Document:

mtem-ex102_176.htm

Exhibit 10.2

 

DEVELOPMENT COLLABORATION AND 

exclusive LICENSE AGREEMENT

between

MOLECULAR TEMPLATES, INC.

and

MILLENNIUM PHARMACEUTICALS, INC.

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

Table of Contents 

Page

	
Article I
	
DEFINITIONS AND INTERPRETATION2
	
 

	
 
	
Section 1.1
	
Definitions2
	
 

	
 
	
Section 1.2
	
Certain Rules of Interpretation in this Agreement and the Schedules21
	
 

	
Article II
	
DEVELOPMENT, REGULATORY AND COMMERCIALIZATION22
	
 

	
 
	
Section 2.1
	
Development22
	
 

	
 
	
Section 2.2
	
Regulatory Activities24
	
 

	
 
	
Section 2.3
	
Commercialization24
	
 

	
 
	
Section 2.4
	
Use of Materials25
	
 

	
Article III
	
LICENSE GRANTS26
	
 

	
 
	
Section 3.1
	
Program License Grant to MTEM26
	
 

	
 
	
Section 3.2
	
Other License Grants26
	
 

	
 
	
Section 3.3
	
Exclusive License Grants and Rights of Reference26
	
 

	
 
	
Section 3.4
	
Rights to Sublicense27
	
 

	
 
	
Section 3.5
	
Use and Licensing of Third Party Technologies27
	
 

	
 
	
Section 3.6
	
Existing Licenses; Compliance with Future In-Licenses28
	
 

	
 
	
Section 3.7
	
IP Rights from Other Partners28
	
 

	
 
	
Section 3.8
	
Disclosure of IP28
	
 

	
 
	
Section 3.9
	
Target Exclusivity29
	
 

	
Article IV
	
GOVERNANCE29
	
 

	
 
	
Section 4.1
	
Alliance Managers29
	
 

	
 
	
Section 4.2
	
Project Managers30
	
 

	
 
	
Section 4.3
	
Joint Steering Committee30
	
 

	
 
	
Section 4.4
	
Joint Development Committee32
	
 

	
 
	
Section 4.5
	
Joint Manufacturing Committee33
	
 

	
 
	
Section 4.6
	
Joint Patent Committee33
	
 

	
 
	
Section 4.7
	
Joint Finance Working Group33
	
 

	
 
	
Section 4.8
	
Quorum34
	
 

	
 
	
Section 4.9
	
Referral to the Joint Steering Committee34
	
 

	
Article V
	
MANUFACTURING AND SUPPLY35
	
 

	
 
	
Section 5.1
	
Responsibility for Manufacturing35
	
 

i

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

	
 
	
Section 5.2
	
Technology Transfer36
	
 

	
 
	
Section 5.3
	
Responsibility for Manufacturing After Technology Transfer37
	
 

	
 
	
Section 5.4
	
Joint Manufacturing Committee37
	
 

	
 
	
Section 5.5
	
Quality Agreement38
	
 

	
Article VI
	
PAYMENTS AND RECORDS38
	
 

	
 
	
Section 6.1
	
Upfront Fee38
	
 

	
 
	
Section 6.2
	
Development Milestone Payments39
	
 

	
 
	
Section 6.3
	
Sales Milestone Payments41
	
 

	
 
	
Section 6.4
	
Royalties Payable by Takeda42
	
 

	
 
	
Section 6.5
	
Co-Development Cost Sharing46
	
 

	
 
	
Section 6.6
	
Royalty Payment Terms47
	
 

	
 
	
Section 6.7
	
Payment Method48
	
 

	
 
	
Section 6.8
	
Late Payments48
	
 

	
 
	
Section 6.9
	
Exchange Control48
	
 

	
 
	
Section 6.10
	
Taxes; Withholding Taxes48
	
 

	
 
	
Section 6.11
	
Royalty Reports; Exchange Rates48
	
 

	
 
	
Section 6.12
	
Audits49
	
 

	
 
	
Section 6.13
	
Confidential Financial Information50
	
 

	
Article VII
	
CONFIDENTIALITY50
	
 

	
 
	
Section 7.1
	
Non-Disclosure Obligations50
	
 

	
 
	
Section 7.2
	
Permitted Disclosures50
	
 

	
 
	
Section 7.3
	
Use of Name53
	
 

	
 
	
Section 7.4
	
Publications53
	
 

	
 
	
Section 7.5
	
Return of Confidential Information54
	
 

	
Article VIII
	
INTELLECTUAL PROPERTY OWNERSHIP54
	
 

	
 
	
Section 8.1
	
Disclosure of Inventions54
	
 

	
 
	
Section 8.2
	
Intellectual Property54
	
 

	
 
	
Section 8.3
	
Patent Prosecution and Maintenance56
	
 

	
 
	
Section 8.4
	
Enforcement of Patent Rights59
	
 

	
 
	
Section 8.5
	
Separate Representation60
	
 

	
 
	
Section 8.6
	
Trademarks61
	
 

	
 
	
Section 8.7
	
Third Party Actions61
	
 

	
 
	
Section 8.8
	
Invalidity or Unenforceability Defenses or Actions62
	
 

ii

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

	
 
	
Section 8.9
	
Takeda Patent Challenge.63
	
 

	
Article IX
	
REPRESENTATIONS AND WARRANTIES; COVENANTS63
	
 

	
 
	
Section 9.1
	
Mutual Representations, Warranties and Covenants63
	
 

	
 
	
Section 9.2
	
Additional Representations, Warranties and Covenants of MTEM64
	
 

	
 
	
Section 9.3
	
Additional Representations, Warranties and Covenants of Takeda67
	
 

	
 
	
Section 9.4
	
Additional Covenants of MTEM68
	
 

	
 
	
Section 9.5
	
Additional Covenants of Takeda69
	
 

	
 
	
Section 9.6
	
DISCLAIMER OF WARRANTIES70
	
 

	
Article X
	
INDEMNITY; LIMITATION OF LIABILITY70
	
 

	
 
	
Section 10.1
	
Indemnity70
	
 

	
 
	
Section 10.2
	
Procedure70
	
 

	
 
	
Section 10.3
	
Limitation of Liability71
	
 

	
 
	
Section 10.4
	
Insurance71
	
 

	
Article XI
	
TERM AND TERMINATION72
	
 

	
 
	
Section 11.1
	
Term72
	
 

	
 
	
Section 11.2
	
Termination by Takeda72
	
 

	
 
	
Section 11.3
	
Termination for Material Breach72
	
 

	
 
	
Section 11.4
	
License Survival Upon Insolvency73
	
 

	
 
	
Section 11.5
	
Effect of Expiration and Termination73
	
 

	
Article XII
	
MISCELLANEOUS77
	
 

	
 
	
Section 12.1
	
Notices77
	
 

	
 
	
Section 12.2
	
Applicable Law; Jurisdiction77
	
 

	
 
	
Section 12.3
	
Dispute Resolution78
	
 

	
 
	
Section 12.4
	
Entire Agreement79
	
 

	
 
	
Section 12.5
	
Severability79
	
 

	
 
	
Section 12.6
	
Force Majeure80
	
 

	
 
	
Section 12.7
	
Assignment and Change of Control80
	
 

	
 
	
Section 12.8
	
Performance by Affiliates81
	
 

	
 
	
Section 12.9
	
Independent Contractors81
	
 

	
 
	
Section 12.10
	
Waiver and Non-Exclusion of Remedies81
	
 

	
 
	
Section 12.11
	
Further Assurances82
	
 

	
 
	
Section 12.12
	
No Benefit to Third Parties82
	
 

	
 
	
Section 12.13
	
Equitable Relief82
	
 

iii

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

	
 
	
Section 12.14
	
Counterparts82
	
 

 

 

Schedules

Schedule 1.1.51: Early Stage Program Plan

Schedule 1.1.132: Phase Ia Clinical Trial Plan and Budget

Schedule 1.1.162: Existing SLT-As

Schedule 1.1.164: Patent Rights and Inventions that cover SLT-A Technology 

Schedule 9.2.5: MTEM Background Patent Rights

Schedule 9.2.8: Future MTEM In-Licenses

Schedule 9.2.11: SLT-As with respect to which MTEM or its Affiliates Control MTEM Background IP

Exhibits

Exhibit 11.5.3: Applicable Royalties and Milestones for Post-Termination License pursuant to Section 11.5.3.

 

 

 

 

iv

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

DEVELOPMENT COLLABORATION AND
EXCLUSIVE LICENSE AGREEMENT

This Development Collaboration and Exclusive License Agreement (this “Agreement”) is entered into as of September 18, 2018 (the “Effective Date”) by and between MOLECULAR TEMPLATES, INC., a Delaware corporation, having its principal place of business at 9301 Amberglen Boulevard, Suite 100, Austin, TX 78729 (“MTEM”) and MILLENNIUM PHARMACEUTICALS, INC., a Delaware corporation, a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited, having its principal place of business at 40 Landsdowne Street, Cambridge, MA 02139 (“Takeda”). MTEM and Takeda may sometimes individually be referred to hereafter as a “Party” or collectively as the “Parties.” 

RECITALS

WHEREAS, MTEM owns or controls certain intellectual property rights relating to technology useful for generating SLT-A Fusion Proteins (as defined below) capable of directing SLT-As to specific tissues or cells; 

WHEREAS, (a) pursuant to the Research Collaboration and Option Agreement (“2016 Research Collaboration Agreement”) between the Parties dated October 31, 2016, MTEM and Takeda generated three SLT-A Fusion Proteins Directed to the Target containing a Takeda Targeting Moiety: [***] and (b) MTEM generated prior to the 2016 Research Collaboration Agreement one SLT-A Fusion Protein containing a 4019 Targeting Moiety Directed to the Target: MT-4019 (each such SLT-A Fusion Protein, a non-limiting example of a CD38 SLT-A Fusion Protein (as defined below)); and whereas currently the [***] CD38 SLT-A Fusion Protein (containing a Takeda Targeting Moiety) is the lead and the other three CD38 SLT-A Fusion Proteins referenced above are the back-ups; 

WHEREAS, Takeda has exercised its option under the 2016 Research Collaboration Agreement to negotiate a license to the CD38 SLT-A Fusion Proteins generated under that agreement, and further seeks a license to MTEM’s CD38 SLT-A Fusion Protein, MT-4019, and the Parties have negotiated the terms set forth herein; 

WHEREAS, the Parties have in parallel been conducting related work under that certain Individual Project Agreement between the Parties dated as of June 18, 2018 as amended and restated on July 27, 2018 (the “IPA”);

WHEREAS, the Parties are also parties to that certain Multi-Target Collaboration and License Agreement dated June 23, 2017 (the “Multi-Target Agreement”), which covers certain SLT-A Fusion Proteins Directed to other targets (as specified therein);

WHEREAS, the Parties desire to Co-Develop one or more Licensed Product(s) (as set forth herein) up to and including Phase Ia Clinical Trial and thereafter MTEM would have an option to continue to Co-Develop the Licensed Product(s) as described further herein; and

WHEREAS, the Parties grant the licenses set forth herein.

NOW, THEREFORE, in consideration of the mutual covenants and obligations set forth herein, the Parties hereto, intending to be legally bound, agree as follows:

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

Article I
DEFINITIONS AND INTERPRETATION

Section 1.1Definitions. For the purposes of this Agreement the following words and phrases shall have the following meanings:

1.1.1“2016 Research Collaboration Agreement” has the meaning set forth in the Recitals. 

1.1.2“4019 Targeting Moiety” means that certain public domain antibody fragment included in MT-4019 [***], including Improvements, modifications, fragments and derivatives thereof and corresponding compositions of matter, methods of making or using any of the foregoing.  

1.1.3“4019 Targeting Moiety Know-How” means any Program Know-How that is related to any 4019 Targeting Moiety, including Improvements, modifications, fragments and derivatives thereof and corresponding compositions of matter, methods of making or using any of the foregoing, but excluding any Product Program Know-How, MTEM Program Know-How and Takeda Program Know-How.

1.1.4“Acceptance” means (a) with respect to a BLA or NDA, the acceptance by FDA of such BLA or NDA for substantive review, which can be evidenced by Takeda’s receipt of notice from FDA of such acceptance or other evidence that FDA has commenced its substantive review, (b) with respect to a Drug Approval Application filed with the EMA, the receipt by Takeda of a letter from the EMA with respect to such Drug Approval Application indicating that there has been a positive outcome of the EMA’s validation of such Drug Approval Application and (c) with respect to a Drug Approval Application filed with the PMDA in Japan, the acceptance by PMDA of such Drug Approval Application for substantive review, which can be evidenced by Takeda’s receipt of notice from PMDA of such acceptance or other evidence that PMDA has commenced its substantive review.

1.1.5“Accounting Standards” means International Financial Reporting Standards, with respect to Takeda, and Generally Accepted Accounting Standards in the U.S. with respect to MTEM, in each case, consistently applied.

1.1.6“Affiliate” of a Party means any corporation or other business entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such Party for so long as such Party controls, is controlled by or is under common control with such corporation or other business entity. As used herein, the term “control” means the direct or indirect ownership of fifty percent (50%) or more of the stock having the right to vote for directors thereof or the ability to otherwise control the management thereof. In the case of Takeda, a corporation or other business entity shall not be an Affiliate of Takeda as a result of an investment in such corporation or other business entity by the venture investment arm of Takeda and its Affiliates.

1.1.7“Agreement” has the meaning set forth in the preamble hereto.

1.1.8“Alliance Manager” has the meaning set forth in Section 4.1.1.

Page 2

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

1.1.9“Antibody” means an unconjugated polyclonal or monoclonal antibody (whether (a) fully human, fully mouse, humanized, fully synthetic, bivalent, monovalent, phage display, in vitro display, ribosome-display, RNA display, DNA display, cell-display, chimeric, polyclonal, polyclonal mixes or any other type of antibody, (b) multiple or single chain, recombinant, in vivo, in vitro or naturally occurring, or a combination of the foregoing in any species, or (c) monospecific or bi-specific) or any analog, derivative, fragment or modification thereof (including a full antibody, single chain antibody, single domain antibody (sdAb (e.g., VHH))), scFv, scFvFc, Fab, or minibody.

1.1.10“Applicable Law” means any law or statute, any rule or regulation (including written governmental interpretations thereof, the guidance related thereto, or the application thereof) issued by a Governmental Authority or Regulatory Authority and any judicial, governmental, or administrative order, judgment, decree, or ruling, in each case as applicable to the subject matter and the parties at issue.

1.1.11“Background IP” means, with respect to a Party, any Know-How, inventions, Patent Rights and other intellectual property rights that are owned or otherwise Controlled (other than pursuant to the license grants set forth in Article III) by such Party or any of its Affiliates (solely or jointly) prior to the Effective Date or thereafter but through activities outside of this Agreement, including under the 2016 Research Collaboration Agreement or the Multi-Target Agreement. 

1.1.12“Bankruptcy Code” has the meaning set forth in Section 11.4.

1.1.13“Biosimilar Product” means, with respect to a Licensed Product in a country or jurisdiction, any product sold by a Third Party that (a) is subject to a license under Section 351(a) or 351(k) of the PHSA and (i) is authorized by the FDA as being “interchangeable” (as defined in Section 351(i)(3) of the PHSA) to such Licensed Product, or (ii) is authorized by the FDA as being a “biosimilar” (as defined in Section 351(i)(2) of the PHSA) regardless of whether such product has been found to be “interchangeable” (as defined in Section 351(i)(3) of the PHSA) to such Licensed Product, (b) has been granted a marketing authorization by the European Commission as a similar biological medicinal product pursuant to Article 10 of Directive 2001/83/EC, as may be amended, or any subsequent or superseding law, stature or regulation or (c) has otherwise received Regulatory Approval as a generic, biosimilar or interchangeable product from another applicable Regulatory Authority in such country or jurisdiction, including by referencing or otherwise relying on Regulatory Approvals (or data therein) of such Licensed Product. 

1.1.14“BLA” means Biologics License Application as described in 21 C.F.R § 601.2, or equivalent FDA application. 

1.1.15“Breaching Party” has the meaning set forth in Section 11.3.1.

1.1.16“Budget Threshold” means for budget updates in a given year, the higher of (a) [***] in the case of the Early Stage Program or [***] in the case of the Post Phase Ia Program and (b) an aggregate [***] budgetary increase from the then current budget set forth in the plan for such Program.

Page 3

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

1.1.17“Business Day” means a day on which national banks located in the Commonwealth of Massachusetts are open for commercial banking business other than a Saturday or Sunday.

1.1.18“Calendar Quarter” means any of the three (3)-month periods beginning on January 1, April 1, July 1 or October 1 of any Calendar Year, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on June 30, 2017 and the last Calendar Quarter shall end on the last day of the Term.

1.1.19“Calendar Year” means (a) for the first Calendar Year, the period commencing on the Effective Date and ending on December 31 of the year during which the Effective Date occurs, (b) for the last Calendar Year, the period commencing on January 1 of the last year of the Term, and ending on the last day of the Term, and (c) each interim period of twelve (12) months commencing on January 1 and ending on December 31.

1.1.20[***]

1.1.21“CD38 SLT-A Fusion Protein” means any SLT-A Fusion Protein (a) used or developed under the 2016 Collaboration Agreement, the IPA or the Programs by MTEM, including those specified in the Recitals or (b) are covered or claimed by the MTEM Background Know-How or MTEM Background Patent Rights, including any SLT-A Technology, or any MTEM SLT-A Program Patent Rights and MTEM SLT-A Program Know-How, in either case that is Directed to the Target.

1.1.22“Change in Control” means with respect to a Party, (a) a merger or consolidation in which (i) such Party is a constituent party, or (ii) a subsidiary of such Party is a constituent party, and such entity in clause (i) or (ii) issues shares of its capital stock pursuant to such merger or consolidation, except in the case of either clause (i) or (ii) any such merger or consolidation involving such Party or a subsidiary of such Party in which the shares of capital stock of such entity outstanding immediately prior to such merger or consolidation continue to represent, or are converted into or are exchanged for shares of capital stock which represent, immediately following such merger or consolidation 50% or more by voting power of the capital stock of (A) the surviving or resulting corporation or (B) the parent corporation of such surviving or resulting corporation, in the case that the surviving or resulting corporation is a wholly owned subsidiary of another corporation immediately following such merger or consolidation; (b) the sale, lease, transfer, exclusive license or other disposition, in a single transaction or series of related transactions, by such Party or a subsidiary of such Party of all or substantially all of the assets of such Party or such subsidiary of such Party taken as a whole (except where such sale, lease, transfer, exclusive license or other disposition is only to a wholly owned subsidiary of such Party or a subsidiary of such Party); or (c) any “person” or “group,” as such terms are defined in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended, and the rules thereunder (collectively, the “Exchange Act”) in a single transaction or series of related transactions, becomes the beneficial owner as defined under the Exchange Act, directly or indirectly, whether by purchase or acquisition or agreement to act in concert or otherwise, of 50% or more by voting power of the then-outstanding capital stock or other equity interests of such Party or a subsidiary of such Party, other than pursuant to a bona fide financing. 

1.1.23“Claim” has the meaning set forth in Section 10.1.1.

Page 4

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

1.1.24“Clinical Trial” means any clinical study conducted on human subjects. Without limiting the foregoing, Clinical Trials includes any Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial.

1.1.25“Co-Development” or “Co-Develop” means the circumstance in which MTEM has the obligation to share Co-Development Costs under this Agreement.

1.1.26“Co-Development Costs” means (a) the Development Costs for the Early Stage Program as further described in Section 2.1.1, and (b) in the case in which the Co-Development Option is exercised, Development Costs for the Post Phase Ia Program Plan as further described in Section 2.1.2(b). 

1.1.27“Co-Development Option” means that certain option described in Section 2.1.2(b).

1.1.28“Co-Development Period” means any period during which the Parties share Co-Development Costs under this Agreement, including (a) the Early Stage Program only or (b) if MTEM exercises the Co-Development Option, the Early Stage Program and the Post Phase Ia Program and, if applicable, ending at the end of the Co-Development Termination Notice Period (or as of the effective date of the termination of the Co-Development Period by Takeda as permitted under this Agreement). 

1.1.29“Co-Development Royalty Term” means, on a Licensed Product-by-Licensed Product and country-by-country basis, and subject to Section 6.5.3 and Section 6.5.6, the period commencing upon the First Commercial Sale of a Licensed Product in such country and ending upon the latest to occur of: (a) the date of expiration of the last Valid Patent Claim of the MTEM Background Patent Rights, the Patent Rights in the Joint Background IP, the MTEM Program Patent Rights, the Takeda Program Patent Rights (including any Takeda Targeting Moiety IP), and any Product Program Patent Rights claiming inventions that were conceived or reduced to practice during the Co-Development Period which Valid Patent Claim covers the Licensed Product or its method of use for an approved indication, in each case that would be infringed by the sale of the applicable Licensed Product in the applicable country, if not for Takeda’s ownership thereof or the licenses granted hereunder; (b) the date of expiration of any regulatory exclusivity for such Licensed Product in such country; and (c) the date of [***].

1.1.30“Co-Development Termination Notice” has the meaning set forth in Section 6.5.2.

1.1.31“Co-Development Termination Notice Period” has the meaning set forth in Section 6.5.2.

1.1.32“Combination Product” means a Licensed Product that contains a CD38 SLT-A Fusion Protein as an active ingredient together with one (1) or more other active ingredients and is sold together for a single invoiced price, including in the case of co-packaging or co-formulation.

1.1.33“Commercialize” or “Commercializing” means to market, promote, distribute, offer for sale, sell, have sold, import, have imported, export, have exported or otherwise commercialize a compound or product. When used as a noun, “Commercialization” means any and all activities involved in Commercializing.

Page 5

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

1.1.34“Commercially Reasonable Efforts” means, with respect to the efforts to be expended, by a Party or its Affiliate with respect to any objective to be undertaken hereunder, reasonable, good faith efforts to accomplish such objective as such Party would normally use to accomplish a similar objective under similar circumstances, it being understood and agreed that with respect to applicable activities, such efforts and resources shall be consistent with those efforts and resources commonly used by such Party under similar circumstances for similar products owned by it or to which it has similar rights that are at a similar stage in their development or product life and are of similar market potential as the applicable Licensed Product taking into account: (a) issues of efficacy, safety and expected and actual approved labeling, (b) the expected and actual competitiveness of alternative products sold by Third Parties in the marketplace, (c) the expected and actual product profile, (d) the expected and actual patent and other proprietary position, (e) the likelihood of regulatory approval given the regulatory structure involved, including regulatory or data exclusivity, and (f) the expected and actual profitability and return on investment of the applicable Licensed Product, or other products in a Party’s portfolio of products, taking into consideration, among other factors, the expected or actual (i) Third Party costs and expenses, (ii) royalty, milestone and other payments payable to Third Parties and to MTEM, and (iii) pricing and reimbursement. Commercially Reasonable Efforts shall be determined on a country-by-country and indication-by-indication basis for each Licensed Product, as applicable, and it is anticipated that the level of effort and resources that constitute “Commercially Reasonable Efforts” with respect to a particular country or indication will change over time, reflecting changes in the status of the applicable Licensed Product and the country(ies) involved. Notwithstanding the foregoing, neither Party shall be obligated to Develop, seek Regulatory Approval for, or Commercialize a Licensed Product: (A) that, in its reasonable opinion after discussion with the other Party, caused or is likely to cause a fatal, life-threatening or other adverse safety event that is reasonably expected, based upon then available data, to preclude obtaining Regulatory Approval for such Licensed Product, or, if Regulatory Approval of such Licensed Product has already been obtained, to preclude continued marketing of such Licensed Product; or (B) in a manner inconsistent with Applicable Law.

1.1.35“Component” means any intermediate, component or unfinished form, element or ingredient of a CD38 SLT-A Fusion Protein or of a Licensed Product.

1.1.36“Confidential Information” has the meaning set forth in Section 7.1.

1.1.37“Contract Manufacturing Organization” or “CMO” has the meaning set forth in Section 5.1.2.

1.1.38“Control” means, with respect to any information, Regulatory Documentation or intellectual property right, possession, whether directly or indirectly, by a Party or its Affiliates (including, except as described below, a Future Acquirer) of the ability (whether by sole, joint or other ownership interest, license or otherwise, other than pursuant to the grants set forth in this Agreement) to grant the right to access or use, or to grant a license or a sublicense to, such information, Regulatory Documentation or intellectual property right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party. Notwithstanding the foregoing, any information or intellectual property right Controlled by a Future Acquirer of MTEM shall not be treated as “Controlled” by MTEM or its Affiliates for purposes of this Agreement to the extent, but only to the extent, that such intellectual property (a) is Controlled by such Future Acquirer of MTEM immediately prior to the time such Future Acquirer qualifies as such, other than pursuant to a license or other grant of 

Page 6

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

rights (whether directly or indirectly) by MTEM or its Affiliates, or (b) is Controlled by such Future Acquirer subsequent to the time that such Future Acquirer qualifies as such but (i) was not Controlled by MTEM or any of its existing Affiliates prior to the time such Future Acquirer qualifies as such and (ii) did not come under the Control of such Future Acquirer due to any license or other grant of rights by MTEM or its Affiliates or any reference or access to any Program IP or MTEM Background IP, Takeda Background IP, Product Information or any other Confidential Information of Takeda or information, Regulatory Documentation or intellectual property right Controlled by MTEM or any of its Affiliates (other than information, Regulatory Documentation or intellectual property Controlled by a Future Acquirer that would be excluded by clause (a) or (b)(i) of this definition). 

1.1.39“CPRIT” has the meaning set forth in Section 9.2.14.

1.1.40“CPRIT Agreements” means any agreements existing as of the Effective Date, entered into by MTEM and CPRIT relating to SLT-A Technology used in relation to CD38 SLT-A Fusion Proteins, CD38 SLT-A Fusion Proteins or the 4019 Targeting Moiety.

1.1.41“Develop” or “Developing” means to discover, research, manufacture, evaluate, compare, or develop a process, compound or product, including conducting non-clinical, clinical research, development and regulatory activities, including any activities necessary or useful to obtain or maintain Regulatory Approval with respect to any product. When used as a noun, “Development” means any and all activities involved in Developing.

1.1.42“Development Costs” means [***] incurred by a Party, its Affiliates, licensees or Sublicensees in connection with performing its applicable Program Activities that are either (a) budgeted in the applicable Program Plan or otherwise specified as Development Costs herein or (b) approved by the Joint Steering Committee as Development Costs for the Early Stage Program or if the Co-Development Option is exercised, the Post Phase Ia Program, as applicable. Examples of Program Activities that may be part of the applicable budget include: clinical manufacturing, regulatory filings and preparation thereof, manufacturing process development, research and development for translational activities, global development activities, and early access programs. 

1.1.43“Development Material” means materials supplied by MTEM hereunder for use in the Early Stage Program or other clinical or nonclinical development.

1.1.44“Directed” means, with respect to the Target, that an Antibody, SLT-A Fusion Protein or other targeting moiety is selected, generated or optimized to preferentially bind to the Target. 

1.1.45“Dispute” has the meaning set forth in Section 12.3. 

1.1.46“Distributor” means any Person(s) appointed by Takeda or any of its Affiliates or its or their Sublicensees to distribute, market or sell product(s), with or without packaging rights, in one or more countries or jurisdictions, in circumstances where such Person purchases its requirements of the Licensed Product(s) from Takeda or its Affiliates or its or their Sublicensees but does not otherwise make any royalty or other payment to any of Takeda or its Affiliates or its or their Sublicensees with respect to its intellectual property rights with respect to the Licensed Product(s).

Page 7

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

1.1.47“Drug Approval Application” means a BLA, an NDA or any corresponding foreign application in the Territory, including, with respect to a country in Europe, a marketing authorization application filed with the EMA pursuant to the centralized approval procedure and, with respect to Japan, a marketing authorization application filed with the PMDA.

1.1.48“Early Stage Development Budget” has the meaning set forth in Section 2.1.1.

1.1.49“Early Stage Program” means IND-enabling studies and the clinical program conducted pursuant to the Early Stage Program Plan and activities related thereto and including activities which may be related to investments in future Post Phase Ia Program Activities, such as process development for manufacturing scale up.

1.1.50“Early Stage Program Activities” means Development activities carried out pursuant to the Early Stage Program Plan.

1.1.51“Early Stage Program Plan” means that certain plan set forth in Schedule 1.1.51 with respect to the IND-enabling studies and the Phase Ia Clinical Trial(s) which shall be completed upon determination of the first maximally tolerated dose if multiple maximally tolerated doses are being pursued. The Early Stage Program Plan may be updated from time to time subject to Section 2.1.1. and may include such preparatory work for the period following the Phase Ia Clinical Trial(s), such as scale up optimization and process development.

1.1.52“Effective Date” has the meaning set forth in the preamble hereto. 

1.1.53“EMA” means the European Medicines Agency, or any successor agency thereto. 

1.1.54“European Union” means the economic, scientific and political organization of member states as it may be constituted from time to time, specifically including any territory that was a member state as of the Effective Date whether or not such territory is a participating member state as of the applicable time.

1.1.55“Event of Force Majeure” has the meaning set forth in Section 12.6.

1.1.56“Exchange Act” has the meaning set forth in the definition of Change in Control.

1.1.57“Excluded Lists” means the United States Department of Health and Human Service’s List of Excluded Individuals/Entities and the United States General Services Administration’s Lists of Parties Excluded from Federal Procurement and Non-Procurement Programs, and any analogous lists pursuant to Applicable Law outside the United States. 

1.1.58“Exclusive License” has the meaning set forth in Section 3.3. 

1.1.59“Existing Third Party Agreement” means any agreement or arrangement between Takeda [***] or any other Third Party in effect as of the Effective Date (including, without limitation, the future exercise of any option or license relating to such agreement or arrangement).

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1.1.60“Expert Panel” has the meaning set forth in Section 12.3. 

1.1.61“Exploit” means make, have made, import, use, sell or offer for sale, including to research, Develop, Commercialize, register, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market or have sold or otherwise dispose of, a compound, product or process. 

1.1.62“Exploitation” means the act of Exploiting.

1.1.63“Extensions” has the meaning set forth in Section 8.3.6.

1.1.64“Facility” means MTEM’s facility located at 9301 Amberglen Blvd., Suite 100, Austin TX 78729. 

1.1.65“FDA” means the United States Food and Drug Administration, and any successor agency thereto. 

1.1.66“FFDCA” means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301, et. seq., as it may be amended from time to time, and the rules, regulations, guidances, guidelines, and requirements promulgated or issued thereunder.

1.1.67“Field” means diagnosis, prevention, control or treatment of any and all human and animal conditions, diseases or disorders. 

1.1.68“First Commercial Sale” means, with respect to any Licensed Product and with respect to any country or jurisdiction in the Territory, the first commercial sale of such Licensed Product by Takeda, its Affiliates, Sublicensees or Distributors to a Third Party for monetary value after all Regulatory Approvals required for the sale of such Licensed Product have been obtained in such country or jurisdiction, in each case for use or consumption of such Licensed Product in such country or jurisdiction by the general public; provided, that sales for clinical study purposes or compassionate, named patient (paid or unpaid) or similar use shall not constitute a First Commercial Sale.  

1.1.69“First Line MM Use” means approved for use as the initial therapy in Multiple Myeloma patients who have not been previously treated for the condition with other therapies.

1.1.70“FTE” means one (1) person (or the equivalent of one (1) person) working full time for one (1) twelve (12) month period in a Development, regulatory or other relevant capacity employed or contracted by a Party and assigned to perform specified work, with such commitment of time and effort to constitute one (1) employee performing such work on a full-time basis, which for purposes hereof shall be eighteen hundred (1,800) hours per year. 

1.1.71“FTE Costs” means, for any period, the FTE Rate multiplied by the number of FTEs who perform Program Activities pursuant to this Agreement in accordance with this Agreement.

1.1.72“FTE Rate” means, as of the Effective Date, [***]; provided, that such rate shall be adjusted annually, with each annual adjustment effective as of each anniversary of the Effective Date, based on the percentage increase over the applicable annual period in the 

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Consumer Price Index (U.S. Bureau of Labor Statistics for all urban consumers, U.S. city average, all items). The FTE Rate shall be deemed inclusive of (a) all expenses incurred per FTE performing the applicable activities hereunder, including salaries, wages, bonuses, benefits, profit sharing, stock option grants, and FICA costs and other similar ex-U.S. costs, meals and entertainment, training, recruiting, relocation, operating supplies, and equipment and other disposable goods to the extent required for the performance of the applicable activities and (b) overhead associated with such FTE and the performance of its activities hereunder. 

1.1.73“Fusion Protein Materials” means CD38 SLT-A Fusion Proteins or Components thereof.

1.1.74“Future Acquirer” means a Third Party to any Change in Control transaction involving MTEM and such Third Party or any of such Third Party’s Affiliates existing immediately prior to such Change in Control. 

1.1.75“Future MTEM In-License” means any agreement with a Third Party entered into by MTEM or any of its Affiliates after the Effective Date and during the Term pursuant to which MTEM obtains rights to Patent Rights or Know-How that would reasonably be expected to constitute MTEM Background IP or MTEM Program IP.

1.1.76“Good Manufacturing Practices” or “GMP” means the then current standards for good manufacturing practices for pharmaceuticals, as set forth in the FFDCA and applicable regulations and guidances promulgated thereunder, including the Code of Federal Regulations, as amended from time to time.

1.1.77 “Governmental Authority” means any applicable multi-national, federal, state, local, municipal or other government authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).

1.1.78“Improvement” means all patentable and non-patentable inventions, discoveries, developments, enhancements, modifications or other know-how or improvements that derive from or relate to a Takeda Targeting Moiety, a 4019 Targeting Moiety, an SLT-A or any Patent Rights or Know-How of a Party, whether made by a Party, its Affiliate or a Third Party acting on a Party’s behalf or jointly by both Parties or their Affiliates or Third Parties acting on their behalf. 

1.1.79“IND” means (a) in the United States, an Investigational New Drug Application, as defined in the FFDCA, filed with the FDA that is required to be filed with the FDA before conducting a Clinical Trial (including all supplements and amendments that may be filed with respect to the foregoing); or (b) any foreign counterpart of the foregoing.

1.1.80“Indemnitee” has the meaning set forth in Section 10.2.1.

1.1.81“Indemnitor” has the meaning set forth in Section 10.2.1.

1.1.82“Infringement Notice” has the meaning set forth in Section 8.4.1.

1.1.83“IPA” has the meaning set forth in the Recitals.

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1.1.84[***] means that certain drug [***] for the treatment of MM, including all formulations, dosage forms, prodrugs, or active metabolites thereof.

1.1.85“Joint Background IP” means any Background IP owned jointly by both Parties or their respective Affiliates, including any Project Technology or Project IP, as defined under the 2016 Research Collaboration Agreement, other than that which is assigned to one Party and solely owned by such Party as set forth herein. 

1.1.86“Joint Development Committee” and “JDC” have the meaning set forth in Section 4.4.1.

1.1.87“Joint Finance Working Group” has the meaning set forth in Section 4.7.1.

1.1.88“Joint Manufacturing Committee” has the meaning set forth in Section 5.4.1.

1.1.89“Joint Other Program IP” means the Joint Other Program Know-How and the Joint Other Program Patent Rights. 

1.1.90“Joint Other Program Know-How” means any Other Program Know-How that is conceived, discovered, developed or otherwise made by or on behalf of both Parties’ (or their Affiliates’ or (sub)contractors) employees or Third Parties acting on such Parties’ behalf, in each case, in the course of such Party’s or Affiliates’ or (sub)contractors’ performance of a Program under this Agreement. For clarity, Joint Other Program Know-How does not include any Other Program Know-How owned solely by Takeda or Other Program Know-How owned solely by MTEM.  

1.1.91“Joint Other Program Patent Rights” means any Patent Rights that claim Joint Other Program Know-How. For clarity, Other Program Patent Rights do not include MTEM Program Patent Rights or Takeda Program Patent Rights or Product Program Patent Rights. 

1.1.92“Joint Patent Committee” has the meaning set forth in Section 8.3.9(a).

1.1.93“Joint Steering Committee” or “JSC” has the meaning set forth in Section 4.3.1.

1.1.94“Know-How” means all proprietary technical information, processes, formulae, data, results, developments, materials, specifications, inventions, improvements, uses, methods, techniques, conceptions, knowledge, discoveries, know-how, trade secrets and other information, whether or not patentable, but that is not generally known, including any tangible embodiments and all intellectual property rights, excluding Patent Rights, in and to any of the foregoing.

1.1.95“Liabilities” has the meaning set forth in Section 10.1.1.

1.1.96“Licensed Product” means any product that incorporates or is comprised of one or more CD38 SLT-A Fusion Proteins.

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1.1.97“Major Market Country” means each of the United States, Japan, France, Germany, Italy, Spain and the United Kingdom.

1.1.98“Manufacture” or “Manufacturing” means to make, have made, produce, manufacture, process, fill, finish, package, label, perform quality control and assurance testing, release, ship or store a compound or product or any intermediate or component thereof. When used as a noun, “Manufacture” or “Manufacturing” means any and all activities involved in Manufacturing a compound or product or any intermediate or component thereof. 

1.1.99“Mono Product” has the meaning set forth in the definition of Net Sales.

1.1.100“MTEM” has the meaning set forth in the preamble hereto.

1.1.101“MTEM Background IP” means the MTEM Background Patent Rights and the MTEM Background Know-How.

1.1.102“MTEM Background Know-How” means any and all Know-How that (a) is Controlled by MTEM or any Affiliate of MTEM as of the Effective Date or, subject to Section 3.5, at any time during the Term and (b) relates to, comprises or consists of an SLT-A, SLT-A Fusion Protein, or a Licensed Product or the Exploitation of any of the foregoing and is necessary or useful to Develop, Manufacture, Commercialize or otherwise Exploit CD38 SLT-A Fusion Proteins or Licensed Products, excluding for clarity the Know-How in the Joint Background IP. MTEM Background Know-How includes the SLT-A Technology and the “SLT-A Technology” as defined under the Multi-Target Agreement. 

1.1.103“MTEM Background Patent Right” means any Patent Right that claims any MTEM Background Know-How.

1.1.104“MTEM Co-Development Cost Amount” means the aggregate amount of Co-Development Costs that MTEM has paid related to the Post Phase Ia Program hereunder after its exercise of the Co-Development Option and through the Co-Development Termination Notice Period.

1.1.105“MTEM Indemnitees” has the meaning set forth in Section 10.1.2.

1.1.106“MTEM Licensee” has the meaning set forth in Section 3.7.

1.1.107“MTEM Program IP” means the MTEM Program Patent Rights and the MTEM Program Know-How.

1.1.108“MTEM Program Know-How” means any Program Know-How which is related to an Improvement of SLT-A Technology, but is not Takeda Program Know-How, 4019 Targeting Moiety Know-How or Product Program Know-How. 

1.1.109“MTEM Program Patent Rights” means any Patent Rights that claim MTEM Program Know-How.

1.1.110“MTEM Prosecution Patent Rights” has the meaning set forth in Section 9.2.3.

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1.1.111“MTEM Regulatory Documentation” means Regulatory Documentation Controlled by MTEM or any of its Affiliates on or after the Effective Date concerning any of the following: SLT-As, SLT-A Fusion Proteins, MTEM Background IP or MTEM Program IP, which Regulatory Documentation is necessary or useful to Develop a CD38 SLT-A Fusion Protein or Exploit a Licensed Product. 

1.1.112“MTEM SLT-A Program Know-How” means any Program Know-How, which is related to an improvement to, or modification of, SLT-A Technology, and which is not Takeda Program Know-How or Product Program Know-How.

1.1.113“MTEM SLT-A Program Patent Rights” means any Patent Rights that claim MTEM SLT-A Program Know-How. 

1.1.114“MTEM Study Materials” means control drug fusion materials generated by MTEM under the Early Stage Program Plan. 

1.1.115“Multi-Target Agreement” has the meaning set forth in the Recitals. 

1.1.116“Multiple Myeloma” or “MM” means multiple myeloma as defined by the National Cancer Institute in the United States. 

1.1.117“NDA” means a New Drug Application filed with the FDA in conformance with Applicable Law, or the foreign equivalent of any such application in any other country filed with a Regulatory Authority to obtain marketing approval for a pharmaceutical product.

1.1.118“Net Sales” means the [***] invoiced amounts for all Licensed Products sold by or for Takeda, its Affiliates and Sublicensees to Third Parties (including wholesalers or Distributors but not any Affiliate or Sublicensee of Takeda), after deduction (if not already deducted in the amount invoiced) of the following items paid by Takeda, its Affiliates and Sublicensees, provided and to the extent that such items are incurred or allowed and do not exceed reasonable and customary amounts in the market in which such sales occurred and are not inconsistent with other similar products of Takeda: 

(a)any [***], including [***];

(b)any [***];

(c)any [***], including [***];

(d)any charges for [***], in each case to the extent borne by Takeda, or its Affiliates or Sublicensees; and

(e)any [***] given or made with respect to [***].

In the event a Licensed Product is a Combination Product, the Net Sales attributable to such Combination Product for a given country shall be calculated as follows:

If Takeda, its Affiliate or Sublicensee separately sells in such country, (i) a product containing as its sole active ingredient a CD38 SLT-A Fusion Protein (the “Mono Product”) and (ii) the other active ingredient in the Licensed Product, then for purposes of the royalties and sales milestones 

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set forth herein, Net Sales for such Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B) where: “A” is Takeda’s (or its Affiliate’s or Sublicensee’s, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction and “B” is Takeda’s (or its Affiliate’s or Sublicensee’s, as applicable) average Net Sales price during the period to which the Net Sales calculation applies in such country or other jurisdiction, for products that contain as their sole active ingredients the other active ingredients in such Combination Product. 

If Takeda, its Affiliate or Sublicensee separately sells in such country or other jurisdiction the Mono Product but does not separately sell in such country or other jurisdiction products containing as their sole active ingredients the other active ingredients in such Combination Product, then for purposes of the royalties and sales milestones set forth herein, Net Sales for such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction A/C where: “A” is Takeda’s (or its Affiliate’s Sublicensee’s, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction, and “C” is Takeda’s (or its Affiliate’s or Sublicensee’s, as applicable) average Net Sales price in such country or other jurisdiction during the period to which the Net Sales calculation applies for such Combination Product.

If Takeda, its Affiliates and Sublicensees do not separately sell in such country or other jurisdiction both the Mono Product and the other active ingredients in such Combination Product, then the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith taking into account the medical contribution to such Combination Product of the CD38 SLT-A Fusion Protein on the one hand, and all of the other active ingredients, as applicable, collectively, on the other hand; provided, that if the Parties cannot agree on such relative value, the Dispute shall be resolved pursuant to Section 12.3. 

All of the foregoing deductions from the gross invoiced sales prices of Licensed Products shall be determined in accordance with the applicable Accounting Standards. In the event that Takeda, its Affiliates or Sublicensees make any adjustments to such deductions after the associated Net Sales have been reported pursuant to this Agreement, the adjustments shall be reported and reconciled in the next report and payment of any royalties due. 

1.1.119“Notice of Dispute” has the meaning set forth in Section 12.3.1.

1.1.120“Notice Period” has the meaning set forth in Section 11.3.1.

1.1.121“Opt-In” means the withdrawal under Article 83(4) of the Agreement on a Unified Patent Court between the participating Member States of the European Union (2013/C 175/01) of the Opt-Out of a Patent Right.

1.1.122“Opt-Out” means the opt-out of a Patent Right from the exclusive competence of the Unified Patent Court under Article 83(3) of the Agreement on a Unified Patent Court between the participating Member States of the European Union (2013/C 175/01).

1.1.123“Other Program IP” means the Other Program Know-How and the Other Program Patent Rights. 

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1.1.124“Other Program Know-How” means any Program Know-How that is not MTEM Program Know-How, Takeda Program Know-How or Product Program Know-How.

1.1.125“Other Program Patent Rights” means any Patent Rights that claim Other Program Know-How.

1.1.126“Party” and “Parties” have the meaning set forth in the preamble hereto.

1.1.127“Patent Challenge” has the meaning set forth in Section 8.9.

1.1.128“Patent Right” means any and all national, regional and international (a) issued patents and pending patent applications (including provisional patent applications), (b) patent applications filed either from the foregoing or from an application claiming priority to the foregoing, including all converted provisionals, substitutions, continuations, continuations-in-part, divisions, renewals and continued prosecution applications, and all patents granted thereon, (c) patents-of-addition, revalidations, reissues, reexaminations and extensions or restorations (including any supplementary protection certificates and the like) by existing or future extension or restoration mechanisms, including patent term adjustments, patent term extensions, supplementary protection certificates or the equivalent thereof, (d) inventor’s certificates, utility models, petty patents, innovation patents and design patents, (e) other forms of government-issued rights substantially similar to any of the foregoing, including so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing and (f) United States and foreign counterparts of any of the foregoing. 

1.1.129“Payments” has the meaning set forth in Section 6.10.

1.1.130“Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.

