EX-10.1 2 pstx-ex101_92.htm EX-10.1 pstx-ex101_92.htm

Exhibit 10.1

CERTAIN INFORMATION CONTAINED IN THIS EXHIBIT, MARKED BY [***], HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE THE REGISTRANT HAS DETERMINED THAT IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

CONFIDENTIAL

EXECUTION VERSION

 

 

 

 

 

COLLABORATION AND LICENSE AGREEMENT BETWEEN

POSEIDA THERAPEUTICS, INC. AND

F. HOFFMANN-LA ROCHE LTD AND HOFFMANN-LA ROCHE INC. AS OF JULY 30, 2022

 

 


CONFIDENTIAL EXECUTION VERSION

 

 

 

TABLE OF CONTENTS

 

 

 

Pages

 

 

 

Article 1

Definitions

1

Article 2

Governance

28

Article 3

Tier 1 Programs; Tier 2 Programs; Collaboration Programs

36

Article 4

Program Transition; Research, Development and Commercialization After Program Transition

47

Article 5

Tier 1 Process Development Program; Manufacturing; Technology Transfer

50

Article 6

Licenses; Licensed Technologies

56

Article 7

Exclusivity

63

Article 8

Financial Terms

66

Article 9

Payment Terms; Reports; Audits

82

Article 10

Confidentiality; Data Privacy & Security

86

Article 11

Publicity; Publications; Use of Name

90

Article 12

Intellectual Property

92

Article 13

Representations, Warranties and Covenants

100

Article 14

Indemnification

103

Article 15

Term; Termination

105

Article 16

Dispute Resolution

113

Article 17

Miscellaneous

117

 

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CONFIDENTIAL EXECUTION VERSION

 

 

EXHIBITS

 

Exhibit 1.18

Authorized Subcontractors

Exhibit 1.29

Cas-CLOVER Gene Editing IP

Exhibit 1.82

ED-Go Candidate Success Criteria

Exhibit 1.83

Ed-Go Data Package

Exhibit 1.88

Excluded Third Party In-License Agreements

Exhibit 1.138-1

Manufacturing Feasibility Criteria for the P-BCMA-ALLO1 Tier 1 Program

Exhibit 1.138-2

Manufacturing Feasibility Criteria for

the P-CD19/CD20-ALLO1 Tier 1 Program

Exhibit 1.166-1

Phase I DE+ Data Package for a Tier 1 Program

Exhibit 1.166-2

Phase I DE+ Data Package for a Tier 2 Program

Exhibit 1.224

Technology Transfer Plan

Exhibit 1.253

Tscm-Enabling IP

Exhibit 3.1.2-1

Tier 1 Development Plan for P-BCMA-ALLO1 Tier 1 Program

Exhibit 3.1.2-2

Tier 1 Development Plan for P-CD19/CD20-ALLO1 Tier 1 Program

Exhibit 3.4.1

Initial Collaboration Research Plan

Exhibit 6.6.1(a)

Study Plan

Exhibit 6.10.1

[***]

Exhibit 8.9.2(a)

Preferred Manufacturers

Exhibit 11.1

Press Release

Exhibit 13.2.4

Encumbrances

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[***] = Certain Confidential Information Omitted

 

 

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CONFIDENTIAL EXECUTION VERSION

 

 

 

COLLABORATION AND LICENSE AGREEMENT

 

THIS COLLABORATION AND LICENSE AGREEMENT (“Agreement”) is made and entered into, as of July 30, 2022 (“Execution Date”), between Poseida Therapeutics, Inc., a Delaware corporation, having its principal place of business at 9390 Towne Centre Dr. #200, San Diego, CA 92121, United States of America (“Poseida”), on the one hand, and F. Hoffmann-La Roche Ltd, having its principal place of business at Grenzacherstrasse 124, CH 4070 Basel, Switzerland (“FHLR”) and Hoffmann-La Roche Inc., having its principal place of business at 150 Clove Rd., Suite 8, Little Falls, NJ 07424, United States of America (“HLR”; FHLR and HLR together referred to as “Roche”), on the other hand. Poseida and Roche are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

 

Background

 

WHEREAS, Poseida is a biotechnology company that researches and develops allogeneic CAR T-cell therapeutic products and has expertise in gene delivery and gene editing technologies.

 

WHEREAS, Roche is a biopharmaceutical company that is engaged in the research, development, manufacture and sale of pharmaceutical products.

 

WHEREAS, Poseida desires to grant to Roche an exclusive license to certain allogeneic CAR T- cell therapeutic products and an option to exclusively license certain other allogeneic CAR T-cell therapeutic products, which Roche would develop and commercialize.

 

WHEREAS, Poseida and Roche desire to collaborate in the research of improvements to CAR T- cell therapy and the research of novel allogeneic CAR T-cell therapeutic products, which Roche would develop and commercialize.

 

WHEREAS, Poseida desires to grant to Roche a non-exclusive license and sublicense to certain technologies for Roche to use and incorporate in the research, development, and commercialization of TCR-expressing cell therapeutic products.

 

NOW THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Roche and Poseida agree as follows:

 

ARTICLE 1

Definitions

 

Capitalized terms used in this Agreement, whether used in the singular or plural, shall have the meanings set forth below, unless otherwise specifically indicated herein.

 

1.1Accounting Standards” means the maintenance of records and books of accounts in accordance with either International Financial Reporting Standards or US Generally Accepted Accounting Principles, in each case as currently used at the applicable time by, and as consistently applied by, the applicable Party or its Affiliate or Sublicensee.

 

1

 


CONFIDENTIAL EXECUTION VERSION

 

 

 

 

1.2

Acquirer is defined in Section 6.11.

 

 

1.3

Acquisition Affiliate is defined in Section 7.2.2.

 

1.4Active Program” means, with respect to a Target, a research or preclinical or clinical development program Directed To such Target, including such program that is conducted by Poseida or its Affiliates outside of this Agreement, with respect to which (a) (i) [***]; and (ii) Poseida, together with its Affiliates, spent at least [***] on such program, during the preceding [***].

 

 

1.5

Additional Collaboration Research Fee is defined in Section 8.4.1.

 

 

1.6

Additional Collaboration Research Plan is defined in Section 3.4.2.

 

 

1.7

Additional Collaboration Research Program is defined in Section 3.4.2.

 

 

1.8

Additional Collaboration Research Project is defined in Section 3.4.2.

 

 

1.9

Additional Collaboration Research Term is defined in Section 3.4.2.

 

 

1.10

[***].

 

1.11Additional Existing Programs” means each of (a) Poseida’s program for the research and development of an Allo CAR T-Cell Therapy [***] for the treatment of Heme Malignancies including [***], and (b) Poseida’s program for the research and development of an Allo CAR T- Cell [***] for the treatment of Heme Malignancies, including [***].

 

1.12Affiliate” means any entity that, directly or indirectly (through one or more intermediaries) controls, is controlled by, or is under common control with a Party, at any point in time and for so long as such control exists. For purposes of the preceding sentence, “controls”, “controlled”, and “control” means (i) the direct or indirect ownership of more than fifty percent (>50%) of the voting stock or other voting interests or interest in the profits of the Party, or (ii) the ability to otherwise control or direct the decisions of the board of directors or equivalent governing body thereof. [***]

 

[***] = Certain Confidential Information Omitted

2

 


CONFIDENTIAL EXECUTION VERSION

[***].

 

 

 

 

1.13

Alliance Manager is defined in Section 2.7.

 

 

1.14

Allo CAR T-Cell Therapy means [***].

 

 

1.15

Allogeneic Licensed Product means [***].

 

1.16Annual Net Sales means, with respect to a Therapeutic Product or Licensed Product, as applicable, all Net Sales of such Therapeutic Product or Licensed Product, as applicable, during a Calendar Year.

 

1.17Antigen Binder” means, with respect to a CAR or CAR Cell, the antigen recognition domains of any and all proteins, protein fragments, or peptides (including full-length antibodies, heavy chain-only antibodies (including VH or VHH), nanobodies, antigen-binding fragments (Fabs), and single-chain variable domain fragments (scFvs)) included in such CAR or expressed by such CAR Cell that bind, or contribute to the binding, to a Target.

 

1.18Authorized Subcontractors” means, [***], the Poseida subcontractors (a) [***] or (b) [***].

 

 

1.19

Autologous Licensed Product means [***].

 

 

1.20

Available Target means [***].

 

 

1.21

[***] is defined in Section 3.4.4(a).

 

1.22Biosimilar Product” means, with respect to a Therapeutic Product in a country or jurisdiction worldwide, [***]

 

[***] = Certain Confidential Information Omitted

3

 


CONFIDENTIAL EXECUTION VERSION

[***].

 

 

 

 

1.23

Board of Directors is defined in Section 1.33(a).

 

1.24Business Day” means any day, other than a Saturday, Sunday or day on which commercial banks located in Switzerland or San Diego, California (US) are authorized or required by law to be closed.

 

1.25Calendar Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 or October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Calendar Quarter of the Term shall end on the last day of the Term.

 

1.26Calendar Year” means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.

 

 

1.27

CAR means a chimeric antigen receptor.

 

1.28CAR Cell means a T-cell expressing a construct encoding the nucleotide sequence of at least one (1) CAR that includes an extracellular domain (including an Antigen Binder), a transmembrane domain, and a cytosolic signaling domain.

 

1.29Cas-CLOVER Gene Editing IP” means (a) all Know-How comprising Cas-CLOVER Gene Editing Technology and (b) all Patents claiming any such Know-How or otherwise Covering any Cas-CLOVER Gene Editing Technology, in each case (a) and (b), Controlled by Poseida or its Affiliates as of the Execution Date or at any time thereafter until the end of the Term. The Patents in clause (b) existing as of the Execution Date are listed on Exhibit 1.29.

