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Exhibit 4.4

DESCRIPTION OF THE REGISTRANT’S SECURITIES
REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES
EXCHANGE ACT OF 1934

Codex DNA, Inc. (the Company) has one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as amended (the Exchange Act): our common stock, par value $0.0001 per share.

As used in this summary, the terms “the Company,” “we,” “our” and “us” refer to Codex DNA, Inc. The following is a description of the material terms and provisions relating to our capital stock. The following description is a summary that is not complete and is subject to and qualified in its entirety by reference to our amended and restated certificate of incorporation and our amended and restated bylaws, and to provisions of the Delaware General Corporation Law. Copies of our amended and restated certificate of incorporation and our amended and restated bylaws, each of which may be amended from time to time, are included as exhibits to the Annual Report on Form 10-K to which this description is an Exhibit.

DESCRIPTION OF CAPITAL STOCK

Our authorized capital stock consists of 100,000,000 shares of common stock, par value $0.0001 per share, and 5,000,000 shares of preferred stock, par value $0.0001 per share.

Common Stock
Voting Rights
Each holder of common stock is entitled to one vote for each share on all matters submitted to a vote of the stockholders, including the election of directors. Our amended and restated certificate of incorporation and amended and restated bylaws do not provide for cumulative voting rights. Because of this, the holders of a plurality of the shares of common stock entitled to vote in any election of directors can elect all of the directors standing for election, if they should so choose. With respect to matters other than the election of directors, at any meeting of the stockholders at which a quorum is present or represented, the affirmative vote of a majority of the voting power of the shares present in person or represented by proxy at such meeting and entitled to vote on the subject matter shall be the act of the stockholders, except as otherwise required by law. The holders of a majority of the stock issued and outstanding and entitled to vote, present in person or represented by proxy, shall constitute a quorum for the transaction of business at all meetings of the stockholders.

Dividends
Subject to preferences that may be applicable to any then-outstanding preferred stock, holders of our common stock are entitled to receive dividends, if any, as may be declared from time to time by our board of directors out of legally available funds.

Liquidation
In the event of our liquidation, dissolution or winding up, holders of our common stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of our debts and other liabilities and the satisfaction of any liquidation preference granted to the holders of any then-outstanding shares of preferred stock.

Rights and Preferences
Holders of our common stock have no preemptive, conversion, subscription or other rights, and there are no redemption or sinking fund provisions applicable to our common stock. The rights, preferences and 

Exhibit 4.4

privileges of the holders of our common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of our preferred stock that we may designate in the future.

Fully Paid and Nonassessable
All of our outstanding shares of common stock are be fully paid and nonassessable.

Preferred Stock
Our board of directors has the authority, without further action by the stockholders, to issue up to 5,000,000 shares of preferred stock in one or more series and to fix the rights, preferences, privileges and restrictions thereof. These rights, preferences and privileges could include dividend rights, conversion rights, voting rights, redemption rights, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation of such series, any or all of which may be greater than the rights of common stock. The issuance of preferred stock could adversely affect the voting power of holders of common stock and the likelihood that such holders will receive dividend payments and payments upon liquidation. In addition, the issuance of preferred stock could have the effect of delaying, deferring or preventing a change in our control or other corporate action. No shares of preferred stock are outstanding, and we have no present plan to issue any shares of preferred stock.

Anti-takeover Effects of Certain Provisions of Delaware Law, Our Amended and Restated Certificate of Incorporation and Our Amended and Restated Bylaws
Certain provisions of Delaware law and certain provisions in our amended and restated certificate of incorporation and amended and restated bylaws summarized below may be deemed to have an anti-takeover effect and may delay, deter or prevent a tender offer or takeover attempt that a stockholder might consider to be in its best interests, including attempts that might result in a premium being paid over the market price for the shares held by stockholders.

Preferred Stock
Our amended and restated certificate of incorporation contains provisions that permit our board of directors to issue, without any further vote or action by the stockholders, shares of preferred stock in one or more series and, with respect to each such series, to fix the number of shares constituting the series and the designation of the series, the voting rights (if any) of the shares of the series and the powers, preferences or relative, participation, optional and other special rights, if any, and any qualifications, limitations or restrictions, of the shares of such series.

Classified Board
Our amended and restated certificate of incorporation provides that our board of directors is divided into three classes, designated Class I, Class II and Class III. Each class will be an equal number of directors, as nearly as possible, consisting of one third of the total number of directors constituting the entire board of directors. The term of initial Class I directors shall terminate on the date of the 2022 annual meeting, the term of the initial Class II directors shall terminate on the date of the 2023 annual meeting, and the term of the initial Class III directors shall terminate on the date of the 2024 annual meeting. At each annual meeting of stockholders beginning in 2022, the class of directors whose term expires at that annual meeting will be subject to reelection for a three-year term.

Removal of Directors
Our amended and restated certificate of incorporation provides that stockholders may only remove a director for cause by a vote of no less than a majority of the voting power of the issued and outstanding capital stock of the Company entitled to vote in the election of directors.

Director Vacancies
Our amended and restated certificate of incorporation authorizes only our board of directors to fill vacant directorships.

Exhibit 4.4

No Cumulative Voting
Our amended and restated certificate of incorporation provides that stockholders do not have the right to cumulate votes in the election of directors.

Special Meetings of Stockholders
Our amended and restated certificate of incorporation and amended and restated bylaws provide that, except as otherwise required by law, special meetings of the stockholders may be called only by the chair of our board of directors, by our chief executive officer or president, or by the board of directors acting pursuant to a resolution adopted by a majority of the board.

Advance Notice Procedures for Director Nominations
Our amended and restated bylaws provide that stockholders seeking to nominate candidates for election as directors at an annual or special meeting of stockholders must provide timely notice thereof in writing. To be timely, a stockholder’s notice generally will have to be delivered to and received at our principal executive offices before notice of the meeting is issued by the secretary of the Company, with such notice being served not less than 90 nor more than 120 days before the meeting. Although the amended and restated bylaws do not give the board of directors the power to approve or disapprove stockholder nominations of candidates to be elected at an annual meeting, the amended and restated bylaws may have the effect of precluding the conduct of certain business at a meeting if the proper procedures are not followed or may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect its own slate of directors or otherwise attempting to obtain control of the company. The stockholder’s notice must also include items described in our amended and restated bylaws. Any stockholder nominee must also provide the information and make the representations as required by our amended and restated bylaws.

Action by Written Consent
Our amended and restated certificate of incorporation and amended and restated bylaws provide that any action to be taken by the stockholders must be effected at a duly called annual or special meeting of stockholders and may not be effected by written consent.

Amending our Certificate of Incorporation and Bylaws
Our amended and restated certificate of incorporation may be amended or altered in any manner provided by the Delaware General Corporation Law (DGCL). Certain amendments to our amended and restated certificate of incorporation will require the approval of a majority of our board of directors and stockholders holding two-thirds of the voting power of our then outstanding capital stock. Our amended and restated bylaws may be adopted, amended, altered or repealed by stockholders only upon approval of at least majority of the voting power of all the then outstanding shares of the common stock, except for any amendment of the above provisions and others, which would require the approval of a two-thirds majority of our then outstanding common stock. Additionally, our amended and restated certificate of incorporation provides that our bylaws may be amended, altered or repealed by the affirmative vote of the majority of our board of directors.

Authorized but Unissued Shares
Our authorized but unissued shares of common stock and preferred stock will be available for future issuances without stockholder approval, except as required by the listing standards of Nasdaq, and could be utilized for a variety of corporate purposes, including future offerings to raise additional capital, acquisitions and employee benefit plans. The existence of authorized but unissued and unreserved common stock and preferred stock could render more difficult or discourage an attempt to obtain control of the company by means of a proxy contest, tender offer, merger or otherwise.

Exhibit 4.4

Exclusive Jurisdiction
Our amended and restated bylaws provide that, unless we consent to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for any derivative action or proceeding brought on our behalf, any action asserting a claim of breach of fiduciary duty, any action asserting a claim arising pursuant to the DGCL, any action regarding our amended and restated certificate of incorporation or amended and restated bylaws, or any action asserting a claim against us that is governed by the internal affairs doctrine. This provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act or any other claim for which the U.S. federal courts have exclusive jurisdiction. Our amended and restated bylaws further provide that the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. Any person or entity purchasing or otherwise acquiring any interest in our securities shall be deemed to have notice of and consented to these provisions. Although we believe these provisions benefit us by providing increased consistency in the application of law for the specified types of actions and proceedings, the provisions may have the effect of discouraging lawsuits against us or our directors and officers. There is uncertainty as to whether a court would enforce such provisions, and the enforceability of similar choice of forum provisions in other companies’ charter documents has been challenged in legal proceedings. We also note that stockholders cannot waive compliance (or consent to noncompliance) with the federal securities laws and the rules and regulations thereunder. See the section titled “Risk Factors - Our amended and restated bylaws designate a state or federal court located within the State of Delaware as the exclusive forum for substantially all disputes between us and our stockholders, and also provide that the federal district courts will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act, each of which could limit our stockholders’ ability to choose the judicial forum for disputes with us or our directors, officers, stockholders, or employees.”

Business Combinations with Interested Stockholders
We are governed by Section 203 of the DGCL. Subject to certain exceptions, Section 203 of the DGCL prohibits a public Delaware corporation from engaging in a business combination (as defined in such section) with an “interested stockholder” (defined generally as any person who beneficially owns 15% or more of the outstanding voting stock of such corporation or any person affiliated with such person) for a period of three years following the time that such stockholder became an interested stockholder, unless (i) prior to such time the board of directors of such corporation approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder; (ii) upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of such corporation at the time the transaction commenced (excluding for purposes of determining the voting stock of such corporation outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned (a) by persons who are directors and also officers of such corporation and (b) by employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer); or (iii) at or subsequent to such time the business combination is approved by the board of directors of such corporation and authorized at a meeting of stockholders (and not by written consent) by the affirmative vote of at least 66 2/3% of the outstanding voting stock of such corporation not owned by the interested stockholder.
Our amended and restated certificate of incorporation and our amended and restated bylaws provide that we must indemnify our directors and officers to the fullest extent authorized by the DGCL. We are expressly authorized to, and do, carry directors’ and officers’ insurance providing coverage for our directors, officers and certain employees for some liabilities. We believe that these indemnification provisions and insurance are useful to attract and retain qualified directors and executive officers.
The limitation on liability and indemnification provisions in our certificate of incorporation and bylaws may discourage stockholders from bringing a lawsuit against directors for breach of their fiduciary duty. These provisions may also have the effect of reducing the likelihood of derivative litigation against directors and officers, even though such an action, if successful, might otherwise benefit us and our 

Exhibit 4.4

stockholders. In addition, your investment may be adversely affected to the extent we pay the costs of settlement and damage awards against directors and officers pursuant to these indemnification provisions.

Listing
Our common stock is listed on the Nasdaq Global Select Market under the symbol “DNAY.” 

Transfer Agent and Registrar
The transfer agent and registrar for our common stock is American Stock Transfer & Trust Co. LLC. The transfer agent and registrar’s address is 6201 15th Avenue, Brooklyn, New York 11219.pfizercollaborationagree

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.    RESEARCH COLLABORATION AND LICENSE AGREEMENT  by and between  PFIZER INC.  and  CODEX DNA, INC.  DECEMBER 20, 2021 

 

Exhibit 10.21  i    TABLE OF CONTENTS1  1. DEFINITIONS AND INTERPRETATION. ...................................................................... 1  1.1. Defined Terms ........................................................................................................ 1  1.2. Interpretation ......................................................................................................... 14  2. LICENSE GRANTS AND TECHNOLOGY TRANSFER. ............................................. 15  2.1. Reciprocal Non-Exclusive Research Program Licenses ....................................... 15  2.2. Non-Exclusive Commercial License under Codex Technology from Codex to  Pfizer ..................................................................................................................... 15  2.3. Output Materials ................................................................................................... 15  2.4. Exclusive Option ................................................................................................... 16  2.5. Unblocking License .............................................................................................. 16  2.6. Right of Reference ................................................................................................ 16  2.7. Permitted Sublicensees ......................................................................................... 17  2.8. Direct Licenses to Affiliates ................................................................................. 17  2.9. No Implied Rights ................................................................................................. 17  2.10. Retained Rights ..................................................................................................... 18  3. PAYMENTS BY PFIZER TO CODEX ........................................................................... 18  3.1. Upfront Payment ................................................................................................... 18  3.2. Technical Milestone Payments ............................................................................. 18  3.3. Development Milestones ...................................................................................... 18  3.4. Sales Milestone Payments..................................................................................... 20  3.5. Products in Both Exclusive and Non-Exclusive Fields ........................................ 22  3.6. Milestone Payment Adjustment; Additional Payments for Previously Achieved  Milestones ............................................................................................................. 22  3.7. Royalty Payments ................................................................................................. 22  3.8. Reports and Payments ........................................................................................... 24  3.9. Payment Terms ..................................................................................................... 25  4. RESEARCH PROGRAM. ................................................................................................ 28  4.1. Scope of Research ................................................................................................. 28  4.2. Research Plan ........................................................................................................ 28  4.3. Allocation of Responsibilities ............................................................................... 28      

 

Exhibit 10.21  ii    4.4. Research Program Governance ............................................................................. 28  4.5. Research Term Extension ..................................................................................... 31  4.6. Research Program Expenses ................................................................................. 31  4.7. Scientific Records ................................................................................................. 31  4.8. Delegation and Subcontracting ............................................................................. 31  4.9. Transfer of Pfizer Materials .................................................................................. 32  5. PRODUCT DEVELOPMENT AND COMMERCIALIZATION. .................................. 34  5.1. General .................................................................................................................. 34  5.2. Regulatory Approvals ........................................................................................... 34  5.3. Commercialization Activities ............................................................................... 34  5.4. Manufacturing ....................................................................................................... 34  5.5. Reporting............................................................................................................... 34  5.6. Other Pfizer Matters .............................................................................................. 34  6. INTELLECTUAL PROPERTY ....................................................................................... 35  6.1. Ownership of Intellectual Property ....................................................................... 35  6.2. Patent Rights ......................................................................................................... 36  6.3. Enforcement and Defense of Patent Rights .......................................................... 38  6.4. Codex Third Party Agreements ............................................................................ 40  7. CONFIDENTIALITY....................................................................................................... 41  7.1. Confidentiality ...................................................................................................... 41  7.2. Authorized Disclosure .......................................................................................... 41  7.3. SEC Filings and Other Disclosures....................................................................... 42  7.4. Residual Knowledge Exception ............................................................................ 42  7.5. Public Announcements; Publications ................................................................... 43  7.6. Obligations in Connection with Change of Control ............................................. 43  8. REPRESENTATIONS, WARRANTIES AND COVENANTS. ..................................... 44  8.1. Mutual Representations and Warranties ............................................................... 44  8.2. Mutual Covenants ................................................................................................. 44  8.3. Representations and Warranties of Codex ............................................................ 44  8.4. Codex Covenants .................................................................................................. 47  8.5. Representation by Legal Counsel ......................................................................... 48  8.6. Disclaimer ............................................................................................................. 48  

 

Exhibit 10.21  iii    9. TERM AND TERMINATION ......................................................................................... 49  9.1. Term ...................................................................................................................... 49  9.2. Termination by Codex .......................................................................................... 49  9.3. Termination by Pfizer ........................................................................................... 49  9.4. Effects of Termination .......................................................................................... 50  9.5. Provision for Insolvency ....................................................................................... 52  10. LIMITATION ON LIABILITY, INDEMNIFICATION AND INSURANCE. ............... 53  10.1. No Consequential Damages .................................................................................. 53  10.2. Indemnification by Pfizer ..................................................................................... 54  10.3. Indemnification by Codex..................................................................................... 54  10.4. Procedure .............................................................................................................. 55  10.5. Insurance ............................................................................................................... 56  11. ANTI-BRIBERY/ANTI-CORRUPTION. ........................................................................ 56  11.1. Foreign Corrupt Practices Act .............................................................................. 56  11.2. Representations and Warranties ............................................................................ 57  11.3. Use of Funds by Codex; Audit by Pfizer .............................................................. 57  12. MISCELLANEOUS. ........................................................................................................ 58  12.1. Assignment ........................................................................................................... 58  12.2. Change of Control of Codex ................................................................................. 58  12.3. Further Actions ..................................................................................................... 58  12.4. Force Majeure ....................................................................................................... 58  12.5. Notices .................................................................................................................. 58  12.6. Amendment ........................................................................................................... 59  12.7. Waiver ................................................................................................................... 59  12.8. Severability ........................................................................................................... 60  12.9. Descriptive Headings ............................................................................................ 60  12.10. Global Trade Control Laws .................................................................................. 60  12.11. Export Control ...................................................................................................... 61  12.12. Dispute Resolution ................................................................................................ 61  12.13. Governing Law ..................................................................................................... 62  12.14. Consent to Jurisdiction .......................................................................................... 62  12.15. Entire Agreement .................................................................................................. 62  12.16. Independent Contractors ....................................................................................... 62  

 

Exhibit 10.21  iv    12.17. Counterparts .......................................................................................................... 62  12.18. No Third Party Rights or Obligations ................................................................... 62      

 

