Royalty Report: Drugs, Antibody, Disease – Collection: 291107

License Grant

Collaborator hereby grants to Licensee of Ireland an exclusive license (exclusive even as to Collaborator), with the right to sublicense, under the Collaborator Technology, to use, have used, Develop, have Developed, Manufacture, have Manufactured, Commercialize and have Commercialized Antibodies and Products in the Territory.

License Property

Product means any pharmaceutical product containing one or more Antibodies whose manufacture, use, sale, offer for sale or importation by Licensee in a given country in the Territory is covered by a Valid Claim under a Collaborator Patent Right or Sponsored Research Patent Right in such country.

Collaborator Patent Right means any Patent Right that (a) is Controlled by Collaborator or any of its Affiliates as of the Effective Date (including the Collaborator Patent Rights that comes into the Control of Collaborator or any of its Affiliates during the Term (other than through the grant of a license by Licensee) and (b) claims or discloses any (i) Antibody or Product (including the composition of matter thereof), (ii) method of making any Antibody or Product or materials used in any method of making any Antibody or Product, or (iii) methods of using any Antibody or Product.

Collaborator Technology means the Collaborator Patent Rights and Collaborator Know-How.

Patent Rights means any and all (a) issued patents, (b) pending patent applications, including all provisional applications, substitutions, continuations, continuations-in-part, divisions and renewals, and all patents granted thereon, (c) patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including patent term adjustments, patent term extensions, supplementary protection certificates or the equivalent thereof, (d) inventor’s certificates, (e) other forms of government-issued rights substantially similar to any of the foregoing and (f) United States and foreign counterparts of any of the foregoing.

Field of Use

This agreement pertains to the drug industry.

License Grant

Licensor hereby grants to Licensee through the period and subject to the limitation on the number of Antigens, the right to receive for each Antigen designated by Licensee, a nonexclusive, worldwide license under the Licensor Licensed Patents to make, have made, use, import, offer to sell and sell Antibodies pursuant to a Licensor License Agreement. This right shall not extend to the Licensor Named Antigens.  The rights of Licensee under the Licensor License Agreements shall include the right to grant sublicenses for Antibodies in accordance with the terms of the applicable Licensor License Agreement.  Each license elected by Licensee hereunder shall be pursuant to a separate Licensor License Agreement and effective as of the date of execution by both parties.

License Property

Antigen means a target molecule, usually a protein, to which an Antibody specifically binds and includes all epitopes on that target molecule.

Antibody means any antibody directed against an Antigen and shall include, without limitation, monospecific and bispecific antibodies (but a separate license shall be required for the antigen involved for each arm of  a  bispecific antibody); less than full-length antibody forms such as Fv, Fab, and F(ab)2; single-chain antibodies; and antibody conjugates bound to a toxin, label or other moiety.  The term 'Antibody' shall include any and all such constructs directed against any particular Antigen.

Licensor Licensed Patents mean the following patents and patent applications known generally as the Cabilly patents and patent applications:

(a) U.S. Patent No. 4,816,567 and the claims relating to chimeric antibodies found in patents or patent applications arising from divisionals, continuations or continuations-in-part of any application from which U.S. Patent No. 4,816,567 claims priority or any substitute applications therefor, any patent issued with respect to any such patent application, any reissue, extension or patent term extension of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent  as well as the foreign counterparts of the foregoing and any and all reissues, reexaminations or extensions of the foregoing (but in any event excluding U.S.S.N. 07/205,419 and foreign counterparts thereof) ('Chimera Patents') and (b)  any patent issuing based on U.S.S.N. 07/205,419 (a continuation of the application maturing into U.S. Patent No. 4,816,567) relating to the coexpression of immunoglobulin chains in recombinant host cells, as well as the divisionals, continuations or continuations-in-part of such U.S.S.N. 07/205,419.

4,816,567 – Recombinant immunoglobin preparations

Field of Use

This agreement pertains to the drug industry.

License Grant

Swiss Licensor shall grant Swiss Licensee a worldwide exclusive license, with the right to sublicense, under Licensor’s Intellectual Property Rights to develop, use, make, have made, export, commercialize, promote, offer for sale, sell and manufacture the Compound in a respective pharmaceutical product subject to the terms of the Commercialization Agreement.

Licensor hereby grants to Licensee the Maximally Available Target Exclusivity for each Licensor Target during the time required to complete the Discovery Project and until the expiration of the Commercialization Option Period.

License Property

Compound Patents shall have the meaning that Licensor shall be the owner of all patents and patent applications directed to compositions of matter related to any Compound identified by Licensor (the Compound Patents) and upon the execution of a Commercialization Agreement, Licensor shall assign to Licesee the Compound Patents; provided, however:
(i)  Licensee shall be the owner of all patents and patent applications directed to compositions of matter related to any IL-5R/CD3 bispecific antibody and Licensor hereby agrees to assign and hereby does assign all of its rights, title and interest in and to such patent or patent application, and, to the extent a third party that was requested by Licensor to perform any services or create any work and thereby became the owner of any rights specific to Licensee Targets, to secure access and use of such rights and then assign them to Licensee in accordance with this agreement; and (ii) any patent or patent application directed solely to any CD3 Antibody shall be owned by Licensor and Licensor shall grant Licensee a Co-exclusive license to such patent or patent application.

Compound shall mean an Antibody to a Licensee Target.

Target shall mean a secreted or at least partially extra-cellularly exposed protein against which Antibodies shall be discovered.

Antibody/ies shall mean antibody/ies or antibody derivative(s), which also includes antibody fragments and bispecific antibody formats.

Intellectual Property Rights means: (i) any and all European and/or foreign patent applications, letters patent, patents, or any division, continuation, continuation-in-part, reissue, or extension thereof, and any applications (including provisional applications) therefore; (ii) any and all trade secrets, know-how, and trade secret rights arising under the laws of Switzerland and/or laws of foreign countries; and (iii) all rights pursuant to (i) and (ii) hereinbefore as may hereafter come into existence, and all renewals and extensions thereof, regardless of whether such rights arise under the laws of Switzerland or any other state, country or jurisdiction.

Field of Use

This agreement pertains to the drug industry.

License Grant

Licensor hereby grants to Japanese Licensee, in the Field and within the Territory:
(a) a non-exclusive right and license, with the right to sublicense, under the Licensor Background Technology to make, have made, use, sell and import Program Antibodies;
(b) a non-exclusive right and license, with the right to sublicense, under any Patent Rights and Know-How Controlled by Licensor Covering any control antibodies provided by Licensor for the sole purpose of using such control antibodies to evaluate the Program Antibodies; and
(c) an exclusive right and license, with the right to sublicense, under any Program Patent Rights or other Patent Rights and Know-How Controlled by Licensor Covering each antibody-producing cell line created by Licensor that expresses a Program Antibody provided by Licensor, for the sole purpose of using such cell line to produce the applicable Program Antibody.

License Property

Licensor Background Technology means any and all Know-How and Patent Rights owned by Licensor as of the Effective Date or that come to be Controlled by Licensor during the Program Term (other than the Program Technology) and, in particular, any such Patent Rights and Know-How Covering any Collaboration Target, Program Antibody or Collaboration Product, that are necessary for (a) research related to Collaboration Target(s) or (b) Research and Development, Manufacture or commercialization of Program Antibody(ies) or Collaboration Product(s). For the avoidance of doubt, the Parties acknowledge that, to the extent any Licensor Background Technology is covered by a license or other agreement with a Third Party, such Licensor Background Technology shall, for all purposes of this Agreement, be subject to the limitations, restrictions and financial obligations established in such Third Party license or agreement, with Licensee being responsible for payment of the portion of the financial obligations related to this Agreement arising as a result of the Collaboration. Licensor Background Technology excludes the Human Engineeringâ„¢ Technology.

