Certain identified information has been omitted from this exhibit because it is not material and of the type that the registrant treats as private or confidential. [***] indicates that information has been omitted. NON-EXCLUSIVE LICENSE AGREEMENT...
Exhibit 10.23
Certain identified information has been omitted from this exhibit because it is
not material and of the type that the registrant treats as private or confidential.
[***] indicates that information has been omitted.
NON-EXCLUSIVE LICENSE AGREEMENT BETWEEN ACUITAS THERAPEUTICS, INC. AND GREENLIGHT BIOSCIENCES INC.
NON-EXCLUSIVE LICENSE AGREEMENT
by and between
ACUITAS THERAPEUTICS, INC.
and
GREENLIGHT BIOSCIENCES INC.
dated
[________________]
TABLE OF CONTENTS
Page | ||||||
ARTICLE 1 |
Definitions | 1 | ||||
ARTICLE 2 | License Grants; Technology Transfer | 9 | ||||
2.1 Licenses by Acuitas |
9 | |||||
2.2 Sublicensing Rights |
9 | |||||
2.3 Technology Transfer |
10 | |||||
2.4 Updates to Appendix 1.40 |
11 | |||||
ARTICLE 3 |
License Limitations | 12 | ||||
ARTICLE 4 |
Payments and Royalties | 12 | ||||
4.1 License Maintenance Fees |
12 | |||||
4.2 Milestone Payments |
12 | |||||
4.3 Royalties |
15 | |||||
4.4 Payment Terms |
15 | |||||
ARTICLE 5 |
Ownership and Inventorship of IP | 17 | ||||
ARTICLE 6 |
Patent Prosecution and Maintenance | 18 | ||||
6.1 Generally |
18 | |||||
6.2 Election Not to Prosecute or Maintain or Pay Patent Costs |
18 | |||||
6.3 Regulatory Exclusivity Periods |
18 | |||||
6.4 Patent Listings |
18 | |||||
6.5 Cooperation |
18 | |||||
ARTICLE 7 |
Patent Enforcement and Defense | 19 | ||||
7.1 Notice; General |
19 | |||||
7.2 Enforcement and Defense |
19 | |||||
ARTICLE 8 |
Confidentiality | 21 | ||||
8.1 Confidential Information |
21 | |||||
8.2 Restrictions |
22 | |||||
8.3 Exceptions |
22 | |||||
8.4 Permitted Disclosures |
22 | |||||
8.5 Return of Confidential Information |
23 | |||||
8.6 Publications |
23 |
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8.7 Terms of this License Agreement; Publicity |
23 | |||||
ARTICLE 9 | Warranties; Limitations of Liability; Indemnification | 24 | ||||
9.1 Representations and Warranties |
24 | |||||
9.2 Additional Representations of Acuitas |
24 | |||||
9.3 Disclaimers |
26 | |||||
9.4 No Consequential Damages |
26 | |||||
9.5 Performance by Others |
26 | |||||
9.6 Indemnification |
26 | |||||
9.7 Insurance |
28 | |||||
ARTICLE 10 | Term and Termination | 29 | ||||
10.1 Term |
29 | |||||
10.2 Termination by Acuitas |
29 | |||||
10.3 Termination by GreenLight |
29 | |||||
10.4 Termination Upon Bankruptcy |
30 | |||||
10.5 Effects of Termination |
31 | |||||
10.6 Survival |
31 | |||||
ARTICLE 11 | General Provisions | 31 | ||||
11.1 Dispute Resolution |
31 | |||||
11.2 Cumulative Remedies and Irreparable Harm |
32 | |||||
11.3 Relationship of Parties |
33 | |||||
11.4 Compliance with Law |
33 | |||||
11.5 Governing Law |
33 | |||||
11.6 Counterparts; Facsimiles |
33 | |||||
11.7 Headings |
33 | |||||
11.8 Waiver of Rule of Construction |
33 | |||||
11.9 Interpretation |
34 | |||||
11.10 Binding Effect |
34 | |||||
11.11 Assignment |
34 | |||||
11.12 Notices |
34 | |||||
11.13 Amendment and Waiver |
35 | |||||
11.14 Severability |
35 | |||||
11.15 Entire Agreement |
35 | |||||
11.16 Force Majeure |
35 |
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List of Appendices
Appendix 1.29 |
Jointly Owned Patents | |
Appendix 1.38 |
Licensed Product including all Targets | |
Appendix 1.40 |
Patents within the Licensed Technology | |
Appendix 9.2 |
Exceptions to Acuitas’ Representations and Warranties in Section 9.2 |
iii
Non-Exclusive License Agreement
This Non-Exclusive License Agreement (“License Agreement”), dated as of [ ] (the “License Agreement Effective Date”), is made by and between Acuitas Therapeutics, Inc., a British Columbia corporation (“Acuitas”), and GreenLight Biosciences Inc., a Delaware corporation (“GreenLight”). Each of Acuitas and GreenLight may be referred to herein as a “Party” or together as the “Parties.”
WHEREAS, Acuitas has proprietary LNP Technology (as defined below);
WHEREAS, GreenLight has expertise and intellectual property relating to gene editing therapeutics, including mRNA Constructs (as defined below) and Genome Editing Constructs (as defined below);
WHEREAS, Acuitas and GreenLight are parties to that certain Development and Option Agreement (dated —, 2020) (the “Development and Option Agreement”), pursuant to which GreenLight has options to take licenses under the Licensed Technology (as defined below) with respect to GreenLight’s Genome Editing Constructs and mRNA Constructs; and
WHEREAS, pursuant to the terms of the Development and Option Agreement, GreenLight has exercised an option with respect to the Licensed Products and the Parties are now entering into a licensing arrangement whereby GreenLight will have a license under the Licensed Technology to develop and commercialize Licensed Products (as defined below).
NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the amount and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
ARTICLE 1
Definitions
The following terms and their correlatives will have the following meanings:
1.1 “Acuitas Indemnitees” has the meaning set forth in Section 9.6(a).
1.2 “Acuitas Patents” has the meaning set forth in Section 7.2(a)(i).
1.3 “Acuitas Background Technology” has the meaning set forth in the Development and Option Agreement.
1.4 “Acuitas Technology” has the meaning set forth in the Development and Option Agreement.
1.5 “Acuitas Sole Technology” has the meaning set forth in the Development and Option Agreement.
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1.6 “Affiliate” of a person or entity means any other person or entity which (directly or indirectly) is controlled by, controls or is under common control with such person or entity. For the purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to an entity will mean (a) in the case of a corporate entity, direct or indirect ownership of voting securities entitled to cast more than fifty percent (50%) of the votes in the election of directors, or (b) in the case of a non-corporate entity, direct or indirect ownership of more than fifty percent (50%) of the equity interests with the power to direct the management and policies of such entity, provided that if local Law restricts foreign ownership, control will be established by direct or indirect ownership of the maximum ownership percentage that may, under such local Law, be owned by foreign interests.
1.7 “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
1.8 “cGMP” means current Good Manufacturing Practices as specified in Parts 210 and 211 of Title 21 of the U.S. C.F.R., ICH Guideline Q7A, or equivalent Laws of an applicable Regulatory Authority at the time of manufacture.
1.9 “CMO” has the meaning set forth in Section 2.3(a).
1.10 “Combination Product” means a product that includes at least one additional active ingredient other than a Licensed Product, or includes at least one proprietary drug delivery system or other proprietary device, in each case sold in conjunction with or used in combination with a Licensed Product (whether packaged together or packaged separately but sold together for a single price). Drug delivery vehicles and excipients shall not be deemed to be “active ingredients,” except in the case where such delivery vehicle or excipient is recognized as an active ingredient in accordance with 21 C.F.R. 210.3(b)(7) or equivalent Laws in other jurisdictions, provided however, should lipid nanoparticles comprised in a Licensed Product be characterized as “active ingredients” at any time during the Term, such lipid nanoparticles will not be considered an “active ingredient” for the purposes of this definition.
1.11 “Confidential Information” has the meaning set forth in Section 8.1.
1.12 “Control” or “Controlled” means, with respect to a particular Technology, Acuitas owns or has a license to use and practice such Technology and has the right to grant a license or sublicense to such Technology without violating the terms of any agreement with any Third-Party and without owing any milestone, royalty or other monetary obligations to a Third-Party under the terms of any agreement with such Third-Party.
1.13 “Covered” and “Covering” means, with reference to a Licensed Product, that without the licenses granted to GreenLight hereunder, the manufacture, development or commercialization of such Licensed Product would infringe a Valid Claim of an LNP Technology Patent.
1.14 “Development and Option Agreement” has the meaning set forth in the Preamble.
1.15 “Diligent Efforts” means, with respect to the efforts to be expended by each Party, active and sustained efforts to conduct the applicable activity, or to attempt to achieve the applicable requirement or goal, in a prompt and expeditious manner, as is reasonably practicable under the circumstances and the terms of this Agreement.
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1.16 “Disclosing Party” has the meaning set forth in Section 8.1.
1.17 “Executive Officers” has the meaning set forth in Section 11.1(b).
1.18 “Field of Use” means all human therapeutic or prophylactic uses of Licensed Products.
1.19 “First Commercial Sale” means the first sale for use or consumption for which revenue has been recognized of any Licensed Product in a country after all required Marketing Authorization Approvals for commercial sale of such Licensed Product, and required pricing or reimbursement approvals, have been obtained in such country.
1.20 “FTE” means the work of a full-time person for one year, or more than one person working the equivalent of a full-time person for one year, where “full-time” is determined by the standard practices in the biopharmaceutical industry in the geographic area in which such personnel are working, but means 1840 hours per year, in the performance of the agreed activities for the Technology Transfer, including scientific management oversight as reasonably required.
1.21 “FTE Costs” mean the actual FTEs employed by Acuitas in the conduct of the agreed activities for the Technology Transfer multiplied by an annual rate per FTE equal to [***] (US[***]), which may be prorated on a daily or hourly basis as necessary. Such FTE Costs represent reimbursement for all costs of FTEs in providing such activities (including salaries and benefits, lab supplies, reagents, equipment and overhead, as well as other G&A costs).
1.22 “GAAP” means generally accepted accounting principles in the United States.
1.23 “GMP” means current good manufacture practices as defined under regulations promulgated by the U.S. Food and Drug Administration.
1.24 “GreenLight Indemnitees” has the meaning set forth in Section 9.6(b).
1.25 “Indemnification Claim Notice” has the meaning set forth in Section 9.6(c).
1.26 “Indemnified Party” has the meaning set forth in Section 9.6(c).
1.27 “Indemnifying Party” has the meaning set forth in Section 9.6(c).
1.28 “Insolvency Legislation” has the meaning set forth in Section 10.4.
1.29 “Joint IP” means the Joint IP as such term is defined in the Development and Option Agreement.
1.30 “Jointly Owned Patents” means the Patents listed in Appendix 1.29 hereto, as amended from time to time.
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1.31 “Know-How” means all Materials and all confidential and proprietary commercial, technical, scientific and other know-how and information, trade secrets, knowledge, technology, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, specifications, data and results (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, preclinical, clinical, safety, manufacturing and quality control data and know-how, including study designs and protocols), in all cases, provided such information is confidential and proprietary, and regardless of whether patentable, in written, electronic or any other form now known or hereafter developed.