1.1.131“Phase I Clinical Trial” means a Clinical Trial of a Licensed Product conducted by or on behalf of Takeda, its Affiliates or Sublicensees that generally provides for the first introduction into humans of a such Licensed Product with, the primary purpose of determining metabolism and pharmacokinetic properties and side effects of such product, in a manner that is generally consistent with 21 C.F.R. § 312.21(a), as amended (or its successor regulation), excluding, for clarity any investigator-initiated Clinical Trials. 

1.1.132“Phase Ia Clinical Trial” means a Phase I Clinical Trial through the end of dose escalation and determination of the maximally tolerated dose. The plan and budget for the Phase Ia Clinical Trial is set forth in Schedule 1.1.132 and as may be updated from time to time subject to Section 2.1.1.

1.1.133“Phase II Clinical Trial” means a Clinical Trial of a Licensed Product conducted by or on behalf of Takeda, its Affiliates or Sublicensees on a sufficient number of subjects for making (and the principal purpose of which is to make) a preliminary determination as to whether a pharmaceutical product is safe for its intended use and obtaining (and to obtain) 

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sufficient information about such product’s efficacy, in a manner that is generally consistent with 21 C.F.R. § 312.21(b), as amended (or its successor regulation), or a similar clinical study prescribed by the Regulatory Authorities in a country or jurisdiction outside the United States, to permit the design of further Clinical Trials of such Licensed Product, excluding, for clarity any investigator-initiated Clinical Trials.

1.1.134“Phase III Clinical Trial” means a Clinical Trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product and conducted by or on behalf of Takeda, its Affiliates or Sublicensees on a sufficient number of subjects for ascertaining (and that is designed to ascertain) the overall risk-benefit relationship of the Licensed Product for its intended use and determining (and to determine) warnings, precautions, and adverse reactions that are associated with such Licensed Product in the dosage range to be prescribed, in a manner that is generally consistent with 21 C.F.R. § 312.21(c), as amended (or its successor regulation), or a similar clinical study prescribed by the Regulatory Authorities in a country or jurisdiction outside the United States, which trial is necessary to support Regulatory Approval of such Licensed Product, excluding, for clarity any investigator-initiated Clinical Trials. 

1.1.135“PHSA” means the United States Public Health Service Act, as may be amended, or any subsequent or superseding law, statute or regulation.

1.1.136“PMDA” means the Pharmaceuticals and Medical Devices Agency in Japan, or any successor agency thereto.

1.1.137“Post-Approval Requirements” means any Clinical Trial or other activity that is either required to be conducted after the grant of Regulatory Approval by a Regulatory Authority as a condition of granting such Regulatory Approval or otherwise pursued in the life cycle management plan to maximize access to impact or access to the Licensed Product.

1.1.138“Post Phase Ia Program” means the nonclinical, manufacturing and Clinical Trial program to be conducted under the Post Phase Ia Program Plan, including any Post-Approval Requirements, but excluding any investigator sponsored trials.

1.1.139“Post Phase Ia Program Activities” means Development activities carried out pursuant to the Post Phase Ia Program Plan.

1.1.140“Post Phase Ia Program Plan” means that certain plan adopted pursuant to Section 2.1.2(b) with respect to any Post Phase Ia Clinical Trial(s), including Post-Approval Requirements.

1.1.141“Product Information” has the meaning set forth in Section 7.1.

1.1.142“Product Program IP” means the Product Program Know-How and the Product Program Patent Rights.

1.1.143“Product Program Know-How” means any Program Know-How in each case that is related to one or more of the following: (a) any CD38 SLT-A Fusion Protein or other SLT-A conjugate comprising a Takeda Targeting Moiety or 4019 Targeting Moiety, any corresponding SLT-A Fusion Protein compositions of matter (e.g., compounds, compositions, 

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combinations and formulations), and methods of making or using any of the foregoing; and conjugates and fusion proteins comprising any of the foregoing and (b) any 4019 Targeting Moiety, in each case (a) and (b), that is not solely related to a Takeda Targeting Moiety or any other proprietary compound of Takeda or the SLT-A Technology.

1.1.144“Product Program Patent Rights” means any Patent Rights that claim Product Program Know-How.

1.1.145“Product Trademarks” has the meaning set forth in Section 8.6.

1.1.146“Program” or “Programs” means the Early Stage Program and the Post Phase Ia Program.

1.1.147“Program Activities” means the Early Stage Program Activities and the Post Phase Ia Program Activities.

1.1.148“Program IP” means the Program Know-How and the Program Patent Rights.

1.1.149“Program Know-How” means Know-How, Improvements and other inventions that are conceived, discovered, developed or otherwise made by or on behalf of one or both of the Parties or their Affiliates in connection with the performance of the Program Activities after the Effective Date, whether or not patented or patentable. For clarity, Program Know-How is divided into four categories: Takeda Program Know-How, MTEM Program Know-How, Product Program Know-How and Other Program Know-How.

1.1.150“Program Patent Rights” means any Patent Rights that claim Program Know-How.

1.1.151“Program Plan” means either the Early Stage Program Plan or the Post Phase Ia Program Plan. 

1.1.152“Project Manager” has the meaning set forth in Section 4.2.1.

1.1.153“Publication” has the meaning set forth in Section 7.4.

1.1.154“Quality Agreement” has the meaning set forth in Section 5.5.

1.1.155“Reciprocal Technology” means any Know-How or Improvements (and any Patent Rights with respect thereto) conceived, discovered, developed or otherwise made by or on behalf of any MTEM Licensee, whether alone or with MTEM, under or in connection with a license or grant of other rights or access in, to or under any SLT-A or SLT-A Fusion Protein (a) that derive from or relate to an SLT-A or SLT-A Fusion Protein, (b) the practice of which is necessary or useful for the Development, Manufacture, Commercialization or other Exploitation of CD38 SLT-A Fusion Proteins or Licensed Products and (c) that would be MTEM Background IP or MTEM Program IP were such Know-How or Patent Rights conceived, discovered, developed or otherwise made by MTEM alone.

1.1.156“Regulatory Approval” means, with respect to a country or jurisdiction in the Territory, any and all approvals (including Drug Approval Applications), licenses, 

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registrations or authorizations of any Regulatory Authority necessary to commercially distribute, sell or market a Licensed Product in such country or jurisdiction, including, where applicable, (a) commercially reasonable pricing or reimbursement approval in such country or jurisdiction, (b) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto) and (c) labeling approval. 

1.1.157“Regulatory Authority” means, with respect to a country or jurisdiction in the Territory, any national (e.g., the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the EMA) regional, state or local regulatory agency, department, bureau, commission, council or other Governmental Authority involved in the granting of a Regulatory Approval or otherwise exercising authority with respect to biopharmaceutical products in such country or jurisdiction. 

1.1.158“Regulatory Documentation” means all (a) applications (including all INDs), registrations, licenses, authorizations and approvals (including Regulatory Approvals), (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files, and (c) clinical and other data contained, referenced or otherwise relied upon in any of the foregoing.

1.1.159“Representatives” has the meaning set forth in Section 5.2.2.

1.1.160“Royalty Report” has the meaning set forth in Section 6.11.1.

1.1.161“Royalty Term” means, on a Licensed Product-by-Licensed Product and country-by-country basis, the period commencing upon the First Commercial Sale of a Licensed Product in such country and ending upon the latest to occur of: (a) the date of expiration of the last Valid Patent Claim of the MTEM Background Patent Rights, the Patent Rights in the Joint Background IP, the MTEM Program Patent Rights, the Takeda Program Patent Rights (other than any Takeda Targeting Moiety IP) and the Product Program Patent Rights, in each case that would be infringed by the sale of the applicable Licensed Product in the applicable country, if not for Takeda’s ownership thereof or the licenses granted hereunder; (b) the date of expiration of any regulatory exclusivity for such Licensed Product in such country; and (c) [***] from the First Commercial Sale of such Licensed Product in such country. 

1.1.162“SLT-A” means (a) any Shiga or Shiga-like toxin A subunit or fragment thereof, including variants, such as deimmunized variants, variants with heterologous epitopes, furin-cleavage resistant variants and combinations thereof, including those listed on Schedule 1.1.162 hereto, which shall be updated periodically by MTEM, and (b) any Improvements to any of the foregoing.

1.1.163“SLT-A Fusion Protein” means any SLT-A conjugated, fused (e.g., as a single polypeptide chain), or otherwise combined with any Antibody or other targeting moiety. For clarity, CD38 SLT-A Fusion Proteins containing a Takeda Targeting Moiety or 4019 Targeting Moiety are SLT-A Fusion Proteins. 

1.1.164“SLT-A Technology” means the Patent Rights set forth on Schedule 1.1.164 and any inventions claimed or described therein.

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1.1.165“Sublicensee” means any Person (other than an Affiliate of Takeda or a Distributor) that is granted a sublicense under Section 3.4 by Takeda or its Affiliate in accordance with the terms of this Agreement to Develop or Commercialize Licensed Products.

1.1.166“Supply Agreement” has the meaning set forth in Section 5.1.1.

1.1.167“Supply Payment” has the meaning set forth in Section 5.1.3.

1.1.168“Supply Price” means, with respect to a quantity of Development Material, the cost of goods of such Development Material [***]. To the extent Development Material is Manufactured directly by MTEM, the cost of goods will equal the fully burdened cost of Manufacturing such Development Material, consisting of the cost of raw materials, direct and identifiable labor, product quality assurance/control costs and other direct and identifiable variable costs and appropriate direct and identifiable costs (or appropriate allocation thereof) yield losses (to the extent consistent with industry practice), storage, and shipping, rent and depreciation of capital expenditures, to the extent directly attributable and allocable to the Manufacture of such Development Material. Without limitation to the foregoing, (a) should any facility or equipment not be used to their full capacity for the Manufacture of Development Material, allocations shall be on the basis of that actually used for the Manufacture and supply of such Development Material and not any amount in respect of idle or unused capacity; and (b) the costs of goods (i) will be calculated in accordance with applicable Accounting Standards and include allocations that are commercially justifiable and consistent with fair industry practices, (ii) will exclude all costs that cannot be linked to a specific Manufacturing activity, such as charges for corporate overhead that are not controllable by the manufacturing plant, and (iii) will exclude any Third Party license payments owed or incurred by MTEM in connection with any Manufacturing activities. Cost of goods shall not include (A) costs that are expressly allocated to be borne by MTEM under this Agreement (e.g., under Article II), (B) costs associated with capability building, unless expressly agreed in writing by the Parties, or (C) any inter-company mark-up between MTEM and its Affiliates. To the extent MTEM uses a contract manufacturer for any of such activities, the cost of goods means the amount paid to the applicable contract manufacturer, including any raw materials, reagents or other components directly purchased by MTEM on behalf of the CMO and any related shipping costs including shipping insurance costs. In no circumstances will the costs incurred by MTEM, and used to calculate the Supply Price, be double counted.

1.1.169“Takeda” has the meaning set forth in the preamble hereto.

1.1.170“Takeda Background IP” means the Takeda Background Know-How and the Takeda Background Patent Rights. 

1.1.171“Takeda Background Know-How” means Know-How in Background IP owned or Controlled by Takeda that is used, or provided for use, by Takeda, in the performance of the Program Activities, excluding Know-How in the Joint Background IP. 

1.1.172“Takeda Background Patent Rights” means any Patent Rights that claim Takeda Background Know-How.

1.1.173“Takeda Program IP” means the Takeda Program Know-How and the Takeda Program Patent Rights.

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1.1.174“Takeda Program Know-How” means any Program Know-How that is related to either one or more of the following: any Takeda Targeting Moiety, including Improvements, modifications, fragments and derivatives thereof and corresponding compositions of matter (including conjugates and fusion proteins), methods of making or using any of the foregoing (“Takeda Targeting Moiety Know-How”), but excluding any Product Program Know-How and, for clarity, MTEM Program Know-How.  

1.1.175“Takeda Program Patent Rights” means any Patent Rights that claim Takeda Program Know-How, for clarity excluding any Product Program Patent Rights and Patent Rights in the Joint Background IP. 

1.1.176“Takeda Targeting Moiety” means any Antibody or other targeting moiety owned or in-licensed from a Third Party by Takeda or its Affiliates, whether in a mono-, bi- or multi-specific format, such as a peptide, cyclic peptide, small molecule or related molecular structure capable of being Directed through its binding to the Target, including non-immunoglobulin scaffolds, including fibronectin, lipocalin, protein A, ankyrin, thioredoxin, and the like.

1.1.177“Takeda Targeting Moiety IP” means the Takeda Targeting Moiety Know-How and the Takeda Targeting Moiety Patent Rights.

1.1.178“Takeda Targeting Moiety Know-How” has the meaning set forth in the definition of Takeda Program Know-How.

1.1.179“Takeda Targeting Moiety Patent Rights” means any Patent Rights that claim the Takeda Targeting Moiety Know-How.

1.1.180“Target” means CD38 and naturally occurring variants or isoforms thereof as well as any fragment or peptide of CD38, variants or isoforms.

1.1.181“Tax” or “Taxes” means any form of tax or taxation, levy, duty, charge, social security charge, contribution or withholding of whatever nature (including any related fine, penalty, surcharge or interest) imposed by, or payable to, any government, state or municipality, or any local, state, federal or other fiscal, revenue, customs, or excise authority, body or official in the Territory.

1.1.182“Technology Recipient” has the meaning set forth in Section 5.2.

1.1.183“Technology Transfer” has the meaning set forth in Section 5.2.

1.1.184“Technology Transfer Documentation” has the meaning set forth in Section 5.2.1.

1.1.185“Term” has the meaning set forth in Section 11.1.

1.1.186“Territory” means all countries and jurisdictions in the world.

1.1.187“Third Party” means any Person other than Takeda, MTEM and their respective Affiliates.

1.1.188“Third Party Action” has the meaning set forth in Section 8.7.1.

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1.1.189“Third Party SLT-A IP” has the meaning set forth in Section 8.7.2.

1.1.190“Transition Point” has the meaning set forth in Section 6.5.2.

1.1.191“Upfront Fee” has the meaning set forth in Section 6.1.

1.1.192“Valid Patent Claim” means, with respect to a Patent Right in a country or jurisdiction, any claim in (a) an issued Patent Right that has not (i) expired, irretrievably lapsed or been abandoned, revoked, dedicated to the public or disclaimed, including any applicable patent term adjustments or extensions, supplementary protection certificates and similar patent term extensions awarded by regional or national patent offices; or (ii) been found to be unpatentable, invalid or unenforceable through reissue, disclaimer or by an unreversed and unappealable decision of a Governmental Authority in such country or jurisdiction; or (b) a patent application which has been pending no longer than seven (7) years from its earliest non-provisional filing date, which has not been cancelled, withdrawn or abandoned without the possibility of revival. Notwithstanding the foregoing, should a patent claim in an application lose its status as a “Valid Patent Claim” because it has been pending for more than seven (7) years, it shall be reinstated as a “Valid Patent Claim” upon issuance.

1.1.193[***] means the [***] and any of its Affiliates.

Section 1.2Certain Rules of Interpretation in this Agreement and the Schedules.

1.2.1Unless otherwise specified, all references to monetary amounts are to United States of America currency (U.S. Dollars);

1.2.2The preamble to this Agreement and the descriptive headings of Articles and Sections are inserted solely for convenience of reference and are not intended as complete or accurate descriptions of the content of this Agreement or of such Articles or Sections;

1.2.3Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word “or” is used in the inclusive sense (and/or);

1.2.4The words “include” and “including” have the inclusive meaning frequently identified with the phrases “without limitation” and “but not limited to”;

1.2.5The words “will” and “shall” have the same meaning;

1.2.6Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. Unless otherwise specified, deadlines within which any payment is to be made or act is to be done within or following specified time period after a date shall be calculated by excluding the day, Business Day, month or year of such date, as applicable, and including the day, Business Day, month or year of the date on which the period ends;

1.2.7Whenever any payment is to be made or action to be taken under this Agreement is required to be made or taken on a day other than a Business Day, such payment shall be made or action taken on the next Business Day following such day to make such payment or do such act; and

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1.2.8Unless otherwise specified, references in this Agreement to any Article, Section, Exhibit or Schedule means references to such Article, Sections, Exhibits or Schedule of this Agreement.

Article II
DEVELOPMENT, regulatory AND COMMERCIALIZATION 

Section 2.1Development.  

2.1.1Early Stage Development. The Early Stage Program Plan is attached hereto as Schedule 1.1.51 and contains the budget for anticipated costs for the Early Stage Program (the “Early Stage Development Budget”). Not less than [***] per Calendar Year, and within the last [***] of a Calendar Year as possible, the JSC or designated subcommittee shall review and if necessary, update the Early Stage Program Plan (including the Early Stage Development Budget) with Takeda having final approval rights for the annually updated Early Stage Program Plan as set forth in Section 4.3.4. During the consideration of any Early Stage Program Plan update, the then-existing Early Stage Program Plan shall remain in effect. Subject to JDC oversight as set forth herein, each Party shall conduct all activities assigned to it under the Early Stage Program Plan using Commercially Reasonable Efforts, and shall from time-to-time during the performance of its obligations under the Early Stage Program Plan, report on such activities.  

2.1.2Post Phase Ia Development. 

(a)Post Phase Ia Program Plan. Upon Takeda’s election, but in no case later than [***] following completion (as described in the Early Stage Program Plan) of the Early Stage Program Plan, Takeda shall propose the Post Phase Ia Program Plan to MTEM in order to assist MTEM in determining whether to exercise its Co-Development Option as set forth below. Such plan will include the initial registration plan, to the extent reasonably determinable, as well as a more detailed [***] projected plan covering the specific anticipated nonclinical, manufacturing activities as well as the Clinical Trials to be conducted, budgets and associated timelines, and a regulatory plan for the lead Licensed Product in the Territory. Takeda, through the JDC or JSC, shall provide MTEM with an opportunity to provide input into the Post Phase Ia Program Plan and will reasonably consider MTEM’s comments on the Post Phase Ia Program Plan, but Takeda shall have the [***] decision regarding the Post Phase Ia Program Plan. Takeda shall be solely responsible for all activities unless the activities are otherwise agreed to be performed by MTEM. The Parties’ respective obligations for development, manufacturing, and otherwise for the Post Phase Ia Program Plan shall be as set forth in the Post Phase Ia Program Plan. Subject to Joint Development Committee oversight as set forth herein, each Party shall conduct all activities assigned to it under the Post Phase Ia Program Plan using Commercially Reasonable Efforts.

(b)Co-Development Option. 

i.Subject to the provisions of this Agreement, Takeda grants to MTEM an option to Co-Develop the Licensed Products that are under Development in accordance with this Agreement, as further set forth herein (“Co-Development Option”). For clarity, MTEM’s rights and obligations under the Co-Development Option shall extend to any or all Licensed Products that are Developed under this Agreement during the Term. Following delivery by Takeda of the Post Phase Ia Program Plan as set forth in Section 2.1.2(a), if MTEM 

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desires to exercise its Co-Development Option, then it shall do so by written notice to Takeda within [***] after such delivery has occurred, provided, however, that MTEM may not exercise its Co-Development Option unless it has paid all Co-Development Costs that have come due pursuant to this Agreement as of the date of such election (and for clarity shall pay Co-Development Costs during the pendency of the Co-Development Option period). 

ii.If MTEM exercises the Co-Development Option, then, and [***], at the beginning of [***], the Joint Steering Committee or designated subcommittee shall prepare an updated Post Phase Ia Program Plan that covers future Development and Commercialization of Licensed Product(s) with a [***] detailed projection on costs and activities for MTEM’s budgeting process. MTEM shall have the opportunity to provide input into the [***] updated Post Phase Ia Program Plan, such input to be reasonably considered by Takeda. Takeda, at the JSC level, shall have [***] decision making regarding any of the annual updates to the Post Phase Ia Program Plan subject to Section 4.3.4. 

iii.If MTEM does not elect the Co-Development Option within the time period specified in this Section 2.1.2(b), then MTEM shall have no further right to fund or participate in the conduct of the Post Phase Ia Program Plan. 

2.1.3Diligence. Takeda shall use Commercially Reasonable Efforts to Develop one Licensed Product in each of the Major Market Countries, which Commercially Reasonable Efforts may be fulfilled through the activities of Takeda’s Sublicensees. MTEM shall use Commercially Reasonable Efforts in conducting any Development activities assigned to it under this Agreement.

2.1.4Records. MTEM and Takeda shall maintain, in good scientific manner, complete and accurate books and records pertaining to their activities under the Early Stage Program Plan and the Post Phase Ia Program Plan, in sufficient detail to verify compliance with their obligations under this Agreement and which books and records shall (a) be appropriate for patent and regulatory purposes, (b) be kept and maintained in compliance with Applicable Law, and (c) properly reflect all work done and results achieved in the performance of their activities hereunder. Such books and records shall be retained by the Parties for at least [***] after the expiration or termination of this Agreement in its entirety or for such longer period as may be required by Applicable Law. During the Co-Development Period, each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy records of the other Party maintained pursuant to this Section 2.1.4 that specifically relate to this Agreement or the activities conducted hereunder (and the audited Party may redact any other portions of such records). After the end of the applicable retention period, if a Party desires to destroy any books or records maintained pursuant to this Section 2.1.4, such Party shall notify the other Party of such desire and the other Party shall have [***] after receipt of such notice to, at its option, either take custody of any such books or records the Party proposes to destroy or allow the Party to destroy such books and records.

2.1.5Development Reports. In the event that the JDC and JSC have been disbanded, then Takeda shall provide to MTEM, through its designated contact person identified in accordance with Section 4.1. with an [***] written report that provides a summary of Takeda’s significant activities related to Development of Licensed Product(s) and status of Clinical Trials and applications for Regulatory Approval necessary for marketing such Licensed 

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Product(s). Such reports shall be deemed Takeda’s Confidential Information for the purposes of Article VII.

2.1.6Subcontracting. Takeda shall have the right to designate its (sub)contractors for its Development activities hereunder. In particular, Takeda has certain preferred providers that it intends to or is required to use and MTEM has no right to object to the use of any such providers as (sub)contractors hereunder. MTEM shall have the right to designate its (sub)contractors for its Development activities hereunder, but such (sub)contractors and the corresponding activities shall be set forth in the Early Stage Program Plan and the Post Phase Ia Program Plan, respectively and subject to approval by the JDC and the JSC. 

Section 2.2Regulatory Activities.

2.2.1As between the Parties, Takeda shall have the sole right to prepare, obtain and maintain Regulatory Approvals (including the setting of the overall regulatory strategy therefor) and other submissions and to conduct communications with the Regulatory Authorities, for CD38 SLT-A Fusion Proteins or Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities with respect to Program Activities). During the Co-Development Period, Takeda shall notify MTEM in advance of any NDA, BLA or IND submissions in any Major Market Country (including any centralized European filing with the EMA) and any material regulatory communications submitted in any Major Market Country relating to any such NDA, BLA or IND submission with reasonable time for MTEM to review and make comments to Takeda, which comments Takeda shall consider in good faith. During the Term, MTEM shall not file any IND, NDA or BLA with respect to any CD38 SLT-A Fusion Protein or Licensed Product (or any other regulatory filing with respect to any CD38 SLT-A Fusion Protein or Licensed Product) unless it is required by law to do so. MTEM shall support Takeda, as may be reasonably necessary, in obtaining Regulatory Approvals for the Licensed Products and in the activities in support thereof, including providing all documents or other materials in the possession or control of MTEM or any of its Affiliates as may be necessary or useful for Takeda or any of its Affiliates or its or their Sublicensees to obtain Regulatory Approvals for Licensed Products including access to the contents in the MTEM Regulatory Documentation that are necessary or useful to compile the Chemistry Manufacturing and Controls section of an IND submission or an application for Regulatory Approval with respect to a Licensed Product and such other relevant information MTEM has created or possesses or Controls as Takeda may reasonably request.

2.2.2All Regulatory Documentation (including all Regulatory Approvals) relating to the Licensed Products with respect to the Territory shall be owned by, and shall be the sole property and held in the name of, Takeda or its designated Affiliate, Sublicensee or designee. MTEM shall, and does hereby, assign, and shall cause its Affiliates and its and their licensees and Sublicensees to assign, to Takeda or its designated Affiliate, Sublicensee or designee, without additional compensation, all of its right, title and interest in and to all Regulatory Documentation to the extent solely relating to any Licensed Product. 

2.2.3Upon request by Takeda, MTEM shall provide the FDA and other applicable Governmental Authorities full access to all MTEM Regulatory Documentation, MTEM Background Know-How and Program IP, in each case, to the extent necessary or useful for the FDA and other applicable Governmental Authorities to consider and approve Takeda, an 

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Affiliate, a Sublicensee or a Third Party as a manufacturer of the Licensed Products, or to consider and act upon any filings with such Governmental Authorities with respect to Licensed Products, including for Regulatory Approvals of the Licensed Products. 

Section 2.3Commercialization. 

2.3.1Except with respect to those obligations of MTEM in support thereof as provided hereunder, Takeda shall have the sole right and responsibility, at its sole expense, for all aspects of the Commercialization of Licensed Products and the CD38 SLT-A Fusion Proteins contained therein including the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehouse and distribute the Licensed Products in the Territory and perform or cause to be performed all related services. As between the Parties, Takeda shall handle all returns, recalls or withdrawals, order processing, invoicing, collection, distribution and inventory management with respect to the Licensed Products in the Territory.

2.3.2Notwithstanding anything herein to the contrary, Takeda shall have the sole right and responsibility, at its sole expense, with regard to any investigator sponsored trials.

2.3.3Takeda shall use Commercially Reasonable Efforts to Commercialize a Licensed Product in a Major Market Country if such Licensed Product receives all Regulatory Approvals in such Major Market Country. 

Section 2.4Use of Materials.

2.4.1MTEM acknowledges and agrees that (a) it shall not use any Takeda Targeting Moiety or other materials supplied by Takeda to MTEM, or any 4019 Targeting Moiety for any purpose other than creating the CD38 SLT-A Fusion Proteins and delivering the resulting CD38 SLT-A Fusion Proteins to Takeda pursuant to, and otherwise performing its obligations under, the applicable Program Plan, (b) it shall only use Takeda Targeting Moieties or other materials supplied by Takeda to MTEM in compliance with all Applicable Laws, (c) it shall not transfer any Takeda Targeting Moieties or other materials supplied by Takeda to MTEM or grant any rights thereto to any Third Party without the express prior written consent of Takeda, (d) Takeda shall retain full ownership of, and all right title and interest to and under, all Takeda Targeting Moieties or other materials supplied by Takeda to MTEM and (e) at the end of the Co-Development Period, or upon earlier termination of this Agreement, MTEM shall at the instruction of Takeda either destroy or return any unused Takeda Targeting Moieties or other materials supplied by Takeda to MTEM, including destroying all information constituting or pertaining to the sequences of Takeda Targeting Moieties or other materials supplied by Takeda to MTEM.

2.4.2Takeda acknowledges and agrees that (a) it shall not use any MTEM Study Materials supplied by MTEM to Takeda for any purpose other than (i) the activities assigned to Takeda under the Programs or (ii) activities within the scope of the Exclusive License, (b) it shall only use MTEM Study Materials supplied by MTEM to Takeda in compliance with all Applicable Laws, (c) except as otherwise provided hereunder or in the Early Stage Program Plan, it shall not transfer any MTEM Study Materials supplied by MTEM or grant any rights thereto to any Third Party without the express prior written consent of MTEM (except that Takeda shall be free to transfer the MTEM Study Materials as necessary or reasonably useful in connection with its exercise of the Exclusive License(s) for the Licensed Product(s)), (d) MTEM shall retain full ownership of, and all right, title, and interest in and to, all 

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MTEM Study Materials supplied by MTEM to Takeda and (e) upon earlier termination of this Agreement for any reason, Takeda shall at the instruction of MTEM either destroy or return any unused MTEM Study Materials supplied by MTEM to Takeda under the Early Stage Program.

2.4.3Each Party acknowledges and agrees that (a) it shall not use any Fusion Protein Materials for any purpose other than (i) in the case of MTEM, activities set forth in the Early Stage Program Plan, or (ii) in the case of Takeda, activities set forth in the applicable Program Plan or otherwise within the scope of the Exclusive License for any Licensed Product, (b) it shall only use Fusion Protein Materials in compliance with all Applicable Laws, (c) except as otherwise provided hereunder or in the Early Stage Program Plan, (i) MTEM shall not transfer any Fusion Protein Materials or grant any rights thereto to any Third Party without the express prior written consent of Takeda and (ii) Takeda shall not transfer any Fusion Protein Materials or grant any rights thereto to any Third Party without the express prior consent of MTEM, but Takeda may, without such consent, transfer Fusion Protein Materials to its (sub)licensees and (sub)contractors in connection with the Program Activities or the exercise of the Exclusive License, and (d) MTEM shall at the instruction of Takeda either deliver to Takeda or destroy any Fusion Protein Materials arising out of the Early Stage Program in its possession or control. The restrictions set forth in this Section 2.4.3 are not intended to limit any rights to under the Multi-Target Agreement.

Article III
LICENSE GRANTS

Section 3.1Program License Grant to MTEM. Subject to the terms and conditions of this Agreement, Takeda shall, and does hereby, grant to MTEM a non-exclusive, non-transferrable (except as set forth in Section 12.7), worldwide, royalty-free right and license in the Field, with the right to grant sublicenses only to permitted subcontractors under Section 2.1.6, to and under (a) the Takeda Background IP, (b) Takeda's interest in the Joint Background IP and (c) Takeda’s right, title and interest in the Program IP and any “Program IP” as defined in the Multi-Target Agreement, in each case ((a)-(c)) solely to conduct Program Activities assigned to it hereunder.

Section 3.2Other License Grants. 

3.2.1Subject to the provisions of this Agreement, Takeda hereby grants to MTEM a non-exclusive, worldwide, royalty-free, fully-paid right and license in the Field, with the right to grant sublicenses through multiple tiers in accordance with Section 3.4, to and under Takeda’s right, title and interest in any Other Program IP for all uses not set forth in the non-exclusive license grant under Section 3.1 or under Section 3.1.1 of the Multi-Target Agreement and excluding [***] with respect to the Target or any target that is a “Target” under the Multi-Target Agreement. 

3.2.2Subject to the provisions of this Agreement, MTEM hereby grants to Takeda a non-exclusive, worldwide, royalty-free, fully-paid and perpetual right and license in the Field, with the right to grant sublicenses through multiple tiers in accordance with Section 3.4, to and under MTEM’s right, title and interest in the Other Program IP for all uses.

Section 3.3Exclusive License Grants and Rights of Reference. MTEM shall, and does hereby, grant to Takeda, and its Affiliates, (a) an exclusive (even as to MTEM, except to the extent required for MTEM to perform its obligations under this Agreement), non-

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transferrable (except as set forth in Section 12.7), royalty-bearing right and license to and under the MTEM Background IP, MTEM’s interest in the Joint Background IP and Program IP, including Product Program IP and Other Program IP; (b) an exclusive right to access and reference to the MTEM Regulatory Documentation solely in connection with its exercise of its rights under clause (a) above; and (c) under the licenses granted in clause (a) and (b) of this Section 3.3, the right to grant sublicenses through multiple tiers in accordance with Section 3.4, and, in each case ((a), (b) and (c)), solely to Develop, Manufacture, Commercialize and otherwise Exploit Licensed Products in the Field (the “Exclusive License”). The Exclusive License shall continue (i) [***]. For clarity, the Exclusive License does not include the right (and no licenses are granted by MTEM hereunder) to incorporate into a Licensed Product or any other product any SLT-A conjugated, fused or other otherwise combined with any antibody, targeting moiety or other molecule selected, generated or optimized to preferentially bind to any target other than the Target. 

Section 3.4Rights to Sublicense. Each Party shall have the right to grant sublicenses (or further rights of reference) to its Affiliates and Third Parties (a) the license granted in Section 3.1 to permitted subcontractors or (b) through multiple tiers of sublicensees, under the licenses and rights of reference granted in Section 3.3, as applicable, to the extent set forth in Section 3.1, Section 3.2 or Section 3.3, as applicable; provided that in each case ((a) and (b)) any such Affiliate or Third Party is bound to the following provisions of this Agreement, mutatis mutandis, including obligations of confidentiality and assignment of inventions comparable in scope to those included herein and any such sublicenses shall otherwise be consistent with the terms and conditions of this Agreement. Notwithstanding the foregoing, Takeda shall have the right to sublicense the licenses in Section 3.3 to academic and research institutions without violating the foregoing sentence, provided that Takeda uses reasonable efforts to ensure that it or its Affiliates own the IP generated therefrom (or at a minimum obtains a non-exclusive license that is sublicensable to MTEM within the scope of the licenses granted to MTEM hereunder). Each Party shall remain obligated for all of its obligations under this Agreement, to the extent not satisfied by or on behalf of such Party or any of its sublicensee, and, as between the Parties, will remain liable for all acts or omissions of its sublicensees hereunder. 

Section 3.5Use and Licensing of Third Party Technologies. 

3.5.1[***] If MTEM intends to use any intellectual property licensed or acquired from a Third Party [***] in the course of conducting activities under this Agreement, and such use by MTEM or Takeda hereunder would (a) require a Party to [***] or (b) result in [***], then MTEM shall provide notice thereof to Takeda and the Parties shall discuss in good faith (x) whether [***] (y) the [***], and (z) in the case of a [***], whether [***] will bear any of such [***]. If the Parties cannot agree upon the foregoing, then MTEM shall not [***] under this Agreement. In the event the Parties agree to [***] (and on the matters described under (x), (y) and (z) of this Section 3.5.1), MTEM may enter into such license and such license shall be sublicensable to Takeda through multiple tiers. Unless otherwise agreed in writing, notwithstanding the foregoing, unless and until this Agreement terminates in its entirety, and solely with respect to use in any Program, MTEM shall not enter into any such Third Party license, or discuss with a Third Party about entering into any such Third Party license, without the prior written consent of Takeda, said consent not to be unreasonably withheld. 

3.5.2Except for any licenses covered by Section 3.5.1, Takeda shall have all decision making authority as to whether to take any license and (a) to include in Co-

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Development Costs any payments due to such Third Party during the Co-Development Period, or (b) for any payments to a Third Party by Takeda not covered by clause (a), such amounts may be deducted under Section 6.4.2 to the extent qualifying for a reduction thereunder.

3.5.3Except as set forth in Section 3.5.1, if Takeda intends to use in the Early Stage Program any new intellectual property acquired from a Third Party [***], and such use by MTEM or Takeda hereunder would trigger a need to take a license to such intellectual property from a Third Party or would trigger a payment to such Third Party, then [***]. In the event that Takeda desires to take such a license, it will be sublicensable to MTEM pursuant to Section 3.1, solely to conduct MTEM’s Program Activities under the Early Stage Program in accordance with Article II as set forth in the Early Stage Program Plan.  

Section 3.6Existing Licenses; Compliance with Future In-Licenses.  

3.6.1MTEM represents and warrants that the MTEM Background IP, as it exists as of the Effective Date, does not include any intellectual property that is in-licensed by MTEM or jointly owned with a Third Party.

3.6.2MTEM shall not terminate or enter into any amendment to, and will not commit any acts or permit the occurrence of any omissions that would cause breach or termination of, any Future MTEM In-License that would adversely affect Takeda or otherwise adversely effect, limit, restrict, impact or otherwise impair Takeda’s rights, or impose additional obligations on Takeda, under this Agreement without first obtaining the prior written consent of Takeda, such consent not to be unreasonably withheld; provided that (a) upon becoming aware of any such breach occurring and prior to any such termination right being triggered with respect to a Future MTEM In-License, MTEM will promptly provide notice thereof to Takeda and (b) unless and until a Future MTEM In-License provides (or MTEM enters into a written agreement, including an amendment to such Future MTEM In-License) that Takeda’s rights under such Future MTEM In-License granted hereunder would survive any termination of such Future MTEM In-License without imposing any additional obligations on Takeda; unless otherwise agreed to in writing by the Parties. 

Section 3.7IP Rights from Other Partners. MTEM shall ensure that any future licensee of MTEM or any sublicensee with respect to the MTEM Background IP or of MTEM’s right, title and interest in or to the Program IP (each, a “MTEM Licensee”), has agreed to (a) promptly disclose in writing to MTEM any Reciprocal Technology, including all relevant information and materials with respect thereto, and (b) assign such Third Party’s rights and interests in such Reciprocal Technology to MTEM or grant to MTEM the irrevocable and royalty-free right and license to Exploit such Reciprocal Technology in connection with CD38 SLT-A Fusion Proteins, including the right to sublicense (through multiple tiers) to Third Parties (including to Takeda on an exclusive basis with respect to the Licensed Products (including any CD38 SLT-A Fusion Protein contained therein)). MTEM will use commercially reasonable efforts to secure the above described license royalty-free to Takeda.

Section 3.8Disclosure of IP. 

MTEM shall (a) disclose and make available to Takeda the MTEM Background IP (including documents, data and information such as the MTEM Regulatory Documentation), Joint Background IP and Program IP in its possession or control as is necessary or reasonably useful to enable Takeda, its Affiliates, and its Sublicensees, to use and reference the MTEM 

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Background IP (including the MTEM Regulatory Documentation), the Joint Background IP and Program IP to practice the Exclusive License on the terms set forth herein and (b) upon Takeda’s reasonable request and with at least [***] notice to MTEM, make available to Takeda at the Facility and any other facilities used in connection with the performance of the Program Activities with respect to the Target, MTEM’s personnel to provide a reasonable amount of technical assistance and training to Takeda’s personnel in order to enable Takeda to use the such intellectual property and MTEM Regulatory Documentation. Promptly upon the issuing, registration, filing, creation or conception of any new Patent Rights Controlled by MTEM claiming any new MTEM Background IP, MTEM shall amend Schedule 9.2.5 to add such Patent Rights and shall promptly provide such amended Schedule to Takeda. 

Section 3.9Target Exclusivity. 

3.9.1Until [***], MTEM agrees, on behalf of itself and its Affiliates (a) to collaborate exclusively with Takeda with respect to the Target and (b) except as set forth herein, not to Develop, Manufacture, use or Commercialize or otherwise Exploit any targeting moiety with respect to the Target (or enable any Third Party to do so) other than pursuant to this Agreement.

3.9.2[***] Takeda agrees, on behalf of itself and its Affiliates (a) to collaborate exclusively with MTEM with respect to the [***] in products that contain a [***] and are [***] and (b) except as set forth herein, not to Develop, Manufacture, use or Commercialize or otherwise Exploit any [***] including [***] or enable any Third Party to engage in the activities set forth in this clause (b), other than pursuant to this Agreement.

3.9.3For purposes of this Section 3.9, “collaborate exclusively” includes conducting the applicable activities, directly or indirectly, itself or in collaboration with a Third Party, including by granting any right or license, including granting any covenant not to sue, with respect to any of the foregoing, but for clarity an investment in a Third Party is not itself sufficient to constitute “collaboration”. 

Article IV
Governance

Section 4.1Alliance Managers. 

4.1.1Appointment of Alliance Managers. Promptly after the Effective Date, the Parties shall each appoint an individual who shall oversee contact between the Parties for all matters under this Agreement regarding, relating to or in connection with the conduct of a Program or activities with respect to CD38 SLT-A Fusion Proteins or Licensed Products (each, an “Alliance Manager”). The Alliance Managers may, but are not required to be, members of the Joint Steering Committee. The Alliance Managers shall have the right to attend all meetings of the Joint Steering Committee and may bring to the attention of the latter any matters or issues either of the Alliance Managers reasonably believes should be discussed by the Joint Steering Committee. Each Party shall bear its own costs and expenses, including travel and lodging, in connection with the activities of its Alliance Manager hereunder. Each Party may replace its Alliance Manager at any time by written notice to the other Party. A Party may replace its designated individual at any time by written notice to the other Party.

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4.1.2Responsibilities. The Alliance Managers shall be responsible for creating and maintaining a constructive work environment between the Parties. Without limiting the generality of the foregoing, the Alliance Managers shall:

(a)Identify and timely bring to the attention of their respective managements any disputes arising between the Parties related to the Agreement;

(b)Provide a single point of communication between the Parties with respect to the Agreements and the Parties’ respective activities hereunder and thereunder;

(c)Plan and coordinate external communications by the Parties with respect to the Agreement and the Parties’ respective activities;

(d)Ensure that meetings of the JSC occur as set forth in this Agreement, that procedures are followed with respect to such meetings (including the giving of proper notice and the preparation and approval of minutes) and that relevant action items resulting from such meetings are appropriately carried out or otherwise addressed; and

(e)Undertake such other responsibilities as the Parties may mutually agree in writing.

Section 4.2Project Managers.

4.2.1Role. Each Party will designate a single individual to serve as its manager under the Early Stage Program Plan and the Post Phase Ia Program Plan (each a “Project Manager”). A Project Manager will serve as the principal point of contact for the appointing Party for matters relating to that Party’s performance under a Program Plan and will be responsible for implementing and coordinating, on a day-to-day basis, all activities under such plans and facilitating the exchange of information among the Parties regarding the performance under such Program Plan. The Project Managers may mutually delegate tasks and responsibilities to sub-managers or sub-program teams, working groups and other team members, as they deem appropriate to efficiently and effectively perform their respective obligations hereunder. Each Party may replace its Project Manager at any time upon written notice to the other Party.

4.2.2Meetings. The Project Managers will meet as soon as practicable after the Effective Date and thereafter at [***] and at such additional times as the Project Managers or the Joint Development Committee or Joint Steering Committee as applicable may deem reasonably appropriate. Meetings of the Project Managers may be conducted in person or by teleconference or video conference as mutually agreed by the Project Managers. Additionally, the Project Managers (or their designees) will maintain close regular communications with each other as to the status of the ongoing activities under the Early Stage Program Plan or the Post Phase Ia Program Plan. Each Project Manager will keep accurate and complete records of his or her activities and meetings and will, from time to time as requested by the Joint Patent Committee or Joint Steering Committee, provide the Joint Patent Committee, Joint Development Committee or Joint Steering Committee with appropriate updates and information to keep the applicable committees apprised of each Party’s performance under this Agreement. 

Section 4.3Joint Steering Committee.

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4.3.1Formation and Composition. Within [***] after the Effective Date, the Parties will establish a Joint Steering Committee (the “Joint Steering Committee” or “JSC”) composed of [***] appointed senior executive representatives of each of Takeda and MTEM (which committee may be the same committee as the one established pursuant to the Multi-Target Agreement). A Party may change one or more of its representatives on the Joint Steering Committee upon written notice to the other Party or elect to have one of its members represented by a delegate at a meeting of the Joint Steering Committee, in which case such delegate shall have the same decision-making authority as the representative for whom he or she is acting as a delegate. The Joint Steering Committee will be chaired by a Takeda representative selected by Takeda from one of the Takeda’s members of the Joint Steering Committee. The Parties may allow additional employees with experience relevant to the meeting agenda to attend meetings of the Joint Steering Committee subject to the confidentiality provisions of Article VII. Only JSC representatives or their appointed delegates shall have voting rights.

4.3.2Functions and Authority. The Joint Steering Committee will be responsible for supervising and managing the Programs. Its functions will be:

(a)Attempting to resolve any disputes arising under any subcommittee of the Joint Steering Committee;

(b)Reviewing and approving Program Plans (including budgets contained therein) and amendments or other modifications thereto formulated by the Parties or the subcommittees as set forth herein; 

(c)Monitoring and reviewing the overall progress of the Programs; 

(d)Establish working teams or additional subcommittees; and

(e)Such other matters as the Parties may mutually agree in writing.

4.3.3Meetings. Until disbanded, the Joint Steering Committee will meet in person or by teleconference or videoconference at least once every [***] until it is disbanded. 

4.3.4Decisions. Each Party shall have [***] on the Joint Steering Committee. During the Co-Development Period (a) in the event that the Joint Steering Committee is unable to reach unanimous agreement on any issue that is subject to its decision-making authority, then either Party may refer the matter for executive escalation pursuant to Section 4.3.7 except (b) Takeda’s representatives on the JSC will have [***] decision making authority at the JSC level to approve any Early Stage Program Plan or the Post Phase Ia Program Plan and any of the annual updates to either of the foregoing as provided to the JSC annually pursuant to Section 2.1.1 and Section 2.1.2, provided that the matter is referred for executive escalation pursuant to Section 4.3.7 prior to Takeda exercising its [***] decision right pursuant to Section 12.3.2. If the matter is not resolved following executive escalation, Takeda’s representatives on the JSC may exercise their [***] decision-making authority. However, in the case of any such updates which may occur outside or distinct from the annual update process, in no event may Takeda's representatives approve any such update without the agreement of MTEM’s representatives if such decision (i) would cause the Budget Threshold for the applicable Program to be exceeded or (ii) assign to MTEM any additional activities under such plan. 