Antibody means any immunoglobulin molecule whether in monospecific or any other form and shall include, without limitation, immunoglobulin fragments, such as Fv, Fab, F(ab’) and single-chain antibodies.

Program Antibody means an Antibody Product that (a) is identified or discovered by Licensor in the course of the Collaboration, or (b) the Parties agree to acquire from a Third Party, and, in the case of clauses (a) and (b), selectively binds to and acts through a Collaboration Target; provided, however, that in no event shall an Antibody Product that is subject to one or more Pre-existing Obligations become a Program Antibody unless such designation is affirmatively agreed to by the Joint Steering Committee after disclosure of the nature of such Pre-existing Obligation(s) by the applicable Party, such agreement not to be unreasonably withheld or delayed.

Antibody Product means any composition of matter or article of manufacture consisting essentially of an Antibody (a) alone or (b) integrally associated with a composition of matter or article of manufacture (including without limitation conjugates bound to a toxin, label or other moiety) providing therapeutic, half-life, safety or other advantages to the Antibody.

Program Patent Rights means any Patent Rights Controlled by a Party or jointly by the Parties that Cover any Program Technology or Program Materials.

Patent Rights means all patents and patent applications existing as of the Effective Date and all patent applications thereafter filed and patents thereafter issued, including, without limitation, any continuations, continuations-in-part, divisionals, provisionals or any substitute applications, any patent issued with respect to any such patent applications, any reissue, reexamination, renewal or extension (including any supplemental protection certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent, and all foreign counterparts of any of the foregoing.

Field of Use

Field means any and all uses except, until the expiration or termination of the Chiron Exclusivity Period, the diagnosis, prevention, control or treatment of Cancer.

License Grant

The English Licensor hereby grants to the English Licensee (i) a non-exclusive worldwide sublicense, with the right to grant further Sublicenses, under the Licensed Patent Rights to make, have made, use, import, offer for sale, and/or sell Licensed Products; and (ii) an exclusive worldwide license, with the right to grant Sublicenses, under the Licensor IP to make, have made, use, import, offer for sale, and/or sell Licensed Products.

License Property

US Patent #5,225,539 – Recombinant altered antibodies and methods of making altered antibodies

Licensed Product shall mean a product comprising a Humanized Antibody, the manufacture, use, offer for sale, sale, or importation of which by an unlicensed third party would infringe one or more Valid Claims of the Licensed Patent Rights, or which incorporates Licensor IP or Licensor Inventions.  The term “Licensed Product” does not include chimeric antibodies or murine antibodies.

Humanized Antibody shall mean an antibody that binds to Sphingosine-1-phosphate and is made by Licensor under this Agreement, the antibody comprising murine complementarity determining regions derived from Sphingomabâ„¢ together with human framework regions, and any modifications thereof.

Licensed Patent Rights shall mean the patents and patent applications licensed to Licensor and with respect to which Licensor has the right to authorize and grant sublicenses, as detailed in hereto, including any divisions, renewals, continuations, extensions, reexaminations, reissues, or continuations-in-part (to the extent that any such continuation-in-part claims subject matter as disclosed in the patents and applications listed thereof, as well as any patent that issues from any of the foregoing.

Licensor IP shall mean (i) any Licensor Invention and (ii) all patented and non-patented proprietary technology and information, in any form whatsoever, that is: (a) necessary or useful for making and using the Licensed Products, without regard to whether or not the technology or information is patentable; (b) owned, controlled, or developed by Licensor, as of the Effective Date or hereafter during the term of this Agreement; and (c) provided by Licensor to Licensee hereunder, including, but not limited to discoveries, formulae, materials, practices, methods, knowledge, know-how, processes, trade secrets, ideas, concepts, manufacturing, engineering, standard operating procedures, flow diagrams and charts, quality assurance, quality control data, technical data, manufacturing technology, research data and records, and all other confidential or proprietary technical and business information relating to the humanization of murine antibodies, generation of chimeric antibodies, or any gene expression vectors used in such methods and all improvements or modifications thereto.  For purposes of clarity, Licensor IP includes Licensor Inventions that satisfy (a), (b) and (c), above, while Licensor IP does not include Licensed Patent Rights as defined hereunder.

Licensor Invention shall mean any discovery or invention to the extent (i) made or conceived or reduced to practice by or on behalf of Licensor in the performance of the humanization of Licensees Sphingomabâ„¢ antibody under this Agreement, whether or not patentable, and (ii) covering only generally applicable methods or techniques for humanizing antibody proteins or for constructing a vector or reagent used to humanize or express an antibody.

Field of Use

Licensee’s lead product candidate, Sphingomab™, is a monoclonal antibody (mAb) against sphingosine-1-phosphate (S1P), an innovative and validated cancer target.

Sphingomabâ„¢ is the original mouse version of this monoclonal antibody.

License Grant

Both parties enter into a joint cooperation.  Licensor grants to Swiss Licensee during the Agreement Period a world-wide license under its Know-How and Patent Rights, with the right to grant sublicenses, to make, have made, use and sell the Product(s) for use in the Field.   Said license shall be exclusive in the Exclusive Territories and shall be co-exclusive with Licensor in the Semi-exclusive Territories.  Licensee grants to Licensor during the Agreement Period a license under its Know-How and Patent Rights, to make, have made, use and sell the Product(s) for use in the Field.  Said license shall be limited to the Semi-exclusive Territories and shall be co-exclusive with Licensee in said Territories.

License Property

Product(s) shall mean the monoclonal antibodies owned or controlled by Licensor and Licensee for use in the Field, as described in the U.S. patent application(s) of Licensor and the U.K. patent application of Licensee, and fragments, toxin conjugates, antibody toxin chimeric constructs, humanized or reshaped antibodies derived from such monoclonal antibodies including such forms as are ready to be administered in humans.

Patent Rights shall mean any patent application or patent(s) owned or controlled by Licensor or Licensee whose claims cover the manufacture, use, or sale of the Product(s), as well as any additional patents hereafter issuing from additional patent applications relating to the Product(s), including, but not limited to, a method of use of the Product(s), and any substitutions, continuations, continuations-in-part, divisions, reissues, re-examinations, renewals, or extensions of the terms thereof.

Field of Use

Field shall mean anti-IgE antibody-based treatments in humans for IgE-mediated reactions, which most likely will include, but not be limited to, asthma and other diseases commonly termed allergies. The anti-IP: treatment is based on mechanisms that are specifically directed towards reducing or eliminating circulating lgE and lgE producing B cells within the immune system. The scope of the Field and definition of Product(s) are not intended to include other areas of allergy research (including approaches such as peptides, or factors, including IL-4 and CD23) or development of antiidiotypic antibodies, which may be useful in modulating lgE production in humans.

The Parties are jointly developing an anti-IgE antibody product to treat allergies and allergic asthma.

