COLLABORATION AND LICENSE AGREEMENT
by and among
SPERO THERAPEUTICS, INC.,
INNOVENT BIOLOGICS (SUZHOU) CO., LTD.,
and
FORTVITA BIOLOGICS (USA), INC.
dated as of July 8, 2026
Exhibit 10.4
Certain identified information has been excluded from the exhibit by marking such portions with brackets (“[***]”) because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential.
COLLABORATION AND LICENSE AGREEMENT
by and among
SPERO THERAPEUTICS, INC.,
INNOVENT BIOLOGICS (SUZHOU) CO., LTD.,
and
FORTVITA BIOLOGICS (USA), INC.
dated as of July 8, 2026
TABLE OF CONTENTS
Article 1 |
|
DEFINITIONS |
1 |
Article 2 |
|
GOVERNANCE |
25 |
2.1 |
|
Alliance Managers |
25 |
2.2 |
|
Committees |
25 |
2.3 |
|
Scope of Governance |
28 |
2.4 |
|
Joint Patent Committee |
28 |
2.5 |
|
Discontinuation of Committees |
29 |
2.6 |
|
Joint Global Study |
29 |
Article 3 |
|
LICENSES; NON-COMPETITION, AND OPTION |
29 |
3.1 |
|
License Grant to Licensee |
29 |
3.2 |
|
License Grant to Innovent |
31 |
3.3 |
|
Right to Sublicense |
33 |
3.4 |
|
Retained Rights |
34 |
3.5 |
|
No Implied Licenses; Negative Covenant |
34 |
3.6 |
|
Non-Competition |
34 |
3.7 |
|
Non-Compete: Effects of Change of Control |
35 |
3.8 |
|
Non-Compete: Acquisition of a Third Party by a Party |
36 |
3.9 |
|
Non-Compete: Distinguishable Competing Product; Option Rights |
36 |
3.10 |
|
Future Upstream License Agreements |
38 |
Article 4 |
|
REGULATORY AND TECHNOLOGY TRANSFER |
39 |
4.1 |
|
Regulatory and Technology Transfer |
39 |
4.2 |
|
Technical Support |
39 |
Article 5 |
|
DEVELOPMENT |
40 |
5.1 |
|
Responsibilities |
40 |
5.2 |
|
Diligence |
40 |
5.3 |
|
Development Plan |
40 |
5.4 |
|
Development Reports |
40 |
5.5 |
|
Records |
41 |
5.6 |
|
Data Exchange and Use |
41 |
Article 6 |
|
COMBINATION CLINICAL TRIALS |
41 |
6.1 |
|
Innovent Combination Clinical Trial |
41 |
6.2 |
|
Licensee Combination Clinical Trial |
42 |
6.3 |
|
Combination Clinical Trial Data |
42 |
Article 7 |
|
REGULATORY |
42 |
7.1 |
|
Licensee Territory |
42 |
7.2 |
|
Innovent Territory |
43 |
7.3 |
|
Provision of Regulatory Submissions |
43 |
7.4 |
|
Notice of Meetings and Regulatory Actions |
43 |
7.5 |
|
Cooperation |
43 |
7.6 |
|
No Harmful Actions |
43 |
7.7 |
|
Notification of Threatened Action |
43 |
7.8 |
|
Rights of Reference |
44 |
7.9 |
|
Adverse Events Reporting |
44 |
7.10 |
|
Remedial Actions |
45 |
7.11 |
|
Safety and Regulatory Audits |
45 |
i
Article 8 |
|
MANUFACTURING AND SUPPLY |
46 |
8.1 |
|
Clinical and Commercial Supply |
46 |
Article 9 |
|
COMMERCIALIZATION; MEDICAL AFFAIRS |
48 |
9.1 |
|
Responsibilities |
48 |
9.2 |
|
Commercialization Diligence |
48 |
9.3 |
|
Commercialization Plan |
48 |
9.4 |
|
Commercialization Reports |
49 |
9.5 |
|
Records |
49 |
9.6 |
|
Product Trademarks |
49 |
9.7 |
|
No Diversion |
50 |
9.8 |
|
Medical Affairs |
50 |
Article 10 |
|
PAYMENTS |
51 |
10.1 |
|
Upfront Payment |
51 |
10.2 |
|
IND Milestone Payment |
51 |
10.3 |
|
Development and Regulatory Milestones |
51 |
10.4 |
|
Distinguishable Competing Product Milestones |
53 |
10.5 |
|
Sales Milestones |
54 |
10.6 |
|
Royalties |
54 |
10.7 |
|
Payment |
57 |
10.8 |
|
Audits |
58 |
10.9 |
|
Interest |
58 |
10.10 |
|
Taxes |
59 |
10.11 |
|
Upstream Costs |
60 |
Article 11 |
|
CONFIDENTIALITY; PUBLICATION |
60 |
11.1 |
|
Confidential Information |
60 |
11.2 |
|
Permitted Disclosures |
61 |
11.3 |
|
Confidential Treatment |
62 |
11.4 |
|
Use of Names |
63 |
11.5 |
|
Publication of Licensed Product Information |
63 |
11.6 |
|
Public Announcements |
64 |
11.7 |
|
Prior Non-Disclosure Agreements |
65 |
Article 12 |
|
REPRESENTATIONS, WARRANTIES, AND COVENANTS |
65 |
12.1 |
|
Representations and Warranties of Each Party |
65 |
12.2 |
|
Additional Representations and Warranties of Innovent |
66 |
12.3 |
|
Additional Representations and Warranties of Licensee |
68 |
12.4 |
|
Covenants |
68 |
12.5 |
|
NO OTHER REPRESENTATIONS OR WARRANTIES |
70 |
Article 13 |
|
INDEMNIFICATION |
70 |
13.1 |
|
By Licensee |
70 |
13.2 |
|
By Innovent |
70 |
13.3 |
|
Procedure |
70 |
13.4 |
|
Insurance |
71 |
13.5 |
|
LIMITATION OF LIABILITY |
71 |
Article 14 |
|
INTELLECTUAL PROPERTY |
72 |
14.1 |
|
Ownership |
72 |
14.2 |
|
Disclosure of Inventions |
72 |
ii
14.3 |
|
Prosecution |
73 |
14.4 |
|
Defense of Third Party Infringement Claims |
74 |
14.5 |
|
Enforcement |
75 |
14.6 |
|
Patent Listing |
77 |
14.7 |
|
Patent Term Extension |
77 |
14.8 |
|
CREATE Act |
77 |
Article 15 |
|
TERM AND TERMINATION |
78 |
15.1 |
|
Term and Expiration |
78 |
15.2 |
|
Termination for Mutual Agreement |
78 |
15.3 |
|
Termination for Convenience |
78 |
15.4 |
|
Termination for Material Breach |
78 |
15.5 |
|
Termination for Certain Licensee Actions |
79 |
15.6 |
|
Licensee Alternative to Termination |
80 |
15.7 |
|
Effects of Termination |
80 |
15.8 |
|
Other Remedies |
82 |
15.9 |
|
Survival |
82 |
Article 16 |
|
DISPUTE RESOLUTION |
82 |
16.1 |
|
General |
82 |
16.2 |
|
Construction |
82 |
16.3 |
|
Escalation |
83 |
16.4 |
|
Arbitration |
83 |
16.5 |
|
Certain Disputes |
84 |
Article 17 |
|
MISCELLANEOUS |
84 |
17.1 |
|
Governing Law |
84 |
17.2 |
|
Force Majeure |
85 |
17.3 |
|
Performance by Affiliates |
85 |
17.4 |
|
Assignment |
85 |
17.5 |
|
Severability |
85 |
17.6 |
|
Notices |
85 |
17.7 |
|
Entire Agreement; Amendments |
87 |
17.8 |
|
Headings |
87 |
17.9 |
|
Independent Contractors |
87 |
17.10 |
|
Waiver |
88 |
17.11 |
|
Waiver of Rule of Construction |
88 |
17.12 |
|
Counterparts |
88 |
17.13 |
|
Language |
88 |
iii
EXHIBITS
Exhibit 1.86 |
Innovent Platform Patents |
|
Exhibit 1.102 |
Licensed Patents |
|
Exhibit 1.104 |
Existing Licensed Product Specific Patents |
|
Exhibit 5.3 |
Licensee Development Plan |
|
Exhibit 8.1(b) |
Supply Agreement Material Terms |
|
Exhibit 11.6 |
Initial Press Release |
|
Exhibit 15.7(c) |
Procedures Applicable to Disagreements With Respect to Reversion Terms or Reversion Sublicense Terms |
|
iv
COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License Agreement (this “Agreement”) is made as of July 8, 2026 (the “Effective Date”), by and among Spero Therapeutics, Inc., a corporation organized and existing under the laws of the State of Delaware (“Licensee”), with offices located at 675 Massachusetts Avenue, 14th Floor, Cambridge, Massachusetts 02139, United States, and Innovent Biologics (Suzhou) Co., Ltd., a company established in the People’s Republic of China (“Innovent Suzhou”), with offices located at 168 Dongping Street, Suzhou Industrial Park, Jiangsu 215123, China, and Fortvita Biologics (USA), Inc., a Delaware corporation with an office and place of business at 950 Page Mill Rd, Suite 204, Palo Alto, California 94304, United States (“Fortvita USA” and, collectively with Innovent Suzhou, “Innovent”). Innovent and Licensee may be referred to in this Agreement individually as a “Party” and together as the “Parties.”
RECITALS
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
The following initially capitalized terms, whether used in the singular or plural, have the respective meanings set forth below:
1.1 “Acquired Party” has the meaning set forth in Section 3.8.
1.2 “Acquisition Party” has the meaning set forth in Section 3.7.
1
1.3 “Adverse Event” means any unwanted or harmful medical occurrence in a patient or subject who is administered a Licensed Product, whether or not considered related to such Licensed Product, including any undesirable sign (including abnormal laboratory findings of clinical concern).
1.4 “Affiliate” means, with respect to a specified Person, any entity that directly or indirectly controls, is controlled by or is under common control with such Person for so long as such control exists. As used in this Section 1.4, “control” (and, with correlative meanings, the terms “controlled by” and “under common control with”) means, in the case of a corporation, the ownership of more than fifty percent (50%) of the outstanding voting securities thereof or, in the case of any other type of entity, an interest that results in the ability to direct or cause the direction of the management and policies of such entity or the power to appoint more than fifty percent (50%) of the members of the governing body of the entity or, where ownership of more than fifty percent (50%) of such securities or interest is prohibited by law, ownership of the maximum amount legally permitted.
1.5 “Agreement” has the meaning set forth in the preamble.
1.6 “Alliance Manager” has the meaning set forth in Section 2.1.
1.7 “Annual Net Sales” means, with respect to a given Licensed Product in a given Calendar Year, the aggregate Net Sales of such Licensed Product in such Calendar Year.
1.8 “Anti-Corruption Laws” has the meaning set forth in Section 12.4(d)(i).
1.9 “Applicable Accounting Standards” means, with respect to a Party, International Financial Reporting Standards (“IFRS”) or GAAP, in each case as generally and consistently applied throughout such Party’s or its Affiliate’s or Sublicensee’s organization. Each Party shall promptly notify the other Party in the event that it changes the Applicable Accounting Standards pursuant to which its records are maintained; provided that, each Party may only use internationally recognized accounting principles (e.g., IFRS, GAAP, etc.) as its Applicable Accounting Standards.
1.10 “Applicable Laws” means all statutes, ordinances, regulations, rules or orders of any kind whatsoever of any Governmental Authority that may be in effect from time to time and applicable to any of the relevant activities contemplated by this Agreement.
1.11 “Assist” means providing, directly or indirectly, a Third Party with (a) any analysis of any of the Licensed Patents or any portion thereof; (b) prior art or analysis of any prior art to any of the Licensed Patents; (c) any documents in Licensee’s possession, custody, or control relating to any of the Licensed Patents, in whole or in part, or to any prior art to any of the Licensed Patents; or (d) financial or technical support, in each case ((a)-(d)), with the intent of assisting a Patent Challenge of any of the Licensed Patents or any portion thereof.
1.12 “Audited Party” has the meaning set forth in Section 10.8(b).
2
1.13 “Biosimilar Product” means, with respect to a Licensed Product that has received Regulatory Approval in a country within the Licensee Territory and is being marketed and sold by Licensee or any of its Affiliates or Sublicensees in such country, any drug product for human use that: (a) is sold in such country by a Third Party who did not purchase or acquire such product or its active components or ingredients in a chain of distribution that included Licensee or any of its Affiliates or Sublicensees; and (b) has received Regulatory Approval in such country as a biosimilar, bioequivalent (or similar designation) of such Licensed Product by the applicable Regulatory Authority in such country, pursuant to an abbreviated approval process in accordance with the then-current rules and regulations in such country, in reliance on a prior Regulatory Approval of such Licensed Product or the data contained or incorporated by reference in a Regulatory Approval for such Licensed Product, where such Licensed Product is the “reference medicinal product,” “reference listed product” or similar designation in such country, including, for clarity, any product for which any Regulatory Approval is sought or obtained pursuant to 42 U.S.C. §262(k) as a biosimilar to such Licensed Product, or any other similar law of any jurisdiction, by reference to a prior Regulatory Approval granted with respect to such Licensed Product; or that is “biosimilar” to such Licensed Product, as the term “biosimilar” is defined in 42 U.S.C. §262(i)(2) or any other similar law of any jurisdiction.
1.14 “Breach Notice” has the meaning set forth in Section 15.4(a).
1.15 “Business Day” means a day other than Saturday, Sunday, or any day on which banks located in New York, U.S., are authorized or obligated to close, or any day that is a government mandated holiday in China. Whenever this Agreement refers to a number of days, such number will refer to calendar days unless Business Days are specified.
1.16 “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31st, June 30th, September 30th and December 31st; provided that the first Calendar Quarter of the Term will extend from the Effective Date until the end of the then-current Calendar Quarter, and the last Calendar Quarter of the Term will end on the effective date of termination or expiration of this Agreement.
1.17 “Calendar Year” means each twelve (12) month period commencing on January 1st and ending on December 31st; provided that the first Calendar Year of the Term will extend from the Effective Date to December 31st of the then-current Calendar Year, and the last Calendar Year of the Term will end on the effective date of the termination or expiration of this Agreement.
1.18 “Cell Culture Media” means the Innovent proprietary cell culture media used by or on behalf of Innovent or any of its Affiliates for the Manufacture of Licensed Compounds and/or Licensed Products.
1.19 “cGMP” means all applicable current Good Manufacturing Practices including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and Eudralex 4, (c) the principles detailed in the ICH Q7 guidelines, and (d) the equivalent Applicable Laws in any relevant country or region, each as may be amended and applicable from time to time.
3
1.20 “Change of Control” means, with respect to a Party, the occurrence of any of the following events: (a) any Third Party acquires, directly or indirectly, the beneficial ownership of any voting security of such Party, or if the percentage ownership of any Third Party in the voting securities of such Party is increased through stock redemption, cancellation, or other recapitalization, and immediately after such acquisition or increase such Third Party is, directly or indirectly, the beneficial owner of voting securities representing more than fifty percent (50%) of the total voting power of all of the then outstanding voting securities of such Party; (b) a merger, consolidation, recapitalization, or reorganization of such Party is consummated which results in shareholders or equity holders of such Party immediately prior to such transaction no longer owning at least fifty percent (50%) of the outstanding voting securities of the surviving entity (or its parent entity) immediately following such transaction; or (c) there is a sale or transfer to a Third Party of all or substantially all of such Party’s consolidated assets that relate to the subject matter of this Agreement, through one or more related transactions. Notwithstanding the foregoing, (i) any investment transaction by venture capital, private equity or other financial investors, including through a private placement, the purpose of which is to raise capital for a Party; (ii) any reorganization, merger or consolidation of a Party in which the holders of the voting securities of such Party immediately prior to such transaction or series of related transactions retain, immediately after such transaction or series of related transactions, at least a majority of the total voting power represented by the outstanding voting securities of such Party or such other surviving or resulting entity; and (iii) any underwritten public offering of equity securities by a Party pursuant to an effective registration statement under the applicable securities laws of any country or jurisdiction shall not, in any case, constitute a Change of Control for purposes of this Agreement.