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4.3.5Minutes and Reports. The Joint Steering Committee shall maintain accurate minutes of its meetings, including all proposed decisions and recommended actions or decisions taken. Promptly after each meeting, a member of the Joint Steering Committee designated by the Joint Steering Committee shall provide the Parties with draft minutes of each meeting, the status of the Programs, any issues requiring decisions and any proposed decisions. Within [***] of each meeting, the Joint Steering Committee chair shall provide final versions of the meeting minutes and such minutes will be recognized as having been accepted by the Parties. 

4.3.6Duration. Except as otherwise agreed by mutual written consent of the Parties, the Joint Steering Committee shall be in existence if during the Co-Development Period or for so long as any of the (a) Joint Development Committee, (b) Joint Manufacturing Committee, or (c) Joint Finance Working Group is in existence hereunder; provided, however, that Takeda shall have the authority to disband the Joint Steering Committee and other committees after Co-Development Period ends or pursuant to its rights in Section 12.7.2.

4.3.7Escalation. If the Joint Steering Committee fails to reach unanimous agreement on a matter within its jurisdiction for a period in excess of [***] the matter shall be resolved in accordance with the procedures set forth in Section 12.3.

4.3.8Subcommittees. The Parties may establish such subcommittees of the Joint Steering Committee as required under this Agreement or as deemed necessary by the Parties. Each such subcommittee shall consist of an equal number of representatives designated by each Party, which number shall be mutually agreed by the Parties. Each Party shall be free to change its representatives on notice to the other or to send a substitute representative to any subcommittee meeting, subject to the confidentiality provisions of Article VII; provided, however, that each Party shall ensure that at all times during the existence of any subcommittee, its representatives on such subcommittee have appropriate expertise and seniority for the then-current stage of Development or Manufacture of Licensed Products, in each case to the extent applicable to the role of the subcommittee. Each subcommittee shall report to, and any disputes under a subcommittee shall be referred to the Joint Steering Committee, subject to Section 4.3.7. The initial four (4) subcommittees of the Joint Steering Committee will be the Joint Development Committee, the Joint Manufacturing Committee, the Joint Patent Committee, and the Joint Finance Working Group, each as further described below.

Section 4.4Joint Development Committee.

4.4.1Formation and Composition. Within [***] after the Effective Date, the Parties shall establish a Joint Development Committee (the “Joint Development Committee” or “JDC”) composed of [***] appointed representatives of each of Takeda and MTEM with experience appropriate to the functions of the JDC. A Party may change one or more of its representatives on the Joint Development Committee upon written notice to the other Party or elect to have one of its members represented by a delegate at a meeting of the Joint Development Committee. The Joint Development Committee will be chaired by a Takeda representative selected by Takeda from one of Takeda’s members of the Joint Development Committee. The Parties may allow additional employees to attend meetings of the Joint Development Committee subject to the confidentiality provisions of Article VII.

4.4.2Functions and Authority. The Joint Development Committee will be responsible for overseeing Development of the Licensed Product(s) under the Early Stage 

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Program as well as, if the Co-Development Option is exercised, the Post Phase Ia Program Plan. For so long as MTEM is obligated to bear its share of the Co-Development Costs, the Joint Development Committee’s functions will be as follows with respect to activities within the scope of this Agreement:

(a)Proposing amendments or modifications to the Early Stage Program Plan or the Post Phase Ia Program Plan (including the budgets contained therein) to the JSC for approval; 

(b)Development operations coordination; 

(c)Coordinating regulatory submissions;

(d)Making any decisions that are assigned to the Joint Development Committee hereunder; and

(e)Such other matters as the Parties may mutually agree in writing.

4.4.3Meetings. Until disbanded, the Joint Development Committee will meet in person or by teleconference or videoconference at least once every [***] during the Co-Development Period or as the Joint Steering Committee otherwise decides. 

4.4.4Decisions. Each Party shall have [***] vote on the Joint Development Committee. In the event that the Joint Development Committee is unable to reach unanimous agreement on any issue that is subject to its decision-making authority for a period in excess of [***] then the matter shall be referred to the JSC for decision. 

4.4.5Minutes and Reports. The Joint Development Committee will maintain accurate minutes of its meetings, including all proposed decisions and recommended actions or decisions taken. Promptly after each meeting, a member of the Joint Development Committee designated by the Joint Development Committee will provide the Parties with draft minutes of each meeting, the status of the Programs, any issues requiring decisions and any proposed decisions. Within [***] of each meeting, the Joint Development Committee chair will provide final versions of the meeting minutes and such minutes will be recognized as having been accepted by the Parties. 

4.4.6Duration. Except as otherwise agreed by mutual written consent of the Parties, the Joint Development Committee shall be in existence only for the Early Stage Program (including during any transition/wind-down period thereafter); provided, that if MTEM has exercised the Co-Development Option, the Joint Development Committee shall continue until the later of (a) the date on which all joint Development activities hereunder (including the transition of Development activities between the Parties) have ceased and (b) the end of the Co-Development Period.

Section 4.5Joint Manufacturing Committee. The Joint Manufacturing Committee shall form and operate as set forth under Section 5.4.

Section 4.6Joint Patent Committee. The Joint Patent Committee shall form and operate as set forth under Section 8.3.9.

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Section 4.7Joint Finance Working Group. The Joint Finance Working Group shall include one representative from each Party during the Co-Development Period. Its responsibilities shall be to:

4.7.1Formation and Composition. The Parties will establish a joint finance working group committee (the “Joint Finance Working Group”) composed of [***] appointed representative of each of Takeda and MTEM. A Party may at any time, by written notice to the other Party’s representative on the Joint Finance Working Group, change its representative on the Joint Finance Working Group, or elect to be represented by a delegate at a meeting of the Joint Finance Working Group. The Joint Finance Working Group, will be chaired by the Takeda representative. The Parties may allow additional employees to attend meetings of the Joint Finance Working Group, subject to the confidentiality provisions of Article VII.

4.7.2Functions and Authority. The Joint Finance Working Group will be responsible for only the following:

(a)facilitate the creation of budgets included in Program Plans and, including the annual updates thereto;

(b)reconcile financial and accounting matters between the Parties;

(c)initiate and execute an effective cost sharing process (cross-charges);

(d)cooperate to ensure that any such budget for a Calendar Year (or any other given period) can be interpreted for the purposes of both Parties’ internal financial and audit reporting requirements, including each Party’s fiscal year reporting as well as timely reporting of interim period costs incurred under any applicable Program Plan;

(e)monitor the budget and expense reporting requirements between the Parties related to Co-Development Costs to ensure that each Party is able to comply with its respective internal financial and audit reporting requirements and, as appropriate, recommending to the JSC for approval, changes to the reporting requirements under this Agreement; and

(f)undertake such other tasks with respect to the implementation and reporting for the Parties’ sharing of Co-Development Costs as the Parties mutually agree in writing.

4.7.3Decisions. It is not intended that the Joint Finance Working Group shall have decision-making authority but in the case of a dispute regarding any matter under the jurisdiction of the Joint Finance Working Group, either Party may escalate the matter to the JSC.

Section 4.8Quorum. For the JSC, a quorum is required for any meeting of the JSC, which quorum will exist if at least [***] representatives (or a delegate thereof) of each Party is present. For the Joint Development Committee, Joint Manufacturing Committee and Joint Patent Committee, a quorum is required for any meeting of such committee, which quorum will exist if at least [***] of each Party is present. If a quorum exists, then the unanimous consent of all attending members of such committee is required in order for any decision to be approved or action taken on behalf of such committee.

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Section 4.9Referral to the Joint Steering Committee. In the event that the Joint Manufacturing Committee, Joint Development Committee or the Joint Patent Committee, as the case may be, cannot agree on a matter that is subject to its decision-making authority for a period in excess of [***] then except as otherwise expressly provided herein, matter shall be referred to the Joint Steering Committee.

Article V
MANUFACTURING AND SUPPLY 

Section 5.1Responsibility for Manufacturing. Subject to oversight by the Joint Manufacturing Committee, as applicable, and subject to this Section 5.1, MTEM shall be primarily responsible for Manufacturing activities with respect to Development Material for a Licensed Product and Components thereof through completion of the first Phase I Clinical Trial for such Licensed Product. Notwithstanding the foregoing, Takeda shall, upon notice to MTEM at any time in Takeda’s sole discretion, have the right to assume, or allow its designee to assume, some or all of such Manufacturing activities as provided in Section 5.2 In addition to the support that MTEM shall provide to Takeda with respect to regulatory filings under Section 2.2.1, at any time and upon Takeda’s sole discretion and reasonable request, MTEM shall prepare manufacturing sections of regulatory filings when MTEM was responsible for the manufacturing activities covered by such filings. 

5.1.1Supply Agreement. Within [***] after the Effective Date (or such other period as agreed by the Parties), the Parties shall agree on a clinical supply agreement between the Parties pursuant to which MTEM would supply [***] as elected by Takeda, for the Phase I Program and (with MTEM’s written approval) thereafter until the completion of the Technology Transfer, which supply agreement shall also include as Co-Development Costs any mutually agreed Manufacturing process development and supply chain development activities for the applicable Licensed Product (or CD38 SLT-A Fusion Protein) beyond the activities conducted pursuant to the [***] with GMP and shall be provided for up to [***] (and if needed prior to the Technology Transfer, such additional quantities as are reasonably requested by Takeda and can be supplied by MTEM through Commercially Reasonable Efforts). If no Supply Agreement for the supply of [***] is in place within the time period specified above, then MTEM shall supply [***] on the terms set forth herein. If Takeda initiates the Technology Transfer from MTEM and no Supply Agreement for the supply of [***] is in place, MTEM shall have the right to complete (or have completed) the Manufacture of any work-in-process Licensed Products or Components thereof and all such costs shall be deemed Co-Development Costs. The Joint Manufacturing Committee shall propose to the Parties, from time to time, amendments to the Supply Agreement as needed to meet Manufacturing objectives, but for clarity, such amendments shall be effective only if and when the Parties duly execute such an amendment.

5.1.2Third Party Suppliers. Takeda acknowledges that MTEM may contract with one or more Third Parties to fulfill its obligations to Manufacture hereunder (each such Third Party, a “Contract Manufacturing Organization” or “CMO”) subject to the approval of such CMO by the Joint Manufacturing Committee pursuant to Section 5.4.2. The Parties hereby agree that each approved CMO is approved solely for performance of Manufacturing within the scope of the applicable CMO agreement as approved by the Joint Manufacturing Committee. Through the Joint Manufacturing Committee, MTEM will keep Takeda informed of all activities of its CMOs and material information related to the Manufacturing [***] as the case may be. With respect to [***] MTEM will provide Takeda with reasonable access to its CMOs, including 

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permitting and enabling Takeda to accompany MTEM in audits and inspections and using reasonable efforts to cause its CMOs to permit Takeda to conduct audits and inspections, as well as for regulatory purposes and technical transfer. The Parties will coordinate audits and inspections through the Joint Manufacturing Committee. MTEM will provide Takeda with each CMO agreement prior to execution for review and comment and to ensure terms are consistent with MTEM’s obligations hereunder and under the Supply Agreement. Comments received within [***] of receipt by Takeda will be given good faith consideration. MTEM will not materially change any agreement with an approved CMO as it relates to [***] including any change to the criteria agreed upon by the Parties through the Joint Manufacturing Committee to which [***] should conform to be considered acceptable for its intended use, except in accordance with the Quality Agreement and otherwise subject to agreement of the Joint Manufacturing Committee.

5.1.3Payment. Takeda shall purchase [***] (including [***] purchased under the Supply Agreement) from MTEM at [***] of the Supply Price, plus all shipping costs, including shipping insurance thereof, for all delivered conforming [***] (“Supply Payment”); provided, however, the Joint Manufacturing Committee, as applicable, shall timely agree upon a schedule for the Supply Payments in consideration for Manufacturing activities (whether conducted directly by MTEM or contracted by MTEM with a CMO pursuant to Section 5.1.2) that are anticipated to take longer than [***]. Such schedule shall take into account the agreed upon Manufacturing activities and milestones for such activities and will include a mechanism for truing up to actual costs, including refunds or credit for non-conforming [***] all in accordance with agreed upon terms set forth in the Supply Agreement. All Supply Payments shall be contingent upon receipt by Takeda of an invoice from MTEM in accordance with the agreed upon schedule and which references the applicable purchase order number. Supply Payments shall be made within [***] of receipt of each such invoice. For clarity, any amounts paid by Takeda under this Section 5.1.3 shall be included in Co-Development Costs, and an equivalent amount shall be deemed paid by MTEM and similarly included in Co-Development Costs.

Section 5.2Technology Transfer. Without limitation to MTEM’s obligations under Section 3.9, at Takeda’s request, for each Licensed Product, MTEM shall, at Takeda’s expense (subject to a mutually agreed reasonable budget with internal time to be calculated on an FTE basis based on a rate that reflects MTEM's actual costs for such FTE), transfer the Manufacturing process for such Licensed Product and any CD38 SLT-A Fusion Proteins and components thereof to Takeda or its designee (the “Technology Recipient”) as set forth in this Section 5.2, which transfer will comprise all necessary and available Know-How, documentation, methods, reagents, processes and other components to enable Takeda or its designee to independently Manufacture Licensed Products (such transfer, the “Technology Transfer”). 

5.2.1Within [***] after Takeda notifies MTEM that it is exercising Technology Transfer rights under this Section 5.2 with respect to a Licensed Product, MTEM shall deliver to the Technology Recipient copies of the then-current Manufacturing process for and any other information reasonably required in order to Manufacture such Licensed Product and the CD38 SLT-A Fusion Proteins and other Components contained therein, including master batch records and any other manufacturing records (collectively, the “Technology Transfer Documentation”). 

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5.2.2During such [***] and upon Takeda’s reasonable request with at least [***] notice to MTEM, MTEM shall also find a convenient time to permit representatives of the Technology Recipient or Takeda, as applicable, (the “Representatives”) to access the Facility during normal business hours to observe the Manufacturing of the Licensed Product and CD38 SLT-A Fusion Proteins included therein. While the Representatives are at the Facility, MTEM shall make available to the Representatives employees of MTEM (or its Affiliates or subcontractors) for consultation with respect to the Technology Transfer Documentation and the Manufacturing process for the Licensed Product and the CD38 SLT-A Fusion Proteins and components contained therein.

5.2.3At Takeda’s request, MTEM shall use commercially reasonable efforts to effect assignments of any existing contract to the extent relating to one or more of the Licensed Products or the CD38 SLT-A Fusion Proteins and components contained therein, or to obtain for Takeda substantially all of the practical benefit and burden under such agreement to the extent applicable to Licensed Product and the CD38 SLT-A Fusion Proteins and components contained therein, including by entering into appropriate and reasonable alternative arrangements on terms agreeable to Takeda. Unless otherwise agreed by the Parties, any agreement with any Contract Manufacturing Organization or other service provider entered into by MTEM on or after the Effective Date that relates to any Licensed Product and the CD38 SLT-A Fusion Proteins and components contained therein shall be assignable or otherwise transferable to Takeda without the consent of the counterparty thereto to the extent related to any Licensed Product and the CD38 SLT-A Fusion Proteins and components contained therein. 

5.2.4Following the completion of the Technology Transfer, MTEM shall, for a period of up to [***] thereafter, provide the Technology Recipient with reasonable access to MTEM’s employees for telephone or in person consultations regarding the Manufacture of the CD38 SLT-A Fusion Proteins and, if applicable, the Licensed Products. 

5.2.5Without limiting the foregoing, MTEM shall take, and shall cause its Affiliates and subcontractors to take, all action and to do all things necessary, proper or advisable to complete the Technology Transfer in accordance with this Section 5.2, including, as applicable, obtaining and making available such information, personnel, products, materials, services, facilities and other resources as reasonably necessary to enable the Technology Recipient to Manufacture the CD38 SLT-A Fusion Proteins and the Licensed Products.

5.2.6Takeda shall pay MTEM for its reasonable, out-of-pocket costs and expenses incurred in the performance of its activities under this Section 5.2 (in which case such amounts paid shall be included as Co-Development Costs), unless the Technology Transfer is a response by Takeda to a material breach by MTEM of its supply obligations hereunder that is not cured by MTEM pursuant to this Agreement, in which case MTEM shall bear all of its own expenses. 

Section 5.3Responsibility for Manufacturing After Technology Transfer. Following completion of the Technology Transfer for a given Licensed Product, including any required validation, but subject at all times to MTEM’s supply rights set forth in Section 5.1, Takeda or its designee shall have the sole right, at its cost, for Manufacturing activities with respect to Licensed Product and the CD38 SLT-A Fusion Proteins and Components contained therein; provided, that if Takeda will outsource such Manufacturing activities to a Third Party, Takeda will take into consideration MTEM’s capabilities to continue to supply CD38 SLT-A 

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Fusion Proteins or the 4019 Targeting Moiety to Takeda at the Supply Price for use in Clinical Trials pursuant to the Supply Agreement.

Section 5.4Joint Manufacturing Committee.

5.4.1Formation and Composition. Within [***] after the Effective Date, the Parties will establish a joint manufacturing committee (the “Joint Manufacturing Committee”) composed of [***] appointed representatives of each of Takeda and MTEM. A Party may change one or more of its representatives on the Joint Manufacturing Committee upon written notice to the other Party or elect to have one of its members represented by a delegate at a meeting of the Joint Manufacturing Committee. The Joint Manufacturing Committee will be chaired by a Takeda representative selected by Takeda from one of Takeda’s members of the Joint Manufacturing Committee. The Parties may allow additional employees to attend meetings of the Joint Manufacturing Committee subject to the confidentiality provisions of Article VII. 

5.4.2Functions and Authority. The Joint Manufacturing Committee shall be responsible for developing a plan for manufacturing process development and supply chain development, including CMO selection, including coordinating inspections of potential CMOs by both Parties, reviewing the progress of such plan, reviewing and serving as a forum for discussing and approving changes to such plan, any Supply Agreement or change in facility location, and such other matters as the Parties may mutually agree in writing. The Joint Manufacturing Committee will keep the Joint Steering Committee reasonably informed of the foregoing. 

5.4.3Decisions. Each Party shall have [***] on the Joint Manufacturing Committee. The Joint Manufacturing Committee shall seek to make all decisions by consensus. In the event that the Joint Manufacturing Committee is unable to reach unanimous agreement on any issue that is subject to its decision-making authority, such matter shall be referred to the Joint Steering Committee for resolution, except that in the case of a dispute at Joint Steering Committee, Takeda will have [***] decision making authority with respect to Manufacturing activities at the JSC level, subject to Section 5.3.

5.4.4Duration. Unless earlier terminated by mutual written consent of the Parties, the Joint Manufacturing Committee shall be in existence until the later of (a) completion of the [***] and (b) (i) completion of the [***] with respect to each Licensed Product that is intended to be clinically developed and (ii) [***] after filing of the last IND for such a Licensed Product has been filed (unless a clinical hold has been imposed with respect to such IND, in which case upon release of the clinical hold or termination of the clinical development of such Licensed Product).

Section 5.5Quality Agreement. Takeda and MTEM shall, in connection with entering into the Supply Agreement, or as otherwise determined by the Joint Manufacturing Committee, and in any event prior to the Manufacture of any CD38 SLT-A Fusion Protein or Licensed Product by MTEM, prepare and enter into a reasonable and customary quality assurance agreement that sets forth the terms and conditions upon which MTEM will conduct its quality activities in connection with this Agreement (the “Quality Agreement”). Each Party shall duly and punctually perform all of its obligations under the Quality Agreement.

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Article VI
PAYMENTS AND RECORDS

Section 6.1Upfront Fee. Takeda shall pay to MTEM an upfront fee of Thirty Million U.S. Dollars ($30,000,000) (“Upfront Fee”) within [***] after the Effective Date.  

Section 6.2Development Milestone Payments. Subject to the terms and conditions of this Agreement, including Section 6.5, Takeda shall pay to MTEM the following milestone payments within [***] after receipt of an invoice following the first occurrence of each event set forth below with respect to the first [***] to achieve such event, whether such events are achieved by Takeda, its Affiliates or Sublicensees, as follows:

				
	
Milestone Number
	
Milestone Event
	
Milestone Payments

(Only One Payment Due for each Milestone Number)

	
 
	
 
	
MTEM Does Not Exercise the Co-Development Option

(Column 1)
	
MTEM Exercises the Co-Development Option

(Column 2)

	
1
	
[***]
	
[***]
	
[***]

	
2
	
[***]
	
[***]
	
[***]

	
3
	
[***]
	
[***]
	
[***]

	
4
	
[***]
	
[***]
	
[***]

	
5
	
[***]
	
[***]
	
[***]

	
6
	
[***]
	
[***]
	
[***]

	
7
	
[***]
	
[***]
	
[***]

	
8
	
[***]
	
[***]
	
[***]

	
9
	
[***]
	
[***]
	
[***]

	
10
	
[***]
	
[***]
	
[***]

	
11
	
[***]
	
[***]
	
[***]

	
12
	
[***]
	
[***]
	
[***]

	
13
	
[***]
	
[***]
	
[***]

	
14
	
[***]
	
[***]
	
[***]

	
15
	
[***]
	
[***]
	
[***]

	
16
	
[***]
	
[***]
	
[***]

 

Each milestone payment in this Section 6.2 is due only once and shall be payable only upon the first achievement of such milestone event (regardless of the number of [***]. Column 2 

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shall apply only if MTEM has exercised the Co-Development Option and the milestone event occurs during the Co-Development Period.  

In the event that Column 2 applies, but MTEM has not paid its share of the Co-Development Costs in full prior to the date the milestone payment would be due, then Takeda shall pay the amount in Column 1 (if any) and then once such Co-Development Costs have been paid to Takeda, then Takeda shall pay the difference between the amount in Column 2 and Column 1 for the applicable milestone, such that Takeda has paid the total amount due to MTEM for the achievement of the applicable milestone. No amounts shall be due under this Section 6.2 for subsequent or repeated achievements of any such milestone event. For clarity, the maximum aggregate amount of milestone payments payable by Takeda pursuant to Column 2 above is Three Hundred Seven Million Five Hundred Thousand U.S. Dollars ($307,500,000). If MTEM does not exercise the Co-Development Option, the possible aggregate amount of milestone payments payable by Takeda pursuant to Column 1 above is One Hundred Sixty Two Million Five Hundred Thousand U.S. Dollars ($162,500,000).  

If a [***] is considered [***] then following [***] then [***] above, as applicable, would be payable upon [***] based on such [***] (if such milestone has not been previously paid). For purposes of clarity, payment of [***] above will not preclude a future payment of [***] above.

Section 6.3Sales Milestone Payments. Subject to the terms and conditions of this Agreement, including Section 6.5, Takeda shall pay to MTEM the following sales milestone payments within [***] after the end of the first Calendar Year in which the aggregate annual Net Sales of all Licensed Products in such Calendar Year reach the following thresholds for the first time:

			
	
Milestone for Aggregate Net Sales for a Calendar Year (“Aggregate Net Sales”)
	
Milestone Payments (Only One Payment Due for each Milestone Number)

	
 
	
MTEM Does Not Exercise the Co-Development Option

(Column 1)
	
MTEM Exercises the Co-Development Option

(Column 2)

	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]

 

Each sales milestone payment is separate and may only be earned once for the aggregate of all Licensed Products, however, if more than one Net Sales threshold is reached in the same Calendar Year, [***] shall be payable during such Calendar Year and [***] shall be payable on the [***] of the following Calendar Year. Column 2 shall apply only in the case in which MTEM has exercised the Co-Development Option and the milestone is achieved with respect to a Calendar Year prior to the Calendar Year in which the Co-Development Period ended. In the 

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event that Column 2 applies, but MTEM has not paid its share of the Co-Development Costs in full prior to the date the milestone payment would be due, then Takeda shall pay the amount in Column 1 (if any) and then once such Co-Development Costs have been paid to Takeda, then Takeda shall pay the difference between the amount in Column 2 and Column 1 for the applicable milestone, such that Takeda has paid the total amount due to MTEM for the achievement of the applicable milestone.

Section 6.4Royalties Payable by Takeda.

6.4.1In consideration for the Exclusive Licenses granted to Takeda herein, and subject to the terms and conditions of this Agreement, including Section 6.5, during the Royalty Term, or in the case in which MTEM exercised its Co-Development Option and the Co-Development Period remains in effect, the Co-Development Royalty Term for a Licensed Product, Takeda shall pay to MTEM royalties on the annual aggregate Net Sales of all Licensed Products sold during the Royalty Term or, if it applies per above in this Section 6.4.1, the Co-Development Royalty Term, for such Licensed Product in the applicable country, which royalties shall be paid at the following rates as set forth below:

			
	
Annual Aggregate Net Sales for all Licensed Products
	
Royalty Rate in the case of No Exercise of Co-Development Option

(Column 1)
	
Royalty Rate in the case of Co-Development

(Column 2)

	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]

	
[***]
	
[***]
	
[***]

 

For avoidance of doubt, the incremental royalty rates set forth above shall only apply to that portion of the Net Sales of royalty-bearing Licensed Products that falls within the indicated range of sales. By way of example, and not in limitation of the foregoing, if, in the case in which the Royalty Term, rather than the Co-Development Royalty Term, applies during a Calendar Year, Net Sales of the Licensed Products, in the aggregate, were equal to [***] and MTEM has not exercised the Co-Development Option, the royalty payable by Takeda would be calculated by adding (i) the royalty due on such Net Sales with respect to the [***] at the first level percentage of [***] (under Column 1), and (ii) the royalty due on Net Sales for the Licensed Products with respect to the next [***] at the second level percentage of [***] (under Column 1). The obligation to pay royalties shall be imposed only once with respect to the same unit of Licensed Product sold by Takeda, its Affiliate or Sublicensee. Takeda shall have no obligation to pay any royalty with respect to Net Sales of any Licensed Product in any country after the Royalty Term or Co-Development Royalty Term, whichever is applicable, for such Licensed Product in such country is not in effect. 

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In the event that Column 2 applies, but MTEM has not paid its share of the Co-Development Costs in full prior to the date any royalty payment would be due, then Takeda shall pay royalties based on the rate in Column 1 (if any) and then once such Co-Development Costs have been paid to Takeda, then Takeda shall pay the difference between such royalties calculated based on Column 1 and the royalties that would have been calculated on the applicable Net Sales based on Column 2, such that Takeda has paid the total royalties due to MTEM. 

6.4.2Royalty Reductions. 

(a)If and for so long as there is a Biosimilar Product being sold by a Third Party in a Calendar Quarter in a country in the Territory, then the royalties otherwise payable by Takeda to MTEM in such country pursuant to Section 6.4.1 shall be reduced by the percent set forth below of the amounts otherwise owed:

		
	
Biosimilar Products unit volume sales for each Licensed Product in such country, as a percentage of total sales of Licensed Products, on the one hand, and Biosimilar Products, on the other hand, in such country
	
Reduction Rate

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

 

The Parties will select a mutually agreeable independent Third Party to identify and calculate the Biosimilar Products unit volume sales for each Licensed Product in a Calendar Quarter in a country in the Territory and such unit volume sales amounts shall be included in each royalty report provided for under Section 6.11. In the event that such independent Third Party is not available or otherwise able to accurately determine or calculate the Biosimilar Product unit volume sales, Takeda shall calculate the Biosimilar Product unit volume sales based on available data in good faith. In the event MTEM disputes in good faith Takeda’s calculation of any Biosimilar Product unit volume sales for a Licensed Product in a country in the Territory, MTEM may by written notice to Takeda require, at MTEM’s cost, that such dispute be resolved in accordance with Section 12.3 by and submitted to a panel of experts; provided, that Takeda shall have the right to recover royalty reductions pursuant to this Section 6.4.2(a) if it prevails after resolution of any such dispute, by offsetting the excess payments with 

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future royalty payments owed to MTEM or obtaining a refund from MTEM, as elected by Takeda.

(b)Subject to the last sentence of Section 6.4.1 and if applicable, Section 6.4.2(f), from and after the date on which a Licensed Product is sold in a country and is not at the time of sale covered by at least one Valid Patent Claim(s) of the MTEM Background Patent Rights, Patent Rights in the Joint Background IP, the Product Program Patent Rights, the MTEM Program Patent Rights, or the Takeda Program Patent Rights (including Takeda Targeting Moiety Patent Rights unless MTEM does not exercise the Co-Development Option or, if exercised, unless MTEM opts out of Co-Development for the applicable Licensed Product but otherwise excluding the Takeda Targeting Moiety Patent Rights) in the country in which such Licensed Product is sold and, if the Co-Development Royalty Term applies to such country, any regulatory exclusivity has expired in the country where such Licensed Product is sold, (i) the royalty rate that would otherwise apply with respect to such country shall each be reduced by (A) [***] in the case in which the Co-Development Royalty Term applies or (B) [***] if the Royalty Term applies, provided (ii) the royalty rate reduction in clause (i) shall no longer apply if thereafter a Valid Patent Claim within the Patent Rights specified above in this clause (b) becomes issued or granted in such country during the Royalty Term or the Co-Development Royalty Term, as the case may be.  

(c)Takeda shall have the right to deduct costs and expenses in accordance with Section 8.7.2, to the extent not otherwise deducted under this Section 6.4.2.

(d)If in the reasonable opinion of Takeda, the Development, Manufacture, Commercialization or other Exploitation of a Licensed Product hereunder infringes or misappropriates or is reasonably expected to infringe or misappropriate any Patent Right, trade secret or other intellectual property right of a Third Party in any country or jurisdiction in the Territory, then Takeda shall have the right, but not the obligation, upon consultation with MTEM, to negotiate and obtain a license to or other rights from such Third Party to such rights as necessary to Develop, Manufacture, Commercialize or otherwise Exploit such Licensed Product in such country or jurisdiction. In the event that Takeda negotiates and obtains any such license from a Third Party, Takeda shall be entitled to deduct [***] of the amounts payable to such Third Party with respect to such Licensed Product from the royalties payable to MTEM hereunder for such Licensed Product in accordance with, and to the extent provided herein. If and for so long as Takeda makes payments to any Third Party under the Existing Third Party Agreement, Takeda may reduce the royalty payments otherwise due as set forth in Section 6.4 by up to [***] of the amount paid to the Third Party but this reduction shall not exceed [***] of Net Sales for the given period. In addition, the reductions under this clause (d), shall not, in the aggregate, reduce the royalty rate by more than [***] of the royalty rate that would otherwise apply to such Licensed Products. Takeda may carry forward, and deduct from future royalty payments due hereunder, any amounts which cannot be deducted under this clause (d) due to such [***] floor.  

(e)If MTEM has or does receive research funding from a Third Party and in exchange is required to pay royalties or other amounts to such Third Party or its designee in consideration therefor, then MTEM shall be [***] responsible for [***]. For clarity, if and for so long as the Parties agree that Takeda should assume the duty to make payments to any Third Party under this clause (e), such payments shall be fully deducted from the amount payable to MTEM under Section 6.4.1.

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(f)Any reductions set forth in this Section 6.4.2 shall be applied, on a Licensed Product-by-Licensed Product and country-by-country basis, to the royalty rate payable to MTEM under Section 6.4.1 in the order in which they are stated ((a), (b), (c), (d) and (e)) and if there is more than one reduction, then the reductions shall be cumulative. Notwithstanding anything to the contrary herein, except in the case in which the Co-Development Royalty Term applies for a Licensed Product in the Territory, the royalties payable to MTEM hereunder for such Licensed Product in such country for any Calendar Quarter shall not be reduced pursuant to clauses ((a) through (d)), collectively, to less than [***] of the amounts otherwise payable pursuant to Section 6.4.1 (prior to application of clauses (a) through (d)) by virtue of the application of the reductions (in (a) through (d)); provided, however, that Takeda may carry over, and deduct from royalties due in any subsequent Calendar Quarter(s), amounts paid to Third Parties pursuant to Section 6.4.2(c) or 6.4.2(d) if Takeda is unable to fully take such deduction as a result of the application of such floor for the given Calendar Quarter. For clarity, there is no floor under this clause (f) on the reduction of royalties payable for Licensed Products in the case in which the Co-Development Royalty Term applies (but the floors set forth in Section 6.4.2(d) shall apply).  

(g)MTEM acknowledges and agrees that the sales levels set forth in this Section 6.2 and Section 6.3 shall not be construed as representing an estimate or projection of anticipated sales of the Licensed Products or implying any level of diligence or Commercially Reasonable Efforts in the Territory and that the sales levels set forth in Section 6.2 and Section 6.4 are merely intended to define Takeda’s royalty and other payment obligations, as applicable, in the event such sales levels are achieved and that the sales levels set forth in Section 6.2 and Section 6.4 are merely intended illustrative purposes only. 

Section 6.5Co-Development Cost Sharing. The Parties shall share Co-Development Costs as follows:  

6.5.1Early Stage Program. MTEM and Takeda shall [***] of the Co-Development Costs with respect to the Early Stage Program (whether incurred by MTEM or Takeda or their respective Affiliates, licensees, or Sublicensees), and including any costs incurred by Takeda under the IPA and markups in the Supply Price, subject to Section 2.1.2(b) and Article IV. 

6.5.2Post Phase Ia Program. Subject to Section 6.5.3, if MTEM has exercised the Co-Development Option in accordance with Section 2.1.2(b), MTEM and Takeda shall [***] of the Co-Development Costs with respect to the Post Phase Ia Program (whether incurred by MTEM or Takeda or their respective Affiliates, licensees, or Sublicensees), subject to Section 2.1.2(b) and Article IV, until, in the case of the delivery of a notice (the “Co-Development Termination Notice”) pursuant to the next sentence, the effective date of the termination of MTEM's Co-Development Option. If, at any point after MTEM’s exercise of the Co-Development Option, MTEM elects to end its Co-Development hereunder, it may do so by providing Takeda with [***] prior written notice (the “Co-Development Termination Notice Period”). MTEM shall continue to be responsible for [***] of the Co-Development Costs incurred prior to the end of the Co-Development Termination Notice Period, in accordance with Section 6.5.2. MTEM shall not be obligated pay for any Co-Development Costs incurred after the end of the Co-Development Termination Notice Period. Effective as of the end of Co-Development Termination Notice Period, Takeda’s milestone obligations under this Article VI shall be reduced to the lower amounts in Column 1 of each applicable table (as if MTEM had not 

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exercised its Co-Development Option), and Takeda shall continue to be obligated to pay royalties at the higher rate set forth in Column 2 of the table in Section 6.4 until the amount of royalties paid to MTEM by Takeda equals, in the aggregate, the MTEM Co-Development Cost Amount (the “Transition Point”), after which, Takeda shall pay royalties at the lower rate set forth in Column 1 of the table in Section 6.4. 

6.5.3Without limiting Takeda's rights to defer payment of a portion of Column 2 milestones and royalties in the event that MTEM has not paid to Takeda its Co-Development Costs it owes as set forth above in this Article VI or Takeda's rights to adjust milestones and royalties as set forth in Section 6.5.2, then in the case of any delay in payment of MTEM’s Co-Development Costs (other than those disputed in good faith by MTEM in writing) for more than [***] then Takeda may elect to terminate the Co-Development Period by written notice to MTEM and the Co-Development Period shall terminate if MTEM has not made such payment within [***] after receipt of such notice, such termination of the Co-Development Period effective at the end of such cure period. Upon effectiveness of such termination, Takeda’s obligation to pay the higher milestone amounts and royalty rates (set forth in the applicable Column 2 of each table in this Article VI) shall cease, and Takeda shall thereafter be obligated to pay the lower (Column 1) amounts and rates.  

6.5.4Reporting and Payment Mechanics. Unless otherwise decided by the Joint Finance Working Group, for any period of Co-Development, until the end of the Co-Development Period, the Parties shall exchange an estimate of their respective Co-Development Costs for each Calendar Quarter within the last week of the Calendar Quarter and shall provide each other with a forecast of its anticipated Co-Development Costs for the upcoming Calendar Quarter. For each Calendar Quarter, the Parties will report to one another their respective Co-Development Costs within [***] of the end of each Calendar Quarter and will then reconcile the Co-Development Costs so each Party shares its portion of the total Co-Development Costs. The reporting will include a summary of internal costs (based on the FTE Rate) and external costs included within the Co-Development Costs, in the same format as the Early Stage Development Budget. The applicable Party shall issue a corresponding invoice by the [***] of each Calendar Quarter for the prior Calendar Quarter and any payment shall be due in [***] from receipt of such invoice.

6.5.5Disputes. Any dispute as to whether certain costs qualify as Co-Development Costs shall be resolved pursuant to the JSC or Section 12.3.  

6.5.6No Double Counting. In no circumstances shall Development Costs incurred by a Party’s Affiliate, licensee or Sublicensee be double counted as Co-Development Costs, and in no circumstances shall any mark-ups among such Party and its applicable Affiliates, licensees or Sublicensees be included as a Co-Development Cost. 

Section 6.6Royalty Payment Terms. Royalties shown to have accrued by each Royalty Report provided for under this Article VI shall be due on the date such Royalty Report is due pursuant to Section 6.11.2. 

Section 6.7Payment Method. All payments by Takeda to MTEM, or payments by MTEM to Takeda in the case of Co-Development, under this Agreement, shall be paid in U.S. Dollars, and all such payments shall be made by bank wire transfer in immediately available funds to the bank account designated by MTEM in writing; provided, that such account 

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information is provided to Takeda at least [***] prior to any such payment becoming due hereunder.

Section 6.8Late Payments. If a Party does not receive payment of any sum due to it on or before the due date therefor, simple interest shall thereafter accrue on the sum due to such Party from the due date until the date of payment at a per-annum rate of [***] over the then-current LIBOR prime rate reported in The Wall Street Journal or the maximum rate allowable by Applicable Law, whichever is lower. 

Section 6.9Exchange Control. If at any time legal restrictions prevent the prompt remittance of part or all royalties with respect to any country in the Territory where any Licensed Product is sold, payment shall be made through such lawful means or method as the Parties reasonably shall determine.

Section 6.10Taxes; Withholding Taxes. The amounts payable pursuant to this Agreement (“Payments”) shall not be reduced on account of any Taxes unless required by Applicable Law. Takeda shall deduct and withhold from the Payments any Taxes that it is required by Applicable Law to deduct or withhold. Notwithstanding the foregoing, if MTEM is entitled under any applicable tax treaty to a reduction of rate of, or the elimination of, or recovery of, applicable withholding tax, it may deliver to Takeda or the appropriate governmental authority the prescribed forms necessary to reduce the applicable rate of withholding or to relieve Takeda of its obligation to withhold tax. In such case Takeda shall apply the reduced rate of withholding, or not withhold, as the case may be, provided that Takeda is in receipt of evidence, in a form reasonably satisfactory to Takeda, for example MTEM’s delivery of all applicable documentation at least [***] prior to the time that the Payments are due. If, in accordance with the foregoing, Takeda withholds any amount, it shall pay to MTEM the balance when due, make timely payment to the proper taxing authority of the withheld amount, and send MTEM proof of such payment within [***] following that payment.

MTEM shall cooperate with Takeda (at Takeda’s expense) in seeking any tax exemption or credits that may be available to Takeda with respect to the Licensed Products or any CD38 SLT-A Fusion Proteins, including the tax credit available under section 45C of the Internal Revenue Code by reason of Takeda’s research and development expenditures contributing to any Licensed Product being granted orphan drug status by the FDA. 

Section 6.11Royalty Reports; Exchange Rates.

6.11.1For so long as any Royalty Term or Co-Development Royalty Term, as applicable, remains in effect, Takeda shall, with respect to each Calendar Quarter (or portion thereof), provide a written report showing, on a consolidated aggregated basis in reasonable detail (a) the Net Sales of Licensed Products sold by Takeda, its Affiliates and its Sublicensees in the Territory during the corresponding Calendar Quarter on which royalties are due (b) the royalties payable in U.S. Dollars, if any, which shall have accrued hereunder based upon such Net Sales of Licensed Products, (c) the withholding taxes, if any, required by law to be deducted in respect of such royalties, (d) the dates of the First Commercial Sale of each Licensed Product in each country in the Territory for which royalties are due hereunder, if it has occurred during the corresponding Calendar Quarter, and (e) the exchange rates (as determined pursuant to Section 6.11.3 herein) used in determining the royalty amount expressed in U.S. Dollars (each, a “Royalty Report”). 

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6.11.2Royalty Reports shall be due within [***] following the end of the Calendar Quarter to which such Royalty Report relates. Takeda shall keep complete and accurate records in sufficient detail to properly reflect all Net Sales and to enable the royalties payable hereunder to be determined. For clarity, “sufficient detail” shall not require Takeda to keep any records thereof beyond records that it maintains in the ordinary course and shall not be required to divulge the proprietary information of any Third Party. 

6.11.3With respect to sales of Licensed Products invoiced in U.S. Dollars, Net Sales and royalties payable shall be expressed in U.S. Dollars. With respect to sales of Licensed Products invoiced in a currency other than U.S. Dollars, Net Sales and royalties payable shall be expressed in the currency of the invoice issued by the Party making the sale together with the U.S. Dollars equivalent of the royalty due, calculated using the average quarter-end rate of exchange for a given Calendar Quarter published in the East Coast Edition of the Wall Street Journal during the applicable Calendar Quarter. 

Section 6.12Audits.

6.12.1Upon the written request of a Party and with at least [***] prior written notice, but not [***] the other Party shall permit an independent certified public accounting firm of internationally recognized standing, selected by such first Party and reasonably acceptable to such other Party, at such first Party’s sole cost and expense (except as set forth in this Section 6.12), to have access during normal business hours to such of the records of such other Party as required to be maintained under this Agreement to verify: (a) the accuracy of the Royalty Reports due hereunder, in the case of MTEM, (b) the accuracy of the Supply Price, in the case of Takeda, or (c) during the period the Parties are sharing Development Costs pursuant to Section 6.5, the accuracy of and support for the Development Costs claimed by the other Party. Such accountants may audit records relating to Royalty Reports, the Supply Price or Development Costs, as applicable, made for any year ending not more than [***] prior to the date of such request. The accounting firm shall disclose to the Party requesting such audit its findings as to whether the Royalty Reports, the Supply Price or the Development Costs, as applicable, were correct or not, together with the specific details concerning any discrepancies, and such information shall be shared at the same time with the other Party. No other information obtained by such accountants shall be shared with the Party requesting such audit.

6.12.2If such accounting firm concludes that any royalties were owed but not paid to MTEM, Takeda shall pay the additional royalties within [***] following the date MTEM delivers to Takeda such accounting firm’s written report so concluding, together with the interest payment required by Section 6.8. If such accounting firm concludes that the Supply Price charged by MTEM was inconsistent with the definition therefor and such inconsistency resulted in an overpayment by Takeda hereunder, MTEM shall reimburse Takeda such overpayment within [***] following the date Takeda delivers to MTEM such accounting firm’s written report so concluding, together with the interest payment required by Section 6.8. The fees charged by such accounting firm shall be paid by the Party requesting such audit; provided, that if the audit discloses that (a) the royalties payable by Takeda for the audited period are more than [***] of the royalties actually paid for such period, then Takeda shall pay the reasonable fees and expenses charged by such accounting firm, (b) the Supply Price payable by Takeda for the audited period is less than [***] of the Supply Price actually paid for such period, then MTEM shall pay the reasonable fees and expenses charged by such accounting firm, or (c) if, during the period Development Costs are being shared by the Parties pursuant to Section 6.5, the share of 

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the other Party’s Development Costs payable by such Party pursuant to Section 6.5 is less than [***] of the amounts actual paid by such Party for such Development Costs, then the audited Party shall pay the reasonable fees and expenses charged by such accounting firm. If such accounting firm concludes that the royalties paid were more than what was owed during such period, MTEM shall refund the overpayments within [***] following the date MTEM receives such accounting firm’s written report so concluding.

Section 6.13Confidential Financial Information. The Parties shall treat all financial information subject to review under this Article VI or under any sublicense agreement as Confidential Information of such Party as set forth in Article VII, and shall cause its accounting firm to retain all such financial information in confidence under terms substantially similar to those set forth in Article VII and with respect to each inspection, the independent accounting firm shall be obliged to execute for each Party’s benefit a reasonable confidentiality agreement prior to commencing any such inspection.

Article VII
CONFIDENTIALITY

Section 7.1Non-Disclosure Obligations. Except as otherwise provided in this Article VII during the Term and for a period of [***] thereafter, each Party and their respective Affiliates shall maintain in confidence, and use only for purposes as expressly authorized and contemplated by this Agreement, all Confidential Information. “Confidential Information” means all confidential or proprietary information (including information relating to such Party’s research programs, development, marketing and other business practices and finances), data, documents or other materials supplied by the other Party or their respective Affiliates under this Agreement, including such information that is marked or otherwise identified as “Confidential”; provided that, notwithstanding anything to the contrary, Confidential Information constituting [***] or relating exclusively to one or more [***] or [***] (“Product Information”) shall be considered the Confidential Information of both MTEM and Takeda (except for any [***] which shall in all cases constitute the Confidential Information of Takeda only (and MTEM shall be considered the receiving Party with respect thereto regardless of which Party generated such [***])) and the terms of this Agreement shall be Confidential Information of both Parties (and both Parties shall be deemed the receiving Party with respect thereto). Without limiting the foregoing, each Party shall use at least the same standard of care as it uses to protect its own Confidential Information to ensure that its and its Affiliates’ employees, agents, consultants, clinical investigators and any sublicensees or subcontractors only make use of the other Party’s Confidential Information for purposes as expressly authorized and contemplated by this Agreement and do not disclose or make any unauthorized use of such Confidential Information. 