License Grant

Licensor grants to Swiss Licensee and to Licensee’s Affiliates, during the Commercialization Term, the exclusive (even as to Licensor) right and license under the Licensor Know-How and Licensor Patents to (i) market, promote, and detail Nutley Dac in the Licensee Territory solely for use in Transplant Induction, and (ii) to sell and offer for sale Nutley Dac in the Licensee Territory under the Trademarks. In addition, Licensor grants to Licensee and to Licensee’s Affiliates, the nonexclusive right under the Licensor Know-How and Licensor Patents to make, have made, use and import Nutley Dac, but only to the extent reasonably necessary for Licensee to carry out its rights and obligations under this Second Amended and Restated Worldwide Agreement. Licensee may sublicense the rights and licenses granted to Licensee, subject to Licensor’s written consent, which consent Licensor may not unreasonably withhold. It shall be deemed reasonable for Licensor to withhold consent with respect to sublicense by Licensee of any of the rights or licenses to any other entity that is developing (in at least one Phase II clinical trial with directional human efficacy data), or marketing or selling in a Major Country any product for the treatment of any Autoimmune Indication. Notwithstanding the preceding sentence, Licensee and its Affiliates may use Third Party distributors in accordance with their customary practices. All sublicenses granted by Licensee or its Affiliates of the licenses set forth in this agreement shall automatically terminate at the end of the Commercialization Term.

License Property

Nutley Dac shall mean the FDA-approved form of Daclizumab manufactured at Licensee’s Nutley, New Jersey facility as of the Amendment Effective Date.

Daclizumab shall be deemed to be a Licensed Product, a humanized antibody now known by the generic name daclizumab, which binds to the interleukin-2 receptor (“IL-2R”). Daclizumab means any product that contains humanized anti-Tac (as defined under Field).

Licensed Product means any product, other than an Excluded Product, in the Field, including any Combination Product, the making, importation, use, offer for sale, or sale of which utilizes Licensee Know-How, Licensee Patents, or Joint Inventions or would, in the absence of this Second Amended and Restated Worldwide Agreement, infringe a Valid Claim of a Licensee Patent.

Combination Product means any product containing both an ingredient that causes it to be considered a Licensed Product and one or more other therapeutically active ingredients.

Other Licensed Products means all Licensed Products other than Daclizumab.

Licensor Patents means all patent applications owned or Controlled by Licensor alone or with a Third Party (“Sole Licensor Patents”) and all patent applications resulting from Joint Inventions (“Joint Licensee-Licensor Patents”) Covering Daclizumab, which are filed prior to or during the term of the 1989 Agreements, the 1999 Agreements or this Second Amended and Restated Worldwide Agreement in the United States or any foreign jurisdiction, including any addition, continuation, continuation-in-part or division thereof or any substitute application therefor; any patent issued with respect to such patent application, any reissue, extension or patent term extension of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent; and any other United States or foreign patent or inventor’s certificate covering products in the Field.

Licensor Patent Rights:
Patent No. 5,585,089, “Humanized Immunoglobulins,” issued December 17, 1996.
Patent No. 5,693,761, “Polynucleotides Encoding Improved Humanized Immunoglobulins,” issued December 2, 1997.
Patent No. 5,693,762, “Humanized Immunoglobulins,” issued December 2, 1997.
Patent No. 6,180,370 “Humanized Immunoglobulins and Method of Making the Same”, issued January 30, 2001.

Trademarks means the trademark “Zenapax®,” and all trademark registrations and applications therefor, and all goodwill associated therewith, and all other trademarks owned by Licensee (except for any Licensee housemarks or trade names) and used in connection with the sale or promotion of Nutley Dac in the Licensee Territory.

Licensor Know-How means, except as otherwise set forth, all inventions, discoveries, trade secrets, information, experience, data, formulas, procedures and results in the Field, and improvements thereon, including any information regarding the physical, chemical, biological, toxicological, pharmacological, clinical, and veterinary data, dosage regimens, control assays and specifications of Daclizumab.

Licensee Patents means both the Licensee Owned Patents and the Licensee Controlled Patents.

Licensee Owned Patents means all patent applications owned by Licensee or its Affiliates (“Sole Licensee Patents”) alone or with a Third Party, and all patent applications resulting from Joint Inventions (“Joint Licensee-Licensor Patents”) covering inventions in the Field that are filed prior to or during the term of this Second Amended and Restated Worldwide Agreement in the United States or any foreign jurisdiction, including any addition, continuation, continuation-in-part or division thereof or any substitute application therefor; any patent issued with respect to such patent application, any reissue, extension or patent term extension of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent; and any other United States or foreign patent or inventor’s certificate covering inventions in the Field. Licensee Owned Patents as of the Effective Date are, specifically, those listed.
Serial No. 60/416,302 – Use of IL-2 Receptor Antibodies

Joint Inventions means any inventions in the Field, whether patented or not, that are jointly made during the period beginning on January 31, 1989 and continuing until the end of the Commercialization Term by at least one (1) Licensor employee or person contractually required to assign or license patent rights covering such inventions to Licensor and at least one (1) Licensee-Nutley or Licensee employee or person contractually required to assign or license patent rights covering such inventions to Licensee-Nutley or Licensee.

Field of Use

Field means any humanized or chimeric antibody that binds to IL-2R, where “humanized” means a genetically engineered combination of a substantially human framework region and constant region, and complementarity determining regions from non-human antibodies, and where “chimeric” means a genetically engineered combination of human constant region and non-human variable region. “Antibodies in the Field” means humanized and chimeric antibodies that bind to IL-2R. It is believed that these Antibodies in the Field may be useful for therapeutic, diagnostic, imaging and similar purposes. It is understood that the Field includes, but is not limited to, that certain humanized murine monoclonal antibody prepared against the p55 component of IL-2R (“humanized anti-Tac”). Furthermore, the Field includes, but is not limited to, all improvements relating to humanized anti-Tac, including without limitation modifications in structure introduced by genetic engineering, or by chemical or enzymatic cleavage. Also included within the Field shall be alternate hosts for producing humanized anti-Tac, methods for purification, formulations incorporating humanized anti-Tac, and uses and methods of use for humanized anti-Tac in human medicine.

Daclizumab is a therapeutic humanized monoclonal antibody which was used for the treatment of adults with relapsing forms of multiple sclerosis.

License Grant

The English Licensor hereby grants, on behalf of itself and its Affiliates, to the English Licensee, effective on the Effective Date, a royalty-bearing, exclusive (even as to Licensor (except to the extent necessary for Licensor to perform the Licensor Development Activities)) worldwide license, with the right to sublicense, under the Licensor Technology to Manufacture, Develop and Commercialize the Products in the Field in the Territory.

Licensee hereby grants, on behalf of itself and its Affiliates, to Licensor, effective on the Effective Date, a royalty-free, non-exclusive license, with the right to sublicense, (i) under the Licensee Technology to the extent necessary for Licensor to perform the Licensor Development Activities and (ii) under any Licensee Improvement Manufacturing Patent Rights for use other than for the Manufacture, Development and/or Commercialization of the Products in the Field in the Territory.

License Property

Xodol means the product currently marketed under the brand name 'Xodol', which is a combination of 5, 7.5 or 10 milligrams (mg) ofhydrocodone, in each case, combined with 300 mg of acetaminophen (it being understood that (x) Licensors existing sublicensee currently markets such product under a different name and (y) such product, whether marketed under such different name or any other name in the future, shall be deemed to be 'Xodol' for the purposes of this Agreement).

Product means any Hydrocodone Product or Combination Product.

Hydrocodone Product means any pharmaceutical product containing Hydrocodone as its sole Active Ingredient that is in a formulation containing the Licensee Technology and which is Developed, Manufactured and Commercialized pursuant to, and in accordance with, this Agreement.

Combination Product means any pharmaceutical product comprised of Hydrocodone and any non-opioid agonist drug as the Active Ingredients.  For purposes of clarity, S-297995 (also known as Naldemedine) is a non-opioid agonist drug.