1.32 “Know-How Royalties” has the meaning set forth in Section 4.3(a).
1.33 “Late Stage Development” means, with respect to a product, that first dosing under Phase 2 Studies has been initiated.
1.34 “Law” or “Laws” means all laws, statutes, rules, regulations, orders, judgments or ordinances having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision.
1.35 “License Agreement” has the meaning set forth in the Preamble.
1.36 “License Agreement Effective Date” has the meaning set forth in the Preamble.
1.37 “Licensed Antibody Product” has the meaning set forth in the Development and Option Agreement.
1.38 “Licensed Genome Editing Product” has the meaning set forth in the Development and Option Agreement.
1.39 “Licensed Product” means the [***]with respect to which GreenLight has exercised the Option under the Development and Option Agreement, which consists of the Targets set forth on Appendix 1.38. For the avoidance of doubt, the term Licensed Product in respect of a given Target encompasses all variants of such Target, including the wild types, naturally occurring variants, engineered variants wherein modifications to the native amino acid sequence have been made (for example, mutated versions, derivatives or fragments) and species homologs and orthologs thereof, provided, however, that any such naturally occurring variant, engineered variant or species homolog or ortholog possesses substantially similar biological activity to such Target(s) (for example antigenicity in case of antigens). In the case of [***]GreenLight may submit multiple [***]for [***]in Appendix 1.38. In the event that GreenLight wishes to include [***]after the Effective Date these additional sequences may be submitted to the Escrow Agent for review. If the Escrow Agent determines that these [***]are not subject to Pre-Existing Restrictions (at the time of review) and are published [***] for known strains or subtypes of [***] then such [***] will be included in Appendix 1.38.
1.40 “Licensed Product Royalty Term” has the meaning set forth in Section 4.3(d).
1.41 “Licensed Technology” means all Acuitas Technology as of the License Agreement Effective Date or generated or obtained during the Term (including the Acuitas Background Technology, Acuitas Sole Technology and Acuitas’ interest in any Joint IP) necessary or useful for the research, development, manufacture, use or sale of a Licensed Product including without limitation the , patents listed, in Appendix 1.40 attached hereto to be updated from time to time.
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1.42 “License Maintenance Fees” means the fees set forth in Section 4.1.
1.43 ”Licensed Vaccine Product” has the meaning set forth in the Development and Option Agreement.
1.44 “LNP” means lipid nanoparticles.
1.45 “LNP Technology” means any Technology that claims, embodies or incorporates delivery systems (and components thereof) based on or incorporating LNPs.
1.46 “LNP Technology Patent(s)” means Patents comprised in the Licensed Technology, including any future Patent which will become part of the Licensed Technology during the Term and further including Acuitas’ rights in the Jointly Owned Patents, unless otherwise set forth herein.
1.47 “Losses” has the meaning set forth in Section 9.6(a).
1.48 “Major Market Country” means each of the United States, the United Kingdom, Germany, France, Italy, Spain and Japan.
1.49 “Marketing Authorization Approval” means, with respect to a country or extra-national territory, any and all approvals (including a Biologics License Application approved by the FDA), licenses, registrations or authorizations of any Regulatory Authority necessary in order to commercially distribute, sell or market a product in such country or some or all of such extra-national territory.
1.50 “Materials” has the meaning set forth in the Development and Option Agreement.
1.51 “Milestone Event” has the meaning set forth in Section 4.2.
1.52 “Milestone Payment” has the meaning set forth in Section 4.2.
1.53 “Minimum Royalty” has the meaning set forth in Section 4.4(c).
1.54 “Net Sales” means, with respect to any Licensed Product, the amount received by GreenLight and its Affiliates and/or Sublicensees for bona fide sales of such Licensed Product to a Third-Party (other than Affiliates and Sublicensees but including distributors for resale), less:
(a) discounts (including mandated, trade, cash, quantity, prompt pay and patient program discounts), retroactive price reductions, commissions, charge-back payments and rebates granted to managed health care organizations or to federal, state and local governments, their agencies, pharmacy benefit managers, and purchasers and reimbursers or to trade customers;
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(b) credits or allowances actually granted upon claims, damaged or defective goods, refunds, rejections or returns of, and for uncollectable amounts on, such Licensed Product, including such Licensed Product returned in connection with recalls or withdrawals;
(c) freight, postage, shipping, handling and insurance charges for delivery of such Licensed Product;
(d) taxes or duties levied on, absorbed or otherwise imposed on the sale of such Licensed Product, including value-added taxes, or other governmental charges otherwise imposed upon the billed amount, such as the annual fee imposed on pharmaceutical manufacturer by the US government, as adjusted for rebates and refunds;
(e) any invoiced amounts from a prior period which are not collected and are written off by GreenLight, its Affiliates or its or their Sublicensees, including bad debts;
(f) wholesaler and distributor administration fees and other reasonable fees paid to selling agents, group purchasing organizations, Third-Party payors, other contractees and managed care entities, in each case with respect to such Licensed Product; and
(g) other customary deductions taken in the ordinary course of business in accordance with GAAP.
Net Sales shall not include any payments among GreenLight, its Affiliates and Sublicensees. Net Sales shall be determined in accordance with GAAP, consistently applied.
Net Sales for any Combination Product shall be calculated on a country-by-country basis by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B), where A is the weighted average price paid for the Licensed Product contained in such Combination Product sold separately in finished form in such country, and B is the weighted average invoice price paid for the other active ingredients (or proprietary drug delivery system or proprietary other device) contained in such Combination Product sold separately in finished form in such country, if such Licensed Product and such other active ingredients (or proprietary drug delivery system or other proprietary device) are each sold separately in such country.
Net Sales of the Licensed Product for any Combination Product if the Licensed Product or other active ingredients (or proprietary drug delivery system or other proprietary device) in such Combination Product are not sold separately in such country, shall be calculated by multiplying the Net Sales of the Combination Product by a fraction, the numerator of which shall be the fair market value of the Licensed Product as if sold separately (in accordance with GAAP), and the denominator of which shall be the aggregate fair market value of all the other active ingredients of such Combination Product, including the Licensed Product, as if sold separately. The fair market value of each component of a Combination Product will be a determined by a Third-Party expert selected by GreenLight and reasonably acceptable to Acuitas.
1.55 “Option Exercise Fee” has the meaning set forth in the Development and Option Agreement.
1.56 “Party” and “Parties” has the meaning set forth in the Preamble.
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1.57 “Patent(s)” means an (a) issued patent, a patent application, and a future patent issued from any such patent application, (b) a future patent issued from a patent application filed in any country worldwide which claims priority from a patent or patent application included in (a), (c) any additions, divisions, continuations, continuations-in-part, invention certificates, substitutions, reissues, reexaminations, extensions, registrations, utility models, supplementary protection certificates and renewals based on any patent or patent application under (a) or (b), but not including any rights that give rise to regulatory exclusivity periods (other than supplementary protection certificates, which will be treated as “Patents” hereunder), and (d) any counterpart of any patent or patent application under (a), (b) or (c) filed in any country worldwide.
1.58 “Patent Costs” means the reasonable, documented, out-of-pocket costs and expenses paid to outside legal counsel, and filing and maintenance expenses, actually and reasonably incurred by a Party in prosecuting and maintaining Patents.
1.59 “Patent Royalties” has the meaning set forth in Section 4.3(a).
1.60 “Permitted Subcontractor” has the meaning set forth in Section 2.2(c).
1.61 “Phase 1 Study” means a human clinical trial of a Licensed Product in any country, the primary purpose of which is the determination of safety and which may include the determination of metabolism and pharmacologic actions of the Licensed Product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness, as more fully defined in 21 C.F.R. §312.21(a) or its successor regulation, or the equivalent in any foreign country.
1.62 “Phase 2 Study” means a human clinical trial of a Licensed Product in any country, the primary purpose of which is to evaluate the effectiveness of the Licensed Product for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the Licensed Product, as more fully defined in 21 C.F.R. §312.21(b) or its successor regulation, or the equivalent in any foreign country.
1.63 “Phase 3 Study” means a human clinical trial of a Licensed Product in any country, the primary purpose of which is to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the Licensed Product and to provide an adequate basis for physician labeling, as more fully defined in 21 C.F.R. §312.21(c) or its successor regulation, or the equivalent in any foreign country.
1.64 “Receiving Party” has the meaning set forth in Section 8.1.
1.65 “Regulatory Authority” means any national (e.g., the United States Food and Drug Administration (“FDA”)), supra-national (e.g., the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental authority, in any jurisdiction in the world, involved in the granting of Marketing Authorization Approval.
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1.66 “Regulatory Exclusivity” means with respect to any country or other jurisdiction in the Territory, an additional market protection, other than Patent protection, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive commercialization period during which GreenLight or its Affiliates or Sublicensees have the exclusive right to market and sell a Licensed Product in such country or other jurisdiction through a regulatory exclusivity right (e.g., new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity, or any applicable data exclusivity).
1.67 “Royalties” has the meaning set forth in Section 4.3(a).
1.68 “Royalty Term” has the meaning set forth in Section 4.3(d).
1.69 “Solely Owned Technology” has the meaning set forth in Article 5.
1.70 “Sublicensee” means any Third-Party that is granted a sublicense as permitted by Section 2.2, either directly by GreenLight or its Affiliates or indirectly by any other Sublicensee hereunder.
1.71 “Targets” has the meaning set forth in the Development and Option Agreement.
1.72 “Technology” means collectively Patents and Know-How.
1.73 “Technology Evaluation Agreement” has the meaning set forth in the Development and Option Agreement.
1.74 “Technology Transfer” has the meaning set forth in Section 2.3(a). 1.75. “Technology Transfer Plan” has the meaning set forth in Section 2.3(a). 1.76. “Term” has the meaning set forth in Section 10.1.
1.75 “Territory” means worldwide.
1.76 “Third-Party” means any person or entity other than GreenLight, Acuitas and their respective Affiliates.
1.77 “Third-Party Claims” has the meaning set forth in Section 9.6(a).
1.78 “Third-Party Royalty Payments” has the meaning set forth in Section 4.3(b).
1.79 1.81. “Transferred Technology” has the meaning set forth in Section 2.3(a).
1.80 1.82. “Valid Claim” means a claim of (a) an issued patent included in the Licensed Technology (other than the Jointly Owned Patents) which has not expired or been abandoned and which has not been disclaimed, canceled, revoked or held invalid or unenforceable by a court or administrative agency of competent jurisdiction from which no further appeal is possible and that is not admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, or (b) a pending patent application included in the Licensed Technology (other than the Jointly Owned Patents) which claim is being actively prosecuted and which has not been (i) canceled, (ii) withdrawn from consideration, (iii) finally determined to be unallowable by the applicable governmental authority (and from which no appeal is or can be taken), (iv) abandoned, or (v) pending for more than five (5) years from the date of priority of such patent application.
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1.81 “Workplan Data” has the meaning set forth in the Development and Option Agreement.
1.82 “Workplan Leaders” has the meaning set forth in the Development and Option Agreement.