Section 7.2Permitted Disclosures. 

7.2.1Notwithstanding the foregoing, but subject to the last sentence of this Section 7.2, the provisions of Section 7.1 shall not apply to information, documents or materials that the receiving Party can conclusively establish:

(a)have become published or otherwise entered the public domain or become generally available to the public other than by breach of this Agreement by the receiving Party or its Affiliates;

(b)are permitted to be disclosed by prior consent of the other Party;

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(c)have become known to the receiving Party by a Third Party, provided such Confidential Information was not obtained by such Third Party directly or indirectly from the disclosing Party on a confidential basis;

(d)prior to disclosure under this Agreement or the Multi-Target Agreement, was already in the possession of the receiving Party, its Affiliates or Sublicensees; or

(e)have been independently developed by or for the receiving Party without reference to the disclosing Party’s Confidential Information (hereunder or under the Multi-Target Agreement, as defined therein);

provided that the exceptions described in clauses (d) and (e) of this Section 7.2.1 shall not apply with respect to Confidential Information constituting (i) in the case of MTEM as the disclosing Party, MTEM Program Know-How that was conceived, discovered, developed or otherwise made by Takeda, (ii) in the case of Takeda as the disclosing Party, Takeda Program Know-How conceived, discovered, developed or otherwise made by MTEM, (iii) Know-How included in the Joint Background IP, (iv) Product Program Know-How or (v) Product Information.

7.2.2Each Party may also disclose Confidential Information as set forth below in this Section 7.2.2. Notwithstanding the disclosures permitted under Section 7.2.2, any Confidential Information so disclosed shall remain subject to the confidentiality obligations of Section 7.1, unless and until any exceptions described in Section 7.2.1 shall apply. Either Party may disclose Confidential Information to the extent such disclosure is made:

(a)in response to a valid order of a court of competent jurisdiction or other Governmental Authority or Regulatory Authority or, if in the reasonable opinion of the receiving Party’s legal counsel, such disclosure is otherwise required by Applicable Law, including by reason of filing with securities regulators (including the rules and regulations of any stock exchange or trading market on which the disclosing Party’s (or its parent’s) securities are traded); provided, that the receiving Party shall first have given notice to the disclosing Party and given the disclosing Party a reasonable opportunity to quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order or requirement be held in confidence by such court or agency or, if disclosed, be used only for the purposes for which the order was issued; provided, further, that the Confidential Information disclosed in response to such court or governmental order or Applicable Law shall be limited to that information which is legally required to be disclosed in response to such court or governmental order or Applicable Law (including the rules and regulations of any stock exchange or trading market on which the disclosing Party’s (or its parent’s) securities are traded);

(b)in the case of the Party controlling prosecution of the applicable Program Patent Rights, solely to the extent reasonably necessary to include in a patent application claiming Program Patent Rights; provided, that the Party filing the patent application shall provide at least [***] prior written notice of such disclosure to the other Party, reasonably consider the other Party’s comments in good faith and take reasonable and lawful actions to avoid or minimize the degree of disclosure;

(c)by Takeda, to a Regulatory Authority, as reasonably required or useful in connection with any filing, submission or communication with respect to any CD38 

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SLT-A Fusion Protein or Licensed Product; provided, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available; 

(d)to a Sublicensee or Distributor as permitted hereunder; provided, that such Sublicensee or Distributor is then subject to obligations of confidentiality and limitations on use of such Confidential Information substantially similar to those contained herein and Takeda otherwise complies with Section 3.4;

(e)by Takeda, its Affiliates or its or their Sublicensees (or “Sublicensee” as defined in the Multi-Target Agreement) to an actual or potential Third Party Manufacturing, Development or Commercialization collaborator, Distributor, contractor or partner with respect to any Licensed Product or any CD38 SLT-A Fusion Protein contained therein or any Component thereof or otherwise as may be necessary or useful in connection with its exercise of rights or performance of obligations hereunder (including in connection with any litigation with respect thereto) or under the Multi-Target Agreement; provided, that such Third Party recipient is, if practicable, then subject to obligations of confidentiality and limitations on use of such Confidential Information substantially similar to those contained herein; 

(f)by Takeda or to an actual or potential investor in or acquirer of the business to which this Agreement or the Multi-Target Agreement relates; provided, that (i) such Third Party recipient is then subject to obligations of confidentiality and limitations on use of such Confidential Information substantially similar to those contained herein and (ii) Takeda shall provide at least [***] prior notice of (including a copy of) any such proposed disclosure to MTEM and shall not make any such disclosure without first obtaining MTEM’s prior written consent (which consent shall not be unreasonably withheld, conditioned or delayed) with respect thereto in each instance (it being understood that if consent with respect to a specific disclosure is given by MTEM with respect to a particular type of audience of Third Parties (e.g., investors not affiliated with a pharmaceutical company), Takeda may subsequently make such specific disclosure to another member of such audience consistent with such consent without obtaining specific consent from MTEM in such instance); and 

(g)by MTEM to actual or potential strategic partners, investors or acquirers; provided, that such disclosures shall be limited to the terms of this Agreement and pre-clinical data and pre-clinical results arising out of the Early Stage Program and shall be limited disclosures that do not divulge or otherwise make available the identity of any CD38 SLT-A Fusion Protein or the targeting moiety contained therein; provided, further, that (i) such Third Party recipient is then subject to obligations of confidentiality and limitations on use of such Confidential Information substantially similar to those contained herein, and (ii) MTEM shall provide at least [***] prior notice of (including a copy of) any such proposed disclosure to Takeda and shall not make any such disclosure without first obtaining Takeda’s prior written consent (which consent shall not be unreasonably withheld, conditioned or delayed) with respect thereto in each instance (it being understood that if consent with respect to a specific disclosure is given by Takeda with respect to a particular type of audience of Third Parties (e.g., investors not affiliated with a pharmaceutical company), MTEM may subsequently make such specific disclosure to another member of such audience consistent with such consent without obtaining specific consent from Takeda in such instance).

7.2.3Press Releases and Other Disclosures to Third Parties. Neither MTEM (or its Affiliates) nor Takeda (or its Affiliates) will, without the prior consent of the 

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other, issue any press release or make any other public announcement or furnish any statement to any Person (other than either Parties’ respective Affiliates) concerning the existence of this Agreement, its terms and the transactions contemplated hereby, except for (a) the initial press release, which will be mutually agreed upon by the Parties as soon as practicable following the Effective Date, (b) disclosures made in compliance with Section 7.1, Section 7.2 and Section 7.3, (c) disclosures made to attorneys, consultants, and accountants retained to represent the Parties in connection with the negotiation and consummation of the transactions contemplated hereby, and (d) press releases by Takeda, in its sole discretion, regarding Takeda’s activities under this Agreement with respect to a Licensed Product. In addition, if so required, first approval by a Party of the contents of a press release or public disclosure shall constitute permission of a Party to use such same contents subsequently, without submission of the press release or public disclosure to a Party for approval.

Section 7.3Use of Name. Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo or trademark of the other Party or any of its Affiliates or any of its or their Sublicensees (or any abbreviation or adaptation thereof) (including any Product Trademark) in any publication, press release, marketing and promotional material or other form of publicity without the prior written consent of such other Party. The restrictions imposed by this Section 7.3 shall not prohibit (a) Takeda from making any disclosure identifying MTEM to the extent required in connection with its exercise of its rights or obligations under this Agreement or the Multi-Target Agreement or (b) either Party from making any disclosure identifying the other Party that is required by Applicable Law or the rules of a stock exchange on which the securities of the disclosing Party are listed (or to which an application for listing has been submitted).

Section 7.4Publications Neither Party may publish, present or announce results, either orally or in writing (a “Publication”), of (a) the Early Stage Program without written consent of the other Party or (b) the Post Phase Ia Program without complying with the provisions of this Section 7.4; provided that, without limiting what is below, MTEM shall not make any such Publication without Takeda’s prior written consent. A Party wishing to make such a Publication will provide the other Party with a copy of the proposed Publication The other Party shall have [***] from receipt of such a proposed Publication to provide comments or proposed changes to the publishing Party. The publishing Party shall (i) in the case of Publications of results of the Early Stage Program, take into account the comments or proposed changes made by the other Party on any Publication, shall provide a final review of the Publication and shall agree to designate employees or others acting on behalf of the other Party as co-authors on any Publication describing results to which such persons have contributed in accordance with standards applicable to authorship of scientific publications, or (ii) in the case of Publications of results from the Post Phase Ia Program, consider the comments or proposed changes made by the other Party. If the other Party reasonably determines that the Publication would entail the public disclosure of such Party’s Confidential Information or of a patentable invention upon which a patent application should be filed prior to any such disclosure, submission of the concerned Publication to Third Parties shall be delayed for such period as may be reasonably necessary for deleting any such Confidential Information of the other Party (if the other Party has requested deletion thereof from the proposed Publication), or the drafting and filing of a patent application claiming such invention, provided such additional period shall not exceed [***] from the date the publishing Party first provided the proposed Publication to the other Party. Notwithstanding anything to the contrary in the foregoing, with respect to any Publications by investigators or other Third Party collaborators of Takeda, such materials shall 

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be subject to review under this Section 7.4 only to the extent that Takeda has the right and ability (after using commercially reasonable efforts) to do so.

Section 7.5Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, with respect to Confidential Information to which such non-requesting Party does not retain rights under the surviving provisions of this Agreement or under the Multi-Target Agreement, each Party shall, upon and in accordance with the other Party’s request in writing, either: (a) promptly destroy all copies of such Confidential Information in the possession or control of the non-requesting Party and confirm such destruction in writing to the requesting Party; or (b) promptly deliver to the requesting Party, at the non-requesting Party’s sole cost and expense, all copies of such Confidential Information in the possession or control of the non-requesting Party. Notwithstanding the foregoing, the non-requesting Party shall be permitted to retain such Confidential Information (i) to the extent necessary or useful for purposes of performing any continuing obligations or exercising any ongoing rights hereunder and, in any event, a single copy of such Confidential Information for archival purposes and (ii) any computer records or files containing such Confidential Information that have been created solely by such non-requesting Party’s automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such non-requesting Party’s standard archiving and back-up procedures, but not for any other uses or purposes. All Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in Section 7.1. In addition, in the case of any expiration or termination of this Agreement, MTEM shall promptly deliver to Takeda at Takeda’s sole cost and expense any and all materials within the Takeda Program IP, including any master cell banks, working cell banks and fusion proteins that contain or encode any targeting moiety within the Takeda Program Know-How or Takeda Background Know-How. 

Article VIII
INTELLECTUAL PROPERTY OWNERSHIP

Section 8.1Disclosure of Inventions. Each Party shall promptly disclose to the other Party any Program IP (except that Takeda shall have no obligation to disclose any Takeda Targeting Moiety IP to MTEM).

Section 8.2Intellectual Property. 

8.2.1Background IP. As between the Parties, subject to the licenses and rights of reference granted in Article III, each Party shall own and retain all right, title and interest in and to any and all Background IP solely owned by such Party and each Party shall own an equal and undivided interest in and to any Joint Background IP except as follows: MTEM hereby assigns and transfers to Takeda all of its right, title and interest in and to any and all Project Technology and Project IP (as defined under the 2016 Research Collaboration Agreement and under the IPA) that relates solely to (a) [***] or (b) [***]. Takeda hereby assigns and transfers to MTEM all of its right, title and interest in and to any and all Project Technology and Project IP (as defined under the 2016 Research Collaboration Agreement and under the IPA) that relates solely to [***]. Subject to the licenses granted hereunder and under the Multi-Target Agreement (if applicable), (i) Takeda may use the Joint Background IP for any and all purposes and (ii) if MTEM exercises its Co-Development Option and does not provide a Co-Development Termination Notice, MTEM may use the Joint Background IP for any purposes (if any) outside the scope of the Exclusive License. 

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8.2.2Takeda Program IP. As between the Parties, subject to the licenses granted in Article III, Takeda shall own and, subject to the licenses granted in Article III, retain all right, title and interest in and to any and all Takeda Program IP. MTEM shall, and does hereby, assign to Takeda and will cause each of its officers, directors, employees, Affiliates, subcontractors and agents to assign to Takeda all such right, title and interest in and to any Takeda Program IP, without additional compensation, as is necessary to fully effect the sole ownership provided for in the first sentence of this Section 8.2.2. 

8.2.3MTEM Program IP. As between the Parties, subject to Section 3.9 and the licenses and rights of reference granted in Article III, MTEM shall own and retain all right, title and interest in and to any and all MTEM Program IP. Takeda shall, and does hereby, assign to MTEM and will cause each of its officers, directors, employees and Affiliates, to assign to MTEM all such right, title and interest in and to any MTEM Program IP, without additional compensation, as is necessary to fully effect the sole ownership provided for in the first sentence of this Section 8.2.3.

8.2.4Product Program IP. As between the Parties, and subject to the licenses and rights of reference granted in Article III, [***] own and retain an equal, undivided interest in and to any Product Program IP. Subject to the licenses granted hereunder and under the Multi-Target Agreement if applicable, [***] may use the Product Program IP for any purpose without consent or accounting by [***] except (a) in the case of [***], for purposes within the scope of the [***] and (b) in the case of [***], subject to the terms of this Agreement within the scope of the [***].

8.2.5Other Program IP. As between the Parties, subject to the licenses and rights of reference granted in Article III, each Party shall own and retain all right, title and interest in and to any and all Other Program IP (other than Joint Other Program IP) that is conceived, discovered, developed or otherwise made solely by or on behalf of such Party (or its Affiliates or its or their sublicensees or (sub)contractors), whether or not patented or patentable and any and all Patent Rights and other intellectual property rights with respect thereto. As between the Parties, subject to the licenses and rights of reference granted in Article III, the Parties shall each own and retain an equal, undivided interest in and to any and all Joint Other Program IP. Subject to the licenses and rights of reference granted in Article III and, in the case of MTEM, its exclusivity obligations hereunder, each Party (and its Affiliates) shall have the right to Exploit the Joint Other Program IP without a duty of seeking consent of or accounting to the other Party (and to the extent such consent is required by Applicable Law, such consent is hereby granted) (except that such right shall be subject to any restrictions or exclusive licenses in this Agreement or any other written agreement between the Parties, including the Multi-Target Agreement); provided, that neither Party shall have the right to disclose (except as provided in Section 7.2) or license (except as may be permitted under Article III) any Joint Other Program IP to any Third Party without the consent of the other Party.  

8.2.6United States Law. The determination of whether Know-How, Improvements and inventions are conceived, discovered, developed or otherwise made by a Party for the purpose of allocating proprietary rights (including Patent Rights, copyright or other intellectual property rights) therein, shall, for purposes of this Agreement, be made in accordance with Applicable Law in the United States as such law exists as of the Effective Date irrespective of where or when such conception, discovery, development or making occurs. Each Party shall, and does hereby, assign, and shall cause its Affiliates and its and their sublicensees to so assign, 

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to the other Party, without additional compensation, such right, title and interest in and to any Know-How, Improvements and other inventions as well as any intellectual property rights with respect thereto, as is necessary to fully effect, as applicable, the sole or joint ownership specified in this Article VIII. 

Section 8.3Patent Prosecution and Maintenance. 

8.3.1MTEM Prosecution and Maintenance. MTEM shall have the first right and authority, but not the obligation, to prepare, file, prosecute and maintain the MTEM Background Patent Rights, the MTEM Program Patent Rights and any Other Program Patent Rights solely owned by MTEM on a worldwide basis and to be responsible for any related pre-grant and post-grant administrative proceedings (including interference, re-issuance, re-examination and opposition proceedings), in each case, at MTEM’s sole cost and expense. MTEM shall keep Takeda reasonably informed and provide reasonable opportunity for Takeda to comment with respect to all material steps with regard to the preparation, filing, prosecution and maintenance of such Patent Rights (including any patent administrative proceeding), and shall reasonably consider such comments in good faith. If MTEM decides not to file for or continue prosecuting any such Patent Rights, then MTEM shall so notify Takeda in writing (which written notice shall be at least [***] before any relevant deadline after considering any extension for such continued prosecution of those Patent Rights). Thereafter, Takeda shall have the right, but not the obligation, to engage in the activities set forth in this Section 8.3.1 with respect to such Patent Rights, as applicable, at Takeda’s sole expense.  

8.3.2Takeda Prosecution and Maintenance. 

(a)Takeda (or its Affiliate or Sublicensee) shall have the sole right and authority, but not the obligation, to prepare, file, prosecute and maintain the Takeda Background Patent Rights, the Takeda Program Patent Rights and the Other Program Patent Rights solely owned by Takeda on a worldwide basis, and to be responsible for any pre-grant and post-grant patent administrative proceedings, as well as Extensions. Takeda shall be responsible for all costs and expenses in connection with the preparation, filing, prosecution and maintenance of any such Patent Rights.

(b)At Takeda’s election in its sole discretion, with respect to any Takeda Program Patent Right or Takeda Background Patent Right related to a Takeda Targeting Moiety, Takeda may afford to MTEM joint ownership in such Patent Right by written notice to MTEM. In such a case, (i) Takeda and MTEM shall each have an equal undivided ownership interest in such Patent Right and (ii) MTEM shall and hereby does grant to Takeda an exclusive, royalty-free, irrevocable, perpetual license under such Patent Rights for all purposes. For clarity, Takeda shall retain all rights under this Article VIII with respect to such Patent Right as a Takeda Program Patent Right or Takeda Background Patent Right notwithstanding such joint ownership, including with respect to prosecution and maintenance, including Extensions, enforcement and defense, and MTEM shall cooperate with respect thereto.  

8.3.3Prosecution and Maintenance of Jointly Owned IP. The Parties shall cooperate and [***] all demonstrated reasonable costs and expenses in connection with the preparation, filing, prosecution and maintenance of Patent Rights in the Joint Background IP, [***] and Joint Other Program Patent Rights, using mutually acceptable counsel, during the periods when the Parties are engaged in Co-Development, including during the Co-Development 

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Period after exercise by MTEM of the Co-Development Option, with decision making authority delegated to the Joint Patent Committee and with Takeda having [***] only with respect to claims in such Patent Rights directed [***] Except during the Co-Development Period, Takeda shall control the prosecution and maintenance of such Patent Rights during the Post Phase Ia Program and thereafter, subject to the cooperation provisions in Section 8.3.5.  

8.3.4Step-In Rights. If Takeda decides in any country not to file, prosecute or, maintain a Patent Rights in the Joint Background IP, a [***] or Joint Other Program Patent Right, or intends to allow such a Patent Right to lapse or become abandoned without having first filed a substitute Patent Right, Takeda shall notify and consult with MTEM of such decision or intention at least [***] prior to the date upon which the subject matter of such Patent Right shall become unpatentable or such Patent Right shall lapse or become irrevocably abandoned, and MTEM shall thereupon have the right (but not the obligation) to assume the prosecution and maintenance thereof at its own expense with counsel of its own choice, subject, at all times, to Takeda’s licenses hereunder and coordination through the Joint Patent Committee. If MTEM later decides not to file, prosecute or maintain such Patent Right, it shall notify Takeda within the [***] period specified above in this Section 8.3.4, mutatis, mutandis, and Takeda shall thereupon have the right, but not the obligation, to assume the prosecution and take the prosecution and maintenance thereof at its own expense with counsel of its own choice without any further obligation to MTEM.

8.3.5Cooperation. The Parties shall at all times fully cooperate with each other in order to reasonably implement the foregoing provisions of this Section 8.3. Such cooperation may include each Party’s execution of necessary legal documents, coordinating filing or prosecution of applications to avoid potential issues during prosecution (including novelty, non-obviousness, written description, enablement, estoppel and double patenting), and the assistance of each Party’s relevant personnel and the transfer of the applicable patent files to the prosecuting Party. In the case that any proposed filing by Takeda with respect to any Patent Rights covered by this Section 8.3 discloses [***] disclosed or claimed by any Patent Rights as to which MTEM has the right to prosecute under this Section 8.3, then the Parties will use good faith efforts to coordinate filings with respect to such species Patent Rights so that such filings by Takeda are made no [***] that filings by MTEM with respect to the corresponding [***] Patent Rights filed by MTEM (provided, however, that the foregoing coordination shall (a) not unreasonably delay Takeda from making any filing with respect to any such Patent Rights and (b) in any event, not delay Takeda from making any such filing by more than [***] after notice by Takeda to MTEM that Takeda is ready to make such proposed filing, which notice shall include a copy of such proposed filing). Without limitation of the foregoing, the Parties shall use good faith, reasonable efforts to avoid creating potential issues in prosecution of the patent applications covered by this Section 8.3. Except as otherwise expressly authorized in this Agreement, Takeda shall not disclose or claim in any patent application, patent or publication any Confidential Information of MTEM without first obtaining MTEM’s prior written consent. Except as otherwise expressly authorized in this Agreement, MTEM shall not disclose or claim in any patent application, patent or publication any Confidential Information of Takeda without first obtaining Takeda’s prior written consent.

8.3.6Patent Term Extension and Supplementary Protection Certificate. As between the Parties, Takeda or its Affiliate or Sublicensee shall at all times have the sole right to make final decisions regarding, and to apply for, patent term extensions based on regulatory approval of Licensed Products in the Territory, including the United States with respect to 

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extensions pursuant to 35 U.S.C. § 156 et. seq. and in other jurisdictions pursuant to supplementary protection certificates, and in all jurisdictions with respect to any other extensions that are now or become available in the future, wherever applicable (collectively, the “Extensions”), including for the Patent Rights in the Joint Background IP or any [***] but excluding the MTEM Background Patent Rights except as specified below. MTEM shall provide prompt and reasonable comments and, as requested by Takeda, assistance with respect thereto as is required under any Applicable Law to obtain such Extension, and shall cooperate in good faith in making decisions regarding, and to apply for, such Extensions as they relate to any of the foregoing Patent Rights. As between the Parties, MTEM shall have the sole right to make final decisions regarding, and to apply for, Extensions for the MTEM Background Patent Rights, the MTEM SLT-A Program Patent Rights and the Other Program IP solely owned by MTEM, but for any such Extensions as they relate to MTEM Background Patent Rights, Takeda may direct MTEM to fill for an Extension if no Extension is available for any Patent Rights in the Joint Background IP or Program Patent Rights with respect to Licensed Products.

8.3.7UPC Opt-Out and Opt-In. MTEM shall, as soon as reasonably practicable on request by Takeda (a) lodge an application with the Registry of the Unified Patent Court in the manner specified by Rule 5 of the Rules of Procedure of the Unitary Patent Court requesting the Opt-Out or Opt-In, as specified by Takeda, of any MTEM Background Patent Right, Patent Right in the Joint Background IP or any Program Patent Right owned solely or jointly by MTEM (or if elected by Takeda, Takeda may lodge such an obligation in the case of any Patent Right in the Joint Background IP or Program Patent Right owned jointly by Takeda), (b) pay the prescribed fee and make such submissions, and (c) take such other actions as may be necessary or useful to secure the Opt-Out or Opt-In, as applicable, of such Patent Right including making any declarations required by Rule 5(3)(e) of the Rules of Procedure of the Unitary Patent Court. Costs of the Parties attributable to the foregoing will be agreed upon by the Parties prior to lodging an application.

8.3.8Common Ownership Under Joint Research Agreements. Notwithstanding anything to the contrary in this Article VIII, Takeda shall have the first right to make an election under 35 U.S.C. § 102(c) when exercising its rights under this Article VIII without the prior written consent of MTEM. If Takeda fails to make such an election within [***] following the date on which the opportunity to make such election arose, then MTEM shall have the right and option to do so at its expense. With respect to any such permitted election, the Parties shall coordinate their activities with respect to any submissions, filings or other activities in support thereof. The Parties acknowledge and agree that this Agreement is a “joint research agreement” as defined in 35 U.S.C. § 100(h). 

8.3.9Joint Patent Committee. 

(a)Formation and Composition. The Parties will establish a joint patent committee (the “Joint Patent Committee”) composed of at least [***] of each of Takeda and MTEM, in each case who is a registered patent attorney or patent agent with relevant experience within the field of pharmaceutical patents. A Party may at any time, by written notice to the other Party’s representative on the Joint Patent Committee, change its representative on the Joint Patent Committee or elect to be represented by a delegate at a meeting of the Joint Patent Committee. The Joint Patent Committee will be chaired by the Takeda representative. The Parties may allow additional employees to attend meetings of the Joint Patent Committee subject to the confidentiality provisions of Article VII.

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(b)Functions and Authority. The Joint Patent Committee will be responsible for only the following:

i.Coordinating with the Parties in accordance with Section 8.3.5 to reasonably avoid creating potential issues in prosecution of the patent applications claiming each Party’s respective Patent Rights; 

ii.Subject to this Section 8.3, discussing patent prosecution strategy relating to prosecution of Patent Rights in the Joint Background IP, MTEM Background Patent Rights, MTEM Program Patent Rights, Product Program Patent Rights and Other Program Patent Rights (other than those solely owned by Takeda) under this Article VIII, and status updates with respect to such Patent Rights; and

iii.Such other matters as the Parties may mutually agree in writing.

(c)Meetings. During the Term until its disbandment, the Joint Patent Committee will meet in person or by teleconference or videoconference when and as reasonably requested by a representative to the Joint Patent Committee.

(d)Decisions. Each Party shall have [***] on the Joint Patent Committee. The Joint Patent Committee will seek to make all decisions by consensus. In the event that the Joint Patent Committee cannot reach consensus on an issue, then the Party that has the right to control the matter under this Article VIII shall have sole and final decision making authority relating to the matter and shall seek the broadest protection practicable for the Parties under the applicable circumstances. If the matter at issue regards any Joint Other Program IP, Product Program IP or Joint Background IP, and agreement cannot be reached, then [***] additional senior executive members, one from each Party, will be asked to assist the Joint Patent Committee in its decision making process in accordance with this clause (d) by consensus. 

(e)Minutes and Reports. The Joint Patent Committee will draft, distribute and maintain accurate minutes of its meetings, including with respect to all proposed decisions and recommended actions or decisions taken, in accordance with policies to be agreed by the Joint Patent Committee.

(f)Duration. Unless earlier terminated by mutual written consent of the Parties, the Joint Patent Committee will be in existence until the expiration of the last to expire of the following: (i) the Program Patent Rights, (ii) Patent Right in the Joint Background IP and (iii) the Takeda Targeting Moiety Patent Rights but only in the case of clause (iii) for as long as MTEM is participating in Co-Development, and (iv) the MTEM Background Patent Rights.

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Section 8.4Enforcement of Patent Rights. 

8.4.1Notification of Infringement. In the event that a Party becomes aware of an infringement or misappropriation of the intellectual property owned by or licensed to the other Party hereunder, which infringement or misappropriation relates to a CD38 SLT-A Fusion Protein or Licensed Product, it shall promptly notify the other Party and provide such other Party with all details of such infringement or misappropriation of which it is aware (each, an “Infringement Notice”).

8.4.2MTEM shall have the first right, at its sole cost and expense, but not the obligation, to determine the appropriate course of action to enforce the MTEM Background Patent Rights, MTEM Program Patent Rights, and Other Program Patent Rights solely owned by MTEM, or otherwise abate the infringement thereof, to take (or refrain from taking) appropriate action to enforce such Patent Rights, to control any litigation or other enforcement action and to enter into, or permit, the settlement of any such litigation or other enforcement action with respect to such Patent Rights. MTEM shall in good faith consider the interests of Takeda in conducting the foregoing activities. If MTEM fails to enforce any such Patent Rights with respect to the Manufacture, Commercialization or other activity by any Third Party with respect to a product that competes with any Licensed Product within [***] following any Infringement Notice, then Takeda shall have the right and option to do so at its expense. MTEM shall reasonably cooperate with Takeda in any such action at Takeda’s expense, to enforce such Patent Rights, including being joined as a party to such action if necessary.

8.4.3Takeda Enforcement. Takeda shall have the sole right, at its sole expense, but not the obligation, to determine the appropriate course of action to enforce the Takeda Background Patent Rights, the Takeda Program Patent Rights, and Other Program Patent Rights solely owned by Takeda, or otherwise to abate the infringement thereof, to take (or refrain from taking) appropriate action to enforce such Patent Rights, to control any litigation or other enforcement action and to enter into, or permit, the settlement of any such litigation or other enforcement action with respect to any such Patent Rights. MTEM and Takeda shall fully cooperate with each other, at Takeda’s expense, in any such action to enforce such Patent Rights, including being joined as a party to such action if necessary, including participating in joint or common interest defenses. MTEM will be informed of any settlement discussions.

8.4.4Enforcement of Jointly Owned IP. Takeda shall have the sole right, but not the obligation, to determine the appropriate course of action to enforce the Patent Rights in the Joint Background IP, Product Program Patent Rights and Joint Other Program Patent Rights with respect to the Manufacture, Commercialization or other activity by any Third Party with respect to a product that competes with any Licensed Product or with respect to any other infringement of such Patent Rights, including the sole right to control any litigation or other enforcement action and to enter into, or permit, the settlement of any such litigation or other enforcement action with respect to the such Patent Rights. Takeda and MTEM agree to cooperate with each other and to [***]. If there are any recoveries that exceed the Parties' costs and expenses, then the Parties shall share any recoveries based on the percentage that each Party bore with regard to such costs and expenses (i.e., in the case in which both Parties fulfill such cost sharing obligation, then the Parties will [***]. Such cooperation shall include participating in joint or common interest defenses and in any settlement discussions and in being joined as a party to such action if necessary, with Takeda having final decision-making authority when agreement cannot be reached after all dispute resolution mechanisms set forth in Section 12.3.

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8.4.5Recoveries. The Party enforcing under this Article VIII shall bear the costs and expenses of such enforcement. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any recovery realized as a result of such enforcement action (whether by way of settlement or otherwise) shall be first allocated to reimburse each Party controlling the enforcement action for its costs and expenses in making such recovery. [***] the Party controlling the enforcement action.

Section 8.5Separate Representation. The Party not bringing an action with respect to an infringement in the Territory under this Article VIII shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense, but such Party shall at all times cooperate fully with the Party bringing such action; provided that to the extent such separate representation is retained and used in connection with any cooperation provision of this Article VIII, the Party bringing such action shall reimburse such cooperating Party for the cost of such counsel, if required under this Article VIII. 

Section 8.6Trademarks. Takeda shall be responsible for the selection, registration, maintenance and defense of all trademarks for use in connection with the sale or marketing of the Licensed Products (collectively, “Product Trademarks”) at Takeda’s own cost and expense, and Takeda shall own such Product Trademarks. MTEM shall not, and shall not permit its Affiliates to, (a) use in their respective businesses, any trademark that is confusingly similar to, misleading or deceptive with respect to or that dilutes any (or any part) of any Product Trademark and (b) do any act that endangers, destroys, or similarly affects, in any material respect, the value of the goodwill pertaining to any Product Trademark. MTEM shall not, and shall not permit its Affiliates to, attack, dispute or contest the validity of or ownership of any Product Trademark or any registrations issued or issuing with respect thereto, other than any Product Trademark that is confusingly similar to, misleading or deceptive with respect to or that dilutes any (or any part) of any Product Trademarks. 

Section 8.7Third Party Actions. 

8.7.1Notification of Third Party Action. Each Party shall promptly disclose to the other Party in writing any warning letter or other notice of infringement or misappropriation received by a Party, or any action, suit or proceeding brought against a Party alleging infringement of a Patent Right or misappropriation of intellectual property of any Third Party with regard to any aspect of the conduct by either Party, its Affiliates, sublicensees or Distributors pursuant to this Agreement or a Program, including any defense or counterclaim in connection with an infringement action initiated pursuant to Section 8.4 (each, a “Third Party Action”). 

8.7.2Takeda Right to Defend. As between the Parties, Takeda, [***] and through counsel of its choosing, shall have the first right, but not the obligation, to defend against any Third Party Action in the Territory alleging that the Development, Manufacture, Commercialization or other Exploitation of any Licensed Product infringes or misappropriates a Third Party’s intellectual property rights; provided, however, that to the extent such Third Party Action alleges that any SLT-A Technology or any other MTEM Background IP (or any Know-How or Patent Right that, but for any misappropriation by or on behalf of MTEM or any of its Affiliates, would be considered an SLT-A Technology or other MTEM Background IP under this Agreement), or the Exploitation thereof, infringes or misappropriates a Third Party’s intellectual property rights (the “Third Party SLT-A IP”), then MTEM shall be entitled to participate in 

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such Third Party Action with its own counsel, [***] and Takeda shall confer with MTEM in the defense and any settlement thereof, and shall consider reasonable recommendations made by MTEM with respect thereto. If Takeda, after consultation with MTEM, obtains a license or other rights from such Third Party to the Third Party SLT-A IP, whether by license, settlement, judgment or otherwise, Takeda shall be entitled to offset a total of up to [***] of the reasonable out-of-pocket costs and expenses of defending or settling such Third Party Action under this Section 8.7.2 (including the payment of any damage awards, settlement amounts or other similar amounts payable to such Third Party for the alleged infringement or misappropriation of such Third Party SLT-A IP, excluding any amounts otherwise deductible under Section 6.4.2(d)) as permitted under Section 6.4.2(g). Nothing in this Section 8.7.2 shall limit MTEM’s obligations under Article X to the extent such Third Party Action relates to a breach of a representation, warranty or covenant of MTEM in Article IX. Any recoveries awarded to Takeda in connection with any Third Party Action defended under this Section 8.7.2 shall be applied first to reimburse each of MTEM and Takeda for its respective reasonable out-of-pocket costs and expenses of defending such claim, suit or proceedings, with the balance of any such recoveries being shared between the Parties [***] to Takeda and [***] to MTEM. For clarity, to the extent such Third Party Action alleges that any Takeda Program IP or Takeda Background IP (or any Know-How or Patent Right that, but for any misappropriation by or on behalf of Takeda or any of its Affiliates, would be considered Takeda Program IP or Takeda Background IP under this Agreement), or the Exploitation thereof, infringes or misappropriates a Third Party’s intellectual property rights and Takeda (with notice to and cooperation with MTEM) obtains a license or other rights from such Third Party to such intellectual property rights, whether by license, settlement, judgment or otherwise, Takeda shall cover all costs and expenses with no offset for defending or settling such Third Party Action under this Section 8.7.2. Takeda shall have the sole and exclusive right to select counsel for such Third Party Actions. MTEM shall have the right to select its own counsel to represent MTEM and consult with Takeda’s selected counsel in any Third Party Action relating to the SLT-A Technology or the MTEM Background IP, or, if MTEM has not delivered a Co-Development Termination Notice and has paid its share of Co-Development Costs in full, the Takeda Targeting Moiety IP and Product Program IP.

8.7.3Consultation; Settlement. The Parties shall consult with one another on all material aspects of the defense and settlement of Third Party Actions. The Parties shall reasonably and in good faith cooperate with each other in all such actions or proceedings. No Party shall admit the invalidity or unenforceability of any Patent Right Controlled by the other Party without the other Party’s prior written consent.

Section 8.8Invalidity or Unenforceability Defenses or Actions. 

8.8.1Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity or unenforceability of any of the Patent Right in the Joint Background IP, Program Patent Rights, the MTEM Background Patent Rights or the Takeda Background Patent Rights by a Third Party of which such Party becomes aware. 

8.8.2In the event that such an invalidity or unenforceability allegation or threatened assertion arises in connection with an enforcement proceeding governed by Section 8.4, then the Party controlling such action shall control the defense of any such allegation or assertion.

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8.8.3In the event that such an allegation or assertion arises outside of an enforcement action under Section 8.4, then the Parties shall discuss in good faith the most favorable approach to defend against any such allegation in light of each Party’s commercial interests in the applicable Patent Rights, including which Party should control the defense of the validity and enforceability of the such Patent Rights except that Takeda shall have the sole right to control the defense with respect to any Program Patent Rights owned or Controlled by Takeda and Takeda Background Patent Rights and the [***] with respect thereto. Takeda shall have the right, but not the obligation, to defend and control the defense of the validity and enforceability of such Patent Rights at its sole expense in the Territory and using counsel of its own choice. If the Party controlling the defense against alleged or threatened assertion of any claim of invalidity or unenforceability with respect to a Program Patent Rights (other than with respect to any Program Patent Rights owned or Controlled by Takeda), Patent Right in the Joint Background IP, or MTEM Background Patent Right elects not to defend or control the defense of the applicable Patent Rights in a suit brought in the Territory or otherwise fails to initiate and maintain the defense of any such claim, suit or proceeding, then the other Party may conduct and control the defense and settlement of any such claim, suit or proceeding using counsel of its own choice at its sole cost and expense. Where a Party controls such an action, the other Party shall have the right to participate in any such claim, suit or proceeding with counsel of its choice at its sole cost and expense (provided, that the controlling Party shall retain control of the defense in such claim, suit or proceeding) and shall cause its Affiliates to, assist and cooperate with the controlling Party, at the controlling Party’s expense, as such controlling Party may reasonably request from time to time in connection with its activities set forth in this Section. In connection with any activities with respect to a defense, claim or counterclaim relating to the Program Patent Rights (other than with respect to any Program Patent Rights owned or Controlled by Takeda) or the MTEM Background Patent Rights pursuant to this Section 8.8, the controlling Party shall (a) consult with the other Party as to the strategy for such activities, (b) consider in good faith any comments from the other Party and (c) keep the other Party reasonably informed of any material steps taken and provide copies of all material documents filed, in connection with such defense, claim or counterclaim, pursuant to Section 8.7.

Section 8.9Takeda Patent Challenge. Takeda or any of its Affiliates or (sub)licensees will provide written notice to MTEM at least [***] prior to initiating any action or proceeding seeking a determination that any Patent Right comprising the [***] or [***] in any country is invalid or unenforceable (including a request for reexamination of any such Patent Right) (such action or proceeding, a “Patent Challenge”), which notice shall (a) state the basis for such Patent Challenge, and (b) include a copy of all relevant prior art or other materials used as the basis for such Patent Challenge. Upon delivery of such notice and during the pendency of any Patent Challenge, all milestone payments and royalties due under this Agreement will be increased by [***] and held in escrow pending the outcome of such Patent Challenge, being paid [***] only upon a finding of validity and enforceability of said Patent Rights covering a Licensed Product, and otherwise said payments and royalties being retained by Takeda (or its Affiliates or (sub)licensees). The foregoing provisions will not apply where MTEM, or any of its Affiliates or licensees, makes any claim or demand under or in connection with any Patent Right, whether informally or in connection with threatened or actual litigation, or whether through an assertion of entitlement to royalties, an action for infringement or otherwise, with respect to a product controlled by Takeda or any of its Affiliates or (sub)licensees (other than a Licensed Product) or the Exploitation thereof, and nothing herein will prejudice Takeda’s (or its Affiliate’s or (sub)licensee’s) ability to challenge the validity or enforceability of such Patent Right.  

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Article IX
REPRESENTATIONS AND WARRANTIES; COVENANTS

Section 9.1Mutual Representations, Warranties and Covenants. Each Party hereby represents and warrants, as of the Effective Date, and covenants (as applicable) to the other Party as follows:

9.1.1Corporate Existence and Power. It is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including the right to grant the licenses granted by it hereunder.

9.1.2Authority and Binding Agreement. As of the Effective Date, (a) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (b) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; (c) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with its terms; and (d) its execution of and performance under this Agreement will not violate or breach any obligation or restriction (including any confidentiality or non-competition obligation or any exclusivity restriction) to which such Party is legally bound by contract, judicial order or otherwise.

9.1.3No Conflict. It is not a party to any agreement that would prevent it from granting the rights granted to the other Party under this Agreement or performing its obligations under this Agreement. It has the full right to grant the licenses or sublicenses (as applicable) granted herein and such grant shall not result in the misappropriation of any Third Party intellectual property or violation of such Third Party’s rights with respect thereto. During the Term, it will not enter into any agreement, contract, commitment or other arrangement that could reasonably be expected to conflict with the rights granted to the other Party hereunder or otherwise prevent the other Party from exercising the rights granted to it hereunder. Neither Party shall misappropriate any trade secret of a Third Party in connection with the performance of its activities hereunder. 

9.1.4No Debarment. (a) Neither it nor any of its Affiliates has been debarred or is subject to debarment pursuant to Section 306 of the FFDCA or analogous provisions of Applicable Law outside the United States or listed on any Excluded List and (b) neither it nor any of its Affiliates has, to its knowledge, used in any capacity, in connection with the activities to be performed under this Agreement, any individual or entity that has been debarred pursuant to Section 306 of the FFDCA or analogous provisions of Applicable Law outside the United States, or that is the subject of a conviction described in such Section or analogous provisions of Applicable Law outside the United States, or listed on any Excluded List.

9.1.5Government Authorizations. It will maintain throughout the Term all material permits, licenses, registrations and other forms of authorizations and approvals from any Governmental Authority, necessary or required to be obtained or maintained by such Party in order for such Party to execute and deliver this Agreement and to perform its obligations hereunder in a manner which complies with all Applicable Law. 

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9.1.6IP Infringement. To each Party’s knowledge, as of the Effective Date, (a) the materials to be supplied by such Party for the conduct of the Early Stage Program and (b) the use and practice of the Takeda and MTEM Background IP for the conduct of the Early Stage Program, in each case ((a) and (b)), would not infringe any intellectual property rights of any Third Party.

Section 9.2Additional Representations, Warranties and Covenants of MTEM. MTEM represents and warrants to Takeda as of the Effective Date, and covenants, as specified below.  

9.2.1Non-Infringement of MTEM Background Patent Rights by Third Parties. To MTEM’s actual knowledge following reasonable internal due inquiry, there are no activities by Third Parties that would constitute misappropriation or infringement of the MTEM Background Patent Rights within the Territory. 

9.2.2Ownership. MTEM Controls the MTEM Background IP, MTEM Program IP, including the SLT-A Technology existing as of the Effective Date, and its interest in any Joint Background IP, Product Program IP or Other Program IP free and clear of all liens and encumbrances that do not conflict with the (a) rights granted Takeda hereunder; (b) rights granted to Takeda under the Multi-Target Agreement; or (c) any other written agreement between the Parties. MTEM has the exclusive right to grant, all rights and licenses (or sublicenses, as the case may be) it purports to grant to Takeda under this Agreement (other than those rights and licenses granted to Takeda in a separate written agreement) and neither such rights and licenses nor any other provision of this Agreement are subject to any in-license or other similar agreements with another Person regarding any intellectual property rights licensed to MTEM hereunder. MTEM has not misappropriated and will not misappropriate any intellectual property of a Third Party in connection with developing the MTEM Background IP, Joint Background IP, Program IP or performing its obligations under the 2016 Research Collaboration Agreement or under this Agreement. 

9.2.3Validity and Enforceability. To MTEM’s actual knowledge following reasonable internal due inquiry, MTEM has complied in all material respects with all Applicable Law with respect to the filing, prosecution and maintenance of those MTEM Background Patent Rights or, with respect to any representations and warranties made before the Effective Date, Program Patent Rights owned by MTEM or otherwise of which MTEM has control of such filing, prosecution and maintenance (the “MTEM Prosecution Patent Rights”) and, to MTEM’s actual knowledge following reasonable internal due inquiry, the filing, prosecution and maintenance of all other MTEM Background Patent Rights and Program Patent Rights have been in compliance in all material respects with all Applicable Laws with respect thereto. To MTEM’s knowledge, MTEM has paid all maintenance and annuity fees with respect to the MTEM Prosecution Patent Rights due and all maintenance and annuity fees with respect to all other MTEM Background Patent Rights have been paid when due. No dispute regarding inventorship has been alleged or threatened with respect to the MTEM Prosecution Patent Rights or Program Patent Rights, and to MTEM’s knowledge, with respect to any other MTEM Background Patent Rights or Program Patent Rights. 

9.2.4No Action or Claim. There (a) are no actual, pending or, to MTEM’s knowledge, alleged or threatened, adverse actions, suits, claims, interferences, re-examinations, oppositions, inventorship challenges or formal governmental investigations involving the MTEM 

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Background IP or, with respect to any representations and warranties made after the Effective Date, involving the Program Patent Rights owned or controlled by MTEM, by or against MTEM or any of its Affiliates, in each case that are in or before any Governmental Authority, and (b) are no actual, pending or, to MTEM’s knowledge, alleged or threatened, adverse actions, suits, claims, interferences, re-examinations, oppositions, inventorship challenges or formal governmental investigations involving the MTEM Background IP, in each case that are in or before any Governmental Authority, which if adversely determined would have a material effect upon the ability of MTEM to use or provide the MTEM Background IP in connection with the activities to be conducted hereunder, or to fulfil its obligations pursuant to the terms of this Agreement. 

