Royalty Report: Drugs, Biotechnology, Veterinary – Collection: 28727

License Grant

Licensor hereby grants to GI and its designated Affiliates which agree in writing to comply with the terms and conditions of this Agreement (with a copy of such written agreement being provided to Licensor) an exclusive, royalty-bearing license under the Licensor GDF-8 Technology, including the right to grant sublicenses, (i) to make, have made, use, import, market, offer for sale and sell GDF-8 Licensed Products in the Territory, in each case only for use solely in the GI Field and (ii) to make, have made and use GDF-8 Licensed Products and Licensor Excluded Products for GI’s and/or its designated Affiliates’ internal research and development purposes (provided, however, that no Licensor Excluded Product may bethe subject of a GI animal or clinical study without the express prior written consent of Licensor, which may be withheld in its sole discretion).

License Property

GDF-8 shall mean the TGF-(b Factor known as GDF-8.

GDF-8 Derivative Product shall mean any pharmaceutical product which primarily acts as

(i) an antagonist or agonist of GDF-8 or the GDF-8 receptor,

(ii) a vaccine against GDF-8,

(iii) a modifier of GDF-8 synthesis, or

(iv) a modulator of the GDF-8 signal transduction pathway, only to the extent that such pharmaceutical product is both (a) developed or sold for the purposes of modulating the effects of GDF-8, and (b) is covered by one or more Valid Claims included within the applicable GDF-8 Patent Rights licensed

GDF-8 Product shall mean GDF-8, including any and all

(i) formulations, mixtures or compositions of GDF-8,

(ii) antibodies targeted against GDF-8,
                (iii) receptors for which GDF-8 is a ligand,
                (iv) antisense molecules or ribozymes that modulate the in vivo production of GDF-8, and

(v) other products for research, diagnostic or therapeutic use containing GDF-8 or any of (i) through (iv) above, which, or which the manufacture use or sale of which, is covered by one or more Valid Claims included within the applicable GDF-8 Patent Rights licensed.

GDF-8 Patent Rights shall mean, with respect to GDF-8, any GDF-8 Product, or any GDF-8 Derivative Product (a) all Patents covering inventions

Our initial focus in the GDF area has been on technologies incorporating Myostatin (also known as GDF-8), a naturally occurring, patented protein that acts to limit skeletal muscle development. Studies have demonstrated that the removal or inhibition of Myostatin results in accelerated and increased development of skeletal muscle tissue (i.e., meat). We have an early stage discovery initiative focused on the identification of agents to effect the inhibition of Myostatin in beef, poultry and swine.

Growth differentiation factor 8, abbreviated GDF-8) is a protein that in humans is encoded by the MSTN gene.

License Grant

Licensor hereby grants to Licensee and its designated Affiliates which agree in writing to comply with the terms and conditions of this Agreement an exclusive, royalty-bearing license under the GI GDF-8 Technology, including the right to grant sublicenses, (i) to make, have made, use, import, market, offer for sale and sell GDF-8 Licensed Products in the Territory, in each case only for use solely in the Licensee Field and (ii) to make, have made and use GDF-8 Licensed Products and GI Excluded Products for Licensee's and/or its designated Affiliates’ internal research and development purposes provided, however, that no GI Excluded Product may be the subject of a Licensee animal or clinical study without the express prior written consent of Licensor, which may be withheld in its sole discretion.

License Property

GDF-8 shall mean the TGF-(b Factor known as GDF-8.

GDF-8 Derivative Product shall mean any pharmaceutical product which primarily acts as
(i) an antagonist or agonist of GDF-8 or the GDF-8 receptor,

(ii) a vaccine against GDF-8,

(iii) a modifier of GDF-8 synthesis, or

(iv) a modulator of the GDF-8 signal transduction pathway, only to the extent that such pharmaceutical product is both (a) developed or sold for the purposes of modulating the effects of GDF-8, and (b) is covered by one or more Valid Claims included within the applicable GDF-8 Patent Rights licensed.

GDF-8 Product shall mean GDF-8, including any and all

(i) formulations, mixtures or compositions of GDF-8,

(ii) antibodies targeted against GDF-8,
(iii) receptors for which GDF-8 is a ligand,
(iv) antisense molecules or ribozymes that modulate the in vivo production of GDF-8, and
(v) other products for research, diagnostic or therapeutic use containing GDF-8 or any of (i) through
(iv) above, which, or which the manufacture use or sale of which, is covered by one or more Valid Claims included within the applicable GDF-8 Patent Rights licensed.

GDF-8 Patent Rights shall mean, with respect to GDF-8, any GDF-8 Product, or any GDF-8 Derivative Product (a) all Patents covering inventions.

Our initial focus in the GDF area has been on technologies incorporating Myostatin (also known as GDF-8), a naturally occurring, patented protein that acts to limit skeletal muscle development. Studies have demonstrated that the removal or inhibition of Myostatin results in accelerated and increased development of skeletal muscle tissue (i.e., meat). We have an early stage discovery initiative focused on the identification of agents to effect the inhibition of Myostatin in beef, poultry and swine.

