products for use in the Field;
–  apply for, obtain and maintain Regulatory Approvals (other than Marketing Authorizations) for Licensed Products and Combination Products for use in the Field;
–  Manufacture, have Manufactured and otherwise make and have made, use and have used Licensed Products and Combination Products for use in the Field;
–  apply for, obtain and maintain Marketing Authorizations for Licensed Products and Combination Products in the Field in the Territory; and
–  Market Licensed Products and Combination Products in the Field in the Territory.

Portions of this license are exclusive, and others are co-exclusive with Licensor.

License Property

The patent is entitled Method for generating a memory T-cell response.

Licensed Product means any form or dosage of pharmaceutical composition or preparation for use in humans which is intended to prevent or treat Mycobacterium tuberculosis but no other disease and which contains
(a) a recombinant replication-impaired or non-replicating MVA, containing heterologous nucleotide sequence encoding all or an immunogenic fragment or fusion protein of antigen 85A of Mycobacterium tuberculosis and no other non-MVA expressed gene (aside from a marker gene); or
(b) a Multivalent TB Product.

Licensed Technology means all Intellectual Property Rights Controlled by the Company in
(a) the Company Patent Rights;
(b) the Company Know-how;
(c) the Master Seed Stock;
(d) Company Seed Stock;
(e) Company Manufacturing Technology;
(f) Emergent ODP Technology; and
(g) the Documents

Multivalent TB Product means a recombinant replication-impaired or non-replicating MVA containing a heterologous nucleotide sequence encoding all or an immunogenic fragment or fusion protein of antigen SSA of Mycobacterium tuberculosis and any promoter or leader nucleotide sequences required for expression of that antigen; and one or more of the following (whether co-formulated or co-administered with such viral vector)
(a) one or more heterologous nucleotide sequences encoding all or an immunogenic fragment or fusion protein of an antigen or antigens, other than SSA, of Mycobactenum tuberculosis and any promoter or leader nucleotide sequences required for expression of that antigen and no antigens (other than MVA antigens and a marker, if present) from any other pathogen;
(b) one or more full length protein(s) or immunogenic fragment(s) or fusion protein(s), of a Mycobacterium tuberculosis antigen or antigens (and including l1poproteins, glycoproteins polysaccharides and protein -polysaccharide conjugates) other than antigen SSA;
(c) an additional vector system for the expression of Mycobactenum tuberculosis antigens, enabling expression within viral, prokaryotic and/or eukaryotic cells;
(d) a delivery system for Mycobacterium tuberculosis antigens including Bacterial RNA capsids, microparticles, vesicles and liposomes.

MVA means modified vaccinia virus Ankara.

MVABSA means a recombinant replication-impaired or non-replicating MVA, containing heterologous nucleotide sequence expressing all or an immunogenic fragment or fusion protein of a major secreted antigen from Mycobacterium tuberculosis, antigen SSA, and no other non-MVA expressed gene (aside from a marker gene), and known as the MVASSA vaccine and described in the Patent Application.

Field of Use

The field of use is the Prevention and treatment of Mycobacterium tuberculosis disease (and only Mycobacterium tuberculosis disease) in humans; provided that with respect to a Combination Product, the Field shalI also include such other indications as a retreated or prevented by the Other Product.

Mycobacterium tuberculosis is a species of pathogenic bacteria in the family Mycobacteriaceae and the causative agent of tuberculosis.  Tuberculosis generally affects the lungs, but can also affect other parts of the body.

License Grant

The Licensee had purchased a License from the principal patent holder, the Licensor, to whom royalty payments were due for strip-based rapid tests sold.

License Property

Products covered by the License included those related to HIV, H.pylori, Tuberculosis and Hepatitis A.  Immunochromatography, the principle upon which the Licensee's rapid tests are based, is a technology covered by many patents.

Field of Use

The rights granted apply to the healthcare industry relating to infectious diseases.

License Grant

Licensor hereby grants to Licensee a non-transferable, non-exclusive, royalty-bearing license, under the Licensor's Lateral Flow Patents, for the Term to manufacture and to exploit the Licensed Products worldwide, provided however that Licensee shall have no license to exploit the Dipstick Product in the United States, but shall have a license to export the Dipstick Product from the United States.

Licensed Products shall mean (a) Licensee's veterinary tuberculosis and parvovirus products, products for the testing of Trypanasoma Cruzi, African Trypanasoma, human tuberculosis, Leishmaniasis, and Leptospirosis, and (b) the Dipstick Product.

License Property

Licensor, among other activities, is in the business of developing, marketing and selling products used to diagnose various diseases, and owns or has rights to grant licenses to a number of patents pertaining to disease diagnosis, including the Inverness Lateral Flow Patents.

“Licensed Products” shall mean (a) Licensee's veterinary tuberculosis and parvovirus products, products for the testing of Trypanasoma Cruzi, African Trypanasoma, human tuberculosis, Leishmaniasis, and Leptospirosis, as described on Schedule D; and (b) the Dipstick Product.

The Dipstick Product means Licensor's HIV 1/2 STAT PAK(TM) Dipstick product.

Field of Use

This agreement pertains to HIV testing relating to the human and veterinary product lines in the drug industry.