CERTAIN INFORMATION CONTAINED IN THIS EXHIBIT, MARKED BY [***], HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE THE REGISTRANT HAS DETERMINED THAT IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. DISTRIBUTION...
Exhibit 10.24
CERTAIN INFORMATION CONTAINED IN THIS EXHIBIT, MARKED BY [***], HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE THE REGISTRANT HAS DETERMINED THAT IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
DISTRIBUTION AND COLLABORATION AGREEMENT BETWEEN
HANGZHOU RUIZHEN THERAPEUTICS CO., LTD.(杭州瑞臻医疗有限公司)
AND
SUREFIRE MEDICAL, INC. D/B/A TRISALUS LIFE SCIENCES
May 7, 2019
TABLE OF CONTENTS
Page | |||
ARTICLE 1 DEFINITIONS | 1 | ||
ARTICLE 2 DISTRIBUTION OF PEDD DEVICES IN NEWCO TERRITORY | 11 | ||
2.1 | Grant of Distribution Rights | 11 | |
2.2 | No Distribution Outside NewCo Territory | 12 | |
2.3 | No Conflicts | 12 | |
2.4 | Subdistributors | 12 | |
2.5 | Forecasts | 12 | |
2.6 | Orders | 13 | |
2.7 | Acceptance, Suspension and Cancellation | 13 | |
2.8 | Order Terms | 13 | |
2.9 | Delivery | 13 | |
2.10 | Return Authorizations | 14 | |
2.11 | Price | 14 | |
2.12 | Payment Terms | 14 | |
2.13 | Taxes | 15 | |
2.14 | Diligence and Marketing Plans | 15 | |
2.15 | Promotional Materials | 15 | |
2.16 | Regulatory Approval | 15 | |
2.17 | Modifications for NewCo Territory | 16 | |
2.18 | Legal Compliance | 16 | |
2.19 | Qualified Personnel | 17 | |
2.20 | Recalls | 17 | |
2.21 | Packaging | 17 | |
2.22 | Distribution Inspections | 17 | |
2.23 | Reverse Engineering | 17 | |
2.24 | TriSalus Trademarks | 18 | |
2.25 | Trademark Restrictions | 18 | |
2.26 | Limited Warranty | 18 | |
2.27 | Warranty Limitations | 18 | |
2.28 | Limitation of Liability | 19 | |
2.29 | Training | 19 | |
2.30 | Customer Support | 19 | |
ARTICLE 3 NEW PEDD DEVICES | 19 | ||
3.1 | Notice of New PEDD Devices | 19 | |
3.2 | Right of First Negotiation | 20 | |
ARTICLE 4 PEDD COMBINATION THERAPIES | 20 | ||
4.1 | In General | 20 | |
4.2 | Identification of PEDD Combination Therapies | 20 |
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TABLE OF CONTENTS
(Continued)
Page | |||
4.3 | Additional PEDD Combination Therapy Notice | 21 | |
4.4 | NewCo Territory Development Plans | 21 | |
4.5 | Grant of Rights in NewCo Territory | 21 | |
4.6 | NewCo Roles and Responsibilities in NewCo Territory | 22 | |
4.7 | TriSalus Roles and Responsibilities in NewCo Territory | 22 | |
4.8 | Third Party Collaboration in NewCo Territory | 23 | |
4.9 | Non-Competition | 23 | |
4.10 | Third Party Combination Therapies | 23 | |
4.11 | TriSalus Option in United States | 24 | |
4.12 | Ex-Commercial Territory Sales; Export Monitoring | 25 | |
4.13 | Safety Reporting | 25 | |
4.14 | Data Sharing. | 26 | |
4.15 | Record Keeping | 26 | |
4.16 | No Implied Rights | 27 | |
ARTICLE 5 GOVERNANCE | 27 | ||
5.1 | Joint Steering Committee | 27 | |
5.2 | Decision Making | 28 | |
5.3 | Alliance Managers | 28 | |
ARTICLE 6 MANUFACTURE AND SUPPLY | 29 | ||
6.1 | PEDD Devices for Distribution in NewCo Territory | 29 | |
6.2 | PEDD Devices for Clinical Studies of PEDD Combination Therapies in NewCo Territory | 29 | |
6.3 | PEDD Devices for Commercialization of PEDD Combination Therapies in NewCo Territory | 29 | |
6.4 | COGS Reduction Plan | 29 | |
6.5 | Continuity of Manufacturing | 29 | |
6.6 | Inspection of TriSalus Manufacturing Facilities | 30 | |
6.7 | NewCo Drug Candidate for United States | 30 | |
ARTICLE 7 CONSIDERATION | 31 | ||
7.1 | Upfront Payment | 31 | |
7.2 | Milestones Payments for PEDD Combination Therapies in the NewCo Territory | 31 | |
7.3 | Royalty Payments for PEDD Combination Therapies in the NewCo Territory | 31 | |
7.4 | Payments for U.S. Option | 31 | |
7.5 | Royalty Payments for PEDD Combination Therapies in the United States | 32 | |
7.6 | Payments for No U.S. Option | 32 | |
7.7 | Milestone and Royalty Payments for Third Party Combination Therapies | 33 | |
7.8 | Milestone and Royalty Payments following Non-Exercise of U.S. Option | 33 |
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TABLE OF CONTENTS
(Continued)
Page | |||
7.9 | Financial Reports and Records | 34 | |
7.10 | Taxes | 34 | |
7.11 | Foreign Exchange | 34 | |
7.12 | Records; Audits | 34 | |
7.13 | Currency | 35 | |
7.14 | Method of Payment | 35 | |
7.15 | Third Party Agreements | 35 | |
7.16 | Confidentiality | 36 | |
ARTICLE 8 INTELLECTUAL PROPERTY | 36 | ||
8.1 | Background IP | 36 | |
8.2 | Collaboration IP | 36 | |
8.3 | Patent Rights | 37 | |
ARTICLE 9 CONFIDENTIALITY | 39 | ||
9.1 | Confidentiality | 39 | |
9.2 | Authorized Disclosure and Use | 40 | |
9.3 | SEC or Similar Filings | 41 | |
9.4 | Public Announcements; Publications | 41 | |
9.5 | Relationship to the Confidentiality Agreement | 42 | |
ARTICLE 10 REPRESENTATIONS, WARRANTIES AND COVENANTS | 43 | ||
10.1 | Representations and Warranties of Each Party | 43 | |
10.2 | Additional Covenants of NewCo | 43 | |
10.3 | Additional Representations and Warranties of TriSalus | 43 | |
10.4 | Covenants of Each Party | 43 | |
10.5 | Compliance with Anti-Corruption Laws | 44 | |
10.6 | Representation by Legal Counsel | 44 | |
10.7 | Disclaimer | 44 | |
ARTICLE 11 TERM AND TERMINATION | 45 | ||
11.1 | Term | 45 | |
11.2 | Termination for Cause | 45 | |
11.3 | Return of Confidential Information | 45 | |
11.4 | General Effects of Termination | 46 | |
11.5 | Survival of Certain Obligations | 46 | |
ARTICLE 12 INDEMNIFICATION, LIABILITY AND INSURANCE | 46 | ||
12.1 | Indemnification by TriSalus | 46 | |
12.2 | Indemnification by NewCo | 46 | |
12.3 | Procedure | 46 |
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TABLE OF CONTENTS
(Continued)
Page | |||
12.4 | Liability | 47 | |
12.5 | Insurance | 47 | |
ARTICLE 13 DISPUTE RESOLUTION | 47 | ||
13.1 | General | 47 | |
13.2 | Binding Arbitration | 47 | |
ARTICLE 14 MISCELLANEOUS | 48 | ||
14.1 | Assignment | 48 | |
14.2 | Further Actions | 48 | |
14.3 | Force Majeure | 48 | |
14.4 | Notices | 48 | |
14.5 | Amendment | 49 | |
14.6 | Waiver | 49 | |
14.7 | Severability | 49 | |
14.8 | Descriptive Headings | 49 | |
14.9 | Governing Law | 49 | |
14.10 | Entire Agreement of the Parties | 50 | |
14.11 | English Language | 50 | |
14.12 | Independent Contractors | 50 | |
14.13 | Counterparts | 50 | |
14.14 | Interpretation | 50 | |
14.15 | Fees | 51 | |
14.16 | Initial Public Offering | 51 |
EXHIBIT LIST
Exhibit 1.23 | Current PEDD Devices |
Exhibit 1.41 | Improved PEDD Devices |
Exhibit 1.45 | Initial Drug Candidates |
Exhibit 2.10 | TriSalus Complaint Handling General Operating Procedures |
Exhibit 2.14 | Marketing Plan Contents |
Exhibit 4.11(c) | Potential Collaboration Company List |
Exhibit 5.1(a) | JSC Members |
Exhibit 7.1 | Note |
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DISTRIBUTION AND COLLABORATION AGREEMENT
This Distribution and Collaboration Agreement (the “Agreement”) is entered into as of May 7, 2019 (the “Effective Date”), between Hangzhou Ruizhen Therapeutics Co., Ltd.(杭州瑞臻医疗有限公司), a limited liability company, a corporation Ltd. organized and existing under the laws of The People’s Republic of China and having a place of business at Xx. 000, Xxxxxxxx 0, Xx. 000 Xxxxxxxxx Xxxx, Xxxxxx Economic and Technological Development Zone, Yuhang District, Hangzhou, Zhejiang, China 311100 (“NewCo”) and Surefire Medical, Inc. d/b/a TriSalus Life Sciences, a corporation organized and existing under the laws of the State of Delaware and having a principal place of business at 0000 X. 00xx Xxxxxx, Xxxxxxxxxxx, XX 00000, XXX (“TriSalus”). NewCo and TriSalus may each be referred to herein individually as a “Party” and collectively as the “Parties”.
