Royalty Report: Drugs, Delivery, Hormones – Collection: 349158

License Grant

Licensor hereby grants to Chinese Licensee a co-exclusive license, with the right to grant sublicenses, under and to the Licensor Intellectual Property and Licensor Collaboration Intellectual Property to (i) Develop the Products for the US and (ii) Manufacture the Products in the Territory solely for sale of Products to Licensor in the US. Licensor also grants Licensee a non-exclusive license under and to the Pen Intellectual Property to assemble the Pen in the Territory for the Manufacture of the Product for Commercialization in the US.  Notwithstanding the foregoing, Licensee will not conduct any clinical trials for the Product in the Territory without Licensor’s consent.

License Property

Pen means the variable dose, multi-dose disposal injection drug delivery device(s) (including autoinjectors and other needle-based and needle-free devices) customized by a Third Party and assembled by Licensee that are used in the US during the Term to deliver formulated Insulin Aspart in the Product intradermally, transdermally, subcutaneously or intramuscularly, but excluding transdermal patch technology.

Insulin Aspart means the recombinant insulin aspart having a molecular formula and sequence.

Product means the Insulin Aspart as the sole active ingredient and in all forms, presentations, and formulations (including manner of delivery and dosage), which is co-Developed by Licensee and Licensor for US market, manufactured by Licensee in the Territory and Commercialized by Licensor or any of its Affiliates or Licensee Partners in the US pursuant to this Agreement, as sold in combination with the Pen (whether or not co-packaged).

Field of Use

The license and collaboration agreement is for the development of a biosimilar insulin aspart product.

Insulin aspart is a type of manufactured insulin used to treat type 1 and type 2 diabetes.

License Grant

Licensor grants a worldwide, exclusive, even as to Licensor, license, with the right to grant sublicenses, under the Licensed Technology, to make, have made, use, sell, offer for sale and import and otherwise Commercialize Licensed Products in the Field in the Territory.

License Property

Licensor is a corporation with proprietary transdermal drug delivery technology, and, has completed a Phase 2 Clinical Trial for a patch utilizing a micro-projection system containing a once-daily formulation of parathyroid hormone (PTH) and a Phase 1 Clinical Trial for such a patch containing a once-weekly formulation of PTH.

Licensed Products means the Daily Product and any Product Patch with a New Dosing Duration.

Daily Product means a Product Patch which is intended to deliver PTH formulations to a patient one time each day.

New Dosing Duration shall be any dosing duration, other than once daily, with respect to a Product Patch or Licensed Product. For example, if a Licensed Product has an administration once daily, then a once weekly administration would be a New Dosing Duration.

Pen means the pre-filled cartridge pen device currently marketed by Licensee to administer via injection once daily formulations of the Licensee’s recombinant human PTH analog (1-34) rhPTH (1-34) or manufactured by Licensee to administer a placebo.

Product Patch means a micro-projection array which pierces through the outmost, the stratum corneum, layer of the skin and either in which the micro-projections are coated with a formulation containing PTH as an active pharmaceutical ingredient, to deliver such active pharmaceutical ingredient into or through the skin, in a passive, diffusion-mediated manner, or to form pathways for diffusion-mediated delivery of PTH as an active pharmaceutical ingredient into or through the skin, in each inclusive of an applicator device, API, patch and packaging. For purposes of clarity, the Product Patch shall include all dosage and timed release formulations of PTH.

Field of Use

Field means all uses of PTH.

Licensee currently markets Forteo®, a once-daily formulation of Licensee’s recombinant human PTH analog (1-34) rhPTH(1-34) administered by subcutaneous injection and approved in the United States for the treatment of severe osteoporosis.

FORTEO is a prescription medicine used to treat postmenopausal women who have osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments. FORTEO can lessen the chance of broken bones (fractures) in the spine and other bones in postmenopausal women with osteoporosis. FORTEO is used to increase the bone mass in men with primary or hypogonadal osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments. FORTEO is used to treat both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments.

License Grant

The Company acquired a license agreement which allows the Company to use controlled delivery technology that may prove useful in the delivery of basal insulin.

License Property

AB101 is a PEGylated basal insulin that has been formulated in biodegradable microspheres to be injected weekly to treat patients with Type 1 and Type 2 diabetes who require basal insulin to control hyperglycemia.

Field of Use

An early-stage development company focused on developing and commercializing proprietary technology to be used with active pharmaceutical ingredients to create sustained release injectable formulations has a license relative to their lead product candidate AB101, which is a potential once-a-week basal insulin injection for the diabetes market.  AB101 for the diabetes market and other product candidates uses the proprietary sustained release formulation capability. As a precursor to clinical studies, they will study the pharmacokinetics and pharmacodynamics of AB101 in two animal species.