S-297995 means (5R, 14S)-17-(Cyclopropylmethyl)-6, 7-didehydro-4,5-epoxy-3 ,6, 14-trihydroxy-N-[1-methyl-l-(3-phenyl-1,2,4-oxadiazol-5-yl)ethyl]morphinan-7-carboxamide Monotosylate including any metabolites, prodrugs, solvates (including hydrates), esters, salts, stereoisomers, racemates, tautomers and polymorphs (including crystal forms), of such compound.

Licensor Technology means the (a) Licensor Know-How and the Licensor Patent Rights, including Licensor Core Technology (b) the Licensor Core Technology Improvements, and (c) all intellectual property rights therein.

Licensor Patent Rights means any Patent Right that Licensor or its Affiliates Controls on the Effective Date or that comes into the Control of Licensor or its Affiliates during the Term (other than any Patent Rights which are Licensee Patent Rights), to the extent that such Patent Right is necessary or useful to Develop, Manufacture, or Commercialize in the Territory, the Products in the Field, including any method of making the Products, any composition or formulations of the Products, or any method of using or administering the Products provided that Licensee Patent Rights excludes any Patent Rights to the extent relating to an Licensee API.  The Licensor Patent Rights existing on the Effective Date are set forth.
8,298,581 – Matrix compositions for controlled delivery of drug substances
8,563,038 – Formulations and methods for the controlled release of active drug substances

Licensor Core Technology means, to the extent covered by any Licensor Patent Rights or Licensor Know-How, in each case, Controlled by Licensor and its Affiliates as of the Effective Date,  (i) any abuse-deterrent drug delivery system, (ii) the formulation of products for which any such abuse-deterrent drug delivery system is used and/or (iii) manufacturing of products containing any such abuse-deterrent drug delivery system.  

Licensor Core Technology includes the Licensor Patent Rights and Licensor Know-How, in each case, Controlled by Licensor and its Affiliates as of the Effective Date to the extent covered by clause (i), (ii) and/or (iii) above.  Notwithstanding anything herein to the contrary, in the event there is a dispute as to whether anything in clause (i), (ii) and/or (iii) above was covered by any such Licensor Know-How as of the Effective Date, Licensor shall have the burden of proof with respect to establishing that it was so covered.

Generic Product means, on a country-by-country basis, any pharmaceutical product that (a) is sold by a Third Party that is not an Affiliate or Sublicensee of Licensee under a marketing authorization granted by a Regulatory Authority to a Third Party and (b) results from (i) an abbreviated new drug application including any amended or successor abbreviated route of approval thereof in the United States (ANDA) or (ii) abbreviated routes of approval in any other countries in the Territory that are comparable to ANDA, which in the case of clause (i) and/or (ii), references the applicable Product, provided that (x) such pharmaceutical product has the same Active Ingredient as the Product and an abuse deterrent system or (y) the Product is the primary basis for the approval of such pharmaceutical product.

Patent Right means any and all (a) patent applications filed in any jurisdiction, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon; (b) all patents, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates or the equivalent thereof; and (c) any other form of government-issued right substantially similar to any of the foregoing, including certificates of invention and applications for certificates of invention.

Field of Use

Field means all therapeutic uses of a Product for any condition, disorder or disease indication in humans or non-human animals, including the treatment, palliation, prevention, diagnosis, and management thereof.

The collaboration is for the development and commercialization of abuse-deterrent hydrocodone-based product candidates.  Abuse-deterrent is for the treatment of pain and in other indications.

License Grant

Licensor, a nonprofit medical research facility, hereby grants to Licensee an exclusive, worldwide license, including the right to sublicense, under the Licensor Patent Rights and the Licensor Technology to make, to have made, to use, and to sell Licensed Products in the Field, subject to the terms of this Agreement. Promptly upon execution of this Agreement, Licensor shall provide Licensee with all information available to Licensor regarding the Licensor Patent Rights and the Licensor Technology.

License Property

The term Licensor Patent Rights shall mean (a) U.S. Patent Application Serial No. 08/210,715, entitled 'Methods and Compositions Useful for Inhibition of Angiogenesis' filed March 14, 1994, together with all foreign counterparts thereof; (b) the patents proceeding from such applications, and (c) all divisionals, continuations, continuation-in-part, reissues, renewals, reexaminations, and extensions thereof, so long as said patents have not been held invalid and/or unenforceable by a court of competent jurisdiction from which there is no appeal or, if appealable, from which no appeal has been taken. The foregoing notwithstanding, Licensor Patent Rights shall not include any claim that covers subject matter not disclosed in said United States Patent Application Serial No. 08/210,715.

The term Licensed Product shall mean any product which (a) if made, used or sold absent the license granted hereby would infringe the valid claim of one or more valid issued patent(s) included within the Licensor Patent Rights, or (b) cannot be developed, manufactured, used or sold without utilizing any part of the Licensor Technology.

The term Licensor Technology shall mean the Licensor LM609 Technology and the Licensor Angiogenesis Technology, whether or not the same is eligible for protection under the patent laws of the United States or elsewhere, and whether or not any such technology would be enforceable as a trade secret or the copying of which would be enjoined or restrained by a court as constituting unfair competition.

The terms Licensor LM609 Technology shall mean, collectively, Hybridoma LM609, LM609, LM609 Gene and  LM609 Sequence information.

The term LM609 Gene shall mean a nucleic acid encoding all or a portion of LM609.

The term LM609 shall mean the anti-avB3 integrin murine antibody produced by Hybridoma LM609 and fragments of said murine antibody.

The term LM609 Sequence Information shall mean the nucleotide sequence embodied in an LM609 Gene isolated from Hybridoma LM609 and the amino acid residue sequence information embodied in LM609.

The term Hybridoma LM609 shall mean the cell line HB 9537 deposited with the American Type Culture Collection.

The term Licensor Angiogenesis Technology shall mean so much of the technology as is proprietary to Licensor disclosed in United States Patent Application Serial No. 08/210,715, entitled 'Methods and Compositions Useful for Inhibition of Angiogenesis' filed March 14, 1994, a copy of which is attached hereto and incorporated herein by
reference.

Technology relates to a murine monoclonal antibody and the use of the antibody as an inhibitor of angiogenesis.
An angiogenesis inhibitor is a substance that inhibits the growth of new blood vessels (angiogenesis).

Field of Use

The term Field shall mean the diagnosis, prevention and treatment of any disease, states or conditions in humans, by use of any antibody or antibody fragment, but excluding the use of (a) LM609, and (b) any other non-immunoglobulin molecules except molecules conjugated to any antibody or antibody fragment, if the molecules conjugated thereto are not themselves inhibitors of alphaV-beta3 integrins.

License Grant

The Swiss Licensor hereby grants to Licensee, under the Licensor Technology, Licensor Inventions, and all patents claiming Licensor Inventions, (i) a co-exclusive license (together with Licensor) to develop in accordance with the Asthma Development Plan and Transplant Development Plan and use Licensed Products in the Collaborative Fields with respect to U.S. Territory and the European Union, (ii) a co-exclusive license (together with Licensor) to import Licensed Products in the Collaborative Fields into the European Union for such Development purposes, (iii) an exclusive license to import, offer for sale and sell Licensed Products in the Collaborative Fields in the U.S. Territory, and (iv) an exclusive license to make Licensed Products in the Collaborative Fields in the Territory.