Exhibit 10.21  v    EXHIBITS  Exhibit A Codex Patent Rights Existing as of the Effective Date  Exhibit B Research Plan  Exhibit C Pfizer Anti-Bribery and Anti-Corruption Principles         SCHEDULES  Schedule 3.7 Sample Royalty Calculation  Schedule 7.5.1 Press Release  Schedule 8.3 Codex’s Knowledge Parties  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  1    RESEARCH COLLABORATION AND LICENSE AGREEMENT  This Research Collaboration and License Agreement (the “Agreement”) is entered into as  of December 20, 2021 (the “Effective Date”), by and between PFIZER INC., a corporation  organized and existing under the laws of Delaware and having a principal place of business at 235  East 42nd Street, New York, NY 10017 (“Pfizer”) and CODEX DNA, Inc., a corporation  organized and existing under the laws of Delaware and having a principal place of business at 9535  Waples St, Suite 10, San Diego, CA 92121 (“Codex”).  Pfizer and Codex may each be referred to  herein individually as a “Party” and collectively as the “Parties.”  WHEREAS, Codex owns or otherwise controls certain patents, patent applications,  technology, know-how, scientific and technical information and other proprietary rights and  information relating to Instruments and Methods (each as defined below);  WHEREAS, Pfizer has extensive experience and expertise in the development,  manufacturing and commercialization of biopharmaceutical products, including mRNA vaccine  products;  WHEREAS, [***] (“Initial Instruments”), along with any instructions, methods,  processes, workflows and other techniques or protocols for use of the Initial Instrument(s) that  were provided to Pfizer to use such Initial Instruments (“Initial Methods”);  WHEREAS, the Parties wish to collaborate to develop the Deliverables (as defined below)  to synthesize DNA and RNA to meet the requirements described in the Research Plan (defined  below);  WHEREAS, subject to the terms of this Agreement, Codex wishes to grant to Pfizer, and  Pfizer wishes to receive from Codex, a non-exclusive license in the Field (as defined below), with  the exclusive option to an exclusive license in each Exclusive Field (as defined below) in the  Territory (as defined below) under certain of Codex’s patents, patent applications, technology,  know-how, scientific and technical information and other proprietary rights and information  relating to the Deliverables to use, research, develop, manufacture, commercialize and otherwise  exploit Products for the Field, including in each Exclusive Field, in each case in the Territory;  NOW THEREFORE, in consideration of the mutual promises and covenants set forth  below and other good and valuable consideration, the receipt and sufficiency of which is hereby  acknowledged, the Parties hereby agree as follows:  1. DEFINITIONS AND INTERPRETATION.  1.1. Defined Terms.  Capitalized terms used and not otherwise defined in this  Agreement shall have the following meanings:  1.1.1. “Acquiring Entity” means (a) a Third Party that merges or consolidates  with or acquires a Party, or to which a Party transfers all or substantially all of its assets to  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  2    which this Agreement pertains in a Change of Control transaction and (b) any Affiliate of  such Third Party prior to the transaction described in clause (a) that is not also an Affiliate  of the relevant Party prior to the transaction described in clause (a).  1.1.2. “Affiliate” means any entity directly or indirectly controlled by,  controlling, or under common control with, a Person, but only for so long as such control  will continue.  For purposes of this definition, “control” (including, with correlative  meanings, “controlled by”, “controlling” and “under common control with”) means (a)  possession, direct or indirect, of the power to direct or cause direction of the management  or policies of an entity (whether through ownership of securities or other ownership  interests, by contract or otherwise), or (b) beneficial ownership of more than 50% (or the  maximum ownership interest permitted by applicable Law) of the voting securities or other  ownership or general partnership interest (whether directly or pursuant to any option,  warrant or other similar arrangement) or other comparable equity interests of an entity;  provided, however, that where an entity owns a majority of the voting power necessary to  elect a majority of the board of directors or other governing board of another entity, but is  restricted from electing such majority by contract or otherwise, such entity will not be  considered to be in control of such other entity until such time as such restrictions are no  longer in effect.  1.1.3.  “Bankruptcy Code” means Title 11 of the United States Code, as  amended.  1.1.4. “Binding Obligation” means, with respect to a Party (a) any oral or written  agreement or arrangement that binds such Party, including any assignment, license  agreement, loan agreement, guaranty, or financing agreement, (b) the provisions of such  Party’s charter, bylaws or other organizational documents or (c) any order, writ, injunction,  decree or judgment of any court or Governmental Authority entered against such Party or  by which any of such Party’s operations or property are bound.  1.1.5. “Biosimilar Version” means, with respect to a Product that is being sold  in a country or regulatory jurisdiction in the Territory (the “Reference Product”), a  biopharmaceutical product sold by a Third Party (other than a Third Party acting on behalf  of or in concert with Pfizer or any Affiliate or Sublicensee of Pfizer) in such country or  regulatory jurisdiction in the Territory that through reference to the Regulatory Approval  of the Reference Product, is eligible for and has achieved Regulatory Approval in such  country or regulatory jurisdiction pursuant to an abbreviated follow-on biological approval  pathway established by the Regulatory Authority in such country or regulatory jurisdiction  pursuant to the applicable Law, or otherwise is approved for marketing and sale in such  country or regulatory jurisdiction by an abridged procedure in reliance, in whole or in part,  on the prior Regulatory Approval of the Reference Product or on the safety and efficacy  data generated for the prior Regulatory Approval (in such country or regulatory  jurisdiction) of the Reference Product, including any such biopharmaceutical product that  (i) with respect to such biopharmaceutical product in the United States, has been approved  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  3    as a biosimilar or interchangeable product by the FDA pursuant to 42 U.S.C. § 262 of the  Public Health Service Act, (ii) with respect to such biopharmaceutical product subject to  the regulatory jurisdiction of the EMA, has been approved as a similar biological medicine  product by EMA as described in CHMP/437/04, issued 30 October 2005, as may be  amended, or any subsequent or superseding law, statute or regulation or (iii) with respect  to such biopharmaceutical product outside the United States and in a country which is not  subject to the regulatory jurisdiction of the EMA, has otherwise obtained Regulatory  Approval from a Regulatory Authority pursuant to similar statutory or regulatory  requirement as that described in the foregoing subsections (i) and (ii) in such other country  or regulatory jurisdiction in the Territory.  1.1.6.  “Business Day” means a day other than a Saturday, Sunday or bank or  other public holiday in New York, New York.  1.1.7. “Calendar Quarter” means the respective periods of three consecutive  calendar months ending on March 31, June 30, September 30 and December 31.  1.1.8. “Calendar Year” means any twelve (12) month period beginning on  January 1 and ending on the next subsequent December 31.  1.1.9. “Change of Control” means, with respect to a Party (a) the acquisition of  beneficial ownership, directly or indirectly, by any Person (other than such Party or an  Affiliate of such Party, and other than by virtue of obtaining irrevocable proxies) of  securities or other voting interest of such Party representing a majority or more of the  combined voting power of such Party’s then outstanding securities or other voting interests,  (b) any merger, reorganization, consolidation or business combination involving such Party  with a Third Party that results in the holders of beneficial ownership (other than by virtue  of obtaining irrevocable proxies) of the voting securities or other voting interests of such  Party (or, if applicable, the ultimate parent of such Party) immediately prior to such merger,  reorganization, consolidation or business combination ceasing to hold beneficial ownership  of at least [***] of the combined voting power of the surviving entity immediately after  such merger, reorganization, consolidation or business combination, (c) any sale, lease,  exchange, contribution or other transfer (in one transaction or a series of related  transactions) of all or substantially all of the assets of such Party to which this Agreement  relates, other than a sale or disposition of such assets to an Affiliate of such Party or (d) the  approval of any plan or proposal for the liquidation or dissolution of such Party (other than  in circumstances where such Party is deemed a Debtor pursuant to Section 9.5).  1.1.10. “Clinical Trial” means a human clinical study conducted on sufficient  numbers of human subjects that is designed to (a) establish that a pharmaceutical product  is reasonably safe for continued testing, (b) investigate the safety and efficacy of the  pharmaceutical product for its intended use, and to define warnings, precautions and  adverse reactions that may be associated with the pharmaceutical product in the dosage  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  4    range to be prescribed or (c) support Regulatory Approval of such pharmaceutical product  or label expansion of such pharmaceutical product.  1.1.11. “Codex Know-How” means any (a) Codex Sole Research Plan Know- How and Codex’s interest in any Joint Research Plan Know-How and (b) other Know-How  that is (i) Controlled by Codex or any of its Affiliates as of the Effective Date or that comes  into the Control of Codex or any of its Affiliates during the Term (other than through the  grant of a license by Pfizer) and (ii) reasonably necessary for Pfizer to implement the  Deliverables, reasonably necessary for Pfizer to practice the licenses or exercise other  rights granted to Pfizer under this Agreement, or reasonably necessary for Pfizer to conduct  activities under the Research Plan or (c) other Know-How that is otherwise provided by or  on behalf of Codex to Pfizer hereunder.   1.1.12. “Codex Patent Right” means any (a) Codex Sole Research Plan Patent  Right and Codex’s interest in any Joint Research Plan Patent Rights and (b) any other  Patent Right that (i) is Controlled by Codex or any of its Affiliates as of the Effective Date  (including the Codex Patent Rights listed in Exhibit A) or (ii) that comes into the Control  of Codex or any of its Affiliates during the Term (other than through the grant of a license  by Pfizer) and, in each case ((i) and (ii)), claims or discloses any invention included in any  Codex Know-How.  1.1.13. “Codex Sole Research Plan Know-How” means any Research Plan Know- How that is invented solely by or on behalf of Codex or its Affiliates in the course of  performing activities under the Research Plan; provided that Codex Sole Research Plan  Know-How excludes the Output Materials Know-How and Pfizer Material Improvements.  1.1.14. “Codex Sole Research Plan Patent Right” means any Patent Right that  claims or discloses any invention included in any Codex Sole Research Plan Know-How.  1.1.15.  “Codex Technology” means any Codex Know-How and Codex Patent  Rights.  1.1.16. “Codex Third Party Agreement” means any agreement between Codex (or  any of its Affiliates) and any Third Party (such Third Party, a “Third Party Licensor”)  pursuant to which Codex or any of its Affiliates obtains Control of any of the Codex  Technology.  1.1.17. “Commercialize” or “Commercializing” means, with respect to a  compound or product, to (a) market, promote, distribute, offer for sale, sell, have sold,  import, have imported, export, have exported or otherwise commercialize such a  compound or product and (b) conduct discovery, pre-clinical, research, or other  Development activities with respect to a compound or product after such compound or  product has received Regulatory Approval.  When used as a noun, “Commercialization”  means any and all activities involved in Commercializing.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  5    1.1.18.  “Commercially Reasonable Efforts” means, with respect to the efforts to  be expended by a Party with respect to any objective, those reasonable, good faith efforts  to accomplish such objective as such Party would normally use to accomplish a similar  objective under similar circumstances.  1.1.19. “Confidential Information” means, with respect to each Party, all Know- How or other information, including proprietary information and materials (whether or not  patentable) regarding or embodying such Party’s or its Representatives’ technology,  products, business information or objectives, that is communicated by or on behalf of the  Disclosing Party to the Receiving Party or its permitted recipients, but only to the extent  that such Know-How or other information in written form is marked in writing as  “confidential” at the time of disclosure, and such Know-How or other information  disclosed orally or in non-tangible form is (a) identified by the Disclosing Party as  “confidential” at the time of disclosure and (b) within [***] days thereafter, the Disclosing  Party provides a written summary of such Know-How or other information marked as  “confidential”.  Failure to mark or identify or summarize Confidential Information  disclosed hereunder as “confidential” shall not cause the information to be considered non- confidential if such information should have been known by a reasonable person with  expertise on the subject matter, based on the nature of the information and the  circumstances of its disclosure, to be Confidential Information, provided that the  Disclosing Party has otherwise made good faith efforts to clearly so mark or identify  Confidential Information as such.  Confidential Information does not include any Know- How or other information that (i) was already known by the Receiving Party (other than  under an obligation of confidentiality to the Disclosing Party) at the time of disclosure by  or on behalf of the Disclosing Party, (ii) was generally available to the public or otherwise  part of the public domain at the time of its disclosure to the Receiving Party, (iii) became  generally available to the public or otherwise part of the public domain after its disclosure  to the Receiving Party, other than through any act or omission of the Receiving Party in  breach of its obligations under this Agreement, (iv) was disclosed to the Receiving Party,  other than under an obligation of confidentiality, by a Third Party who had no direct or  indirect obligation to the Disclosing Party not to disclose such information to the Receiving  Party or (v) was independently discovered or developed by or on behalf of the Receiving  Party without the use of or reference to any Confidential Information belonging to the  Disclosing Party.  The terms and conditions of this Agreement shall be considered  Confidential Information of both Parties.  1.1.20. “Control” or “Controlled” means with respect to any intellectual property  right or material (including any Patent Right, Know-How or other data, information or  material), the ability (whether by sole, joint or other ownership interest, license or  otherwise, other than pursuant to this Agreement) to, without violating the terms of any  agreement with a Third Party, grant a license or sublicense or provide access or other right  in, to or under such intellectual property right or material.  If either Party undergoes a  Change of Control during the Term, any Know-How or Patent Rights of the Acquiring  Entity shall not be deemed to be Controlled by such Party unless: (i) prior to the  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  6    consummation of such Change of Control, such Party or any of its Affiliates also  Controlled such Know-How or Patent Rights of the Acquiring Entity, (ii) any such Know- How or Patent Rights of the Acquiring Entity arises from participation by representatives  of such Acquiring Entity in any activities under this Agreement after such Change of  Control or (iii) such Know-How or Patent Rights of the Acquiring Entity were not used in  the performance of activities under this Agreement prior to the consummation of such  Change of Control, but after the consummation of such Change of Control, such Party or  any of its Affiliates uses any such Know-How or Patent Rights in the performance of its  obligations or exercise of its rights under this Agreement.  1.1.21. “Core Codex DNA Technology” means Codex’s proprietary systems,  platforms and technologies, including its Instruments and proprietary Methods, together  with related workflows and kits/reagents, in each case as proprietary to Codex and  reasonably necessary to operate an Instrument or perform any Method, as applicable, and,  in each case, (a) including any intellectual property rights (including Patent Rights) therein  owned or Controlled by Codex, and (b) excluding any Research Plan Technology.  1.1.22. “Cover” means, with respect to the Instrument, a Product or a Deliverable  and given Patent Right, that a Valid Claim of such Patent Right would, absent a license  thereunder or ownership thereof, be infringed by the use or other Exploitation of such  Instrument, Product or Deliverable.  1.1.23. [***]  1.1.24. “Current Licenses” means any agreement (a) that Codex or its Affiliates  has entered into prior to the Effective Date and (b) pursuant to which Codex or its Affiliates  are (i) granted rights to any Codex Technology as of the Effective Date or (ii) granted a  license or otherwise transferred any right to practice under any Patent Rights or Know- How, in each case that are reasonably necessary to use the Deliverables or perform  activities under this Agreement.  1.1.25. “Current Licensor” means any Third Party that is a party to a Current  License.  1.1.26. “Deliverables” means any tangible Instrument, Method or other Know- How first made or developed by one or both Parties in the conduct of the Research Plan  that are provided to Pfizer hereunder including in accordance with Section 2.11.   1.1.27. “Develop” or “Developing” means to discover, research or otherwise  develop a process, compound or product, including conducting non-clinical and clinical  research and development activities prior to Regulatory Approval.  When used as a noun,  “Development” means any and all activities involved in Developing.  1.1.28. “Development Milestone Payment” means any amounts payable by Pfizer  upon achievement of any Development Milestones in accordance with Section 3.3.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  7    1.1.29. “DNA” means deoxyribonucleic acid.  1.1.30. “Exclusive Fields” means (a) the [***] or (b) [***], in each case (a) and  (b), if Pfizer has exercised the Option for such under Section 2.4, in each case (a) and (b)  unless and until such Field has converted to a Non-Exclusive Field pursuant to this  Agreement (for example, under Sections 5.2 or 9.4.1).  Each of the [***] and the [***] is  an Exclusive Field once Pfizer has exercised the Option for such Field under Section 2.4.  1.1.31. “Exploit” means to Develop, Manufacture, Commercialize, use or  otherwise exploit.  Cognates of the word “Exploit” will have correlative meanings.  1.1.32. “FD&C Act” means the United States Federal Food, Drug, and Cosmetic  Act, as amended, and the rules and regulations promulgated thereunder.  1.1.33. “FDA” means the United States Food and Drug Administration or any  successor agency thereto.  1.1.34. “Field” means [***].  1.1.35. “First Commercial Sale” means, with respect to any Product and with  respect to any country in the Territory, the first sale of such Product (as applicable) by  Pfizer or an Affiliate or Sublicensee of Pfizer to a Third Party in such country after such  Product has been granted Regulatory Approval by the appropriate Regulatory Authority in  such country.  1.1.36. [***]  1.1.37. “GAAP” means United States generally accepted accounting principles,  consistently applied.  1.1.38. “Government Official”, to be broadly interpreted, means (a) any elected  or appointed government official (e.g., a member of a ministry of health), (b) any employee  or person acting for or on behalf of a government official, Governmental Authority, or  other enterprise performing a governmental function, (c) any political party, candidate for  public office, officer, employee, or person acting for or on behalf of a political party or  candidate for public office, and (d) any employee or person acting for or on behalf of a  public international organization (e.g., the United Nations).  For clarity, healthcare  providers employed by government-owned hospitals will be considered Government  Officials.  1.1.39. “Governmental Authority” means any court, agency, department,  authority or other instrumentality of any national, state, county, city or other political  subdivision.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  8    1.1.40. “IND” means an Investigational New Drug Application submitted under  the FD&C Act, or an analogous application or submission with any analogous agency or  Regulatory Authority outside of the United States for the purposes of obtaining permission  to conduct Clinical Trials.  1.1.41. “Indication” means the intended use of a Product for either therapeutic  treatment or for the prevention of a distinct illness, sickness, interruption, cessation or  disorder of a particular bodily function, system, tissue type or organ, or sign or symptom  of any such items or conditions, regardless of the severity, frequency or route of any  treatment, treatment regimen, dosage strength or patient class, for which Regulatory  Approval is being or would be sought and which will be referenced on any Product labeling  in any country. Label extensions shall not be deemed to be separate Indications. By way of  example, each of the following would be considered a separate Indication: breast cancer,  prostate cancer, colon cancer, gastric cancer, lung cancer, etc, but moving from one line of  therapy to another would not be considered a new Indication.   For clarity, a single  Indication would include the primary disease and all variants or sub-divisions or sub- classifications within such primary disease, and regardless of prophylactic or therapeutic  use, pediatric or adult use. For further clarity, any variant or sub-division or sub- classification within a primary disease shall constitute an Indication, but shall not be a  distinct Indication from any other variant or sub-division or sub-classification within such  primary disease.  1.1.42. “Instrument” means Codex’s proprietary fully automated, benchtop gene  synthesis workstations existing during the Research Term that synthesize de novo gene  constructs from digitally submitted sequences.  1.1.43. “Instrument/Methods Know-How” means any Research Plan Know-How  that is invented, developed, or discovered, by either Party alone, or jointly with the other,  whether or not patentable, predominantly directed to (a) any Instrument, (b) kit or reagent  for operation of an Instrument, or (c) Methods, but not any Pfizer Material Improvement  or Output Materials.   1.1.44. “Instrument/Methods Patent Rights” means any Research Plan Patent  Right that claims or discloses any Instrument/Methods Know-How, but not any other  Research Plan Know-How, Output Materials or Pfizer Material Improvement.  1.1.45. “Joint Research Committee” or “JRC” means the joint research committee  described in Section 4.4.2(a).  1.1.46. “Joint Research Plan Know-How” means Research Plan Know-How other  than Output Materials Know-How and Pfizer Material Improvements that is jointly  invented, developed, discovered, or other Know-How, whether or not patentable,  discovered, made or created jointly by (i) Codex or its Representatives and (ii) Pfizer or its  Representatives under this Agreement.    

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  9    1.1.47. “Joint Research Plan Patent Right” means a Patent Right that claims or  discloses any Joint Research Plan Know-How (and does not claim or disclose any invention  included in any Pfizer Sole Research Plan Know-How or Codex Sole Research Plan Know- How).  1.1.48. “Joint Research Plan Technology” means the Joint Research Plan Know- How and the Joint Research Plan Patent Rights.  1.1.49. “Know-How” means any proprietary invention, discovery, development,  data, information, process, method, technique, material (including any chemical or  biological material), technology, result, cell line, compounds, probe, sequence or other  know-how, whether or not patentable, and any physical embodiments of any of the  foregoing.  1.1.50. “Law” means any law, statute, rule, regulation, order, judgment or  ordinance of any Governmental Authority.  1.1.51. “Major EU Market Country” means any of [***].  1.1.52. “Major Market Country” means any [***].  1.1.53. “Manufacture” or “Manufacturing” means to make, produce,  manufacture, process, fill, finish, package, label, perform quality assurance testing, release,  ship or store, and for the purposes of further Manufacturing, distribute, import or export, a  compound or product or any component thereof.  When used as a noun, “Manufacture” or  “Manufacturing” means any and all activities involved in Manufacturing a compound,  protein, device or product or any component thereof.  1.1.54. “Methods” means any instructions, methods, processes, workflows and  other techniques or protocols necessary or useful for use of the Instrument.  1.1.55. “Milestone Payments” shall mean the Technical Milestone Payments, the  Development Milestone Payments and the Sales Milestone Payments.  1.1.56. “Milestones” means the Technical Milestones, the Development  Milestones and the Sales Milestones.  1.1.57. “Net Sales” means: (a) with respect to a Product, the gross receipts from  sales by Pfizer and its Affiliates and Sublicensees of such Product to Third Parties in the  Territory, less in each case (i) bad debts and (ii) sales returns and allowances actually paid,  granted or accrued, including trade, quantity and cash discounts and any other adjustments,  including those granted on account of price adjustments, billing errors, rejected goods,  damaged or defective goods, recalls, returns, rebates, chargeback rebates, reimbursements  or similar payments granted or given to wholesalers or other distributors, buying groups,  health care insurance carriers, chain pharmacies, mass merchandisers, staff model HMO’s,  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  10    pharmacy benefit managers or other institutions, adjustments arising from consumer  discount programs or other similar programs, customs or excise duties, sales tax,  consumption tax, value added tax, and other taxes (except income taxes and all to the extent  paid by Pfizer and non-refundable in accordance with applicable Law) or duties relating to  sales, compulsory or negotiated payments and cash rebates in respect of sales to the United  States government, any state government or any foreign government, or to any other  Governmental Authority, or with respect to any government-subsidized program or  managed care organization, and freight (including storage, shipping and handling) and  insurance (to the extent that Pfizer, its Affiliates or its Sublicensees bear the cost of freight  (including storage, shipping and handling) and insurance for such Product).  For clarity,  the transfer of Product by or among Pfizer, its Affiliates or Sublicensees is not considered  a sale, provided (1) such transfer is intended for further sale, transfer, lease, exchange, or  other disposition and Pfizer, its Affiliates or Sublicensees are not the end users or  consumers, and (2) any amount received by Pfizer, its Affiliates or Sublicensees in  connection with the transfer from such entity to end users shall also be deemed part of Net  Sales of such Product.  Net Sales will be determined from books and records maintained  in accordance with GAAP, as consistently applied by Pfizer with respect to sales of the  Product, as applicable.  1.1.58. “Non-Exclusive Field” means, individually and collectively, the Field  outside of the Exclusive Fields, on an Indication-by-Indication basis.  1.1.59. “Option Exercise Date” means, with respect to each Option, the date on  which Pfizer has delivered written notice of Pfizer’s exercise of such Option to Codex  pursuant to Section 2.4.  1.1.60. “Option Exercise Period” means the period of time beginning on the  Effective Date and ending on the date that is [***].  1.1.61. “Output Materials” means any chemical or biological materials, including  any mRNA or DNA that are produced or generated through or from, or are the result or by- product of, the operation of an Instrument by a Party in the conduct of and in accordance  with the Research Plan.  1.1.62. “Output Materials Know-How” means any Research Plan Know-How that  is invented, developed, or discovered, by either Party alone, or jointly with the other,  whether or not patentable, directed to or embodied in any Output Materials and/or the use  thereof.  1.1.63. “Output Materials Patent Rights” means a Patent Right that claims or  discloses Output Materials Know-How, but not any other Research Plan Know-How.  1.1.64.  “Patent Rights” means any and all (a) issued patents, (b) pending patent  applications, including all provisional applications, substitutions, continuations,  continuations-in-part, divisions and renewals, and all patents granted thereon, (c) patents- 