ARTICLE 2
License Grants; Technology Transfer
2.1 Licenses by Acuitas.
(a) Subject to the terms and conditions of this License Agreement, Acuitas hereby grants to GreenLight : a non-exclusive (except as set forth in subparts (ii) and (iii)) license, with the right to sublicense only as permitted by Section 2.2(b), under the Licensed Technology, to research, develop, have developed, make, have made, keep, use and have used, sell, offer for sale, have sold, import and have imported, export and have exported and otherwise commercialize and exploit Licensed Products in the Field of Use in the Territory
(b) Workplan Data. GreenLight may use Workplan Data generated on the Licensed Product to research, develop, have developed, make, have made, keep, use and have used, sell, offer for sale, have sold, import and have imported, export and have exported and otherwise commercialize and exploit Licensed Products in the Field of Use in the Territory.
2.2 Sublicensing Rights.
(a) Transfer. The licenses granted in Section 2.1 are transferable only upon a permitted assignment of this License Agreement in accordance with Section 11.11.
(b) GreenLight Sublicenses. The licenses granted in Section 2.1 may be sublicensed (with the right to sublicense through multiple tiers), in full or in part, by GreenLight, its Affiliates or Sublicensees to GreenLight’s Affiliates and Third Parties, provided, that for any sublicense to Third Parties:
(i) Each sublicense will be in writing and on terms consistent with and subject to the terms of this License Agreement;
(ii) GreenLight will provide Acuitas with a copy of any sublicense agreement with a Sublicensee within thirty (30) days of execution thereof, which sublicense agreement may be redacted as necessary to protect commercially sensitive information and shall be treated as GreenLight Confidential Information hereunder;
(iii) GreenLight will be responsible for any and all obligations of such Sublicensee as if such Sublicensee were GreenLight hereunder; and (iv) Any sublicense granted by GreenLight to any rights licensed to it hereunder shall terminate immediately upon the termination of the license from Acuitas to GreenLight and its Affiliates with respect to such rights,
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provided that such sublicensed rights shall not terminate if, as of the effective date of such termination pursuant to Sections 10.2, 10.3(a) or 10.4, a Sublicensee is not in material default of its obligations under its sublicense agreement, and within thirty (30) days of such termination, the Sublicensee agrees in writing to be bound directly to Acuitas under a license agreement substantially similar to this License Agreement with respect to the rights sublicensed hereunder, substituting such Sublicensee for GreenLight.
(c) Subcontractors. For clarity purposes, GreenLight is entitled to engage contract research organizations, contract manufacturing organizations and other service providers, as well as academic or non-profit institutions (each a “Permitted Subcontractor”) for the development and manufacture of Licensed Products on behalf of GreenLight. To the extent such Permitted Subcontractors require a license to perform such subcontracted activities under applicable Laws, GreenLight is entitled to grant a limited research and/or manufacturing sublicense (as applicable) without an obligation to meet the conditions of Section 2.3(b)(ii) and (iv).
2.3 Technology Transfer.
(a) Technology Transfer. After the License Agreement Effective Date and promptly upon written request by GreenLight (and in any event within ninety (90) days following designation of the applicable CMO (as defined below), provided such CMO is able to support this timeline), Acuitas will initiate the conduct of a single technology transfer of Know-How relating to the then-current formulation process, raw materials supply and analytical characterization sufficient for the manufacture of Licensed Product (the “Transferred Technology”), to GMP contract manufacturing organization (together with GreenLight as a manufacturer, for purposes of this Section 2.3(a), “CMOs”)) designated by GreenLight subject to Acuitas’ prior written consent, which will not be unreasonably withheld, conditioned or delayed and in accordance with the Development and Option Agreement (the “Technology Transfer”) pursuant to a mutually agreed plan (the “Technology Transfer Plan”). In addition, Acuitas will provide to GreenLight such other Confidential Information and Know-How relating to the then-current formulation of Licensed Product as reasonably necessary to manufacture Licensed Product, and GreenLight shall be entitled to use and disclose such Confidential Information and Know-How for such purposes. Acuitas will exercise Diligent Efforts to enable such CMOs to manufacture such Licensed Product. Initiation of such technology transfer will be determined by GreenLight and will be for the then current formulation of the Licensed Product. Acuitas will be reimbursed for such activities by GreenLight on an FTE basis and GreenLight will also be responsible for all external costs incurred by Acuitas relating to transfer of the Licensed Product formulation to such CMO provided such costs have been approved by GreenLight in advance. For clarity, the then-current formulation of the Licensed Product shall mean a single LNP formulation previously tested by GreenLight in accordance with the Workplan and as determined by the GreenLight (as defined in the Development and Option Agreement). Once the Licensed Product formulation is transferred to such CMO, GreenLight will assume responsibilities for future manufacturing of Licensed Product. Acuitas will provide reasonably requested ongoing technical support including assistance with any INDs if requested by GreenLight with such support reimbursed on a time, materials and FTE basis.
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(b) Activities. Acuitas shall in particular:
(i) transfer to the CMO all documents relating to Licensed Technology necessary or useful for the manufacture of Licensed Products, including documents relating to the Transferred Technology, and which are owned by Acuitas;
(ii) allow GreenLight to monitor the progress of the transfer and to confirm whether the transfer has been successfully completed;
(iii) provide training to the CMO by fully qualified and experienced employees or contractors of Acuitas in respect of the manufacture of Licensed Products. Unless otherwise agreed, the training will be provided at the CMO’s site. For purposes of the training, Acuitas shall make available at least two (2) experienced and competent Acuitas FTEs, the specific qualification of the Acuitas FTEs and the details of the training to be further described in the Technology Transfer Plan; and
(iv) provide ongoing technical support in relation to the Transferred Technology to the CMO, as reasonably requested by GreenLight from time to time.
(c) Diligence. Acuitas shall perform the Technology Transfer in a professional manner and in accordance with the Technology Transfer Plan and use Diligent Efforts to meet the objectives and timelines set forth therein. Acuitas shall ensure that the CMO is trained and empowered to perform the manufacturing. It is understood that successful Technology Transfer cannot be guaranteed and Acuitas will not be found not to have used Diligent Efforts based on the failure by the CMO to achieve any particular result, unless Acuitas contributed to or caused such failure.
(d) Intellectual Property. Any intellectual property generated during the Technology Transfer shall be governed by the intellectual property provisions of the Development and Option Agreement applicable to inventions arising out of the Program (as defined therein).
(e) Payment. GreenLight will reimburse Acuitas on a Calendar Quarter-by-Calendar Quarter basis for (i) FTE Costs based on the number of hours worked by Acuitas’ FTEs, and (ii) any reasonable external costs approved by GreenLight in advance that are incurred by Acuitas, in each case in the performance of the agreed technology transfer activities for the Technology Transfer. Acuitas will send a reasonably detailed invoice to GreenLight no later than fifteen (15) days after the end of each Calendar Quarter, which invoice shall include a summary of all activities by the name of each individual, number of hours devoted by each such individual, and the type/activity performed by each such individual during such Calendar Quarter, and all external costs incurred by Acuitas during such Calendar Quarter. GreenLight agrees to pay undisputed amounts in each such invoice within forty-five (45) days of GreenLight’s receipt thereof.
2.4 Updates to Appendix 1.40. Upon GreenLight’s written request no more frequently than once every twelve (12) months Acuitas shall notify GreenLight of Patents that are added to the Licensed Technology following the License Agreement Effective Date, and anyPatents that are no longer Licensed Technology because they have been abandoned or discontinued in accordance with the terms of Section 6.2. Appendix 1.40 shall be automatically updated to include any such added or deleted Patents.
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ARTICLE 3
License Limitations
No licenses or other rights are granted by Acuitas hereunder to use any trademark, trade name, trade dress or service xxxx owned or otherwise Controlled by Acuitas or any of its Affiliates. All licenses and other rights are or shall be granted only as expressly provided in this License Agreement, and no other licenses or other rights are or shall be created or granted by either Party hereunder by implication, estoppel or otherwise.
ARTICLE 4
Payments and Royalties
4.1 License Maintenance Fees. A license maintenance fee of, for the first and second Options under the Development and Option Agreement, [***], and for the third Option[***], which in each case will be payable on the first and each subsequent anniversary of the License Agreement Effective Date until such time as the first dosing of the first patient in the first Phase 1 Study for the Licensed Product anywhere in the Territory is initiated. For each Licensed Product, in the year in which the Milestone Payment for first dosing of the first patient in the first Phase 1 Study for a Licensed Product anywhere in the Territory is achieved, Acuitas will credit the License Maintenance Fee for that year on a pro rata basis against the Milestone Payment for such Milestone Event. For clarity, this pro rata credit will be up to the maximum amount owing on the milestone payable on initiation of the first Phase 1 for the remaining months in the year to which the License Maintenance Fee applies.
4.2 Milestone Payments. GreenLight will make milestone payments (each, a “Milestone Payment”) to Acuitas upon the first occurrence of each of the milestone events (each, a “Milestone Event”) by GreenLight or its Affiliates with respect to the Licensed Product as set forth below in TABLE 4.2. GreenLight will notify Acuitas of the achievement of each Milestone Event within ten (10) business days of such achievement. Each Milestone Payment will be payable to Acuitas by GreenLight within forty-five (45) days of the achievement of the specified Milestone Event and such payments when owed or paid will be non-refundable and non-creditable. If one or more of the Milestone Events set forth below are not achieved with respect to the Licensed Product for any reason, the payment for such skipped Milestone Event will be due at the same time as the payment for the next achieved Milestone Event for the Licensed Product. For clarity, each Milestone Payment is payable a maximum of one (1) time only.
TABLE 4.2– Milestone Events
First License to be taken under the Development and Option Agreement
Milestone Event |
Milestone Payment | |
[***] | [***] |
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Milestone Event |
Milestone Payment | |
Phase 1 Study for a Licensed Product anywhere in the Territory | [***] | |
[***]Phase 2 Study for a Licensed Product anywhere in the Territory | [***] | |
[***]Phase 3 Study for a Licensed Product anywhere in the Territory | [***] | |
First Marketing Authorization Approval by a Regulatory Authority for a Licensed Product in a Major Market Country | [***] | |
First Commercial Sale of a Licensed Product in a Major Market Country | [***] | |
First achievement of aggregate Net Sales of Licensed Products in a calendar year in the Territory equal to or greater than [***] | [***] |
Second License to be taken under the Development and License Agreement
Milestone Event |
Milestone Payment | |
[***]Phase 1 Study for a Licensed Product anywhere in the Territory | [***] | |
[***]Phase 2 Study for a Licensed Product anywhere in the Territory | [***] | |
[***]Phase 3 Study for a Licensed Product anywhere in the Territory | [***] | |
First Marketing Authorization Approval by a Regulatory Authority for a Licensed Product in a Major Market Country | [***] |
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Milestone Event |
Milestone Payment | |
First Commercial Sale of a Licensed Product in a Major Market Country | [***] | |
First achievement of aggregate Net Sales of Licensed Products in a calendar year in the Territory equal to or greater than [***] | [***] |
Third License to be taken under the Development and License Agreement
Milestone Event |
Milestone Payment | |
[***]Phase 1 Study for a Licensed Product anywhere in the Territory | [***] | |
[***]Phase 2 Study for a Licensed Product anywhere in the Territory | [***] | |
[***]Phase 3 Study for a Licensed Product anywhere in the Territory | [***] | |
First Marketing Authorization Approval by a Regulatory Authority for a Licensed Product in a Major Market Country | [***] | |
First Commercial Sale of a Licensed Product in a Major Market Country | [***] | |
First achievement of aggregate Net Sales of Licensed Products in a calendar year in the Territory equal to or greater than [***] | [***] |
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4.3 Royalties.
