Royalty Report: Drugs, Cancer, Disease – Collection: 55198

License Grant

The Taiwanese Licensor hereby grants sole licensing rights to Licensee, a related party, in the Field and in the Territory under the Intellectual Property, Confidential Information, Data and Trademark, to develop Product.

License Property

Products:
BLI-1005  CNS-Major Depressive Disorder
BLI-1008  CNS-Attention Deficit Hyperactivity Disorder
BLI-1401-1 Anti-Tumor Combination Therapy-Solid Tumor with Anti-PD-1
BLI-1401-2 Anti-Tumor Combination Therapy-Triple Negative Breast Cancer
BLI-1501  Hematology-Chronic Lymphocytic Leukemia

Data shall mean any and all research data, technical data, test and development data, CMC (chemistry, manufacturing and control), pre-clinical and clinical data, formulations, processes, ideas, protocols, regulatory files and the like which are developed by either Party under the Development Program in connection with its performance of this Collaborative Agreement.

Intellectual Property shall mean any patent, copyright, mask work, trade secret, trademark or other proprietary right; including, without limitation, all domestic and foreign applications and registrations therefore, and all renewals and extensions relating thereto; with respect to patent application and patents, all domestic and foreign divisional, continuations, continuations-in-part, substitutions, reissues, re-examinations, renewals and extensions relating thereto; all goodwill associated therewith, and all benefits, privileges, causes of action and remedies relating to any of the foregoing proprietary rights (including, without limitation, the right to use for all past, current or future infringements or violations of the foregoing proprietary rights, and the right to settle and retain proceeds from any such actions).

Field of Use

Field shall mean drug and therapeutic use of the Product based upon the Health Registration Approval and in no event include the use of the Product for functional food, health food nor health supplement.

License Grant

The Taiwanese Licensor hereby grants sole licensing rights to Licensee, a shareholder, in the Field and in the Territory under the Intellectual Property, Confidential Information, Data and Trademark, to develop Product.

License Property

Drug and therapeutic use of five products: BLI-1005 CNS-Major Depressive Disorder; BLI-1008 CNS-Attention Deficit Hyperactivity Disorder; BLI-1401-1 Anti-Tumor Combination Therapy-Solid Tumor with Anti-PD-1; BLI-1401-2 Anti-Tumor Combination Therapy-Triple Negative Breast Cancer; and BLI-1501 Hematology-Chronic Lymphocytic Leukemia
The new drug products that originate from Maitake Combination Therapy. The three drugs licensed from BriVision to Rgene are ABV-1507 HER2/neu Positive Breast Cancer Combination Therapy, ABV-1511 Pancreatic Cancer Combination Therapy and ABV-1527 Ovary Cancer Combination Therapy.

Field of Use

Maitake Combination Therapy for indications including but not limited to the following: breast cancer, brain tumor, hepatocellular carcinoma, pancreatic cancer, renal cell carcinoma, nasopharyngeal carcinoma, prostate cancer, cervix cancer, oral/ pharynx/larynx cancer, lung cancer, leukemia, myeloma, lymphoma, gastric cancer, thyroid cancer, esophageal cancer, gastric cancer, small intestine cancer, large intestine/colon/rectal cancer, ovary cancer, skin cancer, head and neck, soft tissue sarcoma, bone tumor, bladder cancer, and cholangiocarcinomab.”

License Grant

The Canadian Licensor hereby grants to Licensee and Licensee hereby accepts an exclusive sublicense under the Technology to make, have made, use, sell, offer for sale, sublicense, distribute, import, and have imported Product in the Licensee Field in the Territory.

License Property

Technology means the Patent(s) and any and all knowledge, know-how and/or technique or techniques invented, developed and/or acquired, being invented, developed and/or acquired by the University solely or jointly with Licensor relating to the Patent(s) as listed hereto, as amended from time to time, including, without limitation, all research, data, specifications, instructions, manuals, papers or other materials of any nature whatsoever, whether written or otherwise, relating to same.

US Patent Number 5,837,282 – Ionophore-Mediated Liposome Loading

Product means any one or more of Sphingosomal Vinorelbine and Sphingosomal Topotecan.

Sphingosomal Vinorelbine means a liposome that includes sphingomyelin and cholesterol and contains encapsulated vinorelbine, wherein the sphingomyelin comprises less than 20% dihydrosphingomyelin.