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  11    of-addition, reissues, reexaminations and extensions or restorations 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, (e) other forms of government-issued rights substantially similar to any of the  foregoing and (f) United States and foreign counterparts of any of the foregoing.  1.1.65. “Person” means an individual, sole proprietorship, partnership, limited  partnership, limited liability partnership, corporation, limited liability company, business  trust, joint stock company, trust, incorporated association, joint venture or similar entity or  organization, including a government or political subdivision or department or agency of a  government.  1.1.66. “Pfizer Know-How” means any Know-How that is (a) Controlled by  Pfizer or any of its Affiliates on the Effective Date or that comes into the Control of Pfizer  or any of its Affiliates during the Term (other than through the grant of a license by Codex)  and is (b) either reasonably necessary for Codex to conduct activities under the Research  Plan or otherwise provided to Codex hereunder.  1.1.67. “Pfizer Patent Right” means any Patent Right that (a) is Controlled by  Pfizer or any of its Affiliates as of the Effective Date or (b) that comes into the Control of  Pfizer or any of its Affiliates during the Term (other than through the grant of a license by  Codex) and, in each case ((a) and (b)), claims or discloses any invention included in any  Pfizer Know-How.  1.1.68. “Pfizer Quarter” means each of the four (4) thirteen (13) week periods (a)  with respect to the United States, commencing on January 1 of any Pfizer Year and (b)  with respect to any country in the Territory other than the United States, commencing on  December 1 of any Pfizer Year.  1.1.69. “Pfizer Sole Research Plan Know-How” means any (a) Research Plan  Know-How that is invented solely by or on behalf of Pfizer or its Affiliates in the course  of performing activities under the Research Plan, (b) any Pfizer Material Improvement and  (c) any Output Materials Know-How.   1.1.70. “Pfizer Sole Research Plan Patent Right” means any Patent Right that  claims or discloses any invention included in any Pfizer Sole Research Plan Know-How.   All Pfizer Material Improvement and Output Material Patent Rights will be Pfizer Sole  Research Plan Patent Rights.  1.1.71. “Pfizer Technology” means the Pfizer Know-How and Pfizer Patent  Rights.  1.1.72. “Pfizer Year” means the twelve-month fiscal periods observed by Pfizer  (a) commencing on January 1 with respect to the United States and (b) commencing on  December 1 with respect to any country in the Territory other than the United States.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  12    1.1.73. “Phase I Clinical Trial” means a Clinical Trial (whether a Phase Ia or a  Phase Ib trial) that generally provides for the first introduction into humans of a  pharmaceutical product with the primary purpose of determining safety, metabolism and  pharmacokinetic properties and clinical pharmacology of such product, including in a  manner that is generally consistent with 21 CFR § 312.21(a), as amended (or its successor  regulation), or an equivalent clinical study required by a Regulatory Authority outside of  the United States; provided, however, a Phase I Clinical Trial does not include any study  generally characterized by the FDA as an “exploratory IND study” in CDER’s Guidance  for Industry, Investigators, and Reviewers Exploratory IND Studies, January 2006,  irrespective of whether or not such study is actually performed in the United States or under  an IND.  A so-called Phase I/II Clinical Trial shall be deemed to be a Phase I Clinical Trial.  1.1.74. “Price Approval” means, in any country where a Governmental Authority  authorizes reimbursement for, or approves or determines pricing for, pharmaceutical  products, receipt (or, if required to make such authorization, approval or determination  effective, publication) of such reimbursement authorization or pricing approval or  determination (as the case may be).  1.1.75. “Product” means a pharmaceutical or biopharmaceutical product in a  formulation suitable for administration to humans, including mRNA encoding one or more  polypeptides or fragments thereof, including naturally occurring or engineered variants  thereof, for prophylaxis or treatment of a disease in humans, provided that such mRNA  was (a) discovered, designed, encoded or created using the Deliverables by, or on behalf  of, a Party or (b) was transcribed from DNA that was discovered, designed, encoded or  created using the Deliverables by, or on behalf of, a Party.  For the avoidance of doubt,  Instruments, Deliverable(s), and Output Materials are not Products.  For further clarity and  by way of example, updates or changes to (y) the mRNA of a Product to account for   changes to a Product’s formulation, or (z) dosage volume will not constitute a different  Product, so long as such “updated” Product is for the same Indication.   1.1.76. “Public Health Service Act” means the United States Public Health  Service Act (42 U.S.C. 201 et seq), as amended from time to time (including any rules and  regulations promulgated thereunder) or any subsequent or superseding law, statute or  regulation.  1.1.77. “Regulatory Approval” means all technical, medical and scientific  licenses, registrations, authorizations and approvals (including approvals of NDAs,  supplements and amendments, pre- and post- approvals and labeling approvals) of any  Regulatory Authority, necessary or useful for the use, Development, Manufacture, and  Commercialization of a pharmaceutical or biopharmaceutical product in a regulatory  jurisdiction, including commercially reasonable Price Approvals and commercially  reasonable Third Party reimbursement approvals.  For clarity, an emergency use  authorization pursuant to Section 564 of the Federal Food, Drug and Cosmetic Act, 21  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  13    U.S.C.A. 301, et. Seq. and the equivalent to such authorization outside the United States  (an “Emergency Use Authorization”) shall be deemed a “Regulatory Approval”.  1.1.78. “Regulatory Authority” means, with respect to a country in the Territory,  any national (e.g., the FDA), supra-national (e.g., the European Commission, the Council  of the European Union, or the European Medicines Agency), regional, state or local  regulatory agency, department, bureau, commission, council or other Governmental  Authority with authority over the distribution, importation, exportation, manufacture,  production, use, storage, transport, clinical testing or sale of a pharmaceutical product  (including any Product) including, to the extent required in such country, Price Approval,  for pharmaceutical products in such country.  1.1.79. “Representatives” means (a) with respect to Pfizer, its Affiliates, its  Sublicensees and each of their respective officers, directors, employees, consultants,  contractors and agents and (b) with respect to Codex, its Affiliates and each of their  respective officers, directors, employees, consultants, contractors and agents.  1.1.80. “Research Plan” means the Research Plan attached hereto as Exhibit B, as  may be amended from time to time pursuant to Section 4.4.2.  1.1.81. “Research Plan Know-How” means any and all Know-How, whether or  not patentable, made solely by or on behalf of either Party or its Representatives in the  conduct of activities under the Research Plan or made jointly by or on behalf of (i) Codex  or its Representatives and (ii) Pfizer or its Representatives, in each case, in the conduct of  activities under the Research Plan.  1.1.82. “Research Plan Patent Right” means any Patent Right that claims or  discloses any invention included in any Research Plan Know-How.  1.1.83. “Research Plan Technology” means any and all Research Plan Know-How  or Research Plan Patent Rights.  1.1.84. “Research Term” means the period of time beginning on the Effective  Date and expiring on [***] thereof or such later date as may be established pursuant to  Section 4.5, unless earlier terminated pursuant to the terms of this Agreement.  1.1.85. “Residual Knowledge” means knowledge, techniques, experience and  Know-How that (a) are, or are based on any Confidential Information Controlled by the  Disclosing Party and (b) are retained in the unaided memory of any authorized  Representative of the Receiving Party after having access to such Confidential Information  in accordance with this Agreement.  An individual’s memory will be considered to be  unaided if the individual has not intentionally memorized the Confidential Information for  the purpose of retaining and subsequently using or disclosing it.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  14    1.1.86. “RNA” means any form of ribonucleic acid, including messenger RNA  (mRNA), self-amplifying RNA (saRNA) or modified RNA (modRNA).  1.1.87. “Royalty Term” means, with respect to any particular Product or  Exclusive Product (as the case may be) in any particular country in the Territory, the period  that commences on the First Commercial Sale of such Product or Exclusive Product in such  country in the Territory and ends on the earliest to occur of [***].  1.1.88. “Sales Milestone Payment” means any amounts payable by Pfizer upon  achievement of any Sales Milestones in accordance with Section 3.  1.1.89. “Sublicensee” means any Person to whom Pfizer grants or has granted,  directly or indirectly, a license or sublicense with respect to a Product.  1.1.90. “Taxes” means all taxes, charges, fees, levies, or other assessments,  including income, withholding, excise, value added, sales, payroll, transfer, and franchise  taxes imposed by any Governmental Authority.  Such term shall include any interest,  penalties, or additions payable in connection with such taxes, charges, fees, levies, duties,  or other assessments.  1.1.91. “Territory” means worldwide.  1.1.92. “Third Party” means any Person other than Pfizer, Codex or their  respective Affiliates.  1.1.93. “Trademark” means any trademark, trade name, service mark, service  name, brand, domain name, trade dress, logo, slogan or other indicia of origin or  ownership, including the goodwill and activities associated with each of the foregoing.  1.1.94. “Valid Claim” means, with respect to a particular country, a claim of a  Codex Patent Right that is (a) issued and unexpired and has not been (i) held permanently  revoked, unenforceable or invalid by a decision of a court or other Governmental Authority  of competent jurisdiction, which decision is unappealable or unappealed within the time  allowed for appeal, or (ii) cancelled, withdrawn, abandoned, disclaimed or admitted to be  invalid or unenforceable through reissue, disclaimer or otherwise, or (b) a bona fide claim  in a pending patent application that has not been (i) cancelled, withdrawn or abandoned  without being refiled in another application in the applicable jurisdiction or (ii) finally  rejected by an administrative agency action, which action is unappealable or unappealed  within the time allowed for appeal, [***]  The following terms are defined in the section of this Agreement listed opposite each term:  Defined Term Section in Agreement  Agreement Preamble  Codex Preamble  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  15    Codex Indemnified Party 10.2  Codex JRC Members 4.4.2(a)  Codex Permitted Activities 4.9.2  Competing Product 8.4.2  Debtor 9.5.1  Development Milestones 3.3.2  Development Notice 5.6.1  Diligence Issue 5.2.2  Disclosing Party 7.1  Disputed Matter 4.4.2(e)  Effective Date Preamble  Exclusive Development Milestones 3.3.2  Exclusive Marginal Royalty Rate 3.7.2  Exclusive Sales Milestones 3.4.2  Force Majeure 12.4  Global Trade Control Laws 12.10  Indemnified Party 10.4.1  Indemnifying Party 10.4.1  Infringement Claim 6.3.3  Initial Instruments Preamble  Initial Methods Preamble  JRC Co-Chair 4.4.2(b)  Liability 10.2  Licensed Activities 6.3.2(a)  Litigation Conditions 10.4.2  Pfizer Materials 4.9.1  Non-Exclusive Development Milestones 3.3.1  Non-Exclusive Marginal Royalty Rate 3.7.1  Non-Exclusive Sales Milestones 3.4.1  Non-Publishing Party 7.5.2  Notice of Dispute 12.12.1  Option 2.4.1  Party or Parties Preamble  Per Exclusive Product Annual Net Sales 3.7.2  Per Non-Exclusive Product Annual Net Sales 3.7.1  Pfizer Preamble  Pfizer Indemnified Party 10.3  Pfizer JRC Members 4.4.2(a)  Pfizer Material Improvements 4.9.6  Program Director and Program Directors 4.4.1(a)  Publishing Party 7.5.2  Receiving Party 7.1  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  16    Research Program 4.1  Restricted Market 12.10.1  Restricted Parties 12.10.2  Restricted Party Lists 12.10.2  Review Period 7.5.2  Sales Milestones 3.4.2  Technical Milestone 3.2  Technical Milestone Payment 3.2  Term 9.1  Third Party Claim 10.4.1  Total Annual Exclusive Net Sales 3.4.2  Total Annual Net Sales 3.4.1  VAT 3.9.1(a)    1.2. Interpretation.  Except where the context expressly requires otherwise, (a) the use  of any gender herein shall be deemed to encompass references to either or both genders, and the  use of the singular shall be deemed to include the plural (and vice versa), (b) the words “include”,  “includes” and “including” shall be deemed to be followed by the phrase “without limitation”,  (c) the word “will” shall be construed to have the same meaning and effect as the word “shall”,  (d) any definition of or reference to any agreement, instrument or other document herein shall be  construed as referring to such agreement, instrument or other document as from time to time  amended, supplemented or otherwise modified (subject to any restrictions on such amendments,  supplements or modifications set forth herein), (e) any reference herein to any Person shall be  construed to include the Person’s successors and assigns, (f) the words “herein”, “hereof” and  “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its  entirety and not to any particular provision hereof, (g) all references herein to Sections, Exhibits  or Schedules shall be construed to refer to Sections, Exhibits or Schedules of this Agreement, and  references to this Agreement include all Exhibits and Schedules hereto, (h) the word “notice”  means notice in writing (whether or not specifically stated) and shall include notices, consents,  approvals and other written communications contemplated under this Agreement, (i) provisions  that require that a Party, the Parties or any committee hereunder “agree,” “consent” or “approve”  or the like shall require that such agreement, consent or approval be specific and in writing,  whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and  instant messaging), (j) references to any specific law, rule or regulation, or article, section or other  division thereof, shall be deemed to include the then-current amendments thereto or any  replacement or successor law, rule or regulation thereof, and (k) the term “or” shall be interpreted  in the inclusive sense commonly associated with the term “and/or.”  2. LICENSE GRANTS AND TECHNOLOGY TRANSFER.  2.1. Reciprocal Non-Exclusive Research Program Licenses.  During the Research  Term, effective as of the Effective Date:  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  17    2.1.1. To Pfizer.  Subject to the terms and conditions of this Agreement,  including the Options in Section 2.4, Codex hereby grants to Pfizer a non-exclusive,  royalty-free, fully paid-up license (and, to the extent any Codex Technology is Controlled  by Codex pursuant to a Codex Third Party Agreement, a sublicense, as applicable), with  no right to sublicense other than to Affiliates of Pfizer or Third Party subcontractors under  the Codex Technology solely to the extent necessary to perform Pfizer’s activities under  the Research Plan.  2.1.2. To Codex.  Subject to the terms and conditions of this Agreement, Pfizer  hereby grants to Codex a non-exclusive, royalty-free, fully paid-up license in the Territory,  with no right to grant sublicenses other than to Affiliates of Codex or Third Party  subcontractors pursuant to Section 4.8, under the Pfizer Technology solely to the extent  necessary to perform Codex’s activities under the Research Plan.  2.2. Non-Exclusive Commercial License under Codex Technology from Codex to  Pfizer.  Effective as of the Effective Date, subject to the terms and conditions of this Agreement,  Codex agrees to grant and hereby grants to Pfizer a non-exclusive, sublicensable (subject to  Section 2.7) license (and, to the extent any Codex Technology is Controlled by Codex pursuant to  a Codex Third Party Agreement, a sublicense, as applicable) under the Codex Technology to  Develop and use the Deliverables solely to use, have used, Develop, have Developed,  Manufacture, have Manufactured, Commercialize, have Commercialized and otherwise Exploit  Products in the Field.  2.3. Output Materials.  Codex agrees that, as between the Parties, (a) Pfizer is the sole  and exclusive owner of all right, title and interest in and to any Output Materials generated under  the Research Plan by either Party and any Products containing, expressing or encoding such Output  Materials and (b) Codex has no right, title or interest in or to any such Output Materials or Products.   Codex further agrees that consistent with such ownership rights, Pfizer shall have sole authority  over and control of the Development, Manufacture, Regulatory Approval and Commercialization  of such Output Materials and Products in accordance with the terms of Section 5.  2.4. Exclusive Option.  2.4.1. Grant.  Effective as of the Effective Date, subject to the terms and  conditions of this Agreement (including Section 2.10 (Retained Rights)), Codex hereby  grants to Pfizer exclusive options, on the terms set forth in this Section 2.4 (the “ Options”  and each an “Option”), exercisable at Pfizer’s sole discretion during the Option Exercise  Period pursuant to Section 2.4.2, on an Exclusive Field-by-Exclusive Field basis, to obtain  an exclusive (even as to Codex), sublicensable (subject to Section 2.5) license (and, to the  extent any Codex Technology is Controlled by Codex pursuant to a Codex Third Party  Agreement, a sublicense, as applicable) under the Codex Technology (including any  Deliverables therein), to use, have used, Develop, have Developed, Manufacture, have  Manufactured, Commercialize, have Commercialized and otherwise Exploit products in  such Exclusive Field for which Pfizer has exercised the Option pursuant to Section 2.4.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  18    2.4.2. Exercise of the Option.  At any time prior to the expiration of the Option  Exercise Period, on an Option-by-Option basis, Pfizer may exercise its Option(s) in  accordance with the procedure set forth in this Section 2.4.2.  On or before the last day of  the Option Exercise Period, Pfizer shall notify Codex in writing if Pfizer, in its sole  discretion, elects to exercise the Option(s).  For avoidance of doubt, the Exclusive  Development Milestones, Exclusive Sales Milestones and Exclusive Royalties described  in Section 3 shall solely be applicable to any Exclusive Products for use in an Exclusive  Field for which Pfizer has exercised its Option in accordance with this Section 2.  2.4.3. Effects of Exercise of Option.  Upon exercise of an Option in accordance  with Section 2.4.2 in respect of an Exclusive Field, effective upon the Option Exercise Date  with respect to such Exclusive Field and subject to the terms and conditions of this  Agreement (including Section 2.10 (Retained Rights)), Codex hereby grants to Pfizer an  exclusive (even as to Codex), sublicensable (subject to Section 2.7) license (and, to the  extent any Codex Technology is Controlled by Codex pursuant to a Codex Third Party  Agreement, a sublicense, as applicable) under the Codex Technology (including the  Deliverables) to use, have used, Develop, have Developed, Manufacture, have  Manufactured, Commercialize, have Commercialized and otherwise Exploit Products in  such Exclusive Field.  2.5. Unblocking License.  Subject to the terms and conditions of this Agreement and  without limiting Section 2.10, Pfizer hereby grants to Codex a non-exclusive, royalty-free,  perpetual, irrevocable, fully paid-up license in the Territory, with the right to grant sublicenses  (subject to the remainder of this Section 2.5) to Third Parties without Pfizer’s prior written consent,  under any Pfizer Sole Research Plan Patent Rights solely to the extent such Pfizer Sole Research  Plan Patent Rights is directed to Instrument/Methods Know-How and not directed to Output  Materials or Pfizer Material Improvements and is necessary for Codex to practice the Core Codex  DNA Technology.  Notwithstanding the forgoing, Codex would be permitted to sublicense the  foregoing license to a third party licensor of Codex only if (i) Codex has a similar reciprocal  arrangement with such Third Party licensee running to the benefit of Pfizer or (ii) Codex and Pfizer  have agreed upon reasonable terms and conditions with respect to such right to sublicense to such  Third Party, which the Parties agree to negotiate in good faith.   2.6. Right of Reference.  Codex hereby grants to Pfizer, its Affiliates and its  Sublicensees a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any  analogous Law recognized outside of the United States), to all data (including any regulatory  filings or Regulatory Approvals) Controlled by Codex or its Affiliates that relates generally to  DNA or RNA Manufactured by an Instrument and Codex will provide a signed statement  to this  effect, if requested by Pfizer, in accordance with 21 C.F.R. § 314.50(g)(3) (or any analogous Law  outside of the United States).  For clarity, the foregoing obligation to provide any right or reference  does not include any such obligation with respect to any specific DNA or RNA product or  component thereof.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  19    2.7. Permitted Sublicensees.  Pfizer shall have the right to freely grant sublicenses  under any and all rights licensed to Pfizer under this Agreement to Third Party subcontractors,  Affiliates or Third Parties; provided that (a) the rights licensed to Pfizer pursuant to Section 2.1.1  may not be sublicensed to any Sublicensee other than an Affiliate or Third Party subcontractors  without Codex’s prior written consent, such consent not to be unreasonably withheld, delayed or  conditioned and (b) the rights licensed to Pfizer pursuant to Sections 2.2 and 2.4.3 may be  sublicensed to any Sublicensee without Codex’s prior written consent provided that such rights  are licensed as part of an agreement between Pfizer or its Affiliate and a Third Party for such Third  Party to Develop, Manufacture or Commercialize one or more Products (or further versions  thereof).  Upon Codex’s request, Pfizer shall furnish to Codex copies of such sublicense  agreements, subject to redactions for financial, business and technical information (including  confidential information of Third Parties) to the extent not required to ensure compliance with  Section 2.7.  Each sublicense granted by Pfizer shall be granted pursuant to a written agreement  that is subject to and consistent with the terms and conditions of this Agreement.  2.8. Direct Licenses to Affiliates.  Pfizer may, from time to time, request that Codex  grant licenses directly to Affiliates of Pfizer by giving written notice, upon receipt of which Codex  agrees to enter into and sign a separate direct license agreement with such designated Affiliate of  Pfizer.  All such direct license agreements shall be consistent with the terms and conditions of this  Agreement, except for such modifications as may be required by applicable Laws in the country  in which the direct license will be exercised.  The Parties further agree to make any amendments  to this Agreement that are necessary to conform the combined terms of such direct licenses and  this Agreement to the terms of this Agreement as set forth on the Effective Date.  All costs of  making such direct license agreement(s), including Codex’s reasonable attorneys’ fees, under this  Section 2.5 shall be borne by Pfizer.  Pfizer shall remain responsible for the performance of its  Affiliates under any such direct license agreement(s), and any breach of any such direct license  agreement(s) by the Pfizer Affiliate that is a party thereto.  2.9. No Implied Rights.  