(a) Royalties. Subject to the Royalty Term, GreenLight will pay to Acuitas a royalty equal to [***] on Net Sales of all Licensed Products sold by GreenLight, its Affiliates, or Sublicensees in the Territory for which, but for the license granted to GreenLight hereunder, the manufacture or sale of such Licensed Product would infringe a Valid Claim of an LNP Technology Patent in such country (“Patent Royalties”). If, at any time during the Royalty Term, the manufacture or sale of a Licensed Product in a particular country would not infringe a Valid Claim of an LNP Technology Patent, then the Royalty rate used to calculate royalty payments on Net Sales of such Licensed Product in such country shall be the Minimum Royalty (“Know-How Royalties,” and together with the Patent Royalties, the “Royalties”).
(b) Third-Party Royalty Payments. If GreenLight or its Affiliate or Sublicensee considers it necessary or useful to obtain a license from any Third-Party under Technology relating to LNP Technology in order to develop, manufacture or commercialize a Licensed Product, the amount of GreenLight’s Royalty obligations under Section 4.3(a) will be reduced by [***] of the amount of the royalty payments made to such Third-Party (“Third-Party Royalty Payments”), provided, however, that such reduction shall not result in less than the Minimum Royalty.
(c) Minimum Royalty. In no event will the Royalty payable by GreenLight to Acuitas for any Licensed Product and without regard to any Royalty reductions under subparagraph (a) and/or (b) above, be less than the Royalty payable using a royalty rate of [***] (the “Minimum Royalty”).
(d) Royalty Term. The Royalty term (“Royalty Term”) shall be determined on a country-by-country and Licensed Product-by-Licensed Product basis and shall commence on the First Commercial Sale of a Licensed Product in such country and shall expire on the last to occur of (i) the expiration of the last to expire Valid Claim in the Licensed Technology that Covers the Licensed Product in such country, (ii) the expiration of any period of Regulatory Exclusivity, if any, for the Licensed Product in such country, and (iii) ten (10) years from the First Commercial Sale of Licensed Product in such country (the “Licensed Product Royalty Term”). Thereafter, GreenLight’s licenses under Section 2.1 will become irrevocable, fully paid-up and royalty-free on a country-by-country and Licensed Product-by-Licensed Product basis.
(e) For the avoidance of doubt, GreenLight’s obligation to pay Royalties under this Section 4.3 is imposed only once at the applicable Royalty rate set forth in this Section 4.3 with respect to the same unit of Licensed Product, notwithstanding that such Licensed Product may be Covered by more than one Valid Claim of an LNP Technology Patent.
4.4 Payment Terms.
(a) Manner of Payment; Invoices. All amounts specified in this License Agreement are in U.S. dollars and all payments to be made by GreenLight hereunder will be made in U.S. dollars by wire transfer to such bank account as Acuitas may designate. All invoices to be delivered to GreenLight hereunder shall be delivered in accordance with Section 11.12 or in such other manner specified by GreenLight from time to time.
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(b) Records and Audits. GreenLight shall keep, and shall cause each of its Affiliates and Sublicensees, as applicable, to keep adequate books and records of accounting for the purpose of calculating all Royalties payable to Acuitas hereunder. For the three (3) years next following the end of the calendar year to which each shall pertain, such books and records of accounting of GreenLight (including those of GreenLight’s Affiliates) shall be kept at each of their principal places of business and shall be open for inspection at reasonable times and upon reasonable notice by an independent certified accountant selected by Acuitas, and which is reasonably acceptable to GreenLight, for the sole purpose of inspecting the Royalties due to Acuitas under this License Agreement. In no event shall such inspections be conducted hereunder more frequently than once every twelve (12) months or more than once for the same time period. Such accountant must have executed and delivered to GreenLight and its Affiliates a confidentiality agreement as reasonably requested by GreenLight, which shall include provisions limiting such accountant’s disclosure to Acuitas to only the results and basis for such results of such inspection. The results of such inspection, if any, shall be binding on both Parties absent manifest error. Any underpayments shall be paid by GreenLight within thirty (30) days of notification of the results of such inspection. Any overpayments shall be fully creditable against amounts payable in subsequent payment periods, or, upon the request of GreenLight, paid by Acuitas to GreenLight within thirty (30) days of notification of the results of such inspection. Acuitas shall pay for such inspections, except that in the event there is any upward adjustment in aggregate Royalties payable for any calendar year shown by such inspection of more than [***] of the amount paid, GreenLight shall reimburse Acuitas for any reasonable out-of-pocket costs of such accountant.
(c) Reports and Royalty Payments. For as long as Royalties are due under Section 4.4, GreenLight shall furnish to Acuitas a written report for each Calendar Quarter, showing the amount of Net Sales of Licensed Products and Royalties due for such Calendar Quarter. Reports shall be provided within forty-five (45) days of the end of the Calendar Quarter for Net Sales generated by GreenLight and its Affiliates, and within sixty (60) days of the end of the Calendar Quarter for Net Sales generated by Sublicensees. Royalty payments for each Calendar Quarter shall be due at the same time as the last such written report for the Calendar Quarter. The report shall include, at a minimum, the following information for the applicable Calendar Quarter, each listed by Licensed Product and by country of sale: (i) the number of units of Licensed Products sold by GreenLight and its Affiliates and Sublicensees on which Royalties are owed to Acuitas hereunder; (ii) the gross amount received for such sales; (iii) Net Sales; (iv) the amounts of any credits or reductions permitted by Section 4.3; and (v) the computations for any Acuitas currency conversions pursuant to subsection (d) below. GreenLight will require each Sublicensee to share with GreenLight the information listed in the foregoing clauses as it relates to Net Sales made by such Sublicensee, and to the extent practicable, will include such Sublicensee information in such report. All such reports shall be treated as Confidential Information of GreenLight.
(d) Currency Exchange. With respect to Net Sales invoiced in U.S. dollars, the Net Sales and the amounts due to Acuitas hereunder will be expressed in U.S. dollars. With respect to Net Sales invoiced in a currency other than U.S. dollars, payments will be calculated based on standard methodologies employed by GreenLight or its Affiliates or Sublicensees for consolidation purposes for the Calendar Quarter for which remittance is made for Royalties.
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(e) Taxes. GreenLight may withhold from payments due to Acuitas amounts for payment of any withholding tax that is required by Law to be paid to any taxing authority with respect to such payments. GreenLight will provide Acuitas all relevant documents and correspondence and will also provide to Acuitas any other cooperation or assistance on a reasonable basis as may be necessary to enable Acuitas to claim exemption from such withholding taxes and to receive a refund of such withholding tax or claim a foreign tax credit. GreenLight will give proper evidence from time to time as to the payment of any such tax. The Parties will cooperate with each other in seeking deductions under any double taxation or other similar treaty or agreement from time to time in force. Such cooperation may include GreenLight making payments from a single source in the U.S., where possible. Apart from any such permitted withholding and those deductions expressly included in the definition of Net Sales, the amounts payable by GreenLight to Acuitas hereunder will not be reduced on account of any taxes, charges, duties or other levies.
(f) Blocked Payments. In the event that, by reason of applicable Law in any country, it becomes impossible or illegal for GreenLight or its Affiliates or Sublicensees to transfer, or have transferred on its behalf, payments owed to Acuitas hereunder, GreenLight will promptly notify Acuitas of the conditions preventing such transfer and such payments will be deposited in local currency in the relevant country to the credit of Acuitas in a recognized banking institution designated by Acuitas or, if none is designated by Acuitas within a period of thirty (30) days, in a recognized banking institution selected by GreenLight or its Affiliate or Sublicensee, as the case may be, and identified in a written notice given to Acuitas.
(g) Interest Due. If any payment due to Acuitas under this License Agreement is overdue (and is not subject to a good faith dispute), then GreenLight will pay interest thereon (before and after any judgment) at an annual rate of the lesser of two percent (2%) above the prime rate as reported in The Wall Street Journal, Eastern Edition, and the maximum rate permitted by applicable Law, such interest to run from the date upon which payment of such sum became due until payment thereof in full together with such interest.
(h) Mutual Convenience of the Parties. The Royalty and other payment obligations set forth hereunder have been agreed to by the Parties for the purpose of reflecting and advancing their mutual convenience, including the ease of calculating and paying Royalties and other amounts to Acuitas.
ARTICLE 5
Ownership and Inventorship of IP
As between the Parties, and except as set forth in Section 2.3(d) or in the Development and Option Agreement, each Party will own and retain all right, title and interest in and to any and all Know-How, and Patents arising therefrom, that are discovered, created, conceived, developed or reduced to practice solely by or on behalf of such Party under or in connection with activities under this License Agreement (“Solely Owned Technology”). Subject to the licenses hereunder and the other terms and conditions of this License Agreement or any other agreement between the Parties, each Party will be solely responsible for the prosecution and maintenance, and the enforcement and defense, of any Patents within its Solely Owned Technology.
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ARTICLE 6
Patent Prosecution and Maintenance
6.1 Generally. As between the Parties and subject to Section 6.2 below, Acuitas will have the sole right, at its sole cost, to prosecute and maintain LNP Technology Patents. Notwithstanding the foregoing, prosecution and maintenance with respect to the Jointly Owned Patents shall be handled as provided in the Development and Option Agreement provisions for Joint IP.
6.2 Election Not to Prosecute or Maintain or Pay Patent Costs. If Acuitas elects not (i) to file, prosecute or maintain any LNP Technology Patents for which it is responsible under Section 6.1 in any particular country before the applicable filing deadline or continue such activities once filed in a particular country, or (ii) to pay the Patent Costs associated with prosecution or maintenance of any such LNP Technology Patents, then in each such case Acuitas will so notify GreenLight, promptly in writing and in sufficient time to enable Acuitas to meet any deadlines by which an action must be taken to preserve such LNP Technology Patent in such country, if GreenLight so requests. Upon receipt of each such notice by Acuitas, GreenLight will have the right, but not the obligation, to notify Acuitas in writing on a timely basis that Acuitas should continue the prosecution and/or maintenance of such LNP Technology Patent in the respective country, and thereafter, (a) Acuitas would prosecute and maintain such LNP Technology Patent in such country at the direction and expense of GreenLight and any other Acuitas Third-Party licensee of such LNP Technology Patent so electing (on a pro rata basis), (b) Acuitas would make available to GreenLight all documentation and correspondence with respect to such LNP Technology Patent, and (c) GreenLight’s licenses to such LNP Technology Patent under Section 2.1 will automatically become irrevocable, perpetual, fully paid-up and royalty free but such LNP Technology Patent will thereafter no longer be part of the Licensed Technology in such country for all other purposes of this License Agreement (e.g., such LNP Technology Patent will not be considered for purposes of determining whether a Valid Claim exists in a particular country). GreenLight is entitled to discontinue the payment of Patent Costs for any LNP Technology Patents at any time, provided that it will so notify Acuitas in writing in time for such discontinuance.