1.21 “Claims” has the meaning set forth in Section 13.1.
1.22 “Clinical Trial” means any clinical trial of a product in human subjects (a) as defined in 21 C.F.R. §312.21, as amended from time to time, or (b) as prescribed by the Regulatory Authorities in any jurisdiction outside the U.S.
1.23 “CMO” means any Third Party contract manufacturing organization.
1.24 “Combination Product” means any Licensed Product that comprises a Licensed Compound with one or more other clinically or pharmacologically active compounds or ingredients or delivery devices other than a Licensed Compound in a single formulation or final package presentation for sale as a single unit (including separate unit doses so configured). The Licensed Compound portion of any Combination Product shall be deemed the “Licensed Component” and the other clinically or pharmacologically active compounds or ingredients or delivery devices of such Combination Product shall be deemed the “Other Components.”
1.25 “Commercialization” or “Commercialize” means all activities directed to marketing, distribution, promoting or selling of pharmaceutical products (including importing and exporting activities in connection therewith), but excluding activities directed to Manufacturing or Development. “Commercializing” and “Commercialized” have the correlative meanings.
4
1.26 “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party with respect to any objective, [***].
1.27 “Committee(s)” means the JSC or any subcommittee established by the JSC, as applicable.
1.28 “Competing Product” means any monoclonal antibody, bispecific antibody or multispecific antibody Targeting CD40L, excluding any Licensed Compound, any Licensed Product, and any Terminated Product.
1.29 “Confidential Information” has the meaning set forth in Section 11.1.
1.30 “Confidentiality Agreement” means the Mutual Non-Disclosure Agreement between the Parties dated [***].
1.31 “Control” or “Controlled” means, with respect to any Know-How, Patents or other subject matter, that a Party or any of its Affiliates has the legal authority or right (whether by ownership, license or otherwise, without taking into account any license granted by one Party to the other Party pursuant to this Agreement) to grant a license, sublicense, access or right to use (as applicable) under such Know-How, Patents or other subject matter, on the terms and conditions set forth herein, in each case, without breaching the terms of any agreement with a Third Party. Notwithstanding the foregoing, (a) in the event of a Change of Control of a Party, any Know-How, Patents and other subject matter Controlled by the Acquisition Party immediately prior to such Change of Control transaction will not be Licensed Technology, Licensee Product IP, or Grant-Back Technology except, in each case, to the extent any such Know-How, Patents or other subject matter (i) is also Controlled by such Party or any of its Affiliates existing immediately prior to such Change of Control transaction, or (ii) is generated or used by such Party or any of its Affiliates in the Exploitation of any Licensed Compound or Licensed Product after such Change of Control transaction; and (b) Innovent and its Affiliates shall not be deemed to Control any Know-How, Patents or other subject matter licensed to Innovent or any of its Affiliates after the Effective Date unless Licensee elects to receive a sublicense thereunder in accordance with Section 3.10.
1.32 “Cover,” “Covered” or “Covering” means with respect to any Patent and any Licensed Product or Licensed Compound, that, in the absence of the ownership of or a license to such Patent, the Development, Manufacture, use, Commercialization or other Exploitation of such Licensed Product or Licensed Compound would fall within the scope of one or more claims of such Patent (including, with respect to a pending claim of a Patent, as if such pending claim were to issue without modification).
1.33 “Cure Period” has the meaning set forth in Section 15.4(a).
5
1.34 “Data” means (a) any and all results of research, preclinical studies, including in vitro and in vivo studies, Clinical Trials and other testing of any composition of matter, product candidate or product, and (b) any and all other data related to the development, manufacture or commercialization of any composition of matter, product candidate or product, including any biological, chemical, pharmacological, toxicological, pharmacokinetic, preclinical, clinical, CMC, analytical, quality control, mechanical, software and electronic data, results and descriptions.
1.35 “Development” or “Develop” means any research and preclinical and clinical drug or biological development activities, including test method development, toxicology, formulation, quality assurance/quality control development, statistical analysis, preclinical studies and Clinical Trials and regulatory affairs, and regulatory activities, including filing for, obtaining and maintaining Regulatory Approval, but excluding activities directed to Manufacturing or Commercialization. “Developing” has the correlative meaning.
1.36 “Development and Regulatory Milestone Event” has the meaning set forth in Section 10.3(a).
1.37 “Development and Regulatory Milestone Payment” has the meaning set forth in Section 10.3(a).
1.38 “Disclosing Party” has the meaning set forth in Section 11.1.
1.39 “Dispute” has the meaning set forth in Section 16.1.
1.40 “Dispute Referral” has the meaning set forth in Section16.3.
1.41 “Distinguishable Competing Product” has the meaning set forth in Section 3.9.
1.42 “Divestiture” means, with respect to a Competing Product: (a) the divestiture of such Competing Product through: (i) an outright sale or assignment of all material rights in such Competing Product to a Third Party; (ii) an exclusive out-license to a Third Party of all development, manufacture, and commercialization rights with respect to such Competing Product, with no further role, influence, or authority of the applicable Party, directly or indirectly, with respect to such Competing Product; or (iii) a combination of the transactions contemplated by the foregoing clauses (i) and (ii); or (b) the cessation of all Development, Manufacture and Commercialization activities with respect to such Competing Product (subject, if applicable, to applicable wind-down activities and applicable requirements of Applicable Law). For clarity, subject to the preceding sentence, the right of the applicable Party to receive royalties, milestones, or other payments in connection with an acquirer’s, assignee’s, or licensee’s Development, Manufacture, or Commercialization of a Competing Product pursuant to subsection (a) above shall not be deemed to disqualify the applicable sale, assignment, or license from constituting a Divestiture. When used as a verb, “Divest” and “Divested” mean to cause or have caused a Divestiture.
1.43 “Dollars” and “$” mean United States dollars.
1.44 “Effective Date” has the meaning set forth in the preamble.
6
1.45 “EMA” means the European Medicines Agency, or any successor agency thereto.
1.46 “Excluded Formulation Know-How” means any Know-How that (a) consists of a specific Licensed Product formulation or its Manufacture and that is at a concentration of [***] or greater of active pharmaceutical ingredient; or (b) is designed, developed or intended by or on behalf of a Party or its Affiliates for subcutaneous administration (whether delivered by [***]); provided that Excluded Formulation Know-How does not include Know-How that has broader applicability beyond a specific Licensed Product. For clarity, Excluded Formulation Know-How may include specific composition and relative proportions of ingredients in, and specific process conditions used to Manufacture, any such formulation, but does not include more general Know-How that is not specific to such formulation.
1.47 “Existing Upstream License Agreement” means that certain [***].
1.48 “Exploit” means Develop, Manufacture, have Manufactured, use, practice, sell, offer for sale, import, export, Commercialize or otherwise exploit. “Exploitation” has the correlative meaning.
1.49 “Export Controls” has the meaning set forth in Section 12.4(e)(i).
1.50 “FDA” means the United States Food & Drug Administration, or any successor agency thereto.
1.51 “Field” means all human and animal uses.
1.52 “First Commercial Sale” means, on a Licensed Product-by-Licensed Product and country-by-country basis within the Licensee Territory, the first arm’s length sale of a Licensed Product to a Third Party in a country by Licensee or its Affiliate or Sublicensee for use or consumption in such country following receipt of Regulatory Approval of such Licensed Product in such country; provided that in no event will any sale of a Licensed Product in a country (a) at or below cost in connection with the Development of a Licensed Product (including the conduct of Clinical Trials), or (b) at or below cost for charitable purposes or patient access (including in connection with “treatment IND sales,” “named patient sales” and “compassionate use sales”), be considered a “First Commercial Sale.”
1.53 “FTE” means full-time equivalent employee of Innovent based on a total of [***] hours of scientific, technical or managerial activities under this Agreement per Calendar Year. Overtime and work on weekends, holidays, and the like, in each case, will not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution. The portion of an FTE billable by Innovent for one individual during a given accounting period will be determined by dividing the number of hours worked directly by such individual on the work to be conducted under this Agreement during such accounting period and the number of FTE hours applicable for such accounting period based on [***] working hours per Calendar Year.
1.54 “FTE Costs” means, with respect to Innovent and an activity for any period, the FTE Rate multiplied by the applicable number of FTEs performing such activity during such period.
7
1.55 “FTE Rate” means [***] dollars ($[***]) per FTE per Calendar Year.
1.56 “GAAP” means U.S. Generally Accepted Accounting Principles, consistently applied.
1.57 “GCP” means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trials, including, as applicable (a) as set forth in the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Licensee Territory or the Innovent Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent guidelines or Applicable Laws in any other region in the Licensee Territory or the Innovent Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical Data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.
1.58 “GLP” means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or the equivalent guidelines or Applicable Laws in any other region in the Licensee Territory or the Innovent Territory, each as may be amended and applicable from time to time.
1.59 “GLP Tox Study(ies)” means any nonclinical safety and toxicology studies, including IND-enabling studies, conducted in compliance with GLP requirements and designed to support Regulatory Submissions, to be filed with FDA, such as repeat‑dose toxicity, safety pharmacology, genotoxicity, reproductive or developmental toxicity studies.
1.60 “Governmental Authority” means any court, commission, authority, department, ministry, official or other instrumentality of, or being vested with public authority under any law of, any country, region, state or local authority or any political subdivision thereof, or any association of countries.
1.61 “Grant-Back Technology” means, with respect to any Terminated Product, (a) all Know-How Controlled by Licensee or any of its Affiliates that is necessary for the Exploitation of such Terminated Product as of the effective date of termination and at any time during the [***] period prior to the applicable effective date of termination and (b) all Patents that are Controlled by Licensee or any of its Affiliates that Cover such Know-How and/or the Terminated Product as of the effective date of termination and at any time during the [***] period prior to the applicable effective date of termination.
1.62 “Greater China” means the mainland of the People’s Republic of China, Taiwan, Hong Kong and Macau.
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1.63 “GSP” means all applicable Good Supply Practice standards, including, as applicable, as set forth in the then-current good supply practice standards promulgated or endorsed by the FDA as defined in Good Supply Practice for Pharmaceutical Products or the equivalent Applicable Laws in any other region in the Licensee Territory or the Innovent Territory, each as may be amended and applicable from time to time.
1.64 “ICC Rules” has the meaning set forth in Section 16.4(a).
1.65 “ICH” means The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
1.66 “Included FTEs” means an aggregate of [***] hours of services that Licensee requests Innovent to provide to Licensee in accordance with the applicable provisions of this Agreement, which Innovent shall provide in accordance with the applicable provisions of this Agreement without charge to or reimbursement by Licensee.
1.67 “IND” means an investigational new drug application or equivalent application filed with the applicable Regulatory Authority, which application is required to commence or conduct Clinical Trials in the applicable jurisdiction.
1.68 “Indemnitee” has the meaning set forth in Section 13.3.
1.69 “Indemnitor” has the meaning set forth in Section 13.3.
1.70 “Indication” means a specific disease, disorder or condition which is recognized by the applicable Regulatory Authority in a given country or jurisdiction as a discrete disease, disorder or condition in the labeling of a Licensed Product. For clarity, (a) different genetic subtypes, organs of origin, or histologies of a disease, disorder or condition shall not constitute distinct Indications, and (b) treatment of different populations of patients having a disease, disorder or condition (e.g., front-line treatment, treatment of second-line therapy, relapsed refractory treatment and maintenance treatment) shall not constitute distinct Indications. Notwithstanding the foregoing, if the filing of an MAA for a new Indication (i.e., an Indication that is not excluded as a distinct Indication by the foregoing sentence and for which an MAA has not previously been filed) requires the completion of a separate pivotal trial for such Indication, then such Indication shall be deemed to be a distinct Indication for purposes of this Agreement.
1.71 “Indirect Tax” has the meaning set forth in Section 10.10(c).
1.72 “Infringement” has the meaning set forth in Section 14.5(a).
1.73 “Initiation” or “Initiate” means, with respect to a product and a Clinical Trial, dosing of the first patient in such Clinical Trial with such product.
1.74 “Innovent” has the meaning set forth in the preamble.
1.75 “Innovent Combination Clinical Trial” has the meaning set forth in Section 6.1(a).
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1.76 “Innovent Combination Blocking Claim” has the meaning set forth in Section 3.1(e).
1.77 “Innovent Combination Patent” means any Patent Controlled by Innovent or any of its Affiliates that (a) claims or Covers the use of a Licensed Compound or Licensed Product with one or more compounds or products that are not Licensed Compounds or Licensed Products, including an Innovent Product, as a combination therapy, including any method of use, dosing, administration, treatment regimen, or patient population claim specific to such combination therapy, or (b) claims or Covers any data, results, or Know-How generated by or on behalf of Innovent or its Affiliates in the conduct of an Innovent Combination Clinical Trial, in each case ((a) and (b)), solely to the extent such Patent claim is specifically directed to a combination therapy comprising a Licensed Compound or Licensed Product and one or more other compounds or products, including Innovent Products, and not to the Licensed Compound or Licensed Product alone. For clarity, Innovent Combination Patents exclude any Patent, or claim thereof, that specifically Covers the composition of matter, formulation, method of manufacture, or use of a Licensed Compound or Licensed Product other than in a combination therapy with one or more other compounds or products, including an Innovent Product.
1.78 “Innovent Combination Therapy” has the meaning set forth in Section 6.1(a).
1.79 “Innovent Controlled Patents” has the meaning set forth in Section 14.3(d).
1.80 “Innovent Formulation Blocking Claim” has the meaning set forth in Section 3.1(d).
1.81 “Innovent Formulation Patent” has the meaning set forth in Section 3.1(b).
1.82 “Innovent Indemnitee(s)” has the meaning set forth in Section 13.1.
1.83 “Innovent Manufacturing Technology” means the Licensed Know-How consisting of the cell line and related Know-How licensed by [***] to Innovent Suzhou pursuant to the Existing Upstream License Agreement that is used by or on behalf of Innovent or any of its Affiliates for the Manufacture of Licensed Products and Licensed Compounds.
1.84 “Innovent Platform” means Innovent’s platform-based proprietary technology used by Innovent or its Affiliates to discover, generate, develop or manufacture compounds, including Licensed Compound(s).
1.85 “Innovent Platform Know-How” means Licensed Know-How that specifically relates to the Innovent Platform.
1.86 “Innovent Platform Patents” means the Licensed Patents listed in Exhibit 1.86 that Cover the Innovent Platform and/or claim or disclose Innovent Platform Know-How.
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1.87 “Innovent Platform Technology” means (a) Innovent Platform Patents and (b) Innovent Platform Know-How.
1.88 “Innovent Product” means any pharmaceutical product that is proprietary to, and is owned or otherwise Controlled by, Innovent or any of its Affiliates that is not a Licensed Compound or Licensed Product.
1.89 “Innovent Product Marks” has the meaning set forth in Section 9.6(b).
1.90 “Innovent Territory” means Greater China.
1.91 “Invention” means any process, method, composition of matter, article of manufacture, discovery or finding, or other Know-How, patentable or otherwise, that is invented, discovered or generated (a) solely by or on behalf of either Party, its Affiliates, Sublicensees (or (sub)licensees, with respect to Innovent), agents or independent contractors or (b) jointly by or on behalf of both Parties, their Affiliates, Sublicensees (or (sub)licensees, with respect to Innovent), agents or independent contractors, in each case, during the Term in the performance of any activity contemplated by this Agreement or otherwise in the exercise of its (or their) rights or carrying out its (or their) obligations under this Agreement.