9.2.5Completeness. Schedule 9.2.5 includes a complete and correct list, in all respects, of all MTEM Background Patent Rights, said Schedule to be updated in a timely manner with relevant MTEM Background Patent Rights. 

9.2.6No Required Licenses. Except for a certain license relating to a [***] may desire to take, which may or may not be required to Develop, Manufacture or Commercialize the CD38 SLT-A Fusion Proteins or Licensed Products, no rights or licenses are required under or to practice the MTEM Background IP or MTEM Regulatory Documentation for Takeda to Develop, Manufacture or Commercialize the CD38 SLT-A Fusion Proteins or Licensed Products as contemplated herein other than those granted under Article III. 

9.2.7No Prior Written Agreements. Neither MTEM nor any of its Affiliates has previously entered into any written agreement, with respect to or otherwise assigned, transferred, licensed, granted a covenant not to sue, conveyed or otherwise encumbered its entire right, title or interest in or to (a) the MTEM Background IP, MTEM Regulatory Documentation or Joint Background IP, or, solely in the case in which this representation and warranty is made after the Effective Date pursuant to Section, Program Patent Rights or (b) any Patent Right or other intellectual property or proprietary right that would be MTEM Background IP, MTEM Regulatory Documentation or Joint Background IP, but for such assignment, transfer, license, conveyance or encumbrance, in each case ((a) and (b)), that is inconsistent with or otherwise diminish the rights and licenses granted to Takeda under this Agreement. 

9.2.8MTEM In-Licenses. As of the Effective Date, MTEM is not a party to any in-license or cross-license with regard to any MTEM Background IP and there are no prior agreements to which MTEM was a party that have surviving obligations that restrict or have an adverse material impact on either Party with respect to the MTEM Background IP. In the event there are any Future MTEM In-Licenses, MTEM shall update Schedule 9.2.8 accordingly. To MTEM’s knowledge, no Third Party Manufacturer or supplier of CD38 SLT-A Fusion Proteins (including any Component thereof) engaged by MTEM as of the Effective Date Controls (as such defined term would apply to such Third Party if such Third Party were a party to this Agreement) any Know-How or Patent Right, that Takeda would be required to license in order for Takeda to manufacture such CD38 SLT-A Fusion Protein (including any such component thereof) as contemplated hereunder without infringing the intellectual property rights of such Third Party.

9.2.9Manufacturing Agreements. There are no exclusivity provisions or any other restrictions in any agreement between MTEM or its Affiliates, on the one hand, and any Third Party Manufacturer of the CD38 SLT-A Fusion Proteins or Licensed Products (including 

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any Component thereof), on the other hand, that would limit Takeda’s ability to have the CD38 SLT-A Fusion Proteins or Licensed Products (including any Component thereof) Manufactured by such Third Party Manufacturer or any other Person following the Technology Transfer. 

9.2.10Compliance with Applicable Law. The Development of MTEM Background IP and Project IP (As defined in the 2016 Research Collaboration Agreement) conducted by MTEM and its Affiliates and its and their subcontractors has been conducted in compliance with all Applicable Law in all material respects. To MTEM’s actual knowledge following reasonable internal due inquiry, the pending applications included in MTEM Background Patent Rights are being diligently prosecuted in the respective patent offices in the Territory in accordance with Applicable Law and MTEM and its Affiliates have presented all relevant references, documents and information of which it and the inventors are aware to the relevant patent examiner at the relevant patent office where required by law.  

9.2.11SLT-As and MTEM Background IP. Schedule 9.2.11 sets forth a true and complete list of SLT-As with respect to which MTEM or its Affiliates Control MTEM Background IP. With respect to each CD38 SLT-A Fusion Protein, (a) MTEM is not a party to any agreement that would prevent it from granting the rights granted to Takeda under this Agreement or performing its obligations under this Agreement, (b) MTEM has the full right to grant the licenses and other rights granted in Article III, as applicable, granted herein and such grant shall not result in the misappropriation of any Third Party intellectual property or violation of any Third Party’s rights with respect thereto and (c) [***].

9.2.12Government Funding. The inventions claimed by the MTEM Background Patent Rights (a) were not conceived, discovered, developed or otherwise made in connection with any research activities funded, in whole or in part, by any state or the federal government of the United States or any agency thereof, (b) are not a “subject invention” as that term is described in 35 U.S.C. Section 201(e) and (c) are not otherwise subject to the provisions of the Patent and Trademark Law Amendments Act of 1980, as amended, codified at 35 U.S.C. §§ 200-212, as amended, as well as any regulations promulgated pursuant thereto, including in 37 C.F.R. part 401.

9.2.13CPRIT Agreements.

(a)The CPRIT Agreements have been duly executed by both MTEM and the Cancer Prevention and Research Institute of Texas as of the Effective Date, true and accurate copies of which are to be delivered to Takeda prior to the Effective Date, and shall not, taken as a whole, (i) contain any untrue statement of a material fact or (ii) omit to state any material fact necessary to make the statements or facts contained therein, in light of the circumstances under which they were made, not misleading.  

(b)MTEM will ensure that its proprietary engineered toxin body Directed to CD38, MT-4019, is the only CD38 SLT-A Fusion Protein possibly subject to any encumbrance under the CPRIT Agreements, including, but not limited to [***].

9.2.14University IP. No Know-How or inventions (nor any Patent Rights and intellectual property or other proprietary rights) generated by [***] or individuals working on [***] behalf relating to the use or development of methods of making or screening libraries of SLT-A, or compositions of cytotoxic proteins identified therefrom, specific targeting moieties or any Improvements to any of the foregoing whether at, or on behalf of, [***] or otherwise, falls 

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within the scope of MTEM Background Know-How. All Know-How and inventions (and all Patent Rights and intellectual property or other proprietary rights) relating to [***] has been assigned to MTEM or one of its Affiliates, and any milestones or royalties due thereunder will be paid solely by MTEM.

9.2.15The representations and warranties of MTEM in this Agreement and the information, documents and materials furnished to Takeda in connection with its period of diligence prior to the Effective Date, do not, taken as a whole, (a) contain any untrue statement of a material fact or (b) omit to state any material fact necessary to make the statements or facts contained therein, in light of the circumstances under which they were made, not misleading.  

Section 9.3Additional Representations, Warranties and Covenants of Takeda. Takeda represents and warrants to MTEM as of the Effective Date, to the actual knowledge of Takeda following reasonable internal due inquiry as of the Effective Date, and covenants, as specified below. 

9.3.1Ownership. Takeda Controls the Takeda Background IP, its interest in Joint Background IP and its interest in the Program IP free and clear of all liens and encumbrances that do not conflict with the rights granted to MTEM hereunder other than any rights granted to MTEM under the Multi-Target Agreement or any other written agreement between the Parties. Takeda has the right to grant, all rights and licenses (or sublicenses, as the case may be) it purports to grant to MTEM under this Agreement (other than those rights and licenses granted to MTEM in a separate written agreement) and neither such rights and licenses nor any other provision of this Agreement are subject to any in-license or other similar agreements with another Person regarding any intellectual property rights licensed hereunder. Takeda has not misappropriated and will not misappropriate any intellectual property of a Third Party in connection with developing the Takeda Background IP, Takeda Program IP or performing its obligations under the 2016 Research Collaboration Agreement or under this Agreement. 

9.3.2Manufacturing Agreements. There are no exclusivity provisions or any other restrictions in any agreement between Takeda or its Affiliates, on the one hand, and any Third Party Manufacturer of the CD38 SLT-A Fusion Proteins or Licensed Products (including any Component thereof), on the other hand, that would limit MTEM’s ability to have the CD38 SLT-A Fusion Proteins or Licensed Products (including any Component thereof) Manufactured by such Third Party Manufacturer or any other Person as contemplated hereunder.

9.3.3Compliance with Applicable Law. The Development of Takeda Background IP and Project IP (as defined in the 2016 Research Collaboration Agreement) conducted by Takeda and its Affiliates and its and their subcontractors has been conducted in compliance with all Applicable Law in all material respects. 

9.3.4Takeda Background IP and Takeda Targeting Moiety IP. With respect to each CD38 SLT-A Fusion Protein, Takeda is not a party to any agreement that would prevent it from granting the rights granted to MTEM under this Agreement or performing its obligations under this Agreement.

Section 9.4Additional Covenants of MTEM. 

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9.4.1MTEM shall not grant a lien on the MTEM Background IP or MTEM’s interest in any Program IP to any Third Party or knowingly permit a lien to be imposed on the MTEM Background IP or MTEM’s interest in any Program IP other than those disclosed to Takeda by MTEM and that do not conflict with the rights granted Takeda hereunder. MTEM will not misappropriate any intellectual property of a Third Party in connection with developing the MTEM Background IP, Program IP or the performance of the Programs or its other obligations under this Agreement.

9.4.2MTEM shall not enter into any agreement with respect to or otherwise assign, transfer, license, convey or otherwise encumber its right, title or interest in or to (a) the MTEM Background IP for use with a CD38 SLT-A Fusion Protein or Licensed Product. MTEM’s interest in any Program IP or MTEM Regulatory Documentation (including by granting any covenant not to sue with respect thereto) or (b) any Patent Right or other intellectual property or proprietary right that would be MTEM Background IP, Program IP or MTEM Regulatory Documentation, but for such assignment, transfer, license, conveyance or encumbrance, in each case of (a) and (b), that is inconsistent with or otherwise diminishes the rights and licenses granted to Takeda under this Agreement. MTEM shall maintain and perform its obligations under any Future MTEM In-Licenses and maintain such Future MTEM In-Licenses in full force and effect during the Term and will not amend any Future MTEM In-Licenses in a manner than adversely affects Takeda’s rights hereunder, without having first obtained Takeda’s express prior written consent.

9.4.3Without limitation to any product warranty applicable under any Supply Agreement, all Fusion Protein Materials and MTEM Study Materials provided by or on behalf of MTEM hereunder will be Manufactured in conformance with Applicable Law and this Agreement.

9.4.4Neither MTEM nor any of its Affiliates shall use in any capacity, in connection with the performance of the activities hereunder, any Person that has been debarred pursuant to Section 306 of the FFDCA or that is the subject of a conviction described in such section. MTEM shall inform Takeda in writing promptly if it or any such Person that is performing any activities hereunder is debarred or is the subject of a conviction described in Section 306 of the FFDCA or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to MTEM’s knowledge, is threatened, related to the debarment or conviction of it or any such Person performing any activities hereunder.

9.4.5To the extent that any inventions claimed by the MTEM Background IP or Program IP are conceived, discovered, developed or otherwise made in connection with any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof, MTEM shall comply with the provisions of the Patent and Trademark Law Amendments Act of 1980, as amended, codified at 35 U.S.C. §§ 200-212, as amended, as well as any regulations promulgated pursuant thereto, including in 37 C.F.R. part 401.

9.4.6MTEM shall not use any Third Party funding with respect to the performance of the Early Stage Program Activities or the Manufacture of Licensed Products or Components thereof without the prior written consent of Takeda in each case, which consent may be withheld in Takeda’s sole discretion.  

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9.4.7MTEM shall comply with the CPRIT Agreements, shall not amend them without the consent of Takeda, shall notify Takeda of any MTEM breach of the CPRIT Agreements, and shall provide to Takeda any warning and noncompliance notices delivered thereunder.

Section 9.5Additional Covenants of Takeda. 

9.5.1Takeda shall not grant a lien on the Takeda Background IP or Takeda’s interest in any Program IP to any Third Party or knowingly permit a lien to be imposed on the Takeda Background IP or Takeda’s interest in any Program IP (excluding liens that do not conflict with the rights granted MTEM hereunder). Takeda will not misappropriate any intellectual property of a Third Party in connection with developing the Takeda Background IP, Program IP or the performance of the Programs or its other obligations under this Agreement.

9.5.2Takeda shall not enter into any agreement with respect to or otherwise assign, transfer, license, convey or otherwise encumber its right, title or interest in or to (a) the Takeda Background IP as part of a CD38 SLT-A Fusion Protein or Licensed Product or Takeda’s interest in any Program IP (including by granting any covenant not to sue with respect thereto) or (b) any Patent Right or other intellectual property or proprietary right that would be Takeda Background IP, or Program IP, but for such assignment, transfer, license, conveyance or encumbrance, in each case of (a) and (b), that is inconsistent with or otherwise diminishes the rights and licenses granted to MTEM under this Agreement. 

Section 9.6DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENT RIGHTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.

Article X
INDEMNITY; LIMITATION OF LIABILITY

Section 10.1Indemnity.

10.1.1[***] shall defend, indemnify and hold harmless [***] and its Affiliates and Sublicensees and Distributors and their respective directors, officers, employees and agents (the [***]) from and against all liabilities, losses, damages, and expenses, including reasonable attorneys’ fees and costs (collectively, “Liabilities”), incurred by or imposed on any of the [***] as a result of any Third Party claims, suits, actions, terminations or demands (collectively, “Claims”) to the extent such Claims are incurred, relate to, are in connection with or arise out of (a) the breach or non-fulfillment of any representations, warranties or covenants in this Agreement by [***] (b) the negligence, recklessness or willful misconduct of [***] in connection with the performance of its obligations hereunder, (c) violation of Applicable Law by [***] in connection with the performance of its obligations hereunder, or (d) any Third Party agreement to which [***] has been, is or becomes a party, including the [***] except in each 

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case ((a) through (d)), to the extent such Liabilities resulted from any action for which [***] must indemnify [***] under Section 10.1.2(a) or (b).

10.1.2[***] shall defend, indemnify and hold harmless [***], its Affiliates and its and their respective directors, officers, employees and agents (the “[***]”) from and against all Liabilities incurred by or imposed on any of the [***] as a result of any Claims to the extent such Claims are incurred, relate to, are in connection with or arise out of (a) the breach or non-fulfillment of any representations, warranties or covenants in this Agreement by [***], (b) the negligence, recklessness or willful misconduct of [***] in connection with the performance of its obligations hereunder, (c) violation of Applicable Law by [***] in connection with the performance of its obligations hereunder, or (d) the [***] [***] its Affiliates or Sublicensees, except in each case ((a), (b), (c) or (d)), to the extent such Liabilities resulted from any action for which [***] must indemnify [***] under Section 10.1.1.

Section 10.2Procedure.

10.2.1A Party (the “Indemnitee”) that intends to claim indemnification under this Section 10.2 shall promptly provide notice to the other Party (the “Indemnitor”) of any Claim in respect of which the Indemnitee intends to claim such indemnification, which notice shall include a reasonable identification of the alleged facts giving rise to such Liability, and the Indemnitor shall have the right to participate in, and, to the extent the Indemnitor so desires, jointly with any other Indemnitor similarly noticed, to control the defense thereof with counsel selected by the Indemnitor. However, notwithstanding the foregoing, except with respect to any Claim that is a Third Party Action, the process for the defense of which shall be governed by Section 8.7, the Indemnitee shall have the right to participate in, but not control, the defense of any Claim, and request separate counsel, with the fees and expenses to be paid by the Indemnitee, unless (a) representation of such Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between such Indemnitee and any other Party represented by such counsel in such proceedings or (b) the Indemnitor has failed to assume the defense of the applicable Claim, in which case ((a) or (b)), such fees and expenses shall be paid by the Indemnitor. The Indemnitee shall, and shall cause each of its Affiliates and its and their respective directors, officers, employees and agents, as applicable, to, cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals and otherwise providing reasonable access to such indemnitees and other employees and agents of the Indemnitee, in each case as may be reasonably requested in connection therewith; provided, that the Indemnitor shall reimburse the Indemnitee for its reasonable and verifiable out-of-pocket expenses in connection therewith. The Indemnitor may not settle any Claim, and the Indemnitee shall not be responsible for or be bound by any settlement of a Claim that imposes an obligation on it, without the prior written consent of the Indemnitee, which consent shall not be unreasonably withheld, conditioned or delayed.

10.2.2The assumption of the defense of a Claim by the Indemnitor shall not be construed as an acknowledgment that the Indemnitor is liable to indemnify the Indemnitee in respect of the Claim, nor shall it constitute a waiver by the Indemnitor of any defenses it may assert against the Indemnitee’s claim for indemnification. In the event that it is ultimately determined that the Indemnitor is not obligated to indemnify, defend or hold harmless the Indemnitee from and against the Claim, the Indemnitee shall reimburse the Indemnitor for any 

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and all costs and expenses (including attorneys’ fees and costs of suit) and any Liabilities incurred by the Indemnitor in its defense of the Claim. 

Section 10.3Limitation of Liability. EXCEPT (A) IN THE EVENT OF THE WILLFUL MISCONDUCT OR FRAUD OF A PARTY OR A PARTY’S BREACH OF ITS OBLIGATIONS UNDER ARTICLE VII OR SECTION 3.9, (B) AS PROVIDED UNDER SECTION 12.13 OR (C) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS ARTICLE X, NEITHER PARTY NOR ANY OF ITS AFFILIATES OR SUBLICENSEES SHALL BE LIABLE IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR FOR LOST PROFITS SUFFERED BY THE OTHER PARTY AND REGARDLESS OF ANY PRIOR NOTICE OF SUCH DAMAGES.

Section 10.4Insurance. During the Term and thereafter for the period of time required below, each Party shall maintain on an ongoing basis comprehensive general liability insurance in the minimum amount of [***] per occurrence and [***] annual aggregate combined single limit for bodily injury and property damage liability and any other insurance required by Applicable Law. Commencing not later than [***] prior to the first use in humans of a Licensed Product and thereafter for the period of time required below, Takeda shall obtain and maintain on an ongoing basis products liability insurance (including contractual liability coverage on Takeda’s indemnification obligations under this Agreement) in the amount of at least [***] per occurrence and as an annual aggregate combined single limit for bodily injury and property damage liability. All of such insurance coverage may be maintained through a self-insurance plan that substantially complies with the foregoing limits and requirements. Thereafter, Takeda shall maintain such insurance coverage without interruption during the Term and for a period of at least [***] thereafter. Each Party shall provide the other Party at least [***] prior written notice of any cancellation to or material change in its insurance coverage below the amounts and types described above. 

Article XI
TERM AND TERMINATION

Section 11.1Term. Unless earlier terminated pursuant to this Article XI, the term of this Agreement (the “Term”) shall commence on the Effective Date and shall remain in full force and effect until the date of expiration of the last to expire relevant Royalty Term or Co-Development Royalty Term, as applicable. Upon expiration of the Royalty Term or Co-Development Royalty Term, as applicable, for a Licensed Product in a country or jurisdiction, the grants in Section 3.3 shall become fully-paid, royalty-free, freely transferable, sublicensable through multiple tiers, perpetual and irrevocable for such Licensed Product in such country or jurisdiction, with no further obligation to MTEM for such Licensed Product.

Section 11.2Termination by Takeda. Takeda shall have the right, at any time, to terminate this Agreement, in its entirety, by providing not less than ninety (90) days’ prior written notice to MTEM of such termination. 

Section 11.3Termination for Material Breach.

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11.3.1Breach. Either Party may (but is not required to and without limitation of any other right or remedy such Party may have) terminate this Agreement for material breach by the other Party (the “Breaching Party”) of this Agreement if the Breaching Party has not cured such breach within [***] after notice thereof (such period, the “Notice Period”) specifying the breach and its claim of right to terminate, other than:

(a)with respect to a breach that cannot be cured within the Notice Period and the Breaching Party commences actions to cure such breach within the Notice Period, in which case the Notice Period shall be tolled (provided, that the Breaching Party thereafter diligently continues such actions); or

(b)with respect to any alleged breach by Takeda of its diligence obligations set forth in Section 2.1.3 and Section 2.3.3 in which case, MTEM shall first provide written notice thereof to Takeda and the Parties shall meet within [***] after delivery of such notice to Takeda to discuss in good faith such alleged breach and Takeda’s Development and Commercialization plans, as applicable, with respect to the applicable Licensed Product, which discussions shall be concluded before MTEM may issue any such termination notice with respect to such alleged breach; provided, that if either Party initiates a dispute resolution procedure under Section 12.3 as permitted under this Agreement to resolve the dispute for which termination is being sought within [***] following the end of the Notice Period and is diligently pursuing such procedure, the Notice Period shall be tolled and the termination shall become effective only if such breach remains uncured for [***] after the final resolution of the dispute through such dispute resolution procedure (or, if the breach cannot be cured within such [***] period, if the Breaching Party commences actions to cure such breach within such period and thereafter diligently continues such actions). It is understood that termination pursuant to this Section 11.3.1 shall be a remedy of last resort and may be invoked only in the case where the breach cannot be reasonably remedied by the payment of money damages. During any cure period under this Section 11.3.1 in response to a notice from Takeda, any obligation of Takeda to pay milestones under Article VI shall be suspended unless and until MTEM has cured the material breach at issue; provided, however, that within [***] after such cure, Takeda shall pay to MTEM all such suspended milestone payments.  

11.3.2Insolvency. Either Party may terminate this Agreement in its entirety effective immediately upon written notice to the other Party if, at any time such other Party (a) files in any court or agency pursuant to any statute or regulation of any state or country a petition in bankruptcy or insolvency or for reorganization (save for solvent reorganization or solvent reconstruction), (b) files for, appoints or suffers appointment of a receiver or trustee of the Party or over substantially all of its assets that is not discharged within [***] after such filing, (c) proposes a written agreement of composition or extension of substantially all of its debts, (d) files a petition under any bankruptcy or insolvency act or has any such petition filed against that is not discharged within [***] of the filing thereof, (e) proposes or is a party to any dissolution or liquidation, (f) admits in writing its inability generally to meet its obligations as they fall due in the general course or (g) makes an assignment of substantially all of its assets for the benefit of creditors.

Section 11.4License Survival Upon Insolvency. All licenses (and to the extent applicable, rights) granted under or pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of 11 U.S.C. § 101, et. seq. (“Bankruptcy Code”), licenses of rights to “intellectual property” as defined under the Paragraph 101(35A) of the 

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Bankruptcy Code. The Parties agree that the non-bankrupt Party shall retain and may fully exercise all of its rights and elections under Applicable Law. The Parties further agree that, in the event of the commencement of bankruptcy proceeding by or against a bankrupt Party, the other Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any intellectual property that is licensed to such Party pursuant to the license grants set forth in Article III, but only to the extent set forth in such license grants, and all embodiments of such intellectual property; and the same, if not already in the other Party’s possession, shall be promptly delivered to the other Party (a) upon any such commencement of a bankruptcy proceeding, upon the other Party’s written request therefor (which request must identify the specific intellectual property), unless the bankrupt Party (or trustee on behalf of the bankrupt Party) elects within [***] to continue to perform all of its obligations under this Agreement or (b) if not delivered under (a) above, upon rejection of this Agreement by or on behalf of the bankrupt Party, upon written request therefore by the other Party.

Section 11.5Effect of Expiration and Termination. 

11.5.1General Effects. Except where explicitly provided within this Agreement, expiration or termination of this Agreement in its entirety as applicable for any reason, or expiration of this Agreement, will not affect any obligations, including payment of any royalties or other sums which have accrued as of the date of termination or expiration. Notwithstanding the foregoing, but subject to Section 11.1, upon expiration or termination of this Agreement, the Parties’ obligations pursuant to Section 3.9 will [***] terminate in full. Following the delivery of a notice of termination of this Agreement, Takeda shall not be responsible for the payment of any future milestones under this Agreement other than those that were due prior to the delivery of the notice of termination. Except as needed in order to permit the sell-off activities set forth in Section 11.5.2, upon termination of this Agreement in its entirety, all licenses granted by either Party to the other Party hereunder (other than the licenses granted in Section 3.2, which will survive except that the license granted the terminated Party in the case of a termination under Section 11.3 shall terminate) shall terminate and all sublicenses granted by either Party thereunder, shall [***] terminate. For clarity, the Program with respect to the terminated Licensed Products shall terminate effective upon receipt of notice of termination. Upon expiration or termination of this Agreement in its entirety, the Parties will agree upon and implement a plan for the orderly transition or winding down of any in-process regulatory filings or Clinical Trials in a manner consistent with Applicable Laws and standards of ethical conduct of Clinical Trials.

11.5.2Sell-Off. In the case that the licenses granted to Takeda with respect to one or more Licensed Products, notwithstanding such termination, Takeda shall have the right to complete (or have completed) the Manufacture of any work-in-process Licensed Products or Components thereof and sell any existing inventory of Licensed Product(s) (if applicable) with respect to the terminated Licensed Product for a period of up [***] following such termination, subject to Takeda’s obligation to make corresponding payments with respect to any such sales pursuant to Section 6.4. 

11.5.3Effect of Termination by Takeda for Convenience, or by MTEM for Material Breach by Takeda or Takeda Insolvency. If MTEM terminates this Agreement in its entirety pursuant to Section 11.3.1 or Section 11.3.2, or Takeda terminates this Agreement in its entirety pursuant to Section 11.2, then, in addition to Section 11.5.1 and Section 11.5.2, MTEM 

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may request, no later than [***] after the effective date of termination, a written agreement setting forth the following terms and other reasonable and customary license terms:

(a)(i) If MTEM exercised the Co-Development Option and has not delivered a Co-Development Termination Notice, Takeda would grant to MTEM, effective as of the effective date of such termination, a worldwide, exclusive, sublicensable, royalty-bearing license under Takeda’s interest in the Joint Background IP and the Product Program IP and a non-exclusive, sublicensable, royalty-bearing license (where the royalties are set forth on Exhibit 11.5.3) under the Takeda Targeting Moiety IP, and Takeda Background IP (but only to the extent such Takeda Background IP was used during the Term in connection with the Licensed Products that incorporate or are comprised of the CD38 SLT-A Fusion Proteins listed in the Recitals and are in clinical development or being commercialized as of the effective date of termination of this Agreement (“Reversion Products”)) that relates to the Reversion Products and is necessary for the Development, Manufacture or Commercialization of Reversion Products, in each case solely to Develop, Manufacture and Commercialize Reversion Products; or (ii) if MTEM has either not exercised the Co-Development Option or a Co-Development Termination Notice has been delivered, then Takeda shall grant the license described above under the Joint Background IP and the Product Program IP on the terms and conditions referenced above but such license shall not include the Takeda Targeting Moiety IP or Takeda Background IP; if MTEM desires a license to Takeda Targeting Moiety IP or Takeda Background IP for the purposes described above, then MTEM shall notify Takeda in writing within [***] of the effective date of termination whether or not it desires to take such license and if so, then the terms of such license, including additional financial compensation to Takeda, shall be negotiated in good faith for a period of [***] after receipt of such notice from MTEM; 

(b)MTEM shall pay to Takeda (i) the development milestones and royalties set forth in Exhibit 11.5.3 and (ii) the amounts payable by [***] in each case ((i) and (ii)) to the extent arising from MTEM’s (or its Affiliates or (sub)licensees' Development, Manufacture or Commercialization of the Reversion Products), and Section 6.6 through Section 6.11 shall apply, mutatis mutandis, with respect to MTEM’s calculation, reporting and payment of such milestones and royalties on the Reversion Products In addition, MTEM shall be entitled to applicable step downs in Section 6.4.2, mutatis mutandis, except that aggregate deductions shall not exceed [***] and any portions of Section 6.4.2 that is specific to circumstances where the Co-Development Option has been exercised shall be ignored; 

(c)Takeda shall transfer and assign to MTEM all right, title and interest in any regulatory filings (including, but not limited to, INDs and European Union Clinical Trial Authorizations) made by Takeda or any of its Affiliates relating solely to Reversion Products, all regulatory materials relating solely to Reversion Products, and all non-clinical, clinical and other reports, records, data and other information developed or generated by or for Takeda or any of its Affiliates that relates solely to the Reversion Products that are reasonably required for MTEM to continue Development and Commercialization and to satisfy requirements imposed by applicable Regulatory Authorities with respect to the Reversion Products; 

(d)Takeda shall use good faith efforts to continue any ongoing Clinical Trials and shall cooperate with MTEM to effect an orderly transfer of Development, Manufacturing and regulatory responsibilities with respect to the relevant Licensed Product as promptly as practicable, at MTEM’s expense, including by (i) continuing to perform the 

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Development activities for which Takeda is responsible as assigned to Takeda under any applicable Program Plan until entry into a written agreement with MTEM setting forth the license terms following the effective date of termination of this Agreement, (ii) transferring to MTEM all quantities of Licensed Product required to complete any Clinical Trials underway at the time of such termination and (iii) transferring the Manufacturing process for Licensed Products to MTEM or its designee;

(e)At MTEM’s written request (and at MTEM’s cost and no cost to Takeda), to the extent Takeda has the right to do so, the license shall include a sublicense under Takeda’s rights in any or all Third Party agreements (including Existing Third Party Agreements) to the extent reasonably necessary for the Development, Manufacture or Commercialization of Licensed Products; for any such agreement for which Takeda does not have the right to grant a sublicense as contemplated under this clause (e), Takeda shall use commercially reasonable efforts to obtain consent to sublicense but in no event shall Takeda be required to provide any financial consideration to the Third Party in order to obtain such consent, unless MTEM pays to Takeda such financial consideration;

(f)Pursuant to a supply agreement to be negotiated in good faith by the Parties at the transfer price paid by Takeda for the applicable Licensed Product, if Takeda sources such product from a Third Party, or at [***] of Takeda's actual, direct costs of manufacture (excluding allocable overhead, depreciation, and the like), Takeda will supply MTEM with commercial quantities of the applicable Licensed Product in the dosage strength, formulation and presentation under Development or being Commercialized by Takeda, in either case, as of the effective date of termination of this Agreement in its entirety until the earlier of [***] after the effective date of termination of the Agreement or establishment by MTEM of an alternative supply for such Licensed Product. Pursuant to an agreed technology transfer plan, at MTEM's expense, Takeda shall also within [***] after MTEM's request, provide to MTEM or its designee all information in its possession with respect to the Manufacture of such Licensed Product reasonably sufficient for the transfer of such Manufacture to MTEM or a mutually agreed upon contract manufacturer organization;

(g)Takeda will consider in good faith, upon MTEM’s request, the transfer or assignment to MTEM all of Takeda’s and its Affiliates’ right, title and interest in and to any trademarks owned by Takeda or its Affiliates that are used (or held for use) solely and exclusively for any Licensed Products (excluding any trademark containing the word “Takeda” or “Millennium”);

(h)The Parties shall coordinate with regard to facilitating an orderly transition or, if MTEM does not desire to proceed, with regard to an orderly wind-down; and  

(i)[***] may not exercise its final decision making with regard to setting the terms of the termination license agreement under this Section 11.5.3.

11.5.4Effect of Termination by Takeda for Material Breach or for MTEM Insolvency. If Takeda terminates this Agreement in its entirety pursuant to Section 11.3.1 or Section 11.3.2, for clarity, the consequences set forth in Section 11.5.1 and Section 11.5.2 shall apply.  

11.5.5Continuation in Lieu of Termination. If Takeda has the right to terminate this Agreement under Section 11.3 (and MTEM does not dispute such right) but does 

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not elect to exercise such right, this Agreement shall continue in full force and effect with MTEM having the right to exercise its Co-Development Option or its rights to continue Co-Development shall terminate, (a) Takeda shall no longer have any obligations under any of the following: Sections 2.1.3, 2.1.5, 2.3.3, or 3.9.2 or Article VIII and (b) the licenses granted to MTEM hereunder shall terminate, (c) any milestones and royalties due hereunder shall be reduced by [***] of the amount that would otherwise be due under Section 6.2, Section 6.3 and Section 6.4, and (d) Takeda shall have the right to disband any and all committees and decisions within the authority of the applicable committee shall be in the authority of Takeda in its sole discretion. If Takeda has the right to terminate this Agreement under Section 11.3, delivers a notice, but MTEM does not cure the material breach within the specified cure period, then if Takeda later terminates this Agreement in its entirety pursuant to Section 11.2, then Section 11.5.4 shall apply and Section 11.5.3 shall not apply. 

11.5.6Survival.  

(a)The following provisions will survive expiration of this Agreement: Section 2.1.4, Section 2.1.6, Section 2.2, Section 2.3.1, Section 2.3.2, Section 2.4, Section 3.2, Section 3.3, Section 3.4 (to the extent related to the surviving licenses under Section 3.2 and 3.3), Section 3.5.1, Section 3.6, Section 3.8 (as it relates to any Joint Background IP and any jointly owned Program IP), Section 6.5 (for any Co-Development Costs incurred during the Term and any non-cancellable Co-Development Costs committed prior to the date of the expiration of this Agreement and any wind-down or transfer costs, which shall constitute Co-Development Costs), Section 6.6 (for any royalties on Net Sales of Licensed Products by Takeda made during Royalty Term or Co-Development Royalty Term, whichever is applicable, and either during the Term or pursuant to Section 11.5.2), Section 6.7 through  Section 6.13 (for final royalty reporting and payment), Article VII, Section 8.1, Section 8.2, Section 8.3, Section 8.4, Section 8.5, Section 8.7, Section 8.8, and Article X, Article XI and Article XII(other than 12.7.2).

(b)The following provisions will survive termination of this Agreement: Section 2.1.4, Section 2.4, Section 3.2, Section 3.4 (to the extent related to the surviving licenses under Section 3.2), Section 3.8 (as it relates to any Joint Background IP and any jointly owned Program IP), Section 6.5 (for any Co-Development Costs incurred during the Term and any non-cancellable Co-Development Costs committed prior to the date of the termination of this Agreement and any wind-down or transfer costs, which shall constitute Co-Development Costs), Section 6.6 (for any royalties on Net Sales of Licensed Products by Takeda made during Royalty Term or Co-Development Royalty Term, whichever is applicable, and either during the Term or pursuant to Section 11.5.2), Section 6.7 through Section 6.13, Article VII, Section 8.1, Section 8.2, Section 8.3.3, Section 8.3.4 and, as it relates to surviving Section 8.3.3 and Section 8.3.4, Section 8.3.5, Section 8.7 (for any action ongoing as of the date of termination of this Agreement or any action that relates to conduct under this Agreement during the Term) and Article X, Article XI and Article XII (other than Section 12.7.2). 

Article XII
MISCELLANEOUS

Section 12.1Notices. Any consent, notice or report required or permitted to be given or made under this Agreement by one of the Parties to the other shall be in writing, delivered personally or by facsimile (and promptly confirmed by personal delivery, first class air mail or 

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courier), first class air mail or courier, postage prepaid (where applicable), addressed to such other Party at its address indicated below, or to such other address as the addressee shall have last furnished in writing to the address or in accordance with this Section 12.1 and (except as otherwise provided in this Agreement) shall be effective upon receipt by the addressee. This Section 12.1 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement.

If to MTEM:
Molecular Templates, Inc.

185 Hudson Street, Harborside 5, Suite 1510
Jersey City, NJ 07311

Attention: Barbara A. Ruskin, General Counsel

Telephone: [***]

Email: [***]
 

If to Takeda:
Millennium Pharmaceuticals, Inc. 
40 Landsdowne Street

Cambridge, MA 02139

Attention: Legal Department

Telephone: (617) 679-7000

Facsimile: [***]

Section 12.2Applicable Law; Jurisdiction. This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts, without regard to the conflict of law principles thereof that may dictate application of the laws of any other jurisdiction. Subject to Section 12.3, the Parties hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of the Commonwealth of Massachusetts for any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement. 

Section 12.3Dispute Resolution. The Parties agree that if any dispute or disagreement (a “Dispute”) in respect of this Agreement arises between Takeda on the one hand and MTEM on the other, or the JSC where Takeda does not have [***] decision-making authority, subject to Section 12.13, the Parties shall follow the following procedure in an attempt to resolve the dispute or disagreement. 

12.3.1The Party claiming that such a dispute exists shall give notice in writing (“Notice of Dispute”) to the other Party of the nature of the dispute.

12.3.2Within [***] following receipt of a Notice of Dispute, the [***] of MTEM and the [***] (or equivalent) of Takeda shall meet at a mutually agreed upon time and location (which may be by phone) for the purpose of resolving such dispute.

12.3.3In the event of a dispute between the Parties requiring resolution by a panel of experts (“Expert Panel”), such dispute shall be resolved in accordance with this Section 12.3.3. Notice from a Party initiating resolution by the Expert Panel shall contain a statement of the issue forming the basis of the dispute, the position of the moving Party as to the proper resolution of that issue and the basis for such position. Within [***] after receipt of such notice, 

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the responding Party shall submit to the moving Party a statement of its conception of the specific issue in question, its position as to the proper resolution of that issue and the basis for such position. 

(a)Within [***] of the responding Party’s response, each Party shall appoint to the Expert Panel an individual who (i) has expertise in the pharmaceutical or biotechnology industry and the specific matters at issue, (ii) is not a current or former director, employee or consultant of such Party or any of its Affiliates, or otherwise has not received compensation or other payments from such Party (or its Affiliates) for the [***] and (iii) has no known personal financial interest or benefit in the outcome or resolution of the dispute, and the appointing Party shall give the other Party written notice of such appointment; provided, that for such appointment to be effective and for such individual to serve on the Expert Panel, such individual must deliver to the other Party a certificate confirming that such individual satisfies the criteria set forth in clauses (i) through (iii) above, disclosing any potential conflict or bias and certifying that, as a member of the Expert Panel, such individual is able to render an independent decision. Within [***] of the appointment of the second expert, the two (2)-appointed experts shall agree on an additional expert who meets the same criteria as described above, and shall appoint such expert as chair of the Expert Panel. If the Party-appointed experts fail to timely agree on a third expert, then upon the written request of either Party, each Party-appointed expert shall, within [***] of such request, nominate one expert candidate and the CPR Institute for Dispute Resolution shall, within [***] of receiving the names of the Parties’ respective nominees, select one of those experts to serve as the chair of the Expert Panel. Each expert shall agree, prior to his or her appointment, to render a decision as soon as practicable after the appointment of the full Expert Panel. 

(b)Within [***] of the appointment of the third expert, the Expert Panel shall hold a preliminary meeting or teleconference with the Parties or their representatives and shall designate a time and place for a hearing of the Parties on the dispute and the procedures to be utilized at the hearing. The Parties may agree in writing to waive the hearing and have the Expert Panel reach a decision on the basis of written submissions alone. The Expert Panel may order the Parties to produce any documents or information that are relevant to the dispute. All such documents or information shall be provided to the other Party and the Expert Panel as expeditiously as possible but no later than [***] prior to the hearing (if any), along with the names of all witnesses who will testify at the hearing and a brief summary of their testimony. The hearing shall be held in Boston, MA unless otherwise agreed by the Parties, and shall take place as soon as possible but no more than [***] after the appointment of the third expert, unless the Parties otherwise agree in writing or the Expert Panel agrees to extend such time period for good cause shown. The hearing shall last no more than [***], unless otherwise agreed by the Parties or the Expert Panel agrees to extend such time period for good cause shown. After the conclusion of all testimony (or if no hearing is held after all submissions have been received from the Parties), at a time designated by the Expert Panel no later than [***] after the close of the hearing or the receipt of all submissions, each Party shall simultaneously submit to the Expert Panel and exchange with the other Party its final proposed resolution. 

(c)In rendering the final decision (which shall be rendered no later than [***] after receipt by the Expert Panel of the Parties’ respective proposed resolutions), the Expert Panel shall be limited to choosing a resolution proposed by a Party without modification; provided, that in no event shall the Expert Panel render a decision that is inconsistent with the Parties’ intentions as set forth in this Agreement. The agreement of two (2) of the three (3) 

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experts shall be sufficient to render a decision and the Parties shall abide by such decision. The decision of the Expert Panel shall be final and binding on the Parties and may be entered and enforced in any court having jurisdiction. The Parties shall share equally the costs and expenses of the Expert Panel.

12.3.4In the event of an unresolved dispute between the Parties involving intellectual property, including any disputes relating to inventorship or the validity, enforceability or scope of any patent or trademark rights shall, but other than as set forth in Section 12.3.3, such dispute shall, at either Party’s election and subject to Section 12.2, be submitted for resolution by a court of competent jurisdiction.

12.3.5In the event of a dispute regarding any payments owing under this Agreement, all undisputed amounts shall be paid promptly when due and the balance, if any, promptly after resolution of the dispute.

Section 12.4Entire Agreement. This Agreement, together with the Exhibits and Schedules attached hereto and the Quality Agreement, contains the entire understanding of the Parties with respect to the specific subject matter hereof. All express or implied agreements and understandings, either oral or written, heretofore made are expressly superseded by this Agreement (other than the Multi-Target Agreement). This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by both Parties. The Multi-Target Agreement shall remain in effect by its terms, except that with respect to the Licensed Product and Target and other subject matter of this Agreement, this Agreement shall control.  

Section 12.5Severability. Each Party hereby agrees that it does not intend to violate any public policy, statutory or common laws, rules, regulations, treaty or decision of any government agency or executive body thereof of any country or community or association of countries. Should one or more provisions of this Agreement be or become invalid, the Parties shall substitute, by mutual consent, valid provisions for such invalid provisions, in their economic effect, are sufficiently similar to the invalid provisions that it can be reasonably assumed that the Parties would have entered into this Agreement based on such valid provisions. In case such alternative provisions cannot be agreed upon, the invalidity of one or several provisions of this Agreement shall not affect the validity of this Agreement as a whole, unless the invalid provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without the invalid provisions.

Section 12.6Force Majeure. No Party (or any of its Affiliates) shall be held liable or responsible to the other Party (or any of its Affiliates) hereunder, or be deemed to have defaulted under or breached this Agreement, for failure or delay by such Party in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party (or any of its Affiliates), including fire, floods, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, acts of God, earthquakes, or omissions or delays in acting by any Governmental Authority (each, an “Event of Force Majeure”); provided, that the affected Party shall exert all reasonable efforts to eliminate, cure or overcome any such Event of Force Majeure and to resume performance of its obligations promptly. Notwithstanding the foregoing, to the extent that an Event of Force Majeure continues for a period in excess of [***], the affected Party shall promptly notify in writing the other Party of such Event of Force Majeure and within [***] of 

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the other Party’s receipt of such notice, the Parties shall negotiate in good faith either (a) a resolution of the Event of Force Majeure, if possible or (b) an extension by mutual agreement of the time period to resolve, eliminate, cure or overcome such Event of Force Majeure. 

Section 12.7Assignment and Change of Control. 

12.7.1Assignment. Neither Party may assign its rights or, except as provided in Section 12.8 and Article VIII, delegate its obligations under this Agreement, whether by operation of law or otherwise, in whole or in part (including with respect to any CD38 SLT-A Fusion Protein or any Licensed Product) without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed, except that Takeda shall have the right, without such consent, (a) to perform any or all of its obligations and exercise any or all of its rights under this Agreement through any of its Affiliates, Sublicensees or Distributors, and (b) assign any or all of its rights and delegate any or all of its obligations hereunder (including on a CD38 SLT-A Fusion Protein-by-CD38 SLT-A Fusion Protein or Licensed Product-by-Licensed Product basis) to any of its Affiliates or its or their Sublicensees or to any successor in interest (whether by merger, acquisition, asset purchase or otherwise) to all or substantially all of the business to which this Agreement (or the CD38 SLT-A Fusion Protein or Licensed Product(s)) relates; provided that Takeda shall provide written notice to MTEM within [***] after such assignment or delegation. Any permitted successor of Takeda or any permitted assignee of all of Takeda’s rights under this Agreement that has also assumed all of Takeda’s obligations hereunder in writing shall, upon any such succession or assignment and assumption, be deemed to be a party to this Agreement as though named herein in substitution for Takeda, whereupon Takeda shall cease to be a Party to this Agreement and shall cease to have any rights or obligations under this Agreement. All validly assigned rights of Takeda shall inure to the benefit of and be enforceable by, and all validly delegated obligations of Takeda shall be binding on and be enforceable against, the permitted successors and assigns of Takeda. Any attempted assignment or delegation in violation of this Section 12.7 shall be void and of no effect.

12.7.2 Change in Control. MTEM shall notify Takeda in writing as soon as possible after MTEM announces a Change in Control of MTEM (or if the Change in Control will not be publicly announced, then no later than [***] after the signing of the Change in Control). Takeda shall have the right, at its election in its sole discretion, to take one or more of the following actions by written notice to MTEM:

(a)disband any or all of the Joint Steering Committee, the Joint Development Committee and the Joint Manufacturing Committee and the Joint Patent Committee and any other committees or working groups, and terminate the activities of such committees; 

(b)undertake any not yet completed Early Stage Program activities of MTEM, if any, solely and exclusively by (or on behalf of) itself (without any consultation with or approval by MTEM) and neither MTEM nor any of its Affiliates shall have the right to receive reports under Section 2.1.5 from and after the date of such Change in Control and in such case MTEM shall cease conducting such activities; 

(c)require that (i) the Future Acquirer agree in writing to maintain at least the same level of diligence in performing its obligations under this Agreement, including its 

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Manufacturing and its Co-Development payment obligations after the Change in Control, if the Co-Development Option has been exercised, at or above the level of diligence that had been applied prior to the Change in Control, unless otherwise agreed to in writing by the Parties, and (ii) no employee of the Future Acquirer or such Future Acquirer’s Affiliates shall participate in or contribute to the performance of MTEM’s obligations in connection with the Early Stage Program, the Post Phase Ia Program or Manufacturing hereunder (and may not serve as the primary contact or as representative, member, delegate or attendee of the Joint Steering Committee, Joint Manufacturing Committee, the Joint Patent Committee or the Joint Development Committee (if such applicable committee remains constituted, at Takeda’s discretion)) or otherwise be provided or have access to any Confidential Information of Takeda. 