6.3 Regulatory Exclusivity Periods. With respect to any Patent term extension, supplemental protection certificate or any other Patent listing or extension with respect to any LNP Technology Patent Covering a Licensed Product, the Parties will discuss and seek to reach mutual agreement, subject to applicable Law, on which LNP Technology Patents will be subject to such action, and once such agreement is reached, Acuitas will cooperate with such action. Except where required under applicable Law, without the written consent of GreenLight, Acuitas will not apply for, and is not authorized under this License Agreement to apply for, any Patent term extension, supplemental protection certificate or any other Patent listing or extension required for any regulatory exclusivity periods for any Licensed Product. For the avoidance of doubt, Acuitas is not restricted from applying for any Patent term extension, supplemental protection certificate or any other Patent listing or extension required for any regulatory exclusivity periods for any product but the Licensed Products.
6.4 Patent Listings. GreenLight shall have the sole right, in its sole discretion, to make all filings with Regulatory Authorities in the Territory for the Licensed Products in the FDA’s Orange Book or Purple Book or in response to a biosimilar application under Section 351(k) of the Public Health Service Act, and under any similar or equivalent Laws in other countries or jurisdictions. For avoidance of doubt, GreenLight shall have the right to include in such filings patents Controlled by Acuitas, as applicable.
6.5 Cooperation. Each Party will reasonably cooperate with the other Party in those activities involving the LNP Technology Patents set forth in Sections 6.1 to 6.4. Such cooperation includes promptly executing all documents, or requiring inventors, subcontractors, employees and consultants and agents of GreenLight and Acuitas and their respective Affiliates and Sublicensees to execute all documents, as reasonable and appropriate so as to enable such activities in respect of any such LNP Technology Patents in any country.
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ARTICLE 7
Patent Enforcement and Defense
7.1 Notice; General. To the extent not in breach of an obligation of confidentiality, each Party will promptly notify, in writing, the other Party upon learning of any actual or suspected infringement of any LNP Technology Patents by a Third-Party, or of any claim of invalidity, unenforceability, or non-infringement of any LNP Technology Patents, and will, along with such notice, supply the other Party with any evidence in its possession pertaining thereto. Enforcement and defense of Jointly Owned Patents shall be handled pursuant to the Development and Option Agreement provisions for Joint IP.
7.2 Enforcement and Defense.
(a) Enforcement.
(i) As between the Parties, Acuitas will have the first right, but not the obligation, at its sole cost to seek to xxxxx any infringement of the LNP Technology Patents other than the Jointly Owned Patents (the “Acuitas Patents”) by a Third-Party, or to file suit against any such Third-Party for such infringement. If Acuitas elects not to exercise its first right to take action or to bring suit to prosecute such infringement or to continue such action or suit, it shall notify GreenLight in writing of such election within thirty (30) days after becoming aware of or receipt of the notice of the infringement or within fifteen (15) days after the election to stop any such action or suit, as applicable. If after the expiration of the thirty (30) day period (or, if earlier, the date upon which Acuitas provides written notice that it does not plan to bring such action), Acuitas has neither obtained a discontinuance of infringement nor filed suit against any such Third-Party infringer of such Patent, or in the case of an election by Acuitas not to continue to prosecute an infringement of an Acuitas Patent, GreenLight shall have the right, but not the obligation, to take action or bring suit against such Third-Party infringer of Acuitas Patents to the extent the Acuitas Patents are necessary or useful for the research, development, manufacturing and commercialization of the Licensed Product but not necessary or useful for the research, development, manufacturing or commercialization of any other LNP comprising product covered by such Acuitas Patent that is licensed or optioned by Acuitas to a Third-Party or is under Late Stage Development by Acuitas, and Acuitas shall join such suit as plaintiff to the extent required by applicable law, provided that GreenLight shall bear all of the expense of such abatement action or suit.
(ii) Enforcement and defense of the Jointly Owned Patents will be as set forth in the Development and Option Agreement for Joint IP.
(iii) For clarity, GreenLight shall have the sole right to enforce any Patents owned or controlled by GreenLight, other than (for avoidance of doubt) the LNP Technology Patents.
(b) Defense.
(i) As between the Parties, Acuitas will have the first right, but not the obligation, at its sole cost, to defend against a declaratory judgment action or other action to the extent challenging the validity or enforceability of any Acuitas Patent. GreenLight will have the right but not the obligation, at its sole cost, to defend against any other declaratory judgment action or other action challenging any Acuitas Patent that, on the date of first notice of such action, are not necessary or useful for the research, development, manufacturing and commercialization of any lipid nanoparticle comprising product that is licensed or optioned by Acuitas to a Third-Party or is under Late Stage Development by Acuitas. If Acuitas does not take steps to defend within a commercially reasonable time, or elects not to continue any such defense (in which case it will promptly provide notice thereof to GreenLight), then GreenLight shall have the right, but not the obligation, to defend any Acuitas Patents that cover a Licensed Product and no other product licensed or optioned by Acuitas to a Third-Party or commercialized by Acuitas provided that GreenLight shall bear all the expenses of such suit.
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(ii) In the event that any action, suit or proceeding is brought against either Party or an Affiliate of either Party, or a Sublicensee of GreenLight or its Affiliates, alleging the infringement of the Patents or Know-How of a Third-Party by the research, development, manufacture, use, sale, import, export, commercialization or exploitation of a Licensed Product, such Party shall promptly notify the other Party within five (5) business days of the earlier of (x) receipt of service of process in such action, suit or proceeding, or (y) the date such Party becomes aware that such action, suit or proceeding has been instituted.
(iii) (For clarity, GreenLight shall have the sole right to defend any Patents owned or controlled by GreenLight, other than (for avoidance of doubt) the LNP Technology Patents or Joint Patents.
(c) Response to Infringement Claims. Notwithstanding the foregoing, any response to a Third-Party infringer’s counterclaim of invalidity or unenforceability of any LNP Technology Patents shall be controlled by the Party who controls the relevant enforcement proceeding pursuant to Section 7.2(a) unless otherwise mutually agreed by the Parties.
(d) Withdrawal, Cooperation and Participation. With respect to any infringement or defensive action regarding Acuitas Patents identified above in this Section 7.2:
(i) The non-controlling Party will cooperate with the Party controlling any such action (as may be reasonably requested by the controlling Party), including by (A) providing access to relevant documents and other evidence, (B) making its and its Affiliates and Sublicensees and all of their respective employees, subcontractors, consultants and agents available at reasonable business hours and for reasonable periods of time, but only to the extent relevant to such action, and (C) if necessary, being joined as a party, subject for this clause (C) to the controlling Party agreeing to indemnify such non-controlling Party for its involvement as a named party in such action and paying those Losses incurred by such Party in connection with such joinder. The Party controlling any such action will keep the other Party updated with respect to any such action, including providing copies of all documents received or filed in connection with any such action.
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(ii) Each Party will have the right to participate or otherwise be involved in any such action controlled by the other Party, in each case at the participating (i.e., non-controlling) Party’s sole cost and expense. If a Party elects to so participate or be involved, the controlling Party will provide the participating Party and its counsel with an opportunity to consult with the controlling Party and its counsel regarding the prosecution of such action (including reviewing the contents of any correspondence, legal papers or other documents related thereto), and the controlling Party will take into account reasonable requests of the participating Party regarding such enforcement or defense.
(e) Settlement. Neither Party will settle or consent to an adverse judgment in any action which affects the scope, validity or enforcement of any LNP Technology Patents involved therewith, without the prior written consent of the other Party (such consent not to be unreasonably withheld, conditioned or delayed); provided, that this Section 7.2(e) shall not apply to the extent that such settlement or consent to an adverse judgment does not relate to an LNP Technology Patent.
(f) Damages. Unless otherwise agreed by the Parties, all monies recovered upon the final judgment or settlement of any action which may be controlled by either GreenLight or Acuitas and described in Section 7.2(a) or 7.2(b) in each case will be used first to reimburse the controlling Party, and thereafter the non-controlling Party, for each of their out-of-pocket costs and expenses relating to the action, with the balance of any such recovery to be divided as follows:
(i) To the extent such recovery reflects lost profits damages or a reasonable royalty with respect to Licensed Products, GreenLight will retain such lost profits recovery, less the amount of Royalties payable to Acuitas by treating such lost profits recovery as “Net Sales” hereunder; and
(ii) Any other recovery based on Licensed Products will be allocated seventy-five percent (75%) to the Party controlling the action and twenty-five percent (25%) to the other Party; provided, that if such action is controlled by GreenLight and does not relate to an LNP Technology Patent or a Joint Patent then any other recovery will be allocated one hundred percent (100%) to GreenLight.
ARTICLE 8
Confidentiality
8.1 Confidential Information. Each Party (“Disclosing Party”) may disclose to the other Party (“Receiving Party”) and Receiving Party may acquire during the course and conduct of activities under this License Agreement, certain proprietary or confidential information of Disclosing Party in connection with this License Agreement. The term “Confidential Information” means all Confidential Information as defined in or disclosed pursuant to the
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Development and Option Agreement, the terms of this Agreement, and all information of any kind, whether in written, oral, graphical, machine-readable or other form, whether or not marked as confidential or proprietary, that is disclosed or made available by or on behalf of the Disclosing Party to or on behalf of the Receiving Party in connection with this License Agreement.
8.2 Restrictions. During the Term and for ten (10) years [or for so long as any trade secret has value derived from its confidentiality if longer than ten (10) years] thereafter, or with respect to any trade secret included in the Confidential Information for so long as such trade secret is protected under applicable Laws (provided, that Receiving Party has not publicly disclosed such trade secret in breach of its obligations under this Article 8), Receiving Party will keep all Disclosing Party’s Confidential Information in confidence with the same degree of care with which Receiving Party holds its own confidential information, but in no event less than reasonable care. Receiving Party will not use Disclosing Party’s Confidential Information except in connection with the performance of its obligations and exercise of its rights under this License Agreement. Receiving Party has the right to disclose Disclosing Party’s Confidential Information without Disclosing Party’s prior written consent to Receiving Party’s Affiliates, and each of their employees, subcontractors, consultants and agents, in each case who have a need to know such Confidential Information in order to perform their obligations under and exercise their rights under this License Agreement and who are under written obligation to comply with the restrictions on use and disclosure that are no less restrictive than those set forth in this Section 8.2. Receiving Party assumes responsibility for such entities and persons maintaining Disclosing Party’s Confidential Information in confidence and using same only for the purposes described herein.
8.3 Exceptions. Receiving Party’s obligation of nondisclosure and the limitations upon the right to use the Disclosing Party’s Confidential Information will not apply to a specific portion of the Disclosing Party’s Confidential Information to the extent that Receiving Party can demonstrate that such portion: (a) was known to Receiving Party or any of its Affiliates prior to the time of disclosure by the Disclosing Party without obligation of confidentiality; (b) is or becomes public knowledge through no fault or omission of Receiving Party or any of its Affiliates; (c) is obtained on a non-confidential basis by Receiving Party or any of its Affiliates from a Third-Party who is lawfully in possession thereof and under no obligation of confidentiality to Disclosing Party; or (d) has been independently developed by or on behalf of Receiving Party or any of its Affiliates without the aid, application or use of Disclosing Party’s Confidential Information as evidenced by written records.