Growth differentiation factor 8, abbreviated GDF-8) is a protein that in humans is encoded by the MSTN gene.

License Grant

Licensor grants nonexclusive, worldwide, license to Licensee to make, have made, use and sell TGF-beta 2 and TGF-beta Heterodimer as part of a Licensee's Licensed Product solely for research, diagnostic reagents or veterinary uses ('Research, Diagnostic and Veterinary Uses').

Licensee may grant sublicenses under this license only to one other party in any country for each indication of a Research, Diagnostic and Veterinary Use at any one time.

License Property

Licensor has certain patent rights relating to TGF-beta and the TGF-beta receptor.

'TGF-beta' shall mean any protein which is a member of that class of proteins designated as TGF-beta or transforming growth factor-beta (but excluding TGF-beta 2 or TGF-beta Heterodimer), and/or (i) fragments, fusions or precursors of the foregoing, and/or (ii) any derivative protein which results from making deletions, substitutions and/or additions of one or more amino acids to the structure of a TGF-beta (but excluding TGF-beta 2 or TGF-beta Heterodimer), provided that such derivative protein is more similar in structure to the TGF-beta from which it was derived than it is to TGF-beta 2 or TGF-beta Heterodimer and provided that the primary biological activity of the derivative protein is substantially the same as the primary biological activity of the TGF- beta from which it was derived.

'TGF-beta 2' shall mean a protein comprising the amino acid sequence set forth and/or (i) fragments, fusions or precursors of the foregoing, and/or (ii) any derivative protein which results from making deletions, substitutions or additions of one or more amino acids to the structure.

'TGF-beta Heterodimer' shall mean the TGF-beta 2.3 heterodimer.

'TGF-beta Receptor' shall mean a protein, including a lipoprotein or glycoprotein, that interacts with TGF-beta so as to modulate its activity and that binds TGF-beta with high affinity (Kd 1000nM or less). Such TGF-beta Receptor may be cell associated or in soluble form.

Product' shall mean any pharmaceutical formulation or product or method or system which contains the protein TGF-beta 2, TGF-beta Heterodimer or TGF-beta Receptor.

'Phase I/II Clinical Trial' shall mean a controlled study in humans of the safety and efficacy of a Licensed Product for a particular indication or indications in subjects having the disease or condition under investigation.

Field of Use

Therapeutic Use shall mean any use of a Licensed Product or Licensed Method in vivo, in humans and animals, for the prevention, cure, amelioration or modification of any disease, symptom, syndrome, or other medical condition.

License Grant

The Canadian Licensor hereby grants to the Canadian Company for the Licensed Field and in the Licensed Territory, a worldwide exclusive license to exploit the Assets, particularly including but not limited to the Patents, to develop and have developed, to make and have made (including contract production by a toll manufacturer), to use and have used, and to sell or have sold, and otherwise dispose of, Licensed Product.

License Property

The license is non-exclusive with respect to diagnostic  applications for P. haemolytica antibodies and excludes applications related to infectious diseases.

Norelintm is a therapeutic vaccine designed to stimulate in patients production of antibodies against GnRH, resulting in reduced production of hormones that may cause or contribute to the growth of certain sex-hormone dependent cancers.  It has completed a Phase I/II safety and immunogenicity trial in hormone-sensitive prostate cancer suggesting that the approach may be better tolerated than currently available therapies.

Compositions and Treatments for Pneumonia in Animals

Issued U.S. Patent No. 5,849,531 a

Leukotoxin Vaccine Compositions and Uses Thereof

Issued U.S. Patent No. 5,871,750 a

Pasteurella haemolytica Leukotoxin Compositions and Uses Thereof

Issued U.S. Patent No. 5,476,657 a

B.       Robins and Associates Patent Series 9001-0016

Enhanced Immunogenicity Using Leukotoxin Chimeras

         U.S. Application 08/976,566 a

         U.S. Patent 5,708,155 a

         U.S. Patent 5,422,110 a

GnRH Leukotoxin Chimeras

         U.S. Application 09/383,912 a

         U.S. Patent 5,969,126 a

         U.S. Patent 5,723,129 a

         U.S. Patent 5,837,268 a

         U.S. Patent 6,022,960 a

Field of Use

Licensed Field means, and is limited to, the exploitation of the Assets in respect of Licensed Products for use in humans, comprising Gonadotrophin Hormone Releasing Hormone (GnRH), Pasteurella haemolytica proteins or peptides combined with GnRH or Epidermal Growth Factor Receptors or Epidermal Growth Factor Receptor Ligands as defined in Exhibit B hereto, and for clarity excludes all products comprising GDF-8 or Myostatin, and further excludes applications of the Assets and the Patents relating to the diagnosis, treatment, or prevention of infectious diseases.  Assets and know-how in the field of GnRH vaccines and immunological carriers based on Pasteurella haemolytica for humans by, amongst other activities, performing preclinical investigations and a clinical investigation of a certain product, Norelin.