License Property

Licensed Product shall mean any pharmaceutical product having as an active ingredient Daclizumab, but excluding Nutley Dac.  Daclizumab means that certain humanized murine monoclonal antibody directed against the p55 component of IL-2R and given the generic name “Daclizumab” by the United States Adopted Names Council. Daclizumab does not include fragments of such antibody or any antibodies having a different amino acid sequence from such antibody.   IL-2R means the IL-2 receptor.

Licensor Inventions means all inventions that (a) relate to or are useful with antibodies that bind the IL-2 receptor (IL-2R) and (b) are made during the term of this Agreement by employees of Licensor or persons contractually required to assign or license patent rights covering such inventions to Licensor, in the course of performing Licensor’s obligations, or exercising Licensor’s rights, under this Agreement.

Licensor Patents means all patent applications owned or Controlled by Licensor or its Affiliates (“Sole Licensor Patents”) alone or with a Third Party, and all Joint Licensor-Licensee Patents claiming Licensed Products or their manufacture or use in the Collaborative Fields, which are filed prior to or during the term of this Agreement in the U.S. or any foreign jurisdiction, including any addition, continuation, continuation-in-part or division thereof or any substitute application therefor; any patent issued with respect to such patent application, any reissue, extension or patent term extension of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent; and any other U.S. or foreign patent or inventor’s certificate covering Licensed Products in the Collaborative Fields.

Field of Use

Asthma Field means the treatment and/or prevention of asthma or other respiratory diseases.

Transplant Field means the Transplant Indications.

A Collaborative Field (i.e., used in the singular) shall refer either to the Asthma Field (unless and until the Asthma Field is excluded from the definition of Collaborative Field) or the Transplant Field (unless and until the Transplant Field is excluded from· the definition of Collaborative Field.  Collaborative Fields shall be deemed to exclude the field (i.e., Asthma Field or Transplant Field) with respect to which the rights are so terminated.

License Grant

The parties collaborated to develop a long-acting Factor VII compound and amended the Original Agreement to incorporate all of the Amendments into one document.

Licensor hereby grants, and agrees to grant, to Swiss Licensee an exclusive (even as to Licensor), royalty-bearing license under the Licensor Intellectual Property in the Field of Use during the Term, (i) to conduct research, sample, develop (including clinical development), manufacture, make, use, market, promote, sell, offer for sale, have sold, distribute, import and export New Products in the Territory, and (ii) to use the Reagents in the Territory solely for the purpose of making New Products. Such license does not permit Licensee (x) to practice or use the Licensor Intellectual Property outside the Field of Use or (y) to sublicense any of its rights without the prior written approval of Licensor.

Licensor hereby grants, and agrees to grant, to Licensee a worldwide, exclusive (even as to Licensor), perpetual, irrevocable, and royalty-bearing (subject only to the payment of royalties in accordance with this agreement) license, with the right to sublicense, to any Carved Factor VII Claims that do not constitute Licensee Improvements for any and all purposes. In addition to the foregoing, Licensor hereby grants, and agrees to grant, to Licensee a worldwide, exclusive (even as to Licensor), perpetual, irrevocable, and royalty-free license, with the right to sublicense, to any Carved Factor VII Claims that constitute Licensee Improvements for any and all purposes.

License Property

New Product shall mean the following: (a) any of the Licensee Materials modified using either (i) the Licensor Technology, (ii) any Licensor Improvements, or (iii) any combination of all or some of (i) and (ii) above, and (b) any Licensee Materials covered by any Carved Factor VII Claims (except to the extent such claims constitute Licensee Improvements) .

Potential Carved Factor VII Claims shall mean any composition-of-matter claims and any method of treatment claims that are supported by Patent Rights Controlled by Licensor that (i) do or could explicitly and solely recite and claim Licensee Materials, or (ii) any Licensee Improvements made or reduced to practice by Licensor.

Licensor Technology means the Licensor Patents and any Know-How Controlled by Licensor relating to methods and processes for the glycosylation design and remodeling of proteins, peptides and antibodies, including, without limitation, its GlycoAdvance®, GlycoPEGylation™ and GlycoConjugation™ technologies, and other carbohydrate dynthesis processes, and all Know-How resulting from work conducted by Licensor during the Term.

Licensor Patents means (a) all Patent Rights relating to methods and processes for glycosylation design and remodeling of proteins, peptides and antibodies that are Controlled by Licensor, including, but not limited to: (i) the Patent Rights listed, (ii) the Patent Rights developed by Licensor in the conduct of the Work Plan during the Term of this Agreement, and (iii) any later acquired Patent Rights Controlled by Licensor and used to develop any New Product, and (b) all Patent Rights Controlled by Licensor that would be infringed by the research, development (including clinical development), manufacture, making, use, marketing, promotion, sale, offer for sale, distribution, import and export of New Products in the Territory.
US Patent #6,800,468 – UDP-galactose: .beta.-N-acetyl-glucosamine .beta.1,3galactosyltransferases, .beta.3Gal-T5
US Patent #6,995,004 – UDP-N-ACETYLGLUCOSAMINE: GALACTOSE-.beta. 1,3-N-ACETYLGALACTOSAMINE-.alpha.-R / N-ACETYLGLUCOSAMINE-.beta. 1,3,-N-ACETYLGALACTOSAMINE-.alpha.-R (GLCNAC TO GALNAC) .beta.1,6-N-ACETYLGLUCOSAMINYLTRANSFERASE, C2/4GNT
US Patent #6,635,461 – UDP-N-acetylglucosamine: galactose-.beta.1, 3-N-acetylgalactosamine-.alpha.-R/(GlcNAc to GalNAc) .beta.1,6-N-acetylglucosaminyltransferase, C2GnT3

Licensor Improvements means any and all Improvements relating to the Licensor Technology made, conceived, or reduced to practice by (i) either Licensor or Licensee or both in the conduct of the Work Plan under this Agreement, (ii) either Licensor or Licensee or both under this Agreement, (iii) Licensee in the practice of any Licensor Technology under the licenses granted to Licensee in this agreement, or (iv) Licensee in the conduct of any activity using any Ownership Rights assigned to Licensee pursuant to this Agreement, in each case of (i), (ii), (iii) or (iv), other than the Licensee Materials, the Licensee Materials modified using the Licensor Technology and New Product. Specifically excluded from Licensor Improvements are (1) formulations, combinations and methods of treatment to the extent relating to Licensee Materials, the Licensee Materials modified using the Licensor Technology and New Products and (2) analytical techniques and purification methods invented, developed or reduced to practice solely by Licensee that did not originate from or are not derived from Licensor (collectively, the Techniques).

Licensor Intellectual Property means Licensor Technology and the Licensor Improvements.

Patent Rights shall mean individually and collectively any and all patents and/or patent applications and provisional applications, all inventions disclosed therein, and any and all continuations, continuations-in-part, continued prosecution applications, divisions, renewals, patents of addition, reissues, confirmations, registrations, revalidations, revisions and re-examinations thereof, utility models, petty patents, design registrations and any and all patents issuing therefrom and any and all foreign counterparts thereof and extensions of any of the foregoing including without limitation extensions under the U.S. Patent Term Restoration Act, extensions under the Japanese Patent Law, and Supplementary Protection Certificates (SPCs) according to Counsel Regulation (EEC) No. 1768/92 and similar extensions for other patents under any applicable law in any country of the world. Licensee hereby grants to Licensor, for the term of the Work Plan, a non-exclusive, royalty free, license under the Licensee Technology to use such Licensee Technology for the sole purpose of carrying out its obligations under the Work Plan. Licensee shall retain at all times all of its rights, title and interest to the Licensee Technology.