Except as expressly provided in this Agreement, neither Party  shall be deemed to have granted the other Party (by implication, estoppel or otherwise) any right,  title, license or other interest in or with respect to any intellectual property right, including any  Patent Right, Know-How or information Controlled by such Party.  For the avoidance of doubt,  Pfizer shall not (a) sell, lease or otherwise transfer any Instrument, Method or Deliverable to a  Third Party other than a Third Party subcontractor or Sublicensee or (b) use (or authorize, assist  or enable an Affiliate or Third Party to use) any Instrument, Method or Deliverable to perform fee- for-service activities for or on behalf of a Third Party unless such activity is a part of an agreement  with such Third Party for the Development, Manufacture or Commercialization of one or more  Products.  2.10. Retained Rights.  Notwithstanding the exclusive nature of the licenses granted  pursuant to Section 2.4.3 following the exercise of an Option pursuant to Section 2.4.2, Codex  expressly retains the rights to practice Codex Technology in the Exclusive Fields in the Territory  solely in order to (a) perform its obligations under the Research Plan and (b) use, have used and  otherwise Exploit the Instruments, Methods and Deliverables for research use (and authorize  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  20    others to do the same), including research pertaining to any Exclusive Field.   For the avoidance  of doubt, nothing in this Section 2.10 conveys, or is meant to convey or suggest, any right of Codex  (x) to disclose, use or permit the disclosure or use of the Confidential Information of Pfizer or  Pfizer Technology in the conduct of activities described in clause (a) and (b) of the preceding  sentence or (y) to Commercialize or clinically Develop products in an Exclusive Field using Codex  Technology, and (z) Codex’s violation of the foregoing would be a material breach of the terms of  this Agreement.  For clarity, Codex retains the exclusive right to practice, license and otherwise  Exploit the Codex Technology for any reason outside the scope of the licenses granted herein.  2.11. Technology Transfer.  During the Term, Codex will promptly effect the timely  and orderly transfer of Codex Technology and Deliverables to enable Pfizer to perform its  obligations under the Research Plan and to exercise its rights under this Agreement, including by  providing Pfizer with all reasonable assistance necessary or desirable to effect such transfer;  provided that, unless otherwise expressly stated hereunder, Codex will not have an obligation to  effect the transfer to Pfizer of any Codex Know-How first conceived following the Research Term.  3. PAYMENTS BY PFIZER TO CODEX  3.1. Upfront Payment.  Within [***] days following the Effective Date, and upon  receipt of an invoice by Pfizer in accordance with Section 3.9.3, Pfizer shall pay Codex a one-time  payment of $8,000,000 USD in consideration for access to the Codex Technology, and as  consideration, in part, for Codex’s performance of the Research Plan.  3.2. Technical Milestone Payments.  Upon receipt of an invoice by Pfizer in  accordance with Section 3.9.3, Pfizer shall pay Codex the amounts set forth below (each, a  “Technical Milestone Payment”) within [***] days following the first occurrence of each event  specified below next to such amount and as further described in the Research Plan (each, a  “Technical Milestone”):     Technical Milestones Technical Milestone  Payment  (i) [***] [***]  (ii) [***] [***]  (iii) [***] [***]  (iv) [***] [***]    Each of the Technical Milestone Payments set forth above shall be payable one time only, upon  final determination by mutual agreement of the JRC that the applicable Technical Milestone has  been achieved in accordance with the criteria set forth under the Research Plan.  The maximum  amount payable by Pfizer in respect of Technical Milestone Payments if all Technical Milestones  occur shall be [***]USD.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  21    3.3. Development Milestones.  3.3.1. Products in the Non-Exclusive Field(s).  Subject to Section 3.5, with  respect to any Product upon receipt of an invoice by Pfizer in accordance with Section  3.9.3, Pfizer will pay Codex the amounts set forth below within [***] days following the  first occurrence of each event described below (the “Non-Exclusive Development  Milestones”) for the first Product in each Non-Exclusive Field (i.e., on an Indication-by- Indication basis) to achieve such Non-Exclusive Development Milestone.  Pfizer shall  provide Codex with notice of the occurrence of each Non-Exclusive Development  Milestone within [***] of achievement.   Non-Exclusive Development Milestone Development Milestone  Payment for Products in  Non-Exclusive Field  [***] [***] [***]  [***] [***] [***]  [***] [***] [***]    Each of the Development Milestone Payments payable pursuant to this Section 3.3.1 as set  forth above will be payable one time only for each Non-Exclusive Field (regardless of the  number of Products in such Non-Exclusive Field with respect to which the specified Non- Exclusive Development Milestone occurs).  No Development Milestone Payments will be  payable by Pfizer for any subsequent Product for each Non-Exclusive Field regardless of  the number of Products Developed for each Non-Exclusive Field.  Notwithstanding  anything to the contrary in this Agreement, in the event [***] Product achieves the same  Non-Exclusive Development Milestone for more than [***], the Development Milestone  Payment shall be reduced by [***] for the [***] achievement of such Non-Exclusive  Development Milestone by such Product and by [***] for the [***] achievement of such  Non-Exclusive Development Milestone by such Product; provided that a Development  Milestone Payment will not be paid for the achievement of a Non-Exclusive Development  Milestone by the same Product after such Product has achieved such Non-Exclusive  Development Milestone [***] (for clarity, [***]).  For clarification, if one Product replaces  another Product in Development for use in each Non-Exclusive Field, then such  replacement Product will only be subject to Development Milestone Payments that have  not previously been triggered by a Product in such Non-Exclusive Field.  If the Non- Exclusive Development Milestones set forth in (ii) or (iii) of the table immediately above  is achieved prior to the achievement of the Non-Exclusive Development Milestone set forth  in (i), then Pfizer will pay the Development Milestone Payment for the Non-Exclusive  Development Milestone in (i) of the table immediately above together with the payment  for the most recently achieved Non-Exclusive Development Milestone.  In the event the  Non-Exclusive Development Milestone in (iii) of the table immediately above is achieved  prior to the achievement of the Non-Exclusive Development Milestone in (ii) of the table  immediately above, the Non-Exclusive Development Milestone in (ii) of the table  immediately above will not be due or payable.  The maximum amount payable by Pfizer  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  22    under this Agreement with respect to all Non-Exclusive Development Milestones for  Products if all Non-Exclusive Development Milestones will be [***] for each Non- Exclusive Field.  3.3.2. Products in the Exclusive Field(s).  Subject to Section 3.5, on an  Exclusive Field-by-Exclusive Field basis, with respect to any Product in an Exclusive  Field, upon receipt of an invoice by Pfizer in accordance with Section 3.9.3, Pfizer will pay  Codex the amounts set forth below within [***] days following the first occurrence of each  event described below (the “Exclusive Development Milestones” and, together with the  Non-Exclusive Development Milestones, the “Development Milestones”) for the first  Product for an Exclusive Field to achieve such Exclusive Development Milestone.  Pfizer  shall provide Codex with notice of the occurrence of each Exclusive Development  Milestone within [***] of achievement.   Exclusive Development Milestone Development Milestone  Payment  [***] [***] [***]  [***] [***] [***]  [***] [***] [***]    Each of the Development Milestone Payments payable pursuant to this Section 3.3.2 as set  forth above will be payable one time only for each Exclusive Field (regardless of the  number of Products for an Exclusive Field with respect to which, or the number of times  with respect to any Product for a single Exclusive Field, the specified Exclusive  Development Milestone occurs).  No Development Milestone Payments will be payable by  Pfizer for any subsequent Product for an Exclusive Field regardless of the number of  Products Developed for that Exclusive Field.  For clarification, if one Product replaces  another Product in Development for use for an Exclusive Field, then such replacement  Product will only be subject to Development Milestone Payments that have not previously  been triggered by one or more prior Products for such Exclusive Field.  With respect to  each Exclusive Field, if the Exclusive Development Milestones set forth in (ii) or (iii) of  the table immediately above is achieved prior to the achievement of the Exclusive  Development Milestone set forth in (i), then Pfizer will pay the Development Milestone  Payment for the Exclusive Development Milestone in (i) of the table together with the  payment for the most recently achieved Exclusive Development Milestone.  With respect  to each Exclusive Field, in the event the Exclusive Development Milestone in (iii) of the  table immediately above is achieved prior to the achievement of the Exclusive  Development Milestone in (ii) of the table immediately above, the Exclusive Development  Milestone in (ii) of the table immediately above will not be due or payable.  The maximum  amount payable by Pfizer under this Agreement with respect to all Development Milestone  Payments for Products in a single Exclusive Field if all Exclusive Development Milestones  occur with respect to such Exclusive Field will be [***].  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  23    3.4. Sales Milestone Payments.  3.4.1. Products in Non-Exclusive Field.  Subject to Section 3.5, with respect to  any Product in the Non-Exclusive Field, Pfizer will pay Codex, on a Product-by-Product  basis for such Product in the Non-Exclusive Field, the following one-time payments when  aggregate Net Sales of such Product in the Non-Exclusive Field on which royalties have  been paid to Codex under Section 3.7.1 in a Pfizer Year (the “Total Annual Net Sales”)  first reach the respective thresholds indicated below (the “Non-Exclusive Sales  Milestones”):   Non-Exclusive Sales Milestone Sales Milestone Payment  [***] [***] [***]  [***] [***] [***]  [***] [***] [***]    Pfizer will make any Sales Milestone Payment payable pursuant to this Section 3.4.1 with  respect to a Pfizer Year within [***] days after the end of the applicable Pfizer Quarter in  which such Non-Exclusive Sales Milestone is achieved and such payment will be  accompanied by a report identifying the relevant Product in the Non-Exclusive Field, Net  Sales of such Product in the Non-Exclusive Field and the amount payable to Codex under  this Section 3.4.  For the avoidance of doubt, each of the Sales Milestone Payments set  forth above will be payable one time only with respect to each Product in the Non- Exclusive Field to achieve such Sales Milestone, regardless of the number of times the  corresponding Total Annual Net Sales levels are achieved by such Product.  3.4.2. Products in Exclusive Field(s).  Subject to Section 3.5, with respect to  any Products in the Exclusive Field, Pfizer will pay Codex, on an Product-by-Product basis  in the Exclusive Field, the following one-time payments when aggregate Net Sales of such  Product in the Exclusive Field on which royalties have been paid to Codex under Section  3.7.2 in a Pfizer Year (“Total Annual Exclusive Net Sales”) first reach the respective  thresholds indicated below (the “Exclusive Sales Milestones” and, together with the Non- Exclusive Sales Milestones, the “Sales Milestones”):   Exclusive Sales Milestone Sales Milestone Payment  [***] [***] [***]  [***] [***] [***]  [***] [***] [***]    Pfizer will make any Sales Milestone Payment payable pursuant to this Section 3.4.2 with  respect to a Pfizer Year within [***] after the end of the applicable Pfizer Quarter in which  such Exclusive Sales Milestone is achieved and such payment will be accompanied by a  report identifying the relevant Product in the Exclusive Field, Net Sales of such Product in  the Exclusive Field, and the amount payable to Codex under this Section 3.4.  For the  avoidance of doubt, each of the Sales Milestone Payments set forth above will be payable  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  24    one time only with respect to each Product in the Exclusive Field to achieve such Sales  Milestone, regardless of the number of times the corresponding Total Annual Exclusive  Net Sales levels are achieved by such Product.  3.5. Products in Both Exclusive and Non-Exclusive Field.  If a Product contains  mRNA encoding antigens in both a Non-Exclusive Field and Exclusive Field, such Product shall  be deemed and treated as a Product in an Exclusive Field for purposes of this Agreement.  To the  extent that any payment to Codex under this Agreement is based on or for the same event or activity  as a payment or reimbursement of costs under this Agreement or any other license agreement  between Pfizer or any of its Affiliates and Codex or any of its Affiliates, such payment shall be  payable to Codex only once, notwithstanding that the obligation to make such payment or  reimbursement arises under both this Agreement and any such other agreement.  3.6. Milestone Payment Adjustment; Additional Payments for Previously  Achieved Milestones.  Each Development Milestone Payment for a Product in the Non-Exclusive  Field or an Product in the Exclusive Field, as applicable, will be reduced by [***] if, at such time  as the corresponding Development Milestone is achieved, neither the Manufacture or sale of the  Product triggering such Milestone nor Pfizer’s use of the Deliverables used for the Development  or Manufacture of such Product is Covered by a Valid Claim.  Each Sales Milestone Payment for  any Product, as applicable, will be reduced by [***] if, at such time as the corresponding Milestone  is achieved, neither the Manufacture or sale of the Product(s) triggering such Milestone nor  Pfizer’s use of the Deliverables used for the Development or Manufacture of such Product is  Covered by a Valid Claim.  In the event that more than one Sales Milestone is first achieved in a  given Pfizer Year, Pfizer shall pay Codex the Sales Milestone Payment associated with each such  Sales Milestone achieved during such Pfizer Year.  Notwithstanding the above, in the event that a  Development Milestone Payment is made with respect to a Product in the [***] or [***] (when  such Field is part of the Non-Exclusive Field) and the [***] or [***], as applicable, becomes an  Exclusive Field due to Pfizer’s exercise of the relevant Option for such Exclusive Field pursuant  to this Agreement, Pfizer shall pay Codex the differential between the Development Milestone  Payment in the Non-Exclusive Field and the Exclusive Field within [***] days of invoice.  3.7. Royalty Payments.   3.7.1. Royalties for Products in Non-Exclusive Field.  Subject to the  provisions of Section 3.7.4, Pfizer will pay Codex, on a Product-by-Product basis, royalties  on a tiered marginal royalty rate basis as set forth below (the “Non-Exclusive Marginal  Royalty Rates”) based on the annual aggregate Net Sales of such Product in the Non- Exclusive Field in the Territory during each Pfizer Year of the applicable Royalty Term  for such Product in all Non-Exclusive Fields (each, the “Per Non-Exclusive Product  Annual Net Sales”):  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  25    Per Non-Exclusive Product Annual Net  Sales in a Pfizer Year for a Product in  all Non-Exclusive Fields  Non-Exclusive Marginal Royalty  Rate (% Per Non-Exclusive Product  Annual Net Sales)  [***] [***]  [***] [***]  [***] [***]    Each Non-Exclusive Marginal Royalty Rate applicable to sales of Products in the Non- Exclusive Field set forth in the table above will apply only to that portion of the Per Non- Exclusive Product Annual Net Sales of a given Product in the Non-Exclusive Field in the  Territory during a given Pfizer Year that falls within the indicated range.  An example  calculation of royalties under this Section 3.7.1 is set forth in Schedule 3.7.  3.7.2. Royalties for Products in an Exclusive Field(s).  Subject to the  provisions of Section 3.7.4, Pfizer will pay Codex on an Product-by-Product basis,  royalties at the marginal royalty rates set forth below (the “Exclusive Marginal Royalty  Rates”) based on the annual aggregate Net Sales for such Product in the Exclusive Field  in the Territory during each Pfizer Year of the applicable Royalty Term for such Product  in the Exclusive Field (each the “Per Exclusive Product Annual Net Sales”):  [***] Exclusive Marginal Royalty Rate (%  of Per Exclusive Product Annual Net  Sales)  [***] [***]  [***] [***]  [***] [***]    Each Exclusive Marginal Royalty Rate applicable to sales of each Product in the Exclusive  Field set forth in the table above will apply only to that portion of the Per Exclusive Product  Annual Net Sales of a given Product in the Exclusive Field in the Territory during a given  Pfizer Year that falls within the indicated range.  An example calculation of royalties under  this Section 3.7.2 is set forth in Schedule 3.7.  3.7.3. Fully Paid-Up, Royalty Free License.  Following expiration of the  Royalty Term for a Product in a given country, no further royalties will be payable in  respect of sales of such Product in such country and, thereafter the license granted to Pfizer  under this Agreement with respect to such Product in such country will automatically  become fully paid-up, perpetual, irrevocable and royalty-free.  3.7.4. No Adjustment for Codex Third Party Agreements.  As between the  Parties, Codex will be solely responsible for (i) all payment obligations (including any  royalty or other obligations that relate to the Codex Technology) under its agreements with  Third Parties that are in effect as of the Effective Date or that Codex enters into during the  Term and (ii) all payments to inventors (other than inventors that are Representatives of  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  26    Pfizer) of Codex Technology who are Representatives of Codex, including payments under  inventorship compensation Laws.  3.7.5. Biosimilar Entry.  Notwithstanding the foregoing, for Net Sales based on  sales of a Product in a country in the Territory, on a country-by-country basis, any  payments owed with respect to such Product pursuant to this Section 3.7 will be reduced  by [***] for the remainder of the applicable Royalty Term, if at any time (i) one or more  Biosimilar Versions of such Product is available in such country and (ii) such one or more  Biosimilar Versions in the aggregate have achieved in excess of [***] market penetration  (based on unit volume).   3.8. Reports and Payments.  3.8.1. Cumulative Royalties.  The obligation to pay royalties under this  Agreement will be imposed only once with respect to any sale of any given unit of Product.  3.8.2. Royalty Statements and Payments.  As soon as reasonably practicable  (but in no event more than [***] after the end of each Calendar Quarter, Pfizer will deliver  to Codex a report setting forth, for the most recent Pfizer Quarter ending during such  Calendar Quarter, the following information, on a Product-by-Product in the Field,  country-by-country and Territory-wide basis: [***]  3.9. Payment Terms.    3.9.1. Taxes and Withholding.  (a) It is understood and agreed between the Parties that any payments  made by Pfizer to Codex under this Agreement are exclusive of any value added or  similar tax (“VAT”) imposed upon such payments.  Where VAT is properly added  to a payment made under this Agreement, the Party making the payment will pay  the amount of VAT only on receipt of a valid tax invoice issued in accordance with  the laws and regulations of the country in which the VAT is chargeable.  In addition,  in the event any payments made by Pfizer pursuant to this Agreement become  subject to withholding taxes under the Laws or regulations of any jurisdiction or  Governmental Authority, Pfizer will deduct and withhold the amount of such taxes  for the account of Codex to the extent required by applicable Laws or regulations;  such amounts payable to Codex will be reduced by the amount of taxes deducted  and withheld; and Pfizer will pay the amounts of such taxes to the proper  Governmental Authority in a timely manner and transmit to Codex an official tax  certificate or other evidence of such tax obligations together with proof of payment  from the relevant Governmental Authority of all amounts deducted and withheld  sufficient to enable Codex to claim such payment of taxes.  Any such withholding  taxes required under applicable Laws or regulations to be paid or withheld will be  an expense of, and borne solely by, Codex.  Pfizer will provide Codex with  reasonable assistance to enable Codex to recover such taxes as permitted by  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  27    applicable Laws or regulations.  The Parties shall reasonably cooperate with each  other in claiming exemptions from such deductions and withholdings under any  agreement or treaty in effect at the relevant time.  (b) Notwithstanding anything in this Agreement to the contrary, (i) if  an action (including but not limited to any assignment, sublicense or exercise by  any Affiliate of a Party’s rights or obligations under this Agreement, or payment by  any Affiliate of any amount due under this Agreement, or any failure to comply  with applicable Laws or filing or record retention requirements) by a Party leads to  the imposition of withholding tax liability or VAT on the other Party that would  not have been imposed in the absence of such action or in an increase in such  liability above the liability that would have been imposed in the absence of such  action, then the sum payable by that Party (in respect of which such deduction or  withholding is required to be made) shall be increased to the extent necessary to  ensure that the other Party receives a sum equal to the sum which it would have  received had no such action occurred, (ii) otherwise, the sum payable by that Party  (in respect of which such withholding is required to be made) shall be made to the  other Party after deduction of the amount required to be so withheld, which  withheld amount shall be remitted in accordance with applicable Law.  3.9.2. Currency.  All amounts payable and calculations under this Agreement  shall be in United States dollars.  As applicable, Net Sales and any royalty deductions will  be translated into United States dollars at the exchange rate used by Pfizer for public  financial accounting purposes.  If, due to restrictions or prohibitions imposed by national  or international authority, a given payment cannot be made as provided in this Section 3,  Pfizer shall continue to provide Net Sales reports for such royalty payments, such royalty  payments shall continue to accrue in such country, and the Parties shall consult with a view  to finding a prompt and acceptable solution.  If the Parties are unable to identify a mutually  acceptable solution regarding such payment, then Pfizer may elect, in its sole discretion, to  deliver such payment in the relevant jurisdiction and in the local currency of the relevant  jurisdiction.  3.9.3. Method of Payment.  Except as permitted pursuant to Section 3.7.4, each  payment hereunder will be made by electronic transfer in immediately available funds via  either a bank wire transfer, an ACH (automated clearing house) mechanism, or any other  means of electronic funds transfer, at Pfizer’s election, to such bank account as Codex will  designate in writing to Pfizer at least [***] before the payment is due.  All invoice or billing  related questions should be referred to Pfizer’s Accounting Department at [***] or go to  the Accounts Payable Invoice Portal at [***].  3.9.4. Record Keeping.  Pfizer and its Affiliates will keep and will contractually  obligate its Sublicensees to keep books and accounts of record in connection with the sale  of Products in the Field in sufficient detail to permit accurate determination of all figures  necessary for verification of royalties and Sales Milestone Payments to be paid hereunder.   

