EX-10.2 6 d675806dex102.htm EX-10.2 Confidential Treatment Requested. Confidential portions of this document have been redacted and have been separately filed with the Commission. Pharmaceutical License Agreement SP-2577 Salarius Pharmaceuticals, LLC...
Exhibit 10.2
Confidential Treatment Requested. Confidential portions of this document have been redacted and have been separately filed with the Commission.
Pharmaceutical License Agreement
SP-2577
Salarius Pharmaceuticals, LLC
and
HLB LifeScience Co., LTD
November 25, 2016
EXCLUSIVE PHARMACEUTICAL SUBLICENSE AGREEMENT
This AGREEMENT dated as of November 25, 2016 (“Effective Date”) is made by and between Salarius Pharmaceuticals, LLC, a Delaware limited liability company, having its principal place of business at JLABS at Texas Medical Center, 0000 Xxxxxxxx Xxxx., Xxxxx X, Xxxxxxx, Xxxxx, 00000, Xxxxxx Xxxxxx of America (“SALARIUS”) and HLB LifeScience Co., LTD., having offices at X-000, XXX Xxxxxxx Xxxxx, 000, Xxxxxxx-xx 00-xxx, Xxxx-xx, Xxxxx, the Republic of Korea (“HLBLS”).
Introduction
Certain inventions, generally characterized as “(E/Z)-N’-substituted-benzylidene-3-(substituted-sulfonyl) benzohydrazides as inhibitors of histone demethylases” comprising compounds that inhibit Lysine-specific demethylase 1 (LSD1), and assigned University of Utah case number U-5083, hereinafter collectively referred to as the “Invention”, have been made in the course of research at the University of Utah and are Covered By Patent Rights (as defined below).
SALARIUS has obtained from the UURF (as defined below) the exclusive license under the Patent Rights (as defined below) for the commercial development, production, manufacture, use and sale of Licensed Products (as defined below) to certain Drug Technology (as defined below).
HLBLS desires to sublicense from SALARIUS the right to develop, produce, manufacture, use, and sell certain drug formulations that are applied to humans through the use of the Drug Technology in the Licensed Territory (as defined below) and SALARIUS is willing to grant such a sublicense to HLBLS upon the terms and conditions hereinafter set forth.
In consideration of the mutual covenants and promises contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, HLBLS and SALARIUS agree as follows:
I. |
As used in this Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:
1.1 “Affiliate” means any company or other business entity that, directly or indirectly, controls, or is controlled by, or is under common control with a Party. Solely for purposes of this definition, the term “control” means the entity owns, either of record or beneficially, at least fifty percent (50%) of the voting stock of the other entity. An entity will be deemed an Affiliate only while such ownership relationship continues. “Affiliates” is more than one Affiliate.
1.2 “Claim of Infringement” is defined in Section 10.5.1.
1.3 “Covered By” means a claim or claims within any pending or issued patent included in the SALARIUS Patent Rights claiming all, a portion, or a component or step of a Licensed Product.
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1.4 “Collaborator” means any Entity with which HLBLS or one or more of its Affiliates actively conducts significant joint research, and/or co-development, and/or co-promotion, and/or co-marketing activities for the purpose of commercializing Licensed Product(s).
1.5 “Combination Product” means a Licensed Product(s) which is sold in combination with another product or products which themselves are not Licensed Product(s)
1.6 “Commercially Diligent Efforts” means, with respect to a Licensed Product, the reasonably diligent exercise, dedication and expenditure of efforts, money, personnel, and resources as reasonably needed to develop, manufacture, market and sell the Licensed Product that a prudent chief executive officer would devote given then current competitive factors, market conditions, the ability to obtain financing, the availability of development resources, the interest shown by pharmaceutical companies and other likely Collaborators, Sublicensee(s), or assignees.
1.7 “Confidential Information” means all materials, trade secrets, or other information, including, without limitation, proprietary information and materials (whether or not patentable) regarding a Party’s technology, products, business information, or objectives, which is designated as confidential in writing by the disclosing Party, whether by letter or by the use of an appropriate stamp or legend, prior to or at the time any such material, trade secret, or other information is disclosed by the disclosing Party to the other Party. Notwithstanding the foregoing to the contrary, materials, trade secrets, or other information which (i) is orally or visually disclosed by a Party, or (ii) is disclosed in writing without an appropriate letter, stamp, or legend and within thirty (30) days after such disclosure, the disclosing Party delivers to the other Party a written document or documents describing the materials, trade secrets, or other information and referencing the place and date of such oral, visual, or written disclosure and the names of the persons to whom such disclosure was made, or (iii) is disclosed under circumstances that a reasonable person would consider such information to be confidential, shall constitute Confidential Information.