Without limiting the foregoing, MTEM shall not disclose to, and shall implement appropriate protections to prevent the use by such Future Acquirer of any Program IP or other Product Information for uses that are the subject of an exclusive license to Takeda with respect to Development and Commercialization of Licensed Products. 

Section 12.8Performance by Affiliates. The Parties recognize that each may perform some or all of its obligations under this Agreement through Affiliates; provided, that each Party shall remain responsible and be a guarantor of the performance by its Affiliates and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance.

Section 12.9Independent Contractors. MTEM and Takeda each acknowledge that they shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture, agency or any type of fiduciary relationship. Neither MTEM nor Takeda shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior consent of the other Party to do so.

Section 12.10Waiver and Non-Exclusion of Remedies. The waiver by either Party of any right hereunder or the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available, except as expressly set forth herein.

Section 12.11 Further Assurances. Each Party shall execute such additional documents as are necessary to effect the purposes of this Agreement.

Section 12.12 No Benefit to Third Parties. Except as provided in Article X, the covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns and they shall not be construed as conferring any rights on any other parties.

Section 12.13 Equitable Relief. Each Party acknowledges and agrees that the restrictions set forth in Section 3.9, Article VII and Article VIII are reasonable and necessary to protect the legitimate interests of the other Party and that such other Party would not have entered into this Agreement in the absence of such restrictions and that any breach or threatened breach of any provision of such Section or Articles may result in irreparable injury to such other Party for which there will be no adequate remedy at law. In the event of a breach or threatened 

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breach of any provision of such Section or Articles, the non-breaching Party shall be authorized and entitled to seek from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, specific performance and an equitable accounting of all earnings, profits and other benefits arising from such breach, which rights shall be cumulative and in addition to any other rights or remedies to which such non-breaching Party may be entitled in law or equity. Both Parties agree to waive any requirement that the other (a) post a bond or other security as a condition for obtaining any such relief and (b) show irreparable harm, balancing of harms, consideration of the public interest or inadequacy of monetary damages as a remedy. Nothing in this Section 12.13 is intended or should be construed, to limit either Party’s right to equitable relief or any other remedy for a breach of any other provision of this Agreement.

Section 12.14 Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Counterparts may be signed or delivered by facsimile or electronically scanned signature page.

 (The remainder of this page has been intentionally left blank. The signature pages follows.)

 

 

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IN WITNESS WHEREOF, the Parties have executed this Development Collaboration and Exclusive Commercial License Agreement as of the Effective Date.

 

MOLECULAR TEMPLATES, INC.

By: /s/ Eric Poma

Name: Eric Poma

Title: CEO

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

MILLENNIUM PHARMACEUTICALS, INC.

 

By: /s/ Christophe Bianchi

Christophe Bianchi

President

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Schedule 1.1.51.  Early Stage Program Plan

[***]

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Schedule 1.1.132.  Phase Ia Clinical Trial Plan and Budget

{Redacted Schedule 1.1.132 comprises 3 pages}

[***]

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Schedule 1.1.162.  Existing SLT-As

[***]

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Schedule 1.1.164.  Patent Rights and Inventions that cover SLT-A Technology

SLT-A TECHNOLOGY

[***]

 

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Schedule 9.2.5.  MTEM Background Patent Rights

SCHEDULE 9.2.5

MTEM BACKGROUND PATENT RIGHTS

 

	
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Schedule 9.2.8.  Future MTEM In-Licenses

[To be updated by MTEM in the future as required under Section 9.2.8]

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Schedule 9.2.11.  SLT-As with respect to which MTEM or its Affiliates Control MTEM Background IP 

 

Existing SLT-As are described in the following patent applications: 

 

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Page 95

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Page 96

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Page 97

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Exhibit 11.5.3  Applicable Royalties and Milestones for Post-Termination License pursuant to Section 11.5.3.

			
	
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82557933v.1

 
 
Page 98

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.mtem-ex103_177.htm

 

Exhibit 10.3

STATE OF TEXAS

COUNTY OF TRAVIS

This CANCER RESEARCH GRANT CONTRACT (“Contract”) is by and between the Cancer Prevention and Research Institute of Texas (“CPRIT”), hereinafter referred to as the “INSTITUTE”, acting through its Chief Executive Officer, and Molecular Templates, Inc., hereinafter referred to as the “RECIPIENT”, acting through its authorized signing official.

RECITALS

WHEREAS, pursuant to TEX. HEALTH & SAFETY CODE, Ch. 102, the INSTITUTE may make grants to public and private persons in this state for research into the causes and cures for all types of cancer in humans; facilities for use in research into the causes and cures for cancer; research to develop therapies, protocols, medical pharmaceuticals, or procedures for the cure or substantial mitigation of all types of cancer; and cancer prevention and control programs.

WHEREAS, Article III, Section 67 of the Texas Constitution expressly authorizes the State of Texas to sell general obligation bonds on behalf of the INSTITUTE and for the INSTITUTE to use the proceeds from the sale of the bonds for the purposes of cancer research and prevention programs in this state.

WHEREAS, the INSTITUTE issued a request for applications for RFA P-16-TXCO-2: Texas Company Product Development Research Awards on or about January 2016.

WHEREAS, pursuant to TEX. HEALTH & SAFETY CODE § 102.251, and after a review by the INSTITUTE’s scientific research and prevention program committees, the INSTITUTE has approved a Grant (defined below) to be awarded to the RECIPIENT.

WHEREAS, to ensure that the Grant provided to the RECIPIENT pursuant to this Contract is utilized in a manner consistent with “Tex. Const. Article III, Section 67 and other laws, and in exchange for receiving such Grant, the RECIPIENT agrees to comply with certain conditions and deliver certain performance.

WHEREAS, the RECIPIENT and the INSTITUTE desire to set forth herein the provisions relating to the awarding of such monies and the disbursement thereof to the RECIPIENT.

IN CONSIDERATION of the Grant and the premises, covenants, agreements, and provisions contained in this Contract, the parties agree to the following terms and conditions:

Article I

DEFINITIONS

The following terms shall have the following meaning throughout this Contract and any Attachments and amendments.  Other terms may be defined elsewhere in this Contract.

(1)Collaborator - any entity other than the RECIPIENT having one or more personnel participating in the Project and (a) designated as a collaborator in the application submitted by the RECIPIENT requesting the Grant funds awarded by the INSTITUTE, or (b) otherwise approved in writing as a collaborator by the INSTITUTE.

1

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

(2)Contractor - any person or entity, other than a Collaborator or the RECIPIENT (or their respective personnel), who is contracted by the RECIPIENT to perform activities for the Project.

(3)Equipment - an article of tangible, nonexpendable personal property having a useful life of more than one year and an acquisition cost of $5,000 or more per unit.

(4)Grant - the funding assistance authorized by TEX. HEALTH & SAFETY CODE, Ch. 102 in the amount specified in Section 2.01 and awarded by the INSTITUTE to the RECIPIENT to carry out the Project pursuant to the terms and conditions of this Contract.

(5)Indirect Costs - the expenses of doing business that are not readily identified with a particular grant, contract, project, function or activity, but are necessary for the general operation of the organization or the performance of the organization’s activities.

(6)Institute-Funded Activity - all aspects of work conducted on or as part of the Project.

(7)Non-Profit Organization  - a university or other institution of higher education or an organization of the type described in 501(c)(3) of the Internal Revenue Code of 1986, as amended (26 U.S.C. 501 (c)(3)) and exempt from taxation under 501 (a) of the Internal Revenue Code (26 U.S.C. 501 (a)) or any nonprofit scientific or educational organization qualified under a state nonprofit organization statute.

(8)Principal Investigator/Program Director - the individual designated by the RECIPIENT to direct the Project who is principally responsible and accountable to the RECIPIENT and the INSTITUTE for the proper conduct of the Project.  References herein to “Principal Investigator/Program Director” include Co-Principal Investigators or Co-Program Directors as well.  The Principal Investigator/Program Director and Co-Principal Investigators or Co-Program Directors are set forth on Attachment A.

(9)Project  - the activities specified or generally described in the Scope of Work or otherwise in this Contract (including without limitation any of the Attachments to the Contract) that are approved by the INSTITUTE for funding, regardless of whether the INSTITUTE funding constitutes all or only a portion of the financial support necessary to carry them out.

(10)Recipient Personnel - The RECIPIENT’s Principal Investigator/Program Director and RECIPIENT’s employees and consultants working on the Project.

Article II

GRANT AWARD

Section 2.01Award of Monies.  In accordance with the provisions of this Contract and any applicable agency administrative rules, the INSTITUTE shall disburse the proceeds of the Grant to the RECIPIENT in an amount not to exceed $ 15,200,000 to be used solely for the Project.  This award is subject to compliance with the Scope of Work and demonstration of progress towards achievement of the milestones set forth in Section 2.02.  This Grant is not intended to be a loan of money.

Section 2.02Scope of Work and Milestones.  The RECIPIENT shall perform the Project in accordance with this Agreement and as outlined in Application DP160071 submitted by the RECIPIENT and approved by the INSTITUTE.  The RECIPIENT shall conduct the Project within the State of Texas with Texas-based employees, Contractors and/or Collaborators unless otherwise specified in the Scope of Work or the Approved Budget.  The INSTITUTE and the RECIPIENT hereby adopt the terms of Attachment A in their entirety, incorporate them as if fully set forth herein, and agree that the Project description, goals, timeline and milestones included as Attachment A accurately reflect the Scope of Work of the Project to be undertaken by the RECIPIENT (the “Scope of Work”) and the milestones expected to be achieved.  RECIPIENT and the INSTITUTE mutually agree that the outcome of scientific research is unpredictable and cannot be guaranteed.  The RECIPIENT shall use commercially reasonable efforts to complete the goals of the Project pursuant to the timeline reflected in Attachment A and shall timely notify 

2

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

the INSTITUTE if circumstances occur that materially and adversely affect completion thereof.  Modifications, if any, to the Scope of Work must be agreed to in writing by both parties as set forth in Section 2.06 “Amendments and Modifications” herein.  Material changes to the Scope of Work include, but are not limited to, changes in key personnel involved with the Project, the site of the Project, and the milestones expected to be achieved.

Section 2.03Contract Term.  The Contract shall be effective as of December 01, 2016 (the “Effective Date”) and terminate on November 30, 2019 or in accordance with the Contract termination provisions set forth in Article VIII herein, whichever shall occur first (the “Termination Date”).  Unless otherwise approved by the INSTITUTE as evidenced by written communication from the INSTITUTE to the RECIPIENT and appended to the Contract, Grant funds distributed pursuant to the Contract shall be expended no earlier than the Effective Date or subsequent to the Termination Date.  If, as of the Termination Date, the RECIPIENT has not used Grant money awarded by the INSTITUTE for permissible services, expenses, or costs related to the Project and has not received approval from the INSTITUTE for a no cost extension to the contract term pursuant to Section 3.11 “Carry Forward of Unspent Funds and No Cost Extension” herein, then the RECIPIENT shall not be entitled to retain such unused Grant funds from the INSTITUTE.  Certain obligations as set forth in Section 9.09 of this Contract shall extend beyond the Termination Date.

Section 2.04Contract Documentation.  The Contract between the INSTITUTE and the RECIPIENT shall consist of this final, executed Contract, including the following Attachments to the Contract, all of which are hereby incorporated by reference:

(a)Attachment A – Project Description, Goals and Timeline

	
 
	
(b)
	
Attachment B – Approved Budget, including changes approved by the INSTITUTE subsequent to execution of the Contract.

(c)Attachment C – Assurances and Certifications

(d)Attachment D – Intellectual Property and Revenue Sharing

	
 
	
 (e)
	
Attachment E – Reporting Requirements

	
 
	
(f)
	
Attachment F – Approved Amendments to Contract, excluding budget amendments reflected in Attachment B.

Section 2.05Entire Agreement.  All agreements, covenants, representations, certifications and understandings between the parties hereto concerning this Contract have been merged into this written Contract.  No prior contemporaneous representation, agreement or understanding, express or implied, oral or otherwise, of the parties or their agents that may have related to the subject matter hereof in any way shall be valid or enforceable unless embodied in this Contract.

Section 2.06Amendments and Modifications.  Requested amendments and modifications to the Contract must be submitted in writing to the INSTITUTE for review and approval (such approval shall not be unreasonably withheld.) Amendments and modifications (including alterations, additions, deletions, assignments and extensions) to the terms of this Contract shall be made solely in writing and shall be executed by both parties.  The approved amendment shall be reflected in Attachment A if it is change to the Scope of Work, or as part of Attachment B if it is a budget amendment, or as part of Attachment F for all other changes.

Section 2.07Relationship of the Parties.  The RECIPIENT shall be responsible for the conduct of the Project that is the subject of this Contract and shall direct the activities and at all times be responsible for the performance of Recipient Personnel, Collaborators, Contractors and other agents.  The INSTITUTE does not assume responsibility for the conduct of the Project or any Institute-Funded Activity that is the subject of this Contract.  The INSTITUTE and the RECIPIENT shall perform their respective obligations under this Contract as independent contractors and 

3

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

not as agents, employees, partners, joint venturers, or representatives of the other party.  Neither party is permitted to make representations or commitments that bind the other party.

Section 2.08Subcontracting.  Any and all subcontracts entered into by the RECIPIENT in relation to the performance of activities under the Project shall be in writing and shall be subject to the requirements of this Contract.  Without in any way limiting the foregoing, the RECIPIENT shall enter into and maintain a written agreement with each such permitted Contractor with terms and conditions sufficient to ensure the RECIPIENT fully complies with the terms of this Contract, including without limitation the terms set forth in Attachments C, D, and E.  The RECIPIENT agrees that it shall be responsible to the INSTITUTE for the performance of and payment to any Contractor.  Any reimbursements made by the RECIPIENT to a Contractor shall be made in accordance with the applicable provisions of TEX. GOV’T. CODE, Ch. 2251.

Section 2.09Transfer or Assignment by the Recipient.  This Contract is not transferable or otherwise assignable by the RECIPIENT, whether by operation of law or otherwise, without the prior written consent of the INSTITUTE, except as provided in this Section 2.09.  Any such attempted transfer or assignment without the prior written consent of the INSTITUTE (except as provided in this Section 2.09) shall be null, void and of no effect.  For purposes of this section, an assignment or transfer of this Contract by the RECIPIENT in connection with a merger, transfer or sale of all or substantially all of the RECIPIENT’s assets or business related to this Contract or a consolidation, change of control or similar transaction involving the RECIPIENT shall not be deemed to constitute a transfer or assignment, so long as such action does not impair or otherwise negatively impact the revenue sharing terms in Attachment D.  Nothing herein shall be interpreted as superseding the requirement that the Project be undertaken in Texas with Texas-based employees.

If the Principal Investigator leaves the employment of the RECIPIENT or is replaced by the RECIPIENT for any reason during the course of the Grant with someone who is not already designated a co-Principal Investigator in the Application, the RECIPIENT shall notify the INSTITUTE prior to replacing the Principal Investigator.  Written approval by the INSTITUTE is required for the replacement of the Principal Investigator with someone who is not already a co-Principal Investigator in the Application, which approval shall not be unreasonably withheld, conditioned or delayed.

Section 2.10Representations and Certifications.  The RECIPIENT represents and certifies to the best of its knowledge and belief to the INSTITUTE as follows:

	
 
	
(a)
	
It has legal authority to enter into, execute, and deliver this Contract, and all documents referred to herein, and it has taken all actions necessary to its execution and delivery of such documents;

	
 
	
(b)
	
It will comply with all of the terms, conditions, provisions, covenants, requirements, and certifications in this Contract, applicable statutory provisions, agency administrative rules, and all other documents incorporated herein by reference;

	
 
	
(c)
	
It has made no material false statement or misstatement of fact in connection with this Contract and its receipt of the Grant, and all of the information it previously submitted to the INSTITUTE or that it is required under this Contract to submit to the INSTITUTE relating to the Grant or the disbursement of any of the Grant is and will be true and correct at the time such statement is made;

	
 
	
(d)
	
It is in compliance in all material respects with provisions of its charter and of the laws of the State of Texas, and of the laws of the jurisdiction in which it was formed, and (i) there are no actions, suits, or proceedings pending, or threatened, before any judicial body or governmental authority against or affecting its ability to enter into this Contract, or any document referred to herein, or to perform any of the material acts required of it in such documents and (ii) it is not in default with respect to any order, writ, injunction, decree, or demand of any court or any governmental authority which would impair its ability to enter into this Contract, or any document referred to herein, or to perform any of the material acts required of it in such documents;

4

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

	
 
	
(e)
	
Neither the execution and delivery of this Contract or any document referred to herein, nor compliance with any of the terms, conditions, requirements, or provisions contained in this Contract or any documents referred to herein, is prevented by, is a breach of, or will result in a breach of, any term, condition, or provision of any agreement or document to which it is now a party or by which it is bound; and

	
 
	
(f)
	
It shall furnish such satisfactory evidence regarding the representations and certifications described herein as may be required and requested by the INSTITUTE from time to time.

Section 2.11Reliance upon Representations.  By awarding the Grant and executing this Contract, the INSTITUTE is relying, and will continue to rely throughout the term of this Contract, upon the truthfulness, accuracy, and completeness of the RECIPIENT’s written assurances, certifications and representations.  Moreover, the INSTITUTE would not have entered into this Contract with the RECIPIENT but for such written assurances, certifications and representations.  The RECIPIENT acknowledges that the INSTITUTE is relying upon such assurances, certifications and representations and acknowledges their materiality and significance.

Section 2.12Contingent upon Availability of Grant Funds.  This Contract is contingent upon funding being available for the term of the Contract and the RECIPIENT shall have no right of action against the INSTITUTE in the event that the INSTITUTE is unable to perform its obligations under this Contract as a result of the suspension, termination, withdrawal, or failure of funding to the INSTITUTE or lack of sufficient funding of the INSTITUTE for this Contract.  If funds become unavailable to the INSTITUTE during the term of the Contract, Section 8.01(c) shall apply.  For the sake of clarity, and except as otherwise provided by this Contract, if this Contract is not funded, then both parties are relieved of all of their obligations under this Contract.  The INSTITUTE acknowledges and agrees that the Project is a multiyear project subject to Tex.  Health & Safety Code, Ch. 102, Section 102.257.

Section 2.13Confidentiality of Documents and Information.  In connection with work contemplated for the Project or pursuant to complying with various provisions of this Contract, the RECIPIENT may disclose its confidential business, financial, technical, scientific information and other information to the INSTITUTE (“Confidential Information”).  To assist the INSTITUTE in identifying such information, the RECIPIENT shall mark or designate the information as “confidential,” provided however that the failure to so designate does not operate as a waiver to protections provided by applicable law or this Contract.  The INSTITUTE shall use no less than reasonable care to protect the confidentiality of the Confidential Information to the fullest extent permissible under the Texas Public Information Act, Texas Government Code, Chapter 552 (the “TPIA”), and, except as otherwise provided in the TPIA to prevent the disclosure of the Confidential Information to third parties for a period of time equal to three (3) years from the termination of the contract, unless the INSTITUTE and the RECIPIENT agree in writing to extend such time period, provided that this obligation shall not apply to information that:

	
 
	
(a)
	
was in the public domain at the time of disclosure or later became part of the public domain through no act or omission of the INSTITUTE in breach of this Contract;

	
 
	
(b)
	
was lawfully disclosed to the INSTITUTE by a third party having the right to disclose it without an obligation of confidentiality;

	
 
	
(c)
	
was already lawfully known to the INSTITUTE without an obligation of confidentiality at the time of disclosure;

	
 
	
(d)
	
was independently developed by the INSTITUTE without using or referring to the RECIPIENT’s Confidential Information; or

(e)is required by law or regulation to be disclosed.

The INSTITUTE shall hold the Confidential Information in confidence, shall not use such Confidential Information except as provided by the terms of this Contract, and shall not disclose such Confidential Information to third parties without the prior written approval of the RECIPIENT or as otherwise allowed by the terms of the Contract.  Subject 

5

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

in all respects to the terms of this Contract and the TPIA, the INSTITUTE has the right to use and disclose the Confidential Information reasonably in connection with the exercise of its rights under the Contract.

In the event that the INSTITUTE is requested or required (by oral questions, interrogatories, requests for information or documents in legal proceedings, subpoena, civil investigative demand or other similar process by a court of competent jurisdiction or by any administrative, legislative, regulatory or self-regulatory authority or entity) to disclose any Confidential Information, the INSTITUTE shall provide the RECIPIENT with prompt written notice of any such request or requirement so that the RECIPIENT may seek a protective order or other appropriate remedy.  If, in the absence of a protective order or other remedy, the INSTITUTE is nonetheless legally compelled to make any such disclosure of Confidential Information to any person, the INSTITUTE may, without liability hereunder, disclose only that portion of the Confidential Information that is legally required to be disclosed, provided that the INSTITUTE will use reasonable efforts to assist the RECIPIENT, at the RECIPIENT’s expense, in obtaining an appropriate protective order or other reliable assurance that confidential treatment will be accorded the Confidential Information.  To the extent that such Confidential Information does not become part of the public domain by virtue of such disclosure, it shall remain Confidential Information hereunder.

Article III

DISBURSEMENT OF GRANT AWARD PROCEEDS

Section 3.01Payment of Grant Award Proceeds.  The INSTITUTE will advance Grant award proceeds upon request by the RECIPIENT, consistent with the amounts and schedule as provided in Attachment B.  If the RECIPIENT does not request or the Oversight Committee does not authorize advancement of funds for some or the entire Grant award proceeds, disbursement of Grant award proceeds for services performed and allowable expenses and costs incurred pursuant to the Scope of Work will be on a reimbursement basis.  To the extent that completion of certain milestones is associated with a specific tranche of funding as reflected in the Scope of Work, those milestones shall be accomplished before funding may be provided for next tranche of funding.  The INSTITUTE reserves the right to terminate the Contract should a key milestone not be met.

Section 3.02 Requests for Reimbursement and Quarterly Financial Status Reports.  If the RECIPIENT does not receive an advance disbursement of Grant proceeds, the RECIPIENT’s requests for reimbursement shall be made on INSTITUTE Form 269a (Financial Status Report).  If the RECIPIENT has elected to receive an advance disbursement of Grant proceeds, RECIPIENT shall submit INSTITUTE Form 269a (Financial Status Report) to document all costs and allowable expenses paid with Grant proceeds.  The RECIPIENT shall submit the INSTITUTE Form 269a quarterly to the INSTITUTE within 90 days following the end of the quarter covered by the bill.  A final INSTITUTE Form 269a shall be submitted by RECIPIENT not later than 90 days after the Termination Date.  An extension of time for submission deadlines specified herein must be expressly authorized in writing by the INSTITUTE.

Section 3.03 Actual Costs and Allowable Expenses.  Because the Approved budget for the Project(s) as set forth in Attachment B is only an estimate, the parties agree that the RECIPIENT’s billings under this Contract will reflect the actual costs and expenses incurred in performing the Project(s), regardless of the Approved Budget, up to the total contracted amount specified in Section 2.01 “Award of Monies.” The RECIPIENT shall use Grant proceeds only for allowable expenses consistent with state law and agency administrative rules.  Allowable expenses for the Project(s) shall be only as outlined in the Approved Budget and any modifications to same.

Section 3.04 Travel Expenses.  Reimbursement for travel expenditures shall be in accordance with the Approved Budget.  Prior written approval from the INSTITUTE must be obtained before travel that exceeds the amount included in the Approved Budget commences.  Failure to obtain such prior written approval shall result in such excess travel costs constituting expenses that may not be taken into account for the purposes of calculating expenditure of Grant funds under this Contract.

Section 3.05 Budget Modifications.  The total Approved Budget and the assignment of costs may be adjusted based on implementation of the Scope of Work, spending patterns, and unexpended funds, but only by an amendment to the Approved Budget.  In no event shall an amendment to the Approved Budget result in payments in 

6

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

excess of the aggregate amount specified in Section 2.01 “Award of Monies” or in approved supplemental funding for the Project, if any.  The RECIPIENT may make transfers between or among lines within budget categories without prior written approval provided that:

	
 
	
(a)
	
The total dollar amount of all changes of any single line item within budget categories (individually and in the aggregate) is less than 10% of the total Approved Budget;

(b)The transfer will not increase or decrease the total Approved Budget;

	
 
	
(c)
	
The transfer will not materially change the nature, performance level, or Scope of Work of the Project; and

	
 
	
(d)
	
The RECIPIENT submits a revised copy of the Approved Budget including a narrative justification of the changes prior to incurring costs in the new category.

All other budget changes or transfers require the INSTITUTE’s express prior written approval.  Transfer of funds between categories in the Project’s Approved Budget may be allowed if requests are in writing, fit within the Scope of Work and the total Approved Budget, are beneficial to the achievement of the objectives of the Project, and appear to be an efficient, effective use of the INSTITUTE’s funds.

Section 3.06Withholding Payment.  The INSTITUTE may withhold Grant award proceeds from RECIPIENT if required Financial Status Reports (Form 269a) are not on file for previous quarters or for the final period, if material program requirements are not met and remain uncured after a reasonable time period to cure, if the RECIPIENT is in breach of any material term of this Contract, or in accordance with provisions of this Contract as well as applicable state or federal laws, regulations or administrative rules, and the breach remains uncured after a reasonable time period to cure.  The INSTITUTE shall have the right to withhold all or part of any future payments to the RECIPIENT to offset any prior advance payments made to the RECIPIENT for ineligible expenditures that have not been refunded to the INSTITUTE by the RECIPIENT.

Section 3.07Grant Funds as Supplement to Budget.  The RECIPIENT shall use the Grant proceeds awarded pursuant to this Contract to supplement its overall budget.  These funds will in no event supplant existing funds currently available to the RECIPIENT that have been previously budgeted and set aside for the Project.  The RECIPIENT will not bill the INSTITUTE for any costs under this Contract that also have been billed or should have been billed to any other funding source.

Section 3.08Buy Texas.  The RECIPIENT shall apply good faith efforts to purchase goods and services from suppliers in Texas to the extent reasonably possible, to achieve a goal of more than 50 percent of such purchases from suppliers in Texas.

Section 3.09Historically Underutilized Businesses.  The RECIPIENT shall use reasonable efforts to purchase materials, supplies or services from a Historically Underutilized Business (HUB).  The Texas Procurement and Support Services website will assist in finding HUB vendors (http://www.window.state.tx.us/procurement.) The RECIPIENT shall complete a HUB report with each annual report submitted to the INSTITUTE in accordance with Attachment E.

Section 3.10Limitation on Use of Grant Award Proceeds to Pay Indirect Costs.  The RECIPIENT shall not spend more than five percent of the Grant award proceeds for Indirect Costs.

Section 3.11Carry Forward of Unspent Funds and No Cost Extension.  RECIPIENT may request to carry forward unspent funds into the budget for the next year.  Carryover of unspent funds must be specifically approved by the INSTITUTE.  The INSTITUTE may approve a no cost extension for the Contract for a period not to exceed six (6) months after the Termination Date if additional time beyond the Termination date is required to ensure adequate completion of the approved project.  The Contract must be in good fiscal and programmatic standing.  All terms and conditions of the Contract shall continue during any extension period and if such extension is approved, 

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notwithstanding Section 2.03, all references to the “Termination Date” shall be deemed to mean the date of expiration of such extension period.

Article IV

AUDITS AND INSPECTIONS

Section 4.01Record Keeping.  The RECIPIENT, each Collaborator whose costs are funded in all or in part by the Grant shall maintain or cause to be maintained books, records, documents and other evidence (electronic or otherwise) pertaining in any way to its performance under and compliance with the terms and conditions of this Contract (“Records”).  The RECIPIENT, each Collaborator and each Contractor shall use, or shall cause the entity which is maintaining such Records to use generally accepted accounting principles in the maintenance of such Records, and shall retain or require to be retained all of such Records for a period of three (3) years from the Termination Date of the Contract.

Section 4.02Audits.  Upon request and with reasonable notice, the RECIPIENT, each Collaborator and each Contractor whose costs are charged to the Project shall allow, or shall cause the entity which is maintaining such items to allow, the INSTITUTE, or auditors working on behalf of the INSTITUTE, including the State Auditor and/or the Comptroller of Public Accounts for the State of Texas, to review, inspect, audit, copy or abstract all of its Records during regular working hours.  Acceptance of funds directly under the Contract or indirectly through a subcontract under the Contract constitutes acceptance of the authority of the INSTITUTE, or auditors working on behalf of the INSTITUTE, including the State Auditor and/or the Comptroller of Public Accounts, to conduct an audit or investigation in connection with those funds for a period of three (3) years from the Termination Date of the Contract.

Notwithstanding the foregoing, any RECIPIENT expending $500,000 or more in federal or state awards during its fiscal year shall obtain either an annual single audit or a program specific audit.  A RECIPIENT expending funds from only one state program may elect to obtain a program specific audit in accordance with Office of Management and Budget (OMB) Circular A-133 or with the State of Texas Uniform Grant Management Standards (UGMS).  A single audit is required if funds from more than one federal or state program are spent by the RECIPIENT.  The audited time period is the RECIPIENT’s fiscal year, not the INSTITUTE funding period.

Section 4.03Inspections.  In addition to the audit rights specified in Section 4.02 “Audits”, the INSTITUTE shall have the right to conduct periodic onsite inspections within normal working hours and on a day and a time mutually agreed to by the parties, to evaluate the Institute-Funded Activity.  The RECIPIENT shall fully participate and cooperate in any such evaluation efforts.

Section 4.04On-going Obligation to Submit Requested Information.  The RECIPIENT shall, submit other information related to the Grant to the INSTITUTE as may be reasonably requested from time-to-time by the INSTITUTE, by the Legislature or by any other funding or regulatory bodies covering the RECIPIENT’s activities under this Contract.

Section 4.05Duty to Resolve Deficiencies.  If an audit and/or inspection under this Article IV finds there are deficiencies that should be remedied, then the RECIPIENT shall resolve and/or cure such deficiencies within a reasonable time frame specified by the INSTITUTE.  Failure to do so shall constitute an Event of Default pursuant to Section 8.03 “Event of Default.” Upon the RECIPIENT’S request, the parties agree to negotiate in good faith, specific extensions so that the RECIPIENT can cure such deficiencies.

Section 4.06Repayment of Grant Proceeds for Improper Use.  In no event shall RECIPIENT retain Grant funds that have not been used by the RECIPIENT for purposes for which the Grant was intended or in violation of the terms of this Contract.  The RECIPIENT shall repay any portion of Grant proceeds used by the RECIPIENT for purposes for which the Grant was not intended, as determined by the final results of an audit conducted pursuant to the provisions of this Contract.  Unless otherwise expressly provided for in writing and appended to this Contract, the repayment shall be made to the INSTITUTE no later than forty-five (45) days upon a written request by the INSTITUTE specifying the amount to be repaid and detailing the basis upon which such request is being made and 

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the amount shall include interest calculated at an amount not to exceed five percent (5%) annually.  The RECIPIENT may request that the INSTITUTE waive the interest, subject in all cases to the INSTITUTE’S sole discretion.

Section 4.07Repayment of Grant Proceeds for Relocation Outside of Texas.  Unless waived by a vote of the Oversight Committee, the RECIPIENT shall repay the INSTITUTE all Grant proceeds disbursed to RECIPIENT in the event that RECIPIENT relocates its principal place of business outside of the State during the Contract term or within 3 years after the final payment of the Grant funds is made by the INSTITUTE.

Article V

ASSURANCES AND CERTIFICATIONS

Adoption of Attachment C.  The INSTITUTE and the RECIPIENT hereby adopt the terms of Attachment C in their entirety, incorporate them as if fully set forth herein, and agree to perform and be bound by all such terms.

Article VI

INTELLECTUAL PROPERTY AND REVENUE SHARING

Adoption of Attachment D.  The INSTITUTE and the RECIPIENT hereby adopt the terms of Attachment D in their entirety, incorporate them as if fully set forth herein, and agree to perform and be bound by all such terms.

Article VII

REPORTING

Adoption of Attachment E.  The INSTITUTE and the RECIPIENT hereby adopt the terms of Attachment E in their entirety, incorporate them as if fully set forth herein, and agree to perform and be bound by all such terms.

Article VIII

EARLY TERMINATION AND EVENT OF DEFAULT

Section 8.01Early Termination of Contract.  This Contract may be terminated prior to the Termination Date specified in Section 2.03 “Contract Term” by:

(a)Mutual written consent of all parties to this Contract; or

(b)The INSTITUTE for an Event of Default (defined in Section 8.03) by the RECIPIENT; or

	
 
	
(c)
	
The INSTITUTE if allocated funds should become legally unavailable during the Contract period and the INSTITUTE is unable to obtain additional funds for such purposes; or

(d)The RECIPIENT for convenience.

Section 8.02Repayment of Grant Proceeds upon Early Termination.  The INSTITUTE may require the RECIPIENT to repay some or all of the disbursed Grant proceeds in the event of early termination under 8.01 (d) above or under Section 8.01(b) above, to the extent such Event of Default resulted from Grant funds being expended in violation of this Contract.  To the extent that the INSTITUTE exercises this option, the INSTITUTE shall provide written notice to the RECIPIENT stating the amount to be repaid, applicable interest calculated not to exceed five percent (5%) annually, and the schedule for such repayment.  The RECIPIENT may request that the INSTITUTE waive the interest, subject in all cases to the INSTITUTE’S sole discretion.  In no event shall the RECIPIENT retain Grant funds that have not been used by the RECIPIENT for purposes for which the Grant was intended.

Section 8.03Event of Default.  The following events shall, unless expressly waived in writing by the INSTITUTE or fully cured by the RECIPIENT pursuant to the provisions herein, constitute an event of default (each, an “Event of Default”):

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(a)
	
The RECIPIENT’s failure, in any material respect, to conduct the Project in accordance with the approved Scope of Work and to demonstrate progress towards achieving the milestones set forth in Section 2.02;

	
 
	
(b)
	
The RECIPIENT’s failure to conduct the Project within the State of Texas to the extent required under this Contract unless as otherwise specified in the application, Scope of Work or Approved Budget;

	
 
	
(c)
	
The RECIPIENT’s failure to fully comply, in any material respect, with any provision, term, condition, covenant, representation, certification, or warranty contained in this Contract or any other document incorporated herein by reference;

	
 
	
(d)
	
The RECIPIENT’s failure to comply with any applicable federal or state law, administrative rule, regulation or policy with regard to the conduct of the Project;

	
 
	
(e)
	
The RECIPIENT’s material misrepresentation or false covenant, representation, certification, or warranty made by RECIPIENT herein, in the Grant application, or in any other document furnished by RECIPIENT pursuant to this Contract that was misleading at the time that it was made; or

	
 
	
(f)
	
The RECIPIENT ceases its business operations, has a receiver appointed for all or substantially all of its assets, makes a general assignment for the benefit of creditors, is declared insolvent by a court of competent jurisdiction or becomes the subject, as a debtor, of a proceeding under the federal bankruptcy code, which such proceedings are not dismissed within ninety (90) days after filing.

Section 8.04Notice Required.  If the RECIPIENT intends to terminate pursuant to Section 8.01(d) “Early Termination of Contract”, it shall provide written notice to the INSTITUTE pursuant to the notice provisions of Section 9.21 “Notices” no later than thirty (30) days prior to the intended date of termination.

If the INSTITUTE intends to terminate for an Event of Default under Section 8.01(b) by the RECIPIENT, as described in Section 8.03 “Event of Default”, the INSTITUTE shall provide written notice to the RECIPIENT pursuant to Section 9.21 “Notices” and shall include a reasonable description of the Event of Default and, if applicable, the steps necessary to cure such Event of Default.  Upon receiving notice from the INSTITUTE, the RECIPIENT shall have thirty (30) days beginning on the day following the receipt of notice to cure the Event of Default.  Upon request, the INSTITUTE may provide an extension of time to cure the Event of Default(s) beyond the thirty (30) day period specified herein so long as the RECIPIENT is using reasonable efforts to cure and is making reasonable progress in curing such Event(s) of Default.  The extension shall be in writing and appended to the Contract.  If the RECIPIENT is unable or fails to timely cure an Event of Default, unless expressly waived in writing by the INSTITUTE, this Contract shall immediately terminate as of the close of business on the final day of the allotted cure period without any further notice or action by the INSTITUTE required.  In addition, and notwithstanding the foregoing, the INSTITUTE and the RECIPIENT agree that certain events that cannot be cured shall, unless expressly waived in writing by the INSTITUTE, constitute a final Event of Default under this Contract and this Contract shall terminate immediately upon the INSTITUTE giving the RECIPIENT written “Notice of Event of Default and FINAL TERMINATION.”

In the event that the INSTITUTE terminates the Contract under Section 8.01(c) above because allocated funds become legally unavailable during the Contract period, the INSTITUTE shall immediately provide written notification to the RECIPIENT of such fact pursuant to Section 9.21 “Notices.” The Contract is terminated upon the RECIPIENT’s receipt of that notification, subject to Section 9.09 “Survival of Terms.”

Section 8.05Duty to Report Event of Default.  The RECIPIENT shall notify the INSTITUTE in writing pursuant to Section 9.21 “Notices”, promptly and in no event more than (30) days after it obtains knowledge of the 

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occurrence of any Event of Default.  The RECIPIENT shall include a statement setting forth reasonable details of each Event of Default and the action which the RECIPIENT proposes to take with respect thereto.

Section 8.06Obligations/Liabilities Affected by Early Termination.  The RECIPIENT shall not incur new obligations that otherwise would have been paid for using Grant funds after the receipt of notice as provided by Section 8.04 “Notice Required”, unless expressly permitted by the INSTITUTE in writing, and shall cancel as many outstanding obligations as possible.  The INSTITUTE shall not owe any fee, penalty or other amount for exercising its right to terminate the Contract in accordance with Section 8.01.  In no event shall the INSTITUTE be liable for any services performed, or costs or expenses incurred, after the Termination Date of the Contract.  Early termination by either party shall not nullify obligations already incurred, including the RECIPIENT’s revenue sharing obligations as set forth in Attachment D, or the performance or failure to perform obligations prior to the Termination Date.

Section 8.07Interim Remedies.  Upon receipt by the RECIPIENT of a notice of Event of Default, and at any time thereafter until such Event of Default is cured to the satisfaction of the INSTITUTE or this Contract is terminated, the INSTITUTE may enforce any or all of the following remedies (such rights and remedies being in addition to and not in lieu of any rights or remedies set forth herein):

	
 
	
(a)
	
The INSTITUTE may refrain from disbursing any amount of the Grant funds not previously disbursed; provided, however, the INSTITUTE may make such a disbursement after the occurrence of an Event of Default without thereby waiving its rights and remedies hereunder;

	
 
	
(b)
	
The INSTITUTE may enforce any additional remedies it has in law or equity.

The rights and remedies herein specified are cumulative and not exclusive of any rights or remedies that the INSTITUTE would otherwise possess.

Article IX

MISCELLANEOUS

Section 9.01Uniform Grant Management Standards.  Unless otherwise provided herein, the RECIPIENT agrees that the Uniform Grant Management Standards (UGMS), developed by the Governor’s Budget and Planning Office as directed under the Uniform Grant Management Act of 1981, TEX. GOVT.  CODE, Ch. 783, apply as additional terms and conditions of this Contract and that the standards are adopted by reference in their entirety.  If there is a conflict between the provisions of this Contract and UGMS, the provisions of this Contract will prevail unless expressly stated otherwise.

Section 9.02Management and Disposition of Equipment.  During the term of this Contract, the RECIPIENT may use Grant funds to purchase Equipment to be used for the authorized purpose of the Project, subject to the conditions set forth below.  Unless otherwise provided herein, title to Equipment shall vest in the RECIPIENT upon termination of the Contract.

	
 
	
(a)
	
The INSTITUTE must authorize the acquisition in advance and in writing but an acquisition is deemed authorized if included in the Approved Budget for the Project;

	
 
	
(b)
	
Equipment purchased with Grant funds must stay within the State of Texas;

	
 
	
(c)
	
Equipment purchased with Grant funds must be materially deployed to the uses and purposes related to the Project;

	
 
	
(d)
	
In the event the RECIPIENT is indemnified, reimbursed or otherwise compensated for any loss of, destruction of, or damage to the Equipment purchased using Grant funds, it shall use the proceeds to repair or replace said Equipment;

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(e)
	
Equipment may be exchanged (trade-in) or sold without the prior written approval of the INSTITUTE if the proceeds thereof shall be applied to the acquisition cost of replacement Equipment;

	
 
	
(f)
	
The RECIPIENT may use its own property management standards and procedures provided that it observes the terms of UGMS, A-102, in all material respects;

	
 
	
(g)
	
The title or ownership of the Equipment shall not be encumbered for purposes other than the Project nor or transferred other than to a permitted assignee of this Contract, without the prior written approval of the INSTITUTE;

	
 
	
(h)
	
If the original or replacement Equipment is no longer needed for the originally authorized purpose or for other activities supported by the INSTITUTE, the RECIPIENT shall request disposition instructions from the INSTITUTE and, upon receipt, shall fully comply therewith; and

	
 
	
(i)
	
If this Contract is terminated early pursuant to Section 8.01(b), (d), (e), or (f) above, the INSTITUTE shall determine the final disposition of Equipment purchased with Grant award money.

Section 9.03Supplies and Other Expendable Property.  The RECIPIENT shall classify as materials, supplies and other expendable property the allowable unit acquisition cost of such property under $5,000 necessary to carry out the Project.  Title to supplies and other expendable property shall vest in the RECIPIENT upon acquisition.

Section 9.04Acknowledgement of Grant Funding and Publicity.  The parties agree to the following terms and conditions regarding acknowledging Grant funding and publicity:

	
 
	
(a)
	
The parties agree to fully cooperate and coordinate with each other in connection with all press releases and publications regarding the award of the Grant, the execution of the Contract and the Institute-Funded Activities.

	
 
	
(b)
	
The RECIPIENT shall notify the INSTITUTE’s Information Specialist or similar personnel at least three business days prior to any press releases, advertising, publicity, use of CPRIT logo, or other promotional activities that pertain to the Project or any Institute-Funded Activity.  In the event that the INSTITUTE wishes to participate in a joint press release, the RECIPIENT shall coordinate and cooperate with the INSTITUTE’s Information Specialist or similar personnel to develop a mutually agreeable joint press release.

	
 
	
(c)
	
Consistent with the goal of encouraging development of scientific breakthroughs and dissemination of knowledge, publication or presentation of scholarly materials is expected and encouraged.  The RECIPIENT may publish in scholarly journals or other peer-reviewed journals (including graduate theses and dissertations) and may make presentations at scientific meetings without prior notice to or consent of the INSTITUTE, except as may otherwise be set forth in this Contract.  The RECIPIENT shall promptly notify the INSTITUTE when any scholarly presentations or publications have been accepted for public disclosure and shall provide the INSTITUTE with final copies of all such accepted presentations and publications.  The RECIPIENT shall acknowledge receipt of the INSTITUTE funding in all publications, presentations, press releases and other materials regarding the work associated with the Institute-Funded Activities.  The RECIPIENT shall promptly submit an electronic version of all published manuscripts to PubMed Central in accordance with Section 9.05 “Public Access to Research Results.”

	
 
	
(d)
	
When grant funds are used to prepare print or visual materials for educational or promotional purposes for the general public (e.g., patients), and excluding presentations and publications discussed above in subsection (c), the RECIPIENT shall provide a copy of such materials to the 

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INSTITUTE at least ten (10) days prior to printing.  The RECIPIENT shall also acknowledge receipt of the INSTITUTE funding on all such materials including, but not limited to, brochures, pamphlets, booklets, training fliers, project websites, videos and DVDs, manuals and reports, as well as on the labels and cases for audiovisual or videotape/DVD presentations.

Section 9.05Public Access to Results of Institute-Funded Activities.  The RECIPIENT shall submit an electronic version of its final peer-reviewed journal manuscripts that arise from Grant funds to the digital archive National Library of Medicine’s PubMed Central upon acceptance for publication.  These papers must be accessible to the public on PubMed no later than 12 months after publication.  This policy is subject to the terms of Attachment D and does not supplant applicable copyright law.  For clarity, this policy is not intended to require the RECIPIENT to make a disclosure at a time or in any manner that would cause the RECIPIENT to abandon, waive or disclaim any intellectual property rights that it is obligated to protect pursuant to the terms of Attachment D.