1.92 “IRA Subject Product” means any Licensed Product that is designated as a “selected drug” by the Secretary of the U.S. Department of Health and Human Services for drug price negotiation under the Inflation Reduction Act (Public Law No. 117-169) of 2022 in the United States.
1.93 “Joint Inventions” has the meaning set forth in Section 14.1(b).
1.94 “Joint Patents” has the meaning set forth in Section 14.1(b).
1.95 “Joint Steering Committee” or “JSC” has the meaning set forth in Section 2.2(a).
1.96 “Justified Delay” means any delay that is attributable to (a) any toxicity or drug safety issue or Serious Adverse Event that is reasonably related to or observed in connection with, as applicable, any Development or Commercialization activities conducted with respect to a Licensed Product; (b) Licensee’s reasonable response to any guidance or inquiries that are received from, or any action or inaction by, any Regulatory Authority in a Major Market (such as a clinical hold, a recall, or withdrawal) with respect to a Licensed Product; (c) Innovent’s delay in delivering to Licensee any chronic toxicology data or other data in Innovent’s possession and Control that are compliant with FDA requirements and are required for purposes of Licensee’s IND filing in the United States; (d) any need for Licensee to regenerate any data provided by Innovent to Licensee hereunder in order to file Licensee’s first IND for a Licensed Product in the United States to the extent such need arises from guidance received by Licensee from the FDA or is to comply with any Applicable Laws in the United States; (e) any force majeure event that affects a Licensed Product as described in Section 17.2; or (f) any legal injunction issued by a court of competent jurisdiction or by operation of Applicable Laws in any Major Market that affects a Licensed Product.
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1.97 “Know-How” means any scientific or technical information, results, data, and materials of any type whatsoever, in any tangible or intangible form whatsoever, including Data, databases, safety information, practices, methods, techniques, technology, specifications, formulations, formulae, chemical or biological materials, knowledge, know-how, skill, experience, trade secrets, test data including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and manufacturing process and development information, results and data.
1.98 “Knowledge” means, with respect to any representation given by Innovent in this Agreement, the actual knowledge of the executive officers of Innovent and Innovent’s management personnel (including its applicable program managers and legal personnel), in each case, having substantial responsibilities for Innovent’s Development and Manufacture of Licensed Products and legal matters relating thereto, after reasonable inquiry of such Person’s direct reports and outside counsel where such direct reports and outside counsel would reasonably be expected to have substantial additional knowledge relevant to the applicable subject matter, without any obligation to conduct any freedom-to-operate analysis, patent search, patent clearance review, legal investigation, or other independent investigation, or review of archived records to establish Knowledge.
1.99 “Licensed Component” has the meaning set forth in Section 1.24.
1.100 “Licensed Compound” means (a) the molecule known internally by Innovent as IBI355, (b) any backup molecules of IBI355 made by or on behalf of Innovent or any of its Affiliates as of the Effective Date or during the Term that are monoclonal antibodies Targeting CD40L (“Backups”), and (c) any Derivatives of IBI355 or any Backup, in each case of (a) - (c), in the monoclonal antibody modality. For purposes of this definition, “Derivative” means any antibody that (i) is discovered, optimized or modified from or otherwise based on IBI355 or any Backup, (ii) is made by or on behalf of Licensee or its Affiliates or Sublicensees, and (iii) incorporates the antigen-binding sequence of IBI355 or the antigen-binding sequence of a Backup.
1.101 “Licensed Know-How” means any and all Know-How Controlled by Innovent or its Affiliates as of the Effective Date or during the Term, including Innovent’s or its Affiliate’s joint ownership interest in any Know-How within the Joint Inventions, that is necessary or reasonably useful for the Exploitation of any Licensed Compound or Licensed Product in the Field in the Licensee Territory; provided that, (a) subject to Section 3.1, any Excluded Formulation Know-How; and (b) any Know-How generated by or on behalf of Innovent or its Affiliates in the conduct of any Innovent Combination Clinical Trial other than any such Know-How that is safety data (“Innovent Combination Clinical Trial Know-How”), shall each be excluded from the Licensed Know-How (all such Know-How described in clauses (a) and (b), “Excluded Innovent Know-How”).
1.102 “Licensed Patents” means any and all Patents that (a) are Controlled by Innovent or its Affiliates as of the Effective Date or during the Term, including Innovent’s or its Affiliate’s interest in any Joint Patents, and (b) that claim the composition of matter, formulation, method of use or method of manufacture of Licensed Compounds or Licensed Products in the Field in the Licensee Territory, including for clarity, all Licensed Product Specific Patents and Innovent Platform Patents. Without limiting the foregoing, Exhibit 1.102 sets forth a list of all Licensed
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Patents existing as of the Effective Date. For clarity, Licensed Patents exclude Innovent Formulation Patents (subject to Section 3.1) and Innovent Combination Patents.
1.103 “Licensed Product” means any product that comprises or incorporates any Licensed Compound in any form, formulation and delivery mode, including any Combination Product; provided that a Licensed Product may not contain any compound that is proprietary to Innovent but that is not a Licensed Compound.
1.104 “Licensed Product Specific Patents” means any Licensed Patent, other than any Innovent Platform Patent listed in Exhibit 1.86, that includes at least one independent claim that specifically Covers the Licensed Compound or a Licensed Product as a distinct monoclonal antibody that Targets CD40L, including (a) the Licensed Patent existing as of the Effective Date and listed on Exhibit 1.104 (the “Existing Licensed Product Specific Patents”), (b) any patent application claiming priority from such Licensed Patent, including divisions, continuations, continuations-in-part, additions, (c) any patent that issues from such Licensed Patent, including any patent applications claiming priority thereto, and any utility or design patent or certificate of invention, and (d) any re-issues, renewals, extensions, substitutions, re-examinations or restorations, registrations and revalidations, and supplementary protection certificates and equivalents to any of the foregoing (a) through (c).
1.105 “Licensed Technology” means all (a) Licensed Patents and (b) Licensed Know-How.
1.106 “Licensee” has the meaning set forth in the preamble.
1.107 “Licensee Combination Clinical Trial” has the meaning set forth in Section 6.2(a).
1.108 Licensee Combination Blocking Claim” has the meaning set forth in Section 3.2(z).
1.109 “Licensee Combination Patent” means any Patent Controlled by Licensee or any of its Affiliates that (a) claims or Covers the use of a Licensed Compound or Licensed Product with one or more compounds or products that are not Licensed Compounds or Licensed Products, including any compound or product that is proprietary to Licensee, including any method of use, dosing, administration, treatment regimen, or patient population claim specific to such combination therapy, or (b) claims or Covers any data, results, or Know-How generated by or on behalf of Licensee or its Affiliates in the conduct of a Licensee Combination Clinical Trial, in each case ((a) and (b)), solely to the extent such Patent claim is specifically directed to a combination therapy comprising a Licensed Compound or Licensed Product and one or more other compounds or products, including any compounds or products that are proprietary to Licensee and not to the Licensed Compound or Licensed Product alone. For clarity, Licensee Combination Patents exclude any Patent, or claim thereof, that specifically Covers the composition of matter, formulation, method of manufacture, or use of a Licensed Compound or Licensed Product other
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than in a combination therapy with one or more other compounds or products, including any compound or product that is proprietary to Licensee.
1.110 “Licensee Combination Therapy” has the meaning set forth in Section 6.2(a).
1.111 “Licensee Controlled Patents” has the meaning set forth in Section 14.3(b).
1.112 “Licensee Formulation Patent” has the meaning set forth in Section 3.2(b).
1.113 “Licensee Formulation Blocking Claim” has the meaning set forth in Section 3.2(y).
1.114 “Licensee Indemnitee(s)” has the meaning set forth in Section 13.2.
1.115 “Licensee Product IP” means all Know-How and Patents Controlled by Licensee or its Affiliates as of the Effective Date or during the Term that are necessary or reasonably useful to Exploit any Licensed Compound or Licensed Product, including any Patents claiming or Covering any Sole Inventions Controlled by Licensee and any Know-How within Sole Inventions Controlled by Licensee; provided that, (a) subject to Section 3.2, any Excluded Formulation Know-How and (b) any Know-How generated by or on behalf of Licensee or its Affiliates in the conduct of any Licensee Combination Clinical Trial other than any such Know-How that is safety data (“Licensee Combination Clinical Trial Know-How”), shall each be excluded from the Licensee Product IP (such Know-How, “Excluded Licensee Know-How”).
1.116 “Licensee Product Marks” has the meaning set forth in Section 9.6(a).
1.117 “Licensee Territory” means worldwide, excluding the Innovent Territory.
1.118 “Losses” has the meaning set forth in Section 13.1.
1.119 “MAA” means (a) a Biologics License Application (as more fully defined in 21 C.F.R. §601.2, as may be amended) or (b) the equivalent application(s) filed with any Regulatory Authority in any jurisdiction outside the U.S. for approval to market and sell a new drug in such jurisdiction, excluding any application for pricing or reimbursement approvals; but, in each case, including all amendments and supplements to any of the foregoing.
1.120 “Major EU Country” means each of France, Germany, Italy, Spain and the United Kingdom.
1.121 “Major Markets” means the United States, each of the Major EU Countries and Japan.
1.122 “Manufacture” or “Manufacturing” or “Manufactured” means, with respect to a product (or any components or process steps involving any such product), all operations involved in the manufacturing, filling and finishing, quality control testing (including in-process, release and stability testing, if applicable), storage, releasing, packaging, labeling, and supply of such product.
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1.123 “Manufacturing Support” has the meaning set forth in Section 8.1(c).
1.124 “Manufacturing Technology Transfer” has the meaning set forth in Section 8.1(c).
1.125 “Manufacturing Technology Transfer Plan” has the meaning set forth in Section 8.1(c).
1.126 “Material Development Activity” means, with respect to a Licensed Compound or Licensed Product, any material clinical and non-clinical research, Development, Manufacturing and regulatory activities conducted in relation to such Licensed Compound or Licensed Product, including toxicology and pharmacology studies, development of test methods and stability protocols, process development, formulation and delivery system development, quality assurance and quality control, statistical analysis, Clinical Trials, regulatory affairs (including Clinical Trial-related regulatory activities), pharmacovigilance, any activities that are conducted to obtain and maintain any MAA, and any activities carried out in preparation for any of the foregoing.
1.127 “Milestone Payments” means Development and Regulatory Milestone Payments and/or Sales Milestone Payments, as applicable.
1.128 “Net Sales” means, with respect to any Licensed Product, the gross price billed or invoiced on sales of such Licensed Product by Licensee or its Affiliates or Sublicensees (each, a “Selling Party”) to an end user or any Third Party that is not a Sublicensee, less the following deductions, to the extent actually incurred, allowed, paid, accrued or specifically allocated to such gross sales amounts of such Licensed Product:
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To the extent that a Selling Party receives consideration other than or in addition to cash upon the sale or disposition of a Licensed Product, Net Sales will be calculated based on the average price charged for such Licensed Product, as applicable, during the preceding royalty period, or in the absence of such sales, based on such Selling Party’s reasonable determination in good faith of the fair market value of the Licensed Product.
Each of the amounts set forth above will be determined from the books and records of Licensee or its Affiliate or Sublicensee, maintained in accordance with GAAP or, in the case of Sublicensees, such similar accounting principles, consistently applied, and any amounts that are deducted from Net Sales pursuant to one subsection may not be deducted pursuant to another subsection (i.e., a deduction may only be taken once).
Net Sales will exclude any transfer or sale of a Licensed Product (i) at or below cost in connection with the Development or testing of a Licensed Product (including the conduct of Clinical Trials), or (ii) at or below cost for charitable purposes or patient access (including in connection with so-called “treatment IND sales,” “named patient sales” and “compassionate use sales”). Subject to the foregoing, amounts received or invoiced by Licensee or its Affiliates or Sublicensees for the transfer or sale of a Licensed Product by and between Licensee or any of its Affiliates or Sublicensees for resale will not be included in the computation of Net Sales so long as such
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Licensed Product is subsequently resold to a non-Sublicensee Third Party and such subsequent sale is included in the computation of Net Sales under this Agreement.
All discounts, allowances, credits, rebates and other deductions, to the extent allocable across multiple products including a Licensed Product, shall be fairly allocated between such Licensed Product and other products of Licensee or its Affiliates or Sublicensees so that such Licensed Product does not bear a disproportionate portion of such deductions. In no circumstances will Licensee or its Affiliates or Sublicensees sell Licensed Product as a “loss leader”.
Net Sales for a Combination Product in a country shall be calculated as follows:
(i) If both the Licensed Component and the Other Components are sold independently in such country in the same formulation and dosage, then Net Sales will be calculated by multiplying the total Net Sales (as described above) of the Combination Product by the fraction A/(A+B), where A is the average gross selling price in such country of the Licensed Component sold separately in the same formulation and dosage, and B is the (sum of the) average gross selling price(s) in such country of the Other Component(s) sold separately in the same formulation and dosage or device form, during the applicable Calendar Year.
(ii) If the Licensed Component is sold independently of the Other Component(s) in such country in the same formulation and dosage, but the average gross selling price of the Other Component(s) cannot be determined, then Net Sales will be calculated by multiplying the total Net Sales (as described above) of such Combination Product by the fraction A/C, where A is the average gross selling price in such country of such Licensed Component sold independently in the same formulation and dosage and C is the average gross selling price in such country of the Combination Product.
(iii) If the Other Component(s) are sold independently of the Licensed Component in such country in the same formulation and dosage or device form, but the average gross selling price of such Licensed Component cannot be determined, then Net Sales will be calculated by multiplying the total Net Sales (as described above) of such Combination Product by the fraction [1-B/C], where B is the (sum of the) average gross selling price(s) in such country of the Other Component(s) in the same formulation and dosage or device form and C is the average gross selling price in such country of the Combination Product.
(iv) If the average gross selling price of such Licensed Components and the Other Component(s) in the same formulation and dosage or device form, as applicable, cannot be determined, then Net Sales will be calculated by multiplying the total Net Sales (as described above) of such Combination Product by a fraction to be determined by the Parties in good faith based on the relative value contributed by the Licensed Components and Other Components of such Combination Product.
(v) For purposes of calculating the average Net Sales per unit sold of a Licensed Component and Other Component(s) of a Combination Product, any of the deductions described herein that apply to such Combination Product shall be allocated among sales of the Licensed Component and sales of the Other Component(s) included in such Combination Product as follows: (1) deductions that are attributable solely to the Licensed Component or one of the
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Other Component(s) shall be allocated solely to Net Sales of the Licensed Component or such Other Component, as applicable, and (2) all other deductions shall be subject to a reasonable good-faith allocation by the Parties among sales of the Licensed Component and sales of the Other Component(s).
1.129 “NHP PD/Functional Data” means the non-human primate pharmacodynamic and/or functional evidence study results (and expressly excluding data from GLP Tox Studies), which (a) are generated in a controlled and head-to-head NHP study comparing the applicable bispecific or multispecific antibody to a CD40L monospecific antibody at matched exposure levels; (b) include at least one functional readout demonstrating incremental biological activity of the bispecific or multispecific antibody over a CD40L monospecific antibody; and (c) such functional readout(s) have some precedence for either predicting efficacy, or at least be strongly associated with the magnitude of efficacy, in the proposed human disease(s). For purposes of the foregoing, such data shall also demonstrate dual target engagement, including evidence that each binding domain of such bispecific or multispecific antibody is functionally active (e.g. based on assay of receptor occupancy and downstream pathway modulation), and all such data shall be generated within the same study and exposure range to enable appropriate attribution of observed effects. Such study shall be conducted in a stimulated challenge setting (e.g., antigen-driven) in which incremental effect can be meaningfully detected. For clarity, “functional readout” may include, by way of example and without limitation: [***].