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  28    Pfizer and its Affiliates will maintain and will contractually obligate its Sublicensees to  maintain such records for a period of at least three years after the end of the Pfizer Quarter  in which they were generated.  3.9.5. Audits.  Upon [***] days prior notice from Codex, Pfizer will permit an  independent certified public accounting firm of nationally recognized standing selected by  Codex and reasonably acceptable to Pfizer, to examine, at Codex’s sole expense, the  relevant books and records of Pfizer and its Affiliates as may be reasonably necessary to  verify the amounts reported by Pfizer in accordance with Section 3.8.2 and the payment of  royalties and Sales Milestone Payments hereunder.  An examination by Codex under this  Section 3.9.5 will occur not more than once in any Calendar Year and will be limited to  the pertinent books and records for any Calendar Year ending not more than three years  before the date of the request.  The accounting firm will be provided access to such books  and records at Pfizer’s or its Affiliates’ facility(ies) where such books and records are  normally kept and such examination will be conducted during normal business hours.   Pfizer may require the accounting firm to sign a reasonably acceptable non-disclosure  agreement before providing the accounting firm with access to Pfizer’s or its Affiliates’  facilities or records.  Upon completion of the audit, the accounting firm will provide both  Pfizer and Codex a written report disclosing any discrepancies in the reports submitted by  Pfizer or the royalties or Sales Milestone Payments paid by Pfizer, and, in each case, the  specific details concerning any discrepancies.  No other information will be provided to  Codex.  Pfizer shall use commercially reasonable efforts to obtain the right to inspect and  audit such Sublicensee’s books and records for itself, and if such right is obtained, Pfizer  shall disclose the results of any such audit to Codex in accordance with this Section 3.9.5  to the extent permitted by such Sublicensee.  3.9.6. Underpayments/Overpayments.  If such accounting firm concludes that  additional royalties or Sales Milestone Payments were due to Codex, then Pfizer will pay  to Codex the additional royalties or Sales Milestone Payments within [***] of the date  Pfizer receives such accountant’s written report.  Further, if the amount of such  underpayments exceeds more than [***] of the amount that was properly payable to Codex,  then Pfizer will reimburse Codex for Codex’s out-of-pocket costs in connection with the  audit.  If such accounting firm concludes that Pfizer overpaid royalties or Sales Milestone  Payments to Codex, then Codex will refund such overpayments to Pfizer, within [***] of  the date Codex receives such accountant’s report.  3.9.7. Confidentiality.  Notwithstanding any provision of this Agreement to the  contrary, all reports and financial information of Pfizer, its Affiliates or its Sublicensees  which are provided to or subject to review by Codex under this Section 3 will be deemed  to be Pfizer’s Confidential Information and subject to the provisions of Section 7.  3.9.8. Acknowledgement.  Pfizer and Codex acknowledge and agree that: (a)  payments to Codex pursuant to Section 3.2 have been included in this Agreement on the  basis that they are only payable or otherwise relevant if a Technical Milestone has been  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  29    achieved; (b) payments to Codex pursuant to Sections 3.3 and 3.4 have been included in  this Agreement on the basis that they are only payable or otherwise relevant if the  applicable Product in the applicable country (if any) is successfully Developed (in the case  of Section 3.3) or Commercialized (in the case of Section 3.4); and (ii) are solely intended  to allocate amounts that may be achieved upon such successful Development or  Commercialization of such Product between Pfizer (who will receive all Product sales  revenues) and Codex; (c) Milestone Payments are not intended to be used and will not be  used as a measure of damages if this Agreement is terminated for any reason, including  pursuant to Pfizer’s right to terminate at for convenience, before any such success is  achieved and such amounts become due; and (d) Milestone Payments will only be  triggered, and will only be relevant as provided in accordance with the terms and conditions  of such provisions.  Pfizer and Codex further acknowledge and agree that nothing in this  Agreement, or in any document or presentation provided by Pfizer to Codex prior to the  Effective Date will be construed as representing any estimate or projection of (i) the  successful Development or Commercialization of any Product under this Agreement, (ii)  the number of Products that will or may be successfully Developed or Commercialized  under this Agreement, (iii) anticipated sales or the actual value of any Products that may  be successfully Developed or Commercialized under this Agreement or (iv) the damages,  if any, that may be payable if this Agreement is terminated for any reason.  Pfizer makes  no representation, warranty or covenant, either express or implied, that (A) it will  successfully Develop, Manufacture, Commercialize or continue to Develop, Manufacture  or Commercialize any Product in any country, (B) if Commercialized, that any Product  will achieve any particular sales level, whether in any individual country or cumulatively  throughout the Territory or (C) Pfizer will devote, or cause to be devoted, any level of  diligence or resources to Developing or Commercializing any Product in any country, or  in the Territory in general.  3.9.9. Disclosure of Fees.  Consistent with any disclosure policy that may be  implemented from time-to-time by Pfizer regarding payments made to members of the  medical or scientific community, or in accordance with applicable laws or regulations,  Pfizer shall have the right to disclose any terms related to this Agreement, including  Codex’s name and the fees provided hereunder.  Codex also agrees to disclose its  relationship with Pfizer as needed to comply with any disclosure requirements of any  healthcare institution, medical committee, or other medical or scientific organization with  which Codex is affiliated.  This duty to disclose will continue during the term of this  Agreement and for [***] after its termination.  3.9.10. No Double Counting.  To the extent that any payment to Codex or  reimbursement of costs due to Codex under this Agreement is based on or for the same  event or activity as a payment or reimbursement of costs under this Agreement or any other  license agreement between Pfizer or any of its Affiliates and Codex or any of its Affiliates,  such payment or reimbursement of costs shall be payable to Codex only once,  notwithstanding that the obligation to make such payment or reimbursement arises under  both this Agreement and any such other agreement.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  30    4. RESEARCH PROGRAM.  4.1. Scope of Research.  Pfizer and Codex will collaborate during the Research Term  to conduct the research under the Research Plan (the “Research Program”) in accordance with  the terms set forth in this Section 4.  4.2. Research Plan.  The Research Program will be performed by the Parties in  accordance with the Research Plan and the terms and conditions set forth in this Section 4.  4.3. Allocation of Responsibilities.  4.3.1. General.  Each Party shall use Commercially Reasonable Efforts to  perform its obligations under the Research Plan in a professional and timely manner.   Further, each Party shall perform its obligations under the Research Plan in compliance  with all Laws applicable to its activities under the Research Plan.  4.4. Research Program Governance  4.4.1. Collaboration Management.  (a) Program Directors.  During the Research Term, the Research  Program shall have a program director from each Party (each, a “Program  Director” and together the “Program Directors”), initially [***] for Codex and  [***] for Pfizer.  Each Party may change its designated Program Director at any  time upon written notice to the other Party.  The Program Directors shall coordinate  the research efforts of their respective Party in conducting the Research Program.   Each Program Director shall:  (i) use good faith efforts to attend (either in person or by  telecommunications) all meetings of the JRC, but shall be a non-voting  member at such meetings; and  (ii) be the first point of referral for all matters of conflict  resolution within the scope of the JRC’s decision-making authority, and  bring any such disputes to the attention of the JRC in a timely manner.  4.4.2. Joint Research Committee.  (a) Composition.  The Parties shall establish a Joint Research  Committee, comprised of two representatives of Codex and two representatives of  Pfizer.  As of the Effective Date, the JRC representatives shall be [***] for Pfizer  (the ”Pfizer JRC Members”) and [***] for Codex (the “Codex JRC Members”).   Each Party may replace its representatives to the JRC at any time upon notice to  the other Party.  Each Party may invite non-voting employees and, with the other  Party’s JRC Chair’s prior written consent, Third Party consultants to attend  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  31    meetings of the JRC.  All members of the JRC and any invitees of either Party  described above shall agree in writing to be bound to obligations of confidentiality  and assignment of inventions no less restrictive than those that bind the Parties  under this Agreement.  (b) Committee Chair.  The JRC shall be co-chaired by a Pfizer JRC  Member and a Codex JRC Member (each, a “JRC Co-Chair”) named by each  Party.  Each Party may replace its JRC Co-Chair at any time upon notice to the  other Party.  The responsibilities of the JRC Co-Chairs shall be:  (i) to notify each Party at least [***] days in advance of each  JRC meeting;  (ii) to collect and organize agenda items for each JRC meeting;  and  (iii) to prepare the written minutes of each JRC meeting and  circulate such minutes for review and approval by the Parties, and identify  action items to be carried out by the Parties.  (c) Meetings.  During the Research Term, the JRC shall meet at least  quarterly or as frequently as agreed upon by the Parties, either in-person or by audio  or video teleconference.  Either Party may call a special meeting of the JRC by  videoconference or teleconference upon at least [***] Business Days prior written  notice to the other Party if such Party reasonably believes that a significant matter  must be addressed prior to the next scheduled meeting.  Meetings of the JRC will  only occur if at least one representative of each Party is present at the meeting or  participating by teleconference or videoconference.  Each Party shall be responsible  for all of its own expenses of participating in such JRC meetings.  The Parties shall  endeavor to schedule meetings of the JRC in advance as mutually agreed.  The JRC  Co-Chairs shall use good faith efforts to (i) prepare and circulate to each JRC  meeting agenda no later than [***] Business Days prior to the scheduled date for  each JRC meeting and (ii) circulate for review and approval by the Parties written  minutes of each JRC meeting within [***] days after such meeting.  The Parties  shall agree on the minutes of each meeting promptly, but in no event later than the  next meeting of the JRC.  (d) Responsibilities.  The JRC shall oversee and supervise the overall  performance of the Research Plan and within such scope shall:  (i) review the efforts of the Parties under the Research Plan;  (ii) review and approve any revised Research Plan; provided  that any change to a Technical Milestone of the criteria for the  achievement thereof shall require mutual agreement of the Parties;  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  32    (iii) as required under Section 3.2, determine by mutual  agreement of the Parties, whether a Technical Milestone has been  achieved in accordance with the criteria set forth under the Research Plan;  (iv) address such other matters relating to the activities of the  Parties under the Research Program as either Party may bring before the  JRC, including any matters that are expressly for the JRC to decide as  provided in this Agreement; and  (v) attempt to resolve any disputes relating to the Research  Program on an informal basis.  (e) Decision-making.  Notwithstanding the number of Pfizer JRC  Members and Codex JRC Members, each Party will have one (1) vote, and the JRC  will make decisions on a unanimous basis.  The JRC will use good faith efforts to  reach agreement on any and all matters properly brought before it.  If, despite such  good faith efforts, the JRC is unable to reach unanimous agreement on a particular  matter within the scope of the JRC’s decision-making authority, within [***] days  after the JRC first meets to consider such matter, or such later date as may be  mutually acceptable to the Parties (each such matter, a “Disputed Matter”), then  either Party may refer that Disputed Matter for resolution by the appropriate senior  officer of each Party, and such senior officers will promptly initiate discussions in  good faith to resolve such Disputed Matter.  If the senior officers of each Party are  unable to resolve the Disputed Matter within [***] of it being referred to them, then  [***] will have final decision-making authority with respect to all Disputed  Matters, subject only to specific issues identified in this Agreement as expressly  requiring mutual consent of the Parties.  For clarity, the decision-making of the JRC  is limited to matters related to the Research Program and Research Plan (including  the implementation thereof).  (f) Limits on JRC Authority.  Notwithstanding any provision of this  Section 4.4 to the contrary, (i) 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 the JRC unless such delegation or  vesting of rights is expressly provided for in this Agreement or the Parties expressly  so agree in writing, (ii) the JRC shall not have the power to (A) impose any  additional financial obligation on either Party or its Affiliates in a manner  inconsistent with this Agreement, (B) resolve any dispute regarding the existence  of amounts of any payment owed under this Agreement, (C) impose on either Party  or its Affiliates a material obligation to allocate such Party’s or its Affiliate’s  tangible or intangible resources or assets in a certain manner inconsistent with this  Agreement or (D) amend this Agreement or otherwise modify or waive compliance  with this Agreement in any manner and no decision of the JRC shall be in  contravention of any term or condition of this Agreement and (iii) neither Party  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  33    shall require the other Party to (A) breach any obligation or agreement that such  other Party may have with or to a Third Party or (B) perform any activities that are  materially different or greater in scope or more costly than those provided for in the  Research Plan then in effect.  It is understood and agreed that issues to be formally  decided by the JRC are limited to those specific issues that are expressly provided  in Section 4.4.2(d) of this Agreement and disputes which relate to subjects other  than those set forth in Section 4.4.2(d) will be handled according to Section 12.12.  (g) Term.  The JRC shall be dissolved immediately upon expiration of  the Research Term.  4.5. Research Term Extension.  If additional time is needed for the Parties to achieve  the Technical Milestones described in the Research Plan, Pfizer may extend the Research Term at  its option by up to one additional year by providing notice to Codex not later than [***] prior to  the end of the first year of the Research Term.  4.6. Research Program Expenses.  Each Party shall bear all costs and expenses it  incurs in connection with its activities under the Research Program.  4.7. Scientific Records.  Each Party shall maintain complete, current and accurate  records of all activities conducted by it pursuant to the Research Program, and all data and other  information resulting from such activities.  Such records shall fully and properly reflect all work  done and results achieved in the performance of such activities in good scientific manner  appropriate for regulatory and patent purposes, and such records shall comply with applicable  Laws, including applicable national and international guidelines such as the then-current Good  Laboratory Practices promulgated or endorsed by the United States Food and Drug Administration,  and any relevant guidelines under the International Congress on Harmonization.  Each Party will  provide the other Party with reasonable access to such records upon advance written notice as may  be required to undertake the Research Program or to the extent necessary for regulatory purposes  that are within the scope of such Party’s rights and responsibilities under this Agreement.  4.8. Delegation and Subcontracting.  Codex shall not delegate or subcontract any of  its obligations in connection with the Research Program to an Affiliate or Third Party, without  Pfizer’s prior written consent.  Any permitted Affiliate or Third Party subcontractors of either  Party must have reasonably sufficient knowledge, experience and resources to perform such  activities and, such Third Party, as applicable, must have entered into a binding subcontract with  such Party under which such Third Party:  4.8.1. has agreed to assign and does assign to such Party all intellectual property  rights generated during and in the course of its performance of the Research Program;  4.8.2. has agreed to terms and conditions with respect to confidentiality at least  as restrictive as those described in Section 7; and  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  34    4.8.3. has agreed to comply with terms substantially similar to the provisions set  out in Section 4.7 with respect to its performance of the Research Program.  No delegation or subcontracting shall relieve either Party from its obligations under this  Agreement, and the subcontracting Party shall remain fully responsible for the conduct of any  Affiliate or Third Party subcontractor as though it were performing the activities itself.  4.9. Transfer of Pfizer Materials   4.9.1. Transfer.  From time to time during the Research Term, Pfizer may, in its  sole discretion, provide Codex with tangible chemical or biological materials, including  Product(s) (the “Pfizer Materials”).  Any Pfizer Materials are provided on an “as-is” basis  without any representation or warranty of any type, express or implied, including any  representation or warranty of merchantability, non-infringement, title or fitness for a  particular purpose, each of which is hereby expressly disclaimed by Pfizer.  4.9.2. Permitted Use of Pfizer Materials.  Codex shall use the Pfizer Materials  solely in connection with conducting the activities specified in the Research Plan (the  “Codex Permitted Activities”).  Without limiting the generality of the foregoing, except  in the performance of the Codex Permitted Activities, Codex shall not (a) make or attempt  to make any analogues, progeny or derivatives of, or modifications to, the Pfizer Materials  or attempt to reverse engineer, characterize or in any way try to ascertain the identity,  chemical structure, sequence, mechanism of action or composition of the Pfizer Material  or (b) use the Pfizer Materials for its own benefit or for the benefit of any of its Affiliates  or any Third Party.  Further, Codex shall not administer any Pfizer Material to any human.   Codex shall comply with all Laws applicable to the handling and use of the Pfizer  Materials.  Codex shall retain possession over the Pfizer Materials and not provide any  Pfizer Materials to any of its Affiliates or to any Third Party without Pfizer’s prior written  consent, which consent may be withheld in Pfizer’s sole discretion.  4.9.3. Unauthorized Use of Pfizer Materials.  If Codex uses any Pfizer  Material in any manner other than in the performance of the Codex Permitted Activities,  then any and all results of such unauthorized use, whether patentable or not, shall belong  solely and exclusively to Pfizer.  Codex, on behalf of itself and its Affiliates, hereby assigns  and agrees to assign to Pfizer all of Codex’s and its Affiliates’ right, title and interest in  and to all such discoveries and inventions.  Codex further agrees to cooperate with Pfizer  to execute and deliver any and all documents that Pfizer deems reasonably necessary to  perfect and enforce Pfizer’s rights under this Section 4.9.3. Nothing in this Section 4.9.3  shall limit in any way any other remedy that Pfizer may have under this Agreement as a  result of Codex’s unauthorized use of any Pfizer Materials.  4.9.4. Title to Pfizer Materials and Output Materials.  All right, title and  interest in and to the Pfizer Materials shall remain the sole and exclusive property of Pfizer  notwithstanding the transfer to and use by Codex of the same.  Pfizer shall also have any  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  35    and all right, title and interest in and to the Output Materials, which shall be the sole and  exclusive property of Pfizer.  Without limiting Section 6, Codex, on behalf of itself and its  Affiliates, hereby assigns and agrees to assign to Pfizer all of Codex’s and its Affiliates’  right, title and interest in and to all Output Materials.  4.9.5. Return of Pfizer Materials.  At the end of the Research Term (or such  earlier time as Pfizer may request in writing), Codex shall either destroy or return to Pfizer,  at Pfizer’s sole discretion, all unused Pfizer Materials and Output Materials, as applicable.  4.9.6. Ownership of Pfizer Material Improvements and Output Materials.   “Pfizer Material Improvement” means any Research Plan Know-How that is invented,  developed or discovered by either Party that is predominantly directed to any Pfizer  Material or (b) constitutes an improvement or enhancement to, or a derivative or  modification of, any Pfizer Material or any method of making or using, which is  predominantly related to any Pfizer Material, including, without limitation, any Output  Materials.  Without limiting Section 6, Codex, on behalf of itself and its Affiliates, hereby  assigns and agrees to assign to Pfizer all of Codex’s and its Affiliates’ right, title and  interest in and to any and all Pfizer Material Improvements and Output Materials.  Codex  shall promptly notify Pfizer of any Pfizer Material Improvement made by Codex or its  Affiliates and shall reasonably cooperate in obtaining patent and other proprietary  protection for such Pfizer Material Improvement.  Such protection shall be obtained in the  name of Pfizer and at Pfizer’s cost and expense, and Codex shall, and shall cause its  Affiliates to, execute and deliver all requested applications, assignments and other  documents, and take such other actions as Pfizer may reasonably request, in order to perfect  and enforce Pfizer’s rights in any Pfizer Material Improvement.  4.9.7. Activities.  Notwithstanding anything to the contrary in this Agreement,  nothing in this Agreement (including this Section 4.9) shall be deemed to prevent or restrict  in any way the ability of either Party or its Affiliates to conduct any activities in the  Territory, which activities would be allowed under any safe harbor, research exemption,  government or executive declaration of urgent public health need, or similar right available  in law or equity if conducted by a Third Party.  4.9.8. Confidentiality.  Each Party’s obligations under this Section 4.9 are in  addition to, and shall in no way limit, its obligations under Section 7.1 with respect to the  other Party’s materials.  5. PRODUCT DEVELOPMENT AND COMMERCIALIZATION.  5.1. General.  Pfizer shall have sole authority over and control of the Development,  Manufacture, regulatory approval and Commercialization of its Products for all Fields in the  Territory.  5.2. Diligence.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  36    5.2.1. General. Upon exercise of an Option with respect to an Exclusive Field  in accordance with Section 2.4.2, Pfizer shall itself, or through its Affiliates or  Sublicensees, use Commercially Reasonable Efforts to [***]  Pfizer will have no other  diligence obligations with respect to the Development, Regulatory Approval or  Commercialization of Products under this Agreement.  For clarity, if an Exclusive Field  become a Non-Exclusive Field pursuant to this Agreement, Pfizer shall no longer have an  obligation under this Section 5.2.1 with respect to such field.  5.2.2. Assertion of Pfizer Diligence Obligation Claims.  If Codex is, becomes  or reasonably should be aware of facts that might form a reasonable basis to allege that  Pfizer has failed to meet its diligence obligation under Section 5.2.1, then Codex will  promptly notify Pfizer in writing of such potential alleged performance failure (each such  potential alleged performance failure, a “Diligence Issue”).  Promptly upon Pfizer’s receipt  of any notice of a Diligence Issue pursuant to this Section 5.2.2, the Parties shall use  reasonable, good faith efforts to identify an appropriate corrective course of action if a  Diligence Issue exists.  If, no later than [***] days after Pfizer’s receipt of such a notice,  (a) the Parties have not reached consensus regarding whether Pfizer has failed to satisfy its  obligations pursuant to Section 5.2.1 or (b) the Parties have not agreed upon an appropriate  corrective course of action for such Diligence Issue, then such Diligence Issue may be  escalated by either Party and resolved pursuant to the dispute resolution provisions set forth  in Section 12.12.  If Codex fails to notify Pfizer of a Diligence Issue pursuant to this Section  5.2.2 within [***] days after the date that Codex first discovers or reasonably should have  discovered such Diligence Issue, then Pfizer will be deemed to have satisfied its obligations  under Section 5.2.1 with respect to such Diligence Issue.  5.2.3. Remedies for Breach of Pfizer Diligence Obligations.  If it is  determined under Section 5.2.2 that Pfizer failed to meet its diligence obligation with  respect to an Exclusive Field and such failure is a material breach of Pfizer’s obligations  under this Agreement, then Codex may elect to convert Pfizer’s exclusive license with  respect to such Exclusive Field granted under Section 2.4.3 into a non-exclusive license  and the restrictions on Codex under Section 8.4.2 with respect to such Exclusive Field shall  be lifted.  Codex acknowledges and agrees that the election set forth in this Section 5.2.3:  (i) has been negotiated by the Parties to fully address any harm that Codex may incur as a  result of Pfizer’s material breach of the Agreement in the form of a failure to meet its  diligence obligation under Section 5.2.1 with respect to an Exclusive Field and (ii) if  exercised, constitutes Codex’s sole and exclusive remedy with respect to any breach by  Pfizer of its diligence obligation under Section 5.2.1 with respect to the applicable  Exclusive Field.  In the event that Codex elects to convert Pfizer’s exclusive license with  respect to an Exclusive Field to a non-exclusive license, such Exclusive Field will become  a Non-Exclusive Field and will no longer be an “Exclusive Field” under this Agreement,  in each case immediately as of the time of conversion.  5.3. Regulatory Approvals.  Pfizer or its designated Affiliate(s) shall have the sole  authority to file applications for Regulatory Approval for its Products for all Fields in the Territory,  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  37    including communicating with any Regulatory Authority both prior to and following Regulatory  Approval.  