 

 

1.30

Cas-CLOVER Gene Editing Technology means [***].

 

1.31Cell Therapy” means a pharmaceutical product comprising living cells that are administered to a patient and intended to treat, cure, or prevent a disease or condition.

 

 

1.32

Challenge is defined in Section 12.10.1.

 

1.33Change in Control with respect to Poseida, shall be deemed to have occurred if any of the following occurs after the Effective Date:

 

[***] = Certain Confidential Information Omitted

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CONFIDENTIAL EXECUTION VERSION

 

 

 

(a)any “person” or “group” (as such terms are defined below) (i) becomes the “beneficial owner” (as defined below), directly or indirectly, of shares of capital stock or other interests (including partnership interests) then-outstanding and normally entitled (without regard to the occurrence of any contingency) to vote in the election of the directors, managers or similar supervisory positions (“Voting Stock”) of Poseida representing more than fifty percent (>50%) of the total voting power of all outstanding classes of Voting Stock of Poseida or (ii) acquires the power, directly or indirectly, to elect a majority of the members of the board of directors or similar governing body (“Board of Directors”) of Poseida; or

 

(b)Poseida enters into a merger, consolidation or similar transaction with a Third Party (whether or not Poseida is the surviving entity) and as a result of such merger, consolidation or similar transaction (i) the members of the Board of Directors of Poseida immediately prior to such transaction constitute less than a majority of the members of the Board of Directors of such surviving entity immediately following such transaction or (ii) the individuals or entities that beneficially owned, directly or indirectly, the shares of Voting Stock of Poseida immediately prior to such transaction cease to beneficially own, directly or indirectly, shares of Voting Stock of Poseida representing at least a majority of the total voting power of all outstanding classes of Voting Stock of the surviving entity; or

 

(c)Poseida sells or transfers to any Third Party, in one or more related transactions, properties or assets representing all or substantially all of Poseida’s assets to which this Agreement relates.

 

For the purpose of this Section 1.33, (x) “person” and “group” have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934, and the term “group” includes any group acting for the purpose of acquiring, holding or disposing of securities within the meaning of Rule 13d-5(b)(1) under the said Act; (y) a “beneficial owner” shall be determined in accordance with Rule 13d-3 under the aforesaid Act; and (z) the terms “beneficially owned” and “beneficially own” shall have meanings correlative to that of “beneficial owner.” Notwithstanding the foregoing, (A) a transaction solely to change the domicile of Poseida; or (B) any merger or consolidation between Poseida and one or more Affiliates shall not constitute a Change in Control.

 

1.34CICC or Chain of Identity and Chain of Control means a process for the capture of data related to who handled the collection of a donor’s cells or the resulting Cell Therapy, what actions were performed, and the location, data and time of the actions from the start of cell collection through product administration and post-treatment monitoring, including the association of a donor’s unique identifiers to their cells and the resulting Cell Therapy during the same.

 

 

1.35

CMO means a Third Party contract manufacturing organization.

 

 

1.36

[***]

 

[***] = Certain Confidential Information Omitted

5

 


CONFIDENTIAL EXECUTION VERSION

 

 

 

[***].

 

1.37Collaboration Candidate” means, with respect to a Collaboration Program, either the Lead Collaboration Candidate or [***] for such Collaboration Program.

 

 

1.38

Collaboration Improvements is defined in Section 3.4.1.

 

1.39Collaboration IP” means all Program Inventions and Patents claiming such Program Inventions, other than Product IP, Roche Technology Improvements, and Poseida Technology Improvements.

 

 

1.40

Collaboration Product means, with respect to a Collaboration Program, [***].

 

1.41Collaboration Program” means each of the research and development programs conducted under this Agreement (whether solely by Roche or jointly by the Parties) with respect to an Allo CAR T-Cell Therapy Directed To a Collaboration Target(s) (which in the case of CD19 shall be Directed To both CD19 and another Collaboration Target) but not Directed To any additional Target, including the Collaboration Research Program, and if elected by Roche pursuant to Section 3.4.6(a), the Early Development Collaboration Program with respect to such Collaboration Research Program.

 

1.42Collaboration Research Data Package means a set of data, results, documents, records, and reports for each scientific hypothesis or therapeutic concept being investigated by the Parties under the Initial Collaboration Research Plan or the Additional Collaboration Research Plan, as applicable, that meets the content requirements for such set of data, results, documents, records and reports as set forth in the Initial Collaboration Research Plan or the Additional Collaboration Research Plan, as applicable, [***]; provided that any such data within the Collaboration Research Data Package that relates to patients or other clinical trial participants shall be in de-identified form in accordance with Section 10.9 of this Agreement.

 

 

1.43

Collaboration Research Plan is defined in Section 3.4.4(a).

 

[***] = Certain Confidential Information Omitted

6

 


CONFIDENTIAL EXECUTION VERSION

 

 

 

 

1.44

Collaboration Research Program is defined in Section 3.4.3.

 

 

1.45

Collaboration Research Program Designation is defined in Section 3.4.3.

 

 

1.46

Collaboration Research Program Designation Fee is defined in Section 8.4.2.

 

1.47Collaboration Research Term” means, with respect to a Collaboration Research Program, the period of time from the JRT’s approval of the applicable Collaboration Research Plan until the earliest of (a) [***], (b) [***], or (c) [***] from such JRT approval of the applicable Collaboration Research Plan, as may be extended pursuant to Section 3.4.5(a).

 

 

1.48

Collaboration Research Project is defined in Section 3.4.1.

 

 

1.49

Collaboration Target is defined in Section 3.4.3.

 

 

1.50

Commercial License is defined in Section 6.6.4(b).

 

 

1.51

Commercial License Fee is defined in Section 8.5.2.

 

 

1.52

Commercial License Option is defined in Section 6.6.4(a).

 

 

1.53

Commercial License Option Exercise is defined in Section 6.6.4(a).

 

 

1.54

Commercially Reasonable Efforts means [***].

 

 

1.55

Competing Program is defined in Section 7.2.2.

 

 

1.56

Competitive Product means, [***]

 

[***] = Certain Confidential Information Omitted

7

 


CONFIDENTIAL EXECUTION VERSION

 

 

 

[***].

 

1.57Completion” means, with regard to a Phase I DE+, the delivery of the final study report for the Phase I DE+ to Roche.

 

1.58Compulsory Sublicense means a license or sublicense granted to a Third Party, through the order, decree or grant of a governmental authority having competent jurisdiction, authorizing such Third Party to make, use, sell, offer for sale, import or export a Therapeutic Product or Licensed Product in a country or countries.

 

1.59Compulsory Sublicensee” means a Third Party that was granted a Compulsory Sublicense.

 

 

1.60

Confidential Information is defined in Section 10.1.

 

1.61Control” or “Controlled by” means, with respect to any Patents, Know-How or other intellectual property rights, the rightful possession (whether through ownership, license, or otherwise, other than by operations of the licenses granted herein) by a Party, as of the Execution Date or during the Term, of the ability to grant the other Party a license, sublicense or other right to exploit any item or right under such Patents, Know-How or other intellectual property rights, as provided herein, without violating the terms of any agreement with any Third Party; [***].

 

1.62Cover (including variations such as Covered”, “Covering and the like), means, with respect to a Valid Claim in a country and in reference to a particular Therapeutic Product or Licensed Product, as applicable, (whether alone or in combination with one or more other ingredients) that the use, manufacture, sale, offer for sale or import, as applicable, of such Therapeutic Product or Licensed Product in such country would, but for ownership thereof or a license granted in this Agreement thereunder, infringe such Valid Product Claim in such country [***] or if such Valid Claim is a claim in a pending application for a Patent, would infringe such claim if it were issued.

 

1.63CPA Firm” means an independent, certified and internationally recognized public accounting firm selected by the auditing Party and reasonably acceptable to the Party to be audited.

 

[***] = Certain Confidential Information Omitted

8

 


CONFIDENTIAL EXECUTION VERSION

 

 

 

1.64Data Room means, with respect to an Additional Existing Program, a virtual or physical due diligence data room containing all material data and information, including relevant Patents, relevant Third Party agreements, pre-clinical, clinical, and CMC data, and regulatory correspondence, for such Additional Existing Program to the extent Controlled by Poseida and reasonable and customary for the purpose of due diligence.

 

 

1.65

Designated Licensed Target is defined in Section 6.6.4(c).

 

 

1.66

Diagnostics IP means [***].

 

1.67Directed To” means, with respect to a Target and a Cell Therapy, that a CAR or T-cell receptor of such Cell Therapy binds directly to such Target, and such binding causes or is intended to cause pharmacologically relevant activity. When required grammatically, the defined term “Directed To” may be separated and will have the same meaning set forth above; e.g., when discussing Targets To which a product is Directed.

 

 

1.68

Disclosing Party is defined in Section 10.1.

 

 

1.69

Disposition Transaction is defined in Section 8.10.

 

 

1.70

Dispute is defined in Section 16.1.

 

 

1.71

Divestiture is defined in Section 7.2.2(b).

 

 

1.72

FTC is defined in Section 15.1.

 

1.73Donor Selection IP” means (a) all Know-How comprising the Donor Selection Technology and (b) all Patents claiming any such Know-How, in each case (a) and (b), Controlled by Poseida or its Affiliates as of the Execution Date or at any time thereafter until the end of the Term.

 

 

1.74

Donor Selection Technology means [***].

 

 

1.75

[***].

 

1.76Early Development Candidate Success Criteria” means, with respect to an Early Development Collaboration Program, the criteria for identifying a Lead Collaboration Candidate and [***].

 

 

1.77

Early Development Collaboration Expenses is defined in Section 8.4.3.