1.8 “Drug Technology” means any technology licensed, owned or licensable by SALARIUS that relates to compound, devices or compositions for the formulation/compound known as SP-2577 comprising the Invention (product profile attached as Attachment 1) in the Field of Use Covered By the Patent Rights.
1.9 “Effective Date” is defined in the first paragraph above.
1.10 “Entity” means a corporation, an association, a joint venture, a partnership, a trust, a business, an institution, an individual, a government or political subdivision thereof, including an agency, or any other organization that can exercise independent legal standing.
1.11 “Fair Market Value” means the cash consideration which HLBLS or its Sublicensees would realize from an unaffiliated, unrelated buyer in an arm’s length sale of an identical item sold in the same quantity, under the same terms, and at the same time and place.
1.12 “Field of Use” means all human uses.
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1.13 “First Commercial Sale” means with respect to any Licensed Product, the first sale of such Licensed Product for human use after the MFDS has approved a New Drug Application (“NDA”) or Premarket Approval (“PMA”) or accepted a 510(k), or an equivalent Marketing Authorization for such Licensed Product, excluding, however, any sale or other distribution for use in a clinical trial or for a compassionate use (i.e., under a “single patient IND” study, a “treatment IND” or “treatment protocol” under an existing commercial IND or their equivalents) invoiced to a Third Party other than to an Affiliate or Collaborator.
1.14 “K-IFRS” means generally accepted accounting principles in the Republic of Korea consistently applied by HLBLS, its Affiliates, its Sublicensees or its distributors in their respective financial statements, audited if applicable.
1.15 “HLBLS Improvement(s)” means any intellectual or tangible property that constitute improvements or enhancements in the Field of Use to, or modifications of, the SALARIUS Patent Rights in the Field of Use that are conceived, originated, acquired or reduced to practice by HLBLS, its Collaborators and their respective Affiliates, but does not include new chemical entities as defined by the US Food and Drug Administration in 21 CFR 314.108(a).
1.16 “Insolvent” means being unable to meet one’s debt obligations to another Entity as such debt obligations become due and not being able to provide reasonable financial assurances of becoming able to meet such obligations.
1.17 ”Invention” is defined in the Introduction to this Agreement.
1.18 “IND” is defined in Section 6.4.
1.19 “JRC” is defined in Section 5.1.
1.20 “MFDS” means the Korean Ministry of Food and Drug Safety, or any successor agency thereto.
1.21 “Licensed Products” means any product, apparatus, or any other subject matter, the manufacture, design, creation, use, importation, distribution, or sale of which is Covered By a Valid Claim included within the SALARIUS Patent Rights.
1.22 “Licensed Territory” means the Republic of Korea.
1.23 “Losses” is defined in Section 10.5.2.
1.24 “Marketing Authorization” means all necessary and appropriate regulatory approvals to allow the marketing and sale of a Licensed Product(s), including but not limited to new drug/device submissions and reimbursement and pricing approvals, in the Field of Use in the Territory.
1.25 “Net Sales” means the gross revenue and other consideration billed or invoiced by HLBLS, its Collaborators and their respective Affiliates for Licensed Products which are sold, leased or otherwise commercialized by or for HLBLS, its Collaborators or any of their respective Affiliates; however, sales or other transfers of Licensed Products between HLBLS and its Collaborators and their respective Affiliates shall be excluded from the computation of Net Sales, and no payments will be payable to SALARIUS on such sales or transfers except where such Affiliates are end users or consumers; less the following deductions, directly attributable to the sale of such Licensed Product and specifically identified on the invoice, and borne by the seller to the extent they are included in such gross revenue or other consideration:
(i) trade, cash and quantity discounts;
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(ii) price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities;
(iii) taxes on sales (such as sales, value added or use taxes) to the extent added to the sale price;
(iv) freight, insurance and other transportation charges to the extent added to the sale price;
(v) amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions, including, but not limited to, rebates or wholesaler charge backs.
Any deduction listed in subsections (i) – (v) shall not be taken with respect to a particular unit of Licensed Product until HLBLS or the applicable selling Entity bills or invoices amounts from the sale of such unit of Licensed Product (thereby resulting in such amounts being included in Net Sales), and no deduction shall be taken in a manner that counts a particular charge, payment, discount, tax, or other deductible item more than once. Net Sales shall not include upfront, lump sum, milestone or debt or equity contributions not made in payment for Licensed Products.