1.130 “NMPA” means the National Medical Products Administration, formerly known as the China Food and Drug Administration, and local or provincial counterparts thereto, and any successor agency(ies) or authority thereto having substantially the same function.
1.131 “Non-Compete Period” has the meaning set forth in Section 3.6(a).
1.132 “Other Components” has the meaning set forth in Section 1.24.
1.133 “Out-of-Pocket Costs” means the reasonable and documented amounts paid by a Party or any of its Affiliates to Third Party subcontractors (without mark-up by such Party or any of its Affiliates) under arm’s length arrangements for services or material provided by such subcontractors in performance of activities under this Agreement.
1.134 “Party” or “Parties” has the meaning set forth in the preamble to this Agreement.
1.135 “Patent” or “Patents” means (a) all national, regional and international patents and patent applications, including any provisional patent application, (b) any patent applications claiming priority from such patent applications or provisional patent applications, including divisions, continuations, continuations-in-part and additions, (c) any patent that issues from any of the foregoing patent applications, including any utility or design patent or certificate of invention, and (d) any re-issues, renewals, extensions, substitutions, re-examinations or restorations, registrations and revalidations, and supplementary protection certificates and equivalents applicable to any of the foregoing.
1.136 “Patent Challenge” has the meaning set forth in Section 15.5(b).
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1.137 “Person” means any individual, sole proprietorship, corporation, joint venture, limited liability company, partnership, limited partnership, limited liability partnership, trust or any other private, public or governmental entity.
1.138 “Pharmacovigilance Agreement” has the meaning set forth in Section 7.9(a).
1.139 “Phase 1 Clinical Trial” means a Clinical Trial of a Licensed Product that is described as a phase 1 clinical trial in its protocol, or that would otherwise satisfy the requirements of 21 C.F.R. §312.21(a), as amended from time to time, or the corresponding requirements of any applicable jurisdiction in the Licensee Territory other than the United States.
1.140 “Phase 1/2 Clinical Trial” means a Clinical Trial of a Licensed Product that combines into a single protocol both a Phase 1 Clinical Trial and a Phase 2 Clinical Trial.
1.141 “Phase 2 Clinical Trial” means a Clinical Trial of a Licensed Product that is described as a phase 2 clinical trial in its protocol or that would otherwise satisfy the requirements of 21 C.F.R. §312.21(b), as amended from time to time, or the corresponding requirements of any applicable jurisdiction in the Licensee Territory other than the United States.
1.142 “Phase 2/3 Clinical Trial” means a Phase 2 Clinical Trial of a Licensed Product that is commenced without sufficient statistical powering to satisfy the criteria for a Phase 3 Clinical Trial but that becomes a Registrational Clinical Trial based on the strength of the Data generated in such Clinical Trial.
1.143 “Phase 3 Clinical Trial” means a Clinical Trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. § 312.21(c), as amended from time to time, or the corresponding requirements of any applicable jurisdiction in the Licensee Territory other than the United States.
1.144 “PMDA” means the Japanese Pharmaceutical and Medical Device Administration or any successor agency thereto.
1.145 “Pricing and Reimbursement Approval” means any approval, agreement, determination or other decision by the applicable Governmental Authority of a country or jurisdiction that establishes prices charged to end-users for pharmaceutical or biologic products at which a particular pharmaceutical or biologic product will be reimbursed by applicable Governmental Authority in such country or jurisdiction.
1.146 “Prosecution” means, with respect to a Patent, the filing, preparation, prosecution (including conducting all correspondence and interactions with any patent office and seeking, conducting and defending any interferences, inter partes reviews, reissue proceedings, reexaminations, and oppositions and similar proceedings), and maintenance thereof, including obtaining patent term extensions, regulatory exclusivity, supplemental protection certificates, or their equivalents with respect thereto. When used as a verb, “Prosecute” and “Prosecuting” mean to engage in Prosecution. “Prosecution,” “Prosecute,” and “Prosecuting” exclude any enforcement action with respect to a Patent.
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1.147 “Public Official” means (a) any officer, employee or representative of any regional, federal, state, provincial, county or municipal government or government department, agency or other division; (b) any officer, employee or representative of any commercial enterprise that is owned or controlled by a government, including any state-owned or controlled veterinary or medical facility; (c) any officer, employee or representative of any public international organization, such as the African Union, the International Monetary Fund, the United Nations or the World Bank; and (d) any person acting in an official capacity for any government or government entity, enterprise or organization identified above.
1.148 “Quality Agreement” has the meaning set forth in Section 8.1(b)(i).
1.149 “Receiving Party” has the meaning set forth in Section 11.1.
1.150 “Registrational Clinical Trial” means a Clinical Trial of a Licensed Product conducted with a defined dose or set of defined doses of such Licensed Product on sufficient numbers of human patients, which Clinical Trial is prospectively designed to be sufficient for the filing of an MAA of such Licensed Product with the applicable Regulatory Authority in the Licensee Territory.
1.151 “Regulatory Approval” means, with respect to a Licensed Product in a region or a country, the approvals from the necessary Governmental Authority to import, market and sell such Licensed Product in such region or country (excluding Pricing and Reimbursement Approvals).
1.152 “Regulatory Authority” means any applicable Governmental Authority responsible for granting Regulatory Approvals for a Licensed Product, including the FDA, the EMA, the PMDA, the NMPA and any other corresponding national or regional Governmental Authority.
1.153 “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights (other than any exclusivity rights conferred by Patents) conferred by a Regulatory Authority on a Licensed Product under Applicable Laws in a country or jurisdiction in connection with the Regulatory Approval for such Licensed Product in such country or jurisdiction that prevents another party other than the Regulatory Approval holder and such Regulatory Authority from using and from otherwise relying on the Regulatory Approval or data supporting the Regulatory Approval for such Licensed Product without the prior written authorization of the Regulatory Approval holder.
1.154 “Regulatory Submissions” means (a) any filing, application, or submission with any Regulatory Authority, (b) any authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and MAAs, (c) all material correspondence or communication with or from the relevant Regulatory Authority, and (d) the minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.
1.155 “Remedial Action” has the meaning set forth in Section 7.10.
1.156 “Representative” has the meaning set forth in Section 11.1.
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1.157 “Requisite Amount” means (a) following the Initiation of a Phase 1 Clinical Trial for a Licensed Product in the Licensee Territory but prior to the Initiation of a Phase 2 Clinical Trial for a Licensed Product in the Licensee Territory, [***] dollars ($[***]), (b) following the Initiation of a Phase 2 Clinical Trial for a Licensed Product in the Licensee Territory but prior to receipt of top line data for a Phase 2 Clinical Trial for a Licensed Product in the Licensee Territory, [***] dollars ($[***]), or (c) following the Initiation of a Phase 3 Clinical Trial for a Licensed Product in the Licensee Territory, [***] dollars ($[***]).
1.158 “Reversion License” has the meaning set forth in Section 15.7(b).
1.159 “Reversion Terms” has the meaning set forth in Section 15.7(c).
1.160 “Royalty Payment” has the meaning set forth in Section 10.6(a).
1.161 “Royalty Term” has the meaning set forth in Section 10.6(b).
1.162 “Safety Risk” means a Party’s reasonable belief, based upon information that becomes available to such Party or an analysis of the existing information that is conducted by such Party, that a Licensed Product has a safety issue that would reasonably be expected to have a material adverse effect on the Development or Commercialization of Licensed Products.
1.163 “Sales Milestone Event” has the meaning set forth in Section 10.5(a).
1.164 “Sales Milestone Payment” has the meaning set forth in Section 10.5(a).
1.165 “Securities Regulator” has the meaning set forth in Section 11.2(d).
1.166 “Senior Executive” means (a) with respect to Innovent, its Chief Executive Officer (or any of his or her direct reports having authority to agree to a final resolution of a disputed matter under this Agreement) (or any of his or her direct reports having authority to agree to a final resolution of a disputed matter under this Agreement) and (b) with respect to Licensee, its Chief Executive Officer (or any of his or her direct reports having authority to agree to a final resolution of a disputed matter under this Agreement).
1.167 “Serious Adverse Event” means any Adverse Event that, at any dose: (a) results in death; (b) is life-threatening; (c) requires inpatient hospitalization or prolongation of existing hospitalization; (d) results in persistent or significant disability/incapacity; or (e) is a congenital anomaly/birth defect. In the case of other Adverse Events, medical and scientific judgment should be exercised in deciding whether expedited reporting is appropriate. Such events may be important medical events that may not be immediately life-threatening or result in death or hospitalization but which may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the first sentence of this definition. Such events should usually be considered Serious Adverse Events.
1.168 “Shelving Event” means, prior to the first Regulatory Approval in the United States of a Licensed Product, any consecutive [***] period during which Licensee fails to (a) conduct any Material Development Activity and (b) expend at least the Requisite Amount (based on external costs only and excluding internal cost (e.g., direct labor costs)) with respect to the
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Licensed Compound and Licensed Product; provided that, any such failure is not attributable to a Justified Delay. For clarity, satisfaction of the criterion in clause (a) and (b) above with respect to one Licensed Product during an applicable period precludes the occurrence of a Shelving Event during such period.
1.169 “Sole Inventions” has the meaning set forth in Section 14.1(b).
1.170 “Sublicensee” means a Third Party to whom Licensee or any of its Affiliates has granted or grants a sublicense under any of the rights or licenses granted to Licensee pursuant to this Agreement. For clarity, a Third Party that was granted a further sublicense (including through multiple tiers) by a Sublicensee will also be deemed a Sublicensee and such further Sublicensee will be bound by the terms of this Agreement applicable to Sublicensees.
1.171 “Supply Agreement” has the meaning set forth in Section 8.1(b)(i).
1.172 “Target” means any receptor, ligand or other molecule that is potentially associated with a disease or condition, and potentially has a biological activity that is modified by direct interaction with an antibody.
1.173 “Targeting” means, with respect to a Target and any Licensed Compound or other compound, product, antibody, antibody fragment or agent, that such Licensed Compound or other compound, product or agent binds to and activates, inhibits, or otherwise modulates such Target as its primary mechanism of action.
1.174 “Tax” or “Taxes” means any present or future taxes, levies, imposts, duties, charges, assessments or fees of any nature (including any interest thereon), including VAT.
1.175 “Term” has the meaning set forth in Section 15.1(a).
1.176 “Terminated Product” means each Licensed Product that Licensee is Developing and/or Commercializing at the time of termination.
1.177 “Third Party” means an entity other than (a) Licensee and its Affiliates or (b) Innovent and its Affiliates.
1.178 “Third Party Infringement Claim” has the meaning set forth in Section 14.4.
1.179 “Third Party License” has the meaning set forth in Section 10.6(c)(ii).
1.180 “U.S.” means the United States and its territories.
1.181 “U.S. Dollars” means United States dollars, the lawful currency of the U.S.
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1.182 “Valid Claim” means (a) a claim of an issued and unexpired Patent that has not been permanently revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, which decision is not appealable or is not appealed within the time allowed for appeal, and has not been abandoned, disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise or (b) a claim of a pending Patent application that (i) has not been pending for more than [***] years from the filing date of the earliest Patent application from which such pending Patent application derives priority, and (ii) (A) has not been cancelled, withdrawn or abandoned, or (B) finally rejected by an administrative agency action from which no appeal can be taken or that has not been appealed within the time allowed for appeal; provided that, in the case of a pending claim that ceases to be a Valid Claim due to the foregoing time limit of clause (b)(i), if such pending claim later issues, such claim shall thereafter be considered a Valid Claim for all purpose hereunder so long as it meets the requirements of clause (a).
1.183 “VAT” means value-added taxes or other similar taxes.
1.184 “Withholding Amount” has the meaning set forth in Section 10.10(b).
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Additional Definitions:
Additional Data Plan |
Section 10.3(d) |
Additional Development and Regulatory Milestone Event |
Section 10.4(a) |
Additional Development and Regulatory Milestone Payment |
Section 10.4(a) |
[***] |
Section 3.6(d) |
Ancillary Agreement |
Section 17.7 |
Consulting Firm |
Section 2.2(e)(iii)(B) |
Development Plans |
Section 5.3 |
Entity |
Section 17.9 |
Extended Option Period |
Section 3.9(b) |
Initial Option |
Section 3.9(b) |
Initial Option Period |
Section 3.9(b) |
Joint Patent Committee or JPC |
Section 2.4 |
Launch Quarter |
Section 10.6(c)(iv) |
Licensee Development Plan |
Section 5.3 |
Licensee Product Patents |
Section 14.3(a) |
[***] |
Section 1.47 |
Negotiation Period |
Section 8.1(e) |
Notified Party |
Section 2.2(e)(iii)(A) |
Notifying Party |
Section 2.2(e)(iii)(A) |
Option |
Section 3.9(b) |
Option Exercise Fee |
Section 3.9(e) |
Product Infringement |
Section 14.5(b)(i) |
Safety Matter |
Section 2.2(e)(iii)(A) |
Safety Matter Notice |
Section 2.2(e)(iii)(A) |
Secondary Manufacturer |
Section 8.1(e) |
Selling Party |
Section 1.128 |
Regulatory Assistance |
Section 7.5 |
Regulatory and Technology Transfer |
Section 4.1(a) |
Regulatory and Technology Transfer Plan |
Section 4.1(a) |
Reversion Sublicense Terms |
Section 15.7(c) |
Tax Action |
Section 10.10(b) |
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ARTICLE 2
GOVERNANCE
2.1 Alliance Managers. Promptly following the Effective Date, each Party shall designate an individual to act as the primary business contact for such Party for matters related to this Agreement (each such individual appointed, an “Alliance Manager”), unless another individual is expressly specified in this Agreement or designated by the Parties for a particular purpose. The Alliance Managers will (a) facilitate the flow of information between the Parties and otherwise promote communication, coordination and collaboration between the Parties by providing central points of contact for communication by and between the Parties’ functions/subject matter experts; and (b) manage the JSC (and any other Committee) meetings by (i) calling meetings; (ii) preparing and issuing minutes of each such meeting within [***] thereafter; and (iii) preparing and circulating an agenda for each upcoming meeting of each Committee, in each case, at the direction of and in consultation with the then-current chair of the applicable Committee. Each Party may remove and replace its Alliance Manager at any time by written notice to the other Party.
2.2 Committees.
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2.3 Scope of Governance. Notwithstanding the creation of a Committee, each Party will retain the rights, powers and discretion granted to it hereunder, and no Committee will be delegated or vested with rights, powers or discretion unless such delegation or vesting is expressly provided herein. No decision of a Committee will be in contravention of any terms and conditions of this Agreement. Only those specific issues that are expressly provided in this Agreement to be decided by such Committee may be decided by such Committee. Each Party has final decision-making authority with respect to the implementation of its operational, day-to-day activities.
2.4 Joint Patent Committee.
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2.5 Discontinuation of Committees. All Committees will continue to exist until the first to occur of: (a) the Parties’ written agreement to disband such Committee; and (b) unless otherwise agreed by the Parties, the first Regulatory Approval of the first Licensed Product in the U.S. Upon the occurrence of any event described in clause (a) or (b) above, all Committees will disband and shall have no further authority or duties under this Agreement. After the JSC ceases to exist, (i) each Party shall designate a contact person for the exchange of information previously exchanged through the JSC, and (ii) any decisions that are designated under this Agreement as being subject to the review or approval of the JSC will be made by written agreement of the Parties directly, subject to the other terms and conditions of this Agreement.