ARTICLE 1
DEFINITIONS
1.1 “Affiliate” shall mean, with respect to an entity, any Person directly or indirectly controlled by, controlling or under common control with, such entity, but only for so long as such control shall continue. For purposes of this definition, “control” (including, with correlative meanings, “controlled by”, “controlling” and “under common control with”) means (a) possession, direct or indirect, of the power to direct or cause the direction of the management or policies of an entity (whether through ownership of securities or other ownership interests, by contract or otherwise), or (b) beneficial ownership of at least fifty percent (50%) of the voting securities or other ownership interest of an entity.
1.2 “Agreement” shall have the meaning set forth in the first paragraph of this Agreement.
1.3 “Alliance Manager” shall have the meaning set forth in Section 5.3.
1.4 “Anti-Corruption Laws” shall mean applicable anti-corruption laws and regulations, including those laws and regulations for combatting bribery of foreign public officials in the United States and the People’s Republic of China (e.g., the United States Foreign Corrupt Practices Act, as amended, and the Organization for Economic Co-operation and Development (OECD) Convention).
1.5 “Applicable Laws” shall mean any national, international, federal, state or local laws, treaties, statutes, ordinances, rules and regulations, including any rules, regulations, guidance, guidelines or requirements of (a) any government authority (including any Regulatory Authority) having the force or effect of law or (b) any national securities exchange or securities listing organization, in each case as in effect from time to time during the Term. For clarity, Applicable Laws shall include Anti-Corruption Laws.
1.6 “Business Day” shall mean any day other than a Saturday, Sunday or holiday on which banks in the State of Colorado are authorized by Applicable Law to be closed.
1.7 “Calendar Quarter” shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
1.8 “Calendar Year” shall mean each successive period of twelve (12) months commencing on January 1 and ending on December 31.
1.9 “Change of Control” shall mean, with respect to a Party, (a) a merger, reorganization or consolidation of such Party with a Third Party which results in the voting securities of such Party outstanding immediately prior thereto ceasing to represent at least fifty (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization or consolidation, (b) a Third Party becoming the beneficial owner of fifty (50%) or more of the combined voting power of the outstanding securities of such Party, other than as a result of an equity financing primarily for purposes of raising capital, or (c) the sale or other transfer to a Third Party of all or substantially all of such Party’s business or assets to which this Agreement relates.
1.10 “Greater China” shall mean The People’s Republic of China, including Hong Kong, Macau and Taiwan.
1.11 “Clinical Data or Filing” shall mean (a) any clinical and pre-clinical data (including data from post-approval studies) and clinical protocol regarding any PEDD Combination Therapy (as defined below) (including any PEDD Device or NewCo Drug Candidate utilized in such PEDD Combination Therapy) or (b) any IDE, IND, Regulatory Approval Application, Regulatory Approval or other regulatory filing regarding any PEDD Combination Therapy (including any PEDD Device or NewCo Drug Candidate utilized in such PEDD Combination Therapy).
1.12 “COGS” shall mean the fully-allocated cost of goods sold for PEDD Devices supplied hereunder, as determined by TriSalus in accordance with United States GAAP, which only includes direct material, direct labor and manufacturing overhead (fixed and variable).
1.13 “COGS Reduction Plan” shall have the meaning set forth in Section 6.4.
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1.14 “Collaboration IP” shall mean any invention or other Know-How, including all Patent Rights and other intellectual property rights in the foregoing, that is discovered or generated in the course of performing activities under this Agreement (a) solely by or on behalf of employees, agents or independent contractors of TriSalus or any of its Affiliates, (b) solely by or on behalf of employees, agents or independent contractors of NewCo or any of its Affiliates or (c) jointly by or on behalf of (a) employees, agents or independent contractors of TriSalus or any of its Affiliates and (b) employees, agents or independent contractors of NewCo or any of its Affiliates.
1.15 “Commercialization” or “Commercialize” shall mean activities directed to marketing, promoting, distributing, importing, exporting, using for commercial purposes or selling a product, including obtaining pricing and reimbursement approvals. Commercialization shall not include any activities related to Development or Manufacturing.
1.16 “Commercial Supply Agreement” shall have the meaning set forth in Section 6.3.
1.17 “Commercial Territory” shall mean, with respect to a Party, any territory in which such Party has the right to Commercialize a PEDD Combination Therapy pursuant to this Agreement.
1.18 “Commercially Reasonable Best Efforts” shall mean reasonable best efforts and resources of a Party to carry out its obligations in a diligent and sustained manner using such effort and employing such resources normally used by an established life sciences company in the research, development or commercialization of a similar product owned by such Party or to which such Party has exclusive rights that is of similar market potential at a similar stage in its development or product life.
1.19 “Competing PEDD Devices” shall have the meaning set forth in Section 2.3.
1.20 “Confidential Information” of a Party shall mean all Know-How or other information, including information of a Third Party, regarding such Party’s technology, products, business or objectives that is communicated in any way or form by the Disclosing Party to the Receiving Party, either prior to, on or after the Effective Date of this Agreement, and whether or not such Know-How or other information is identified as confidential at the time of disclosure. Subject to Sections 9.3 and 9.4, the terms and conditions of this Agreement shall be considered Confidential Information of each Party.
1.21 “Continuing Party” shall have the meaning set forth in Section 8.3(a)(ii).
1.22 “Control” or “Controlled” shall mean with respect to any intellectual property right (including any Know-How, Patent Right or right regarding access or reference to Clinical Data or Filings or other data or information), possession of the ability (whether by sole or joint ownership, license or otherwise, other than pursuant to this Agreement) to grant, without violating the terms of any agreement, a license, access or other right in, to or under such intellectual property right.
1.23 “Current PEDD Devices” shall mean TriSalus’ single-use disposable intravascular access Pressure-Enabled Drug Delivery infusion systems that have been developed by TriSalus to be used for the loco-regional delivery of drugs for the treatment of tumors in the liver or pancreas, as sold by TriSalus as of the Effective Date and described more fully on Exhibit 1.23.
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1.24 “Customer” shall mean customers solicited by NewCo or its permitted subdistributors within the NewCo Territory.
1.25 “Declining Party” shall have the meaning set forth in Section 8.3(a)(ii).
1.26 “Designated Indication” shall mean indications for the treatment of tumors in the liver or pancreas that are applicable to the Development and Commercialization of the PEDD Combination Therapies hereunder.
1.27 “Develop” or “Development” shall mean to discover, research or otherwise develop a product, including toxicology, pharmacology and other similar efforts, test method development, stability testing, manufacturing process development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, pre-clinical and clinical studies (including pre- and post-approval studies), development of diagnostic assays in connection with clinical studies and all activities directed to obtaining any Regulatory Approval.
1.28 “Disclosing Party” shall have the meaning set forth in Section 9.1.
1.29 “Dispute” shall have the meaning set forth in Section 13.1.
1.30 “Distribute” shall mean to promote, distribute, offer for sale and sell the PEDD Devices.
1.31 “Down Payment” shall have the meaning set forth in Section 2.12.
1.32 “Effective Date” shall have the meaning set forth in the first paragraph of this Agreement.
1.33 “Executive Officers” shall mean the Chief Executive Officer of NewCo (or an officer of NewCo designated by such Chief Executive Officer) and the Chief Executive Officer of TriSalus (or an officer of TriSalus designated by such Chief Executive Officer).
1.34 “FD&C Act” shall mean the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended, and the rules and regulations promulgated thereunder.
1.35 “FDA” shall mean the United States Food and Drug Administration or any successor agency thereto.
1.36 “First Commercial Sale” shall mean the first sale of the applicable PEDD Combination Therapy or Third Party Combination Therapy under this Agreement by a Selling Person to a Third Party in the applicable country.
1.37 “Forecast” shall have the meaning set forth in Section 2.5.
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1.38 “GAAP” shall mean United States generally accepted accounting principles applied on a consistent basis.