To the extent Pfizer requests any information or support with respect to any such  application for Regulatory Approval for a Product, Codex shall provide reasonably requested  support or information with any reasonable out-of-pocket costs incurred to be at Pfizer’s expense.  5.4. Commercialization Activities.  5.4.1. General.  Pfizer shall have sole and exclusive control over all matters  relating to the Commercialization of its Products for the Field in the Territory, including  sole and exclusive control over (a) pricing of such Products in the Field and (b) the  negotiation of pricing with Regulatory Authorities and other Third Parties for such  Products in the Field.  5.4.2. Branding.  Pfizer or its designated Affiliates or Sublicensees shall select  and own all Trademarks used in connection with the commercialization of any and all  Output Materials and its Products for the Field in the Territory.  Neither Codex nor its  Affiliates shall use or seek to register, anywhere in the world, any Trademark not otherwise  in use by Codex at the time of selection by Pfizer, its designated Affiliate or Sublicensee  which is confusingly similar to any Trademark used by or on behalf of Pfizer, its Affiliates  or Sublicensees in connection with any such Product for the Field in the Territory.  5.5. Manufacturing.  Pfizer shall have the exclusive right to Manufacture, itself or  through one or more Affiliates or Third Parties selected by Pfizer in its sole discretion, its Products  for the Field in the Territory.  For clarity, Pfizer shall have no diligence obligations with respect  to the Manufacture of such Products.  5.6. Reporting.  All information or written reports provided by Pfizer to Codex under  this Section 5.6 shall be deemed Confidential Information of Pfizer and subject to Section 7.  5.6.1. Development Notices.  Pfizer shall notify Codex in writing promptly  following Pfizer’s decision to [***] with respect to a Product that has been (a) discovered,  designed, encoded or created using the Deliverables or (b) transcribed from DNA that was  discovered, designed, encoded or created using the Deliverables (such notice, a  “Development Notice”).  5.6.2. Progress Reports.  Until the First Commercial Sale of a Product, Pfizer  will provide Codex with an annual written report summarizing, on a Product-by-Product  basis, Pfizer’s activities to Develop Products in the Field.  5.7. Other Pfizer Matters.  Codex understands and acknowledges that Pfizer may have  present or future initiatives or opportunities, including initiatives or opportunities with its Affiliates  or Third Parties, involving the manufacture or synthesis of DNA or RNA, including products,  programs, technologies or processes that are similar to, and in some instances may compete with,  a Product, Instrument, or other program, technology or processes covered by this Agreement.   Codex acknowledges and agrees that nothing in this Agreement will be construed as a  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  38    representation, warranty, covenant or inference that Pfizer will not itself Develop, Manufacture or  Commercialize or enter into business relationships with one or more of its Affiliates or Third  Parties to develop, Manufacture or synthesize DNA or RNA, or Manufacture or Commercialize  any products, instruments, programs, technologies or processes that are similar to or that may  compete with any Instrument, Product or other program, technology or process covered by this  Agreement.  6. INTELLECTUAL PROPERTY  6.1. Ownership of Intellectual Property.  Except as otherwise explicitly set forth in  this Agreement, the Parties hereby agree that ownership and inventorship of any Know-How made  by any Party, solely or jointly, pursuant to this Agreement and any and all Patent Rights claiming  or disclosing any invention included in such Know-How shall be determined in accordance with  United States patent laws.  6.1.1. Ownership of Pfizer Technology.  As between the Parties, subject to  Section 6.1.3, Pfizer shall own all right, title and interest in and to the Pfizer Technology.   Codex, on behalf of itself and its Affiliates, hereby assigns and agrees to assign to Pfizer  all of Codex’s and its Affiliates’ right, title and interest in and to all Pfizer Sole Research  Plan Know-how and Pfizer Sole Research Plan Patent Rights.  Codex further agrees to  cooperate with Pfizer (at Pfizer’s request and expense) to execute and deliver any and all  documents that Pfizer deems reasonably necessary to perfect and enforce Pfizer’s rights in  and to the Pfizer Technology under this Section 6.1.1.  6.1.2. Ownership of Codex Technology.  As between the Parties, subject to  Section 6.1.3, Codex shall own all right, title and interest in and to the Codex Technology.   Pfizer further agrees to cooperate with Codex (at Codex’s request and expense) to execute  and deliver any and all documents that Codex deems reasonably necessary to perfect and  enforce Codex’s rights in and to the Codex Technology under this Section 6.1.2.  6.1.3. Ownership of Joint Research Plan Technology.  The Parties will jointly  own any Joint Research Plan Technology.  Subject to the licenses or other rights granted  to Pfizer under Sections 2.1, 2.2, 2.3, and 2.4 and the Parties’ other rights and obligations  under this Agreement (including Codex’s obligations under Section 8.4), each Party shall  be free to exploit, either itself or through the grant of licenses to Third Parties (which Third  Party licenses may be further sublicensed), Joint Research Plan Technology throughout the  world without restriction, without the need to obtain further consent from or provide notice  to the other Party, and without any duty to account or otherwise make any payment of any  compensation to the other Party.  6.1.4. Disclosure.  Each Party will promptly disclose to the other Party all  inventions within the Research Plan Know-How that it develops or invents, whether solely  or jointly with others (in any event, prior to the filing of any patent application with respect  to such inventions), including all invention disclosures or other similar documents  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  39    submitted to such Party by its or its Affiliates’ employees, agents, or independent  contractors relating thereto.  Each Party will also promptly respond to reasonable requests  from the other Party for additional information relating thereto.  6.2. Patent Rights.  6.2.1. Filing, Prosecution and Maintenance of Patent Rights.  (a) Codex Sole Research Plan Patent Rights and Instrument/Methods  Patent Rights.  Codex shall have the sole right, at its sole expense, to file, prosecute  and maintain the Codex Sole Research Plan Patent Rights and Instrument/Methods  Patent Rights in its sole discretion; provided, however that no Codex Sole Research  Plan Patent Right shall claim or disclose any Pfizer Sole Research Plan Know-How,  in each case without Pfizer’s prior written consent.  (b) Pfizer Sole Research Plan Patent Rights.  Pfizer shall have the sole  right, at its sole expense, to file, prosecute and maintain the Pfizer Sole Research  Plan Patent Rights, including Pfizer Material Improvements or Output Material  Patent Rights, in its sole discretion; provided, however that no Pfizer Sole Research  Plan Patent Right shall claim or disclose any Codex Sole Research Plan Know- How, in each case without Codex’s prior written consent.  (c) Joint Research Plan Technology.  Notwithstanding anything  herein to the contrary, in the event the Parties make any Joint Research Plan Know- How that is not Instrument/Method Know-How, the Parties shall discuss the timing  of the filing and content of Joint Research Plan Patent Rights with the mutual goal  of preserving the value of the Joint Research Plan Patent Rights.  Unless otherwise  agreed in writing by the Parties, (1) Pfizer will have the sole right to file, prosecute  and maintain any Joint Research Plan Patent Rights that Cover or are primarily  directed to one or more Products and (2) Codex will have the first right to file,  prosecute and maintain other Joint Research Plan Patent Rights, in each case at such  Party’s own cost and expense.  With respect to Joint Research Plan Patent Rights,  each Party will, as applicable, (i) provide the other Party a reasonable opportunity  and reasonable time to review and provide comment to such Party’s counsel  regarding relevant substantive communications by such Party and drafts of any  responses or other proposed substantive filings by such Party before any applicable  filings are submitted to any relevant patent office (or Governmental Authority) and  (ii) reflect any reasonable and timely comments offered by the other Party in any  final filings submitted by such Party to any relevant patent office (or Governmental  Authority).  In addition, if the Party with the first right to file, prosecute and  maintain elects to cease the prosecution or maintenance of any Joint Research Plan  Patent Right in any country or jurisdiction, it shall notify the other Party in writing  sufficiently in advance (but not less than [***] before any action is required) so that  such other Party may, at its discretion, assume the responsibility for the filing,  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  40    prosecution or maintenance of such Joint Research Plan Patent Right in such  designated country.  The Parties agree that either Party may use internal patent  counsel and agents, filing clerks, and paralegals employed by such Party, for  coordinating worldwide filings of such Patent Rights, for prosecution before the  European and Japanese Patent Offices, and for directly instructing US and ex-US  outside counsel and patent agents, including by providing draft applications and  responses, and that such Party may employ its preferred outside counsel and patent  agents to conduct such activities as required for US and ex-US prosecution).  (d) The Parties shall at all times reasonably cooperate with each other  in order to reasonably implement the foregoing provisions of this Section 6.2.1.   Such cooperation may include each Party’s execution of necessary legal  documents, coordinating filing and/or prosecution of applications to avoid potential  issues during prosecution (including novelty, enablement, estoppel and double  patenting, execution of amendments and documents for reliance on the CREATE  Act, if needed), and the assistance of each Party’s relevant personnel.  Without  limiting the foregoing, it is understood that even if a Party is permitted to reference  the other Party’s technology created, discovered or utilized in the Research  Program in a patent application filed pursuant to this Agreement, the filing Party  shall not file any such patent application without first notifying the non-filing Party  of the disclosure of the non-filing Party’s technology.  If the non-filing Party  determines that any such filing could adversely affect its filing strategy, the filing  Party shall delay filing any such patent application and the Parties shall cooperate  in accordance with this Section 6.2.1(d) to determine a strategy that would protect  each Party’s interests.  However, the filing Party will only be required to delay  filing for a maximum of [***] days after notice to the non-filing Party unless the  non-filing Party can show that a limited additional time period would allow it to  protect its interests without prejudice to the filing Party’s interests.  Pfizer shall not  disclose and/or claim in any patent application, patent or publication any Codex  Confidential Information without Codex’s prior written consent.  Codex shall not  disclose and/or claim in any patent application, patent or publication any Pfizer  Confidential Information without Pfizer’s prior written consent.  6.2.2. Clarifications.  For clarity, (i) prosecution under this Section 6.2 includes  opposition, revocation, post-grant review or other patent office proceedings, unless such  proceedings are concurrent with Third Party litigation under Section 6.3, in which case the  provisions of Section 6.3 shall govern the Parties’ rights and obligations with respect to  such proceedings, and (ii) Third Party declaratory judgment actions or other court actions  relating to Patent Rights shall be governed by Sections 6.3.2 and 6.3.3, if applicable.  6.2.3. Liability.  To the extent that a Party is obtaining, prosecuting or  maintaining a Patent Right or otherwise exercising its rights under this Section 6.2, such  Party, and its Affiliates, employees, agents or representatives, will not be liable to the other  Party in respect of any act, omission, default or neglect on the part of any such Party, or its  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  41    Affiliates, employees, agents or representatives, in connection with such activities  undertaken in good faith.  6.2.4. Recording.  If Pfizer deems it necessary or desirable to register or record  this Agreement or evidence of this Agreement with any patent office or other appropriate  Governmental Authority(ies) in one or more jurisdictions in the Territory, Codex shall  reasonably cooperate (at Pfizer’s request and expense) to execute and deliver to Pfizer any  documents accurately reflecting or evidencing this Agreement that are necessary or  desirable, in Pfizer’s reasonable judgment, to complete such registration or recordation.   Pfizer shall reimburse Codex for all reasonable out-of-pocket expenses, including  attorneys’ fees, incurred by Codex in complying with the provisions of this Section 6.2.4.  6.3. Enforcement and Defense of Patent Rights.  6.3.1. Enforcement.  (a) Enforcement of Codex Patent Rights.  Codex shall have the sole  right, but no obligation, to take action to obtain a discontinuance of infringement  or bring suit against a Third Party infringing or challenging the validity or  enforceability of any Codex Patent Right other than a Joint Research Plan Patent  Right.  (b) Enforcement of Pfizer Patent Rights.  Pfizer shall have the sole  right, but no obligation, to take action to obtain a discontinuance of infringement  or bring suit against a Third Party infringing or challenging the validity or  enforceability of any Pfizer Patent Right other than a Joint Research Plan Patent  Right.  (c) Enforcement of Joint Research Plan Patent Rights.   Notwithstanding anything herein to the contrary, each Party will promptly notify  the other in the event of any actual, potential or suspected infringement of a patent  under the Joint Research Plan Patent Rights by any Third Party.  As between Pfizer  and Codex, Pfizer will have the sole right, but not the obligation, to institute  litigation or take other steps to remedy infringement in connection with the Joint  Research Plan Patent Rights by the development, manufacture or  commercialization of an Product in the Territory, and any such litigation or steps  will be at Pfizer’s expense, subject to Codex’s obligation to indemnify Pfizer for  such expenses pursuant to Section 10; provided that any infringement recoveries  resulting from such litigation or steps relating to a claim of Third Party  infringement, after deducting Pfizer’s out of pocket expenses (including counsel  fees and expenses) in pursuing such claim, will be deemed Net Sales.  Pfizer will  not, without the prior written consent of Codex, enter into any compromise or  settlement relating to such litigation that (i) admits the invalidity or unenforceability  of any Codex Patent Right or Joint Research Plan Patent Right or (ii) requires Pfizer  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  42    to abandon any Joint Research Plan Patent Right.  Codex, upon request of Pfizer,  agrees to timely commence or to join in any such litigation, at Pfizer’s expense, and  in any event to cooperate with Pfizer in such litigation or steps at Pfizer’s expense.   Codex will have the right to consult with Pfizer about such litigation and to  participate in and be represented by independent counsel in such litigation at  Codex’s own expense.  Neither Party will incur any liability to the other Party (other  than that related to a Party’s indemnification obligation pursuant to Section 10) as  a consequence of any litigation initiated or pursued pursuant to this Section 6.3 or  any unfavorable decision resulting therefrom, including any decision holding any  Codex Patent Right or Joint Research Plan Patent Right invalid or unenforceable.   With respect to instituting litigation or taking other steps to remedy infringement  in connection with the other Joint Research Plan Patent Rights, the Parties shall  determine a mutually agreeable course of action.  In no event shall a Party make an  argument or settle a dispute which would render a claim in a Joint Research Plan  Patent Right to be invalid or unenforceable without the other Party’s prior written  consent.  6.3.2. Allegations of Infringement and Right to Seek Third Party Licenses.  (a) Notice.  If Codex receives written notice from a Third Party that  the practice of any Codex Technology, or the exercise of any other right granted by  Codex to Pfizer hereunder (collectively, the “Licensed Activities”) by Pfizer or  any of its Affiliates or Sublicensees is alleged by such Third Party to infringe,  misappropriate or otherwise violate such Third Party’s Patent Rights or other  intellectual property rights, or Codex otherwise identifies any Third Party Patent  Rights or other intellectual property rights that may be relevant to such activities,  Codex shall, promptly upon becoming aware of such allegation or identification,  notify Pfizer in writing.  (b) Pfizer Option to Negotiate.  If Pfizer determines, in its sole  discretion, that, in order for Pfizer, its Affiliates or Sublicensees to engage in the  Licensed Activities, it is necessary or desirable to obtain a license under one or  more Patent Rights or other intellectual property rights Controlled by a Third Party,  then Pfizer shall have the sole right, but not the obligation, to negotiate and enter  into an exclusive license or other agreement with such Third Party in the Field  under such Patent Rights or other intellectual property rights; provided that if and  to the extent such Patent Rights are necessary to practice Core Codex DNA  Technology, Pfizer shall only negotiate and enter into a non-exclusive license or  other agreement with such Third Party with respect to the Non-Exclusive Field.  6.3.3. Third Party Infringement Suits.  Each of the Parties shall promptly  notify the other in the event that any Third Party files any suit or brings any other action  alleging patent infringement by Pfizer or Codex or any of their respective Affiliates or  Sublicensees with respect to the practice of any Codex Technology or Licensed Activities  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  43    (any such suit or other action referred to herein as an “Infringement Claim”).  In the case  of any Infringement Claim against Pfizer (including its Affiliates or Sublicensees) alone or  against both Pfizer and Codex (including its Affiliates), Pfizer shall have the right, but not  the obligation, to control the defense of such Infringement Claim, including control over  any related litigation, settlement, appeal or other disposition arising in connection  therewith.  Codex, upon request of Pfizer, agrees to join in any litigation associated with  any Infringement Claim at Pfizer’s expense and in any event to cooperate with Pfizer at  Pfizer’s expense.  Codex will have the right to consult with Pfizer concerning any  Infringement Claim and to participate in and be represented by independent counsel in any  associated litigation in which Codex is a party at Codex’s own expense.  If Pfizer elects to  control the defense of any Infringement Claim and Codex is obligated under Section 10.3  to indemnify Pfizer (including any Pfizer Indemnified Party) with respect to such  Infringement Claim, then (a) Pfizer will bear [***] incurred in investigating, preparing or  defending such Infringement Claim notwithstanding the provisions of Section 10.3 and (b)  Codex will otherwise indemnify Pfizer and any applicable Pfizer Indemnified Parties to  the full extent provided for under Section 10.3.  In the case of any Infringement Claim  against Codex alone, Pfizer shall have the right to consult with Codex concerning such  Infringement Claim and Pfizer, upon request of Codex, will reasonably cooperate with  Codex at Codex’s expense (but Pfizer shall have no obligation to join any Infringement  Claim or associated litigation).  6.3.4. Enforcement and Defense of Know-How.  (a) Misappropriation Actions Relating to Codex Know-How.  Codex  shall have the sole right, but no obligation, to take action to obtain a discontinuance  of misappropriation or bring suit against a Third Party that is misappropriating, or  that is suspected of misappropriating, any Codex Know-How other than a Joint  Research Plan Know-How.  (b) Misappropriation of Actions Relating to Pfizer Know-How.  Pfizer  shall have the sole right, but no obligation, to take action to obtain a discontinuance  of misappropriation or bring suit against a Third Party that is misappropriating, or  that is suspected of misappropriating, any Pfizer Know-How and Pfizer Sole  Research Plan Know-How other than a Joint Research Plan Know-How.  (c) Misappropriation of Joint Research Plan Know-How.  Each Party  will promptly notify the other in the event of any actual, potential or suspected  misappropriation of Joint Research Plan Know-How by any Third Party, and the  Parties shall determine a mutually agreeable course of action.  In no event shall a  Party, without the prior written consent of other Party, enter into any compromise  or settlement relating to such misappropriation claim that (i) admits that all or any  portion of the Joint Research Plan Know-How is not protectable under relevant  trade secret Laws or (ii) requires the other Party to abandon trade secret protection  for any Joint Research Plan Know-How.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  44    6.4. Codex Third Party Agreements.  If on or after the Effective Date, Codex  contemplates entering into a Codex Third Party Agreement under which Pfizer would be obligated  to comply with any additional non-financial provisions as a sublicensee or transferee, then Codex  shall (a) notify Pfizer of such agreement and (b) provide Pfizer [***] to review and provide  comments to the terms of such agreement prior to signing with any reasonable comments provided  by Pfizer to be considered and implemented in good faith by Codex; provided that for any such  Codex Third Party Agreement, Codex shall notify Pfizer within [***] days of execution of such  agreement, such notice to be accompanied by a copy of such Codex Third Party License  Agreement, and Pfizer will not be granted a sublicense under such Codex Third Party Agreement  unless it notifies Codex in writing of such sublicense acceptance within [***] days of Codex’s  notice.  7. CONFIDENTIALITY  7.1. Confidentiality.  Except to the extent expressly authorized by this Agreement, the  Parties agree that, during the Term and for five years thereafter, each Party (the “Receiving  Party”) receiving any Confidential Information of the other Party (the “Disclosing Party”)  hereunder shall: (a) keep the Disclosing Party’s Confidential Information confidential; (b) not  disclose, or permit the disclosure of, the Disclosing Party’s Confidential Information; and (c) not  use, or permit to be used, the Disclosing Party’s Confidential Information for any purpose other  than as expressly permitted under the terms of this Agreement.  7.2. Authorized Disclosure.  7.2.1. Disclosure to Party Representatives.  Notwithstanding the foregoing  provisions of Section 7.1, the Receiving Party may disclose Confidential Information  belonging to the Disclosing Party to the Receiving Party’s Representatives who (a) have a  need to know such Confidential Information in connection with the performance of the  Receiving Party’s obligations or the exercise of the Receiving Party’s rights under this  Agreement and (b) have agreed in writing to non-disclosure and non-use provisions with  respect to such Confidential Information that are at least as restrictive as those set forth in  this Section 7.  7.2.2. Disclosure to Third Parties.  Notwithstanding the foregoing provisions  of Section 7.1, each Party may disclose Confidential Information belonging to the other  Party to the extent such disclosure is reasonably necessary:  (a) to Governmental Authorities (i) to the extent desirable to obtain or  maintain INDs or Regulatory Approvals for any Output Material or Product within  the Territory, and (ii) in order to respond to inquiries, requests or investigations  relating to Output Material, Products or this Agreement;  (b) to outside consultants (including any professional advisor),  potential acquisition partners (including any potential successors in interest),  private investors or financing sources, contractors, advisory boards, managed care  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  45    organizations, and non-clinical and clinical investigators, in each case to the extent  desirable to develop, register or market any Output Material, Product; provided that  the Receiving Party shall obtain the same confidentiality obligations from such  Third Parties as it obtains with respect to its own similar types of confidential  information, and at least as restrictive as those set forth in this Section 7;  (c) in connection with filing or prosecuting Patent Rights or  Trademark rights as permitted by this Agreement,  (d) in connection with prosecuting or defending litigation arising from  this Agreement;  (e) subject to the provisions of Section 7.5.2, in connection with or  included in scientific presentations and publications relating to Output Material,  Products, including abstracts, posters, journal articles and the like, and posting  results of and other information about clinical trials to clinicaltrials.gov or PhRMA  websites;  (f) Pfizer may disclose Confidential Information belonging to Codex  (including the terms of this Agreement) to any bona fide or potential Sublicensee  or co-development or co-promotion partner who has agreed in writing to non- disclosure and non-use provisions with respect to such Confidential Information  that are at least as restrictive as those set forth in this Section 7; and  (g) to the extent necessary or desirable in order to enforce its rights  under this Agreement.  If a Party deems it reasonably necessary to disclose Confidential Information  belonging to the other Party pursuant to this Section 7.2.2, then the Party disclosing  pursuant to this Section 7.2.2 shall to the extent possible give reasonable advance  written notice of such disclosure to the other Party and take such measures to ensure  confidential treatment of such information as is reasonably required by the other  Party, at the other Party’s expense.  7.3. SEC Filings and Other Disclosures.  Either Party may disclose the terms of this  Agreement and make any other public written disclosure regarding the existence of, or  performance under, this Agreement, to the extent required, in the reasonable opinion of such  Party’s legal counsel, to comply with applicable Law, including the rules and regulations  promulgated by the United States Securities and Exchange Commission or any equivalent  Governmental Authority, securities exchange or securities regulator in any country in the  Territory.  Before disclosing this Agreement or any of the terms hereof pursuant to this Section  7.3, the Parties will consult with one another on the terms of this Agreement to be redacted in  making any such disclosure, with the Party disclosing pursuant to this Section 7.3 providing as  much advanced notice as is feasible under the circumstances (but in no event less than [***] unless  law requires otherwise), and giving good faith consideration to the comments of the other Party.   