 

 

1.78

Early Development Collaboration Plan is defined in Section 3.4.6(a).

 

 

1.79

Early Development Collaboration Program is defined in Section 3.4.4(b).

 

[***] = Certain Confidential Information Omitted

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CONFIDENTIAL EXECUTION VERSION

 

 

 

1.80Early Development Collaboration Term means, with respect to an Early Development Collaboration Program, the period of time from the JDT’s approval of the applicable Early Development Collaboration Plan until the earliest of (a) [***], (b) [***], or (c) [***] from such JDT approval of the applicable Early Development Collaboration Plan, as may be extended pursuant to Section 3.4.7(a).

 

 

1.81

[***].

 

1.82ED-Go Candidate Success Criteria means, for a Collaboration Research Program, the criteria for identifying a Lead Collaboration Candidate [***] that are suitable for [***], as set forth in the applicable Collaboration Research Plan and consistent with the general criteria in Exhibit 1.82.

 

1.83ED-Go Data Package” means, with respect to a Tier 2 Program or Collaboration Program, the complete set of data, results, documents, records, and reports listed in Exhibit 1.83 (as may be amended by the JRT) to enable evaluation of a Lead Collaboration Candidate and, if applicable, [***] against the relevant ED-Go Candidate Success Criteria, provided that any such data within the ED-Go Data Package that relates to patients or other clinical trial participants shall be in de-identified form in accordance with Section 10.9 of this Agreement.

 

 

1.84

ED-Go Decision is defined in Section 3.4.4(b).

 

1.85Effective Datemeans the first (1st) Business Day immediately following the HSR Clearance Date. Upon the request of either Party, the Parties shall memorialize the Effective Date, as defined in the immediately preceding sentence, in a written document for their records.

 

1.86Exchange” means a securities exchange or other stock market on which a Party’s securities are traded.

 

1.87Excluded Target means any Target (a) [***] or (b) [***], in each case of (a) and (b), at the time of receipt of Roche’s applicable Nomination of such Target.

 

1.88Excluded Third Party In-License Agreements” means those agreements set forth on Exhibit 1.88.

 

1.89Existing Third Party Agreement Payments means the payments owed pursuant to the Third Party In-License Agreements existing as of the Execution Date as set forth on Exhibit 6.10.1.

 

[***] = Certain Confidential Information Omitted

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1.90FDA” means the United States Food and Drug Administration, or any successor entity thereto performing similar functions.

 

 

1.91

Field means any and all uses.

 

 

1.92

First Commercial Sale means [***].

 

 

1.93

FTC is defined in Section 15.1.

 

1.94FTE” means full-time equivalent employee (i.e., one (1) fully-committed or multiple partially-committed employees aggregating to one (1) full-time employee) by Poseida (or any of its Affiliates) and assigned to perform specific 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 will be [***] hours per Calendar Year.

 

1.95FTE Costs” means all costs and expenses for the employee providing the applicable services, which shall be calculated at the FTE Rate [***].

 

1.96FTE Rate means, with respect to an FTE, a rate of [***] per FTE per Calendar Year (to be pro-rated on an hourly basis) and is subject to [***].

 

 

1.97

Full Licensed Technologies Transfer is defined in Section 6.6.2(c).

 

 

1.98

German WHT Requirement is defined in Section 9.9.

 

 

1.99

Heme Malignancy means a hematologic cancer [***]

 

[***] = Certain Confidential Information Omitted

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[***].

 

1.100HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended from time to time.

 

1.101HSR Clearance Date” means the expiration or termination of (a) all applicable waiting periods and requests for information (and any extensions thereof) under the HSR Act and (b) any agreements with the FTC or the DOJ not to consummate the transactions contemplated by this Agreement; provided, however, that if Roche receives a letter from the FTC before the Effective Date stating that the FTC has not finished its HSR investigation, then Roche may, at its option, by written notice to Poseida, delay the Effective Date up to thirty (30) days from the expiration of the thirty (30)-day statutory waiting period under the HSR Act (not from the date of receipt of such FTC letter).

 

1.102HSR Filing means filings by the Parties with the US Federal Trade Commission and the Antitrust Division of the US Department of Justice of a Notification and Report Form with respect to the matters set forth in this Agreement, together with all required documentary attachments thereto.

 

1.103IND means an investigational new drug application filed with the FDA pursuant to 21 C.F.R. §312 before the commencement of clinical trials of a product, or any comparable filing with any relevant Regulatory Authority in any other jurisdiction.

 

 

1.104

Indemnitee is defined in Section 14.3.

 

 

1.105

Indemnitor is defined in Section 14.3.

 

1.106Indication” means a specific disease, disorder or condition that is recognized by the applicable Regulatory Authority in a given country or jurisdiction as a disease, disorder or condition. All variants of a single disease, disorder or condition (whether classified by severity or otherwise), regardless of the patient population, shall be treated as the same Indication. By way of example, (a) the treatment of a disease, disorder or condition in a particular patient population and the treatment of the same disease, disorder or condition in another population (e.g., adult population and pediatric population) shall be treated as the same Indication and (b) label expansions for a given Indication (e.g., front-line, second line, third line, metastatic, adjuvant, etc.) shall be treated as the same Indication.

 

 

1.107

Indirect Tax is defined in Section 9.10.

 

1.108Information Security Incident” means, with respect to Confidential Information, any unauthorized use, unauthorized disclosure, corruption (including ransomware attack) or loss or other misuse of, or unauthorized access to, such Confidential Information. Information Security Incidents do not include unsuccessful attempts or activities that do not compromise the security of Confidential Information, including unsuccessful log-in attempts, pings, port scans, denial of service attacks, or other network attacks on firewalls or networked systems.

 

 

1.109

“Infringement” is defined in Section 12.10.1.

 

[***] = Certain Confidential Information Omitted

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1.110

Initial Collaboration Research Plan is defined in Section 3.4.1

 

 

1.111

Initial Collaboration Research Program is defined in Section 3.4.1.

 

 

1.112

Initial Collaboration Research Term is defined in Section 3.4.1.

 

 

1.113

“Initial Licensed Technologies Transfer is defined in Section 6.6.1(b).

 

 

1.114

Initial Research License Term is defined in Section 6.6.1(a)

 

1.115Initiation means, with respect to a clinical trial, the first dosing of the first human subject in such clinical trial.

 

 

1.116

iPSC-Derived Licensed Product means [***], in either case, (a) [***], and (b) [***].

 

 

1.117

JDT is defined in Section 2.2.1.

 

 

1.118

JDT Co-Chair is defined in Section 2.2.1.

 

 

1.119

JMT is defined in Section 2.3.1.

 

 

1.120

JMT Co-Chair is defined in Section 2.3.1.

 

 

1.121

Joint IP is defined in Section 12.2.

 

 

1.122

Joint Patent means a Patent within the Joint IP.

 

 

1.123

JRT is defined in Section 2.1.1.

 

 

1.124

JRT Co-Chair is defined in Section 2.1.1.

 

 

1.125

JSC is defined in Section 2.4.1.

 

 

1.126

JSC Co-Chair is defined in Section 2.4.1.

 

1.127Know-How” means all non-public information, inventions (whether or not patentable), improvements, practices, formula, trade secrets, techniques, methods, procedures, knowledge, results, data (including pharmacological, toxicological, pharmacokinetic, pre-clinical and clinical information and test data, related reports, structure-activity relationship data, statistical analysis, and analytical and quality control data), protocols, processes, models, designs, and other information regarding discovery, development, marketing, pricing, distribution, cost, sales and manufacturing. Know-How shall not include any Patents.

 

 

1.128

Launch Quarter is defined in Section 8.9.3.

 

[***] = Certain Confidential Information Omitted

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1.129

Lead Collaboration Candidate is defined in Section 3.4.4.

 

1.130Licensed Product means an Off-The-Shelf TCR-Expressing Cell Therapy Directed To a Designated Licensed Target but not Directed To any additional Target or a Personalized TCR- Expressing Cell Therapy. For clarity, a Licensed Product shall exclude a Tier 1 Product, Tier 2 Candidate, Optioned Tier 2 Product and Collaboration Product.

 

1.131Licensed Target” means a solid tumor Target designated in accordance with Section 6.6.2(d).

 

 

1.132

Licensed Technologies is defined in Section 6.6.1.

 

 

1.133

Licensed Technologies Know-How is defined in Section 6.6.2(c).

 

 

1.134

Loss or Losses is defined in Section 14.1.

 

1.135Major European Country” means France, Germany, Italy, Spain or the United Kingdom.

 

1.136Manufacture” and “Manufacturing” means all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping, and holding of any Tier 1 Product, Tier 2 Candidate, Collaboration Product, or Licensed Product or any intermediate thereof, beginning with the selection of donors and ending with delivery of the applicable Tier 1 Product, Tier 2 Candidate, Collaboration Product, or Licensed Product (as applicable) to a patient’s treating physician or treatment center, including process development, formulation, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance, quality control, and establishment of CICC.

 

1.137Manufacturing Costs” means, with respect to a Therapeutic Product Manufactured and supplied by Poseida to Roche for development or clinical use:

 

(a)When Poseida or its Affiliate Manufactures such Therapeutic Product directly, the sum of (i) and (ii) below:

 

 

(i)

[***]

 

 

(ii)

[***].

 

All Manufacturing Costs in subsection (a) will be determined according to and consistent with Poseida’s Accounting Standards in the manner consistently applied to all products manufactured by Poseida.

 

[***] = Certain Confidential Information Omitted

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(b)

When Poseida uses a CMO to Manufacture such Therapeutic Product,

[***].