1.39 “Generic Version” shall mean a marketed generic version of a particular PEDD Combination Therapy or Third Party Combination Therapy that has received Regulatory Approval under an Abbreviated New Drug Application by the FDA or any equivalent Regulatory Approval in any other jurisdiction as may be available at the time, which generic version contains all and only the same active ingredients as the NewCo Drug Candidate or Third Party Drug Candidate, respectively, that is included as part of the PEDD Combination Therapy or Third Party Combination Therapy, respectively, and administered as an infusion therapy.
1.40 “IDE” shall mean an Investigational Device Exemption (including any amendments thereto), as defined in the FD&C Act, or other applicable submission to a Regulatory Authority that is required to be filed with an applicable Regulatory Authority before beginning clinical testing of a medical device in human subjects, or a similar filing in any country or regulatory jurisdiction outside the United States.
1.41 “Improved PEDD Devices” shall mean TriSalus’ single-use, disposable intravascular access infusion systems that are improved versions of the Current PEDD Devices Developed by TriSalus after the Effective Date that have been developed by TriSalus to be used for the loco-regional delivery of drugs for the treatment of tumors in the liver or pancreas as reflected in the TriSalus development pipeline attached hereto as Exhibit 1.41.
1.42 “IND” shall mean an Investigational New Drug Application (including any amendments thereto), as defined in the FD&C Act, or other applicable submission that is required to be filed with the FDA before the commencement of human clinical studies of a drug or biologic, or a similar filing in any country or regulatory jurisdiction outside the United States.
1.43 “Indemnified Party” shall have the meaning set forth in Section 12.3.
1.44 “Indemnifying Party” shall have the meaning set forth in Section 12.3.
1.45 “Initial Drug Candidates” shall mean the pharmaceutical product candidates listed on Exhibit 1.45, in any form or formulation.
1.46 “Initial PEDD Combination Therapy” shall mean a PEDD Combination Therapy incorporating an Initial Drug Candidate.
1.47 “Joint Collaboration IP” shall have the meaning set forth in Section 8.2(c).
1.48 “Joint Patent Right” shall mean Patent Rights within the Joint Collaboration IP.
1.49 “JSC” shall mean the joint steering committee established by TriSalus and NewCo under Section 5.1(a).
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1.50 “Know-How” shall mean proprietary inventions, discoveries, data, information, processes, methods, techniques, materials, technology, results, trade secrets or other know-how, whether or not patentable. For clarity, Know-How excludes Patent Rights.
1.51 “Leading Party” shall have the meaning set forth in Section 8.3(b)(iv).
1.52 “Liability” shall have the meaning set forth in Section 12.1.
1.53 “Manufacturing” or “Manufacture” shall mean activities directed to producing, manufacturing, processing, packaging, labeling, quality assurance testing and release, shipping and storage of a product.
1.54 “Marketing Plans” shall have the meaning set forth in Section 2.14.
1.55 “Net Sales” shall mean the gross amount invoiced for any sale of the applicable PEDD Combination Therapy or Third Party Combination Therapy (inclusive of the PEDD Device and NewCo Drug Candidate or Third Party Drug Candidate utilized therein) by the applicable Party or its Affiliate or Sublicensee (a “Selling Person”), to a non-Affiliate of the Selling Person, less the following , in each case to the extent specifically related to such PEDD Combination Therapy or Third Party Combination Therapy and taken by the Selling Person or otherwise paid for or accrued by the Selling Person (“Permitted Deductions”):
(a) trade, cash, promotional and quantity discounts and wholesaler fees;
(b) taxes on sales (such as excise, sales or use taxes or value added taxes) to the extent imposed upon and paid directly with respect to the sales price (and excluding taxes based on income);
(c) freight, insurance, packing costs and other transportation charges to the extent included in the invoice price to the buyer;
(d) amounts repaid or credits taken by reason of damaged goods, rejections, defects, expired dating or returns or because of retroactive price reductions;
(e) charge back payments and rebates granted to (i) managed healthcare organizations, (ii) federal, state or provincial or local governments or other agencies, (iii) purchasers and reimbursers, or (iv) trade customers, including wholesalers and chain and buying groups; and
(f) documented customs duties actually paid by the Selling Person.
Such Permitted Deductions shall be determined in accordance with GAAP.
Sales of the applicable PEDD Combination Therapy or Third Party Combination Therapy between a Party, its Affiliates or Sublicensees for resale, or for use in the Manufacture of such PEDD Combination Therapy or Third Party Combination Therapy, shall not be included within Net Sales, provided, however, that any subsequent sale of such PEDD Combination Therapy or Third Party Combination Therapy by such Party or its Affiliate or Sublicensee to a non- Affiliate Third Party shall be included within Net Sales.
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Notwithstanding the foregoing, Net Sales shall not include any consideration received by a Selling Person in respect of the sale, use or other disposition of such PEDD Combination Therapy or Third Party Combination Therapy in a country as part of a clinical study prior to the receipt of all Regulatory Approvals required to commence commercial sales of such PEDD Combination Therapy or Third Party Combination Therapy in such country.
A PEDD Combination Therapy or Third Party Combination Therapy provided by a Selling Person free of charge, as samples, for administration to patients enrolled in clinical studies or distributed through a not-for-profit foundation or other compassionate use program to eligible patients shall not be included in Net Sales, provided that such Selling Person receives no cash consideration from such samples, clinical studies, not-for-profit foundation or program.
1.56 “NewCo” shall have the meaning set forth in the first paragraph of this Agreement.
1.57 “NewCo Drug Candidate” shall mean any pharmaceutical product or pharmaceutical product candidate, in any form or formulation, that NewCo has the exclusive right (by ownership, license or otherwise) to Develop, Manufacture and Commercialize in the NewCo Territory, including the Initial Drug Candidates, as well as any pharmaceutical product or pharmaceutical product candidates that are in-licensed to NewCo from a Third Party other than NewCo.
1.58 “NewCo Improvements” shall have the meaning set forth in Section 8.2(b).
1.59 “NewCo Indemnified Party” shall have the meaning set forth in Section 12.1.
1.60 “NewCo IP” shall mean, collectively, the NewCo Patent Rights and NewCo Know-How.
1.61 “NewCo Know-How” shall mean any Know-How that (a) NewCo or any of its Affiliates Controls as of the Effective Date or that comes into the Control of NewCo or any of its Affiliates during the Term (other than through the grant of a license by NewCo) and (b) is necessary or useful in the Development, Manufacture or Commercialization of the applicable PEDD Combination Therapies or NewCo Drug Candidates, excluding, following a Change of Control of NewCo, any Know-How Controlled prior to such Change of Control by the acquirer or any of its Affiliates.
1.62 “NewCo Manufacturing IP” shall mean any NewCo IP that is necessary or useful in the Manufacture of the NewCo Drug Candidate utilized in the applicable PEDD Combination Therapy.
1.63 “NewCo Patent Right” shall mean any Patent Right that (a) NewCo or any of its Affiliates Controls as of the Effective Date or that comes into the Control of NewCo or any of its Affiliates during the Term (other than through the grant of a license by TriSalus) and (b) claims any NewCo Know-How, excluding, following a Change of Control of NewCo, any Patent Right Controlled prior to such Change of Control by the acquirer or any of its Affiliates.
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1.64 “NewCo Territory” shall mean Greater China.
1.65 “NewCo Territory Development Plan” shall have the meaning set forth in Section 4.4.
1.66 “New PEDD Device” shall have the meaning set forth in Section 3.1.
1.67 “New PEDD Device Distribution Rights” shall have the meaning set forth in Section 3.1.
1.68 “New PEDD Device Notice” shall have the meaning set forth in Section 3.1.
1.69 "NMPA" means the National Medical Products Administration or any successor Regulatory Authority with jurisdiction in China.
1.70 “Order” shall mean a written description of the PEDD Devices that NewCo desires to purchase that conforms to the requirements of this Agreement and is sent to TriSalus by mail, email, facsimile or similar means.
1.71 “Party(ies)” shall have the meaning set forth in the first paragraph of this Agreement.
1.72 “Patent Rights” shall mean all patents and patent applications, whether domestic or foreign, including all continuations, continuations-in-part, divisions, provisionals and renewals, and letters of patent granted with respect to any of the foregoing, patents of addition, supplementary protection certificates, registration or confirmation patents and all reissues, re-examination and extensions thereof.
1.73 “Payee” shall mean a Party entitled to receive payment pursuant to this Agreement.
1.74 “Payor” shall mean a Party responsible for paying any payment obligations required under this Agreement.
1.75 “PEDD Combination Therapy” shall mean any therapy Developed pursuant to this Agreement utilizing a PEDD Device to deliver a NewCo Drug Candidate for a Designated Indication, including the Initial PEDD Combination Therapies. For the avoidance of doubt, a therapy developed pursuant to this Agreement will be deemed a “PEDD Combination Therapy” regardless of whether the Regulatory Approval for such therapy specifies the use of the applicable PEDD Device in the labeling.