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  46    Further, if a Party discloses this Agreement or any of the terms hereof in accordance with this  Section 7.3, such Party shall, at its own expense, seek such confidential treatment of confidential  portions of this Agreement and such other terms, as may be reasonably requested by the other  Party and limit its disclosure of such Confidential Information to only that required to comply with  applicable Law.  7.4. Residual Knowledge Exception.  Notwithstanding any provision of this  Agreement to the contrary, Residual Knowledge shall not be considered Confidential Information  for purposes of this Section 7; provided that, for clarity, a Party’s rights to Residual Knowledge  hereunder shall not include the right to practice any Patent Right owned or Controlled by the other  Party that claims or discloses such Residual Knowledge unless otherwise expressly granted in  another provision of this Agreement or in another agreement between the Parties.  7.5. Public Announcements; Publications.    7.5.1. Announcements.  Except as may be expressly permitted under  Section 7.3 or this Section 7.5, neither Party will make any public announcement regarding  this Agreement without the prior written approval of the other Party.  For the sake of clarity,  nothing in this Agreement shall prevent Pfizer from making any scientific publications or  public announcement with respect to any Product under this Agreement; provided,  however, that, except as permitted under Section 7.2, Pfizer shall not disclose any of  Codex’s Confidential Information in any such publication or announcement without  obtaining Codex’s prior written consent to do so.  The Parties agree that the Parties will  issue a mutually agreed upon joint press release regarding the signing of this Agreement  following the Effective Date, substantially similar to the draft set forth in Schedule 7.5.1.  7.5.2. Publications.  During the Term, each Party (the “Publishing Party”)  shall submit to the other Party (the “Non-Publishing Party”) for review and approval any  proposed publication or public presentation which contains the Non-Publishing Party’s  Confidential Information.  In addition, except as otherwise permitted pursuant to Section  7.3 or Section 7.5.1, each Publishing Party shall submit to the Non-Publishing Party for  review and approval any proposed publication or public presentation relating to the  Research Program.  In both instances, such review and approval will be conducted for the  purposes of preserving the value of the Codex Technology and the Pfizer Technology, and  the rights granted to Pfizer hereunder and determining whether any portion of the proposed  publication or presentation containing the Non-Publishing Party’s Confidential  Information should be modified or deleted.  Written copies of such proposed publication  or presentation required to be submitted hereunder shall be submitted to the Non- Publishing Party no later than [***] days before submission for publication or presentation  (the “Review Period”).  The Non-Publishing Party shall provide its comments with respect  to such publications and presentations within [***] days of its receipt of such written copy.   The Review Period may be extended for an additional [***] days in the event the Non- Publishing Party can, within [***] days of receipt of the written copy, demonstrate  reasonable need for such extension including for the preparation and filing of patent  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  47    applications.  Each Publishing Party will comply with standard academic practice  regarding authorship of scientific publications and recognition of contribution of other  parties in any publication governed by this Section 7.5.2, including International  Committee of Medical Journal Editors standards regarding authorship and contributions.   For the sake of clarity, Pfizer’s obligation to submit any publication to Codex for review  and approval under this Section 7.5.2 shall not apply to any publication which does not  contain Codex’s Confidential Information.  In addition, Codex may use and disclose certain  anonymized data obtained from performing the Research Program for the purpose of  presenting the capabilities of the Codex Technology, Instrument or Methods to existing or  prospective Codex partners, investors, acquirers or to members of the media; provided, that  the use and disclosure of such anonymized data fall under one of the use rights as listed in  Exhibit E, and Codex obtains Pfizer’s prior written consent from Pfizer prior to such  disclosure.  Such anonymized data to be used from the Research Program shall make no  reference to the fact that the data was generated under this Agreement, using the Pfizer  Materials provided by Pfizer or the name or mechanism of action of any Product.  7.6. Obligations in Connection with Change of Control.  If Codex is subject to a  Change of Control during the Research Term, Codex will, and it will cause its Representatives to,  ensure that no Confidential Information of Pfizer is released to (a) any Affiliate of Codex that  becomes an Affiliate as a result of the Change of Control or (b) any other Representatives of Codex  (or of the relevant surviving entity of such Change of Control) who become Codex Representatives  as a result of the Change of Control, unless such Affiliate or other Representatives, as applicable,  have signed confidentiality agreements which include equivalent obligations to those set out in  this Section 7. If any Change of Control of Codex occurs, Codex shall promptly notify Pfizer,  share with Pfizer the policies and procedures it plans to implement in order to protect the  confidentiality of Pfizer’s Confidential Information prior to such implementation and make any  adjustments to such policies and procedures that are reasonably requested by Pfizer.  8. REPRESENTATIONS, WARRANTIES AND COVENANTS.  8.1. Mutual Representations and Warranties.  Each of Codex and Pfizer hereby  represents and warrants to the other Party that:  8.1.1. it is duly organized, validly existing and in good standing under the laws  of the jurisdiction of its organization;  8.1.2. the execution, delivery and performance of this Agreement by such Party  has been duly authorized by all requisite action under the provisions of its charter, bylaws  and other organizational documents, and does not require any action or approval by any of  its shareholders or other holders of its voting securities or voting interests;  8.1.3. it has the power and authority to execute and deliver this Agreement and  to perform its obligations hereunder;  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  48    8.1.4. this Agreement has been duly executed and is a legal, valid and binding  obligation on each Party, enforceable against such Party in accordance with its terms; and  8.1.5. the execution, delivery and performance by such Party of this Agreement  and its compliance with the terms and provisions hereof does not and will not conflict with  or result in a breach of or default under any Binding Obligation existing as of the Effective  Date.   8.2. Mutual Covenants.  Each of Codex and Pfizer hereby covenants to the other Party  that, from the Effective Date until expiration or termination of this Agreement, it will perform its  obligations under this Agreement in compliance with applicable Laws.  8.3. Representations and Warranties of Codex.  As of the Effective Date, Codex  hereby represents and warrants to Pfizer that:  8.3.1. the execution and delivery of this Agreement by Codex, and the  consummation of the transactions contemplated hereby and thereby, do not require any  material consent, waiver, authorization or approval of, or any notice to or other filing with,  any Governmental Authority;  8.3.2. it is in compliance in all material respects with all Laws applicable to the  ownership of the Initial Instrument and Initial Methods, including all manufacturing,  development, marketing and regulatory filing and maintenance activities related to the  Initial Instrument and Initial Methods to the extent necessary for Codex to perform those  activities assigned to it under the Research Program;  8.3.3. [***];  8.3.4. it has and will have the full right, power and authority to grant all of the  right, title and interest in the licenses and other rights granted or to be granted to Pfizer,  Pfizer’s Affiliates or Pfizer’s Sublicensees under this Agreement;  8.3.5. (a) Exhibit A sets forth a true and complete list of all Codex Patent Rights  as of the Effective Date, (b) each such Codex Patent Right is in full force and effect and  (c) Codex or its Affiliates have timely paid all filing and renewal fees payable with respect  to such Codex Patent Rights;  8.3.6. (a) the issued and pending Codex Patent Rights as of the Effective Date,  are, or upon issuance, will be, valid and enforceable patents and (b) [***];  8.3.7. Codex, its Affiliates and Third Parties and Representatives acting on  Codex’s behalf in connection with this Agreement have complied with all applicable Laws,  including any disclosure requirements, in connection with the filing, prosecution and  maintenance of the Codex Patent Rights;  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  49    8.3.8. Codex, its Affiliates, and to its knowledge, all Third Parties and  Representatives acting on Codex’s behalf, have and will comply in all material respects  with all applicable Law and accepted pharmaceutical industry business practices,  including, to the extent applicable, the FD&C Act (21 U.S.C. § 301, et seq.), the Anti- Kickback Statute (42 U.S.C. § 1320a-7b), Civil Monetary Penalty Statute (42 U.S.C. §  1320a-7a), the False Claims Act (31 U.S.C. § 3729 et seq.), comparable state statutes, the  regulations promulgated under all such statutes, and the regulations issued by the FDA,  consistent with the ‘Compliance Program Guidance for Pharmaceutical Manufacturers’  published by the Office of Inspector General, U.S. Department of Health and Human  Services;  8.3.9. [***];  8.3.10. Codex, its Affiliates, and to its knowledge all Third Parties and  Representatives acting on Codex’s behalf, have and will continue to comply with the laws  and regulations of the countries where it operates, including anti-bribery and anti- corruption laws, including, to the extent applicable, the U.S. Foreign Corrupt Practices Act  of 1977 and the U.K. Bribery Act 2010, accounting and record keeping laws, and laws  relating to interactions with healthcare professionals or healthcare providers and  Government Officials;  8.3.11. [***];  8.3.12. [***];  8.3.13. no Codex Technology existing as of the Effective Date is subject to any  funding agreement with any government or Governmental Authority;  8.3.14. [***];  8.3.15. there is no (a) claim, demand, suit, proceeding, arbitration, inquiry,  investigation or other legal action of any nature, civil, criminal, regulatory or otherwise,  pending or, to the best knowledge of Codex, threatened against Codex or any of its  Affiliates or (b) judgment or settlement against or owed by Codex or any of its Affiliates,  in each case with respect to the Codex Technology, the Current Licenses, or the Instrument,  or the transactions contemplated by this Agreement;  8.3.16. [***];  8.3.17. there are no Current Licenses and no Third Party has any right, title or  interest in or to, or any license under, any Codex Technology; and  8.3.18. the (a) conduct of the Research Plan by or on behalf of Codex, including  the use of the Initial Instrument and Initial Methods in the conduct of the Research Plan,  (b) use by or on behalf of Pfizer of the Initial Instruments and Initial Methods in the conduct  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  50    of the Research Plan and (c) the use by Codex or the authorized use by Pfizer of the  Deliverables, in each case ((a)-(c)), (x) does not and will not infringe any issued patent of  any Third Party or (y) will not infringe the claims of any published Third Party patent  application when and if such claims issue.  For purposes of this Section 8.3, “knowledge” means the actual knowledge of the individuals listed  in Schedule 8.3, after consulting with their direct reports.  8.4. Codex Covenants.  In addition to the covenants made by Codex elsewhere in this  Agreement, Codex hereby covenants to Pfizer that, from the Effective Date until expiration or  termination of this Agreement:  8.4.1. it shall not, and shall cause its Affiliates not to (a) exclusively license, sell,  assign or otherwise transfer (other than in a connection with a permitted assignment of this  Agreement by Codex pursuant to Section 12.1) to any Person (other than Pfizer or its  Affiliates or Sublicensees pursuant to the terms of this Agreement) any Codex Technology  (or agree to do any of the foregoing) or (b) incur or permit to exist, with respect to any  Codex Technology, any lien, encumbrance, charge, security interest, mortgage, liability,  assignment, grant of license or other Binding Obligation that is or would be inconsistent  with the licenses and other rights granted to Pfizer or its Affiliates under this Agreement;  8.4.2. [***];  8.4.3. it will (a) not enter into any Codex Third Party Agreement that adversely  affects (i) the rights granted to Pfizer, Pfizer’s Affiliates or Sublicensees hereunder or (ii)  Codex’s ability to fully perform its obligations hereunder; (b) not amend or otherwise  modify any Codex Third Party Agreement or consent or waive rights with respect thereto  in any manner that (i) adversely affects the rights granted to Pfizer or Pfizer’s Affiliates or  Sublicensees hereunder or (ii) Codex’s ability to fully perform its obligations hereunder;  (c) promptly furnish Pfizer with true and complete copies of all Codex Third Party  Agreements executed following the Effective Date and amendments thereto, in each case  which may be redacted with respect to matters unrelated to the Agreement (including the  rights and obligations hereunder); (d) remain, and cause its Affiliates to remain, in  compliance in all material respects with all Codex Third Party Agreements; and (e) furnish  Pfizer with copies of all notices received by Codex or its Affiliates of any alleged breach  or default by Codex or its Affiliates under any Codex Third Party Agreement within five  Business Days after receipt thereof;  8.4.4. it will not enter into or otherwise allow itself or its Affiliates to be subject  to any agreement or arrangement which limits the ownership or licensed rights of Pfizer or  its Affiliates with respect to, or limits the ability of Pfizer or its Affiliates to grant a license,  sublicense or access, or provide or provide access or other rights in, to or under, any  intellectual property right or material (including any Patent Right, Know-How or other data  or information), in each case, that would, but for such agreement or arrangement, be  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  51    included in the rights licensed or assigned to Pfizer or its Affiliates pursuant to this  Agreement; and  8.4.5. [***].  8.4.6. [***]  8.5. Pfizer Covenants.  In addition to the covenants made by Pfizer elsewhere in this  Agreement, Pfizer hereby covenants to Codex that, from the Effective Date until expiration or  termination of this Agreement:   8.5.1. [***]; and  8.5.2. [***].  8.6. Representation by Legal Counsel.  Each Party hereto represents that it has been  represented by legal counsel in connection with this Agreement and acknowledges that it has  participated in the drafting hereof.  In interpreting and applying the terms and provisions of this  Agreement, the Parties agree that no presumption shall exist or be implied against the Party which  drafted such terms and provisions.  8.7. Disclaimer.  THE FOREGOING REPRESENTATIONS AND WARRANTIES  OF EACH PARTY ARE IN LIEU OF ANY OTHER REPRESENTATIONS AND  WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF  MERCHANTABILITY OR ANY IMPLIED WARRANTIES OF FITNESS FOR A  PARTICULAR PURPOSE, ALL OF WHICH ARE HEREBY SPECIFICALLY EXCLUDED  AND DISCLAIMED.  9. TERM AND TERMINATION  9.1. Term.  The term of this Agreement (the “Term”) will commence on the Effective  Date and expire upon the expiration of the last to expire Royalty Term, unless this Agreement is  terminated earlier in accordance with this Section 9 or pursuant to Section 12.2.  9.2. Termination by Codex.  Codex may terminate this Agreement for cause, at any  time during the Term, by giving written notice to Pfizer in the event that Pfizer commits a material  breach of its obligations under this Agreement and such material breach remains uncured for [***]  days, measured from the date written notice of such material breach is given to Pfizer; provided,  however, that if any breach is not reasonably curable within [***] days and if Pfizer is making a  bona fide effort to cure such breach, such termination shall be delayed for a time period to be  agreed by both Parties  in order to permit Pfizer a reasonable period of time to cure such breach.   If the alleged material breach relates to non-payment of any amount due under this Agreement, the  cure period shall be tolled pending resolution of any bona fide dispute between the Parties as to  whether such payment is due.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  52    9.3. Termination by Pfizer.  9.3.1. Termination for Convenience.  Pfizer may (1) terminate this Agreement  in its entirety without cause, for any or no reason, upon at least [***] days prior written  notice to Codex or (2) it may terminate its exclusive license under Section 2.4 with respect  to either Exclusive Field, without cause, for any or no reason, upon at least [***] days prior  written notice to Codex.  9.3.2. Termination for Cause.  Pfizer may terminate (1) this Agreement in its  entirety for cause at any time during the Term or (2) its exclusive license under Section 2.4  with respect to either Exclusive Field, in each case ((1) and (2)), by giving written notice  to Codex, in the event that Codex commits a material breach of its obligations under this  Agreement and such material breach remains uncured for [***] days, measured from the  date written notice of such material breach is given to Codex; provided, however, that if  any breach is not reasonably curable within [***] days and if Codex is making a bona fide  effort to cure such breach, such termination shall be delayed for a time period to be agreed  by both Parties in order to permit Codex a reasonable period of time to cure such breach.  9.3.3. Termination for Global Trade Control Laws-related Breach.   Notwithstanding anything to the contrary in this Agreement, Pfizer may terminate this  Agreement in whole or relevant part, immediately and without regard to any cure period,  if, in Pfizer’s reasonable opinion, a violation of Global Trade Control Laws has occurred.   Any such termination will be deemed for cause under Section 9.2 or 9.3.2, under which  Pfizer will not be responsible for any related payments due, even if activities have already  occurred.  Codex will be responsible for reimbursing Pfizer for any payments due to Pfizer  under this Agreement that are specifically blocked due to violation of Global Trade Control  Laws.  9.3.4. Termination for Compliance with the Law-related Breach.  Pfizer may  terminate this Agreement pursuant to Section 9.3.2 if (a) Codex breaches any of its  representations or warranties set forth in Sections 8.3.7 through 8.3.10, or if Pfizer learns  that improper payments are being or have been made to Government Officials by Codex  with respect to services performed in connection with this Agreement.  Any such  termination will be deemed for cause under Section 9.3.2, under which Pfizer will not be  responsible for any related payments due, even if activities have already occurred.  9.4. Effects of Termination  9.4.1. Effect of Termination.  (a) Termination for Cause by Codex; Termination for Convenience by  Pfizer.    (i) Complete Termination.  In the event that Codex terminates  this Agreement in its entirety for cause pursuant to Section 9.2 or Pfizer  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  53    terminates this Agreement without cause pursuant to Section 9.3.1, except  as otherwise expressly provided herein, all rights and obligations of each  Party hereunder shall cease (including all rights and licenses and  sublicenses granted by either Party to the other Party hereunder).  (ii) Partial Termination.  In the event that Pfizer, pursuant to  Section 9.3.1(2), terminates its exclusive license under Section 2.4 with  respect to an Exclusive Field, the exclusive license with respect to such  Exclusive Field will terminate as of the effective date of such termination  and, at Pfizer’s request, such Exclusive Field will become a Non- Exclusive Field subject to the non-exclusive license in Section 2.2 of this  Agreement.  (b) Termination for Cause by Pfizer.  (i) Complete Termination.  (A) In the event that Pfizer terminates this Agreement  in its entirety pursuant to Section 9.3.2, except as otherwise  expressly provided herein, all other rights and obligations of each  Party with respect to all Products throughout the Territory shall  cease.  (B) [***].    (ii) Partial Termination.  (A) In the event that Pfizer, pursuant to Section  9.3.2(2), terminates its exclusive license under Section 2.4 with  respect to an Exclusive Field, the exclusive license with respect to  such Exclusive Field will terminate as of the effective date of such  termination and, at Pfizer’s request, such Exclusive Field will  become a Non-Exclusive Field subject to the non-exclusive license  in Section 2.2 of this Agreement.  (B) [***].  9.4.2. Accrued Rights.  Expiration or termination of this Agreement for any  reason shall be without prejudice to any right which shall have accrued to the benefit of  either Party prior to such termination, including damages arising from any breach under  this Agreement.  Expiration or termination of this Agreement shall not relieve either Party  from any obligation which is expressly indicated to survive such expiration or termination.  9.4.3. Survival.  