 

 

1.138Manufacturing Feasibility Criteria” means (a) for Poseida’s P-BCMA-ALLO1 Tier 1 Program, the set of criteria for the Manufacturing Process for such Tier 1 Program attached hereto as Exhibit 1.138-1, and (b) for Poseida’s P-CD19/CD20-ALLO1 Tier 1 Program, the set of criteria for the Manufacturing Process for such Tier 1 Program attached hereto as Exhibit 1.138-2, in each case as such criteria may be amended by unanimous agreement of the JMT.

 

 

1.139

[***] is defined in Section 8.2.2.

 

 

1.140

Manufacturing Process means [***].

 

1.141Manufacturing Transition Initiation Date means, (a) with respect to a Tier 1 Program, the date that is the earliest of (i) [***], (ii) [***] or (iii) [***]; (b) with respect to an Optioned Tier 2 Program, the Program Transition Initiation Date; and (c) with respect to a Collaboration Program, the Program Transition Initiation Date.

 

1.142Marketing Authorization” means with respect to a Therapeutic Product or Licensed Product, final Regulatory Approval (including pricing approval, where required) required to sell such Therapeutic Product or Licensed Product, as applicable, for an Indication in accordance with the applicable law of a given country.

 

1.143Materials” means any chemical or biological substances including any: (i) organic or inorganic chemical or compound; (ii) gene; (iii) vector or construct, whether plasmid, phage, virus or any other type; (iv) host organism, including bacteria and eukaryotic cells; (v) eukaryotic or prokaryotic cell line or expression system; (vi) protein, including any peptide or amino acid sequence, enzyme, antibody or protein conferring targeting properties and any fragment of a protein or peptide or enzyme; (vii) genetic material, including any genetic control element (e.g., promoters); (viii) virus; or (ix) assay or reagent.

 

[***] = Certain Confidential Information Omitted

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1.144Minimum Active Dose means, with respect to a Phase I DE+, the lowest dose of a Therapeutic Product that a patient receives in such Phase I DE+ [***].

 

 

1.145

[***].

 

1.146Net Sales” means, with respect to a given Therapeutic Product or Licensed Product in a given period on or after the First Commercial Sale in a country, [***].

 

 

1.146.1

Sale of Therapeutic Product or Licensed Product by Roche and Affiliates.

[***].

 

 

1.146.2

Sale of Therapeutic Product or Licensed Product by Sublicensee. [***].

 

[***] = Certain Confidential Information Omitted

16

 


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1.146.3Sale of Therapeutic Product or Licensed Product by a Compulsory Sublicensee. [***].

 

 

1.146.4

Therapeutic Products or Licensed Product Sold in Combination.

[***].

 

 

1.147

Nomination is defined in Section 6.6.2(d).

 

 

1.148

Off-The-Shelf TCR-Expressing Cell Therapy means [***].

 

 

1.149

Option is defined in Section 3.2.1.

 

 

1.150

Option Exercise Fee is defined in Section 8.3.1.

 

 

1.151

Option Exercise Period is defined in Section 3.2.1.

 

 

1.152

Option Maintenance Election is defined in Section 3.2.2.

 

 

1.153

Option Maintenance Fee is defined in Section 8.3.2.

 

[***] = Certain Confidential Information Omitted

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1.154Optioned Tier 2 Product means, with respect to an Optioned Tier 2 Program, (a) a Tier 2 Candidate within such Optioned Tier 2 Program, and (b) any Allo CAR T-Cell Therapy, other than a Collaboration Product, (i) that is Directed To [***], (ii) [***] and (iii) [***].

 

1.155Optioned Tier 2 Program” means a Tier 2 Program for which Roche has timely exercised its Option pursuant to Section 3.2.1 or 3.2.2.

 

1.156Out-of-Pocket Costs” means costs and expenses paid to Third Parties (or payable to Third Parties and accrued in accordance with Accounting Standards) by either Party or its Affiliates or Sublicensees in connection with activities under this Agreement without markup, excluding FTE Costs.

 

 

1.157

P-BCMA-ALLO1 Tier 1 Program is defined in Section 1.245.

 

 

1.158

P-BCMA/CD19-ALLO1 Tier 2 Program is defined in Section 1.248.

 

 

1.159

P-CD19/CD20-ALLO1 Tier 1 Program is defined in Section 1.245.

 

 

1.160

P-CD70-ALLO1 Tier 2 Program is defined in Section 1.248.

 

1.161Patent” means any and all patent or patent application or any patents issuing therefrom or claiming priority thereto, worldwide, together with any extensions (including patent term extensions and supplementary protection certificates) and renewals thereof, reissues, re- examinations, substitutions, confirmation patents, registration patents, invention certificates, patents of addition, renewals, divisionals, continuations, and continuations-in-part of any of the foregoing.

 

 

1.162

Personal Data is defined in Section 10.9.

 

 

1.163

Personalized TCR-Expressing Cell Therapy means [***].

 

1.164Phase I Clinical Trial” means a human clinical trial, the principal purpose of which is preliminary determination of safety and pharmacokinetics of a Therapeutic Product as described in 21 C.F.R. §312.21, or similar clinical study in a country other than the US.

 

1.165Phase I DE+ means the portion of a Phase I Clinical Trial in which (a) increasing doses of a Therapeutic Product are administered for the purpose of identifying a recommended dose for a Phase II Clinical Trial of such Therapeutic Product and (b) a minimum of [***]

 

[***] = Certain Confidential Information Omitted

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CONFIDENTIAL EXECUTION VERSION

 

 

 

[***] are dosed with such Therapeutic Product at the Minimum Active Dose or higher dose as set forth in the applicable protocol.

 

1.166Phase I DE+ Data Package means, with respect to a Tier 1 Program, a Tier 2 Program for which Roche has made an Option Maintenance Election, or an Early Development Collaboration Program, the complete set of data, results, documents, records, and reports (to be drafted and as may be amended by the JDT), [***] is dosed with the Minimum Active Dose or higher dose in the applicable Phase I DE+, provided that any such data within the Phase I DE+ Data Package that relates to patients or other clinical trial participants shall be in de-identified form in accordance with Section 10.9 of this Agreement. The Phase I DE+ Data Package list for the P- BCMA-ALLO1 Tier 1 Program is attached hereto as Exhibit 1.166-1. The Phase I DE+ Data Package list for the P-CD19/CD20-ALLO1 Tier 1 Program is attached hereto as Exhibit 1.166-2.

 

1.167Phase II Clinical Trial” means a human clinical trial, for which the primary endpoints include a determination of dose ranges or a preliminary determination of efficacy of a product in patients being studied as described in 21 C.F.R. §312.21, or similar clinical study in a country other than the US. For the avoidance of doubt, any Phase I DE+ activities within a Tier 1 Program, Tier 2 Program, or Collaboration Program shall not be considered a Phase II Clinical Trial.

 

1.168Phase III Clinical Trial” means a controlled human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a product for one or more Indications in order to obtain Marketing Authorization of such product for such Indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the US.

 

1.169Poseida Background IP” means all (a) Know-How Controlled by Poseida or its Affiliates at the Execution Date or during the Term and (b) Patents claiming such Know-How. [***].

 

 

1.170

Poseida Indemnitees is defined in Section 14.2.

 

 

1.171

Poseida Prosecuted Patents is defined in Section 12.4.1.

 

 

1.172

Poseida Technology Improvement means [***]

 

[***] = Certain Confidential Information Omitted

19

 


CONFIDENTIAL EXECUTION VERSION

 

 

 

[***].

 

 

1.173

Poseida Technology Product means [***].

 

 

1.174

[***].

 

 

1.175

Prior NDA is defined in Section 10.6.

 

1.176Process Development IP” means (a) any Know-How (including any composition of matter, article of manufacture, method of use, or other subject matter), whether patentable or not, that is discovered or conceived by or on behalf of one or both Parties or their Affiliates solely or jointly with others, in the course of conducting activities pursuant to each Tier 1 Process Development Plan during the applicable Tier 1 Process Development Term, [***] and (b) any Patents claiming such Know-How.

 

 

1.177

Product IP means, with respect to a particular Therapeutic Product, a Program Invention

(a) [***] or (b) [***], and (c) any Patent specifically claiming any of the foregoing in (a) or (b) and does not claim any other subject matter within Poseida Background IP.

 

1.178Product Trademarks” means the Trademarks to be used for the commercialization of Therapeutic Products or Licensed Products worldwide and any registrations thereof or any pending applications relating thereto worldwide (excluding, in any event, any Trademarks, service marks, names or logos that include any corporate name or logo of either Party or its Affiliate or Sublicensee).

 

 

1.179

Product-Specific Patent means [***].

 

[***] = Certain Confidential Information Omitted

20

 


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1.180Program Invention” means any Know-How (including any composition of matter, article of manufacture, method of use, or other subject matter), whether patentable or not, that is discovered or conceived by or on behalf of one or both Parties or their Affiliates solely or jointly with others, [***].

 

 

1.181

Program Transition is defined in Section 4.1.

 

1.182Program Transition Initiation Date is defined (a) with respect to a Tier 1 Program, in Section 3.1.2, (b) with respect to a Tier 2 Program, in Section 3.2.1 or 3.2.3, as applicable, and (c) with respect to a Collaboration Program, in Section 3.4.4(b), 3.4.5(c), 3.4.6(b) or 3.4.7(c), as applicable.

 

 

1.183

Proposed Target is defined in Section 6.6.2(d).

 

1.184Prosecution and Maintenance” or “Prosecute and Maintain,” with respect to a given Patent, means all activities associated with the preparation, filing, prosecution, and maintenance of such Patent, as well as supplemental examinations, re-examinations, reissues, applications for patent term extensions, calculation and applications for patent term adjustments, supplementary protection certificates, and the like with respect to such Patent. For clarity, Prosecute and Maintain shall not include any such actions with respect to a Patent brought by a Third Party, including any reexaminations, inter partes reviews, and post grant reviews, as well as interferences and derivation proceedings, oppositions and other similar proceedings brought by a Third Party with respect to such Patent.