1.76 “PEDD Combination Therapy Notice” shall have the meaning set forth in Section 4.3
1.77 “PEDD Devices” shall mean the Current PEDD Devices and Improved PEDD Devices.
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1.78 “Permitted Deductions” shall have the meaning set forth in Section 1.55.
1.79 “Person” shall mean an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision or department or agency of a government.
1.80 “Phase I Clinical Study” means a human clinical study of a product, the principal purpose of which is gaining evidence of the safety and tolerability of, and information regarding pharmacokinetics and potential pharmacological activity in a target patient population, as described in 21 C.F.R.§ 312.21(a) (as amended or any replacement thereof), or a similar clinical study prescribed by the NMPA or other Regulatory Authority in a country other than the United States.
1.81 “Phase II Clinical Study” means a human clinical study of a product, the principal purpose of which is a determination of safety and efficacy in the target patient population, as described in 21 C.F.R. 312.21(b) (as amended or any replacement thereof), or a similar clinical study prescribed by the NMPA or other Regulatory Authority in a country other than the United States.
1.82 “Phase III Clinical Study” means a human clinical study of a product, the principal purpose of which is to establish safety and efficacy in the target patient population, as described in 21 C.F.R. §312.21(c) (as amended or any replacement thereof), or a similar clinical study prescribed by the NMPA or other Regulatory Authority in a country other than the United States.
1.83 “Price” shall have the meaning set forth in Section 2.11.
1.84 “Prosecuting Party” shall have the meaning set forth in Section 8.3(a)(ii).
1.85 “PRVI” shall mean TriSalus’s coaxial micro-catheter PEDD Device system, which includes real-time pressure sensing capabilities, that is branded as the Pancreas Retrograde Infusion Therapy™ infusion system as of the Effective Date.
1.86 “Recall” shall have the meaning set forth in Section 2.20.
1.87 “Receiving Party” shall have the meaning set forth in Section 9.1.
1.88 “Regulatory Approval” shall mean, with respect to any product in any regulatory jurisdiction and for any indication, any license, registration, authorization or approval of any Regulatory Authority necessary for the marketing and sale of such product in such regulatory jurisdiction for such indication.
1.89 “Regulatory Approval Application” shall mean, with respect to a product in any regulatory jurisdiction for any indication, an application submitted to the appropriate Regulatory Authority for such regulatory jurisdiction seeking Regulatory Approval of such product for use in such indication in such regulatory jurisdiction.
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1.90 “Regulatory Authority” shall mean, with respect to any national, supra-national, regional, state or local regulatory jurisdiction, any agency, department, bureau, commission, council or other governmental entity involved in the granting of a Regulatory Approval for such jurisdiction, including the FDA with respect to the United States and the NMPA with respect to China.
1.91 “Response Period” shall have the meaning set forth in Section 3.1.
1.92 “Right of Reference” shall mean a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b), and any comparable right existing under the laws or regulations of any other jurisdiction.
1.93 “Royalty Term” shall mean, with respect to the applicable PEDD Combination Therapy or Third Party Combination Therapy on a country-by-country basis, the later of (a) ten (10) years after first commercial sale of such therapy in such country, or (b) the first commercial sale of a Generic Version of such therapy by any Third Party (other than a Sublicensee) in such country.
1.94 “Selling Person” shall have the meaning set forth in Section 1.55.
1.95 “SPARK” shall mean Trisalus’s single catheter infusion PEDD Device system, which includes a self-expanding tip, that is branded as the SPARK™ infusion system as of the Effective Date.
1.96 “Sublicensee” shall mean any Person who has received, directly or indirectly, from a Party a sublicense under any right granted to such Party by the other Party under this Agreement, which sublicense is granted in accordance with the terms and conditions of this Agreement.
1.97 “Term” shall have the meaning set forth in Section 11.1.
1.98 “Third Party” shall mean any Person other than NewCo, TriSalus and their respective Affiliates. For clarity, a Third Party for purposes of this definition includes any company other than NewCo and TriSalus.
1.99 “Third Party Combination Therapy” shall have the meaning set forth in Section 4.10.
1.100 “Third Party Drug Candidate” shall mean any pharmaceutical product or pharmaceutical product candidate, in any form or formulation, that is Controlled by a Third Party and is not a NewCo Drug Candidate.
1.101 “Training” shall have the meaning set forth in Section 2.29.
1.102 “TriSalus” shall have the meaning set forth in the first paragraph of this Agreement.
1.103 “TriSalus Improvements” shall have the meaning set forth in Section 8.2(a).
1.104 “TriSalus Indemnified Party” shall have the meaning set forth in Section 12.1.
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1.105 “TriSalus IP” shall mean, collectively, the TriSalus Patent Rights and TriSalus Know-How.
1.106 “TriSalus Know-How” shall mean any Know-How that (a) TriSalus or any of its Affiliates Controls as of the Effective Date or that comes into the Control of TriSalus or any of its Affiliates during the Term (other than through the grant of a license by NewCo) and (b) is necessary or useful in the Development, Manufacture or Commercialization of the applicable PEDD Combination Therapies or PEDD Devices, excluding, following a Change of Control of TriSalus, any Know-How Controlled prior to such Change of Control by the acquirer or any of its Affiliates.
1.107 “TriSalus Manufacturing IP” shall mean any TriSalus IP that is necessary or useful in the Manufacture of the PEDD Device utilized in the applicable NewCo Combination Therapy.
1.108 “TriSalus Patent Right” shall mean any Patent Right that (a) TriSalus or any of its Affiliates Controls as of the Effective Date or that comes into the Control of TriSalus or any of its Affiliates during the Term (other than through the grant of a license by NewCo) and (b) claims any TriSalus Know-How, excluding, following a Change of Control of TriSalus, any Patent Right Controlled prior to such Change of Control by the acquirer or any of its Affiliates.
1.109 “TriSalus Territory” shall mean all territories outside Greater China.
1.110 “TriSalus Trademarks” shall have the meaning set forth in Section 2.24.
1.111 “U.S. License” shall have the meaning set forth in Section 4.11(a).
1.112 “U.S. NewCo Drug Candidate Patent Rights” shall have the meaning set forth in Section 8.3(a)(ii).
1.113 “U.S. Option” shall have the meaning set forth in Section 4.11(a).
1.114 “U.S. Option Notice” shall have the meaning set forth in Section 4.11(b).
ARTICLE 2
DISTRIBUTION OF PEDD DEVICES IN NEWCO TERRITORY
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(a) Distribute the PEDD Devices outside the NewCo Territory, or actively approach individual customers outside the NewCo Territory, including by direct mail or visits, or establish warehouses or distribution outlets outside the NewCo Territory for the PEDD Devices. NewCo shall refer to TriSalus any inquiries and leads that NewCo may receive for the purchase of PEDD Devices (or any other TriSalus products) for delivery to or use outside of the NewCo Territory;
(b) Distribute any PEDD Device to any party if NewCo knows, or in the exercise of its reasonable good faith business judgment should know, that such Distribution will result in the Distribution of any PEDD Device outside of the NewCo Territory; or
(c) conduct or authorize any person or entity to conduct any advertising primarily intended to be disseminated outside of the NewCo Territory for any PEDD Device, whether by means of television, radio, print media, outdoor, Internet, or any other means.
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Units of
the Current PEDD Device per Calendar Year | Price | |
Less than [***] units | COGS plus [***]% | |
Equal to or greater than [***] units | COGS plus [***]% |
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(a) Prior to placing the first Order under Section 2.6, NewCo shall be registered with Regulatory Authorities and shall hold a valid resale permit or license for the NewCo Territory as may be required under Applicable Laws.
(b) NewCo shall maintain adequate written procedures for warehouse control and Distribution of PEDD Devices, including handling, storage and shipment, and adequate records of shipments to Customers for at least [***] years or until the end of the useful life of the PEDD Devices, whichever is longer, all in accordance with Applicable Laws. Such records shall be made available to TriSalus or its representative for inspection, upon request, and shall be in such a form as to enable TriSalus or Regulatory Authorities to trace the location of all PEDD Devices.
(c) NewCo shall comply with Applicable Laws with regard to timely reporting of adverse events and deficiencies of the PEDD Devices in the NewCo Territory, and shall immediately (and in any event within forty eight (48) hours) notify TriSalus of any such adverse events. In addition, NewCo shall promptly notify TriSalus of all written and oral complaints of any kind concerning the PEDD Devices, but in no event more than two (2) Business Days following NewCo’s receipt of such complaints. NewCo shall also provide additional information and documentation as may be requested by TriSalus within twenty-four (24) hours of such request. NewCo shall cooperate with TriSalus in the resolution of such complaints, and shall take such action to resolve such complaints as may be reasonably requested by TriSalus. NewCo shall maintain records of all complaints relating to the PEDD Devices for the longer of the period required by Applicable Laws or as TriSalus may reasonably request and shall make such records available to TriSalus for inspection and copying upon request.