1.26 “Party” means HLBLS or SALARIUS; “Parties” means HLBLS and SALARIUS.
1.27 “Regulatory Authorities” means the principal governmental organization(s) or agency(ies) that has/have the right to approve the sale and, if applicable price, of Licensed Products in the Licensed Territory, including, without limitation, the MFDS.
1.28 “Royalty Term” means, on a Licensed Product by Licensed Product basis, the period of time for which HLBLS’s royalty obligations are due to SALARIUS and commence on the First Commercial Sale for each such Licensed Product and shall terminate on the expiration, invalidation or abandonment of the last Valid Claim in the SALARIUS Patent Rights.
1.29 “SALARIUS Improvement(s)” means any intellectual or tangible property that constitute improvements or enhancements in the Field of Use to, or modifications of, the SALARIUS Patent Rights in the Field of Use that are conceived, originated, acquired or reduced to practice by SALARIUS or its Affiliates, but does not include new chemical entities as defined by the US Food and Drug Administration in 21 CFR 314.108(a).
1.30 “SALARIUS Know-how” means SALARIUS’ methods, processes, techniques and data that relate to the SALARIUS Patent Rights which are necessary or useful for developing, manufacturing, using or selling a Licensed Product (including but not limited to preclinical study, reports, protocols, and data), now or in the future owned or Controlled by SALARIUS, whether or not: (i) the same is eligible for protection under the patent laws in the Territory; (ii) enforceable as a trade secret; or (iii) the copying of which would be enjoined or restrained by a court as constituting unfair competition.
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1.31 “SALARIUS Patent Rights” means and includes all of the patentable intellectual property in the Licensed Territory (i) owned by SALARIUS, and (ii) licensed to SALARIUS under the UURF License and, including but not limited to the patents and/or patent applications listed in Attachment 2 and from divisionals and continuations (other than continuations-in-part) of these applications and any reissues of such patents; continuation-in-part applications and patents directed to subject matter specifically described in the patent(s) and/or patent application(s) listed in Attachment 2 reissues, renewals, registrations, confirmations, reexaminations, extensions, of any such patents.
1.32 “SALARIUS Technology Rights” means the SALARIUS Know-how and the SALARIUS Patent Rights.
1.33 “Step Down Royalty” is defined in Section 4.2.
1.34 “Step Down Royalty Term” means, on a Licensed Product by Licensed Product basis, a period of time for which HLBLS’s step down royalty obligations are due and shall commence after the Royalty Term where there are SALARIUS Patent Rights and with the First Commercial Sale where there are no SALARIUS Patent Rights, but in no event shall exceed twenty (20) years from the date of the First Commercial Sale of the Licensed Product.
1.35 “Sublicense” is defined in Section 3.1.
1.36 “Sublicensee(s)” means any Third Party which enters into a Sublicense.
1.37 “Third Party” means any company other than HLBLS, SALARIUS, and Parties’ Affiliates.
1.38 “University” means the University of Utah.
1.39 “UURF” is the University of Utah Research Foundation which has licensed SALARIUS Patent Rights and SALARIUS Technology Rights to SALARIUS.
1.40 “University License Agreement” means the License Agreement entered into on the 3rd day of August, 2011 by and between UURF as “Licensor,” and SALARIUS as “Licensee”, as it may be amended from time to time.
1.41 “Valid Claim” means a claim of any unexpired United States or foreign patent or patent application that shall not have been withdrawn, canceled, or disclaimed, nor held invalid by a court of competent jurisdiction in an unappealed or unappealable decision.
II. |
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2.2 SALARIUS Improvements - License Grant to HLBLS. SALARIUS hereby grants to HLBLS a license with the right to sublicense to SALARIUS Improvements to the extent it has the rights to do so and to the extent necessary to make, have made, use, offer to sell and sell Licensed Products in the Licensed Territory in the Field of Use where, but for this grant of SALARIUS Improvements, the exercise of such rights would constitute an infringement of a Valid Claim of the SALARIUS Improvements. With effect from the date of SALARIUS’s notice to HLBLS under Section 2.4 below the SALARIUS Improvement reported in such notice shall be deemed to be part of the SALARIUS Patent Rights and subject to the terms and conditions of this Agreement.
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[ *** ] = Confidential material redacted and filed separately with the Commission.
III. |
IV. |
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[ *** ] = Confidential material redacted and filed separately with the Commission.