 

 

1.185

R&D License is defined in Section 6.6.2(b).

 

 

1.186

R&D License Fee is defined in Section 8.5.1.

 

 

1.187

R&D License Option is defined in Section 6.6.2(a).

 

 

1.188

R&D License Term is defined in Section 6.6.2(b).

 

 

1.189

Receiving Party is defined in Section 10.1.

 

 

1.190

Register is defined in Section 12.5.

 

1.191Regulatory Approval” means, with respect to a Therapeutic Product or Licensed Product, as applicable, in a country or jurisdiction, any and all approvals (including INDs and Biologics License Applications and any supplements thereto), licenses, registrations, or authorizations of any Regulatory Authority necessary to Manufacture, use, store, import, transport, commercially distribute, sell, or market such Therapeutic Product or Licensed Product, as applicable in such country, including, where applicable, (a) pricing or reimbursement approval in

 

[***] = Certain Confidential Information Omitted

21

 


CONFIDENTIAL EXECUTION VERSION

 

 

 

suchcountry,(b) post-approvalmarketingauthorizations(includinganyprerequisite Manufacturing approval or authorization related thereto), and (c) labeling approval.

 

1.192Regulatory Authority” means any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the development, Manufacturing, commercialization or other use or exploitation (including the granting of Regulatory Approvals) of the pharmaceutical or biological products in any jurisdiction, including the FDA.

 

1.193Regulatory Documentation” means all (a) applications (including all INDs and other regulatory filings), 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 regulatory drug lists, adverse event files, and complaint files; and (c) data, including all information that is made, collected, or otherwise generated pursuant to a clinical trial, contained or relied upon in any of the foregoing (including data related to the Manufacturing Process), in each case ((a), (b), and (c)) relating to a Therapeutic Product.

 

 

1.194

Regulatory Transfer is defined in Section 4.1.1.

 

 

1.195

Release is defined in Section 11.2.

 

 

1.196

[***].

 

 

1.197

[***].

 

 

1.198

[***].

 

 

1.199

[***].

 

 

1.200

[***].

 

1.201Roche Background IP” means all (a) Know-How Controlled by Roche or its Affiliates at the Execution Date or during the Term and (b) Patents claiming such Know-How, in each case

(a) and (b). [***].

 

 

1.202

Roche Indemnitees is defined in Section 14.1.

 

 

1.203

Roche Materials is defined in Section 3.5.1.

 

[***] = Certain Confidential Information Omitted

22

 


CONFIDENTIAL EXECUTION VERSION

 

 

 

1.204Roche Product” means any proprietary therapeutic product developed, in-licensed or acquired by Roche that is not the subject of this Agreement.

 

 

1.205

Roche Prosecuted Patents is defined in Section 12.4.2(a).

 

 

1.206

Roche Technology Improvement means [***].

 

 

1.207

[***].

 

 

1.208

[***].

 

 

1.209

[***].

 

 

1.210

[***].

 

 

1.211

[***].

 

 

1.212

Royalty Eligible Allogeneic Licensed Product is defined in Section 8.8.3(a).

 

 

1.213

Royalty Eligible Autologous Licensed Product is defined in Section 8.8.3(a).

 

 

1.214

Royalty Term is defined in Section 8.8.4.

 

 

1.215

Rules is defined in Section 16.2.1.

 

 

1.216

Sales means [***]

 

[***] = Certain Confidential Information Omitted

23

 


CONFIDENTIAL EXECUTION VERSION

 

 

 

[***].

 

 

1.217

Sell-Off Period is defined in Section 15.7.4.

 

 

1.218

Study Plan is defined in Section 6.6.1(a).

 

1.219Sublicensee” means any Third Party, other than [***], to which Roche or any of its Affiliates grants a sublicense under the rights licensed to Roche under this Agreement to commercialize a Therapeutic Product or Licensed Product.

 

1.220Target” means a naturally occurring human protein or biological molecule from which an antigen is derived, including all peptides derived from such protein and all forms (including forms arising from mutations in the gene that encodes such protein or biological molecule) of such protein or biological molecule.

 

 

1.221

Target Extension Fee is defined in Section 8.5.3.

 

 

1.222

Technical Update is defined in Section 6.7.

 

 

1.223

Technology Transfer is defined in Section 5.4.

 

1.224Technology Transfer Plan” means, with respect to the Technology Transfer of a Therapeutic Program, the plan that (a) lists documents and Materials (i) to be transferred from Poseida to Roche during the Technology Transfer to effect the Technology Transfer and (ii) [***],

(b) describes activities to be undertaken by the Parties to facilitate the transfer of such Know-How and (c) states an estimated timeline and allocation of responsibility with respect to such Technology Transfer, in each case (a)-(c), to denote successful completion of the Technology Transfer consistent with the general criteria set forth in Exhibit 1.224.

 

[***] = Certain Confidential Information Omitted

24

 


CONFIDENTIAL EXECUTION VERSION

 

 

 

 

1.225

[***].

 

 

1.226

[***].

 

 

1.227

[***].

 

 

1.228

[***].

 

 

1.229

[***].

 

 

1.230

Term is defined in Section 15.2.

 

 

1.231

[***].

 

1.232Therapeutic Product means a Tier 1 Product, an Optioned Tier 2 Product, or a Collaboration Product.

 

1.233Therapeutic Program means a Tier 1 Program, Optioned Tier 2 Program, or a Collaboration Program.

 

 

1.234

Third Party means any entity other than a Party or any of its Affiliates.

 

 

1.235

Third Party Claims is defined in Section 14.1.

 

1.236Third Party In-License Agreements” means any contract or agreement with a Third Party pursuant to which Poseida, during the Term, in-licenses or otherwise maintains Control of Patents, Know-How or other intellectual property rights for purposes of this Agreement (which, for clarity, subject to Section 6.10.3, exclude the Excluded Third Party In-License Agreements).

 

 

1.237

Tier 1 Activities is defined in Section 3.1.2.

 

 

1.238

Tier 1 Development Expenses is defined in Section 8.2.1.

 

[***] = Certain Confidential Information Omitted

25

 


CONFIDENTIAL EXECUTION VERSION

 

 

 

 

1.239

Tier 1 Development Plan is defined in Section 3.1.2.

 

1.240Tier 1 Development Term” means, with respect to a Tier 1 Development Program, the period of time from the Effective Date until the Completion of the Phase I DE+ for the applicable Tier 1 Program.

 

 

1.241

Tier 1 Process Development Plan is defined in Section 5.1.

 

 

1.242

Tier 1 Process Development Program is defined in Section 5.1.

 

1.243Tier 1 Process Development Term” means, with respect to a Tier 1 Process Development Program, the period of time from the JMT’s approval of the applicable Tier 1 Process Development Plan until Technology Transfer of the applicable Tier 1 Program.

 

1.244Tier 1 Product” means, (a) with respect to the P-BCMA-ALLO1 Tier 1 Program, Poseida’s Allo CAR T-Cell Therapy product known as P-BCMA-ALLO1, (b) with respect to the P-CD19/CD20-ALLO1 Tier 1 Program, Poseida’s Allo CAR T-Cell Therapy product known as P-CD19/CD20-ALLO1, or (c) [***].

 

1.245Tier 1 Program means each of (a) Poseida’s program for the research and development of Allo CAR T-Cell Therapies Directed To BCMA alone (the “P-BCMA-ALLO1 Tier 1 Program”), and (b) Poseida’s program for the research and development of Allo CAR T-Cell Therapies Directed To both CD19 and CD20 (the “P-CD19/CD20-ALLO1 Tier 1 Program”).

 

1.246Tier 1 Target” means (a) with respect to the P-BCMA-ALLO1 Tier 1 Program, B-cell maturation antigen (“BCMA”) (also known as tumor necrosis factor receptor superfamily member 17 (TNFRSF17)) and (b) with respect to the P-CD19/CD20-ALLO1 Tier 1 Program, each of CD19 and CD20.

 

1.247Tier 2 Candidate” means, (a) with respect to the P-BCMA/CD19-ALLO1 Tier 2 Program, Poseida’s Allo CAR T-Cell Therapy product known as P-BCMA/CD19-ALLO1 and (b) with respect to the P-CD70-ALLO1 Tier 2 Program, Poseida’s Allo CAR T-Cell Therapy candidate(s) to be designated by Poseida as it progresses such program.

 

1.248Tier 2 Program means each of (a) Poseida’s program for the research and development of Allo CAR T-Cell Therapies Directed To both BCMA and CD19 (the P-BCMA/CD19-ALLO1 Tier 2 Program”), and (b) Poseida’s program for the research and development of Allo CAR T- Cell Therapies Directed To CD70 alone (the “P-CD70-ALLO1 Tier 2 Program”).

 

1.249Tier 2 Target means (a) with respect to the BCMA/CD19-ALLO1 Tier 2 Program, each of BCMA and CD19 and (b) with respect to the P-CD70-ALLO1 Tier 2 Program, CD70 (also known as tumor necrosis factor superfamily member 7 (TNFSF7)).

 

[***] = Certain Confidential Information Omitted

26

 


CONFIDENTIAL EXECUTION VERSION

 

 

 

 

1.250

Title 11 is defined in Section 15.4.

 

1.251Trademark” means any word, name, symbol, color, designation or device or any combination thereof that functions as a source identifier, including any trademark, trade dress, brand mark, service mark, trade name, brand name, logo or business symbol, whether or not registered.

 

 

1.252

[***].