Licensor Exclusive Compounds shall mean any and all forms of erythropoietin and granulocyte colony stimulating factor including, but not limited to, with respect to either of the foregoing: full length proteins, truncated proteins, fusion proteins, analogs, mutants, splice variants, and conjugates with other molecular entities such as proteins, peptides, organic or inorganic substances.

Field of Use

Licensor's technology is to develop and commercialize next-generation versions of Factors VIIa, VIII and IX.

Factor VIIa is used in the treatment of bleeding episodes and for the prevention of bleeding during surgery or invasive procedures in patients with congenital hemophilia with inhibitors to coagulation factors VIII or IX.

License Grant

Licensor hereby grants to Japanese Licensee, under the Licensed Technology, an exclusive, royalty-bearing license, with the right to grant sublicenses, to develop, have developed, make, have made, use, sell, offer for sale and import Licensed Products within the Licensed Field in the Licensee Territory.

License Property

Licensed Product shall mean:
          (i)   any Clinical Candidate (as defined in the Collaboration Agreement);
          (ii)  any compound (a) which is identified, developed or discovered by Licensee using Licensed Technology and (b) which acts through activation of the insulin signal transduction pathway for the treatment of diabetes mellitus or insulin resistance in humans; and
          (iii) any compound which is an analog, homolog or chemical modification of a compound described in clause (i) or (ii) and which acts through activation of the insulin signal transduction pathway for the treatment of diabetes mellitus or insulin resistance in humans.

Licensed Technology shall mean the Licensed Patent Rights and the Licensed Know-How.

Licensed Patent Rights shall mean all of (i) Licensors interest in any patents and patent applications (including any divisions, continuations-in-part, reissues, extensions, renewals, supplementary protection certificates and foreign counterparts thereof) covering inventions made in the course of the Research Program (the Research Program Patents) and (ii) other patents and patent applications (including any divisions, continuations-in-part, reissues, extensions, renewals, supplementary protection certificates and foreign counterparts thereof) owned or Controlled by Licensor, but only to the extent such other patents and patent applications are necessary or useful for Licensee for the manufacture, use, sale, offer for sale or import of Licensed Products which are covered by the Research Program Patents.

Field of Use

License is for the development of a Type II diabetes drug.  The molecular fingerprinting is a family of small molecules that have demonstrated they can bind to and activate the insulin receptor to lower blood glucose levels in diabetes patients.

License Grant

Licensor hereby grants Licensee an exclusive (even as to Licensor), royalty-bearing license in the territory, without the right to grant sublicensees, under all Patent Rights and Know-How Controlled by Licensor (other than Patent Rights and Know-How jointly owned by Licensor and one or more of its Third Party collaborators) to make, have made, use, offer to sell, sell, import, export and otherwise Develop and Commercialize all JAK-3 Kinase Inhibitors having as their primary mechanism of action JAK-3 Kinase Inhibitory Activity (and products containing any such JAK-3 Kinase Inhibitors) in the Licensee Field during the JAK-3 exclusivity period.

Licenosr hereby grants Licensee an exclusive (even as to Licensee), royalty-bearing license in the  Territory, without the right to grant sublicenses, under all of Licensors rights under all JAK-3 Joint Patent Rights to make, have made, use, offer to sell, sell, import, export and otherwise Develop and Commercialize all JAK-3 Kinase Inhibitors having as their primary mechanism of action JAK-3 Kinase Inhibitory Activity (and products containing any such JAK-3 Kinase Inhibitors) in the Licensee Field during the term.

Licensor hereby grants Licensee an exclusive (even as to Licensor), royalty-beariing license in the Territory, with the right to grant sublicenses, (Sublicensing), under the Licensor IP and Licensors rights, title and interests in the Joint IP to make, have made, use, offer to sell, sell, import, export and otherwise Develop and Commercialize Licensee Available Compounds (and any Licensee Products containing any such Licensee Available Compounds) in the Licensee Field.

License Property

JAK-3 Kinase Inhibitor means a molecule that has JAK-3 Kinase Inhibitory Activity at an in vitro fifty percent (50%) inhibitory concentration (IC50) of less than or equal to 1 micromolar.

JAK-3 Kinase Inhibitory Activity means, when used to describe a compound, that the compound binds to the protein tyrosine kinase enzyme known as Janus Activating Kinase 3 (JAK-3).

JAK-3 Joint Patent Right means Joint Patent Rights that claim inventions that are reasonably necessary to make, have made, use, offer to sell, sell, import, export and otherwise Develop and Commercialize Agreement Compounds.

Licensor Patent Right means all Patent Rights Controlled by Licensor as of the Effective Date or during the term, as are reasonably necessary to Develop, make, have made, use, import or export Agreement Compounds, or to make, have made, use. offer to sell, sell, import, export or otherwise Commercialize Products based thereon; provided, however, that if a Third Party becomes an Affiliate of Licensor pursuant to a Change of Control Transaction as a result of which such Third Party is able to elect a majority of the members of the board of directors of Licensor (or its successor company) or any of its 'controlling Affiliates' (Change of Control Transaction), 'Licensor Patent Rights' not include any Patent Rights that were Controlled by such Third Party (and not by Licensor) prior to the completion of such Change of Control Transaction.  It is understood that Licensor Patent Rights shall not include any intellectual property owned or licensed by Licensor relating to (i) the creation or use of encoding technology for combinatorial libraries, (ii) tag and/or marker compound engineering, encoding or decoding, or (iii) high throughput screening assays.

Licensor Available Compound means:
(a)  any Licensor Compound or Collaboration Compound selected by Licensor for Development (Compound Selection) and for which Licensor is fulfilling the diligence obligations required (Compound Selection); and (b)  any Licensor Compound or Collaboration Compound with respect to which Licensor has undertaken Development in the Licensee Field if permitted and for which Licensor is fulfilling the diligence obligations required (Compound Selection).

Patent Rights means any and all (a) patents, (b) pending patent applications, including, without limitation, all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon, (c) all patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including, without limitation, supplementary protection certificates or the equivalent thereof (d) inventor’s certificates, and (e) all United States and foreign counterparts of any of the foregoing.

Product(s) means Licensor Product(s) or Licensee Product(s), as the case may be.

Licensor Product means a pharmaceutical preparation containing a Licensor Available Compound.  For purposes of clarity, any pharmaceutical preparations containing the same Licensor Available Compound will be deemed to be the same Licensor Product.

Licensee Product means a pharmaceutical preparation containing a Licensee Available Compound.  For purposes of clarity, any pharmaceutical preparations containing the same Licensee Available Compound will be deemed to be the same Licensee Product.  For the avoidance of doubt, a Licensee Product will not be considered to be separate, distinct and different from another Licensee Product solely on the basis of its use for a different indication, method of production or manufacture, method of delivery or dosage level.

Field of Use

Licensor Field means all uses of a Product in non-human animals, and all topical uses of a Product for the treatment or prevention of skin and eye diseases in humans where such Product would be applied directly to the skin or eye and would have its therapeutic effect at or near a target site on the skin or eye.

Licensee Field means all human therapeutic and prophylactic uses of a Product other than uses included within the Licensor Field.

License Grant

The purpose of this contract is to acknowledge the assignment by French Assignor, and individual and Assignee's co-founder, Chairman and Chief Executive Officer, to French Assignee of all his rights to and under the Existing Patents and Current Patent Applications, and to organize the assignment and transfer by Assignor to Assignee and/or its Affiliates of his rights on and to any and all Current Results for the agreed price.

The Parties also agree hereby on the financial compensation for the assignment by Assignor to Assignee and/or its Affiliates of any rights on and to Future Results including any rights as a co-inventor of patentable inventions to be covered by Future Patent Applications.