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2.30 Customer Support NewCo shall use all Commercially Reasonable Best Efforts to provide support for all subdistributors, users and customers that have purchased PEDD Devices in the NewCo Territory and shall maintain facilities necessary to provide such customer support. NewCo shall facilitate and assist TriSalus in providing training for clinical sites as necessary for the conduct of clinical Development of PEDD Combination Therapies hereunder, and for two (2) years after first commercial sale of PEDD Devices in the NewCo Commercial Territory, any physician training required to properly use the PEDD Devices.
ARTICLE 3
3.1 Notice of New PEDD Devices. In the event that, at any time during the Term, TriSalus Develops any single-use disposable intravascular access Pressure-Enabled Drug Delivery™ infusion system that has been or will be developed by TriSalus to be used for the loco-regional delivery of drugs for the treatment outside the scope of liver or pancreatic cancers, such infusion systems shall not be considered a Current PEDD Device or Improved PEDD Device (a “New PEDD Device”). Prior to the initiation of any discussion with a Third Party regarding Distribution, Commercialization or Manufacturing of a New PEDD Device in the NewCo Territory by TriSalus or any Third Party appointed by TriSalus, TriSalus shall provide NewCo with written notice of such New PEDD Device (including a description in reasonable detail of the specifications and any approved or proposed labeling for such New PEDD Device) (a “New PEDD Device Notice”), and NewCo shall notify TriSalus in writing within ten (10) Business Days after receipt of such New PEDD Device Notice (the “Response Period”) as to whether NewCo wishes to discuss the potential grant to NewCo of the exclusive, non-transferable right to Distribute such New PEDD Device directly or through Third Parties to Customers in the NewCo Territory (“New PEDD Device Distribution Rights”). If NewCo does not respond to TriSalus within the Response Period that NewCo is interested in engaging in such discussion with TriSalus, then TriSalus shall have no further obligation to NewCo with respect to that particular New PEDD Device.
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ARTICLE 4
(b) . At least on a semi-annual basis during the Term, the Parties shall provide a written report and continue to update the JSC on any potential additional NewCo Drug Candidates and Third Party Drug Candidates that may be suitable for Development as PEDD Combination Therapies. Notwithstanding anything to the contrary in this Agreement, NewCo shall have the sole right to decide whether to Develop any PEDD Combination Therapy for the NewCo Territory, provided that if TriSalus objects to such Development based upon safety issues supported by scientific evidence, then the Parties shall mutually agree to the final decision on whether to pursue such Development. If the Parties are unable to reach agreement on such decision, the matter may thereafter be resolved in accordance with Article 13. NewCo shall use Commercially Reasonable Best Efforts to acquire exclusive rights (by ownership, license or otherwise) to any NewCo Drug Candidates for Development, Manufacture and Commercialization in accordance with this Agreement.
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4.6 NewCo Roles and Responsibilities in NewCo Territory.
4.7 | TriSalus Roles and Responsibilities in NewCo Territory. |
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4.8 Third Party Collaboration in NewCo Territory. Subject to the provisions of Section 4.10 hereof, the JSC shall review and comment on any proposed collaboration between NewCo and any Third Party relating to the Development or Commercialization of any Third Party Combination Therapies in the NewCo Territory. If such proposed collaboration (in TriSalus’ reasonable, good faith determination) may cause harm to TriSalus’ interests (e.g., a collaboration involving the use of a device that is competitive with the PEDD Devices or involving a Third Party that is engaged directly or indirectly in the Development, Manufacture or Commercialization of such competitive devices), NewCo shall not enter into any such collaboration with such Third Party, and the rights and licenses granted to NewCo pursuant to Section 4.5 may not be transferred or sublicensed by NewCo to such Third Party, without the prior written consent of TriSalus. Otherwise, NewCo shall have the sole right to form such collaborations with Third Parties in the NewCo Territory, subject to Sections 2.4 and 4.5.
(a) NewCo and its Affiliates shall not work directly or with any Third Party device manufacturer on the Development, Manufacture or Commercialization of drug-device or biologic- device combination therapies based on NewCo Drug Candidates using any such devices that are competitive with the PEDD Devices in indications for the loco-regional delivery of drugs for the treatment of tumors in the liver or pancreas for which the PEDD Devices are an appropriate delivery system.
(b) TriSalus and its Affiliates shall not work directly or with any Third Party drug developer in the Development, Manufacture or Commercialization in the NewCo Territory of drug- device or biologic-device combination therapies using any therapies that are competitive with any PEDD Combination Therapies in the NewCo Territory for the loco-regional delivery of drugs for the treatment of tumors in the liver or pancreas.
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4.11 TriSalus Option in United States.
(a) NewCo hereby grants to TriSalus at least two (2) options (the “U.S. Option”) to obtain an exclusive, non-transferable license (with the right to grant sublicenses through multiple tiers) under the NewCo IP to Develop, Manufacture and have Manufactured (as provided in Section 6.7) and Commercialize NewCo Drug Candidates as PEDD Combination Therapies in the United States (the “U.S. License”), excluding NewCo Drug Candidates with respect to which NewCo does not Control such rights in the United States. TriSalus’ ability to engage a Third Party manufacturer for any NewCo Drug Candidates under the U.S. License is subject to the Third Party rights granted to NewCo. For clarity, each clinical Designated Indication shall be considered a single option.
(b) TriSalus has the right to exercise such U.S. Option with respect to the applicable PEDD Combination Therapy by providing NewCo with written notice of such exercise at any time during the Development of such PEDD Combination Therapy, or within [***] days after receipt of a written notice from NewCo of the availability of such U.S. Option (the “U.S. Option Notice”), which notice shall include the clinical trial results for the corresponding milestones as described in Section 7.4; provided that (i) NewCo shall not issue a U.S. Option Notice prior to the completion of a Phase I Clinical Study for the PEDD Combination Therapy unless the Parties otherwise agree, and (ii) TriSalus may on written notice to NewCo (delivered within such [***] day period) delay exercise until NewCo provides clinical data from a completed Phase II Clinical Study. If TriSalus exercises the U.S. Option with respect to a PEDD Combination Therapy, then the grant of the U.S. License with respect to such PEDD Combination Therapy shall thereupon automatically become effective and NewCo, its Affiliates and any Third Party licensor, shall not Develop or Commercialize the NewCo Drug Candidate utilized in such PEDD Combination Therapy in the United States in combination with any device that (in TriSalus’ reasonable, good faith determination) is competitive with any PEDD Device.
(c) For NewCo Drug Candidates which NewCo in-licenses from the Third Parties referenced in Exhibit 4.11(c) (Initial Collaboration Company List) and Controls the right to Develop, Manufacture and Commercialize in the United States, NewCo shall not grant any of such rights to a Third Party unless and until NewCo has first granted the U.S. Option to TriSalus with respect to such NewCo Drug Candidate pursuant to Section 4.11(a). For any other NewCo Drug Candidates in- licensed from other Third Parties, upon request, NewCo shall use Commercially Reasonable Best Efforts to assist TriSalus in negotiating rights to such NewCo Drug Candidates in the United States.
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In addition, if TriSalus enters into any collaborative agreement with any Third Party with the assistance of NewCo pursuant to which TriSalus obtains the exclusive right to Develop, Manufacture and Commercialize a NewCo Drug Candidate as a PEDD Combination Therapy in the United States, then NewCo shall be deemed to have fulfilled its obligation pursuant to Section 4.11(a) solely with respect to such NewCo Drug Candidate. For clarity, no amounts shall be due pursuant to Sections 7.4 or 7.5 with respect to such PEDD Combination Therapy and such collaborative agreement satisfies the requirement that NewCo has offered to TriSalus the U.S. Option with respect to such NewCo Drug Candidate in order to avoid the payment of retroactive license fees pursuant to Section 7.6.
(d) TriSalus Shall use Commercially Reasonable Best Efforts to Develop and Commercialize the PEDD Combination Therapy in the United States subject to any U.S. Option after the exercise of such U.S. Option. If TriSalus fails to exercise the U.S. Option in accordance with Section 4.11(b) or elects not to pursue the Development and Commercialization following exercise of the U.S. Option, NewCo shall have the right to Develop and Commercialize the PEDD Combination Therapy in the U.S. subject to reimbursement of any payments made under Section 7.4 and Development costs incurred by TriSalus, and subject to the payment terms in Section 7.8.
4.12 | Ex-Commercial Territory Sales; Export Monitoring. |
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4.14 | Data Sharing. |
(a) Each Party shall promptly disclose to and share with, or cause to be disclosed to and shared with, the other Party, at no cost to the other Party, the Clinical Data or Filings, written or electronic, generated by or otherwise coming into the Control of such Party or any of its Affiliates in connection with the Development, Manufacture or Commercialization of any PEDD Combination Therapy.
(b) Each Party disclaims any representation or warranty that Clinical Data or Filings provided pursuant to Section 4.14(a) shall meet the requirements of any particular country, or that such Clinical Data or Filings shall be adequate or usable by the other Party in connection with seeking any Regulatory Approval in any particular country.