2.6 Joint Global Study. If either Party wishes to conduct a multi-regional Clinical Trial with a Licensed Product that includes the Licensee Territory and the Innovent Territory, (a) such Party shall submit to the JSC the proposed strategy, protocol design, expected budget and process timeline for such Clinical Trial for review and discussion and (b) if the Parties agree that such Clinical Trial may be conducted, the Parties shall prepare a joint development plan that sets forth the timeline, budget, cost allocation, and other details of such Clinical Trial to be conducted by or on behalf of the Parties, and shall submit such plan to the JSC for its review and approval.
ARTICLE 3
LICENSES; NON-COMPETITION, AND OPTION
3.1 License Grant to Licensee. Subject to the terms and conditions of this Agreement, Innovent, on behalf of itself and its Affiliates, hereby grants to Licensee the following licenses:
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The above licenses exclude Excluded Innovent Know-How and Innovent shall not be obligated to disclose such Excluded Innovent Know-How to Licensee; provided that, if at any time during the Term, Innovent files a Patent Covering or claiming Excluded Formulation Know-How that is necessary or reasonably useful to Exploit any Licensed Compound or Licensed Product (each, an “Innovent Formulation Patent”), then (a) Innovent will provide Licensee with prompt written notice which notice shall include a description of such Innovent Formulation Patent, and (b) thereafter if Licensee notifies Innovent that Licensee wishes to include the Innovent Formulation Patent as Licensed Patent for purposes of this Agreement, the Parties will negotiate in good faith the terms pursuant to which the Innovent Formulation Patent will be included as Licensed Patent for purposes of this Agreement.
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For clarity, the non-assertion covenants in the foregoing clauses (d) and (e) do not constitute licenses to use any Innovent Combination Patent or Innovent Formulation Patent.
Licensee acknowledges and agrees that (a) Innovent obtained the rights to certain Licensed Technology under the Existing Upstream License Agreement; (b) the licenses granted by Innovent to Licensee under this Section 3.1 with respect to such Licensed Technology constitute sublicenses under the Existing Upstream License Agreement and are subject and subordinate to Sections 2.4, 2.5, 3, 4.3.1, 4.3.2, 8, 9.2 and 10.5 of the Existing Upstream License Agreement; (c) Licensee shall comply with Sections 2.4, 2.5, 4.2, 4.3.1, 4.3.2, 6.1, 6.3, 8, 10.5 and 15.4 of the Existing Upstream License Agreement as applicable to Licensee as a sublicensee; and (d) Innovent’s licenses to certain Licensed Technology under the Existing Upstream License Agreement and the licenses granted by Innovent to Licensee under this Section 3.1 with respect to such Licensed Technology are non-exclusive. Innovent shall use commercially reasonable efforts to obtain, promptly following the Effective Date, any consent or approval required under the Existing Upstream License Agreement to permit Innovent to grant the sublicenses to Licensee hereunder with respect to Licensed Technology owned or controlled by [***], including any such consent or approval required to permit Licensee to grant further sublicenses with respect to such Licensed Technology; provided that, (i) Licensee agrees to cooperate with Innovent and provide any reasonable assistance to Innovent as Innovent may reasonably request in order to facilitate Innovent’s negotiations with [***] with respect to such consent or approval and (ii) if Innovent, despite using commercially reasonable efforts, is unable to obtain any such consent or approval, Innovent shall discuss in good faith with Licensee a reasonable arrangement that will provide Licensee with all of the benefits of, subject to the related obligations under, such Upstream License Agreement as if the appropriate consent or approval had been obtained. Innovent shall keep Licensee reasonably informed of the status of such efforts, including by consulting with Licensee regarding each draft of any such consent or approval and considering in good faith any timely comments thereon provided by Licensee.
3.2 License Grant to Innovent. Subject to the terms and conditions of this Agreement, Licensee, on behalf of itself and its Affiliates, hereby grants to Innovent the following licenses:
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The above licenses exclude Excluded Licensee Know-How and Licensee shall not be obligated to disclose such Excluded Licensee Know-How to Innovent; provided that, if at any time during the Term, Licensee files a Patent Covering or claiming formulation Know-How that is necessary or reasonably useful to Exploit any Licensed Compound or Licensed Product (each, a “Licensee Formulation Patent”), then (a) Licensee will provide Innovent with prompt written notice which notice shall include a description of such Licensee Formulation Patent, and (b) thereafter if Innovent notifies Licensee that Innovent wishes to include the Licensee Formulation Patent as Licensee Product IP for purposes of this Agreement, the Parties will negotiate in good faith the terms pursuant to which the Licensee Formulation Patent will be included as Licensee Product IP for purposes of this Agreement.
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For clarity, the non-assertion covenants in the foregoing clauses (y) and (z) do not constitute licenses to use any Licensee Combination Patent or Licensee Formulation Patent.
Neither Licensee nor its Affiliates shall negotiate or obtain an upstream license agreement with any Third Party that includes a license within the Innovent Territory to any Patent or Know-How that will constitute Licensee Product IP without the prior written consent of Innovent, excluding non-exclusive license agreements for licenses of a scope of use within the scope of the license set forth in Section 3.1(b). Subject to the foregoing, Innovent acknowledges and agrees that if Innovent provides such consent and the licenses granted by Licensee to Innovent under this Section 3.2 with respect to Licensee Product IP constitute sublicenses under any such upstream license agreement between Licensee or any of its Affiliates, on the one hand, and Third Party licensors, on the other hand, then such licenses under this Section 3.2 shall be subject and subordinate to all applicable provisions of such upstream license agreements and Innovent shall be responsible for paying to Licensee any royalty, milestone and other license fee amounts thereunder that are reasonably attributable to Innovent’s sublicense thereunder; provided that, Innovent may elect not to receive a sublicense under any such Licensee Product IP and if Innovent makes such election, such Licensee Product IP shall not be sublicensed to Innovent under this Section 3.2 unless and until Innovent has agreed to the foregoing obligations.
3.3 Right to Sublicense.
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3.4 Retained Rights.
3.5 No Implied Licenses; Negative Covenant. Except as set forth herein, nothing in this Agreement grants any license or other intellectual property interest of either Party to the other Party, by implication or otherwise, under any Know-How, trademarks or Patents of the other Party. Each Party shall not, and shall not permit any of its Affiliates, Sublicensees (or (sub)licensees in the case of Innovent), or subcontractors to, practice any Patent or Know-How licensed to it by the other Party outside the scope of the licenses granted to such Party under this Agreement.
3.6 Non-Competition. Subject at all times to Section 3.7, Section 3.8, and Section 3.9:
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3.7 Non-Compete: Effects of Change of Control. Notwithstanding Section 3.6(a) and Section 3.6(b), if a Party (each, a “Change of Control Party”) undergoes a Change of Control with a Third Party or Licensee grants a Sublicense to a Third Party (such Third Party, together with any of its Affiliates existing prior to such Change of Control or such Sublicensee together with its Affiliates, an “Acquisition Party”), the Acquisition Party shall have the right to engage in the Exploitation of a Competing Product that would otherwise be prohibited by Section 3.6(a) or Section 3.6(b), as applicable, and such conduct shall not constitute a breach by such Party of its obligations set forth in Section 3.6(a) or Section 3.6(b), as applicable, provided that (i) such Acquisition Party Exploits the Competing Product independently of the activities under this Agreement and does not use any Licensed Technology (with respect to Licensee as the Change of Control Party), any Licensee Product IP (with respect to Innovent as the Change of Control Party) or any Confidential Information of either Party (with respect to either Party as the Change of Control Party) in the Exploitation of such Competing Product, and (ii) such Change of Control Party and such Acquisition Party institute and enforce commercially reasonable technical and administrative procedures and safeguards designed to ensure that the requirements set forth in the
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foregoing clause (i) are met, including by creating “firewalls” to prevent disclosure of non-public plans or non-public information relating to such Licensed Technology or Licensee Product IP, as applicable and the Licensed Products and Confidential Information, to any personnel (including sales teams) of such Acquisition Party (and its Affiliates), who are conducting any activities with respect to the applicable Competing Product (except to senior management or executive personnel in the course of carrying out their management or executive functions).
3.8 Non-Compete: Acquisition of a Third Party by a Party. If either Party or any of its Affiliates merges or consolidates with, or otherwise acquires a Third Party (whether such transaction occurs by way of a sale of assets, merger, consolidation or similar transaction) (an “Acquired Party”) that is engaged in Exploitation of a Competing Product as of the closing of such transaction that would be prohibited by Section 3.6(a) or Section 3.6(b), as applicable, and such merger, consolidation or acquisition does not result in a Change of Control of such Party, then the Acquired Party may continue the Exploitation of such Competing Product for a period not to exceed [***] following the closing of such transaction, and such Party shall not be deemed to be in breach of its obligations set forth in Section 3.6(a) or Section 3.6(b), as applicable, provided that (i) no later than the end of such [***] period, such Party or its Affiliate or its Acquired Party (A) Divests its interest in such Competing Product, or (B) terminates the Exploitation of such Competing Product; and, in either case promptly provides the other Party with written confirmation of such Divestiture or termination, and (ii) during such [***] period, such Party and the Acquired Party implement and enforce “firewall” procedures that would satisfy the requirements of Section 3.7, mutatis mutandis.
3.9 Non-Compete: Distinguishable Competing Product; Option Rights.
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3.10 Future Upstream License Agreements.
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ARTICLE 4
REGULATORY AND TECHNOLOGY TRANSFER
4.1 Regulatory and Technology Transfer. The JSC shall coordinate the conduct of the Regulatory and Technology Transfer described in this Article 4.
4.2 Technical Support. Promptly following the Effective Date, Innovent shall provide the Regulatory and Technology Transfer pursuant to Section 4.1(a) and, during the first [***] after the Effective Date, Innovent shall make available to Licensee Innovent’s and its Affiliates’ applicable personnel on a reasonable basis to answer questions and provide technical support with respect to any Regulatory Submissions and Know-How transferred to Licensee pursuant to Section 4.1(a) as requested in writing by Licensee (such support, the “Technical Support”). Licensee shall reimburse Innovent for its (a) Out-of-Pocket Costs and (b) FTE Costs for any FTEs used to conduct Technical Support in excess of the Included FTEs, in each case ((a) and (b)), incurred in the performance of such Technical Support. Innovent will invoice Licensee for such Out-of-Pocket Costs and FTE Costs following each Calendar Quarter in which such FTE Costs and Out-of-Pocket Costs are incurred. For clarity, if any Regulatory and Technology Transfer requires the translation of Regulatory Submissions into English as requested by Licensee, Licensee may engage a Third Party to perform such translations, and such translations shall be at Licensee’s cost and expense. Alternatively, Licensee may elect on a case-by-case basis to have Innovent perform such
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translations, in which case Licensee shall pay Innovent the FTE Costs for any FTEs used to perform such translations in excess of the Included FTEs; provided that the Parties anticipate that Licensee will generally elect to have Third Parties perform such translations.
ARTICLE 5
DEVELOPMENT
5.1 Responsibilities. As between the Parties, Licensee shall (itself or through its Affiliates or Sublicensees) have the sole right and responsibility, at its sole cost and expense, to conduct all Development of Licensed Products in the Field in the Licensee Territory, except for any non-clinical Development activities conducted by Innovent as expressly provided in Section 3.2(b).
5.2 Diligence.
5.3 Development Plan. Each Party shall provide the JSC with non-binding, high-level written development plans that includes its anticipated timeline and budget for material Development work (including all Clinical Trials) to be conducted by or on behalf of the applicable Party, its Affiliates and Sublicensees (or, with respect to Innovent, (sub)licensees) in order to obtain Regulatory Approval of the Licensed Product in its territory (each, a “Development Plan”). Exhibit 5.3 (the “Licensee Development Plan”) sets forth the initial Development Plan for Licensee. Innovent shall provide the JSC with its Development Plan promptly after Innovent has prepared such Development Plan and in any case within [***] after the Effective Date. From time to time during the Term, but not less than [***], each Party will provide the JSC, for its review, with any amendment to its Development Plan.
5.4 Development Reports. Each Party will keep the JSC reasonably informed of the status, progress and results of its Development and regulatory activities with respect to Licensed Compounds and Licensed Products and will update the JSC regarding such status, progress and results not less than [***], including with regard to any Clinical Trial designs, clinical data, Adverse Events, and regulatory communications with Regulatory Authorities with respect to Licensed Products. All updates and reports provided by a Party pursuant to this Section 5.4 will be the Confidential Information of such Party.
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5.5 Records. Each Party shall, and shall cause its Affiliates to, and shall require its Sublicensees (or, with respect to Innovent, (sub)licensees) or subcontractors to, maintain complete, current and accurate records in either tangible or electronic form of all material Development activities with respect to the Licensed Products, in each case in accordance with such Person’s reasonable internal documentation and record retention practices. Such records will be maintained in sufficient detail to properly reflect, in good scientific manner, all material work done, and the results of studies and Clinical Trials undertaken and, further, will be at a level of detail appropriate for Patent and regulatory purposes. In addition, such Party will document all non-clinical studies and Clinical Trials of Licensed Products in formal written study reports according to Applicable Laws and applicable national and international guidelines. Upon the written request of either Party, the Parties shall discuss in good faith and may agree on the reasonable scope of records, reports, information and Data to be provided by one Party to the other Party for the other Party’s use for the Development, Manufacture, and Commercialization of the Licensed Products in such other Party’s territory, in each case in accordance with the terms of this Agreement. All records, reports, information and Data provided by a Party pursuant to this Section 5.5 shall be deemed the Confidential Information of such Party.
5.6 Data Exchange and Use. Each Party shall, at its own cost and expense, promptly provide the other Party with copies of all Data (including all Clinical Trial data and supporting documentation, e.g., protocols and case report forms) generated from its Development of the Licensed Compounds and Licensed Products, and shall take all necessary steps, including with respect to any informed consent forms and Regulatory Approvals, that may be reasonably required to ensure that such Data can be delivered to the other Party in compliance with Applicable Laws. For clarity, any such Data will be owned by each Party in accordance with Section 14.1 and shall be subject to the licenses, rights and obligations set forth herein.
ARTICLE 6
COMBINATION CLINICAL TRIALS
6.1 Innovent Combination Clinical Trial.
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6.2 Licensee Combination Clinical Trial.
6.3 Combination Clinical Trial Data. Each Party shall share with the other Party any safety data generated by or on behalf of such Party in connection with the conduct of (a) with respect to Innovent, Innovent Combination Clinical Trials or (b) with respect to Licensee, Licensee Combination Clinical Trials, as applicable, in each case to the extent reasonably necessary for patient safety, pharmacovigilance, or compliance with Applicable Laws. Except for such safety data, neither Party shall be obligated under this Agreement to disclose, provide, or grant access to any other data, results, Know-How or other information arising from any such Innovent Combination Clinical Trials (with respect to Innovent) or Licensee Combination Clinical Trials (with respect to Licensee), as applicable.
ARTICLE 7
REGULATORY
7.1 Licensee Territory. Subject to Innovent’s rights under Section 3.2, Licensee shall (itself or through its Affiliates or Sublicensees) have the sole right and responsibility, at its sole cost and expense, to (a) conduct all regulatory activities leading up to and including the obtaining of all Regulatory Approvals for Licensed Products from the applicable Regulatory Authorities on a country-by-country basis in the Licensee Territory and (b) prepare, file for, obtain, hold, and maintain all INDs and Regulatory Approvals and, as applicable, associated pricing and reimbursement approvals for Licensed Products on a country-by-country basis in the Licensee Territory. Licensee will keep Innovent reasonably informed of material regulatory developments related to any Licensed Product in the Licensee Territory, including with respect to material decisions of any Regulatory Authority in the Licensee Territory regarding any Licensed Product.