The provisions of this Agreement shall only apply to Results generated by Assignor during the period ending on the earlier of (i) the term of this Agreement and (ii) the Employment Period.

License Property

Current Patent Applications means:

No. 1. The French patent application n°FR1753775 filed on April, 28th 2017 and entitled “20-Hydroecdysone extract of pharmaceutical grade, its use and its preparation”.
No. 2. The French patent application n°FR1758071 filed on May, 31st 2017 and entitled “Use of 20-hydroxyecdysone and the derivatives thereof in the treatment of myopathies”.
No. 3. The French patent application n°FR1851778 filed on February, 28th 2018 and entitled “Phytoecdysones for their use in the prevention of the loss of muscular strength during an immobilisation” .
No. 4. The French patent application n°FR 1902726, entitled “Phytoecdysones and their derivatives for their use in the treatment of neuromuscular diseases “.
No. 5. The French patent application n°FR 1902727, entitled “Phytoecdysones and their derivatives for their use in the treatment of alterations of the respiratory function”.
As well as any and all (I) provisional and non-provisional applications, foreign patent application, patent cooperation treaty (PCT) applications, substitutions, continuations, continuations-in-part, divisions and renewals of the above describe patent applications, (ii) all patents granted thereon, and (iii) all reissues, re-examinations and extensions or restorations, including supplementary protection certificates or the equivalent thereof, granted thereon and corresponding priority rights.

Existing Patents means the patent applications filed by Licensee before July 13, 2015 as well as any and all (I) provisional and non-provisional applications, foreign patent application, patent cooperation treaty (PCT) applications, substitutions, continuations, continuations-in-part, divisions and renewals of such patent applications, (ii) all patents granted thereon, and (iii) all reissues, re-examinations and extensions or restorations, including supplementary protection certificates or the equivalent thereof, granted thereon and corresponding priority rights.

Future Patent Application means (I) any patent or patent application based on Current Results for which Assignor is designated as an inventor or co-inventor and/or (ii) a patent application filed on the basis of Future Results and for which Licensor is designated as an inventor or co-inventor, as well as any and all (x) provisional and non-provisional applications, foreign patent application, patent cooperation treaty (PCT) applications, substitutions, continuations, continuations-in-part, divisions and renewals of such patent applications described in (I) and (ii), (y) all patents granted thereon, and (z) all reissues, re-examinations and extensions or restorations, including supplementary protection certificates or the equivalent thereof, granted thereon and corresponding priority rights.

The myopathies are neuromuscular disorders in which the primary symptom is muscle weakness due to dysfunction of muscle fiber.

Field of Use

This agreement pertains to the drug industry.  Assignee is a biotechnology company that develops drug candidates to treat age-related and genetic degenerative diseases, especially those affecting muscular and visual functions.

License Grant

Licensor hereby grants to Licensee an exclusive (even as to Licensor), royalty free (except as otherwise expressly set forth herein)  license under the Patent Rights and the Licensed Know-How, solely in the Territory, to make, have made, develop, import, market, offer for sale, use, obtain Regulatory Approval for, and sell the Product.

License Property

Product means the intranasally-administered formulation of the calcitonin product (that is the subject of existing ANDA No. 76-979 filed by Licensor and accepted by the FDA, or any ANDA incorporating the elements thereof, or any amendment, supplement or successor thereto.

Patent Application: 60/4S6,921; March 21, 2003  (TITLE: NASAL CALCITONIN FORMULATIONS CONTAINING CHLOROBUT ANOL)

Patent Rights means (i) the patents and patent applications listed; (ii) all continuation, divisional, continuation-in-part, continued prosecution, re-examination, reissue, utility model, petty, and other patent applications claiming subject matter therein or claiming priority from any of the foregoing and all patents that issue therefrom; (iii) all counterparts, substitutions, restorations, extensions (including, without limitation, patent term extensions), supplementary protection certificates, registrations, confirmations, validations and renewals of any of the foregoing; and (iv) all other U.S. patents, patent applications (provisional and non-provisional), utility models, invention certificates, and other grants for the protection of inventions or industrial designs, in each case that are Controlled by Licensor or its Affiliates now or in the future and that cover or are useful for the Product or the making (including development, testing, packaging, and Manufacturing), preparation, importation, use, or sale of the Product.

Field of Use

This agreement pertains to the drug industry.

License Grant

License to Commercialize Collaboration Compounds –  Licensor grants to Licensee a worldwide, exclusive license, with the right to sublicense, under the Licensor IP and Licensors interest in the Collaboration IP, to make, have made, use, sell, offer to sell and import Collaboration Compounds, and/or Collaboration Products based on such Collaboration Compounds, for any and all uses and indications in the Licensee Field.

License to Compounds (Other than Collaboration Compounds)  Derived from Licensee Compounds – Licensor grants to Licensee a worldwide, exclusive license, with the right to sublicense, under the Licensor IP and Licensors interest in the Collaboration IP, to make, have made, use, sell, offer to sell and import Collaboration Compounds, and/or Collaboration Products based on such Collaboration Compounds, for any and all uses and indications in the Licensee Field.

License Property

Collaboration Product shall mean a pharmaceutical product containing a Collaboration Compound that is sold by Licensee or Licensor, or their respective Sublicensees or Affiliates.  It is understood that, in the event any Collaboration Compound is sold for therapeutic purposes, such Collaboration Compound shall be deemed a Collaboration Product and shall be subject to milestones and royalties as set forth in this Agreement.

Collaboration Compound shall mean a Licensor Compound or a Non-Exclusive Compound or a compound that is derived, directly or indirectly, from a Licensee Compound, Licensor Compound, or Non-Exclusive Compound; in each case, that modulates the biological activity of a Collaboration Target at a level of potency to be established by the JRC.  A compound shall be deemed to have been derived directly from another compound if it (i) is the result of a chemical modification made to such a compound, (ii) is otherwise obtained from a chemical synthesis program based on one or more such compounds, (iii) is based on proprietary structure-activity data obtained from the testing of one or more such compounds, or (iv) is specifically or generically within the scope of one or more claims of any patent application or patent filed by Licensor or Licensee or their Affiliates to protect any compound in category (i), (ii) or (iii) above.  A compound shall be deemed to have been derived indirectly from another compound if it is the result of a series of iterations of any or all of (i) through (iv) above.  For purposes of clarity, any compound synthesized in the course of the Collaboration and based on a Licensee Compound, Licensor Compound, or Non-Exclusive Compound which is active against a Collaboration Target at the level of potency established by the JRC shall be deemed a Collaboration Compound.  Joint Research Committee or “JRC” shall mean the entity organized to manage the scientific implementation of the Collaboration.

Licensee IP shall mean Licensee Patents and Licensee Know-how.

Collaboration IP shall mean Collaboration Patents and Collaboration Know-how.  Collaboration IP shall not include Licensor IP or Licensee IP.

Licensor IP shall mean Licensor Patents and Licensor Know-how.  Licensor IP shall not include any intellectual property owned or licensed by Licensor or its Affiliates relating to the ECLiPSâ„¢ technology (i.e., the creation or use of encoded combinatorial libraries or any tag and/or marker compounds).

Licensee Patents shall mean all Patents in the Territory Controlled by Licensee or its Affiliates as the effective date, or any other Patent Controlled by Licensee during the Term; in each case, necessary for the discovery, development, manufacture, importation or use of one or more Collaboration Compounds and/or the development, manufacture, use, sale, importation or commercialization of corresponding Collaboration Products.