(c) Subject to Section 4.14(d), each Party and its Affiliates and Sublicensees shall have the right as set forth in this Section 4.14(c)to use, without additional payment, any and all Clinical Data or Filings provided pursuant to Section 4.14(a) to support any regulatory filings for PEDD Combination Therapies (i) in the NewCo Territory, in the case of NewCo and its Affiliates and Sublicensees, or (ii) in the United States, in the case of TriSalus and its Affiliates and Sublicensees. Without limiting the foregoing, each Party hereby grants to the other Party and its Affiliates and Sublicensees a Right of Reference to any and all Clinical Data or Filings provided pursuant to Section 4.14(a), for regulatory filings (A) in the NewCo Territory, in the case of NewCo and its Affiliates and Sublicensees, or (B) in the United States, in the case of TriSalus and its Affiliates and Sublicensees.
(d) Each Party shall use commercially reasonable efforts to obtain from each Affiliate or Sublicensee (i) an obligation by the Affiliate or Sublicensee to disclose to and share with such Party (for disclosure to and sharing with the other Party as set forth in Section 4.14(a)) any and all Clinical Data or Filings generated by or otherwise coming into the Control of such Affiliate or Sublicensee, and (ii) the right of the other Party and its Affiliates and Sublicensees to disclose and to use such Clinical Data or Filings as set forth in Section 4.14(c).
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ARTICLE 5
5.1 | Joint Steering Committee. |
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Members of the JSC shall have the right to participate in the meetings held by teleconference or videoconference. In addition, the JSC may act on any matter or issue without a meeting if it is documented in a written consent signed by each member of the JSC.
5.2 | Decision Making. |
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The Alliance Managers shall lead the communications between the Parties and shall be responsible for following-up on decisions made by the JSC.
ARTICLE 6
6.1 PEDD Devices for Distribution in NewCo Territory. TriSalus shall Manufacture (or have Manufactured by one or more Third Party contract manufacturers) and supply NewCo with PEDD Devices for Distribution in the NewCo Territory as set forth in Article 2.
6.4 COGS Reduction Plan. [***].
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6.6 Inspection of TriSalus Manufacturing Facilities. Upon reasonable advanced notice to TriSalus, NewCo shall have the right for it or its representatives to inspect TriSalus manufacturing facilities to confirm compliance with the obligations of this Agreement with respect to the Manufacture of PEDD Devices supplied to NewCo; provided that such inspections occur not more than [***], or at such other frequency as is reasonably necessary for NewCo to comply with Applicable Laws.
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ARTICLE 7
7.1 Upfront Payment. Not later than ten (10) days after the Effective Date, NewCo (or its related third party) shall pay $10,000,000 to TriSalus and TriSalus shall issue to NewCo (or its related third party) a convertible promissory note in such amount in substantially the form attached hereto as Exhibit 7.1 (the “Note”).
7.2 Milestones Payments for PEDD Combination Therapies in the NewCo Territory. With respect to each PEDD Combination Therapy, within ten (10) Business Days following receipt of Regulatory Approval for such PEDD Combination Therapy in the NewCo Territory NewCo shall pay TriSalus a milestone payment in the amount of $2,500,000.
Portion
of Annual Net Sales of the applicable PEDD Combination Therapy in the NewCo Territory |
Marginal Royalty Rate | ||
Less than [***] | [***] | % | |
Equal to or exceeding [***] | [***] | % |
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Portion
of Annual Net Sales of the applicable PEDD Combination Therapy in the United States |
Marginal Royalty Rate |
||
Less than [***] | [***] | % | |
Equal to or exceeding [***] | [***] | % |
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Portion
of Annual Net Sales of the applicable Third Party Combination Therapy in the NewCo Territory |
Marginal Royalty Rate |
||
Less than [***] | [***] | % | |
Equal to or exceeding [***] | [***] | % |
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Portion
of Annual Net Sales of the applicable PEDD Combination Therapy in the United States |
Marginal Royalty Rate |
||
Less than [***] | [***] | % | |
Equal to or exceeding [***] | [***] | % |
7.10 Taxes. Payor shall make all payments to Payee under this Agreement without deduction or withholding for taxes except to the extent that any such deduction or withholding is required by Applicable Laws in effect at the time of payment. Any tax required to be withheld on amounts payable under this Agreement shall promptly be paid by Payor on behalf of Payee to the appropriate governmental authority, and Payor shall furnish Payee with proof of payment of such tax. Any such tax required to be withheld shall be an expense of and borne by Xxxxx. Payor and Payee shall cooperate with respect to all documentation required by any governmental authority or reasonably requested by Payor to secure a reduction in the rate of applicable withholding taxes. If Payor had a duty to withhold taxes in connection with any payment it made to Payee under this Agreement but Payor failed to withhold, and such taxes were assessed against and paid by Payor, then Payee shall indemnify Payor from and against such taxes (including interest).
7.11 Foreign Exchange. With respect to Net Sales invoiced or expenses incurred in a currency other than United States dollars, such Net Sales invoiced or expenses incurred shall be converted into the United States dollars equivalent using a rate of exchange equal to the average rate of exchange to the U.S. dollar during the three month period preceding the date of the corresponding royalty is paid as published by the Wall Street Journal.
7.12 Records; Audits. Payor shall keep, and shall require its Affiliates and Sublicensees to keep, complete and accurate books of accounts and records for the purpose of determining the basis and accuracy of payments to be made under this Agreement, including royalties. Such records shall be kept in accordance with GAAP (with respect to a Chinese entity, the Chinese generally accepted accounting standards) and such entity’s usual internal practices and procedures (which shall be commercially reasonable) consistently applied. Such books and records shall be kept for at least [***] following the end of the Calendar Year to which they pertain. Such records shall be open for inspection by Xxxxx during such [***] period by independent accountants reasonably acceptable to Payor, solely for the purpose of verifying the basis and accuracy of payments made hereunder. Such inspections shall be made no more than once each Calendar Year, at a reasonable time and on reasonable notice, and shall be limited to information related to the applicable payments. Results of any such inspection shall be deemed to be the Confidential Information of Payor, and any such independent accountant shall be required to enter into a customary confidentiality agreement with Payor. If any errors in favor of Payor are discovered in the course of such inspection, then within thirty (30) days of written request by Xxxxx, Payor shall pay Payee those amounts that Payee would have received in the absence of such errors, plus interest in accordance with Section 7.9. Inspections conducted under this Section 7.12 shall be at the expense of Payee, unless a variation or error in favor of Payor exceeding five percent (5%) of the amount due for the period covered by the inspection is established in the course of such inspection, whereupon all reasonable, documented, out-of-pocket costs relating to the inspection for such period shall be paid promptly by Payor. If an overpayment by Payor is discovered in the course of such inspection, the amount of such overpayment shall be, at Payor’s election, refunded within thirty (30) days of written request by Xxxxx or credited against future amounts payable under this Agreement.
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ARTICLE 8
8.1 Background IP. Each Party shall retain all right, title and interest in and to all Patent Rights and Know-How owned by or licensed to such Party as of the Effective Date or discovered, generated or acquired by such Party after the Effective Date but independently of the activities, and without use of Confidential Information of the other Party, under this Agreement.
8.2 | Collaboration IP. |
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8.3 | Patent Rights. |
(a) | Filing, Prosecution and Maintenance of Patent Rights. |
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(b) | Enforcement of Patent Rights. |
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ARTICLE 9
9.1 Confidentiality. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, during the Term and for [***] thereafter, each Party (the “Receiving Party”) receiving any Confidential Information of the other Party (the “Disclosing Party”) hereunder shall keep such Confidential Information confidential and shall not publish or otherwise disclose or use such Confidential Information for any purpose other than as provided for in this Agreement, except for Confidential Information that the Receiving Party can establish:
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(i) was already known by the Receiving Party (other than under an obligation of confidentiality) at the time of disclosure by the Disclosing Party and such Receiving Party has documentary evidence to that effect;
(ii) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party;
(iii) became generally available to the public or otherwise part of the public domain after its disclosure to the Receiving Party, and other than through any act or omission of the Receiving Party in breach of this Agreement; or
(iv) was disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others.
9.2 | Authorized Disclosure and Use. |
(i) file or prosecute patent applications which the Receiving Party is authorized to file or prosecute hereunder;
(ii) | prosecute or defend litigation; |
(iii) exercise rights and perform obligations under this Agreement, provided such disclosure is covered by non-disclosure and non-use obligations consistent with this Agreement;
(iv) facilitate discussions with actual and potential Sublicensees of the Receiving Party, subject to appropriate non-disclosure and non-use agreements;
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(v) facilitate discussions with actual and potential investors (including lenders) or acquirers in connection with an investment in or acquisition of the Receiving Party, subject to appropriate non-disclosure and non-use agreements; or
(vi) | comply with Applicable Laws. |
In the event that the Receiving Party shall reasonably deem it necessary to disclose Confidential Information belonging to the Disclosing Party pursuant to Section 9.2(a)(ii) or 9.2(a)(vi), the Receiving Party shall to the extent possible give reasonable advance notice of such disclosure to the Disclosing Party and take reasonable measures to assist in obtaining a protective order or confidential treatment of such information.