8.4 Permitted Disclosures. Receiving Party may disclose Disclosing Party’s Confidential Information to the extent (and only to the extent) such disclosure is permitted under Section 8.2 or is reasonably necessary in the following instances:
(a) in order and to the extent required to comply with applicable Laws (including any securities Laws or regulations or the rules of a securities exchange applicable to Receiving Party) or with orders in connection with a legal or administrative proceeding;
(b) in connection with litigation between the Parties;
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(c) in connection with filing, prosecuting and enforcing LNP Technology Patents in connection with Receiving Party’s rights and obligations pursuant to this License Agreement;
(d) to acquirers, subject to Section 11.11, or permitted assignees, investment bankers, investors and lenders, including pursuant to a bona fide diligence review by potential acquirers, assignees, investment bankers, investors and lenders; and
(e) in the case of GreenLight, to (i) Permitted Subcontractors, (ii) licensees, Sublicensees, assignees and collaboration partners, or (iii) potential subcontractors, licensees, Sublicensees, assignees or collaboration partners, but in case (iii) only such information that is reasonably necessary or useful for the potential licensee, Sublicensee, assignee or collaboration partner to evaluate the Licensed Product and LNP/Licensed Product manufacturing processes; provided, that (1) where reasonably possible, Receiving Party will notify Disclosing Party of Receiving Party’s intent to make any disclosure pursuant to subsection (a) sufficiently prior to making such disclosure so as to assist and allow Disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information to be disclosed, including obtaining an adequate protective order, and (2) with respect to subsections (c) and (d), each of those entities are required to comply with the restrictions on use and disclosure in Section 8.2 (other than investment bankers, investors and lenders, which must be bound prior to disclosure by commercially reasonable obligations of confidentiality).
8.5 Return of Confidential Information. Upon expiry or earlier termination of this License Agreement, each Party will destroy or return (as shall be specified by the other Party) to the other Party all copies of the Confidential Information of the other Party; provided, that a Party may retain: (a) one copy of such Confidential Information for record-keeping purposes, for the sole purpose of ensuring compliance with this License Agreement; (b) any copies of such Confidential Information as is required to be retained under applicable Laws; (c) any copies of such Confidential Information as are necessary or useful for such Party to exercise a right or fulfill an obligation hereunder; and (c) any copies of any computer records and files containing Confidential Information that have been created by such Party’s routine archiving/backup procedures, in each case provided that such copies are maintained in accordance with this Article 8.
8.6 Publications. Notwithstanding anything in this License Agreement to the contrary, only GreenLight is permitted to publish the results of its development under this License Agreement, provided, however, that it will not disclose Acuitas Confidential Information (as defined in the Development and Option Agreement) in any publication by GreenLight of the results of any Licensed Product development by GreenLight without Acuitas’ prior written consent, which will not be unreasonably withheld, conditioned or delayed. GreenLight will comply with standard academic practice regarding authorship of scientific publications and recognition of the contributions of other parties in any scientific publications.
8.7 Terms of this License Agreement; Publicity. The Parties agree that the existence and terms of the Parties’ relationship and this License Agreement will be treated as Confidential Information of both Parties, and thus may be disclosed only as permitted by Sections 8.2 or 8.4. Except as required by applicable Laws (including any securities Laws or the regulations or rules
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of a securities exchange) or otherwise agreed by the Parties in writing, each Party agrees not to issue any press release or public statement disclosing information relating to the existence of this License Agreement or the transactions contemplated hereby or the terms hereof without the prior written consent of the other Party.
ARTICLE 9
Warranties; Limitations of Liability; Indemnification
9.1 Representations and Warranties. Each Party represents and warrants to the other as of the License Agreement Effective Date that:
(a) it is a corporation duly organized, validly existing, and in good standing under the Laws of the jurisdiction in which it is incorporated,
(b) it has the legal right and power to enter into this License Agreement, to extend the rights and licenses granted or to be granted to the other in this License Agreement, and to fully perform its obligations hereunder,
(c) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this License Agreement and the performance of its obligations hereunder,
(d) this License Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms,
(e) the execution, delivery and performance of this License Agreement by such Party does not violate any Law of any court, governmental body or administrative or other agency having jurisdiction over such Party, and
(f) no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable Laws currently in effect, is necessary for the transactions contemplated by this License Agreement or for the performance of its obligations under this License Agreement.
9.2 Additional Representations of Acuitas. Except as set forth on Appendix 9.2, Acuitas hereby represents and warrants to GreenLight as of the License Agreement Effective Date as follows:
(a) Impairment. Neither Acuitas nor any of its Affiliates has entered into as of the Effective Date any agreement or otherwise licensed, granted, assigned, transferred, conveyed or otherwise encumbered or disposed of any right, title or interest in or to any of its assets, including any Technology, that would in any way conflict with or impair the scope of any rights or licenses granted to GreenLight hereunder. .
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(b) Patents and Know-How. Appendix 1.40 sets forth a complete and accurate list of all LNP Technology Patents . Acuitas Controls, and will Control during the Term, the Licensed Technology, and is entitled to grant the licenses specified herein. All Acuitas inventors of the Licensed Technology have validly assigned their rights to the Licensed Technology to Acuitas. To Acuitas’ knowledge, the LNP Technology Patents have been diligently prosecuted and maintained in accordance with applicable Laws. None of the LNP Technology Patents are or have been involved in any opposition, cancellation, interference, reissue or reexamination proceeding, and to Acuitas’ knowledge as of the License Agreement Effective Date, no Licensed Technology is the subject of any judicial, administrative or arbitral order, award, decree, injunction, lawsuit, proceeding or stipulation. As of the License Agreement Effective Date, neither Acuitas nor any of its Affiliates has received any notice alleging that the LNP Technology Patents are invalid or unenforceable or challenging Acuitas’ ownership of or right to use the Licensed Technology.
(c) Entire LNP Technology. The Acuitas Technology licensed to GreenLight under this License Agreement comprises all LNP Technology owned or Controlled by Acuitas.
(d) Encumbrances. Acuitas and its Affiliates are not subject to any payment obligations to Third Parties as a result of the execution or performance of this License Agreement. As of the License Agreement Effective Date, neither Acuitas nor any of its Affiliates has granted any liens or security interests on the Licensed Technology, and the Licensed Technology as licensed hereby is free and clear of any mortgage, pledge, claim, security interest, covenant, easement, encumbrance, lien or charge of any kind.
(e) Defaults. The execution, delivery and performance by Acuitas of this License Agreement and the consummation of the transactions contemplated hereby will not result in any violation of, conflict with, result in a breach of or constitute a default under any understanding, contract or agreement to which Acuitas is a party or by which it is bound, in each case as would reasonably be expected to have an adverse effect on the rights granted to GreenLight hereunder.
(f) Litigation. There is no action, suit, proceeding or investigation pending or, to the knowledge of Acuitas, currently threatened in writing against or affecting Acuitas that questions the validity of this License Agreement, the right of Acuitas to enter into this License Agreement or consummate the transactions contemplated hereby or that relates to the Licensed Technology.
(g) Infringement. Neither Acuitas nor any of its Affiliates has received any notice of any claim, nor does Acuitas or its Affiliates have any knowledge of any reasonable basis for any claim, that any Patent, Know-How or other intellectual property owned or controlled by a Third-Party would be infringed or misappropriated by the practice of any Licensed Technology in connection with the production, use, research, development, manufacture or commercialization of any Licensed Product. .
(h) Third-Party Infringement. To Acuitas’ knowledge, no Third-Party is infringing or has infringed any Patent within the Licensed Technology or is misappropriating or has misappropriated any Know-How within the Licensed Technology.
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9.3 Disclaimers. Without limiting the respective rights and obligations of the Parties expressly set forth herein, each Party specifically disclaims any guarantee that any Licensed Product will be successful, in whole or in part. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS LICENSE AGREEMENT, THE PARTIES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTY OF ANY KIND UNDER THIS LICENSE AGREEMENT, EITHER EXPRESS OR IMPLIED.
9.4 No Consequential Damages. NOTWITHSTANDING ANYTHING IN THIS LICENSE AGREEMENT OR OTHERWISE, NEITHER PARTY WILL BE LIABLE TO THE OTHER OR ANY THIRD-PARTY WITH RESPECT TO ANY SUBJECT MATTER OF THIS LICENSE AGREEMENT FOR ANY INDIRECT, PUNITIVE, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES; PROVIDED THAT THIS SECTION 9.4 WILL NOT APPLY TO BREACHES OF A PARTY’S OBLIGATIONS UNDER ARTICLE 8 OR THE PARTIES’ INDEMNIFICATION RIGHTS AND OBLIGATIONS UNDER SECTION 9.6.
9.5 Performance by Others. The Parties recognize that each Party may perform some or all of its obligations under this License Agreement through Affiliates and Third-Party agents provided, however, that each Party will remain responsible and liable for the performance by its Affiliates and Third-Party agents and will cause its Affiliates and Third-Party agents to comply with the applicable provisions of this License Agreement in connection therewith.
9.6 Indemnification.
(a) Indemnification by GreenLight. GreenLight will indemnify Acuitas, its Affiliates and their respective directors, officers, employees and agents, and their respective successors, heirs and assigns (collectively, “Acuitas Indemnitees”), and defend and hold each of them harmless, from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) (collectively, “Losses”) in connection with any and all suits, investigations, claims or demands of Third Parties (collectively, “Third-Party Claims”) against the Acuitas Indemnitees to the extent arising from or occurring as a result of: (i) the breach by GreenLight of any provision of this License Agreement; (ii) any negligence or willful misconduct on the part of any GreenLight Indemnitee in connection with this Agreement; or (iii) the development or commercialization by or on behalf of GreenLight or any of its Affiliates or Sublicensees of Licensed Products other than if related to a Licensed Technology component thereof, except in each case (i)-(iii) to the extent Acuitas is obligated to indemnify GreenLight in accordance with Section 9.6(b) of this License Agreement.
(b) Indemnification by Acuitas. Acuitas will indemnify GreenLight, its Affiliates, its Sublicensees and their respective directors, officers, employees and agents, and their respective successors, heirs and assigns (collectively, “GreenLight Indemnitees”), and defend and hold each of them harmless, from and against any and all Losses in connection with any and all Third-Party Claims against GreenLight Indemnitees to the extent arising from or occurring as a result of: (i) the breach by Acuitas of any provision of this License Agreement; or (ii) any negligence or willful misconduct on the part of any Acuitas Indemnitee in connection with this Agreement; except in each case (i)-(ii) to the extent GreenLight is obligated to indemnify Acuitas in accordance with Section 9.6(a) of this License Agreement.
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(c) Notice of Claim. All indemnification claims provided for in Sections 9.6(a) and 9.6(b) will be made solely by such Party to this License Agreement (the “Indemnified Party”). The Indemnified Party will promptly notify the Indemnifying Party (the “Indemnifying Party”) in writing of any Losses or the discovery of any fact upon which the Indemnified Party intends to base a request for indemnification under Section 9.6(a) and 9.6(b) (each such notice, an “Indemnification Claim Notice”), provided that the failure to promptly provide such notice and details shall not relieve the Indemnifying Party of any of its indemnification obligations hereunder except to the extent that the Indemnifying Party’s defense of the relevant Third-Party Claim is prejudiced by such failure. Each Indemnification Claim Notice must contain a description of the claim and the nature and estimated amount of such Loss (to the extent that the nature and amount of such Loss is known at such time). The Indemnified Party will furnish promptly to the Indemnifying Party copies of all papers and official documents received in respect of any Losses and Third-Party Claims.
(d) Defense, Settlement, Cooperation and Expenses.