Section 9.06Work to be Conducted in State.  The RECIPIENT agrees that it will use reasonable efforts to direct that any new or expanded preclinical testing, clinical trials, commercialization or manufacturing that is part of or relating to any Institute-Funded Activities take place in the State of Texas, including the establishment of facilities to meet this purpose.  If the RECIPIENT decides not to conduct such work in the State of Texas, the RECIPIENT shall provide a prior written explanation to the INSTITUTE detailing the RECIPIENT’s reasons for conducting the work outside of the State of Texas and the RECIPIENT’s efforts made to conduct the work in the State of Texas.

Section 9.07Duty to Notify.  During the term of this Contract and for a period of five (5) years thereafter, the RECIPIENT is under a continuing obligation to notify the INSTITUTE’s Chief Executive Officer at the same time it is required to notify any Federal or State entity of any unexpected adverse event or condition that materially impacts the performance or general public perception of the conduct or results of the Project and Institute-Funded Activities, including any impact to the Scope of Work included in the Contract and events or results that have a serious adverse impact on human health, safety or welfare.  By way of example only, if clinical testing of the results of Institute-Funded Activities reveal an unexpected risk of developing serious health conditions or death, then the RECIPIENT shall, at the same time it notifies any Federal or State entity, promptly so notify the INSTITUTE’s Chief Executive Officer even if such results are not available until after the term of this Contract.  Notice required under this section shall be made as promptly as reasonably possible and shall follow the procedures set forth in Section 9.21 “Notices.”

Section 9.08Severability.  If any provision of this Contract is construed to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or enforceability shall not affect any other provisions hereof.  The invalid, illegal or unenforceable provision shall be deemed stricken and deleted to the same extent and effect as if never incorporated herein.  All other provisions shall continue as provided in this Contract.

Section 9.09Survival of Terms.  Termination or expiration of this Contract for any reason will not release either party from any liabilities or obligations set forth in this Contract that: (1) the Parties have expressly agreed shall survive any such termination or expiration; or (2) remain to be performed or by their nature would be intended to be applicable following any such termination or expiration.  Such surviving terms include, but are not limited to, Sections 2.13, 4.01, 4.02, 4.05, 4.06, 8.02, 8.06, 9.04, 9.05, 9.06, 9.07, 9.09, 9.14, 9.15, 9.16, 9.17, 9.18, and Attachment D.

Section 9.10Binding Effect and Assignment or Modification.  This Contract and all terms, provisions and obligations set forth herein shall be binding upon and shall inure to the benefit of the parties and their successors and permitted assigns, including all other state agencies and any other agencies, departments, divisions, governmental entities, public corporations or other entities which shall be successors to either of the parties or which shall succeed to or become obligated to perform or become bound by any of the covenants, agreements or obligations hereunder of either of the parties hereto.  Upon a permitted assignment of this Contract by RECIPIENT, all references to “the RECIPIENT” herein shall be deemed to refer to such permitted assignee.

Section 9.11No Waiver of Contract Terms.  Neither the failure by the RECIPIENT or the INSTITUTE, in any one or more instances, to insist upon the complete and total observance or performance of any term or provision 

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hereof, nor the failure of the RECIPIENT or the INSTITUTE to exercise any right, privilege or remedy conferred hereunder or afforded by law, shall be construed as waiving any breach of such term or provision or the right to exercise such right, privilege or remedy thereafter.  In addition, no delay on the part of either the RECIPIENT or the INSTITUTE, in exercising any right or remedy hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any right or remedy preclude other or further exercise thereof or the exercise of any other right or remedy.

Section 9.12No Waiver of Sovereign Immunity.  No provision of this Contract is in any way intended to constitute a waiver by the INSTITUTE, the RECIPIENT (if applicable), or the State of Texas of any immunities from suit or from liability that the INSTITUTE, the RECIPIENT, or the State of Texas may have by operation of law.

Section 9.13Force Majeure.  Neither the INSTITUTE nor the RECIPIENT will be liable for any failure or delay in performing its obligations under the Contract if such failure or delay is due to any cause beyond the reasonable control of such party, including, but not limited to, unusually severe weather, strikes, natural disasters, fire, civil disturbance, epidemic, war, court order or acts of God.  The existence of such causes of delay or failure will extend the period of performance in the exercise of reasonable diligence until after the causes of delay or failure have been removed.  Each party must inform the other in accordance with Section 9.21 “Notices” within five (5) business days, or as soon as it is practical, of the existence of a force majeure event or otherwise waive this right as a defense.

Section 9.14Disclaimer of Damages.  IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, SPECIAL, PUNITIVE, EXEMPLARY, INCIDENTAL OR CONSEQUENTIAL DAMAGES.  THIS LIMITATION WILL APPLY REGARDLESS OF WHETHER OR NOT THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

Section 9.15Indemnification and Hold Harmless.  Except as provided herein, the RECIPIENT agrees to fully indemnify and hold the INSTITUTE and the State of Texas harmless from and against any and all claims, demands, costs, expenses, liabilities, causes of action and damages of every kind and character (including reasonable attorneys fees) which may be asserted by any third party in any way related or incident to, arising out of, or in connection with (1) the RECIPIENT’s negligent, intentional or wrongful performance or failure to perform under this Contract, (2) the RECIPIENT’s receipt or use of Grant funds, or (3) any negligent, intentional or wrongful act or omission committed by the RECIPIENT as part of an Institute-Funded Activity or during the Project.  In addition, the RECIPIENT agrees to fully indemnify and hold the INSTITUTE and the State of Texas harmless from and against any and all costs and expenses of every kind and character (including reasonable attorneys fees, costs of court and expert fees) that are incurred by the INSTITUTE or the State of Texas arising out of or related to a third party claim of the type specified in the preceding sentence.  Notwithstanding the preceding, such indemnification shall not apply in the event of the sole or gross negligence of the INSTITUTE.  If the RECIPIENT is a State of Texas agency or institution of higher education, then this Section 9.15 is subject to the extent authorized by the Texas Constitution and the laws of the State of Texas.

The RECIPIENT acknowledges and agrees that this indemnification shall apply to, but is not limited to, employment matters, taxes, personal injury, and negligence.

It is understood and agreed that it is not the intent of the parties to expand or increase the liability of the State of Texas under this Article.  This provision is intended to prevent the RECIPIENT, the INSTITUTE and the State of Texas from attempting or appearing to assume liability it does not have the statutory or legal power to assume.

Section 9.16Alternative Dispute Resolution.  If applicable, the dispute resolution process provided for in TEX. GOVT. CODE, Ch. 2260 shall be used, as further described herein, to resolve any claim for breach of contract made against the INSTITUTE (excluding any uncured Event of Default).  The submission, processing and resolution of a party’s claim are governed by the published rules adopted by the Attorney General pursuant to TEX. GOVT. CODE, Ch. 2260, as currently effective, hereafter enacted or subsequently amended.

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Section 9.17Applicable Law and Venue.  This Contract shall be construed and all disputes shall be considered in accordance with the laws of the State of Texas, without regard to its principles governing the conflict of laws.  Provided that the RECIPIENT first complies with procedures set forth in Section 9.16 “Alternative Dispute Resolution,” exclusive venue and jurisdiction for the resolution of claims arising from or related to this Contract shall be in the federal and state courts in Travis County, Texas.

Section 9.18Attorneys’ Fees.  In the event of any litigation, appeal or other legal action to enforce any provision of the Contract, the RECIPIENT shall pay all expenses of such action, including attorneys’ fees and costs, if the INSTITUTE is the prevailing party.  If the RECIPIENT is a State of Texas agency or institution of higher education, then this Section 9.18 is subject to the extent authorized by the Texas Constitution and the laws of the State of Texas.

Section 9.19Counterparts.  This Contract may be executed in any number of counterparts, each of which when so executed and delivered shall be an original, but such counterparts shall together constitute one and the same instrument.

Section 9.20Construction of Terms. The headings used in this Contract are inserted only as a matter of convenience and for reference and shall not affect the construction or interpretation of this Contract.  Where context so indicates, a word in the singular form shall include the plural, a word in the masculine form the feminine, and vice-versa.  The word “including” and similar constructions (such as “includes”, “included”, “for example”, “such as”, and “e.g.”) shall mean “including, without limitation” throughout this Contract.  The words “and” and “or” are not intended to convey exclusivity or nonexclusivity except where expressly indicated or where the context so indicates in order to give effect to the intent of the parties.

Section 9.21Notices.  All notices, requests, demands and other communications will be in writing and will be deemed given on the date received as demonstrated by (i) a courier’s receipt or registered or certified mail return receipt signed by the party to whom such notice was sent, provided that such notice was sent to the Authorized Signing Official (ASO) at the address provided in the CPRIT Grants Management System, (ii) a fax confirmation page showing that such fax was successfully transmitted to the fax number provided in the CPRIT Grants Management System, or (iii) via correspondence in the CPRIT Grants Management System.

 

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DP160071, Contract Attachment A

Abstract and Significance

Multiple myeloma accounts for 10% of all hematological malignancies in the United States.  An estimated 26,850 people were diagnosed with the disease in the United States in 2015 with an estimated 11,200 deaths resulting from the disease (SEER Cancer Statistics, 2015).  The five-year survival rate for myeloma is only 45%.

Historically, there have been three major classes of therapeutics used to treat multiple myeloma: steroids, proteasome inhibitors, and the thalidomide-derived immunomodulatory drugs (IMiDs).  In 2015, daratumumab, an antibody to CD38, and elotuzumab, an antibody to CS1, became the first biologics approved for multiple myeloma.  Daratumumab in particular has shown robust single-agent activity (29% response rate) in relapsed/refractory patients indicating that CD38 plays an important role in myeloma disease progression.

Because of the generally poor outcome in myeloma patients, there is a high need for new therapeutics to treat the disease.  Molecular Templates has developed a novel scaffold of biologics against cancer by fusing the single chain variable fragment of an antibody (scFv) to a proprietarily modified form of the Shiga-like toxin A subunit (SLTA), an enzymatic inactivator of ribosome activity.  These compounds combine the specificity of an antibody with a novel and potent direct mechanism of cell-kill.  Molecular Templates’ first compound, MT-3724 targets CD20 and is in a first-in-human dose-escalation study at MD Anderson and Memorial Sloan Kettering in heavily pre-treated patients with non-Hodgkins lymphoma (NHL).  To date, there have been twelve patients treated with no dose-limiting toxicities seen.  Of the eleven patients evaluable for efficacy, there has been one complete metabolic response (patient to undergo allogeneic transplant), one partial response, one mixed response, three stable diseases (all with tumor regression), and five patients with progressive disease.  This efficacy is especially impressive since MT-3724 has not yet reached linear pharmacokinetics in its dose escalation.

Molecular Templates has designed MT-4019ND for the treatment of multiple myeloma.  MT-4019ND has a high-affinity scFv that specifically targets CD38 fused to a proprietary de-immunized form of SLTA.  MT-4019ND has shown extremely potent in vitro and in vivo activity against tumor cells expressing CD38.  MT-4019ND has shown potent synergistic activity in combination with pomalidomide, the standard of care for refractory myeloma patients.  MT-4019ND mirrors MT-3724 in terms of scaffold construction with similar absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics (PK) characteristics.

CD38 was chosen as a target because of the clinical activity of daratumumab.  Daratumumab works primarily by directing complement dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC) to CD38+ myeloma cells.  Although immune recruitment can be a potent mechanism of cell-kill, roughly 70% of CD38+ refractory patients fail to respond to daratumumab monotherapy.

There is strong precedence in oncology for developing different mechanisms of action against the same validated target.  There is an approved antibody, small molecule, and antibody-drug conjugate targeting HER2 in breast cancer, for example as well as multiple small molecules and antibodies to EGFR.  In multiple myeloma, three different IMiDs (lenalidomide, pomalidomide, and thalidomide) are used sequentially in treatment.  MT-4019ND was engineered to provide a different mechanism of destruction targeting CD38+ myelomas.  In in vitro and in vivo studies, MT-4019ND shows excellent specificity, potency and safety as well as synergistic activity in combination with an IMiD.  MT-3724 is administered as an infusion and has predictable PK and ADME characteristics.  MT-4019ND shares a scaffold with MT-3724 which has shown excellent safety and notable efficacy in its first-in-human study.

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This application outlines a strategy to move MT-4019ND into clinical studies and rapidly characterize its activity in myeloma patients with no other treatment options.  The development plan outlined in this application follows that of daratumumab and has the potential to show early signs of safety and efficacy and to form the basis of an accelerated FDA approval.  Molecular Templates has successfully demonstrated that it can efficiently move pre-clinical leads into first-in-human studies.  The early clinical data seen the company’s lead compound MT-3724 strongly suggest the scaffold used to construct MT-4019ND is safe and effective.

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Layperson’s Summary

In 2015, there were approximately 27,000 new cases of multiple myeloma diagnosed in the US making it the second most prevalent blood cancer.  The five-year survival rate for multiple myeloma is 45% and the median survival is approximately 4 years.

CD38 is a protein expressed on the surface of myeloma cells.  Recently, daratumumab, an antibody that specifically targets CD38, was approved for the treatment of patients with multiple myeloma.  Daratumumab works primarily by binding myeloma cells and recruiting an immune response to them.  Most patients’ immune system will ultimately stop responding to daratumumab allowing the disease to progress.

Molecular Templates, a venture-backed biopharmaceutical company in Georgetown, TX, has developed a novel multiple myeloma drug that targets CD38 but works in a different way from daratumumab.  MT-4019ND is a fusion of an antibody fragment that binds CD38 with a highly toxic bacterial protein.  MT-4019ND binds CD38 on the surface of myeloma cells but instead of recruiting an immune response, it directly kills the myeloma cell through its toxin component.  MT-4019ND has shown a potent ability to kill myeloma cell lines in the laboratory and in animal models of myeloma.  Molecular Templates has a similar compound in the clinic for lymphoma that appears safe and effective in patients.

Molecular Templates seeks $15.3M in CPRIT financing to move MT-4019ND through clinical studies in patients with refractory multiple myeloma.

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Timelines: project_timeline.pdf 

		
	
Goal 

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TIMELINE

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Grant ID: DP160071

Principal Investigator/Program Director: Jason Kim

ATTACHMENT B - Detailed Budget Form

					
	
Budget
	
Budget Year 1
	
Budget Year 2
	
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Total Budget

	
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$15,200,000.00

	
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$15,200,000.00

* Note:

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ATTACHMENT C

ASSURANCES AND CERTIFICATIONS

This Attachment C is hereby incorporated into and made a part of that certain CANCER RESEARCH GRANT CONTRACT (“Contract”) by and between the Cancer Prevention and Research Institute of Texas (“CPRIT” or the “INSTITUTE”) and the RECIPIENT.  A capitalized term used in this Attachment shall have the meaning given to term in the Contract or in the Attachments to the Contract, unless otherwise defined herein.  In the event of a conflict between the provisions of this Attachment and the provisions of the Contract, this Attachment shall control.

By signing this Contract, RECIPIENT certifies compliance with the following assurances and certifications required by the INSTITUTE (listed below).  RECIPIENT further acknowledges that its obligations pursuant to the following assurances and certifications are ongoing.

Section C1.01Demonstration of Matching Funds.  Pursuant to TEX. HEALTH & SAFETY CODE § 102.255(d) and T.A.C. 25 § 703.11, RECIPIENT has an amount of funds equal to one-half of the amount of the Grant to be disbursed each fiscal year of the Contract term dedicated to the research that is the subject of the Grant as demonstrated by the form incorporated herein to Attachment C.  The RECIPIENT shall update the matching funds certification and verficiation annually for each fiscal year that Grant funds are disbursed.

Section C1.02Payment of Taxes.  RECIPIENT’s payment of franchise taxes is current or, if the RECIPIENT is exempt from payment of franchise taxes, that it is not subject to the State of Texas franchise tax.  If franchise tax payments become delinquent during the Contract term, payments under this Contract will be withheld until the RECIPIENT’s delinquent franchise tax is paid in full.  The RECIPIENT also acknowledges that it is not otherwise exempt from state sales or occupancy tax as a result of this Contract.

Section C1.03Compliance with Confidentiality Guidelines Relating to Personal and Medical

Information.  RECIPIENT complies with all applicable laws, rules and regulations relating to personal and medical information.  Without in any way limiting the foregoing, RECIPIENT maintains and enforces appropriate facility and information technology access rules and procedures to protect against inappropriate disclosure of patient records and all other documents deemed confidential by law, which are maintained in connection with the Project and Institute-Funded Activities, including provisions that comply with the requirements of the INSTITUTE’s rules, 25 T.A.C. Section 703.14.  Upon request from the INSTITUTE, RECIPIENT will timely furnish a copy of the RECIPIENT’s facility and information technology access rules and procedures, as well as any other applicable confidentiality guidelines.

If RECIPIENT, including any Collaborators or Contractors, works directly with patients or otherwise has access to or maintains patient personal and medical information, RECIPIENT specifically addresses Health Insurance Portability and Accountability Act of 1996 regulations concerning confidentiality of personal and medical information.  Any disclosure of confidential information in any way related to the Project (including information that may be required by reports and inspections) must be in accordance with all applicable laws.

Section C1.04Conduct of Research or Service Provided.  RECIPIENT understands that the Project must be conducted with full consideration for the ethical and medical implications of the research performed or services delivered and comply with all federal and state laws regarding the conduct of the research or service.

Section C1.05Regulatory Certificates, Licenses and Permits.  All personnel, facilities and equipment involved or to be involved in the Project are certified, licensed, permitted, registered or approved by the appropriate regulating agency, where applicable.  Any revocation, surrender, expiration, non-renewal, inactivation or suspension of any such certification, license, permit, registration or approval shall constitute grounds for Contract termination.

22

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Section C1.06Assurances and Certifications in Accordance with the NIH Grants Policy Statement:

(a)Civil Rights.  Compliance with Title VI of the Civil Rights Act of 1964.

	
 
	
(b)
	
Handicapped Individuals.  Compliance with Section 504 of the Rehabilitation Act of 1973 as amended.

	
 
	
(c)
	
Sex Discrimination.  Compliance with Section 901 of Title IX of the Education Amendments of 1972 as amended.

	
 
	
(d)
	
Age Discrimination.  Compliance with the Age Discrimination Act of 1975, as amended.

	
 
	
(e)
	
Patents, Licenses and Inventions.  Compliance with the Standard Patent Rights clauses as specified in 37 CFR, Part 401 or 35 U.S.C. 203, if appropriate and applicable, in a manner that adequately protects the INSTITUTE’S rights in the Project Results.

	
 
	
(f)
	
Human Subjects.  Compliance with the requirements of federal policy concerning the safeguarding of the rights and welfare of human subjects who are involved in activities supported by federal funds.  Before any funding may be released for any Project involving human subjects, RECIPIENT must receive approval from RECIPIENT’s Institutional Review Board (IRB).  Upon request, a copy of RECIPIENT’s IRB approval must be provided to the INSTITUTE.

	
 
	
(g)
	
Human Biological/Anatomical Material.  Compliance with the recommendations of the NIH Office of Human Subject Research Medical Administrative Series (MAS) #MO1-2 entitled “Procurement and Use of Human Biological Materials for Research,” and any other federal or state requirements.

	
 
	
(h)
	
Use of Animals.  Compliance with applicable portions of the Animal Welfare Act (PL 89-544 as amended) and appropriate Public Health Service Policy on Humane Care and Use of Laboratory Animals regulations.  Before any funding may be released for any Project involving animal subjects, RECIPIENT must receive approval from RECIPIENT’s Institutional Animal Care and Use Committee (IACUC).  Upon request, a copy of RECIPIENT’s IACUC approval must be provided to the INSTITUTE.

	
 
	
(i)
	
Debarment and Suspension.  RECIPIENT certifies that neither it nor the Principal Investigator/Project Director or any other Recipient Personnel or personnel of any Collaborator or Contractor assigned to work on the Project are debarred, suspended, proposed for debarment, declared ineligible or otherwise excluded from participation in the Project by any federal or state department or agency.

	
 
	
(j)
	
Non-Delinquency on Federal or State Debt.  RECIPIENT certifies that neither it, nor any person to be paid from funds under this Contract, is delinquent in repaying any Federal debt as defined by OMB Circular A-129 or any debt to the State of Texas.

	
 
	
(k)
	
Eligibility to Receive Payments on State Contracts.  RECIPIENT certifies that it and the Principal Investigator/Project Director are not ineligible to receive the Grant award under this Contract pursuant to Tex. Fam. Code Ann.  Section 231.006 and acknowledges that this Contract may be terminated and payment may be withheld if this certification is inaccurate.

	
 
	
(l)
	
Drug-Free Workplace.  Compliance with the Drug-Free Workplace Act of 1988 (45 CFR 82).

	
 
	
(m)
	
Misconduct in Science.  Compliance with 42 CFR Part 50, Subpart A, and Final Rule as published at 54 CFR 32446, August 8, 1989.

23

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

	
 
	
(n)
	
Objectivity of Research/Conflict of Interest.  Compliance with the NIH requirement to maintain a written standard of conduct and comply with 42 CFR Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research.  RECIPIENT must notify the INSTITUTE of any conflicting financial interests and assure that the interest has been managed, reduced or eliminated.

	
 
	
(o)
	
Trafficking in Persons.  Compliance with the NIH regulations on trafficking in persons as published at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-055.html .

	
 
	
(p)
	
Criminal Misconduct.  RECIPIENT shall promptly report issues to the INSTITUTE involving potential civil or criminal fraud related in any way to the Project, the Institute-Funded Activity or this Contract, such as false claims or misappropriation of federal or state funds.

Section C1.07Tobacco Free Workplace Policy.  Pursuant to T.A.C. 25 § 703.20, RECIPIENT certifies that its board of directors, governing body, or similar has adopted and enforces a Tobacco-Free Workplace Policy that meets or exceeds all of the following minimum standards:

	
 
	
(a)
	
Prohibits the use of all forms of tobacco products, including but not limited to cigarettes, cigars, pipes, water pipes (hookah), bidis, kreteks, electronic cigarettes, smokeless tobacco, snuff and chewing tobacco;

	
 
	
(b)
	
Designates the property to which the policy applies (“designated area”).  The designated area(s) must at least comprise all buildings and structures where the CPRIT project is taking place, as well as the sidewalks, parking lots, walkways, and attached parking structures immediately adjacent but only to the extent the CPRIT Grant Recipient owns, leases as the sole tenant, or controls the building, sidewalks, parking lots and/or parking structures.  In the event that the RECIPIENT does not own, lease as the sole tenant, or control the building, sidewalks, parking lots and/or parking structures, then the designated area(s) must include all areas under the RECIPIENT’s control;

	
 
	
(c)
	
Applies to all employees and visitors in the designated area(s); and

	
 
	
(d)
	
Provides for or refers employees to tobacco use cessation services.

If RECIPIENT cannot meet the minimum standards as set forth in this section, RECIPIENT certifies that it has received an approved waiver from the INSTITUTE’s CEO for the current fiscal year.

Section C1.08No Donations to the Institute or a Foundation Established to Support Institute.  RECIPIENT certifies that as of June 14, 2013, it has not made and will not make a contribution, during the term of the Contract, to the INSTITUTE or to any foundation established specifically to support the INSTITUTE.

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DP160071 - Product Development Research Contract Attachment C Part 2 Matching Compliance Certification (MCC) - Initial

For Public or Private Institutions of Higher Education ONLY (all other entities proceed to the section below): The grant recipient may credit toward the matching funds requirement the dollar equivalent to the difference between the institution’s federally approved indirect cost rate for research projects and CPRIT’s [***] indirect cost allowance.  If a Public or Private Institution of Higher Education intends to fulfill its match requirement using expended funds only (no federally approved indirect cost rate credit), then choose “No” on the first question and proceed with the form submission.

If the grant recipient’s Federally Approved Indirect Cost Rate is greater than or equal to [***] (the [***] matching funds requirement and the [***] CPRIT Indirect Cost Rate), then no further action is required once the appropriate information has been entered in lines “a” through “d” and in the “Enter Certification of Initial Matching Funds Encumbered” field below.

If the combined Federally Approved Indirect Cost Rate and the CPRIT Indirect Cost Rate calculated for the Project is less than [***], then the grant recipient must use the section below to demonstrate that it has encumbered funds available and not yet expended that are dedicated to the CPRIT-funded project for the portion of the match requirement not met by the Federally Approved Indirect Cost Rate credit.

		
	
Public or Private Institution of Higher Education: 
(Choose ‘No’ if You Are Using Encumbered Funds)
	
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Matching funds Requirement + CPRIT Indirect Cost Rate:
	
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Federally Approved Cost Rate for Project for Year 1:
	
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Percentage to fulfill match requirement for Year 1:
	
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Certified Year 1 Approved Budget:
	
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Remaining Dollar amount to fulfill match requirement for the Award year 1:
	
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Match based on prior year credit/deficiency:
	
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Enter Certification of Initial Matching Funds Encumbered:
	
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The information above is the entity/Institution’s demonstration of encumbered available funds pursuant to its certification in Attachment C.  The information in the certification shall be updated annually.  By approving this form the grant recipient certifies that it has the matching funds available as reflected on the form.

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ATTACHMENT D

INTELLECTUAL PROPERTY AND REVENUE SHARING

This Attachment D is hereby incorporated into and made a part of that certain CANCER RESEARCH GRANT CONTRACT (“Contract”) by and between the Cancer Prevention and Research Institute of Texas (“CPRIT” or the “INSTITUTE”) and the RECIPIENT.  A capitalized term used in this Attachment shall have the meaning given the term in the Contract or in the Attachments to the Contract, unless otherwise defined herein.  In the event of a conflict between the provisions of this Attachment and the provisions of the Contract, this Attachment shall control.

PART 1

OWNERSHIP AND INTELLECTUAL PROPERTY PROTECTION

Section D1.01Ownership of Project Results.  RECIPIENT and its Collaborators, and (to the extent applicable) any third party participating in the development of the Project Results, shall retain ownership of the Institute-Funded Technology and the Institute-Funded IPR, subject to the terms of the Contract.  A Collaborator as defined in the Contract is not a third party that engages with RECIPIENT as a licensing partner.

Section D1.02Transfer or Assignment of Rights to a Third Party.  RECIPIENT shall notify the INSTITUTE of any proposed transfer or assignment of rights in any Project Results to a third party and provide to INSTITUTE a copy of the agreement under which the proposed transfer or assignment is to occur.  RECIPIENT shall ensure that, in any assignment or transfer of Project Results, the transferee or assignee agrees in writing to: (i) recognize that the Institute-Funded IPR and Institute-Funded Technology, as applicable, is transferred or assigned subject to the licenses, interests and other rights in such Project Results provided to the INSTITUTE in the Contract and any applicable law or regulation, (ii) take all actions necessary to protect all such licenses, interests and other rights, and (iii) be responsible for and pay all amounts required under Part 4 of this Attachment D.  Any attempted transfer or assignment of rights in any Project Results to a third party without written agreement to the conditions in (i) – (iii) above shall be null, void and of no effect.

Section D1.03Protection of Institute-Funded IPR.  Subject to Section D5.01, RECIPIENT shall use commercially reasonable efforts to appropriately protect the Institute-Funded IPR, including without limitation, diligently seeking registration and maintenance of patents and copyrights covering the Institute-Funded Technology, as appropriate.  If RECIPIENT elects to abandon any patent applications filed or patents issued covering any Institute-Funded Technology in any Major Market Country, RECIPIENT shall provide the INSTITUTE with prior written notice of such election, with sufficient time (but no less than [***]) for the INSTITUTE to exercise its rights under this Section D1.03 with respect thereto.  Upon notice of the aforesaid, the INSTITUTE shall have the right, but not the obligation, to pursue protection of the applicable Institute-Funded Technology on its own behalf in such Major Market Country, including directing the filing, prosecution and maintenance of patent applications or patents covering the applicable Institute-Funded Inventions in any of such Major Market Countries for which the INSTITUTE exercises its rights under this Section D1.03.  In the Major Market Countries where the INSTITUTE pursues protection of the Institute-Funded Technology under this Section D1.03, RECIPIENT agrees to grant, and does hereby grant, to the INSTITUTE anon-exclusive, irrevocable, royalty-free, perpetual license with right to sublicense in the applicable Major Market Countries to the applicable Instituted-Funded Technology and any applicable Project Results.  For clarification, a determination by RECIPIENT to (i) abandon a patent application in favor of a continuation or divisional application or the like, or (ii) narrow the scope of the claimed subject matter, shall not be deemed an election to abandon such Institute-Funded IPR.

Section D1.04Cost of Protection.  The INSTITUTE shall not be responsible for, and no Grant funds may be used to pay for, any costs or expenses associated with RECIPIENT’s efforts to protect the Institute-Funded IPR.

Section D1.05 Inventions.

(a)Disclosures and Patent Applications.  RECIPIENT shall notify INSTITUTE of each Institute-Funded Invention by delivering to INSTITUTE a copy of the invention disclosure within [***] after RECIPIENT receives or generates it.  In the event that a patent application is filed on the invention 

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disclosure, RECIPIENT shall provide the INSTITUTE with a complete copy of such patent application and associated filing documents within [***] of its filing.

(b)Patent Prosecution and Maintenance.  For all Institute-Funded Inventions for which patent protection is pursued, RECIPIENT shall provide an annual written report to the INSTITUTE regarding the status of pending applications and issued patents that are Institute-Funded IPR.

Section D1.06Required Agreements with Recipient Personnel and Contractors.  The RECIPIENT shall have, maintain and enforce written policies or agreements applicable to Recipient Personnel and Contractors with terms sufficient to enable RECIPIENT to fully comply with all terms and conditions of this Contract, including that Recipient Personnel and Contractors agree to and hereby assign any Institute-Funded Inventions to RECIPIENT.  RECIPIENT shall promptly report to INSTITUTE any material breach of such policies or agreements relating to or affecting any of the provisions of this Contract.

Section D1.07Agreements with Collaborators.  All agreements between RECIPIENT and a Collaborator, or a third party participating in the development of the Project Results, relating to or affecting joint ownership of any Project Result shall recognize the licenses, interests and other rights provided to the INSTITUTE in the Contract.  RECIPIENT shall provide to the INSTITUTE a copy of each such agreement affecting joint ownership of any Project Result.

PART 2

NON-COMMERCIAL LICENSES

Section D2.01RECIPIENT License.  In granting an Exclusive License to any Project Results, RECIPIENT shall retain the right to Exploit all Project Results (including material embodiments thereof) for education, research and other non-commercial purposes, and the right to grant the licenses pursuant to Section D2.02 below.

Section D2.02INSTITUTE License.  RECIPIENT agrees to grant, and does hereby grant, to the INSTITUTE a non-exclusive, irrevocable, royalty-free, perpetual, worldwide license with right to sublicense under the Project Results and, subject to any existing third party rights, any Necessary Additional IPR to Exploit all Project Results (including material embodiments of Project Results) by the INSTITUTE, other governmental entities and agencies of the State of Texas, and private or independent institutions of higher education (as defined by Texas law) located in Texas, for education, research and other non-commercial purposes only pursuant to industry-standard confidentiality and/or material transfer agreements to be entered into between the parties, as applicable.  RECIPIENT shall make the Institute-Funded Technology available by reasonable means to the INSTITUTE in order for the INSTITUTE to exercise its rights under this Section D2.02, at no cost to RECIPIENT.  A copy of any written license granted by INSTITUTE under this Section D2.02 will be provided to RECIPIENT by INSTITUTE within [***] of the effective date of such license.

Section D2.03No Implied Licenses.  No implied licenses are granted under this Agreement including without limitation any license to any Intellectual Property Rights owned or controlled by RECIPIENT outside of the Institute-Funded IPR.  Nothing in this Agreement shall be construed to impose an obligation on RECIPIENT to license or otherwise make available any of its Intellectual Property Rights or other resources owned or controlled by it except as expressly provided in this Agreement.

PART 3

COMMERCIALIZATION OF PROJECT RESULTS

Section D3.01Commercialization Strategy.  RECIPIENT shall be under a continuing obligation throughout the term of this Contract to enhance and improve the commercial development plan submitted with the Application and to provide an annual written report to the INSTITUTE regarding the RECIPIENT’s and its licensee’s efforts to commercialize or otherwise bring to practical application Project Results.  The INSTITUTE may, at its option and at any time, provide RECIPIENT with comments regarding the RECIPIENT’s commercial development plan and 

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strategy, in which case RECIPIENT shall consider in good faith and, if appropriate, use reasonable efforts to account for and incorporate the INSTITUTE’s input into such commercial development plan and strategy.

Section D3.02Commercialization Efforts.  The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01.  For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

Section D3.03Licensing of Project Results.  Each License Agreement entered into by the RECIPIENT shall include an acknowledgement by the licensee that (i) such License Agreement is subject to the INSTITUTE’s licenses, interests and other rights under this Contract, and (ii) to the extent that there is a conflict between the terms of the License Agreement and the terms of this Contract, the terms of this Contract shall prevail.  In addition, all License Agreements shall include terms obligating the licensee to report to the RECIPIENT such information as is required for the RECIPIENT to fully comply with the terms of the Contract, including without limitation the reporting obligations set forth in Attachment E, and to allow RECIPIENT to make the grants specified in Sections D2.02.  The RECIPIENT shall monitor the performance of its licensees and such licensees’ compliance with the terms of the License Agreements and shall take commercially reasonable actions to enforce the terms of all License Agreements.  The RECIPIENT shall [***] report to the INSTITUTE any material breach of a License Agreement relating to or affecting any of the material provisions of this Contract.

Section D3.04Cost of Licensing Activities.  The INSTITUTE shall not be responsible for, and no Grant funds may be used to pay for, any costs or expenses associated with the RECIPIENT’s Licensing Activities.

Section D3.05Survival.  The licenses, rights and obligations set forth in this Attachment D, except Section D3.01, shall survive any termination of this Contract, including any termination for convenience by RECIPIENT.

Section D3.06Recipient Opt-Out.  In the event RECIPIENT determines, after diligently attempting to comply with the terms of Section D3.02, to cease its efforts, either directly or through a licensee, to commercialize or otherwise bring to practical application the Project Results, it will so notify the INSTITUTE in writing promptly thereafter.  Such written notice must identify the Project Results and provide a reasonable explanation of the reasons for the RECIPIENT’s election.  Upon receipt of such notice, the INSTITUTE and RECIPIENT shall meet within [***] to review the Project Results and rationale for the RECIPIENT’s election.  Provided that RECIPIENT’s determination to cease its efforts was not based on material safety concerns related to the Project Results, the INSTITUTE and RECIPIENT shall engage in good faith negotiations regarding an alternative commercialization strategy and/or revenue sharing approach.

The INSTITUTE and RECIPIENT may consider, among other options, an award of equity in the RECIPIENT, expansion or modification of the Institute Funded Activity to cover other commercial products or commercial services being advanced by the RECIPIENT, or some combination thereof.  Unless otherwise agreed, if the INSTITUTE and RECIPIENT are unable to achieve an alternative strategy or agreement within [***] of the RECIPIENT’s initial notice of election, and provided that RECIPIENT’s determination to cease its efforts was not based on material safety concerns related to the Project Results, the INSTITUTE shall have the right, but not the obligation, to exercise its rights in Section D5.01 in relation to the Project Results at the INSTITUTE’s expense.  If the INSTITUTE elects to exercise its rights under Section D5.01 in relation to the Project Results, the INSTITUTE shall notify the RECIPIENT in writing within the later of [***] of INSTITUTE’s receipt of the RECIPIENT’s initial notice of election or [***] following a declaration by one of the Parties that good faith negotiations have failed.  In the event that the INSTITUTE exercises its option under this Section D3.06, the RECIPIENT shall cooperate with the INSTITUTE’s efforts and provide to INSTITUTE sufficient information such as relevant feasibility studies, trial results, regulatory summaries, and pertinent schedules or deadlines in relation to the Project Results, in commercializing or otherwise bringing to practical application the applicable Project Results at the INSTITUTE’s cost.  For clarity, so long as the RECIPIENT is making efforts to commercialize at least one Commercial Product or 

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Commercial Service, RECIPIENT shall have no obligation to provide the written notice as described in this Section D3.06.

PART 4

REVENUE SHARING

Section D4.01Revenue Sharing Percentages.  In consideration for the Grant Award Proceeds paid to the RECIPIENT by the INSTITUTE under the Contract:

a.RECIPIENT shall pay to the INSTITUTE during the Revenue Term the following payments until the INSTITUTE receives the aggregate amount of four hundred percent (400%) of the Grant Award Proceeds:

(i)a revenue sharing percentage of [***] of Revenue for Cumulative Revenue greater than [***] and less than or equal to [***];

(ii)a revenue sharing percentage of [***] of Revenue for Cumulative Revenue greater than [***] and less than or equal to [***]; and

(iii)a revenue sharing percentage of [***] of Revenue for Cumulative Revenue greater than [***].

For clarity, no payments will be made by the RECIPIENT to the INSTITUTE under this Section D4.01(a) until the Cumulative Revenue of the Recipient is greater than [***].

b.  In the event the RECIPIENT and/or its licensee is required to obtain a license under Intellectual Property Rights of one or more Third Parties in order to make Sales of Commercial Products and/or Commercial Services in any given country (“Participating License Sources”), then the revenue sharing percentages set forth under Section D4.01(a)(i)-(iii) may be reduced by [***] for every [***] royalty paid to such Third Parties on Commercial Products and/or Commercial Services in such country, as applicable, provided that in no event will the payments otherwise due to the INSTITUTE under Section D4.01(a) be less than [***] of the payments that would be payable to the INSTITUTE absent the effects of this Section D4.01(b).  By way of example, if the RECIPIENT is required to obtain such a license from a Third Party in a country wherein the RECIPIENT pays a [***] royalty for Intellectual Property Rights that cover Commercial Products and Commercial Services in such country, the revenue sharing percentages under Section D4.01(a)(i), (ii), and (iii) would be reduced to [***] in such country, respectively.

Section D4.02Continued Revenue Sharing.  In the event the INSTITUTE receives during the Revenue Term the aggregate amount of four hundred percent (400%) of the Grant Award Proceeds from the RECIPIENT, the RECIPIENT will continue to pay the INSTITUTE a revenue sharing percentage of one-half percent (0.5%) of Revenue for all Revenue generated during the remainder of the Revenue Term.  For clarity, this revenue sharing percentage cannot be reduced as set forth in Section D4.01(b).

Section D4.03Equity.  Nothing herein prohibits the INSTITUTE from negotiating with the RECIPIENT for an equity share in the RECIPIENT in addition to or in lieu of the revenue sharing set forth in Sections D4.01 and D4.02, when mutually agreed to by the INSTITUTE and the RECIPIENT.  But under no circumstances is the INSTITUTE obligated to negotiate for an equity share in the RECIPIENT in lieu of the revenue sharing set forth herein.

Section D4.04 Statements and Timing of Payments.  All payments owed pursuant to this Part 4 shall be made to the Cancer Prevention and Research Institute of Texas, and are payable on or before the thirtieth day following the end of the calendar quarter in which the Revenue is received or, in the case of Section D4.05, the monetary recovery is received.  For each payment specified in Sections D4.01 and D4.02, the payment shall be accompanied by a statement specifying for such calendar quarter: (i) the Contract to which the payment relates, (ii) the identities 

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of, royalty percentages, and amounts actually paid to any Participating License Sources, (iii) the License Agreements, if any, to which the payment relates, (iv) the quantity of all Sales of each Commercial Product and Commercial Service since the last payment, if Sales are applicable to the current payment, (v) the gross consideration from all such Sales, if Sales are applicable to the current payment, and (vi) a calculation of the amount of the payment to the Cancer Prevention and Research Institute of Texas.

Section D4.05Recoveries in Enforcement Actions.  In the event that the RECIPIENT receives any monetary recovery from its enforcement of Institute-Funded IPR against infringement by a third party, then it shall pay to the State of Texas a share of such monetary recovery, including any punitive damages, less the documented fees and expenses that are directly associated with such enforcement and are paid by RECIPIENT to third parties, at the same rate and in the same manner as it shares Revenue pursuant to Sections D4.01 and D4.02 (including any adjustments allowed by Section D4.01(b)).  For clarity, if the enforcement action is resolved by way of the execution of a License Agreement with the allegedly infringing third party and such License Agreement is consistent with this Part 4, then this Section D4.05 is not intended to apply to such License Agreement or the consideration specified therein.

Section D4.06Revenue-Related Records.  In addition to satisfying the requirements of Article IV of the Contract and Section E1.03 of Attachment E, the RECIPIENT shall keep complete and accurate Revenue-related records until the fourth anniversary of the date of the payment of the last payment owed hereunder, in sufficient detail to permit the INSTITUTE to confirm the accuracy of the statements delivered to the INSTITUTE under Section D4.04 and the calculation of the payments owed hereunder.

Section D4.07Audit of Revenue-Related Records.  Upon at least fifteen (15) days’ advance written notice, the RECIPIENT shall permit the INSTITUTE or its representatives or agents, at the INSTITUTE’s expense, to examine the Revenue-related records of the RECIPIENT pursuant to Section D4.06 once per calendar year during regular business hours for the purpose of and to the extent necessary to verify the RECIPIENT’s compliance with this Part 4.  The rights of the INSTITUTE under this Section D4.07 shall terminate on the fourth anniversary of the date of the payment of the last payment owed hereunder.  In the event that any such examination reveals an underpayment to the INSTITUTE of greater than [***] of the amounts previously paid by the RECIPIENT to the INSTITUTE, then the RECIPIENT shall reimburse the INSTITUTE for the cost of such examination.

PART 5

OPT-OUT AND DEFAULT

Section D5.01RECIPIENT Opt-Out.  If the INSTITUTE elects to exercise its rights in relation to the Project Results under Section D3.06, the INSTITUTE shall have the right, but not the obligation, to pursue protection of the Applicable Institute-Funded IPR on its own behalf, including directing the filing, prosecution and maintenance of patents covering the applicable Institute-Funded Inventions and/or to commercialize or otherwise bring to practical application Project Results covered by the Applicable Institute-Funded IPR, at its own cost, either directly or through one or more licensees.  For the purposes of this Part 5, “Applicable Institute-Funded IPR” shall mean all Project Results.  If the INSTITUTE elects to exercise any such rights under this Section D5.01, it shall notify RECIPIENT in writing pursuant to the notification requirements in Section D3.06 and RECIPIENT shall thereafter comply with the terms of Section D5.03 with regard to the Applicable Institute-Funded IPR.

Section D5.02RECIPIENT Default.  In the event that the INSTITUTE notifies RECIPIENT in writing of RECIPIENT’s failure to materially comply with its obligations under Section D3.02, and RECIPIENT fails within [***] of such notice either: (a) to cure such failure, or in the event that such failure cannot be reasonably cured within such [***] period, to provide to INSTITUTE a plan to cure such failure that INSTITUTE deems acceptable, (b) to provide written notice to the INSTITUTE that such failure was due to material safety concerns, or (c) to provide proper notice pursuant to Section 3.06, then without further action on the part of the RECIPIENT or INSTITUTE, the RECIPIENT shall be deemed to have provided the INSTITUTE the complete, written notice of its cessation of efforts as described in Section 3.06, and the INSTITUTE shall be free to exercise its rights under Section 3.06.

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Section D5.03RECIPIENT Cooperation upon Opt-Out or Default.  In the event that the INSTITUTE exercises any of its rights under Section D5.01, the RECIPIENT shall:

	
 
	
(1)
	
subject to [***], transfer and assign, and does hereby assign, all of its right, title and interest in and to the applicable Project Results to the INSTITUTE or the INSTITUTE’s designee, to the maximum extent allowed by law, including where relevant and necessary to facilitate the foregoing transfer, requesting and diligently attempting to obtain any approvals required by law or otherwise in relation to such transfer, and subject to [***], hereby grants to the INSTITUTE a non-exclusive, royalty-free, perpetual, fully transferable and sublicensable license under any Institute-Funded Technology and Necessary Additional IPR to Exploit the Project Results for the development, manufacture and sale of Commercial Products and Commercial Services and for all other purposes reasonably related thereto;

	
 
	
(2)
	
to the extent that RECIPIENT is unable to transfer all of its right, title and interest in and to the applicable Project Results to the INSTITUTE as specified in Section D5.03(1), and subject to [***], RECIPIENT hereby grants to the INSTITUTE an exclusive, royalty-free, perpetual, fully transferable and sublicensable license under the Applicable Institute-Funded IPR to Exploit the Project Results for the development, manufacture and sale of Commercial Products and Commercial Services and for all other purposes reasonably related thereto, provided that the INSTITUTE may exercise the foregoing rights only after exercising its right under Section D5.01;

	
 
	
(3)
	
cooperate with the INSTITUTE’s efforts, and at the INSTITUTE’s cost, in protecting Applicable Institute-Funded IPR and Institute-Funded Technology, and in commercializing or otherwise bringing to practical application the applicable Project Results, including making relevant Recipient Personnel (to the extent still obligated to RECIPIENT), Contractors, Collaborators, records (including without limitation, laboratory notebooks, electronic records and data), papers, information, samples, specimens and other materials related to the applicable Project Results reasonably available for such purposes and executing any documents and taking any further action reasonably necessary to effectuate the intent of this Section D5.03; and

	
 
	
(4)
	
subject to applicable law, not take any action that would oppose or impede the INSTITUTE’s ability to protect the applicable Project Results.