9.4 | Public Announcements; Publications. |
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For clarity, TriSalus has the sole right for any announcement, public release, and publications in relation to PEDD Device matters and independent of NewCo Combination Therapy and NewCo has the sole right for any announcement, public release, and publications in relation to drugs independent of NewCo Combination Therapy.
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ARTICLE 10
REPRESENTATIONS, WARRANTIES AND COVENANTS
10.1 Representations and Warranties of Each Party. Each of TriSalus and NewCo hereby represents and warrants to the other Party as follows:
10.2 Additional Covenants of NewCo. NewCo hereby covenants and agrees that it shall initiate [***] human clinical trials for PEDD Combination Therapies within [***] following the date of Regulatory Approval of SPARK in the NewCo Territory.
10.3 Additional Representations and Warranties of TriSalus. As of the Effective Date of this Agreement and to the best of TriSalus’ knowledge, PEDD Devices, when used in accordance with the applicable approved Instructions for Use, do not infringe any intellectual property rights owned by a Third Party in the NewCo Territory.
10.4 Covenants of Each Party. Each of TriSalus and NewCo hereby covenants to the other Party as follows:
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10.5 Compliance Anti-Corruption Laws. Notwithstanding anything to the contrary contained herein and without limiting the foregoing, each Party represents, warrants and covenants that (a) it has complied and will comply with Anti-Corruption Laws, in all material respects; (b) it has not permitted and will not knowingly permit any Person acting on its behalf to violate any Anti-Corruption Laws; and (c) its and its Affiliates and their employees, agents and contractors will not make any payments or transfer of value which have the purpose or effect of public or commercial bribery, acceptance of or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining or retaining business or any other improper advantage. Each Party will promptly report to the other Party if there is a government or judicial determination of a violation of Anti-Corruption Laws by or on behalf of such Party.
10.6 Representation by Legal Counsel. Each Party represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting of this Agreement. In interpreting and applying the terms and conditions of this Agreement, the Parties agree that no presumption shall exist or be implied against the Party which drafted such terms and conditions.
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ARTICLE 11
11.1 Term. The term of this Agreement (the “Term”) shall commence on the Effective Date and shall remain in effect unless and until this Agreement is terminated in accordance with this Article 11.
11.2 | Termination for Cause. |
(a) Termination with Right to Cure. In the event of a material breach of this Agreement, the non-breaching Party shall have the right to terminate this Agreement by written notice to the breaching Party specifying the nature of such breach in reasonable detail. Other than with respect to those termination conditions set forth in Section 11.2(b) hereof, such termination shall become effective ninety (90) days from receipt of such notice by the breaching Party to permit the breaching Party time to cure such breach, except that such period shall be thirty (30) days in the event the basis of the alleged material breach is a failure to make payment(s) under this Agreement, in each case unless the breaching Party has cured such breach within such period. Payment delays due to the foreign exchange approval process shall not be considered a material breach.
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11.4 General Effects of Termination. Termination of this Agreement for any reason shall not release a Party from any indebtedness, liability or other obligation incurred hereunder by such Party prior to the date of such termination. In addition, termination of this Agreement pursuant to Section 11.2 shall not be exclusive of or prejudicial to any legal or equitable rights or remedies each Party may have on account of any breach of this Agreement. Further, upon termination of this Agreement for any reason and TriSalus’ request, NewCo shall use Commercially Reasonably Best Efforts to promptly assign, transfer and otherwise transition to TriSalus all activities for Commercialization and Distribution of PEDD Devices, together with any and all inventory, products, documents, materials, and information (whether tangible or intangible) associated with such Distribution, that are held or Controlled by or under authority of NewCo or its Affiliates, and shall take such actions and execute such other instruments, assignments and documents as may be necessary to effect the foregoing transfer to TriSalus. Except as otherwise provided in this Article 11, all rights and obligations of the Parties under this Agreement shall terminate upon the termination of this Agreement. In the event of a termination of this Agreement for reasons other than for (a) an uncured material breach of NewCo’s payment obligations hereunder or (b) NewCo’s material breach under Section 11.2(b) (Termination with No Right to Cure), TriSalus shall use Commercially Reasonable Best Efforts to satisfy NewCo’s reasonable requirements for PEDD Device supply in accordance with the applicable terms of this Agreement and any Commercial Supply Agreement then in effect as necessary to support continued Development and/or Commercialization of PEDD Combination Therapies that were in Development prior to such termination.
11.5 Survival of Certain Obligations. The following provisions of this Agreement, along with any other provisions that, by their nature should survive termination, shall survive any termination of this Agreement and remain in effect: Sections 2.12, 2.13, 2.20, 2.23, 2.28, 4.11, 4.12(b), 4.13, 4.14, 4.15, 6.6, 6.7, 10.7, 11.3 and 11.4, and Articles 7, 8, 9, 12, 13 and 14.
ARTICLE 12
INDEMNIFICATION, LIABILITY AND INSURANCE
12.1 Indemnification by TriSalus. TriSalus shall indemnify, defend and hold harmless NewCo, its Affiliates and their respective directors, officers, employees and agents (each, a “NewCo Indemnified Party”) from and against any and all liability, loss, damage, expense (including reasonable attorneys’ fees and expenses) and cost (collectively, a “Liability”) that the NewCo Indemnified Party may be required to pay to one or more Third Parties to the extent resulting from or arising out of: (a) any breach of any representation or warranty made by TriSalus in this Agreement; (b) any breach or violation of any covenant or agreement of TriSalus in this Agreement by TriSalus, its Affiliates or Sublicensees or their respective directors, officers, employees and agents; (c) the negligence, willful misconduct or violation of Applicable Law or breach of the terms and conditions of this Agreement by or of TriSalus, its Affiliates or Sublicensees or their respective directors, officers, employees and agents; or (d) the Development, Manufacture or Commercialization of any PEDD Device or PEDD Combination Therapy by TriSalus or its Affiliates or Sublicensees, except, in each case, to the extent that such Liability results from any matter with respect to which NewCo is obligated to indemnify TriSalus pursuant to Section 12.2.
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12.2 Indemnification by NewCo. NewCo shall indemnify, defend and hold harmless TriSalus, its Affiliates and their respective directors, officers, employees and agents (each, a “TriSalus Indemnified Party”) from and against any and all Liability that the TriSalus Indemnified Party may be required to pay to one or more Third Parties to the extent resulting from or arising out of: (a) any breach of any representation or warranty made by NewCo in this Agreement; (b) any breach or violation of any covenant or agreement of NewCo in this Agreement by NewCo, its Affiliates, Sublicensees or subdistributors or their respective directors, officers, employees and agents; (c) the negligence, willful misconduct or violation of Applicable Law or breach of the terms and conditions of this Agreement by or of NewCo, its Affiliates, Sublicensees or subdistributors or their respective directors, officers, employees and agents; or (d) the Development, Manufacture or Commercialization of any PEDD Device, NewCo Drug Candidate or PEDD Combination Therapy by NewCo or its Affiliates, Sublicensees or subdistributors, except, in each case, to the extent that such Liability results from any matter with respect to which TriSalus is obligated to indemnify NewCo pursuant to Section 12.1.
12.3 Procedure. Each Party shall notify the other promptly in the event it becomes aware of a claim for which indemnification may be sought hereunder. In furtherance and not in limitation of the preceding sentence, in case any proceeding (including any governmental investigation) shall be instituted involving any NewCo Indemnified Party or TriSalus Indemnified Party in respect of which indemnity may be sought pursuant to this Article 12, TriSalus (if such proceeding is initiated against a TriSalus Indemnified Party) or NewCo (if such proceeding is initiated against a NewCo Indemnified Party) (such Party referred to as the “Indemnified Party”) shall promptly notify the other Party (the “Indemnifying Party”) in writing within ten (10) days after the Indemnified Party first becomes aware of such proceeding and the Indemnifying Party and Indemnified Party shall then promptly meet to discuss how to respond to any claims that are the subject matter of such proceeding. The Indemnifying Party shall have the right to assume the defense of any Third Party claim subject to indemnification obligations hereunder. The Indemnifying Party, upon assuming the defense of the claim, shall retain counsel reasonably satisfactory to the Indemnified Party to conduct the defense of the claim and shall pay the fees and expenses of such counsel related to such proceeding. The Indemnified Party agrees to cooperate fully with the Indemnifying Party in the defense of any such claim, action or proceeding, or any litigation resulting from any such claim. In any such proceeding, the Indemnified Party shall have the right to retain its own counsel, but the fees and expenses of such counsel shall be at the expense of the Indemnified Party unless (a) the Indemnifying Party and the Indemnified Party shall have mutually agreed to the retention of such counsel or (b) the named parties to any such proceeding (including any impleaded parties) include both the Indemnifying Party and the Indemnified Party and representation of both Parties by the same counsel would be inappropriate due to actual or potential differing interests between them. All such fees and expenses shall be reimbursed as they are incurred. The Indemnifying Party shall not be liable for any settlement of any proceeding effected without its written consent, but if settled with such consent, the Indemnifying Party agrees to indemnify the Indemnified Party from and against any loss or liability by reason of such settlement.