(i) Control of Defense. At its option, the Indemnifying Party may assume the defense of any Third-Party Claim by giving written notice to the Indemnified Party within thirty (30) days after the Indemnifying Party’s receipt of an Indemnification Claim Notice. Upon assuming the defense of a Third-Party Claim, the Indemnifying Party may appoint as lead counsel in the defense of the Third-Party Claim any legal counsel selected by the Indemnifying Party (the Indemnifying Party will consult with the Indemnified Party with respect to such counsel and a possible conflict of interest of such counsel retained by the Indemnifying Party). In the event the Indemnifying Party assumes the defense of a Third-Party Claim, the Indemnified Party will immediately deliver to the Indemnifying Party all original notices and documents (including court papers) received by the Indemnified Party in connection with the Third-Party Claim.
(ii) Right to Participate in Defense. Without limiting Section 9.6(d)(i), any Indemnified Party will be entitled to participate in, but not control, the defense of such Third-Party Claim and to employ counsel of its choice for such purpose; provided, however, that such employment will be at the Indemnified Party’s own cost and expense unless (A) the Indemnifying Party has failed to assume the defense and employ counsel in accordance with Section 9.6(d)(i) (in which case the Indemnified Party will control the defense), (B) the Indemnifying Party is not diligently defending the interests of both Parties, or (C) the interests of the Indemnified Party and the Indemnifying Party with respect to such Third-Party Claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under applicable Law, ethical rules or equitable principles, in which case the Indemnifying Party will assume one hundred percent (100%) of any such costs and expenses of counsel for the Indemnified Party.
(iii) Settlement. With respect to any Third-Party Claims that relate solely to the payment of money damages in connection with a Third-Party Claim and that will not (A) result in the Indemnified Party’s becoming subject to injunctive or other relief, (B) include any admission or concession of liability or wrongdoing on the part of the Indemnified Party, or (C) otherwise adversely affect the business of the Indemnified Party in any manner, and as to which the Indemnifying Party will have acknowledged in writing the obligation to indemnify the Indemnified Party hereunder, the Indemnifying Party will have the sole right to agree to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, on such terms as the
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Indemnifying Party, in its sole discretion, will deem appropriate, provided that such settlement or other disposition results in a complete release of all such Third-Party Claims. With respect to all other Losses in connection with Third-Party Claims, where the Indemnifying Party has assumed the defense of the Third-Party Claim in accordance with Section 9.6(d)(i), the Indemnifying Party will have authority to agree to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss only if it obtains the prior written consent of the Indemnified Party (such consent not to be unreasonably withheld, delayed or conditioned). The Indemnifying Party will not be liable for any settlement or other disposition of a Loss by an Indemnified Party that is reached without the prior written consent of the Indemnifying Party. Regardless of whether the Indemnifying Party chooses to defend or prosecute any Third-Party Claim, no Indemnified Party will admit any liability with respect to or settle, compromise or discharge, any Third-Party Claim without the prior written consent of the Indemnifying Party, such consent not to be unreasonably withheld, delayed or conditioned.
(iv) Cooperation. Regardless of whether the Indemnifying Party chooses to defend or prosecute any Third-Party Claim, the Indemnified Party will, and will cause each other Indemnified Party to, cooperate in the defense or prosecution thereof and will furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith, at the Indemnifying Party’s expense. Such cooperation will include access during normal business hours afforded to the Indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Third-Party Claim, and making Indemnified Parties and other employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the Indemnifying Party will reimburse the Indemnified Party for all its reasonable out-of-pocket costs and expenses in connection therewith.
(v) Costs and Expenses. Except as provided above in this Section 9.6(d), the costs and expenses, including attorneys’ fees and expenses, incurred by the Indemnified Party in connection with any claim will be reimbursed on a Calendar Quarter basis by the Indemnifying Party, without prejudice to the Indemnifying Party’s right to contest the Indemnified Party’s right to indemnification and subject to prompt refund in the event the Indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party.
9.7 Insurance. Each Party will maintain at its sole cost and expense, an adequate liability insurance or self-insurance program (including product liability insurance) to protect against potential liabilities and risk arising out of activities to be performed under this License Agreement and upon such terms (including coverages, deductible limits and self-insured retentions) as are customary in the respective industry of such Party for the activities to be conducted by such Party under this License Agreement. Subject to the preceding sentence, such liability insurance or self-insurance program will insure against all types of liability, including personal injury, physical injury or property damage arising out of the manufacture, sale, use, distribution or marketing of Licensed Products. The coverage limits set forth herein will not create any limitation on a Party’s liability to the other under this License Agreement. Upon the request of a Party, the other Party will provide evidence of the insurance coverage required by this Section 9.7.
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ARTICLE 10
Term and Termination
10.1 Term. This License Agreement will commence as of the License Agreement Effective Date and, unless sooner terminated in accordance with the terms hereof or by mutual written consent, will continue on a Licensed Product-by-Licensed Product and a country-by-country basis, until there are no more Royalty payments owed Acuitas in such country with respect to such Licensed Product (the longest such period of time hereunder, the “Term”). Upon expiration of the Term with respect to the applicable Licensed Product in the applicable country, the licenses contained in Section 2.1 will become fully paid-up, royalty-free, perpetual and irrevocable with respect to such Licensed Product in such country.
10.2 Termination by Acuitas.
(a) Breach. Acuitas will have the right to terminate this License Agreement in full upon delivery of written notice to GreenLight in the event of a material breach by GreenLight of this License Agreement, provided that such material breach has not been cured within sixty (60) days after written notice thereof is given by Acuitas to GreenLight specifying the nature of the alleged breach.
(b) Disputed Breach. If GreenLight disputes in good faith the existence or materiality of a breach specified in a notice provided in accordance with Section 10.2(a), and GreenLight provides Acuitas notice of such dispute within such sixty (60) day period, then Acuitas shall not have the right to terminate this License Agreement under Section 10.2(a) unless and until it is finally determined, in accordance with Section 11.1, that GreenLight has materially breached this License Agreement and GreenLight has failed to cure such breach within sixty (60) days following such decision. It is understood and agreed that during the pendency of such dispute, all of the terms and conditions of this License Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder. During the pendency of any such dispute, GreenLight shall pay to Acuitas all Milestone Payments and Royalty payments set forth herein that may become due during such period.
10.3 Termination by GreenLight.
(a) Breach. GreenLight will have the right to terminate this License Agreement in full upon delivery of written notice to Acuitas in the event of a material breach by Acuitas of its obligations under this License Agreement, provided that such breach has not been cured within sixty (60) days after written notice thereof is given by GreenLight to Acuitas specifying the nature of the alleged breach
(b) Discretionary Termination. GreenLight will have the right to terminate this License Agreement in full at its discretion for any reason by delivering written notice to Acuitas, such termination to be effective thirty (30) days following the date of such notice.
(c) Alternative to Termination Under Section 10.3(a).
(i) If GreenLight has the right to terminate this License Agreement under Section 10.3(a), then GreenLight may, in lieu of exercising such termination right, elect to have this License Agreement continue in full force and effect, provided that the following will apply: starting immediately after the end of such applicable cure period, GreenLight may reduce by [***] the Milestone Payments and the Royalty rates subject to the Minimum Royalty.
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(ii) In the event Acuitas notifies GreenLight within thirty (30) days of receipt of GreenLight’s notice of material breach that Acuitas reasonably and in good faith disputes GreenLight’s right to terminate this License Agreement pursuant to Section 10.3(a), GreenLight shall instead deposit such [***] of Milestone Payments and Royalty payments into an escrow account maintained by a mutually agreeable Third-Party pending the resolution of such dispute in accordance with Section 11.1. If Acuitas raises such dispute, the informal dispute resolution process in Section 11.1(a) shall not apply, and the negotiation period for the Executive Officers in Section 11.1(b) shall be limited to ten (10) days.
(iii) In the event that it is established through the dispute resolution process that GreenLight did have the right to terminate this License Agreement under Section 10.3(a), then the escrowed funds shall be released to GreenLight and the [***] reduction shall continue to apply going forward. In the event that it is established through the dispute resolution process that GreenLight did not have the right to terminate this License Agreement under Section 10.3(a), then the escrowed funds plus interest payable by GreenLight in accordance with Section 4.4(g) shall be released to GreenLight and GreenLight will pay to Acuitas the full amount of the Milestone Payments and Royalties that would have been payable, and the Milestone Payments and the Royalty payments going forward shall continue to be paid in accordance with Article 4 and the terms of this Agreement without any reduction under this Section 10.3(c).
10.4 Termination Upon Bankruptcy. If either Party makes an assignment for the benefit of creditors, appoints or suffers appointment of a receiver or trustee over all or substantially all of its property, files a petition or commences a proceeding under any bankruptcy or insolvency act in any state or country or has any such petition or application filed against it which is not discharged within one hundred twenty (120) days of the filing thereof, then the other Party may thereafter terminate this License Agreement effective immediately upon written notice to such Party. All rights and licenses granted under or pursuant to this License Agreement by Acuitas are, and will otherwise be deemed to be, for purposes of Section 65.11(7) of the Bankruptcy and Insolvency Act, R.S.C. 1985, c. B-3 and Section 32(6) of the Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C-36, and comparable laws in other jurisdictions (the “Insolvency Legislation”), a grant of “right to use intellectual property” as used in the Insolvency Legislation. The Parties agree that GreenLight and its Affiliates and Sublicensees, as licensees of such rights under this License Agreement, will retain and may fully exercise all of their rights and elections under the Insolvency Legislation subject to the payment of amounts provided for herein. Without limiting GreenLight’s rights under the Insolvency Legislation, if Acuitas becomes insolvent or makes an assignment for the benefit of its creditors or there is filed by or against Acuitas any bankruptcy, receivership, reorganization or similar proceeding pursuant to or under the Insolvency Legislation or otherwise, GreenLight shall be entitled to a copy of any and all such intellectual property and all embodiments of such intellectual property, and the same, if not in the possession of Acuitas, shall be promptly delivered to it (a) before this License Agreement is disclaimed, repudiated, rescinded or terminated by or on behalf of Acuitas, within thirty (30) days after GreenLight’s written request, unless Acuitas, or its trustee or receiver, elects within thirty (30) days to continue to perform all of its obligations under this
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License Agreement, or (b) after any disclaimer, repudiation, rescission or termination of this License Agreement by or on behalf of Acuitas, if not previously delivered as provided under clause (a) above. All rights of the Parties under this Section 10.4 and under the Insolvency Legislation are in addition to and not in substitution of any and all other rights, powers, and remedies that each Party may have under this License Agreement, the Insolvency Legislation, and any other applicable Laws.
10.5 Effects of Termination. Upon termination (but not expiration of the Term pursuant to Section 10.1) of this License Agreement for any reason:
(a) Cessation of Rights. Except as otherwise expressly provided herein, all rights and licenses granted by Acuitas to GreenLight in Section will terminate.
(b) Sell Off. Notwithstanding the termination of GreenLight’s licenses and other rights under this License Agreement, GreenLight shall retain the right to distribute, sell or otherwise dispose of its existing inventory of the Licensed Products, in each case that is intended for distribution, sale or disposition in the Territory, for a period of not more than three (3) months following the date of the effective termination, as though this License Agreement had not been terminated, and such distribution, sale or other disposition shall not constitute infringement of the Patents or other intellectual property or proprietary rights of Acuitas or its Affiliates. GreenLight’s right to distribute, sell or otherwise dispose of its existing inventory of the Licensed Products pursuant to this Section 10.5(b) shall be subject to GreenLight’s continuing obligation to pay Royalties with respect to the Net Sales.