Licensor Patents shall mean all Patents in the Territory Controlled by Licensor or its Affiliates as the Effective Date, or any other Patent Controlled by Licensor during the Term; in each case, necessary for the discovery, development, manufacture, importation or use of one or more Collaboration Compounds and/or the development, manufacture, use, sale, importation or commercialization of corresponding Collaboration Products.

Collaboration Patents shall mean (i) all patents and patent applications claiming any invention or discovery which was conceived or reduced to practice during the Collaboration Term and in the course of the Collaboration, by employees or agents of Licensee, Licensor or any of their respective Affiliates, either alone or jointly (including, without limitation, the synthesis and composition of matter of any Collaboration Compound, or method of use thereof; and (ii) any divisions, continuations, continuations-in-part, reissues, reexaminations, extensions or other governmental actions which extend any of the subject matter of the patent applications or patents in (i) above, and any substitutions, confirmations, registrations, revalidations, or additions of any of the foregoing, in each case, which is owned or Controlled, in whole or part, by license, assignment or otherwise by Licensor or Licensee during the term of this Agreement; provided, however, that Collaboration Patents shall not include any Licensee Patents or Licensor Patents.

Licensor Compound shall mean any compound brought to the Collaboration by Licensor, which is Controlled by Licensor at or after the Effective Date, and which is proprietary to Licensor by virtue of being within the Licensor IP.

Field of Use

The primary objective of the alliance is to identify active molecules and bring them forward to clinical proof of concept, yielding novel candidates for drug development in various therapeutic areas.

Licensor Field shall mean, with respect to each Collaboration Compound for which Licensor has received approval to develop pursuant, all human and animal disorders and diseases treated by modulation of a Collaboration Target by such Collaboration Compound.

Licensee Field shall mean, with respect to each Collaboration Compound, all human and animal disorders and diseases treated by modulation of a Collaboration Target by such Collaboration Compound.

License Grant

Licensor hereby grants to Licensee a worldwide exclusive right and license under the Licensor Patent Rights, the Licensor Know-How, and Licensors rights in the Joint Patent Rights and the Joint Know-How, to make, have made, use, have used, sell, distribute, offer for sale and import Licensed Products in the Licensed Field. In addition, Licensor hereby grants to Licensee a worldwide nonexclusive right and license to use Licensors Materials and Information to the extent and only to the extent necessary to develop and commercialize Licensed Products in the Licensed Field.

License Property

Licensed Product shall mean any product that contains a Properdin Antibody, or any service that utilizes a Properdin Antibody.

Licensor Patent Rights shall mean, collectively, (a) all patents and patent applications listed and any foreign counterparts claiming priority therefrom; (b) all patent applications heretofore or hereafter filed in any country which claim (and only to the extent they claim) the Licensor Materials and Information or the use thereof; (c) all patents that have issued or in the future issue from any of the foregoing patent applications, including without limitation utility, model and design patents and certificates of invention; and (d) all divisionals, continuations, continuations-in-part,reissues, reexamination certificates or renewals from, extensions of or additions to any such patents or patent applications. Notwithstanding the foregoing, Licensor Patent Rights shall not include any Patent Rights that are within the Licensee Patent Rights, the Joint Patent Rights or the Properdin Antibody Patent Rights.

Patent Application Pending: US 09/138,723

Licensor Know-How shall mean all Know-How developed or acquired by Licensor solely or jointly with a Third Party that is related to Properdin Antibodies.

Joint Patent Rights shall mean all Patent Rights that claim Joint Inventions.

Joint Know-How shall mean Know-How developed or acquired jointly by employees or agents of both Licensor and Licensee as a result of their collaboration under the 1999 Agreement or under this Agreement; provided that such Know-How does not include subject matter within the Licensee Materials and Information, the Licensor Materials and Information or the Properdin Antibody Materials and Information.

Licensor Materials and Information shall mean, collectively, (a) the Antigen; (b) all reagents, samples and other chemical or biological materials regarding the Antigen which resulted or is otherwise derived from use of the Antigen under the 1999 Agreement or which results or is otherwise derived from use of the Antigen under this Agreement; and (c) all information (and all tangible and intangible embodiments thereof) regarding the foregoing, irrespective of inventorship, which is disclosed by Licensor to Licensee hereunder or which resulted or is otherwise derived from use of the Antigen under the 1999 Agreement or which results or is otherwise derived from use of the Antigen pursuant to this Agreement. Notwithstanding the foregoing, Licensor Materials and Information shall not include subject matter within the Licensee Materials and Information or the Properdin Antibody Materials and Information.

Field of Use

Acquiring right relates to the development and commercialization of anti-properdin antibody therapies.  An anti-properdin antibody may be a potential treatment for cardiovascular or inflammatory disease.

License Grant

The licenses granted include the right of each licensee to use its Affiliates in exercising such rights and carrying out its obligations under this Agreement.

Licensor hereby grants to Licensee the exclusive (except as to Licensor to permit it conduct its Co-Funded Development and/or Co-Commercialization activities and those activities under the ITMN-191 Transition Plan hereunder) license under the Licensor Know-How and Licensor Patent Rights and under Licensor’s rights in Joint Know-How and Joint Patent Rights to develop, make, have made, use, import, export, offer for sale and sell Licensed Compounds and Products in the Territory.

License Property

ITMN-191 shall mean that Macrocycle identified within Licensee as ITMN-191, together with its salts and esters, which is hereby designated a Licensed Compound.

Macrocycle shall mean any cyclic macromolecule in the Field containing a substituted proline moiety and optional Pl and P3 groups as part of the backbone ring and supporting the attachment of Pl and P4 groups.

Licensee Patent Rights shall mean any and all patents and patent applications in the Field in the Territory which are Controlled by Licensor during the term of this Agreement which Cover any activity permitted under this Agreement, all to the extent that the subject matter claimed therein is used in the course of performing any activity permitted under this Agreement, including, but not limited to, the making, using, selling, offering to sell, exporting or importing Lead Compound, Licensed Compounds, Products, Passed Compounds or Reverted Compounds. For the purposes of this Agreement, “patents and patent applications” shall be deemed to include certificates of invention and applications for certificates of invention, as well as divisions, continuations, continuations-in-part, reissues, renewals, extensions, supplementary protection certificates, and the like of any such patents and patent applications and foreign equivalents thereof.

Joint Patent Rights shall mean any and all patents and patent applications in the Field in the Territory which are invented jointly during the term of this Agreement by employees of both Parties according to the U.S. laws pertaining to joint inventorship. For the purposes of this Agreement, “patents and patent applications” shall be deemed to include certificates of invention and applications for certificates of invention, as well as divisions, continuations, continuations-in-part, reissues, renewals, extensions, supplementary protection certificates, and the like of any such patents and patent applications and foreign equivalents thereof.

Licensed Compound shall mean (a) ITMN-191 and (b) Collaboration Compounds properly included by Licensee as Licensed Compounds; provided however, Licensee may substitute a Lead Compound for an existing Licensed Compound as set forth in this Agreement; provided further there shall not be more than two (2) Licensed Compounds at any time during the Term unless Licensee shall have exercised its option to expand the number of Licensed Compounds pursuant to this agreement.

Product(s) shall mean any pharmaceutical preparation containing a Licensed Compound for any and all uses in humans, including any Combination Product.

Field of Use

Field shall mean the treatment and/or prevention of acute or chronic HCV infection in humans by administering a compound whose mechanism of clinical activity results solely from  binding to and inhibiting the serine protease active site of HCV NS3/4A.