4.2 Annual Net Royalties: HLBLS shall pay to SALARIUS a percentage of all Net Sales by HLBLS and its Affiliates of Licensed Products covered by a Valid Claim of a patent or patent application of the SALARIUS Patent Rights according to the following schedule:
Annual Net Sales | Royalty on Net Sales | |
Annual Net Sales of less than [ *** ] | [***] | |
Annual Net Sales of [ *** ] but less than [ *** ] | [***] | |
Annual Sales of [ *** ] and above | [***] |
4.3 Step Down Royalty: HLBLS shall pay to SALARIUS a step down royalty (the “Step Down Royalty”) on Net Sales of each Licensed Product that is [ *** ] of the applicable rate under Section 4.1 above during the Step Down Royalty Term for the applicable Licensed Product where such Licensed Product utilizes SALARIUS Know-how.
X = A/B, where
X = the pro rata portion of Net Sales attributable to the Licensed Products (expressed as a percentage), and
A = the average invoice price of the component in the Combination Product utilizing the Licensed Products sold separately, and
B = the average invoice price of the Combination Product.
In the event a substantial number of separate sales are not made of one or more component(s) of the Combination Product during the relevant royalty period so as to enable a reasonable calculation of average invoice prices of components, then Net Sales will be determined using the same formula shown above, where
A = the total inventory cost of the component in the Combination Product utilizing Licensed Product, and
B = the total inventory cost of all of the products and components in the Combination Product.
Inventory cost would be determined in accordance with HLBLS’s regular accounting methods consistently applied.
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[ *** ] = Confidential material redacted and filed separately with the Commission.
4.6 One Royalty: In no event shall more than one royalty be due SALARIUS for any Licensed Product sold by HLBLS or its Affiliates. Payments under Section 4.5 above shall not be deemed to be royalties due SALARIUS.
(a) | number or volume of Licensed Products manufactured, leased and sold by and/or for HLBLS, its Affiliates and reported to HLBLS by all Sublicensees; |
(b) | accounting for Net Sales, noting the deductions applicable as provided in Section 1.25; |
(c) | royalties, earned royalties, royalties due on other payments from Sublicensees, Affiliates, and assignees due under this Article 4; |
(d) | total royalties then due to SALARIUS; |
(e) | names and addresses of all Sublicensees; |
(f) | the amount spent on product development; and |
(g) | an approximation of the number of full-time equivalent employees working on the Licensed Products. |
Each report shall be in substantially similar form as Exhibit “4.7” attached hereto. Each such report shall be signed by an officer of HLBLS or Sublicensee (or the officer’s designee). Simultaneously with the delivery of each such report, HLBLS shall tender payment of all amounts shown to be due thereon and not then paid. If no royalties were due during the reporting period, HLBLS shall so report. HLBLS will continue to deliver royalty reports to SALARIUS after the termination or expiration of this Agreement until such time as no royalties are due to SALARIUS. Payments to SALARIUS under Sections 4.1 through 4.4 shall be due within forty five (45) days of HLBLS receiving the revenue from the Sublicensee with respect to which such payments are due.
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4.9 Income Tax Withholding. If laws, rules or regulations require withholding of income taxes or other rates imposed upon payments set forth in this Article 4, HLBLS may make such withholding payments as required and subtract such withholding payments from the payments set forth in this Article 4. HLBLS shall submit appropriate proof of payment of the withholding rates to SALARIUS within a reasonable period of time. HLBLS shall use efforts consistent with its usual business practices to ensure that any withholding taxes imposed are reduced as far as possible under the provisions of the current or any future double taxation treaties or agreements between foreign countries, and the Parties shall cooperate with each other with respect thereto, with the appropriate Party under the circumstances providing the documentation required under such treaty or agreement to claim benefits thereunder.
V. |
5.4 Decisions by the JRC: Decisions by the JRC will be made by consensus. If the JRC is unable to reach agreement with respect to a particular matter within its purview within thirty (30) days, the matter will be submitted in writing to the Chief Executives of HLBLS and SALARIUS for discussion and resolution. In the event that the Chief Executives of each Party cannot reach agreement within ten (10) business days after receiving the written submission from the JRC, which period may be extended by mutual agreement of the Parties, if the issue relates to preclinical or clinical studies for a Licensed Product and SALARIUS reasonably believes the matter may have consequences outside the Licensed Territory such as but not limited publication of clinical trial results or regulatory filings, the Chief Executive of SALARIUS shall have the right to make the decision. On all matters with consequences limited to the Licensed Territory, HLBLS shall have the right to make the decision.