 

1.253Tscm-Enabling IP” means (a) all Know-How comprising Tscm-Enabling Technology and (b) all Patents claiming any such Know-How or otherwise Covering any Tscm-Enabling Technology, in each case (a) and (b), Controlled by Poseida or its Affiliates as of the Execution Date or at any time thereafter until the end of the Term. The Patents in clause (b) existing as of the Execution Date are listed on Exhibit 1.253.

 

 

1.254

Tscm-Enabling Technology means [***].

 

 

1.255

US means the United States of America and its territories and possessions.

 

 

1.256

US Dollars or $ means US dollars.

 

1.257Valid Claim” means (a) with respect to a Therapeutic Product or Licensed Product, a claim of an issued and unexpired Patent that has not been (i) disclaimed; (ii) dedicated to the public; (iii) abandoned; (iv) declared invalid, unenforceable or revoked by a decision of a court, government agency or other authority having jurisdiction, which decision is unappealable or unappealed within the time allowed for appeal; or (v) admitted to be invalid or unenforceable through reexamination, reissue or otherwise, or (b) with respect to a Therapeutic Product, a claim of a pending application for a Patent that (i) was filed in good faith and with a reasonable belief that such claim will be found patentable and granted, (ii) has been pending for less than [***] and

(iv) has not been finally cancelled, withdrawn, abandoned or rejected by an administration agency action from which no appeal can be taken.

 

1.258Valid Product Claim means, (a) for a Tier 1 Product or Optioned Tier 2 Product, a Valid Claim in a [***], (b) for a Collaboration Product, a Valid Claim [***], (c) for a Royalty-Eligible Autologous Licensed Product or a Royalty-Eligible Allogeneic Licensed Product, a Valid Claim in a Patent [***],

 

[***] = Certain Confidential Information Omitted

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CONFIDENTIAL EXECUTION VERSION

 

 

 

and (d) for an iPSC-Derived Licensed Product, a Valid Claim in a Patent [***].

 

 

1.259

Voting Stock is defined in Section 1.33(a).

 

 

1.260

Withholding Tax Action is defined in Section 9.8.

 

 

1.261

Working Group is defined in Section 2.5.

 

ARTICLE 2

Governance

 

 

2.1

Joint Research Team.

 

2.1.1Formation and Composition. Promptly after the Effective Date, and in any event within [***], after the Effective Date, the Parties shall establish a joint research team (the JRT”) to coordinate and provide oversight with respect to activities under the Initial Collaboration Research Program, Additional Collaboration Research Program (as applicable), and Collaboration Research Programs prior to the JRT’s confirmation of a Lead Collaboration Candidate or Back- Up Collaboration Candidate(s) that meets the applicable ED-Go Candidate Success Criteria and to receive status updates on Tier 2 Programs until Poseida’s selection of a Tier 2 Candidate for which to commence IND-enabling activities. The JRT shall be composed of up to [***] representatives designated by each of Poseida and Roche (though the Parties need not have the same number of representatives on the JRT). Each Party shall designate one of its representatives as its primary contact for JRT matters (such Party’s JRT Co-Chair”). The Parties, through their respective Alliance Managers, shall align on membership of the JRT ensuring that representatives are appropriate for the tasks then being undertaken and the stage of research, in terms of their seniority, function in their respective organizations, training and experience. A Party may replace any or all of its JRT representatives (or JRT Co-Chair) at any time by informing the other Party in advance in writing (which may be by email). Once established, the JRT shall meet [***]. Either Party may invite a reasonable number of other employees, consultants, research contractors, or scientific advisors to attend a JRT meeting in a non-voting capacity with prior written notice to the other Party; provided that such invitees are bound by appropriate confidentiality and invention assignment obligations consistent with the terms of this Agreement. Unless otherwise agreed by the Parties, the JRT shall meet and operate during the period commencing upon its formation until [***] after the last to occur of (a) expiration of the last Collaboration Research Term or (b) completion of all activities under all Tier 2 Programs prior to Poseida’s selection of the applicable Tier 2 Candidate to commence IND-enabling activities therefor. Thereafter, the JRT shall cease operations and perform no further functions under this Agreement. Notwithstanding the foregoing, following dissolution of the JRT, the Parties upon mutual agreement may re-establish the JRT as needed.

 

2.1.2Responsibilities of the JRT. The JRT shall be responsible for performing the following functions:

 

[***] = Certain Confidential Information Omitted

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(a)consulting with the JDT as needed regarding any activities before the JRT’s confirmation of a Lead Collaboration Candidate or [***] that meets the applicable ED-Go Candidate Success Criteria for each Tier 1 Program;

 

(b)monitoring and discussing the progress of each Tier 2 Program prior to Poseida’s selection of a Tier 2 Candidate to commence IND-enabling activities therefor;

 

(c)reviewing and discussing the ED-Go Data Packages prepared by Poseida for each Tier 2 Program as set forth in Section 3.2.1 (provided that for the avoidance of doubt, Roche and not the JRT shall have the sole right to make an Option Maintenance Election pursuant to Section 3.2.2 or to exercise an Option pursuant to Section 3.2.1 or 3.2.3);

 

(d)monitoring and discussing the progress of the Initial Collaboration Research Program and, if applicable, the Additional Collaboration Research Program;

 

(e)drafting and approving any amendments to the Initial Collaboration Research Plan (including alternative Collaboration Research Projects) and, if applicable, drafting and approving the Additional Collaboration Research Plan, and any amendments thereto (including alternative Additional Collaboration Research Projects) (provided that for the avoidance of doubt, Roche and not the JRT shall have the sole right to select the Collaboration Research Projects to be tested);

 

(f)reviewing and discussing the Collaboration Research Data Packages prepared by the Parties for each Collaboration Research Project as set forth in Sections 3.4.1 and

3.4.2 (provided that for the avoidance of doubt, Roche and not the JRT shall have the sole right to make a Collaboration Research Program Designation pursuant to Section 3.4.3);

 

(g)drafting and approving the Collaboration Research Plans (including the applicable ED-Go Candidate Success Criteria under Section 3.4.4), and any amendments thereto;

 

(h)identifying a Lead Collaboration Candidate and one or two Back-Up Collaboration Candidate(s) for each Collaboration Research Program;

 

(i)reviewing and discussing test results for potential Lead Collaboration Candidates and [***] against the applicable ED-Go Candidate Success Criteria and determining whether or not such ED-Go Candidate Success Criteria have been met;

 

(j)reviewing and approving any ED-Go Candidate Remediation Plan for a Collaboration Research Program;

 

(k)coordinating Program Transition for Optioned Tier 2 Programs for which Roche does not make an Option Maintenance Election pursuant to Section 3.2.2 and for Collaboration Research Programs for which Roche makes an ED-Go Decision and does not elect an Early Development Collaboration Program under Section 3.4.4(b), as applicable;

 

(l)establishing, dissolving and overseeing Working Groups, as appropriate, to carry out its functions and resolving any Disputes that arise in such Working Groups; and

 

[***] = Certain Confidential Information Omitted

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(m)performing such other functions as agreed to by the Parties or as specified in this Agreement.

 

2.1.3Decisions. The JRT shall operate as to matters within its responsibility by attempting to reach agreement by consensus, with each Party casting [***]. In the event that agreement on a particular matter cannot be reached by the JRT within [***] or such longer period as the JRT members agree, after the JRT first meets to consider such matter, the matter shall be referred to the JSC, which shall resolve such matter in accordance with Section 2.4.3.

 

 

2.2

Joint Development Team.

 

2.2.1Formation and Composition. Within [***] after the Effective Date, the Parties shall establish a joint development team (the “JDT”) to coordinate and provide oversight with respect to the Tier 1 Activities, activities under any Early Development Collaboration Programs, and development activities conducted by Poseida for any Tier 2 Program for which Roche makes an Option Maintenance Election pursuant to Section 3.2.2 (but only until the earlier of Roche’s timely exercise of its Option for such Tier 2 Program or the expiration of the Option Exercise Period for such Tier 2 Program without exercise by Roche of the Option). The JDT shall be composed of up to [***] representatives designated by each of Poseida and Roche (though the Parties need not have the same number of representatives on the JDT). Each Party shall designate one of its representatives as its primary contact for JDT matters (such Party’s “JDT Co-Chair”). The Parties, through their respective Alliance Managers, shall align on membership of the JDT ensuring that representatives are appropriate for the tasks then being undertaken and the stage of development, in terms of their seniority, function in their respective organizations, training and experience. A Party may replace any or all of its JDT representatives (or JDT Co-Chair) at any time by informing the other Party in advance in writing (which may be by email). Once established, the JDT shall meet [***]. Either Party may also invite a reasonable number of other employees, consultants, clinical contractors, or scientific advisors to attend a JDT meeting in a non-voting capacity with prior written notice to the other Party; provided that such invitees are bound by appropriate confidentiality and invention assignment obligations consistent with the terms of this Agreement. Unless otherwise agreed by the Parties, the JDT shall meet and operate during the period commencing upon its formation until completion of the last Program Transition of a Tier 1 Program, Optioned Tier 2 Program, or Collaboration Research Program (or Early Development Collaboration Program, as applicable), unless earlier dissolved by the JSC. Thereafter, the JDT shall cease operations and perform no further functions under this Agreement.