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7.2 Innovent Territory. Subject to Licensee’s rights under Section 3.1(b), Innovent shall (itself or through its Affiliates or (sub)licensees) have the sole right, at its sole cost and expense, to (a) conduct all regulatory activities leading up to and including the obtaining of all Regulatory Approvals for Licensed Products from the applicable Regulatory Authorities on a region-by-region basis in the Innovent Territory, and (b) prepare, file for, obtain, hold and maintain all INDs and Regulatory Approvals and, as applicable, all associated pricing and reimbursement approvals for Licensed Products on a region-by-region basis in the Innovent Territory. Innovent will keep Licensee reasonably informed of material regulatory developments related to any Licensed Product in the Innovent Territory, including with respect to material decisions of any Regulatory Authority in the Innovent Territory regarding any Licensed Product.
7.3 Provision of Regulatory Submissions. Each Party will promptly notify the other Party in writing of any material Regulatory Submission or any material comment or material correspondence for any Licensed Product submitted to or received from any Regulatory Authority in its respective territory and will provide the other Party with copies thereof as soon as reasonably practicable.
7.4 Notice of Meetings and Regulatory Actions. Each Party will provide the other Party with written notice of any material meeting or discussion with any Regulatory Authority in such Party’s territory related to any Licensed Product as promptly as possible and no later than [***] after receiving notice thereof. At the notifying Party’s request, subject to Section 7.5, the other Party will reasonably cooperate with the notifying Party in preparing for any such meeting or discussion. If any Regulatory Authority takes, or gives notice of its intent to take, any regulatory action with respect to any Licensed Product, then such Party will notify the other Party of such actual or proposed action within [***] after receipt of such notice (or, if action is taken without notice, within [***] of such Party becoming aware of such action).
7.5 Cooperation. Each Party will reasonably cooperate with the other Party in obtaining any Regulatory Approvals for the Licensed Products in the other Party’s territory; provided that, to the extent that Licensee provides a written request to Innovent to provide Licensee Regulatory Assistance pursuant to this Section 7.5 (“Regulatory Assistance”), Innovent will use Commercially Reasonable Efforts to provide such Regulatory Assistance. Licensee shall reimburse Innovent for its (i) Out-of-Pocket Costs and (ii) FTE Costs for any FTEs used to conduct Regulatory Assistance in excess of the Included FTEs, in each case ((i) and (ii)), incurred in the performance of such Regulatory Assistance. Innovent will invoice Licensee for such Out-of-Pocket Costs and FTE Costs following each Calendar Quarter in which such FTE Costs and Out-of-Pocket Costs are incurred.
7.6 No Harmful Actions. If either Party reasonably believes that the other Party is taking or intends to take any action with respect to a Licensed Product that is reasonably likely to have a material adverse impact upon the regulatory status of such Licensed Product within such Party’s territory, then such Party will have the right to bring the matter to the attention of the JSC for good faith discussion.
7.7 Notification of Threatened Action. Each Party will, within [***], notify the other Party in writing of any information it receives regarding any threatened or pending action, inspection or communication by any Third Party that would reasonably be expected to affect the
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safety or efficacy claims with respect to any Licensed Products or the continued marketing of any Licensed Products. Upon receipt of such notice, the Parties will promptly consult with each other in an effort to arrive at a mutually acceptable and appropriate action to take in order to address such matter.
7.8 Rights of Reference.
7.9 Adverse Events Reporting.
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7.10 Remedial Actions. Each Party and its Affiliates will (and will use reasonable efforts to cause its Sublicensees (or (sub)licensees in the case of Innovent) to) inform the other Party immediately (and promptly confirm such communication by written notice) if such Party or its Affiliate or Sublicensee (or (sub)licensee, as applicable) obtains information indicating that any Licensed Product may be subject to any recall, recovery, corrective action or other regulatory action by any Governmental Authority (a “Remedial Action”). The Parties will assist each other in gathering and evaluating such information as is reasonably necessary to determine the necessity of conducting a Remedial Action with respect to a Licensed Product in the Licensee Territory or Innovent Territory, as applicable. Each Party shall have sole discretion with respect to any matter relating to any Remedial Action for any Licensed Product in its territory. In the event that a Party determines that any Remedial Action with respect to any Licensed Product in its territory should be commenced or is required by any Regulatory Authority having jurisdiction over the matter, such Party will control and coordinate all efforts necessary to conduct such Remedial Action in its territory and shall be responsible for the cost and expense of such Remedial Action.
7.11 Safety and Regulatory Audits. Each Party will notify the other Party with respect to any inspection of such Party or its Affiliates or Sublicensees (or, with respect to Innovent, (sub)licensees) (including Clinical Trial sites) by any Governmental Authority directed to any Licensed Product (a) no later than [***] after such Party receives notice of such inspection or (b) within [***] after the completion of any such inspection that is conducted by any Governmental Authority without prior notice. To the extent required by Applicable Laws, each Party will permit Governmental Authorities outside of its territory to conduct inspections of such Party or its Affiliates or Sublicensees (or, with respect to Innovent, (sub)licensees) (including Clinical Trial sites) relating to any Licensed Product, and will ensure that all such Affiliates and Sublicensees (or, with respect to Innovent, (sub)licensees) permit such inspections. Following any such
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regulatory inspection related to any Licensed Product that is reasonably expected to have a material impact on the Development or Commercialization of such Licensed Product in the other Party’s territory, each Party will provide the other Party with an unredacted copy of any finding, notice, or report provided by any Governmental Authority in connection with such inspection (or any portion of such inspection that is related to such Licensed Product) within [***] of such Party receiving the same.
ARTICLE 8
MANUFACTURING AND SUPPLY
8.1 Clinical and Commercial Supply.
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ARTICLE 9
COMMERCIALIZATION; MEDICAL AFFAIRS
9.1 Responsibilities. Licensee (itself or through its Affiliates or Sublicensees) will have the sole right and responsibility for the Commercialization of Licensed Products in the Field in the Licensee Territory, at its sole cost and expense. Innovent (itself or through its Affiliates or (sub)licensees) will have the sole right and responsibility for the Commercialization of Licensed Products in the Field in the Innovent Territory, at its sole cost and expense.
9.2 Commercialization Diligence. Licensee shall (itself or through its Affiliates or Sublicensees) use Commercially Reasonable Efforts to Commercialize at least one (1) Licensed Product in at least one (1) Indication in at least two (2) of the Major Markets (including the United States) in which Regulatory Approval for such Licensed Product was obtained.
9.3 Commercialization Plan. No later than [***] before the anticipated date of the submission of the first MAA for the Licensed Product in the Licensee Territory, Licensee shall submit to the JSC (or a joint Commercialization subcommittee established by the JSC), for its review and discussion, a written Commercialization plan that sets forth the high-level timeline and high-level summary of the major Commercialization activities planned for the Licensed Product
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in Licensee Territory for the [***] period beginning on the date of submission of such MAA (the “Commercialization Plan”). Thereafter, from time to time, but no less than [***], Licensee will provide the JSC, for its review, with any material updates or amendments to the Commercialization Plan. Notwithstanding the foregoing, in the event Licensee grants a sublicense or undergoes a Change of Control, neither Licensee nor any Sublicensee or acquirer of Licensee shall thereafter have any obligation under this Section 9.3 to provide any Commercialization Plan to the JSC or Innovent.
9.4 Commercialization Reports. During the Term, Licensee will keep the JSC reasonably informed of its and its Affiliates’ Commercialization activities with respect to the Licensed Product in the Licensee Territory. Licensee will, from time to time no less than [***], provide the JSC with a high-level summary of its and its Affiliates significant Commercialization activities. Notwithstanding the foregoing, in the event Licensee grants a sublicense or undergoes a Change of Control, neither Licensee nor any Sublicensee or acquirer of Licensee shall thereafter have any obligation under this Section 9.4 to inform or update either the JSC or Innovent regarding its or its Affiliates Commercialization activities with respect to the Licensed Product.
9.5 Records. Licensee shall, and shall cause its Affiliates to, and shall require its Sublicensees or subcontractors to, maintain complete, current and accurate records in either tangible or electronic form of all material Commercialization activities with respect to the Licensed Products, in each case in accordance with its reasonable internal documentation and record retention practices.
9.6 Product Trademarks.
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9.7 No Diversion. Each of Innovent and Licensee hereby covenants and agrees that (a) it will not, and will ensure that its Affiliates and Sublicensees (or, with respect to Innovent, (sub)licensees) will not, directly or indirectly, promote, market, distribute, import, sell or have sold any Licensed Product, including via internet or mail order, outside its respective territory; (b) it will not, and will ensure that its Affiliates and Sublicensees (or, with respect to Innovent, (sub)licensees) will not: (i) unless otherwise agreed by the Parties in writing, establish or maintain any branch, warehouse or distribution facility for any Licensed Products in any country or region outside its territory, (ii) engage in any advertising or promotional activities relating to any Licensed Products that are directed primarily to customers or other purchaser or users of any Licensed Products located in any country or region outside its territory, (iii) solicit orders for any Licensed Products from any prospective purchaser located in any country or region outside its territory, or (iv) sell or distribute any Licensed Products to any Person in such Party’s territory who, to such Party’s knowledge, intends to sell or has in the past sold any Licensed Products in any country or region outside its territory; (c) if such Party or any of its Affiliates or Sublicensees (or, with respect to Innovent, (sub)licensees) receives any order for any Licensed Products from a prospective purchaser reasonably believed to be located in a region or country outside its territory, then such Party will, and will ensure that its Affiliates and Sublicensees (or, with respect to Innovent, (sub)licensees) will, not accept such order and will promptly refer that order to the other Party; (d) it will not, and will ensure that its Affiliates and Sublicensees (or, with respect to Innovent, (sub)licensees) will not, deliver or tender (or cause to be delivered or tendered) any Licensed Products into a country or region outside its territory; and (e) it will not, and will ensure that its Affiliates and Sublicensees (or, with respect to Innovent, (sub)licensees) will not, knowingly restrict or impede in any manner the other Party’s exercise of its exclusive rights to Commercialize any Licensed Products in such other Party’s territory; provided that the foregoing shall not restrict either Party’s Development or Manufacturing (including packaging and labeling) rights with respect to Licensed Products under this Agreement.
9.8 Medical Affairs. Each Party will be solely responsible, at its sole cost and expense, for conducting medical affairs activities with respect to Licensed Products in its respective territory, and with respect to Innovent Combination Therapies and Licensee Combination Therapies, as applicable, worldwide, including (a) communications with key opinion leaders, (b) participation in medical education, symposia and advisory boards (to the extent related to medical affairs or clinical guidance), (c) preparation of publications, congress presentations and posters and published manuscripts, (d) any activities performed in connection with patient registries and post-approval trials, and (e) obtaining educational grants and research grants, conducting investigator-initiated studies and making charitable donations, in each case, to the extent related to the promotion, marketing, sale or other Commercialization of Licensed Products. Each Party will conduct all such medical affairs activities in accordance with Applicable Laws.
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ARTICLE 10
PAYMENTS
10.1 Upfront Payment. In partial consideration of the rights granted by Innovent to Licensee hereunder, Licensee will pay to Fortvita USA a one-time, non-refundable and non-creditable payment of thirty-five million Dollars ($35,000,000) within [***] after the Effective Date.
10.2 IND Milestone Payment. In partial consideration of the rights granted by Innovent to Licensee hereunder, subject to Section 10.3(d), Licensee will pay Fortvita USA a one-time, non-refundable and non-creditable preliminary payment of [***] Dollars ($[***]) upon the acceptance of an IND filing for the first Licensed Product in the United States.
10.3 Development and Regulatory Milestones.
|
Development and Regulatory Milestone Events |
Development and Regulatory Milestone Payments |
1. |
[***] |
$[***] |
2. |
[***] |
$[***] |
3. |
[***] |
$[***] |
4. |
[***] |
$[***] |
5. |
[***] |
$[***] |
6. |
[***] |
$[***] |
7. |
[***] |
$[***] |
8. |
[***] |
$[***] |
9. |
[***] |
$[***] |
10. |
[***] |
$[***] |
11. |
[***] |
$[***] |
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|
Development and Regulatory Milestone Events |
Development and Regulatory Milestone Payments |
12. |
[***] |
$[***] |
13. |
[***] |
$[***] |
|
Total Development and Regulatory Milestone Payments |
$[***] |
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10.4 Distinguishable Competing Product Milestones.
Additional Development and Regulatory Milestone Events for Distinguishable Competing Products that are Licensed Products |
Additional Development and Regulatory Milestone Payments |
[***] |
$[***] |
[***] |
$[***] |
Total Additional Development and Regulatory Milestone Payments for Distinguishable Competing Products that are Licensed Products |
$[***] |
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10.5 Sales Milestones.
Sales Milestone Events based upon Annual Net Sales of all Licensed Products in the Licensee Territory |
Sales Milestone Payments |
Annual Net Sales ≥ $[***] |
$[***] |
Annual Net Sales ≥ $[***] |
$[***] |
Annual Net Sales ≥ $[***] |
$[***] |
Annual Net Sales ≥ $[***] |
$[***] |
Annual Net Sales ≥ $[***] |
$[***] |
Total Sales Milestone Payments |
$[***] |
10.6 Royalties.
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Portion of Annual Net Sales of each Licensed Product in the Licensee Territory in a given Calendar Year |
Royalty Rate |
$[***] to $[***] |
[***]% |
Greater than $[***] and up to $[***] |
[***]% |
Greater than $[***] and up to $[***] |
[***]% |
Greater than $[***] and up to $[***] |
[***]% |
Greater than $[***] |
[***]% |
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For clarity, the Existing Upstream License Agreement shall not be a Third Party License for purposes of this Section 10.6(c)(ii).
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10.7 Payment.
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10.8 Audits.
10.9 Interest. Licensee will pay interest on any amounts payable to Fortvita USA that are overdue under this Agreement from the day payment was initially due at [***] percent ([***]%) plus the prime or equivalent rate per annum quoted by The Wall Street Journal on the first Business Day after such payment is due, computed on the basis of a year of three hundred and sixty five (365) days, calculated from the due date until the date of payment; provided that in no
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case will such interest rate exceed the highest rate permitted by Applicable Laws. The payment of such interest will not foreclose a Party from exercising any other rights it may have as a result of such overdue payment.
10.10 Taxes.
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10.11 Upstream Costs. Except as set forth under Section 8.1(d), Innovent shall bear and be responsible for all financial obligations that Innovent owes to Third Parties pursuant to any written agreement pursuant to which Innovent or its Affiliates has Control of any Licensed Technology from a Third Party as of the Effective Date, including any such amounts that Innovent owes in connection with the grant to Licensee under this Agreement of the licenses to Develop and Commercialize Licensed Compounds and Licensed Products.
ARTICLE 11
CONFIDENTIALITY; PUBLICATION
11.1 Confidential Information. Except as expressly provided in this Agreement, each Party agrees that, during the Term and for [***] thereafter (or, with respect to Confidential Information that is a trade secret of the Disclosing Party, until such trade secret no longer qualifies as a trade secret under Applicable Law), such Party (the “Receiving Party”) will keep confidential and will not publish or otherwise disclose and will not use for any purpose, other than as expressly provided for in this Agreement, any information furnished to it by or on behalf of the other Party (the “Disclosing Party”) pursuant to this Agreement or under the Confidentiality Agreement
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(subject to clauses (a)-(d) below, “Confidential Information”), whether before or after the Effective Date, and whether in written, electronic, oral, visual, graphic or any other form. The Receiving Party may use the Disclosing Party’s Confidential Information only to the extent required to exercise its rights or perform its obligations under this Agreement. The Receiving Party will use at least the same standard of care as it uses to protect proprietary or confidential information of its own that is of similar nature and value, but no less than reasonable care, to ensure that its and its Affiliates’ employees, agents, consultants and other representatives (“Representatives”) do not publish or disclose or make any unauthorized use of the Confidential Information of the Disclosing Party. The Receiving Party will promptly notify the Disclosing Party upon discovery of any unauthorized use or disclosure of the Disclosing Party’s Confidential Information by the Receiving Party, its Affiliates or their respective Representatives. Notwithstanding any provision to the contrary set forth in this Agreement, the terms of this Agreement and all Joint Inventions will be deemed the Confidential Information of both Parties, and each Party will be deemed to be the Receiving Party and Disclosing Party with respect thereto. Notwithstanding the foregoing, “Confidential Information” will not include information that the Receiving Party can prove by competent evidence:
11.2 Permitted Disclosures. Notwithstanding the provisions of Section 11.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
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11.3 Confidential Treatment.