If the INSTITUTE exercises its rights under Sections D5.01, the RECIPIENT shall have no further claim to or interest in the applicable Project Results, except as set forth in Section D2.01 of this Attachment and shall not be entitled to any share of Revenue or any other compensation with respect to such Project Results, except to the minimum extent required by law, if any.  To the extent that the INSTITUTE has exercised its rights under Section D5.01 and RECIPIENT is unable to transfer all of its right, title and interest in and to the applicable Project Results to the INSTITUTE as specified in D5.03(1), then the INSTITUTE’s license set forth in D5.03(2) includes the right, but not the obligation, for the INSTITUTE at its cost to: (i) direct the filing, prosecution and maintenance of patents covering the applicable Project Results, and (ii) enforce all Applicable Institute-Funded IPR relevant to the Project Results against any infringement by a third party.  Subject to the statutory duties of the Texas Attorney General, if any, RECIPIENT shall cooperate fully with the INSTITUTE in any action brought by the INSTITUTE to enforce the Institute-Funded IPR in the applicable Project Results, at the INSTITUTE’s cost, including without limitation, joining the enforcement action in name as a party plaintiff after all required approvals are obtained; provided that the INSTITUTE or its designee shall have full control over such enforcement action and shall receive and retain all monetary and other recoveries resulting from such enforcement actions, including any punitive damages.

PART 6

DEFINITIONS

Throughout this Attachment D, the following underlined terms shall have the meanings given below.

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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

(1)Commercial Product means anything that is based on, utilizes or is developed from, or materially incorporates, the Project Results and that is capable of being sold, licensed, transferred or conveyed to another party or is capable of otherwise being Exploited or disposed of, whether in exchange for consideration or not.

(2)Commercial Service means any service performed that is based on, utilizes or is developed from, or materially incorporates, the Project Results.  For clarity, Commercial Service does not include non¬commercial research and development performed by RECIPIENT or its Collaborators or licensees.

(3)Cumulative Revenue means after the First Commercial Sale worldwide of a Commercial Product or Commercial Service, the sum of all Revenue in all years and calendar quarters up to the calendar quarter in which the applicable revenue sharing percentage in Section D4.01 is being paid.

(4)Exclusive License means a License Agreement under which the specific rights granted to the licensee with respect to the Project Results, including without limitation scope of use and territorial rights, are granted on an exclusive basis.

(5)Exclusivity means any exclusivities granted by the government in a country to provide an entity with protection from competitors in the commercial market for a defined period of time, including but not limited to patent-based exclusivities (and any patent term extensions, supplementary protection certificates or patent term adjustments thereof, and the like), and market-based “data” exclusivities (e.g., orphan drugs, new chemical entities, biologics, new formulations or combinations, and pediatric, and the like).  For the avoidance of doubt, Exclusivity shall not mean any protection gained solely from either trade secrets or trademarks.

(6)Exploit or Exploitation means make, have made, use, sell, offer to sell, import, export, or otherwise commercialize, dispose of, practice, copy, distribute, create derivative works of, publicly perform or publicly display.

(7)First Commercial Sale means the first bona fide arm’s length Sale of a Commercial Product or Commercial Service to a Third Party by or on behalf of RECIPIENT or its licensees for monetary value, for use or consumption by the end user of such Commercial Product or Commercial Service.  For clarity, Sales of a Commercial Product or Commercial Service for registration samples, clinical trial purposes or compassionate use sales, named patient use, test marketing, sampling and promotional uses, inter-company transfers to affiliates of RECIPIENT or its licensees, shall not constitute a First Commercial Sale.

(8)Grant Award Proceeds means the sum of all monies paid by INSTITUTE to RECIPIENT under the Contract.  For clarity, Grant Award Proceeds will not be diminished by the amount of any funds repaid to INSTITUTE by RECIPIENT under Section 4.07 of the Contract.

(9)Institute-Funded IPR means any and all Intellectual Property Rights in and to Institute-Funded Technology.  In no event shall Institute-Funded IPR include any intellectual property rights and/or technology in existence and owned/controlled by the RECIPIENT prior to the receipt of funds from the INSTITUTE or arising from activities conducted independently of the Project or acquired independently of the Project.

(10)Institute-Funded Invention means an Invention conceived or first reduced to practice by or on behalf of RECIPIENT, including by Recipient Personnel, Contractor(s) and/or Collaborator(s) in the performance of Institute-Funded Activity.

(11)Institute-Funded Technology means any and all of the following resulting or arising, in whole or in part, from Institute-Funded Activity during the Contract term: (a) proprietary and confidential information, including but not limited to data, trade secrets, materials and know-how; (b) databases, compilations and collections of data; (c) tools, methods and processes; and (d) works of authorship, excluding all scholarly works, but including, without limitation, computer programs, source code and executable code, whether embodied in software, firmware or otherwise, documentation, files, records, data and mask works; and all instantiations of the foregoing in any form and embodied in any form, including but not limited to therapeutics, drugs, drug delivery systems, drug 

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formulations, devices, diagnostics, biomarkers, reagents, methodologies and research tools.  Institute-Funded Technology includes Institute-Funded Inventions.  Institute-Funded Technology shall not include items that were conceived of, in existence, or owned/controlled by RECIPIENT prior to receipt of funds from the INSTITUTE or arising from activities conducted independently of the Project or acquired independently of the Project, such as: (a) proprietary and confidential information, including but not limited to data, trade secrets, materials and know-how; (b) databases, compilations and collections of data; (c) tools, methods and processes; and (d) works of authorship, excluding all scholarly works, but including, without limitation, computer programs, source code and executable code, whether embodied in software, firmware or otherwise, documentation, files, records, data and mask works; and all instantiations of the foregoing in any form and embodied in any form, including but not limited to therapeutics, drugs, drug delivery systems, drug formulations, devices, diagnostics, biomarkers, reagents, methodologies and research tools.

(12)Intellectual Property Rights or IPR means any and all of the following and all rights in, arising out of, or associated therewith: (a) all United States and foreign patents and utility models and applications therefor, and all reissues, re-examinations, divisionals, renewals, substitutions, extensions, provisionals, continuations and continuations-in part thereof, and equivalent or similar rights anywhere in the world in inventions and discoveries; (b) all trade secrets and rights in know-how, materials and proprietary information; (c) all copyrights, copyright registrations and applications therefor, and all other rights corresponding thereto throughout the world; (d) all mask works, mask work registrations and applications therefor, and any equivalent or similar rights in semiconductor masks, layouts, architectures or topology; and (e) any similar, corresponding or equivalent rights to any of the foregoing anywhere in the world.

(13)Invention means any idea, composition of matter, method, device, process or discovery that is conceived and/or reduced to practice, whether patentable or not.

(14)License Agreement means an agreement by which an owner of a Project Result grants any right to Exploit such Project Result to a Third Party in exchange for consideration.

(15)Licensing Activities means the efforts of RECIPIENT or its Collaborator to negotiate, execute or enforce a License Agreement.

(16)Major Market Country means one or more of the following: [***].

(17)Necessary Additional IPR means any Intellectual Property Rights (a) owned by RECIPIENT, and (b) identified by the Institute and agreed to in writing by RECIPIENT, that are not Project Results but are necessary to Exploit the Project Results for the specific purposes set forth in the applicable Section of this Attachment D.

(18)Project Results means any and all Institute-Funded Technology and Institute-Funded IPR.

(19)Revenue means the gross consideration, whether cash (for example, but not by way of limitation, any milestone fees, license fees, sublicense fees, or assignment fees) or non-cash (for example, but not by way of limitation, securities, direct equity interest, indirect equity interest, trade or barter considerations, and the like), received from Sales to a Third Party by or on behalf of the RECIPIENT and its licensees (including RECIPIENT’s affiliates and sublicensees of RECIPIENT’s licensee), net of: (a) trade or quantity discounts or rebates, credits, allowances or refunds given for rejected or returned Commercial Products or Commercial Services, (b) any sales, value-added or other tax or governmental charge levied on the sale, transportation or delivery of a Commercial Product or Commercial Service (but excluding any income tax owed by the RECIPIENT), and (c) any separately stated charges for freight, postage, shipping and insurance.  The foregoing notwithstanding, any consideration: (i) received and used by RECIPIENT or its licensees for the purpose of research or development of Commercial Products and Commercial Services, or (ii) received from Sales made solely in the performance of clinical trials designed to obtain regulatory approval for a Commercial Product or Commercial Service, or (iii) received by RECIPIENT or its licensees from Sales made for compassionate use where no profit was obtained by RECIPIENT or its licensees shall not be included in this term.

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(20)Revenue Term means the period commencing on the date of the First Commercial Sale of a Commercial Product or Commercial Service and ending, on a country-by-country basis, when there is not, or there no longer exists, any Exclusivity for the Commercial Product or Commercial Service in such country.  If there is no Exclusivity for a Commercial Product or Commercial Service in any Major Market Country, the Revenue Term shall mean the period commencing on the date of the First Commercial Sale of such Commercial Product or Commercial Service and ending [***] later.

(21)Sale or Sales means any sale, license, lease, transfer, conveyance or other Exploitation or disposition of a Commercial Product or Commercial Service for which consideration from a first Third Party is received.  For clarity, transfer or assignment of a Commercial Product or Commercial Service in connection with a merger, consolidation, transfer or sale of all, or substantially all, of RECIPIENT’s business or assets, or change of control or similar transaction involving the RECIPIENT will not constitute a Sale.

(22)Third Party means a party other than (a) the RECIPIENT, (b) any affiliate or licensee of the RECIPIENT, either directly or through any sublicenses, or (c) an entity that enjoys any special course of dealing with any of (a) or (b) above.

Other terms may be defined elsewhere in this Attachment or in the Contract.

 

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ATTACHMENT E

REPORTING REQUIREMENTS

This Attachment E is hereby incorporated into and made a part of that certain CANCER RESEARCH GRANT CONTRACT (“Contract”) by and between the Cancer Prevention and Research Institute of Texas (“CPRIT” or the “INSTITUTE”) and the RECIPIENT.  A capitalized term used in this Attachment shall have the meaning given to term in the Contract or in the Attachments to the Contract, unless otherwise defined herein.  In the event of a conflict between the provisions of this Attachment and the provisions of the Contract, this Attachment shall control.

INSTITUTE and RECIPIENT agree as follows:

ANNUAL REPORTING

Section E1.01Annual Reports.  The RECIPIENT shall submit  reports  annually to the INSTITUTE  within [***]  of  the anniversary of the Effective Date of this Contract or at such other time as may be specified herein.  The reports shall be submitted by the means and in the form(s) required by the INSTITUTE and shall be signed by the Principal Investigator/Program Director and the RECIPIENT’s Authorized Signing Official.  To the extent possible, the reports shall only include information that may be shared publicly.  However, if it is necessary to submit information in the reports that the RECIPIENT considers confidential in order to fully comply with the terms of this Contract, then the RECIPIENT shall use reasonable efforts to mark such information as “confidential” and shall, to the extent practicable, to segregate such information within the reports to facilitate its redaction should redaction ever be necessary or appropriate.

Section E1.02Contents of Reports.  Each report shall contain a signed verification (electronic signature is acceptable) of RECIPIENT’s compliance with each of its obligations as set forth in the Contract and shall include the following for the period covered by such report, as may then be applicable:

	
(a)
	
Project Data.  During the term of the Contract, RECIPIENT shall include in its annual report each of the following (except that the final annual report due under this part (a) shall be due within [***] after the end of the term of the Contract):

	
 
	
(1)
	
A brief statement of the progress made to under the Scope of Work, including the progress to achieve the Project Goals and Timelines set forth in Attachment A.

	
 
	
(2)
	
A brief statement of the Project Goals for the twelve months following submission of the report.

	
 
	
(3)
	
New jobs created in the preceding twelve month period as a result of the Grant funds awarded to RECIPIENT.

	
 
	
(4)
	
An inventory of the Equipment purchased for the Project using Grant funds.

	
 
	
(5)
	
A HUB report in accordance with Section 3.08 “Historically Underutilized Businesses” of the Contract.

	
(b)
	
Commercialization Data.  During the term of the Contract and continuing thereafter for so long as RECIPIENT has ongoing obligations to the INSTITUTE with respect to protection, development, commercialization and licensing of Project Results pursuant to Attachment D, RECIPIENT shall provide information about commercialization activities in a format specified by the INSTITUTE.

	
(c)
	
Revenue Sharing Data.  During the term of the Contract and continuing thereafter for so long as RECIPIENT has ongoing obligations to the INSTITUTE with respect to revenue sharing pursuant to Attachment D:

	
 
	
(1)
	
A statement of the identities of the funding sources, amounts and dates of funding for all funding sources for the Project.

	
 
	
(3)
	
A brief statement of the RECIPIENT’s efforts to secure additional funds to support the Project.

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(4)
	
All financial information necessary to verify the calculation of the revenue sharing amounts specified in Attachment D.

	
(d)
	
Additional Data.  In addition to the foregoing, RECIPIENT shall use commercially reasonable efforts to also promptly report any other information required by this Contract or otherwise reasonably requested by the INSTITUTE, the Legislature, or any other funding or regulatory bodies covering the RECIPIENT’s activities under this Contract.

Section E1.03 Record Keeping and Audits.  The provisions of Article IV of the Contract shall apply fully to all information reported to the INSTITUTE pursuant to this Attachment, except that the right of the State of Texas to audit and the RECIPIENT’s obligation to maintain Records shall continue until four years after the date of each such report made by RECIPIENT hereunder.

Section E1.04  Confidentiality of Documents and Information.  The provisions of Section 2.13 “Confidentiality of Documents and Information” of the Contract shall apply fully to all Confidential Information reported, delivered or submitted to the INSTITUTE pursuant to this Attachment E.

 

 

 

 

 

 

 

 

 

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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

Grant ID: 

DP160071 

PI/PD/CR: Jason Kim

Organization: Molecular Templates, Inc.

Approved Contract Documents

			
	
Title
	
Approved By
	
Approved Date

	
Product Development Base Contract
	
Kim, Jason
	
04 Sep 2018

	
Attachment A - Goals and Objectives
	
Nelson, Lisa
	
06 Sep 2018

	
Attachment B - Verification Request of Contract Document
	
Kim, Jason
	
07 Sep 2018

	
Attachment C Part 1 - Assurances and Certifications
	
Kim, Jason
	
31 Aug 2018

	
Attachment C Part 2 - Matching Compliance Certification
	
Lansdowne, Bob
	
07 Sep 2018

	
Attachment D - Intellectual Property and Revenue Sharing
	
Kim, Jason
	
04 Sep 2018

	
Attachment E - Reporting Requirements
	
Kim, Jason
	
04 Sep 2018

	
Chief Executive Officer Approval
	
Roberts, Wayne
	
18 Sep 2018

 

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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Grant ID:  DP160071PI/PD/CR:  Jason Kim

Attachment F – CPRIT Contact Change Notification

 

 

As indicated by the signatures below, the INSTITUTE and the RECIPIENT agree to the following amendments to the CPRIT Contract:

Contract Document F: I.  Amendments to CANCER RESEARCH GRANT CONTRACT (A) In Article 1, DEFINITIONS, delete Section (6) (Institute-Funded Activity) in its entirety and replace it with amended Section (6) shown below: (6) Institute-Funded Activity - all aspects of work funded by the Institute and conducted as part of the Project as set forth in the Project Description and/or Scope of Work (Attachment A).  (B) In Article 1, DEFINITIONS, amend Section (9) (Project), after “the activities specified” to delete the term “or generally” and replace it with -- and --.  Amended Section (9) is shown below: (9) Project - the activities specified and described in the Scope of Work or otherwise in this Contract (including without limitation any of the Attachments to the Contract) that are approved by the INSTITUTE for funding, regardless of whether the of the financial support necessary to carry them out.  II.  Amendments to Attachment A: PROJECT DESCRIPTION, GOALS AND TIMELINES (SCOPE OF WORK) – (A) On the Timeline page of Attachment A, insert the following note in the [***].  III.  Amendments to Attachment D: INTELLECTUAL PROPERTY AND REVENUE SHARING (A) In Part 1, Section D1.01, delete the section in its entirety and replace it with amended Section D1.01 shown below: Section D1.01 Ownership of Project Results.  RECIPIENT and its Collaborators, and (to the extent applicable) any third party participating in the research, development or commercialization of [***], shall with respect to INSTITUTE [***] Institute-Funded Technology and the Institute-Funded IPR, subject to the terms of the Contract.  (B) In Part 1, Section D1.02, first sentence, delete “third Party” and replace with --Third Party--; after “or transfer or assignment is to occur,” insert -- under provisions of confidentiality and redacted for (a) [***] and (b) other confidential subject matter on a case-by-case basis with approval of the INSTITUTE.  --; and in the second sentence, move “to” (after “writing”) to directly follow “(i)”; insert “to” directly after (ii); directly after (iii), delete “be responsible for and pay” and replace it with -- that --; and after “under Part 4 of this Attachment D,” insert -- will be paid by[***].  Amended Section D1.02 is shown below: Section D1.02 Transfer or Assignment of Rights to a Third Party.  RECIPIENT shall notify the INSTITUTE of any proposed transfer or assignment of rights in any Project Results to a Third Party and provide to INSTITUTE a copy of the agreement under which the proposed transfer or assignment is to occur, under provisions of confidentiality and redacted for (a) [***] and (b) other confidential subject matter on a case-by-case basis with approval of the INSTITUTE.  RECIPIENT shall ensure that, in any assignment or transfer of Project Results, the transferee or assignee agrees in writing: (i) to recognize that the Institute-Funded IPR and Institute-Funded Technology, as applicable, is transferred or assigned subject to the licenses, interests and other rights in such Project Results provided to the INSTITUTE in the Contract and any applicable law or regulation, (ii) to take all actions necessary to protect all such licenses, interests and other rights, and (iii) that all amounts required under Part 4 of this Attachment D will be paid [***].  Any attempted transfer or assignment of rights in any Project Results to a Third Party without written agreement to the conditions in (i) – (iii) above shall be null, void and of no effect.  (C) In Part 1, Section D1.03, first sentence, after “RECIPIENT shall use commercially reasonable efforts,” insert -- including, as applicable, [***], --; and in the third sentence, after “Upon notice of the aforesaid, the INSTITUTE shall have the right, but not the obligation,” insert -- subject to IPR ownership rights of [***] and [***] in and to [***], --.  Amended Section D1.03 is shown below: Section D1.03 Protection of Institute-Funded IPR.  Subject to Section D5.01, RECIPIENT shall use commercially reasonable efforts, including, as applicable, [***], to appropriately protect the Institute-Funded IPR, including without limitation, diligently seeking registration and maintenance of patents and copyrights covering the Institute-Funded Technology, as appropriate.  If RECIPIENT elects to abandon any patent applications filed or patents issued covering any Institute-Funded Technology in any Major Market Country, RECIPIENT shall provide the INSTITUTE with prior written notice of such election, with sufficient time (but no less than [***]) for the INSTITUTE to exercise its rights under this Section D1.03 with respect thereto.  Upon notice of the aforesaid, the INSTITUTE shall have the right, but not the obligation, subject to IPR ownership rights of [***] and [***] in and to [***], to pursue protection of the applicable Institute-Funded Technology on its own behalf in such Major Market Country, including directing the filing, prosecution and maintenance of patent applications or patents covering the applicable Institute-Funded Inventions in any of such Major Market Countries for which the INSTITUTE exercises 

38

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Grant ID:  DP160071PI/PD/CR:  Jason Kim

Attachment F – CPRIT Contact Change Notification

 

its rights under this Section D1.03.  In the Major Market Countries where the INSTITUTE pursues protection of the Institute-Funded Technology under this Section D1.03, RECIPIENT agrees to grant, and does hereby grant, to the INSTITUTE a non-exclusive, irrevocable, royalty-free, perpetual license with right to sublicense in the applicable Major Market Countries to the applicable Instituted-Funded Technology and any applicable Project Results.  For clarification, a determination by RECIPIENT to (i) abandon a patent application in favor of a continuation or divisional application or the like, or (ii) narrow the scope of the claimed subject matter, shall not be deemed an election to abandon such Institute-Funded IPR.  (D) In Part 1, Section D1.05(a), first sentence, after “within [***] after RECIPIENT receives or generates it” insert -- , unless agreed to otherwise by INSTITUTE --.  Amended Section D1.05(a) is shown below: Section D1.05 Inventions.  (a) Disclosures and Patent Applications.  RECIPIENT shall notify INSTITUTE of each Institute-Funded Invention by delivering to INSTITUTE a copy of the invention disclosure within [***] after RECIPIENT receives or generates it, unless agreed to otherwise by INSTITUTE.  In the event that a patent application is filed on the invention disclosure, RECIPIENT shall provide the INSTITUTE with a complete copy of such patent application and associated filing documents within [***] of its filing.  (E) In Part 2, Section D2.01, first sentence, after “(including material embodiments thereof” insert -- [***] --.  Amended Section D2.01 is shown below: Section D2.01 RECIPIENT License.  In granting an Exclusive License to any Project Results, RECIPIENT shall retain the right to Exploit all Project Results (including material embodiments thereof [***]) for education, research and other non-commercial purposes, and the right to grant the licenses pursuant to Section D2.02 below.  (F) In Part 2, Section D2.02, delete this section in its entirety and replace with the following amended Section D2.02, as shown below: Section D2.02 INSTITUTE License.  RECIPIENT hereby grants to the INSTITUTE a non-exclusive, irrevocable, royalty-free, perpetual, worldwide license, solely for academic, non-commercial purposes, under the Project Results and to Exploit any Necessary Additional IPR, said license specifically [***], and with a right to sublicense to a permitted sublicensee of the INSTITUTE, consisting of other governmental entities and agencies of the State of Texas, and private or independent institutions of higher education (as defined by Texas law) located in Texas, for education, research and other non-commercial purposes only, pursuant to industry-standard confidentiality and/or material transfer agreements to be entered into between the parties, as applicable.  RECIPIENT shall make all non-excluded Institute-Funded Technology available by reasonable means to the INSTITUTE in order for the INSTITUTE to exercise its rights under this Section D2.02, at no cost to RECIPIENT.  A copy of any written sublicense granted by INSTITUTE under this Section D2.02 will be provided to RECIPIENT by INSTITUTE within [***] of the effective date of such sublicense.  (G) In Part 2, Section D2.03, delete this section in its entirety and replace with the following amended Section D2.03, as shown below: Section D2.03 No Implied Licenses.  No implied licenses are granted under this Contract including without limitation any license to any Intellectual Property Rights owned or controlled by RECIPIENT or [***] or [***] outside of the Institute-Funded IPR.  Nothing in this Attachment D to the Contract shall be construed to impose an obligation on RECIPIENT to license or otherwise make available any of its Intellectual Property Rights or other resources owned or controlled by it except as expressly provided in this Attachment.  (H) In Part 3, Section D3.01, first sentence, delete “enhance” and replace it with -- implement --; and after “to commercialize or otherwise bring to practical application” insert -- at least one Commercial Product directed to the molecular target described in the --.  Amended Section D3.01 is shown below: Section D3.01 Commercialization Strategy.  RECIPIENT shall be under a continuing obligation throughout the term of this Contract to implement and improve the commercial development plan submitted with the Application and to provide an annual written report to the INSTITUTE regarding the RECIPIENT’s and its licensee’s efforts to commercialize or otherwise bring to practical application at least one Commercial Product [***] Project Results.  The INSTITUTE may, at its option and at any time, provide RECIPIENT with comments regarding the RECIPIENT’s commercial development plan and strategy, in which case RECIPIENT shall consider in good faith and, if appropriate, use reasonable efforts to account for and incorporate the INSTITUTE’s input into such commercial development plan and strategy.  (I) In Part 3, Section D3.02, second sentence, after “considered to be” insert -- diligent and commercially reasonable efforts --.  Amended Section D3.02 is shown below: Section D3.02 Commercialization Efforts.  The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial 

39

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Grant ID:  DP160071PI/PD/CR:  Jason Kim

Attachment F – CPRIT Contact Change Notification

 

development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01.  For the avoidance of doubt, partnering or licensing activities shall be considered to be diligent and commercially reasonable efforts to commercialize.  (J) In Part 3, Section D3.03, first sentence, delete “(i)”; at line 4, after “Contract,” delete “[***] and replace with -- [***] --; in the second sentence, after “the reporting obligations set forth in Attachment E” insert -- to this Contract --; and after the last sentence, insert -- “[***]  -- Amended Section D3.03 is shown below: Section D3.03 Licensing of Project Results.  Each License Agreement entered into by the RECIPIENT shall include an acknowledgement by the licensee that such License Agreement is subject to the INSTITUTE’s licenses, interests and other rights under this Contract, [***].  In addition, all License Agreements shall include terms obligating the licensee to report to the RECIPIENT such information as is required for the RECIPIENT to fully comply with the terms of the Contract, including without limitation the reporting obligations set forth in Attachment E to this Contract, and to allow RECIPIENT to make the grants specified in Sections D2.02.  The RECIPIENT shall monitor the performance of its licensees and such licensees’ compliance with the terms of the License Agreements and shall take commercially reasonable actions to enforce the terms of all License Agreements.  The RECIPIENT shall [***] report to the INSTITUTE any material breach of a License Agreement relating to or affecting any of the material provisions of this Contract.  [***]  (K) In Part 3, Section D3.06, first sentence, after “commercialize or otherwise bring to practical application” insert -- [***] --; and in the last sentence, after “is making efforts to commercialize at least one Commercial Product or Commercial Service” insert -- [***] --.  Amended Section D3.06 is shown below: Section D3.06 Recipient Opt-Out.  In the event RECIPIENT determines, after diligently attempting to comply with the terms of Section D3.02, to cease its efforts, either directly or through a licensee, to commercialize or otherwise bring to practical application [***] the Project Results, it will so notify the INSTITUTE in writing promptly thereafter.  Such written notice must identify the Project Results and provide a reasonable explanation of the reasons for the RECIPIENT’s election.  Upon receipt of such notice, the INSTITUTE and RECIPIENT shall meet within [***] to review the Project Results and rationale for the RECIPIENT’s election.  Provided that RECIPIENT’s determination to cease its efforts was not based on material safety concerns related to the Project Results, the INSTITUTE and RECIPIENT shall engage in good faith negotiations regarding an alternative commercialization strategy and/or revenue sharing approach.  The INSTITUTE and RECIPIENT may consider, among other options, an award of equity in the RECIPIENT, expansion or modification of the Institute Funded Activity to cover other commercial products or commercial services being advanced by the RECIPIENT, or some combination thereof.  Unless otherwise agreed, if the INSTITUTE and RECIPIENT are unable to achieve an alternative strategy or agreement within [***] of the RECIPIENT’s initial notice of election, and provided that RECIPIENT’s determination to cease its efforts was not based on material safety concerns related to the Project Results, the INSTITUTE shall have the right, but not the obligation, to exercise its rights in Section D5.01 in relation to the Project Results at the INSTITUTE’s expense.  If the INSTITUTE elects to exercise its rights under Section D5.01 in relation to the Project Results, the INSTITUTE shall notify the RECIPIENT in writing within [***] of INSTITUTE’s receipt of the RECIPIENT’s initial notice of election or [***] following a declaration by one of the Parties that good faith negotiations have failed.  In the event that the INSTITUTE exercises its option under this Section D3.06, the RECIPIENT shall cooperate with the INSTITUTE’s efforts and provide to INSTITUTE sufficient information such as relevant feasibility studies, trial results, regulatory summaries, and pertinent schedules or deadlines in relation to the Project Results, in commercializing or otherwise bringing to practical application the applicable Project Results at the INSTITUTE’s cost.  For clarity, so long as the RECIPIENT is making efforts to commercialize at least one Commercial Product or Commercial Service [***], RECIPIENT shall have no obligation to provide the written notice as described in this Section D3.06.  (L) In Part 5, Section D5.01, delete this section in its entirety and replace with amended Section D5.01, as shown below: Section D5.01 RECIPIENT Opt-Out.  If the INSTITUTE elects to exercise its rights in relation to the Project Results under Section D3.06, the INSTITUTE shall have the right, but not the obligation, to pursue protection of the applicable Institute-Funded IPR on its own behalf, including directing the filing, prosecution and maintenance of patents covering the applicable Institute-Funded Inventions and/or to commercialize or otherwise bring to practical application Project Results covered by the applicable Institute-Funded IPR, at its own cost, either directly or through one or more licensees.  If the INSTITUTE elects to exercise any such rights under this Section D5.01, it shall notify RECIPIENT in writing pursuant to the notification requirements in Section D3.06 and RECIPIENT shall thereafter 

40

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Grant ID:  DP160071PI/PD/CR:  Jason Kim

Attachment F – CPRIT Contact Change Notification

 

comply with the terms of Section D5.03 with regard to all applicable Institute-Funded IPR in which RECIPIENT has a right to assign or license.  (M) In Part 5, Section D5.02, replace each of three occurrences of “3.06” with -- D3.06 --.  Amended Section D5.02 in relevant part is shown below: Section D5.02 RECIPIENT Default.  In the event that the INSTITUTE notifies RECIPIENT in writing of RECIPIENT’s failure to materially comply with its obligations under Section D3.02, and RECIPIENT fails within [***] of such notice either: (a) to cure such failure, or in the event that such failure cannot be reasonably cured within such [***] period, to provide to INSTITUTE a plan to cure such failure that INSTITUTE deems acceptable, (b) to provide written notice to the INSTITUTE that such failure was due to material safety concerns, or (c) to provide proper notice pursuant to Section D3.06, then without further action on the part of the RECIPIENT or INSTITUTE, the RECIPIENT shall be deemed to have provided the INSTITUTE the complete, written notice of its cessation of efforts as described in Section D3.06, and the INSTITUTE shall be free to exercise its rights under Section D3.06.  (N) In Part 5, Section D5.03, delete this section in its entirety and replace with the following amended Section D5.03, as shown below: Section D5.03 RECIPIENT Cooperation upon Opt-Out or Default.  In the event that the INSTITUTE exercises any of its rights under Section D5.01 or D5.02, the RECIPIENT shall: (1) subject to [***], transfer and assign, and does hereby assign, all of its right, title and interest in and to the applicable Institute-Funded IPR to the INSTITUTE or the INSTITUTE’s designee, to the maximum extent allowed by law, including where relevant and necessary to facilitate the foregoing transfer, requesting and diligently attempting to obtain any approvals required by law or otherwise in relation to such transfer, and subject to [***], hereby grants to the INSTITUTE a non-exclusive, royalty-free, perpetual, fully transferable and sublicensable license under any Institute-Funded Technology and Necessary Additional IPR to Exploit the Institute-Funded IPR and Institute-Funded Technology for the development, manufacture and sale of Commercial Products and Commercial Services and for all other purposes reasonably related thereto; (2) to the extent that RECIPIENT is unable to transfer all of its right, title and interest in and to the applicable Institute-Funded IPR to the INSTITUTE as specified in Section D5.03(1), and subject to [***], RECIPIENT hereby grants to the INSTITUTE an exclusive, royalty-free, perpetual, fully transferable and sublicensable license under the applicable Institute-Funded IPR to Exploit the applicable Institute-Funded IPR and Institute-Funded Technology for the development, manufacture and sale of Commercial Products and Commercial Services and for all other purposes reasonably related thereto, provided that the INSTITUTE may exercise the foregoing rights only after exercising its right under Section D5.01; (3) cooperate with the INSTITUTE’s efforts, and at the INSTITUTE’s cost, in protecting applicable Institute-Funded IPR and Institute-Funded Technology, and in commercializing or otherwise bringing to practical application the applicable Project Results (subject to [***]), including making relevant Recipient Personnel (to the extent still obligated to RECIPIENT), Contractors, Collaborators, records (including without limitation, laboratory notebooks, electronic records and data), papers, information, samples, specimens and other materials related to the applicable Project Results reasonably available for such purposes and executing any documents and taking any further action reasonably necessary to effectuate the intent of this Section D5.03; and (4) subject to applicable law, not take any action that would oppose or impede the INSTITUTE’s ability to protect the applicable Institute-Funded IPR.  If the INSTITUTE exercises its rights under Sections D5.01, the RECIPIENT shall have no further claim to or interest in the applicable Project Results, except as set forth in Section D2.01 of this Attachment and shall not be entitled to any share of Revenue or any other compensation with respect to such Project Results, except to the minimum extent required by law, if any.  To the extent that the INSTITUTE has exercised its rights under Section D5.01 and RECIPIENT is unable to transfer all of its right, title and interest in and to the applicable Project Results to the INSTITUTE as specified in D5.03(1), then the INSTITUTE’s license set forth in D5.03(2) includes the right, but not the obligation, and subject to [***] and [***] in and to [***], for the INSTITUTE at its cost to: (i) direct the filing, prosecution and maintenance of patents covering the applicable Project Results, and (ii) enforce all applicable Institute-Funded IPR relevant to the Project Results against any infringement by a third party.  Subject to the statutory duties of the Texas Attorney General, if any, RECIPIENT shall cooperate fully with the INSTITUTE in any action brought by the INSTITUTE to enforce the Institute-Funded IPR in the applicable Project Results, at the INSTITUTE’s cost, including without limitation, joining the enforcement action in name as a party plaintiff after all required approvals are obtained; provided that the INSTITUTE or its designee shall have full control over such enforcement action and shall receive and retain all monetary and other recoveries resulting from such enforcement actions, including any punitive damages.  (O) Part 6, Definitions, is amended to add new Sections 

41

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Grant ID:  DP160071PI/PD/CR:  Jason Kim

Attachment F – CPRIT Contact Change Notification

 

(3), (5), (22) and (23); to amend Sections (11) - (14); and original sections have been renumbered to preserve consecutive numbering.  Accordingly, Part 6, Definitions is deleted in its entirety and replaced with the following amended Part 6, Definitions, as shown below: PART 6 DEFINITIONS Throughout this Attachment D, the following underlined terms shall have the meanings given below.  (1) Commercial Product means anything that is based on, utilizes or is developed from, or materially incorporates, the Project Results and that is capable of being sold, licensed, transferred or conveyed to another party or is capable of otherwise being Exploited or disposed of, whether in exchange for consideration or not.  (2) Commercial Service means any service performed that is based on, utilizes or is developed from, or materially incorporates, the Project Results.  For clarity, Commercial Service does not include non- commercial research and development performed by RECIPIENT or its Collaborators or licensees.  (3) CPRIT Project No.  CC121020 Institute-Funded IPR means any and all Intellectual Property Rights in the following, resulting or arising from Institute-Funded Activity during the CPRIT Project No.  CC121020 Contract term: international patent applications [***] and [***], and related (a) proprietary and confidential information, including but not limited to data, trade secrets and know-how; (b) databases, compilations and collections of data; (c) tools, methods and processes; and (d) works of authorship, excluding all scholarly works, but including, without limitation, computer programs, source code and executable code, whether embodied in software, firmware or otherwise, documentation, files, records, data and mask works; and all applications of the foregoing in any form and embodied in any form, including but not limited to therapeutics, drugs, drug delivery systems, drug formulations, devices, diagnostics, biomarkers, reagents and research tools.  In no event shall Institute-Funded Technology include items that were conceived of, in existence, or owned/controlled by RECIPIENT prior to receipt of funds from the INSTITUTE to the RECIPIENT for Project No.  CC121020.  (4) Cumulative Revenue means after the First Commercial Sale worldwide of a Commercial Product or Commercial Service, the sum of all Revenue in all years and calendar quarters up to the calendar quarter in which the applicable revenue sharing percentage in Section D4.01 is being paid.  (5) [***] means proprietary information, data, results, technologies, Inventions, materials, molecules and compositions owned, licensed or otherwise controlled by RECIPIENT’s [***] or [***].  For the sake of clarity, “[***]” does not include CPRIT Project No.  CC121020 Institute-Funded IPR.  (6) Exclusive License means a License Agreement under which the specific rights granted to the licensee with respect to the Project Results, including without limitation, scope of use and territorial rights, are granted on an exclusive basis.  (7) Exclusivity means any exclusivities granted by the government in a country to provide an entity with protection from competitors in the commercial market for a defined period of time, including but not limited to patent-based exclusivities (and any patent term extensions, supplementary protection certificates or patent term adjustments thereof, and the like), and market-based “data” exclusivities (e.g., orphan drugs, new chemical entities, biologics, new formulations or combinations, and pediatric, and the like).  For the avoidance of doubt, Exclusivity shall not mean any protection gained solely from either trade secrets or trademarks.  (8) Exploit or Exploitation means make, have made, use, sell, offer to sell, import, export, or otherwise commercialize, dispose of, practice, copy, distribute, create derivative works of, publicly perform or publicly display.  (9) First Commercial Sale means the first bona fide arm’s length Sale of a Commercial Product or Commercial Service to a Third Party by or on behalf of RECIPIENT or its licensees for monetary value, for use or consumption by the end user of such Commercial Product or Commercial Service.  For clarity, Sales of a Commercial Product or Commercial Service for registration samples, clinical trial purposes or compassionate use sales, named patient use, test marketing, sampling and promotional uses, inter- company transfers to affiliates of RECIPIENT or its licensees, shall not constitute a First Commercial Sale.  (10) Grant Award Proceeds means the sum of all monies paid by INSTITUTE to RECIPIENT under the Contract.  For clarity, Grant Award Proceeds will not be diminished by the amount of any funds repaid to INSTITUTE by RECIPIENT under Section 4.07 of the Contract.  (11) Institute-Funded IPR means any and all Intellectual Property Rights in and to Institute-Funded Technology pertaining to RECIPIENT Proprietary Technologies.  In no event shall Institute-Funded IPR include [***].  Institute-Funded IPR also shall not include RECIPIENT Background IPR and/or technology in existence and (a) owned/controlled by the RECIPIENT prior to the receipt of funds from the INSTITUTE under this Agreement; (b) arising from activities conducted independently of a CPRIT funded Project, including CPRIT Project No.  CC12010; or (c) acquired independently of the Project.  (12) Institute-Funded Invention means an Invention conceived by or on behalf of RECIPIENT, including by Recipient Personnel, Contractor(s) and/or Collaborator(s) in the performance of Institute-Funded Activity.  (13) Institute-Funded 

42

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Grant ID:  DP160071PI/PD/CR:  Jason Kim

Attachment F – CPRIT Contact Change Notification

 

Technology means any and all of the following resulting or arising, in whole or in part, from Institute-Funded Activity during the Contract term: (a) proprietary and confidential information, including but not limited to data, trade secrets, materials and know-how; (b) databases, compilations and collections of data; (c) tools, methods and processes; and (d) works of authorship, excluding all scholarly works, but including, without limitation, computer programs, source code and executable code, whether embodied in software, firmware or otherwise, documentation, files, records, data and mask works; and all instantiations of the foregoing in any form and embodied in any form, including but not limited to therapeutics, drugs, drug delivery systems, drug formulations, devices, diagnostics, biomarkers, reagents, methodologies and research tools.  Institute-Funded Technology includes Institute-Funded Inventions.  Institute-Funded Technology shall not include subject matter that was conceived of, in existence, or owned/controlled by RECIPIENT prior to receipt of funds from the INSTITUTE under the Contract, [***], or any other subject matter arising from activities conducted independently of the Project or acquired independently of the Project, such as but not limited to: (a) proprietary and confidential information, including but not limited to data, trade secrets, materials and know-how; (b) databases, compilations and collections of data; (c) tools, methods and processes; and (d) works of authorship, excluding all scholarly works, but including, without limitation, computer programs, source code and executable code, whether embodied in software, firmware or otherwise, documentation, files, records, data and mask works; and all instantiations of the foregoing in any form and embodied in any form, including but not limited to therapeutics, drugs, drug delivery systems, drug formulations, devices, diagnostics, biomarkers, reagents, methodologies and research tools.  (14) Intellectual Property Rights or IPR means any and all of the following and all rights in, arising out of, or associated therewith: (a) all United States and foreign patents and utility models and applications therefor, and all reissues, re-examinations, divisionals, renewals, substitutions, extensions, provisionals, continuations and continuations-in part thereof, and equivalent or similar rights anywhere in the world in Inventions and other discoveries; (b) all trade secrets and other rights in data, methods, results, discoveries, technology, know-how, compositions, materials and information; (c) all copyrights, copyright registrations and applications therefor, and all other rights corresponding thereto throughout the world; (d) all mask works, mask work registrations and applications therefor, and any equivalent or similar rights in semiconductor masks, layouts, architectures or topology; and (e) any similar, corresponding or equivalent rights to any of the foregoing anywhere in the world.  (15) Invention means any idea, composition of matter, method, device, process or discovery that is conceived and/or reduced to practice, whether patentable or not.  (16) License Agreement means an agreement by which an owner of a Project Result grants any right to Exploit such Project Result to a Third Party in exchange for consideration.  (17) Licensing Activities means the efforts of RECIPIENT or its Collaborator to negotiate, execute or enforce a License Agreement.  (18) Major Market Country means one or more of the following: [***].  (19) Necessary Additional IPR means any Intellectual Property Rights (a) solely owned by RECIPIENT, and (b) identified by the Institute and agreed to in writing by RECIPIENT, [***], that are not Project Results but are necessary to Exploit the Project Results for the specific purposes set forth in the applicable Section of this Attachment D.  [***].  (20) Project Results means any and all Institute-Funded Technology and Institute-Funded IPR.  (21) Revenue means the gross consideration, whether cash (for example, but not by way of limitation, any milestone fees, license fees, sublicense fees, or assignment fees) or non-cash (for example, but not by way of limitation, securities, direct equity interest, indirect equity interest, trade or barter considerations, and the like), received from Sales to a Third Party by or on behalf of the RECIPIENT and its licensees (including RECIPIENT’s affiliates and sublicensees of RECIPIENT’s licensee), net of: (a) trade or quantity discounts or rebates, credits, allowances or refunds given for rejected or returned Commercial Products or Commercial Services, (b) any sales, value-added or other tax or governmental charge levied on the sale, transportation or delivery of a Commercial Product or Commercial Service (but excluding any income tax owed by the RECIPIENT), and (c) any separately stated charges for freight, postage, shipping and insurance.  The foregoing notwithstanding, any consideration: (i) received and used by RECIPIENT or its licensees for the purpose of research or development of Commercial Products and Commercial Services, or (ii) received from Sales made solely in the performance of clinical trials designed to obtain regulatory approval for a Commercial Product or Commercial Service, or (iii) received by RECIPIENT or its licensees from Sales made for compassionate use where no profit was obtained by RECIPIENT or its licensees shall not be included in this term.  (22) RECIPIENT Background IPR means all RECIPIENT IPR conceived of, in existence, or owned, licensed or otherwise controlled by RECIPIENT prior to receipt of funds from 

43

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Grant ID:  DP160071PI/PD/CR:  Jason Kim

Attachment F – CPRIT Contact Change Notification

 

the INSTITUTE under the Contract.  For the sake of clarity, “RECIPIENT Background IPR” does not include any CPRIT Project No.  CC121020 Institute-Funded IPR.  (23) RECIPIENT Proprietary Technology means RECIPIENT’s proprietary information, technologies, materials, molecules, compositions and know-how relating to its platform technology and Shiga IA-based engineered toxin bodies (ETBs), including its proprietary ETB directed to the CD38 molecular target, “[***]” as described in Exhibit A to the Contract, and wherein [***].  (24) Revenue Term means the period commencing on the date of the First Commercial Sale of a Commercial Product or Commercial Service and ending, on a country-by-country basis, when there is not, or there no longer exists, any Exclusivity for the Commercial Product or Commercial Service in such country.  If there is no Exclusivity for a Commercial Product or Commercial Service in any Major Market Country, the Revenue Term shall mean the period commencing on the date of the First Commercial Sale of such Commercial Product or Commercial Service and [***].  (25) Sale or Sales means any sale, license, lease, transfer, conveyance or other Exploitation or disposition of a Commercial Product or Commercial Service for which consideration from a first Third Party is received.  For clarity, transfer or assignment of a Commercial Product or Commercial Service in connection with a merger, consolidation, transfer or sale of all, or substantially all, of RECIPIENT’s business or assets, or change of control or similar transaction involving the RECIPIENT will not constitute a Sale.  (26) Third Party means a party other than (a) the RECIPIENT, (b) any affiliate or licensee of the RECIPIENT, either directly or through any sublicenses, or (c) an entity that enjoys any special course of dealing with any of (a) or (b) above.  Other terms may be defined elsewhere in this Attachment or in the Contract.

Description: Amendments to add two definitions to the Base Contract, to reflect a potential timeline change in Aim 1 in Attachment A, and to make several changes to Attachment D.

		
	
RECIPIENT
	
INSTITUTE

	
Molecular Templates, Inc.
	
Cancer Prevention & Research Institute of Texas

	
ASO Name: Kim, Jason
	
CEO Name: Roberts, Wayne

	
Submitted Date: 18 Sep 2018
	
Approved Date: 18 Sep 2018

 

82565892v.1

 
 
44

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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