Sphingosomal Topotecan means a liposome that includes sphingomyelin and cholesterol and contains encapsulated topotecan, wherein the sphingomyelin comprises less than 20% dihydrosphingomyelin.

Intellectual Property Rights means all intellectual property rights subject to protection by intellectual property laws in any country of the world, arising under statutory or common law, contract, or otherwise, and whether or not perfected, including without limitation, all (a) patents, reissues of and re-examined patents, and patent applications, whenever filed and wherever issued, including without limitation, continuations, continuations-in-part, substitutes and divisions of such applications and all priority rights resulting from such applications; (b) rights associated with works of authorship including without limitation copyrights, moral rights, copyright applications, copyright registrations, synchronization rights, mask work rights, mask work applications, mask work registrations; (c) rights associated with trademarks, service marks, trade names, logos, trade dress, goodwill and the applications for registration and registrations thereof; (d) rights relating to the protection of trade secrets and confidential information; (e) rights analogous to those set forth in this Section and any and all other proprietary rights relating to intangible property; and (f) divisions, continuations, renewals, reissues and extensions of the foregoing (as and to the extent applicable) now existing, hereafter filed, issued or acquired.

Field of Use

Marqibo (sphingosomal vincristine), INX-0125 (sphingosomal vinorelbine) and INX-0076 (sphingosomal topotecan) are proprietary drugs using INEX's proprietary sphingosomal drug delivery technology. This technology is designed to provide prolonged blood circulation, tumor accumulation and extended drug release at the cancer site. These characteristics are intended to increase the effectiveness while reducing the side effects of the encapsulated drug.
Marqibo has completed phase 2 clinical trials and is ready to enter phase 3 clinical trials in first-line aggressive non-Hodgkin's lymphoma and acute lymphoblastic leukemia. An Investigational New Drug (IND) application has been approved for the commencement of phase 1 clinical trials for INX-0125 in both the US and Canada and preclinical development is being completed for INX-0076.

License Grant

Licensor hereby grants to Licensee and its Affiliates a license under the Licensor Licensed IP to research, develop,  make, have made, use,  sell, offer for sale, import, and export the Products within the Asian Territories, within the Field.  The license granted herein is exclusive within the Asian Territories without any reservation of rights by Licensor, and will remain in effect until this Agreement is terminated in accordance.  For avoidance of doubt, the  foregoing license shall also include the right to practice the Licensor Licensed IP to manufacture Products anywhere in the world.

License Property

Clofarabine is a purine nucleoside antimetabolite which is FDA-approved for treating relapsed or refractory acute lymphoblastic leukaemia (ALL) in children after at least two other types of treatment have failed.

Product shall mean any product, service, test, or information, including Clofarabine, which, but for the license granted herein, would infringe one or more claims of a Licensor Patent or is discovered, developed, manufactured, approved, marketed or sold using Licensor Know-How or used with Licensor Know-How.

Licensor has rights in patents and technical information relating to the development and uses of 2-flouro-2-halo substituted purine nucleosides Clofarabine.

Patent shall mean (i) patent applications filed in any country within the Asian Territories; (ii) all divisional,  continuation (in whole or in part), reissues, substitute applications and extensions with respect to any of the applications described in (i); (iii) all issued or granted patents resulting from any of the applications described  above; and (iv) all issued or granted reissue, re-examination, renewal or extension patents, supplementary protection certificates, and confirmation or registration patents based on any of the patents described in (iii).

Intellectual Property shall mean all inventions, discoveries, know-how, methods, processes, data, information,  technology, research tools, compositions, tangible materials and formulas that are invented, discovered, developed or otherwise generated by or for either party or their respective Affiliates prior to or during the term of this Agreement, and all Intellectual Property Rights therein and thereto anywhere in the world.

Intellectual Property Rights shall mean any and all now known or hereafter existing:  (i) rights associated with works of authorship, including exclusive exploitation rights, copyrights, and moral rights; (ii) trademark and trade name rights and similar rights; (iii) trade secret rights; (iv) patents and industrial property rights; (v) other  proprietary rights in Intellectual Property of every kind and nature, whether arising by operation of law, by contract or license, or otherwise; and (vi) all registrations, applications, renewals, extensions, combinations,  divisions, or reissues of the foregoing, in each case in any jurisdiction throughout the Asian Territories.

Field of Use

Clofarabine has been shown to be effective in vitro and in vivo against hematologic malignancies and solid tumors, as well as potentially effective for various other therapeutic indications such as autoimmune diseases and transplantation immunity.