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11.4 Use of Names. Subject to Section 11.6, neither Party nor any of its Affiliates will mention or otherwise use any company name, logo or trademark of the other Party or any of its Affiliates in any publication, press release, marketing and promotional material or other form of publicity in connection with this Agreement or activities hereunder without the prior written approval of such other Party; provided that such consent will not be required for a Party’s use of the other Party’s company name and logo to identify such other Party as a collaborator on such first Party’s website, in public presentations or pursuant to any of the permitted disclosures set forth in Section 11.2 and Section 11.6(b).
11.5 Publication of Licensed Product Information. Each Party recognizes that the publication, such as by public oral presentation, manuscript or abstract, of the results of Development activities, including Clinical Trials, with respect to the Licensed Products may be beneficial to both Parties, provided such publications are subject to reasonable controls to protect Confidential Information of each Party. Accordingly, each Party will have the right to review and comment on any material proposed for publication or public oral or visual presentation by the other Party that includes Confidential Information of such Party or data generated from the Development of the Licensed Products under this Agreement. The Party desiring to make any such publication will provide the other Party with a written copy of the proposed publication in reasonably sufficient time prior to publication to allow the other Party to comment upon such announcement prior to publication. With respect to any manuscripts proposed for publication, the other Party will respond with comments as soon as practicable to the other Party but in no event later than [***] from the
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date of delivery to such Party. With respect to public oral presentation materials, abstracts, and posters, the other Party will respond with comments as soon as practicable to the other Party but in no event later than [***] from the date of delivery to such Party. Each Party will comply with the other Party’s request to delete such other Party’s Confidential Information in any such proposed publication. In addition, if any such publication contains patentable subject matter to which the non-publishing Party has any ownership or license rights, then, at the non-publishing Party’s request, the publishing Party will either delete the patentable subject matter from such publication or delay any submission for publication or other public disclosure for an additional period of up to [***] so that appropriate Patent applications may be prepared and filed.
11.6 Public Announcements.
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11.7 Prior Non-Disclosure Agreements. Upon execution of this Agreement, the terms of this Article 11 will supersede any prior non-disclosure, secrecy or confidentiality agreement between the Parties, including the Confidentiality Agreement. Any information disclosed under such prior agreements by or on behalf of Innovent will be deemed disclosed by Innovent under this Agreement, and any information disclosed under such prior agreements by or on behalf of Licensee will be deemed disclosed by Licensee under this Agreement.
ARTICLE 12
REPRESENTATIONS, WARRANTIES, AND COVENANTS
12.1 Representations and Warranties of Each Party. Each Party represents and warrants to the other Party as of the Effective Date that:
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12.2 Additional Representations and Warranties of Innovent. Innovent represents and warrants to Licensee that, as of the Effective Date:
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12.3 Additional Representations and Warranties of Licensee. Licensee represents and warrants to Innovent that as of the Effective Date:
12.4 Covenants.
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12.5 NO OTHER REPRESENTATIONS OR WARRANTIES. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL SUCH REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.
ARTICLE 13
INDEMNIFICATION
13.1 By Licensee. Licensee will indemnify, defend and hold harmless Innovent and its Affiliates, and their directors, officers, employees and agents (individually and collectively, the “Innovent Indemnitee(s)”), from and against all losses, liabilities, damages and expenses (including reasonable attorneys’ fees and costs) (individually and collectively, “Losses”) incurred by them in connection with any claims, demands, actions or other proceedings by any Third Party (individually and collectively, “Claims”) arising after the Effective Date to the extent arising from any of the following, as applicable: (a) the Exploitation of any Licensed Compound or Licensed Product by or under the authority of Licensee, (b) the negligence or willful or intentional misconduct of Licensee or any of its Affiliates, Sublicensees or any other Licensee Indemnitee, or (c) Licensee’s breach of this Agreement, including any of its representations, warranties, or covenants hereunder; in each case (a) through (c), except to the extent such Losses arise from, are based on, or result from any activity or occurrence for which Innovent is obligated to indemnify the Licensee Indemnitees pursuant to Section 13.2.
13.2 By Innovent. Innovent will indemnify, defend and hold harmless Licensee and its Affiliates, and their directors, officers, employees and agents (individually and collectively, the “Licensee Indemnitee(s)”), from and against all Losses incurred by them in connection with any Claims to the extent arising from any of the following, as applicable: (a) the Exploitation of any Licensed Compound by or under the authority of Innovent (other than by or on behalf of Licensee), (b) the negligence or willful or intentional misconduct of Innovent or any of its Affiliates, (sub)licensees (other than Licensee), sublicensees or other Innovent Indemnitee, or (c) Innovent’s breach of this Agreement, including any of its representations, warranties, or covenants hereunder; in each case (a) through (c) above, except to the extent such Losses arise from, are based on, or result from any activity or occurrence for which Licensee is obligated to indemnify the Innovent Indemnitees pursuant to Section 13.1.
13.3 Procedure. A Party that intends to claim indemnification under Section 13.1 or Section 13.2, as applicable (the “Indemnitee”) with respect to any Claim will: (a) notify the other Party (the “Indemnitor”) in writing of such Claim as soon as reasonably practicable after it receives notice of such Claim (it being understood that the Indemnitee’s failure to deliver written notice of such Claim to the Indemnitor within a reasonable time after the Indemnitee receives notice of such Claim, will relieve the Indemnitor of its indemnification obligations under Section 13.1 or Section 13.2, as applicable, with respect to such Claim only to the extent such failure is prejudicial to the Indemnitor’s ability to defend such Claim); (b) permit the Indemnitor to assume direction and control of the defense of the Claim (including the right to settle the claim solely for
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monetary consideration) using counsel reasonably satisfactory to the Indemnitee; and (c) cooperate fully with the Indemnitor and its legal representatives in the investigation and defense of the Claim, as requested by the Indemnitor (at the expense of the Indemnitor). If the Indemnitor does not assume control of such defense within [***] after receiving notice of the Claim from the Indemnitee, then the Indemnitee will control such defense and, without limiting the Indemnitor’s indemnification obligations, the Indemnitor will reimburse the Indemnitee for all documented costs, including reasonable attorney fees, incurred by the Indemnitee in defending itself within [***] after receipt of any invoice therefor from the Indemnitee. The Party not controlling such defense may participate therein at its own expense. The Party controlling such defense will keep the other Party advised of the status of such Claim and the defense thereof and will consider recommendations made by the other Party with respect thereto. The Indemnitee will not agree to any settlement of such Claim without the prior written consent of the Indemnitor, which will not be unreasonably withheld, delayed or conditioned. The Indemnitor will not agree to any settlement of such Claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnitee from all liability with respect thereto, that imposes any liability or obligation on the Indemnitee or that acknowledges fault by the Indemnitee; in each case, without the prior written consent of the Indemnitee.
13.4 Insurance. Licensee, at its own expense, will obtain and maintain, during the Term and for [***] thereafter, reasonable insurance, including commercial general liability insurance and product liability insurance, at levels adequate to cover its obligations hereunder and consistent with industry standards. Licensee will furnish to Innovent on request certificates issued by the insurance company setting forth the amount of its liability insurance. It is understood that such insurance will not be construed to create a limit of Licensee’s liability with respect to its indemnification obligations under this Article 13 or otherwise. Commercial insurance will be obtained from reputable and financially secure insurance carriers having a minimum A.M. Best rating (or equivalent) of A-. Licensee will ensure continuity of coverage for claims which may be presented during the [***] period following the expiration or termination of this Agreement.
13.5 LIMITATION OF LIABILITY. SUBJECT TO AND WITHOUT LIMITING (A) OBLIGATIONS WITH RESPECT TO THIRD PARTY CLAIMS IN CONNECTION WITH THE INDEMNIFICATION OBLIGATIONS OF EACH PARTY WITH RESPECT TO CLAIMS UNDER SECTION 13.1 OR SECTION 13.2, (B) LIABILITY AS A RESULT OF A BREACH OF ARTICLE 11, (C) LIABILITY FOR BREACH OF ANY COVENANTS UNDER SECTION 3.6, OR (D) A PARTY’S LIABILITY FOR INFRINGEMENT OR MISAPPROPRIATION OF THE OTHER PARTY’S INTELLECTUAL PROPERTY RIGHTS, INCLUDING ANY INTELLECTUAL PROPERTY RIGHTS LICENSED TO THE OTHER PARTY, NEITHER PARTY OR ANY OF ITS AFFILIATES WILL BE LIABLE TO THE OTHER PARTY UNDER ANY CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, MULTIPLIED OR CONSEQUENTIAL DAMAGES OR FOR LOST PROFITS (EVEN IF DEEMED DIRECT DAMAGES) ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT.
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ARTICLE 14
INTELLECTUAL PROPERTY
14.1 Ownership.
14.2 Disclosure of Inventions.
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14.3 Prosecution.
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14.4 Defense of Third Party Infringement Claims.
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14.5 Enforcement.
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14.6 Patent Listing. Licensee shall have the sole and exclusive right to make all patent listings (such as the FDA Orange Book, Purple Book and any foreign equivalent) of any Licensee Controlled Patents with respect to any Licensed Product in the Licensee Territory. Innovent shall have the sole and exclusive right to make all patent listings of any Innovent Controlled Patent with respect to any Licensed Product in the Innovent Territory and of any Innovent Platform Patents worldwide.
14.7 Patent Term Extension. As between the Parties, with respect to each Licensed Product, Licensee shall have the sole right to apply for any patent term extensions (including supplementary protection certificates) in the Licensee Territory for the Licensee Controlled Patents and Innovent shall have the sole right to apply for any patent term extensions (including supplementary protection certificates) in the Innovent Territory for the Innovent Controlled Patents. If Licensee, with respect to a Licensed Product, wishes Innovent to apply for patent term extensions for an Innovent Controlled Patent, Licensee shall promptly notify Innovent in writing, in which case the Parties will discuss such proposal within [***] after such notice is received by Innovent; provided that Innovent, after considering Licensee’s request in good faith, shall have the right to decline any such request to apply for a patent term extension (including a supplementary protection certificates) for an Innovent Controlled Patent. Innovent shall have the sole right to apply for any patent term extensions (including supplemental protection certificates) worldwide for any Innovent Platform Patents.
14.8 CREATE Act. It is the Parties’ intention that this Agreement is a “joint research agreement” as that phrase is defined in 35 U.S.C. § 102(c) as amended by the Cooperative Research and Technology Enhancement (CREATE) Act, including the provisions of 35 U.S.C. § 102(b)(2)(c). The Parties agree to cooperate and to take reasonable actions to maximize the protections available for Licensed Compounds and Licensed Products under such safe harbor provisions.
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ARTICLE 15
TERM AND TERMINATION
15.1 Term and Expiration.
15.2 Termination for Mutual Agreement. This Agreement may be terminated in its entirety at any time by the Parties’ mutual written agreement.
15.3 Termination for Convenience. Licensee may terminate this Agreement in its entirety upon ninety (90) days’ prior written notice to Innovent at any time prior to a First Commercial Sale, and upon one hundred and fifty (150) days’ prior written notice to Innovent at any time following a First Commercial Sale.
15.4 Termination for Material Breach.
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If the allegedly breaching Party reasonably and in good faith disagrees as to whether there has been a material breach of this Agreement, such allegedly breaching Party may provide the other Party with written notice of such disagreement within [***] following receipt of the Breach Notice. Following a timely notice of disagreement, (i) the other Party will not have the right to terminate this Agreement under Section 15.4(a) unless and until it has been determined, in accordance with Article 16, that the allegedly breaching Party has materially breached this Agreement and such breaching Party fails to cure such breach within the period for cure determined in such dispute resolution, (ii) during the pendency of such dispute resolution process, the relevant Cure Period with respect to such alleged material breach will be tolled from the date the allegedly breaching Party provides the other Party with notice of such Dispute until the resolution of such Dispute in accordance with Article 16, provided that for any Dispute regarding payment, such tolling of the Cure Period will only apply with respect to the payment of the disputed amounts and not with respect to any undisputed amounts, and (iii) during the pendency of such dispute resolution process, all of the terms and conditions of this Agreement will remain in effect, and the Parties will continue to perform all of their respective obligations under this Agreement.
15.5 Termination for Certain Licensee Actions.
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15.6 Licensee Alternative to Termination. If Licensee has the undisputed right under Section 15.4(a) to terminate this Agreement as a result of the material breach of this Agreement by Innovent of any of the following Sections: 3.1 (License Grant to Licensee); 3.6(b) (Innovent Non-Compete); 4.1 (Technology Transfer); 8.1(b)(ii) (Initial Supply by Innovent); 12.1(a), 12.1(b), 12.1(c) or 12.1(d) (Representations and Warranties of Each Party); 12.2(a), 12.2 (c), 12.2(d), 12.2(e), 12.2(g), 12.2(h) or 12.2(i) (Additional Representations and Warranties of Innovent); or 12.4(a), 12.4(b) or 12.4(c) (Covenants), that has a material adverse impact on the value of the rights and licenses granted to Licensee under this Agreement, then Licensee may, in lieu of such termination, elect for this Agreement to remain in full force and effect by notifying Innovent of such election within [***] of the end of the applicable Cure Period. If Licensee makes such election, then all Licensee’s payment obligations under Article 10 on and after the date of such election shall be reduced by [***] percent ([***]%). Licensee’s exercise of such remedy shall be its sole and exclusive remedy, and Innovent’s sole liability, for damages or other harm caused by the material breach by Innovent giving rise to Licensee’s termination right.
15.7 Effects of Termination. Upon the termination (but not expiration) of this Agreement for any reason, the provisions of this Section 15.7 will apply.
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15.8 Other Remedies. Termination or expiration of this Agreement for any reason will not constitute a waiver or release of, or otherwise be deemed to prejudice or adversely affect, any rights, remedies or claims, whether for damages or otherwise, that a Party may have hereunder or that may arise out of or in connection with such termination or expiration.
15.9 Survival. Termination or expiration of this Agreement will not affect any rights or obligations of the Parties under this Agreement that have accrued prior to the date of termination or expiration. The following provisions will survive the termination or expiration of this Agreement for any reason: Articles 1, Article 11, 13, 16, 17, and Sections 3.1(c), 3.1(d), 3.1(e), 3.2(x), 3.2(y), 3.2(z), 5.5, 10.8, 10.10, 12.5, 14.1, 15.1, 15.7, 15.8 and 15.9.
ARTICLE 16
DISPUTE RESOLUTION
16.1 General. Except for any matter subject to resolution in accordance with Section 2.2(e)(iii), the Parties agree that any claim, dispute or controversy between the Parties or any of their Affiliates arising from, relating to or in connection with this Agreement, including with respect to its formation, applicability, breach, termination, enforcement, interpretation or validity (a “Dispute”), will be resolved in accordance with this Article 16.