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The Indemnifying Party shall not, without the written consent of the Indemnified Party, effect any settlement of any pending or threatened proceeding in respect of which the Indemnified Party is, or arising out of the same set of facts could have been, a party and indemnity could have been sought hereunder by the Indemnified Party, unless such settlement includes an unconditional release of the Indemnified Party from all liability on claims that are the subject matter of such proceeding.
12.4 Liability. Except with respect to liability arising from a breach of Article 8 or Article 9 or a Party’s gross negligence or willful misconduct in connection with this Agreement, or to the extent such Party may be required to indemnify the other Party under this Article 12, neither Party nor its respective Affiliates shall be liable to the other for special, punitive or consequential damages, whether based on contract or tort, or arising under Applicable Law or otherwise, in connection with this Agreement.
ARTICLE 13
13.1 General. Any controversy, claim or dispute arising out of or relating to this Agreement (a “Dispute”) shall be settled, if possible, through good faith negotiations between the Parties. However, subject to Section 5.2 with respect to decisions of the JSC, if the Parties are unable to settle such dispute after good faith negotiations, the matter shall be referred to the Executive Officers (having authority to bind the Parties with respect to such dispute, subject to obtaining any necessary corporate or management approvals) to be resolved by negotiation in good faith as soon as is practicable but in no event later than thirty (30) days after referral. The resolution, if any, of a referred matter shall be reduced to writing signed by such Executive Officers and thereafter shall be final and binding on the Parties.
13.2 Binding Arbitration. If the Executive Officers are unable to settle a Dispute after good faith negotiation in the manner set forth above, then such Dispute shall be resolved exclusively through binding arbitration. The arbitration shall be administered by the American Arbitration Association (“AAA”) located in New York, New York, by one (1) arbitrator in accordance with the then effective AAA Commercial Arbitration Rules. The costs of the arbitration, including administrative and arbitrators’ fees, shall be shared equally by the Parties, and each Party shall bear its own costs and attorneys’ and witness’ fees incurred in connection with the arbitration. Any award may be entered in a court of competent jurisdiction for a judicial recognition of the decision and applicable orders of enforcement. The language of the arbitration shall be English, and the location of the arbitration shall be in New York, New York. The Parties and arbitrator shall use commercially reasonable efforts to complete any such arbitration within ninety (90) days from the issuance of notice of a referral of any Dispute to arbitration. The arbitrator shall determine what discovery will be permitted, consistent with the goal of limiting the cost and time which the Parties must expend for discovery, provided that the arbitrator shall permit such discovery as they deem necessary to permit an equitable resolution of the Dispute.
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ARTICLE 14
14.1 Assignment. Neither this Agreement nor any interest hereunder shall be assignable by either Party, without the prior written consent of the other Party, except that a Party may make an assignment of its entire interest in this Agreement without the other Party’s consent to a successor to all or substantially all of the business of such Party to which this Agreement relates, whether by merger, sale of stock, sale of assets, exclusive transfer of technology or other transaction. Each Party shall promptly notify the other Party in writing of any assignment under the provisions of this Section 14.1. This Agreement shall be binding upon the successors and permitted assigns of the Parties, and the name of a Party appearing herein shall be deemed to include the names of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this Agreement. Any assignment not in accordance with this Section 14.1 shall be void.
14.2 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of the Agreement.
14.3 Force Majeure. Neither Party shall be liable to the other for delay or failure in the performance of the obligations on its part contained in this Agreement if and to the extent that such failure or delay is due to circumstances beyond its control which it could not have avoided by the exercise of reasonable diligence. Such Party shall notify the other Party in writing promptly should such circumstances arise, giving an indication of the likely extent and duration thereof, and shall use commercially reasonable efforts to resume performance of its obligations as soon as practicable.
If to NewCo:
Hangzhou Ruizhen Therapeutics Co., Ltd.(杭州瑞臻医疗有限公司)
No. 605, Building 4, Xx. 000 Xxxxxxxxx Xxxx
Yuhang Economic and Technological Development Zone
Yuhang District, Hangzhou, Zhejiang, China
311100
Attn: Director
Electronic Mail: [***]
If to TriSalus:
TriSalus Life Sciences
0000 X. 00xx Xxxxxx
Westminster, CO 80031
USA
Attn: Chief Executive Officer; General Counsel
Electronic Mail: [***]
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14.7 Severability. If any clause or portion thereof in this Agreement is for any reason held to be invalid, illegal or unenforceable, the same shall not affect any other portion of this Agreement, as it is the intent of the Parties that this Agreement shall be construed in such fashion as to maintain its existence, validity and enforceability to the greatest extent possible. In any such event, this Agreement shall be construed as if such clause of portion thereof had never been contained in this Agreement, and there shall be deemed substituted therefor such provision as will most nearly carry out the intent of the Parties as expressed in this Agreement to the fullest extent permitted by Applicable Law.
14.8 Descriptive Headings. The descriptive headings of this Agreement are for convenience only and shall be of no force or effect in construing or interpreting any of the provisions of this Agreement.
14.9 Governing Law. This Agreement shall be governed by and interpreted in accordance with the substantive laws of the State of New York, without regard to conflict of law principles of any jurisdiction. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.
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14.10 Entire Agreement of the Parties. This Agreement, together with the exhibits attached hereto, constitutes and contains the complete, final and exclusive understanding and agreement of the Parties respecting the subject matter hereof and cancels and supersedes any and all prior negotiations, correspondence, understandings and agreements, whether oral or written, among the Parties respecting the subject matter hereof.
14.11 English Language. This Agreement shall be written and executed in the English language. Any translation of this Agreement into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.
14.13 Counterparts. This Agreement may be executed in two counterparts, each of which need not contain the signature of more than one Party but all such counterparts taken together shall constitute one and the same agreement. Counterpart signature pages delivered via facsimile or e-mail in PDF or similar electronic format shall be deemed binding as originals.
14.14 Interpretation. Except where the context requires otherwise, (a) the use of any gender herein shall be deemed to encompass references to either or both genders, and the use of the singular shall be deemed to include the plural (and vice versa), (b) the words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation,” (c) the word “will” shall be construed to have the same meaning and effect as the word “shall,” (d) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (e) any reference herein to any Person shall be construed to include the Person’s successors and assigns, (f) the words “herein”, “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (g) all references herein to Sections or Exhibits shall be construed to refer to Sections or Exhibits of this Agreement, and references to this Agreement include all Exhibits hereto, (h) the word “notice” shall mean notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement, (i) provisions that require that a Party, the Parties or any committee hereunder “agree,” “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging), and (j) references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof.
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14.15 | Fees. |
TriSalus shall reimburse NewCo for up to [***] of its documented legal fees and direct out-of- pocket expenses incurred in connection with the due diligence and the negotiation and execution of this Agreement. NewCo shall submit to TriSalus a written invoice along with reasonable documentation of such expenses, which shall be due and payable by TriSalus within [***] of the invoice date.
14.16 | Initial Public Offering. |
In accordance with the terms of this Agreement, the Parties agree to negotiate in good faith to amend any provision of this Agreement as may be required by Applicable Law.
(The remainder of this page is intentionally left blank. The signature page follows.)
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Duly authorized representatives of the Parties have duly executed this Agreement to be effective as of the Effective Date.
SUREFIRE MEDICAL, INC. | ||
D/B/A TRISALUS LlFE SCIENCES | ||
By: | /s/ Xxxx X. Xxxxx | |
Name: | Xxxx X. Xxxxx | |
Title: | CEO, President | |
Hangzhou Ruizhen Therapeutics Co., Ltd. | ||
杭州瑞臻医疗有限公司) | ||
By: | /s/ Xxxx Xxx Xxxxx | |
Name: | Xxxx Xxx Xxxxx | |
Title: | Legal Representative |
Exhibit 1.23
Current PEDD Devices
[***]
Exhibit 1.41
Improved PEDD Devices
[***]
Exhibit 1.45
Initial Drug Candidates
[***]
Exhibit 2.10
TriSalus Complaint Handling General Operating Procedure
[***]
Exhibit 2.14
Marketing Plan Contents
[***]
Exhibit 4.11(c)
Potential Collaboration Company List
[***]
Exhibit 5.1(a)
JSC Members
[***]
Exhibit 7.1
Form of Note
[***]
[Signature page to Note]