 

2.2.2Responsibilities of the JDT. The JDT shall be responsible for performing the following functions:

 

(a)monitoring and discussing the progress (including budgets) of the Tier 1 Programs until Program Transition and of any Tier 2 Program for which Roche makes an Option Maintenance Election pursuant to Section 3.2.2 (including interactions with Regulatory Authorities concerning such Tier 2 Program) until the earlier of Program Transition or expiration of the applicable Option Exercise Period without Roche exercising its Option;

 

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(b)drafting and approving the Tier 1 Development Plan for the P-CD19/CD20- ALLO1 Tier 1 Program;

 

(c)drafting and approving any amendments to the Tier 1 Development Plan (including any protocol amendments) for each Tier 1 Program;

 

(d)reviewing and discussing the Phase I DE+ data for each Tier 1 Program on a quarterly basis and the final Phase I DE+ Data Packages;

 

(e)reviewing and discussing the Phase I DE+ data for each Tier 2 Program for which Roche has made an Option Maintenance Election as set forth in Section 3.2.2 and final Phase I DE+ Data Package (provided that for the avoidance of doubt, Roche and not the JRT shall have the sole right to exercise the Option pursuant to Section 3.2.3);

 

(f)drafting and approving the Early Development Collaboration Plan (including the Early Development Candidate Success Criteria) for an Early Development Collaboration Program as set forth in Section 3.4.6, and any amendments thereto;

 

(g)reviewing and discussing data and results for potential Lead Collaboration Candidates and [***] against the applicable Early Development Candidate Success Criteria;

 

(h)reviewing and approving any Early Development Candidate Remediation Plan for an Early Development Collaboration Program;

 

(i)coordinating the preparation of, and involvement in, interactions with Regulatory Authorities in the development of Therapeutic Programs, prior to and during Regulatory Transfer (and at Roche’s request after Regulatory Transfer), including discussing the implementation of any action plan to address requests from a Regulatory Authority with respect to such Therapeutic Programs;

 

(j)coordinating with the JMT to consider manufacturing and CMC in the development of each Therapeutic Program;

 

(k)coordinating Program Transition for Tier 1 Programs, Optioned Tier 2 Programs for which Roche made an Option Maintenance Election pursuant to Section 3.2.2, and Early Development Collaboration Programs, as applicable;

 

(l)establishing, dissolving and overseeing Working Groups, as appropriate, to carry out its functions and resolving any Disputes that arise in such Working Groups; and

 

(m)performing such other functions as agreed to by the Parties or as specified in this Agreement.

 

2.2.3Decisions. The JDT shall operate as to matters within its responsibility by attempting to reach agreement by consensus, with each Party casting [***]. In the event that agreement on a particular matter cannot be reached by the JDT within [***] or such longer period as the JDT members agree, after the JDT first meets to consider such

 

[***] = Certain Confidential Information Omitted

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matter, the matter shall be referred to the JSC, which shall resolve such matter in accordance with Section 2.4.3.

 

 

2.3

Joint Manufacturing Team.

 

2.3.1Formation and Composition. Within [***] of the Effective Date, the Parties shall establish a joint manufacturing team (the “JMT”) to coordinate and oversee: (a) the Technology Transfer for each Tier 1 Program, Optioned Tier 2 Program and Collaboration Program and (b) prior to the applicable Technology Transfer, the development, improvement, validation and performance of the Manufacturing Process for each Tier 1 Program, Tier 2 Program, and Collaboration Program. The JMT shall be composed of up to [***] representatives designated by each of Poseida and Roche (though the Parties need not have the same number of representatives on the JMT). Each Party shall designate one of its representatives as its primary contact for JMT matters (such Party’s JMT Co-Chair”). The Parties, through their respective Alliance Managers, shall align on membership of the JMT ensuring that representatives are appropriate for the tasks then being undertaken and the stage of Manufacturing Process development, in terms of their seniority, availability, function in their respective organizations, training and experience. A Party may replace any or all of its JMT representatives (or JMT Co-Chair) at any time by informing the other Party in advance in writing (which may be by email). Once established, the JMT shall meet [***]. Either Party may invite a reasonable number of other employees, consultants, manufacturing contractors, or scientific advisors to attend a JMT meeting in a non-voting capacity with prior written notice to the other Party; provided that such invitees are bound by appropriate confidentiality and invention assignment obligations consistent with the terms of this Agreement. The JMT shall meet and operate during the period commencing upon its formation until completion of the last Technology Transfer of a Tier 1 Program, Optioned Tier 2 Program, or Collaboration Program, unless earlier dissolved by the JSC. Thereafter, the JMT shall cease operations and perform no further functions under this Agreement.

 

2.3.2Responsibilities of the JMT. The JMT shall be responsible for performing the following functions:

 

(a)drafting and approving the Tier 1 Process Development Plan for each Tier 1 Program, and any amendments thereto;

 

(b)drafting andapproving the Technology Transfer Plans,and any amendments thereto;

 

(c)reviewing and discussing, no less than once per Calendar Quarter, the Manufacturing Costs for a Tier 1 Program;

 

 

(d)

[***];

 

(e)reviewing and determining whether or not Poseida has achieved the applicable Manufacturing Feasibility Criteria for a Tier 1 Program;

 

(f)coordinating the initial technology transfers for each Tier 1 Program pursuant to Section 5.3;

 

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(g)coordinating the Technology Transfer for each Tier 1 Program, Optioned Tier 2 Program, and Collaboration Program;

 

(h)prior to the applicable Technology Transfer, discussing Manufacturing Process development and improvement updates and coordinating and proposing to the JRT or JDT, as applicable, any of such Manufacturing Process improvements, for each Tier 1 Program, Tier 2 Program, or Collaboration Program;

 

(i)coordinating with the JDT to provide CMC and manufacturing updates as they pertain to the development of each Therapeutic Program;

 

(j)coordinating with the JDT to create and implement any action plans to address requests from a Regulatory Authority with respect to each Therapeutic Program;

 

(k)coordinating the Initial Licensed Technologies Transfer pursuant to Section 6.6.1(b) and Full Licensed Technologies Transfer pursuant Section 6.6.2(c) and any updates thereto;

 

(l)discussing and attempting to resolve any potential or evolving disagreement between the Parties related to the Manufacturing Process development or Technology Transfers;

 

 

(m)

establishing CICC and data integrity procedures and policies;

 

(n)establishing, dissolving and overseeing Working Groups, as appropriate, to carry out its functions and resolving any Disputes that arise in such Working Groups; and

 

(o)performing such other functions as agreed to by the Parties or as specified in this Agreement.

 

2.3.3Decisions. The JMT shall operate as to matters within its responsibility by attempting to reach agreement by consensus, with each Party casting [***]. In the event that agreement on a particular matter cannot be reached by the JMT within [***] or such longer period as the JMT members agree, after the JMT first meets to consider such matter, the matter shall be referred to the JSC, which shall resolve such matter in accordance with Section 2.4.3.

 

 

2.4

Joint Steering Committee.

 

2.4.1Formation and Composition. Within [***] of the Effective Date, the Parties shall establish a joint steering committee (the “JSC”) to monitor and provide strategic oversight of the activities under this Agreement, all in accordance with this Section 2.4.1. The JSC shall be composed of up to [***] representatives from each of the Parties (though the Parties need not have the same number of representatives on the JSC). Each Party shall designate one of its representatives as its primary contact for JSC matters (such Party’s “JSC Co-Chair”). The Parties, through their respective Alliance Managers, shall align on membership of the JSC ensuring that representatives are appropriate for the issues germane to the Dispute in terms of their seniority, availability, function in their respective organizations, training and experience. A Party may replace any or all of its JSC representatives (or JSC Co-Chair) at any time by informing the

 

[***] = Certain Confidential Information Omitted

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other Party in advance in writing (which may be by email). Once established, the JSC shall meet [***] and shall meet at such other times as deemed appropriate by the JSC. Either Party may invite a reasonable number of other employees, consultants, contractors or scientific advisors to attend a JSC meeting with prior written notice to the other Party; provided that such invitees are bound by appropriate confidentiality and invention assignment obligations consistent with the terms of this Agreement. The JSC shall meet and operate during the period commencing upon its formation until each of the JRT, JDT and JMT have been dissolved, unless earlier dissolved by mutual agreement by the Parties. Thereafter, the JSC shall cease operations and perform no further functions under this Agreement.

 

2.4.2Responsibilities of the JSC. The JSC shall be responsible for performing the following functions:

 

(a)reviewing and discussing the research, development, and Manufacture of Therapeutic Products and any other ongoing activities under this Agreement;

 

(b)facilitating the flow of information between the Parties with respect to the research, development, and Manufacture of Therapeutic Products;

 

 

(c)

overseeing the activities of the JRT, JDT, and JMT and providing guidance

thereto;

 

 

(d)

attempting to resolve issues presented to it by, and Disputes within, each of

the JRT, JDT, JMT and the JSC’s Working Groups;

 

(e)establishing, dissolving, and overseeing any JSC Working Groups as appropriate, to carry out its functions and resolving any Disputes that arise in such Working Groups;

 

 

(f)

dissolving or re-establishing each of the JRT, JDT, and JMT; and

 

(g)performing such other functions as agreed to by the Parties or as specified in this Agreement.

 

2.4.3Decisions. The JSC shall operate as to matters within its responsibility by attempting to reach agreement by consensus, with each Party casting [***]. If the JSC cannot, or does not, reach consensus on an issue at a meeting or within [***] thereafter, then (a) [***] and

(b) [***]; provided that:

 

(i)neither Party shall have the right to amend the Agreement or waive its obligations under the Agreement;

 

[***] = Certain Confidential Information Omitted

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[***]; and

 

(ii)

neither Party shall have the final decision-making authority over:

 

 

(iii)

[***].

 

 

2.5Working Groups. From time to time, the JRT, JDT, JMT, or JSC may establish and delegate duties to sub-committees or directed teams (each, a Working Group”) on an as-needed basis to oversee particular projects or activities. Each such Working Group shall be constituted and shall operate as the applicable JRT, JDT, JMT, or JSC determines; provided that each Working Group shall have equal representation from each Party, unless otherwise mutually agreed. Working Groups may be established on an ad hoc basis for specific purposes and durations. Each Working Group and its activities shall be subject to the oversight, review and approval of, and shall report to, the committee or team that formed said Working Group. In no event shall the authority of the Working Group exceed that specified for the applicable JRT, JDT, JMT, or JSC that formed the Working Group to this Article 2. All decisions of a Working Group shall be made by consensus. Any disagreement between the designees of Roche and Poseida on a Working Group shall be referred to the applicable JRT, JDT, JMT, or JSC that formed the Working Group for resolution. In the event that the JRT, JDT, JMT, or JSC is disbanded, then the Working Groups thereunder shall also automatically be disbanded.