VI. | Obligations Related to Development, Costs, Marketing and Commercialization. |
6.1 HLBLS’s Diligence Obligations: Upon execution of this Agreement, HLBLS shall proceed with Commercially Diligent Efforts itself or through the efforts of its Affiliates, Collaborators, Sublicensees, and their respective Affiliates to develop, make, have made, use, offer to sell and sell the Licensed Products in order to make them readily available to the general public as soon as possible on commercially reasonable terms. Until such time as the first Marketing
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Authorization is approved for a Licensed Product, HLBLS shall document its efforts, which shall be consistent with those utilized by companies of similar size and type that have successfully developed products similar to the Licensed Product(s). At a minimum, Commercially Diligent Efforts shall be based upon the commercialization plan submitted to SALARIUS by HLBLS as required under Section 6.2.
6.2 Commercialization Plan: HLBLS shall deliver to SALARIUS, on or before six (6) calendar months after the Effective Date a commercialization plan detailing each phase of development, the target markets and time frames toward First Commercial Sale of one or more Licensed Products.
6.3 Preclinical Studies: SALARIUS shall use its reasonable commercial efforts to complete preclinical development and file an IND under the US FDA. SALARIUS shall provide the preclinical study reports, data, and copy of the IND to HLBLS. HLBLS shall use its reasonable commercial efforts to file an Investigational New Drug (“IND”) application to initiate clinical studies of Licensed Products under the MFDS within two (2) years after receiving the US FDA IND and preclinical study data.
6.4 Preclinical Development Costs: Salarius shall provide its preclinical reports and data to HLBLS at no cost. HLBLS shall be responsible for costs associated with preclinical development and formulation development of Licensed Products where such development is required by MFDS and was not submitted under US FDA.
6.5 Clinical Development Costs: HLBLS shall be responsible for all costs associated with clinical development of Licensed Products undertaken solely in the Licensed Territory. The Parties may agree to collaborate on clinical development under MFDS and other Regulatory Authorities, and costs of such clinical development will be shared on a pro-rata basis calculated by future market share projections.
6.6 Governmental Approvals: HLBLS shall be solely responsible for obtaining all necessary approvals from Regulatory Authorities in the Licensed Territory for the use, development, production, distribution, sale and import or export of any Licensed Products, including but not limited to Marketing Authorizations, all at HLBLS’ expense, including, without limitation, preclinical and clinical trials and regulatory filings. HLBLS shall have sole responsibility for any warning labels, packaging and instructions as to the use of Licensed Products and for the quality control for any Licensed Product. HLBLS, its Affiliates or Sublicensees shall own all regulatory filings and documents filed with the applicable Regulatory Authorities with respect to the Licensed Products and all Marketing Authorizations in the Territory.
6.7 Salarius Assistance: SALARIUS shall provide HLBLS with all information related to the Drug Technology, SALARIUS Patent Rights, and SALARIUS Know How, as may be known or possessed by SALARIUS in tangible form and as may be reasonably necessary for HLBLS to exploit the licenses granted in this Agreement, including any materials related to the acquisition of any government approvals for the Licensed Products. SALARIUS shall provide HLBLS with reasonable technical assistance in connection with transfer of such information.
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6.8 HLBLS Assistance: HLBLS shall provide SALARIUS with all information related to the Drug Technology and HLBLS Improvements, as may be known or possessed by HLBLS and as may be reasonably necessary or convenient to assist for SALARIUS to exploit the Drug Technology, including any materials related to the acquisition of any government approvals for the Licensed Products during the Agreement. HLBLS shall provide SALARIUS with reasonable technical assistance in connection with transfer of such information and English translations of such materials during the Agreement.
VII. |
VIII. | Representations, Warranties, and Disclaimer |
8.1 Representations and Warranties of SALARIUS: SALARIUS hereby represents and warrants that: (i) SALARIUS has the authority, including through agreement with the UURF, to grant to HLBLS all of the rights granted hereunder; (ii) SALARIUS has licensed, owns or controls all rights to the SALARIUS Technology Rights; and (iii) SALARIUS is unaware of any rights superior to SALARIUS’s in the Drug Technology which would prevent HLBLS from fully exercising the rights licensed to it herein.
