Royalty Report: Drugs, Disease, Osteoarthritis – Collection: 256298

License Grant

This agreement is an exclusive license throughout the world to discover, develop, make, have made, market, sell and import certain Licensed Products throughout the world under the Licensor Patent Rights and Licensor Know-How.

Licensor grants an exclusive license, even as to Licensor, under the Licensed Technology, to make, have made, use, sell, offer for sale and import Licensed Product in the Territory in the Field and an exclusive license, even as to Licensor, under the Licensed Technology, to make, have made, use, and import Active Pharmaceutical Ingredient (API) and PTH in the Territory.

License Property

Licensor has certain proprietary technology related to oral PTH, and has patents and know-how relating to pharmaceutical compositions for oral delivery of an active PTH peptide and the manufacture thereof.

PTH means all forms of parathyroid hormone.  Parathyroid hormone (PTH), also called parathormone or parathyrin, is a hormone secreted by the parathyroid glands that is important in bone remodeling, which is an ongoing process in which bone tissue is alternately resorbed and rebuilt over time.

Licensed Product means a drug product in finished pharmaceutical form, in any formulation containing or incorporating PTH, alone or in combination with any pharmacologically active ingredient which is a non-peptide or non-peptidomimetic or proprietary Licensee peptide, which product incorporates Licensor Know-How and/or is covered by Licensor Patent Rights and/or Joint Patent Rights.

Field of Use

The Field means the use of the Licensed Product for the prophylactic and/or therapeutic treatment of human diseases including, but not limited to, osteoporosis.

The licensing agreement is to develop an oral formulation of an analog of PTH currently in clinical development for the treatment of osteoporosis.

License Grant

The Parties previously entered into the Agreement to provide for the license grant of certain Licensed Technology to discover, develop, make, have made, market, sell and import certain Licensed Products throughout the world under the Licensees Patent Rights and Licensees Know-How.

With this amendment, Licensor consents and agrees that Licensee may enter into one or more agreements with a designated Third Party providing for the development, manufacturing, marketing or sale of 1-34 PTH into a drug product in the Field in finished pharmaceutical form in an oral formulation containing or incorporating 1-34 PTH, alone or in combination with a peptide or a small molecule that is not proprietary to Licensor, and which such oral formulation of 1-34 PTH product incorporates Licensee Know-How or is covered by Licensee Patent Rights, a 1-34 PTH Product.

With this amendment, Licensor grants back to Licensee, but only to the extent necessary to effectuate the specific Third Party Agreement, an exclusive license, even as to Licensor, under the Licensed Technology that relates solely to the manufacturing of 1-34 PTH API for use solely in a 1-34 PTH Product for Licensee to make and sell to Third Party, and for Third Party as Licensee’s licensee to subsequently sell, have sold, make, have made and import 1-34 PTH API for use solely in a 1-34 PTH Product in the Territory in the Field. For the avoidance of doubt, the foregoing license back to Licensee shall only apply to Licensed Technology that is solely related to the manufacturing of 1-34 PTH API for use solely in a 1-34 PTH Product and not any other aspects of Licensed Technology such as, but not limited to, Licensed Technology as to the oral delivery method or amidation technology relating to 1-34 PTH API or a 1-34 PTH Product, and Licensor retains all other rights to the Licensed Technology granted to Licensor under the Agreement.

License Property

1-34 PTH means all formulations of PTH 1-34OH including, but not limited to fusion proteins, muteins and chemical modifications of any or all of the aforementioned PTH 1-34OH. For the avoidance of doubt, 1-34 PTH shall not include any other formulations of PTH 1-34 or any other formulations of PTH.

Field of Use

This amendment further defines that the product in the Field may be in the finished pharmaceutical form in an oral formulation.  The original agreement defines the Field as the use of the Licensed Product for the prophylactic and/or therapeutic treatment of human diseases including, but not limited to, osteoporosis.

License Grant

The Parties agree to continue their collaboration on research and development programs to research the use of the Licensor's Technology for oral delivery of parathyroid hormone molecule and human growth hormone molecules (excluding calcitonin) and human growth hormone molecules (not to include secretagogues) and mimetics (PTH and HGH), as well as to study the potential for the Licensors Technology to improve non-oral administration routes, including, but not limited to, the injectable (sub-cutaneous, intra-venous, intra-muscular, intra-peritoneal and depot), buccal, nasal, ocular, pulmonary, transdermal and vaginal administration routes (the 'Non-Oral Routes') of proteins all as more specifically set forth in the PTH and HGH Work Plans. Licensor will make available to Lilly access to all Licensor Technology relevant for the Program.

License Property

Licensor is engaged in the research and development of proprietary synthetic chemical compounds that enable the delivery of therapeutic macromolecules and other compounds that are not currently deliverable by oral means or by certain non-oral means.

The strategic alliance is to develop oral formulations of ForTeo (recombinant parathyroid hormone) and Humatrope (human growth hormone (HGH)) utilizing the Licensor's proprietary drug delivery technology.

Field of Use

Licensee is engaged in research to produce, therapeutic macromolecules and other compounds that are not currently deliverable by oral means or by certain non-oral means.

License Grant

Licensor grants a perpetual, irrevocable, exclusive license, with the full right to sublicense, under the Licensor Patent Rights to make, have made, use, import, export, sell, and have sold Products in the Field and in the Territory.

Licensor grants a perpetual, irrevocable, exclusive license, with the full right to sublicense, to use the Licensor Technology in the Field and in the Territory.

License Property

The intellectual property relates to nucleic acids, the Licensor Patent Rights, or Oligonucleotide Delivery Compositions.

Product means an Oligonucleotide Formulation Product or a Special Product.

Oligonucleotide Formulation Product means an Oligonucleotide Delivery Composition the manufacture, use, or sale of which would constitute, but for the licenses granted Licensee pursuant to this Agreement, infringement of any issued, unexpired claim within the Licensor Patent Rights.

Special Product means any article, composition of matter, combination, device or kit other than an Oligonucleotide Formulation Product the manufacture, use, or sale of which would constitute, but for the licenses granted Licensee pursuant to this Agreement, infringement of any issued, unexpired claim within the Licensor Patent Rights.

Oligonucleotide Delivery Composition means any composition of matter that is complexed with an oligonucleotide composition (or analog of an oligonucleotide composition) for the delivery of such oligonucleotide composition (or analog of an oligonucleotide composition) to a targeted medium, including, but not limited to a biological organism, tissue or cell.

Field of Use

Field means all fields of use other than therapeutic, diagnostic, prophylactic and palliative uses in mammals, including humans.  The research plan is to evaluate the combination of Licensor Biotech liposome-based formulations and Licensee siRNAs via topical administration in tissue culture and whole plant assays.