 

2.6Committee Meetings; Minutes. In order to hold any committee or team meeting or to make a committee or team decision under this Article 2, at least [***] of such committee or team from each Party must participate in the meeting or vote; provided that either Party may defer a meeting or a vote if such Party desires to postpone until the applicable committee or team members are able to attend, so long as such postponement does not cause material or undue delays to any Tier 1 Program, Tier 2 Program, or Collaboration Program. Committees may meet in person or via teleconference, video conference or the like, provided that [***], unless otherwise agreed by the Parties. Each Party shall bear the expense of its respective representatives’ participation in committee and team meetings. Each committee or team shall keep minutes of its meetings that record in writing any key decisions made. Action items assigned or completed and other appropriate matters may be recorded in such meeting minutes as needed. The Parties shall alternate the responsibility for keeping such meeting minutes for a particular committee or team. Meeting minutes shall be sent to both Parties promptly after a meeting for review, comment and approval. A decision that is made at a committee or team meeting shall be recorded in minutes and decisions that are made by the committee or team outside of a meeting shall be documented in writing (which may be by email).

 

[***] = Certain Confidential Information Omitted

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2.7Alliance Managers. Promptly following the Effective Date, each Party shall designate an individual to act as the primary business contact for such Party for matters related to this Agreement (such Party’s “Alliance Manager”), unless another contact is expressly specified in the Agreement or designated by the Parties for a particular purpose. The Alliance Managers shall promote communication and collaboration between the Parties, ensure appropriate decision making, and assist in the resolution of potential and pending issues and potential Disputes in a timely manner. The Alliance Managers may attend all meetings of the committees and teams contemplated herein as non-voting participants. Either Party may replace its Alliance Manager at any time by notifying the other Party’s Alliance Manager in writing (which may be by email).

 

2.8Limitations on Authority. Each Party shall retain the rights, powers, and discretion granted to it under this Agreement, and no such rights, powers, or discretion shall be delegated to or vested in a committee or team unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing. No committee or team shall have the power to amend, modify or waive compliance with this Agreement, which may only be amended or modified, or compliance with which may only be waived, as provided in Section 17.8.

 

2.9Party Structure. The Parties recognize that each Party possesses an internal structure (including various committees, teams and review boards) that will be involved in administering such Party’s activities under this Agreement. Each Party shall have the right to make routine day- to-day decisions relating to the conduct of those activities for which it has a performance or other obligation hereunder, in each case in a manner consistent with the then-current applicable plan and the terms and conditions of this Agreement.

 

ARTICLE 3

Tier 1 Programs; Tier 2 Programs; Collaboration Programs

 

 

3.1

Tier 1 Programs

 

3.1.1General. For each Tier 1 Program, except with respect to the Tier 1 Activities as described in Section 3.1.2 and the Manufacturing activities under Section 5.1, as between the Parties, Roche shall be responsible for all aspects of research and development of Tier 1 Products, which it shall conduct in its sole discretion and control, [***].

 

3.1.2Tier 1 Development Plan; Conduct of Tier 1 Activities. For each Tier 1 Program, in addition to its Manufacturing activities as set forth in Section 5.2.1(a), Poseida shall be responsible for conducting all research and development activities through the Completion of Phase I DE+ (the “Tier 1 Activities”) as set forth in a written development plan agreed upon by the JDT, as may be amended by the JDT (each, a “Tier 1 Development Plan”). The initial Tier 1 Development Plan for the P-BCMA-ALLO1 Tier 1 Program is attached hereto as Exhibit 3.1.2- 1 and the initial Tier 1 Development Plan for the P-CD19/CD20-ALLO1 Tier 1 Program is attached hereto as Exhibit 3.1.2-2. Poseida shall use Commercially Reasonable Efforts to perform the Tier 1 Activities under each Tier 1 Development Plan within the timelines and budgets set forth therein. Poseida shall provide Roche regular updates on the progress of the Tier 1 Programs at JDT meetings (with consultation by the JRT as needed for activities conducted prior to commencing IND-enabling activities, if any). [***], Poseida shall perform all such Tier 1 Activities [***] and under the JDT’s oversight. For clarity, any

 

[***] = Certain Confidential Information Omitted

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activities to be performed with respect to a Phase I DE+ after Completion of such Phase I DE+ (e.g., additional patient enrollment, clinical site maintenance, study wind-down, or patient follow- up) shall be conducted by Roche [***]; provided however, in the event that Roche requests that Poseida conduct, and Poseida consents to conducting, any post-Completion of Phase I DE+ activities for such Phase I DE+, the Parties shall discuss the scope, duration, and budget of such activities, and the FTE Costs and Out-of-Pocket Costs incurred by Poseida in the performance of such activities shall be [***]. Notwithstanding the foregoing, [***]. For each Tier 1 Program, the Program Transition Initiation Date shall be deemed to have occurred on the date of the earlier of

(a) the completion of all Tier 1 Activities for such Tier 1 Program or (b) the assumption by Roche of all then-remaining Tier 1 Activities pursuant to the preceding sentence for such Tier 1 Program.

 

 

3.2

Tier 2 Programs

 

3.2.1Exclusive Option; Option Exercise at ED-Go. For each Tier 2 Program, Poseida hereby grants Roche an exclusive option to acquire the exclusive license set forth in Section 6.2.1 (each, an Option”). Poseida shall use Commercially Reasonable Efforts to continue the research activities with respect to each Tier 2 Program, [***], until achieving Poseida has selected a Tier 2 Candidate ready to commence IND-enabling activities. Poseida shall provide Roche with prompt written notice of such Tier 2 Candidate selection for each Tier 2 Program. Promptly following such Tier 2 Candidate selection but in no event later than [***] thereafter, Poseida shall prepare, and deliver to Roche, an ED-Go Data Package for the applicable Tier 2 Program. At any time between the Effective Date and [***] after Roche’s receipt of the complete ED-Go Data Package for the applicable Tier 2 Program (as such period may be extended under Section 3.2.2) (the “Option Exercise Period”), Roche may exercise its Option by providing written notice to Poseida of such exercise. If Roche exercises the Option for a Tier 2 Program pursuant to this Section 3.2.1 at any time, Roche shall be deemed to have exercised the “Option at ED-Go” and shall pay the “ED-Go” Option Exercise Fee for such Tier 2 Program to Poseida pursuant to Section 8.3.1. Upon Poseida’s receipt of Roche’s written notice of its exercise of the Option for a Tier 2 Program pursuant to this Section 3.2.1, and after the HSR Clearance Date, if applicable, with respect to the exercise of such Option, such Tier 2 Program shall be deemed an Optioned Tier 2 Program, the licenses granted to Roche under Section 6.2 shall become effective with respect to such Optioned Tier 2 Program, and the Program Transition Initiation Date shall be deemed to have occurred on such date with respect to such Optioned Tier 2 Program.

 

3.2.2Option Maintenance Election. Notwithstanding anything to the contrary in Section 3.2.1, for each Tier 2 Program, at any point prior to the expiration of the applicable Option Exercise Period, Roche may elect not to exercise its Option pursuant to Section 3.2.1, but instead elect to: (a) have Poseida use Commercially Reasonable Efforts to continue leading research and development activities for such Tier 2 Program, [***], until the Completion of the Phase I DE+,

(b) promptly following such Completion of a Phase I DE+, have Poseida prepare, and deliver to Roche, a Phase I DE+ Data Package for such Tier 2 Program, and (c) extend

 

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the expiration date of its Option Exercise Period for such Tier 2 Program until [***] after Roche’s receipt of the complete Phase I DE+ Data Package (an Option Maintenance Election”). Roche may make an Option Maintenance Election by providing written notice to Poseida of such Option Maintenance Election prior to expiration of the Option Exercise Period under Section 3.2.1 for the applicable Tier 2 Program. If Roche makes such an Option Maintenance Election for a Tier 2 Program, Roche shall pay Poseida an Option Maintenance Fee for such Tier 2 Program pursuant to Section 8.3.2. Upon Poseida’s receipt of Roche’s written notice of its Option Maintenance Election for a Tier 2 Program, the abovementioned clauses (a)-(c) shall become effective for such Tier 2 Program.

 

3.2.3Option Exercise at Phase I DE+. Roche may exercise its Option for a Tier 2 Program for which Roche has made an Option Maintenance Election and paid the Option Maintenance Fee at any time prior to expiration of the extended Option Exercise Period by providing written notice to Poseida of such exercise. If Roche exercises the Option for a Tier 2 Program pursuant to this Section 3.2.3 at any time, Roche shall be deemed to have exercised the Option at “Phase I DE+” and shall pay Poseida the “Phase I DE+” Option Exercise Fee pursuant to Section 8.3.1. Upon Poseida’s receipt of Roche’s written notice of its exercise of the Option for a Tier 2 Program pursuant to this Section 3.2.3 and the payment of the “Phase I DE+” Option Exercise Fee for such Tier 2 Program pursuant to Section 8.3.1, such Tier 2 Program shall be deemed an Optioned Tier 2 Program, the licenses granted to Roche under Section 6.2 shall become effective with respect to such Optioned Tier 2 Program, and the Program Transition Initiation Date shall be deemed to have occurred on such date with respect to such Optioned Tier 2 Program.

 

3.2.4Reporting. During