8.2 SALARIUS Disclaimer: SALARIUS specifically disclaims any guarantee that HLBLS will be successful in developing and commercializing a Licensed Product, in whole or in part. The failure of HLBLS to successfully develop or commercialize a Licensed Product will not, of itself, constitute a breach of any representation or warranty or other obligation under this Agreement. SALARIUS does not make any representation or warranty or guaranty that the Drug Technology together with the SALARIUS Technology will be sufficient for the successful development and commercialization of a Licensed Product. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, SALARIUS MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OR CONDITIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE DRUG TECHNOLOGY OR THE SALARIUS TECHNOLOGY, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF THE SALARIUS TECHNOLOGY, PATENTED OR UNPATENTED, OR NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
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8.3 Representations and Warranties of SALARIUS: HLBLS represents and warrants to SALARIUS as follows:
8.3.1 Organization: It is a corporation duly organized, validly existing and in good standing under the laws of the Republic of Korea.
8.3.2 Authority: It has full corporate power and authority to execute and deliver this Agreement and to consummate the transactions contemplated hereby. All corporate acts and other proceedings required to be taken to authorize such execution, delivery, and consummation have been duly and properly taken and obtained.
8.3.3 Enforceability: This Agreement has been duly executed and delivered by HLBLS and constitutes legal, valid, and binding obligations of HLBLS enforceable against HLBLS in accordance with its terms.
8.3.4 Approvals and Consents: No approval, authorization, consent, or other order or action of or filing with any court, administrative agency or other governmental authority is required for the execution and delivery by HLBLS of this Agreement or the consummation by HLBLS of the transaction contemplated hereby.
8.3.5 No Conflicts: None of the execution, delivery, or performance of this Agreement by HLBLS (i) conflicts with or results in a breach under the charter documents or any material contractual undertaking of HLBLS or its Affiliates or (ii) conflicts with or results in a violation of any of the laws of the jurisdiction of incorporation of HLBLS. HLBLS has not, to the best of its knowledge entered into, nor will HLBLS, after the Effective Date, knowingly enter into any written or oral agreement that is or would be inconsistent with its obligations under this Agreement or deprives or would deprive SALARIUS of the benefits of this Agreement.
8.4 Covenant of HLBLS: HLBLS hereby covenants and agrees to use reasonable efforts to develop, and obtain all necessary regulatory approvals for, and commercialize Licensed Products in the Licensed Territory.
IX. |
9.1 Ownership: Between them SALARIUS and the UURF, shall own the entire right and title to all SALARIUS Technology Rights.
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X. |
10.2 SALARIUS Option: Within ninety (90) days after SALARIUS becomes, or is made, aware of any infringement, suspected infringement or unauthorized use or misappropriation by a third party in the Field of Use in the Licensed Territory, as provided in Section 10.1 above, and provided that SALARIUS shall have advised HLBLS of its decision to file suit within the ninety (90) day period provided in paragraph (a) above, SALARIUS shall have the right to initiate an infringement or other appropriate suit anywhere in the world against such third party.
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SALARIUS shall provide HLBLS with an opportunity to make suggestions and comments regarding such suit and shall promptly notify HLBLS of the commencement of such suit. SALARIUS shall keep HLBLS promptly informed of, and shall from time to time consult with HLBLS regarding, the status of any such suit and shall provide HLBLS with copies of all documents filed in, and all written communications relating to, such suit.
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10.5.3 SALARIUS Indemnity: HLBLS shall indemnify, hold harmless and defend SALARIUS, UURF, the University, and their respective Affiliates, officers, employees and agents (the “SALARIUS Indemnitees”), against any and all Losses (including reasonable fees of attorneys) resulting from or arising out of exercise of: (a) any license granted under this Agreement limited to Losses resulting from causes that are reasonably within HLBLS’s control, including but not limited to defects in testing, labeling, manufacture or other application of the Licensed Products, or (b) any breach by HLBLS of any provision, representation, warranty or covenant given by HLBLS under this Agreement, or (c) any negligent or willful act, error, or omission of HLBLS, its agents, employees, Affiliates, or Sublicensees, except to the extent that where such claims, suits, losses, damages, costs, liabilities, fees, or expenses result solely from the negligent acts or omissions, or misconduct of the SALARIUS Indemnitees. HLBLS shall give SALARIUS timely notice of any claim or suit instituted of which HLBLS has knowledge that in any way, directly or indirectly, affects or might affect SALARIUS, and SALARIUS shall have the right at its own expense to participate in the defense of the same.
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[ *** ] = Confidential material redacted and filed separately with the Commission.