16.2 Construction. Except where the context expressly requires otherwise, (a) the use of any gender herein will be deemed to encompass references to either or both genders, and the use of the singular will be deemed to include the plural (and vice versa), (b) the words “include”, “includes” and “including” will be deemed to be followed by the phrase “without limitation”, (c) the word “will” will 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 will 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 will be construed to include the person’s successors and assigns, (f) the words “herein”, “hereof” and “hereunder”, and words of similar import, will 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 will be construed to
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refer to Sections or Exhibits as described in this Agreement, (h) the word “notice” means notice in writing (whether or not specifically stated), (i) provisions that require that a Party, the Parties or any committee hereunder “agree”, “consent” or “approve” or the like will 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), (j) references to any specific law, rule or regulation, or section or other division thereof, will be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation, and (k) the term “or” will be interpreted in the inclusive sense commonly associated with the term “and/or” where applicable.
16.3 Escalation. Either Party, through the delivery of written notice, may refer any Dispute to the Senior Executives for attempted resolution. In the event the Senior Executives are unable to resolve such Dispute within [***] following the delivery of such written notice, then, upon the written request of either Party to the other Party (“Dispute Referral”), the Dispute will be subject to further resolution in accordance with Section 16.4 or Section 16.5, as applicable.
16.4 Arbitration.
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16.5 Certain Disputes. Notwithstanding any provision to the contrary set forth in Section 16.4, in the event of a Dispute with respect to (a) the validity, scope, enforceability or ownership of any Patent or other intellectual property rights, or (b) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory, and such Dispute is not resolved in accordance with Section 16.3, such Dispute will not be submitted to an arbitration proceeding in accordance with Section 16.4, unless otherwise agreed by the Parties in writing, and instead, either Party may initiate litigation in a court of competent jurisdiction.
ARTICLE 17
MISCELLANEOUS
17.1 Governing Law. This Agreement will be governed by and construed in accordance with the laws of the State of New York, without reference to any rules of conflict of laws that may result in the application of the laws of a different jurisdiction.
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17.2 Force Majeure. Neither Party will be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, including embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, pandemics, epidemics, quarantines, or other acts of God or any other deity (or orders of any Governmental Authority related to any of the foregoing), or acts, omissions or delays in acting by any Governmental Authority. The affected Party will notify the other Party of such force majeure circumstances as soon as reasonably practical, the JSC will review and discuss any such matter and the affected Party will promptly undertake Commercially Reasonable Efforts necessary to cure such force majeure circumstances.
17.3 Performance by Affiliates. Notwithstanding any provision to the contrary set forth in this Agreement, each Party will have the right to perform any or all of its obligations and exercise any or all of its rights under this Agreement through any Affiliate. Each Party hereby guarantees the performance by its Affiliates of its obligations under this Agreement and will cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement will be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.
17.4 Assignment. Neither Party may assign this Agreement without the other Party’s prior written consent (such consent not to be unreasonably withheld, conditioned or delayed); except that (a) either Party may make such an assignment without such consent to a Third Party successor to all or substantially all of the business or assets of such Party to which this Agreement relates (whether by merger, sale of stock, sale of assets or otherwise), and (b) either Party may assign this Agreement without such consent to an Affiliate. Any attempted assignment or transfer in violation of this Section 17.4 (Assignment) will be null and void. Subject to the foregoing, this Agreement will be binding on and inure to the benefit of the Parties and their respective successors and permitted assigns.
17.5 Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein will not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties will in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.
17.6 Notices. All notices which are required or permitted hereunder will be in writing and sufficient if delivered personally, sent by email or facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized
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overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:
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If to Innovent: |
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Innovent Biologics (Suzhou) Co., Ltd. |
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168 Dongping Street |
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Suzhou Industrial Park |
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Jiangsu 215123, China |
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Attention: [***] |
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E-mail: [***] |
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With a copy (which shall not constitute notice) to: |
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Innovent Biologics (Suzhou) Co., Ltd. |
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Attention: General Counsel |
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E-mail: [***] |
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with a copy (which shall not constitute notice) to: |
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Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. |
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One Financial Center |
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Boston, MA 02111 |
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Attn: [***] |
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[***] |
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If to Licensee: |
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Spero Therapeutics, Inc. |
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675 Massachusetts Avenue, 14th Floor |
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Cambridge, Massachusetts 02139 |
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United States |
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Attention: Chief Executive Officer |
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E-mail: [***] |
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with copies (which shall not constitute notice) to: |
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Spero Therapeutics, Inc. |
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Attention: Head of Legal |
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E-mail: [***] |
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Wilmer Cutler Pickering Hale and Dorr LLP |
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60 State Street |
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Boston, MA 02109 |
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United States |
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Attn: Steven D. Barrett |
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steven.barrett@wilmerhale.com |
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or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice will be deemed to have been given: (a) when delivered if personally delivered; (b) if sent by email, upon electronic confirmation of receipt; (c) on the Business Day after dispatch if sent by nationally recognized overnight courier; or (d) on the fifth Business Day following the date of mailing if sent by mail.
17.7 Entire Agreement; Amendments. The Agreement contains the entire understanding of the Parties with respect to the subject matter hereof. All express or implied agreements and understandings, either oral or written, with regard to the subject matter hereof (including the licenses granted hereunder), including the Confidentiality Agreement, are superseded by the terms of this Agreement. Neither Party is relying on any representation, promise, or warranty not expressly set forth in this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both Parties hereto. To the extent there is any conflict between the terms of this Agreement and the terms of the Pharmacovigilance Agreement, the Supply Agreement or a Quality Agreement (each, an “Ancillary Agreement”), the terms of such Ancillary Agreement will control solely with respect to the primary subject matter thereof, and the terms of this Agreement will control otherwise.
17.8 Headings. The captions to the several Sections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the Sections of this Agreement.
17.9 Independent Contractors. It is expressly agreed that Innovent and Licensee will be independent contractors and that the relationship between the two Parties will not constitute a partnership, joint venture or agency. Neither Innovent nor Licensee has the authority to make any statements, representations or commitments of any kind, or to take any action, which will be binding on the other Party, without the prior written consent of the other Party. Nothing contained in this Agreement shall be deemed or construed by the Parties, any of their Affiliates or any Third Party to treat the relationship between the Parties contemplated by this Agreement as a partnership, joint venture or other business entity under Treasury Regulations Section 301.7701 1(a)(2) (or any corresponding provision under state, local or non U.S. tax law) (an “Entity”). No Party (or successor or assignee) intends, for Tax purposes, on reporting the relationships established by this Agreement as an Entity, including either (a) making any disclosure that the relationships established by this Agreement may give rise to an Entity (whether on a U.S. Internal Revenue Service Form 8275 or otherwise) or (b) withholding any amounts from payments made to the other Party pursuant to Section 1446 of the Code (or any corresponding provision under state, local or non U.S. tax law), unless required by a Governmental Authority on audit or other examination. Notwithstanding the foregoing, if the arrangement between the Parties as contemplated by this Agreement is determined to constitute an Entity under Applicable Law (as determined based on the opinion (on a “should” basis) of a nationally recognized law or accounting firm) or by a Governmental Authority on audit or other examination, the Party that is aware of such determination shall provide notice to the other Party regarding such treatment and the Parties will reasonably cooperate with one another to satisfy any tax filing or reporting obligation arising as a result of such determination, including by providing any information, forms or other certifications necessary to satisfy such obligations.
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17.10 Waiver. The waiver by either Party of any right hereunder, the failure of the other Party to perform, or a breach by the other Party will not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party, whether of a similar nature or otherwise. No waiver shall be binding unless in writing and signed by the waiving Party.
17.11 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 Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement will be construed against the drafting Party will not apply.
17.12 Counterparts. This Agreement may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. Each Party will be entitled to rely on the delivery of executed electronic or PDF copies of counterpart execution pages of this Agreement and such electronic or PDF copies will be legally effective to create a valid and binding agreement among the Parties.
17.13 Language. This Agreement is in the English language only, which language will be controlling in all respects, and all versions hereof in any other language will be for accommodation only and will not be binding upon the Parties. All communications and notices to be made or given pursuant to this Agreement, and any dispute or other proceeding related to or arising hereunder, will be in the English language.
[Signature Page Follows]
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
Innovent Biologics (Suzhou) Co., Ltd. |
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Spero Therapeutics, Inc. |
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By: |
/s/ De-chao Michael Yu |
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/s/ Esther Rajavelu |
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Name: De-chao Michael Yu |
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Esther Rajavelu |
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Title: Director |
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Chief Executive Officer and |
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President |
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Fortvita Biologics (USA), Inc. |
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/s/ De-chao Michael Yu |
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De-chao Michael Yu |
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[Signature Page to Collaboration and License Agreement]
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Exhibit 8.1(b)
Supply Agreement Material Terms
The Supply Agreement to be negotiated and entered into by and between Licensee and Innovent pursuant to Section 8.1(b) of this Agreement will contain, among others, the key terms provided in the table below. In this table, capitalized terms have the meanings set forth in this Agreement.
Category |
Key Terms |
Supply for Licensee Territory |
Subject to the terms of the Supply Agreement, Innovent, itself or through its Affiliates or its CMO(s) (“Supplier”), will Manufacture Licensed Compounds and Licensed Products for use by Licensee and its Affiliates and Sublicensees in Development (including use in Clinical Trials) in and for the Licensee Territory. Licensee will purchase, and Innovent will supply, such quantities of Licensed Compounds and Licensed Products required by Licensee and its Affiliates and Sublicensees for such Development (including use in Clinical Trials) in the Licensee Territory. |
Delivery: |
Deliveries of Licensed Compounds and Licensed Products in unlabeled bottles to Licensee will be made FCA (INCOTERMS 2020) [***]. Licensee or its Affiliates or Sublicensees will be responsible for packaging and labeling Licensed Products for use in Clinical Trials in accordance with Applicable Laws at their own expense. Supplier will supply Licensed Products released for delivery by Supplier in accordance with the procedures to be set forth in the Quality Agreement, including any required documentation (e.g., certificate of analysis), or, with respect to any supply prior to execution of the Quality Agreement, in accordance with Innovent’s standard procedures. |
Specifications: |
The specifications for Licensed Products supplied pursuant to the Supply Agreement will be set forth in the Quality Agreement entered into in connection with the Supply Agreement, or, with respect to any supply prior to execution of the Quality Agreement, such specifications as the Parties have agreed in writing (the “Specifications”).
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Warranty: |
Supplier will warrant that, as of the delivery date (to be defined in Supply Agreement), the Licensed Products (a) conform to the Specifications and other quality requirements set out in the Supply Agreement and the Quality Agreement, as applicable, (b) are not adulterated or misbranded, and (c) are free and clear of any security interest, lien or other encumbrance. |
Price: |
The price of Licensed Compounds Licensed Products will be [***]% of Supplier’s Cost of Goods for such Licensed Compounds and Licensed Products supplied for Development purposes. Supplier will invoice Licensee for the price of Licensed Compounds and Licensed Products concurrently with delivery, which invoices shall be payable within [***] after receipt of |
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Category |
Key Terms |
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invoice. The Parties acknowledge that, as of the Effective Date, Innovent’s current estimate of Cost of Goods for the supply of Licensed Compounds and Licensed Products under this Exhibit 8.1(b), is set forth below:
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Batch size/ |
COGS range |
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COGS per batch |
[***] |
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[***] |
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[***] |
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COGS per vial |
[***] |
[***] |
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Notes: 1. Provided COGS are estimated based on current BOM and process specifications; 2. Outsourced pricing is based on current quotation and subject to fluctuation based on sales volume; 3. The COGS will vary with different capacity utilization rates; 4. The COGS are not committed and are not used for CDMO service. “Cost of Goods” means, in respect of the Licensed Compound or Licensed Product, the fully absorbed cost as calculated in a manner consistent with Applicable Accounting Standards, including the costs of materials and other resources consumed, direct labor, quality assurance costs, equipment maintenance costs, and other costs variable with production, plus an appropriate allocation of the indirect labor, relevant depreciation and amortization, facilities’ utilities, insurance, fixed overhead and other fixed costs, and freight into or between sites in the supply chain, in each case specifically allocable to the Licensed Compound or Licensed Product, but excluding any profit made by Innovent or any of its Affiliates through the application of transfer pricing. To the extent that Licensed Product is sourced from a CMO, COGS shall include the actual invoiced price paid by Innovent to such CMO for the Manufacture of such Licensed Product. |
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Forecast: |
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Key Terms |
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Initial Supply |
Timeline (Product Released and available for Shipment to Licensee) |
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[***] |
[***] |
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2 |
[***] |
[***] |
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3 |
[***] |
[***] |
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[***] |
[***] |
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[***] |
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Other Support Services: |
To the extent the Parties agree on any Manufacturing support services to be provided by Supplier, the Parties will detail such services in the Supply Agreement. |
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Governing Law: |
The Supply Agreement will be governed by the laws of the State of New York, without reference to any rules of conflict of laws that may result in the application of the laws of a different jurisdiction. |
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Additional Terms: |
The Supply Agreement will contain other reasonable and customary terms and conditions typical for supply from licensors to licensees, to be negotiated by the Parties, including procedures for acceptance and rejection of Licensed Products, indemnification and term and termination. |
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Exhibit 15.7(c)
Procedures Applicable to Disagreements With Respect to Reversion Terms or Reversion Sublicense Terms
If the Parties are unable to agree upon the Reversion Terms and/or Reversion Sublicense Terms within [***] after the effective date of termination, then either Party shall have the right, upon written notice to the other Party (such notice, a “Baseball Arbitration Notice”), to refer such matter to an independent (i.e., not a current or former employee, officer, director, consultant or subcontractor of either Party or any of its Affiliates), impartial and conflict-free Third Party arbitrator who shall have at least [***] of experience in the biopharmaceutical industry and relevant subject matter expertise (a “Baseball Arbitrator”). The Baseball Arbitrator shall be mutually agreed to by the Parties; provided that if the Parties are unable to agree on a Baseball Arbitrator within [***] (or such other time period as may be agreed by the Parties) after a Party provides the other Party the Baseball Arbitration Notice, then each Party shall select one Baseball Arbitrator and those two Baseball Arbitrators will select the one Baseball Arbitrator within [***] thereafter. The Parties shall use their best efforts to cause the Baseball Arbitrator (mutually agreed by the Parties or selected by the two Baseball Arbitrators selected by the Parties, as applicable) to be selected and retained within [***] after a Party provides the other Party the Baseball Arbitration Notice.
Each Party shall submit to the Baseball Arbitrator (a) its proposal for the Reversion Terms and/or Reversion Sublicense Terms within [***] after the selection of the Baseball Arbitrator (“Proposed Resolution”) and (b) such other information as may be requested by the Baseball Arbitrator within [***] after such request. Each Party’s Proposed Resolution, and any additional information provided to the Baseball Arbitrator by such Party, shall be simultaneously provided to the other Party.
The Baseball Arbitrator will be instructed to select one or the other of the two Proposed Resolutions submitted by the Parties no later than [***] after the receipt of each Party’s Proposed Resolution (or if one Party does not submit its Proposed Resolution, then [***] after receipt of the submitted Proposed Resolution) and to select the Proposed Resolution that is most reasonable under the circumstances. The Baseball Arbitrator shall select only one of the Proposed Resolutions (without making any changes to such Proposed Resolution) and shall render such Proposed Resolution as the Baseball Arbitrator’s final decision. Notwithstanding anything to the contrary in this Agreement, the Baseball Arbitrator shall not have the authority to render any decision other than selecting one Proposed Resolution submitted by a Party pursuant to this Exhibit 15.7(c). The Baseball Arbitrator shall promptly notify the Parties of its determination in writing, and such decision shall be final and binding on the Parties. Each Party shall bear the costs and expenses of its Baseball Arbitrator and the costs and expenses of any Baseball Arbitrator agreed to by the Parties or selected by their Baseball Arbitrators shall be shared equally (50/50).
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