10.6 Survival. In addition to the termination consequences set forth in Section 10.5, the following provisions will survive termination or expiration of this License Agreement: Article 1 (to the extent applicable to any other surviving provisions), Article 3, Article 5, Article 8 and Article 11, and Sections 2.1 (in accordance with (i) the last sentence of Section 4.4(d), to the extent applicable, (ii) Section 6.2, to the extent applicable, or (iii) the last sentence of Section 10.1 but only upon expiration of the Term), 2.3(b)(iv) (only upon the circumstances set forth therein), 4.4(b), 9.3, 9.4, 9.5, 9.6, the last sentence of Section 10.1 (only upon expiration of the Term), 10.4, 10.5 and this Section 10.6. Termination or expiration of this License Agreement will not relieve the Parties of any liability or obligation which accrued hereunder prior to the effective date of such termination or expiration nor preclude either Party from pursuing all rights and remedies it may have hereunder or at Law or in equity with respect to any breach of this License Agreement nor prejudice either Party’s right to obtain performance of any obligation. All other rights and obligations will terminate upon termination or expiration of this License Agreement.
ARTICLE 11
General Provisions
11.1 Dispute Resolution.
(a) Disputes. Disputes arising under or in connection with this License Agreement will be resolved pursuant to this Section 11.1; provided, however, that in the event a dispute cannot be resolved without an adjudication of the rights or obligations of a Third-Party (other than any GreenLight Indemnitees or Acuitas Indemnitees identified in Section 9.6), the dispute procedures set forth Sections 11.1(b) and 11.1(c) will be inapplicable as to such dispute.
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(b) Dispute Escalation. In the event of a dispute between the Parties, the Parties will first attempt in good faith to resolve such dispute by negotiation and consultation between themselves or the Workplan Leaders. In the event that such dispute is not resolved on an informal basis within twenty (20) days, any Party may, by written notice to the other, have such
(c) dispute referred to each Party’s Chief Executive Officer or his or her designee (who will be a senior executive “Executive Officers”), who will attempt in good faith to resolve such dispute by negotiation and consultation for a thirty (30) day period following receipt of such written notice.
(d) Dispute Resolution. In the event the Executive Officers of the Parties are not able to resolve such dispute as set forth above, the Executive Officers will together elect whether to submit the dispute to mediation, litigation or arbitration. In the absence of such an agreement, either Party may elect to initiate litigation. The Parties hereby irrevocably and unconditionally consent to submit to the exclusive jurisdiction of the state and federal courts located in the State of Washington for any disputes, including for (1) interim or provisional relief or (2) breaches of Article 6 or Article 7 for which the Parties agree injunctive relief or equitable remedies will be available arising out of or relating to this Agreement, and further agree that service of any process, summons, notice or document by certified mail shall be effective service of process for any action, suit or proceeding brought against the Parties in any such court. The Parties hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding arising out of this Agreement in the state or federal courts located in the State of Washington and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum.
(e) Injunctive Relief. Notwithstanding the dispute resolution procedures set forth in this Section 11.1, in the event of an actual or threatened breach hereunder, the aggrieved Party may seek equitable relief (including restraining orders, specific performance or other injunctive relief) in any court or other forum, without first submitting to any dispute resolution procedures hereunder.
(f) Prevailing Party. The prevailing Party in any suit related to this License Agreement will be entitled to recover from the losing Party all out-of-pocket fees, costs and expenses (including those of attorneys, professionals and accountants and all those arising from appeals and investigations) incurred by the prevailing Party in connection with such arbitration or suit.
11.2 Cumulative Remedies and Irreparable Harm. All rights and remedies of the Parties hereunder will be cumulative and in addition to all other rights and remedies provided hereunder or available by agreement, at Law or otherwise. Each Party acknowledges and agrees that breach of any of the terms or conditions of this License Agreement may cause irreparable harm and damage to the other and that such damage may not be ascertainable in money damages and that as a result thereof the non-breaching Party may be entitled to seek from a court equitable or injunctive relief restraining any breach or future violation of the terms contained herein by the breaching Party without the necessity of proving actual damages or posting bond. Such right to equitable relief is in addition to whatever remedies either Party may be entitled to as a matter of Law or equity, including money damages.
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11.3 Relationship of Parties. Nothing in this License Agreement is intended or will be deemed to constitute a partnership, agency, employer-employee or joint venture relationship between the Parties. No Party will incur any debts or make any commitments for the other, except to the extent, if at all, specifically provided therein. There are no express or implied Third-Party beneficiaries hereunder (except for GreenLight Indemnitees and Acuitas Indemnitees for purposes of Section 9.6). For clarity, GreenLight does not grant to Acuitas any rights or licenses under this License Agreement to any GreenLight Technology or intellectual property rights.
11.4 Compliance with Law. Each Party will perform or cause to be performed any and all of its obligations or the exercise of any and all of its rights hereunder in good scientific manner and in compliance with all applicable Law, including the U.S. Foreign Corrupt Practices Act and foreign equivalents thereof. Without limiting the foregoing, each Party agrees that it has not, and covenants that it, its Affiliates, and its and its Affiliates’ directors, employees, officers, and anyone acting on its behalf, will not, in connection with the performance of this Agreement, directly or indirectly, make, promise, authorize, ratify or offer to make, or take any action in furtherance of, any payment or transfer of anything of value for the purpose or intent of influencing, inducing or rewarding any act, omission or decision to secure an improper advantage; or improperly assisting it in obtaining or retaining business for it or the other Party, or in any way with the purpose or effect of public or commercial bribery.
11.5 Governing Law. This License Agreement will be governed by and construed in accordance with the Laws of the State of New York, United States, without respect to its conflict of Laws rules in the event of a dispute in accordance with Section 11.1, provided that any dispute relating to the scope, validity, enforceability or infringement of any Patents or Know-How will be governed by, and construed and enforced in accordance with, the substantive Laws of the jurisdiction in which such Patents or Know-How apply.
11.6 Counterparts; Facsimiles. This License Agreement may be executed in one or more counterparts, each of which will be deemed an original, and all of which together will be deemed to be one and the same instrument. Facsimile or PDF execution and delivery of this License Agreement by either Party will constitute a legal, valid and binding execution and delivery of this License Agreement by such Party.
11.7 Headings. All headings in this License Agreement are for convenience only and will not affect the meaning of any provision hereof.
11.8 Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this License Agreement. Accordingly, the rule of construction that any ambiguity in this License Agreement will be construed against the drafting Party will not apply.
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11.9 Interpretation. Whenever any provision of this License Agreement uses the term “including” (or “includes”), such term will be deemed to mean “including without limitation” (or “includes without limitations”). “Herein,” “hereby,” “hereunder,” “hereof” and other equivalent words refer to this License Agreement as an entirety and not solely to the particular portion of this License Agreement in which any such word is used. All definitions set forth herein will be deemed applicable whether the words defined are used herein in the singular or the plural. Unless otherwise provided, all references to Sections and Appendices in this License Agreement are to Sections and Appendices of this License Agreement. References to any Sections include Sections and subsections that are part of the related Section.
11.10 Binding Effect. This License Agreement will inure to the benefit of and be binding upon the Parties, their Affiliates, and their respective lawful successors and assigns.
11.11 Assignment. This License Agreement may not be assigned by either Party, nor may either Party delegate its obligations or otherwise transfer licenses or other rights created by this License Agreement, except as expressly permitted hereunder or otherwise without the prior written consent of the other Party, which consent will not be unreasonably withheld, conditioned or delayed; provided that either Party may assign this License Agreement without such consent to an Affiliate or to its successor in connection with the sale of all or substantially all of its assets or business or that portion of its business pertaining to the subject matter of this License Agreement (whether by merger, consolidation or otherwise).
11.12 Notices. All notices, requests, demands and other communications required or permitted to be given pursuant to this License Agreement will be in writing and will be deemed to have been duly given upon the date of receipt if delivered by hand, email, recognized international overnight courier, or registered or certified mail, return receipt requested, postage prepaid to the following addresses:
if to GreenLight: | GreenIight Biosciences Inc. | |||
Xxxxx 0000 | ||||
000 Xxxxxx Xxxxxx | ||||
Xxxxxxx XX 00000 Attention: [***]GLB CFO
| ||||
With a copy to: | Xxxxx Xxxx LLP
Attention: [***] [***] | |||
If to Acuitas: |
Acuitas Therapeutics Inc. 0000 Xxxxxxxx Xxxx Xxxxxxxxx, X.X. X0X 0X0 Attention: President and CEO [***] |
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With a copy to: |
XxXxxxxx Xxxxxxxx LLP Suite 2400 000 Xxxxxxx Xxxxxx Xxxxxxxxx, X.X. Xxxxxx X0X 0X0 Attention: [***]. [***] |
Either Party may change its designated address by notice to the other Party in the manner provided in this Section 11.12.
11.13 Amendment and Waiver. This License Agreement may be amended, supplemented, or otherwise modified only by means of a written instrument signed by both Parties; provided that any unilateral undertaking or waiver made by one Party in favor of the other will be enforceable if undertaken in a writing duly executed by the Party to be charged with the undertaking or waiver. Any waiver of any rights or failure to act in a specific instance will relate only to such instance and will not be construed as an agreement to waive any rights or fail to act in any other instance, whether or not similar.
11.14 Severability. In the event that any provision of this License Agreement will, for any reason, be held to be invalid or unenforceable in any respect, such invalidity or unenforceability will not affect any other provision hereof, and the Parties will negotiate in good faith to modify the License Agreement to preserve (to the extent possible) their original intent.
11.15 Entire Agreement. This License Agreement, together with the Development and Option Agreement, are the sole agreements with respect to the subject matter hereof and supersede all other agreements and understandings between the Parties with respect to same subject matter.
11.16 Force Majeure. Neither Acuitas nor GreenLight will be liable for failure of or delay in performing obligations set forth in this License Agreement (other than any obligation to pay monies when due), and neither will be deemed in breach of such obligations, if such failure or delay is due to natural disasters or any unexpected causes reasonably beyond the control of Acuitas or GreenLight that are unforeseeable; provided that the Party affected will promptly notify the other of the force majeure condition and will exert reasonable efforts to eliminate, cure or overcome any such causes and to resume performance of its obligations as soon as possible. In the event it is not possible to resume performance within six (6) months, such failure or delay will be considered a material breach and subject to Sections 10.2(a) and 10.3(a).
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WITNESS WHEREOF, the Parties have caused this Non-Exclusive License Agreement to be executed by their respective duly authorized officers as of the License Agreement Effective Date.
ACUITAS THERAPEUTICS, INC. |
By: |
||
(Signature) |
Name: |
Title: |
Date: |
GREENLIGHT BIOSCIENCES, INC. |
By: | ||
(Signature) |
Name: |
Title: |
Date: |
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Appendix 1.38
Licensed Product
[***]
[***]
[***]
Appendix 1.29
Jointly Owned Patents
Appendix 1.40
Patents within the Licensed Technology as of the License Agreement Effective Date
Appendix 9.2
Exceptions to Acuitas’ Representations and Warranties in Section 9.2