XI. |
(a) | the SALARIUS Indemnitees product liability coverage; |
(b) | includes a contractual endorsement providing coverage for all liability arising out of bodily injury and property damage, or other damage alleged to relate to Licensed Products or activities undertaken in connection with this Agreement and Licensed Products, including the development, manufacture, use, sale or other disposition of Licensed Products and all activities associated therewith; and |
(c) | provides the SALARIUS Indemnitees with product liability coverage in an amount no less than One Million United States Dollars ($1,000,000) per occurrence for bodily injury and United States One Million Dollars ($1,000,000) per occurrence for property damage, subject to a reasonable aggregate amount of not less than Two Million United States Dollars (US$2,000,000). |
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HLBLS will use reasonable efforts to have the SALARIUS Indemnitees named as additional insureds. All rights of subrogation will be waived against them and their insurers. The nature and extent of such insurance shall be commensurate with usual and customary industry practices for similarly situated companies. The specified minimum insurance amounts will not constitute a limitation on HLBLS’s obligation to indemnify SALARIUS Indemnities under this Agreement. HLBLS shall provide SALARIUS with certificates of insurance evidencing the above insurance coverage upon request by SALARIUS. HLBLS will provide SALARIUS with written notice of at least thirty (30) days prior to the cancellation, non-renewal, or material change in such insurance.
XII. |
12.1 Patent Marking: HLBLS shall permanently and legibly xxxx all Licensed Products made, used or sold under the terms of this Agreement, or their containers, in accordance with all applicable patent-marking and notice provisions as appropriate for the practice in the Licensed Territory.
12.2.1 By HLBLS: HLBLS may use the name “The University of Utah Research Foundation” and/or “Salarius Pharmaceuticals” in factually based materials related to the Licensed Products and the business of HLBLS; provided, however, that HLBLS may not use the name of SALARIUS, UURF, the University, nor their respective officers, employees and agents, in connection with any name, brand or trademark related to Licensed Products without the prior express written consent of the named party. For example, HLBLS may include a statement in promotional materials that refers to the fact that a product is based on technology developed at The University of Utah, but HLBLS may not include the name of SALARIUS, UURF, the University, or like designation in a product or service name.
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XIII. |
(a) | was known or used by the receiving Party prior to its date of disclosure to the receiving Party, as evidenced by the prior written records of the receiving Party; or |
(b) | either before or after the date of the disclosure to the receiving Party is lawfully disclosed to the receiving Party by sources other than the disclosing Party rightfully in possession of the Confidential Information; or |
(c) | either before or after the date of the disclosure to the receiving Party becomes published or generally known to the public, other than through the sale of Licensed Products in the ordinary course, through no fault or omission on the part of the receiving Party or an Affiliate; or |
(d) | is independently developed by or for the receiving Party without reference to or reliance upon the Confidential Information; or |
(e) | is required to be disclosed by the receiving Party to comply with applicable laws, to defend or prosecute litigation or to comply with governmental regulations, provided that the receiving Party provides prior written notice of such disclosure to the other Party and takes reasonable and lawful actions to avoid and/or minimize the degree of such disclosure. |
13.3 Publications: The Parties will treat matters of authorship of scientific abstracts, manuscripts or other publications (or presentations) in a proper collaborative spirit, giving credit where it is due. With respect to HLBLS’s publications and presentations, HLBLS shall not submit or present any written or oral publication, any manuscript, abstract or the like which includes data or other information related to the SALARIUS Technology or Confidential Information without first obtaining the prior written consent of SALARIUS.
13.4 Publicity: No public announcement concerning the existence or the terms of this Agreement shall be made, either directly or indirectly, by either Party, except as may be legally required by applicable laws, regulations, or judicial order, without first obtaining the approval of the other Party and agreement upon the nature, text, and timing of such announcement, which approval and agreement shall not be unreasonably withheld. The Party desiring to make any such public announcement shall provide the other Party with a written copy of the proposed announcement in sufficient time prior to public release to allow such other Party to comment upon such announcement, prior to public release. Except as may be legally required by applicable laws, regulations or judicial order, neither Party shall issue any press release or make any public announcement which includes or otherwise uses the name of the other Party in any public statement or document except with the prior written consent of such Party.
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XIV. |
14.4.1 SALARIUS Breach: HLBLS shall be entitled to terminate this Agreement by written notice to SALARIUS in the event that SALARIUS shall be in default of any of its obligations hereunder and shall fail to remedy any such default within one hundred twenty (120) days after notice thereof by HLBLS.
14.4.2 Nonpayment: In the event HLBLS fails to pay any amounts due and payable to SALARIUS hereunder, and fails to make such payments within thirty (30) days after receiving written notice of such failure, SALARIUS may (in addition to such other remedies as SALARIUS may have in law or in equity) terminate this Agreement immediately upon notice to HLBLS.
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14.6 Consequences of Expiration or Termination:
14.6.1 Rights Upon termination by SALARIUS: Upon termination of this Agreement under Section 14.2 or by SALARIUS under Section 14.3, 14.4 or 14.5, (i) all rights and licenses granted by SALARIUS to HLBLS shall terminate and revert to SALARIUS and (ii) HLBLS shall return to SALARIUS or destroy at SALARIUS’ option the SALARIUS Know-how. In addition HLBLS shall at no cost to SALARIUS transfer to SALARIUS the benefit of all development work and Market Authorizations that it has obtained or under its control. At the same time, HLBLS shall provide to SALARIUS at no cost to SALARIUS all CMC data, preclinical testing and stability data and results and clinical trial data and results relating to the development of Licensed Products and a technology transfer package for all processes, formulations, and protocols for the manufacture of Licensed Products. If HLBLS has licensed any technology from Third Parties relating to the SALARIUS Technology or any Licensed Product, HLBLS shall use commercially reasonable efforts to obtain the rights to transfer and to transfer such rights to SALARIUS at no cost to SALARIUS.
14.6.2 Payments: Not later than ninety (90) days after the expiration or termination date of this Agreement, each Party shall pay to the other Party any amounts that are then due and payable, including but not limited to any final period royalty report and payment.
14.7 Survival of Obligations; Return of Confidential Information: Termination or expiration of this Agreement for any reason shall be without prejudice to any rights which shall have accrued to the benefit of either Party prior to such termination or expiration, including but not limited to the obligations of the Parties with respect to the protection and nondisclosure of Confidential Information and product liability indemnification, and shall not relieve either Party from its obligations which are expressly indicated to survive expiration or termination of this Agreement, including, without limitation, those under Sections 8.2, 9.1, 11.2, 11.3, 12.2, 14.6 and 14.7, and Articles I, IV, XIII, XV and XVI.
XV. |
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15.2 Non-Arbitrable Disputes: Section 15.1 shall not apply to any dispute, controversy or claim that concerns (i) the validity, enforceability or infringement of a SALARIUS Patent Right, trademark or copyright; or (ii) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory. All such disputes, controversies or claims, and all judicial actions brought in order to enforce the instituting Party’s rights hereunder through specific performance, injunction or similar equitable relief, shall be brought only in the state or federal courts sitting in Wilmington, Delaware. The Parties hereby submit to the exclusive jurisdiction of such courts.
XVI. |
16.1 Governing Law: This Agreement shall be governed by, subject to and interpreted in accordance with the laws of the State of Delaware, United States of America excluding any choice of law rules, which may direct the application of the laws of another jurisdiction. The application of the UN Convention on Contracts for the International Sale of Goods (1980) is excluded.
To HLBLS: | HLB LifeScience Co., LTD X-000, XXX Xxxxxxx Xxxxx, 000, Xxxxxxx-xx 00-xxx, Xxxx-xx Xxxxx, Xxxxx | |
To SALARIUS: | Salarius Pharmaceuticals, Inc. 0000 Xxxxxxxx Xxxx., Xxxxx X Xxxxxxx, XX 00000 XXX |
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16.18 Not Binding until Signed: This Agreement shall not be binding upon the Parties until it has been signed below by or on behalf of each Party.
[ signature page follows ]
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Salarius Pharmaceuticals, LLC | HLB LifeScience Co., LTD. | |||||||
By: | /s/ Xxxxxxxx X. Xxxxxxxx | By: | /s/ Ha Xxxxx Xxx | |||||
Name: Xxxxxxxx X. Xxxxxxxx | Name: Ha Xxxxx Xxx | |||||||
Title: Executive Chair | Title: CEO | |||||||
Date: 11/17/2016 | Date: 11/25/2016 |
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ATTACHMENT 1
Product Profile
SP-2577 Product Profile
Drug Name: SP-2577mesylate salt
Chemical Name: (E)-N’-(1-(5-chloro-2-hydroxyphenyl)ethylidene)-3-((4-methylpiperazin-1-yl)sulfonyl)benzohydrazide methanesulfonate salt
Chemical Formula: X00X00XXX0X0X.XX0XX0X
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Xxxxxxxxxx 2
SALARIUS Patent Rights
Patents: WO20l3025805A1; Substituted (E)-N’-(1-phenylethylidene) benzohydrazide analogs as histone demethylase inhibitors
Patent Applications: US2015/0065495A1; Substituted-1H-Benzimidazole series compounds as Lysine-specific Demethylase 1 (LSD1) inhibitors
EXHIBIT A
SALARIUS Know-how
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