The following sections, together with any sections that  expressly survive (including any perpetual licenses granted hereunder), shall survive  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  54    expiration or termination of this Agreement for any reason: Sections 1 (Definitions and  Interpretation), 2.5 (Unblocking License), 2.9 (No Implied Rights), 2.10 (Retained Rights),  3.9.4 (Record Keeping), 3.9.5 (Audits), 3.9.6 (Underpayments/Overpayments), 4.9.2  (Permitted Use of Pfizer Materials), 4.9.3 (Unauthorized Use of Pfizer Materials), 4.9.4  (Title to Pfizer Materials and Output Materials), 4.9.5 (Return of Pfizer Materials), 4.9.6  (Ownership of Pfizer Material Improvements and Output Materials), 4.9.7 (Activities),  4.9.8 (Confidentiality), 6.1 (Ownership of Intellectual Property), 7 (Confidentiality) (for  the period set forth therein), 9.4 (Effects of Termination), 9.5 (Provision for Insolvency),  10.1 (No Consequential Damages), 10.2 (Indemnification by Pfizer), 10.3 (Indemnification  by Codex), 10.4 (Procedure), and 12 (Miscellaneous).    9.5. Provision for Insolvency.  9.5.1. Termination Right.  Codex shall be deemed a “Debtor” under this  Agreement if, at any time during the Term (a) a case is commenced by or against Codex  under the Bankruptcy Code, (b) Codex files for or is subject to the institution of bankruptcy,  reorganization, liquidation or receivership proceedings (other than a case under the  Bankruptcy Code), (c) Codex assigns all or substantially all of its assets for the benefit of  creditors, (d) a receiver or custodian is appointed for Codex’s business or (e) substantially  all of Codex’s business is subject to attachment or similar process; provided, however, that  in the case of any involuntary case under the Bankruptcy Code, Codex shall not be deemed  a Debtor if the case is dismissed within [***] days after the commencement thereof.  If  Codex is deemed a Debtor, then Pfizer may terminate this Agreement by providing written  notice to Codex.  If Pfizer terminates this Agreement pursuant to this Section 9.5.1, then  (i) all licenses granted to Pfizer under this Agreement shall become irrevocable and  perpetual, (ii) Pfizer shall have no further obligations to Codex under this Agreement other  than [***].  9.5.2. Rights to Intellectual Property.  All rights and licenses now or hereafter  granted by Codex to Pfizer under or pursuant to any Section of this Agreement, including  Sections 2.1.1, 2.2 and, following the exercise of an Option pursuant to Section 2.4.2,  Section 2.4.3 hereof, are rights to “intellectual property” (as defined in the Bankruptcy  Code).  The Parties hereto acknowledge and agree that the payments provided for under  Sections 3.1, 3.2, 3.3 and 3.4 and all other payments by Pfizer to Codex hereunder, other  than royalty payments pursuant to Section 3.7, do not constitute royalties within the  meaning of Section 365(n) of the Bankruptcy Code or relate to licenses of intellectual  property hereunder.  If (a) a case under the Bankruptcy Code is commenced by or against  Codex, (b) this Agreement is rejected as provided in the Bankruptcy Code and (c) Pfizer  elects to retain its rights hereunder as provided in Section 365(n) of the Bankruptcy Code,  then Codex (in any capacity, including debtor-in-possession) and its successors and assigns  (including any trustee) shall provide to Pfizer all intellectual property licensed hereunder,  and agrees to grant and hereby grants to Pfizer and its Affiliates a right to access and to  obtain possession of and to benefit from and, in the case of any chemical or biological  material or other tangible item of which there is a fixed or limited quantity, to obtain a pro  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  55    rata portion of, each of the following to the extent related to any Output Material or Product  and the rights and licenses granted to Pfizer under or pursuant to this Agreement: (i) copies  of pre-clinical and clinical research data and results; (ii) all of the following (to the extent  that any of the following are so related): cell lines, antibodies, assays, reagents and other  biological materials; (iii) Product samples; (iv) Codex Technology, (v) laboratory notes  and notebooks; (vi) Product data or filings, and (vii) Rights of Reference in respect of  regulatory filings and approvals, all of which constitute “embodiments” of intellectual  property pursuant to Section 365(n) of the Bankruptcy Code, and (viii) all other  embodiments of such intellectual property, whether any of the foregoing are in Codex’s  possession or control or in the possession and control of any Third Party but which Codex  has the right to access or benefit from and to make available to Pfizer.  Codex shall not  interfere with the exercise by Pfizer or its Affiliates of rights and licenses to intellectual  property licensed hereunder and embodiments thereof in accordance with this Agreement  and agrees to use Commercially Reasonable Efforts to assist Pfizer and its Affiliates (at  Pfizer’s request) to obtain such intellectual property and embodiments thereof in the  possession or control of Third Parties as reasonably necessary or desirable for Pfizer or its  Affiliates or Sublicensees to exercise such Person’s rights and licenses in accordance with  this Agreement.  9.5.3. No Limitation of Rights.  All rights, powers and remedies of Pfizer  provided in this Section 9.5 are in addition to and not in substitution for any and all other  rights, powers and remedies now or hereafter existing at Law or in equity (including the  Bankruptcy Code) in the event of the commencement of a case under the Bankruptcy Code  involving Codex.  10. LIMITATION ON LIABILITY, INDEMNIFICATION AND INSURANCE.  10.1. No Consequential Damages.  Except with respect to liability arising from a breach  of Section 6 or 7, a breach by Codex of Section Error! Reference source not found., from any  willful misconduct or intentionally wrongful act, or to the extent such Party may be required to  indemnify the other Party under this Section 10, in no event will either Party or its Representatives  be liable under this Agreement for any special (only as related to indirect, incidental or  consequential damages), indirect, incidental, consequential or punitive damages, whether in  contract, warranty, tort, negligence, strict liability or otherwise, including loss of profits or revenue  suffered by the other Party or any of its Representatives.  Without  limiting the generality of the  foregoing, “consequential damages” will be deemed to include, and neither Party will be liable to  the other Party or any of such other Party’s Representatives or stockholders for any damages based  on or measured by loss of projected or speculative future sales of the Products, any Milestone  Payments due upon any unachieved Development Milestone under Section 3.3, any Sales  Milestone Payment due upon any unachieved Sales Milestones under Section 3.4, any unearned  royalties under Section 3.7 or any other unearned, speculative or otherwise contingent payments  provided for in this Agreement.  EXCEPT WITH RESPECT TO LIABILITY ARISING FROM  A BREACH OF SECTION 6 OR 7, A BREACH BY CODEX OF SECTION Error! Reference  source not found., FROM ANY WILLFUL MISCONDUCT OR INTENTIONALLY  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  56    WRONGFUL ACT OR OMISSION, OR TO THE EXTENT SUCH PARTY MAY BE  REQUIRED TO INDEMNIFY THE OTHER PARTY UNDER THIS SECTION 10, A PARTY’S  AGGREGATE LIABILITY UNDER OR IN CONNECTION WITH THIS AGREEMENT FOR  ANY CLAIM (INCLUDING RELATED LOSSES, COSTS OR DAMAGES OF ANY NATURE)  IN A GIVEN CALENDAR YEAR SHALL NOT EXCEED [***].  10.2. Indemnification by Pfizer.  Pfizer will indemnify, defend and hold harmless  Codex, each of its Affiliates, and each of its and its Affiliates’ employees, officers, directors and  agents (each, a “Codex Indemnified Party”) from and against any and all claims, causes, or  allegations (whether threatened or pending), judgments, expenses, damages, liabilities,  obligations, fees (including the reasonable fees of attorneys and other consulting or testifying  professionals), costs and losses (collectively, “Liabilities”) that the Codex Indemnified Party is  required to pay to one or more Third Parties resulting from or arising out of:  10.2.1. the Development, Manufacture, Commercialization or use of any Product  by, on behalf of, or under the authority of Pfizer, its Affiliates or Sublicensees (other than  by any Codex Indemnified Party) except to the extent that such Liabilities arise from a  claim that the practice of the Codex Technology infringes or misappropriates any issued  patent or other proprietary right owned or possessed by any Third Party or any breach by  Codex of any representations, warranties or covenants pursuant to this Agreement;  10.2.2. the material breach by Pfizer of any of its representations, warranties or  covenants set forth in Section 8.1 or 8.2; or  10.2.3. the gross negligence, recklessness or intentional acts of Pfizer or any  Pfizer Indemnified Party;  except, in each case, to the extent caused by the gross negligence, recklessness or  intentionally wrongful acts of Codex or any Codex Indemnified Party.  10.3. Indemnification by Codex.  Codex will indemnify, defend and hold harmless  Pfizer, and each of its Affiliates, Sublicensees, permitted contractors, and distributors, and each of  Pfizer’s and their respective employees, officers, directors and agents (each, a “Pfizer  Indemnified Party”) from and against any and all Liabilities that the Pfizer Indemnified Party is  required to pay to one or more Third Parties resulting from or arising out of:  10.3.1. the material breach by Codex of any of its representations, warranties or  covenants set forth in Section 8.1, Section 8.2, Section 8.3 (except with respect to Section  8.3.18) or Section 8.4;   10.3.2. the breach by Codex of Section 8.3.18; or  10.3.3. the gross negligence, recklessness or intentional acts of Codex or any  Codex Indemnified Party;  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  57    except, in each case, to the extent caused by the gross negligence, recklessness or intentionally  wrongful acts of Pfizer or any Pfizer Indemnified Party.  10.4. Procedure.  10.4.1. Notice.  Each Party will notify the other Party in writing in the event it  becomes aware of a claim for which indemnification may be sought hereunder.  In the  event that any Third Party asserts a claim or other proceeding (including any governmental  investigation) with respect to any matter for which a Party (the “Indemnified Party”) is  entitled to indemnification hereunder (a “Third Party Claim”), then the Indemnified Party  shall promptly notify the Party obligated to indemnify the Indemnified Party (the  “Indemnifying Party”) thereof; provided, however, that no delay on the part of the  Indemnified Party in notifying the Indemnifying Party shall relieve the Indemnifying Party  from any obligation hereunder unless (and then only to the extent that) the Indemnifying  Party is prejudiced thereby.  10.4.2. Control.  Subject to Pfizer’s right to control any actions described in  Section 6.3.3 (even where Codex is the Indemnifying Party), the Indemnifying Party shall  have the right, exercisable by notice to the Indemnified Party within [***] after receipt of  notice from the Indemnified Party of the commencement of or assertion of any Third Party  Claim, to assume direction and control of the defense, litigation, settlement, appeal or other  disposition of the Third Party Claim (including the right to settle the claim solely for  monetary consideration) with counsel selected by the Indemnifying Party and reasonably  acceptable to the Indemnified Party; provided that (a) the Indemnifying Party has sufficient  financial resources, in the reasonable judgment of the Indemnified Party, to satisfy the  amount of any adverse monetary judgment that is sought, (b) the Third Party Claim seeks  solely monetary damages and (c) the Indemnifying Party expressly agrees in writing that  as between the Indemnifying Party and the Indemnified Party, the Indemnifying Party shall  be solely obligated to satisfy and discharge the Third Party Claim in full (the conditions set  forth in clauses (a), (b) and (c) above are collectively referred to as the “Litigation  Conditions”).  Within [***] after the Indemnifying Party has given notice to the  Indemnified Party of its exercise of its right to defend a Third Party Claim, the Indemnified  Party shall give notice to the Indemnifying Party of any objection thereto based upon the  Litigation Conditions.  If the Indemnified Party reasonably so objects, the Indemnified  Party shall continue to defend the Third Party Claim, at the expense of the Indemnifying  Party, until such time as such objection is withdrawn.  If no such notice is given, or if any  such objection is withdrawn, the Indemnifying Party shall be entitled, at its sole cost and  expense, to assume direction and control of such defense, with counsel selected by the  Indemnifying Party and reasonably acceptable to the Indemnified Party.  During such time  as the Indemnifying Party is controlling the defense of such Third Party Claim, the  Indemnified Party shall cooperate, and shall cause its Affiliates and agents to cooperate  upon request of the Indemnifying Party, in the defense or prosecution of the Third Party  Claim, including by furnishing such records, information and testimony and attending such  conferences, discovery proceedings, hearings, trials or appeals as may reasonably be  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  58    requested by the Indemnifying Party.  In the event that the Indemnifying Party does not  satisfy the Litigation Conditions or does not notify the Indemnified Party of the  Indemnifying Party’s intent to defend any Third Party Claim within ten Business Days  after notice thereof, the Indemnified Party may (without further notice to the Indemnifying  Party) undertake the defense thereof with counsel of its choice and at the Indemnifying  Party’s expense (including reasonable, out-of-pocket attorneys’ fees and costs and  expenses of enforcement or defense).  The Indemnifying Party or the Indemnified Party,  as the case may be, shall have the right to join in (including the right to conduct discovery,  interview and examine witnesses and participate in all settlement conferences), but not  control, at its own expense, the defense of any Third Party Claim that the other Party is  defending as provided in this Agreement.  10.4.3. Settlement.  The Indemnifying Party shall not, without the prior written  consent of the Indemnified Party, enter into any compromise or settlement that commits  the Indemnified Party to take, or to forbear to take, any action.  The Indemnified Party shall  have the sole and exclusive right to settle any Third Party Claim, on such terms and  conditions as it deems reasonably appropriate, to the extent such Third Party Claim  involves equitable or other non-monetary relief to be provided solely by the Indemnified  Party, but shall not have the right to settle such Third Party Claim to the extent such Third  Party Claim involves monetary damages without the prior written consent of the  Indemnifying Party. Each of the Indemnifying Party and the Indemnified Party shall not  make any admission of liability in respect of any Third Party Claim without the prior  written consent of the other Party, and the Indemnified Party shall use reasonable efforts  to mitigate Liabilities arising from such Third Party Claim.  10.5. Insurance.  Each Party further agrees to obtain and maintain, during the Term,  commercial general liability insurance, including products liability insurance, with reputable and  financially secure insurance carriers to cover its indemnification obligations under Section 10.2 or  Section 10.3, as applicable, in each case with limits of not less than [***] per occurrence and in  the aggregate.  Insurance shall be procured with carriers having an A.M. Best Rating of A-VII or  better.  Notwithstanding any provision of this Section 10.5 to the contrary, either Party may meet  its obligations under this Section 10.5 through self-insurance at such described limits above.   Neither Party’s insurance will be construed to create a limit of liability with respect to its  indemnification obligations under this Section 10.  11. ANTI-BRIBERY/ANTI-CORRUPTION.  11.1. Foreign Corrupt Practices Act.  Codex will comply with the U.S. Foreign Corrupt  Practices Act of 1977 (as may be amended or revised from time-to-time) and the principles relating  thereto, as stated in Exhibit C to this Agreement, which is attached hereto and incorporated by  reference herein.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  59    11.2. Representations and Warranties.  Codex hereby represents and warrants that:  11.2.1. It is licensed, registered, or qualified under local law, regulations, policies,  and administrative requirements to do business and, to the extent required by applicable  Law, has obtained licenses or completed such registrations as may be necessary or required  by Law to provide the goods or services encompassed within this Agreement (including,  without limitation, Exhibit C);  11.2.2. It has not and will not directly or indirectly offer or pay, or authorize such  offer or payment, of any money or anything of value to improperly or corruptly seek to  influence any Government Official (as such term is defined under Exhibit C), and, if Codex  is itself a Government Official, has not accepted, and will not accept in the future, such a  payment; and  11.2.3. All information provided by Codex during Pfizer’s pre-contractual due  diligence, including all information provided in the “Third Party Entity Due Diligence  Questionnaire,” is complete, truthful and accurate.  11.2.4. It undertakes to update these representations or warranties if (during the  Term) Codex becomes aware, or should have become aware, that Codex, or any of the  employees or individuals who will be primarily responsible for performing under this  Agreement, or a relative of such an employee or individual, becomes a Government  Official or if a Governmental Authority or Government Official becomes an owner of  Codex.    11.3. Audit by Pfizer.  Codex shall permit, during the Term and for three years after  final payment has been made under this Agreement, Pfizer’s internal and external auditors' access  to any relevant books, documents, papers, and records of Codex involving transactions or activities  related to this Agreement.  12. MISCELLANEOUS.  12.1. Assignment.  Neither this Agreement nor any interest hereunder shall be assignable  by a Party without the prior written consent of the other Party, except as follows: (a) subject to the  provisions of Section 12.2, as applicable, a Party may assign its rights and obligations under this  Agreement by way of sale of itself or the sale of the portion of its business to which this Agreement  relates, through merger, sale of assets and/or sale of stock or ownership interest, provided that the  assignee shall expressly agree to be bound by such Party’s obligations under this Agreement and  that such sale is not primarily for the benefit of its creditors and (b) such Party may assign its rights  and obligations under this Agreement to any of its Affiliates, provided that the assignee shall  expressly agree to be bound by such Party’s obligations under this Agreement and that such Party  shall remain liable for all of its rights and obligations under this Agreement.  In addition, Pfizer  may assign its rights and obligations under this Agreement to a Third Party where Pfizer or its  Affiliate is required, or makes a good faith determination based on advice of counsel, to divest a  Product in order to comply with Law or the order of any Governmental Authority as a result of a  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  60    merger or acquisition, provided that the assignee shall expressly agree to be bound by Pfizer’s  obligations under this Agreement.  Each Party shall promptly notify the other Party of any  assignment or transfer under the provisions of this Section 12.1.  This Agreement shall be binding  upon the successors and permitted assigns of the Parties and the name of a Party appearing herein  shall be deemed to include the names of such Party’s successors and permitted assigns to the extent  necessary to carry out the intent of this Agreement.  Any assignment not in accordance with this  Section 12.1 shall be void.  12.2. Change of Control of Codex.  Codex shall notify Pfizer in writing promptly (and  in any event within [***]) following the entering into of a definitive agreement with respect to a  Change of Control of Codex.  12.3. Further Actions.  Each Party agrees to execute, acknowledge and deliver such  further instruments, and to do all such other acts, as may be necessary or appropriate in order to  carry out the express purposes and intent of this Agreement.  12.4. Force Majeure.  Each Party shall be excused from the performance of its  obligations under this Agreement to the extent that such performance is prevented by force majeure  (defined below) and the nonperforming Party promptly provides notice of the prevention to the  other Party.  Such excuse shall be continued so long as the condition constituting force majeure  continues and the nonperforming Party takes Commercially Reasonable Efforts to remove the  condition.  For purposes of this Agreement, “force majeure” shall include conditions beyond the  control of the Parties, including an act of God, voluntary or involuntary compliance with any  regulation, Law or order of any government, war, act of terror, civil commotion, labor strike or  lock-out, epidemic, failure or default of public utilities or common carriers, destruction of  production facilities or materials by fire, earthquake, storm or like catastrophe.  12.5. Notices.  Any notice or notification required or permitted to be provided pursuant  to the terms and conditions of this Agreement (including any notice of force majeure, breach,  termination, change of address, etc.) shall be in writing and shall be deemed given upon receipt if  delivered personally or by facsimile transmission (receipt verified), five days after deposited in the  mail if mailed by registered or certified mail (return receipt requested) postage prepaid, or on the  next Business Day if sent by overnight delivery using a nationally recognized express courier  service and specifying next Business Day delivery (receipt verified), to the Parties at the following  addresses or facsimile numbers (or at such other address or facsimile number for a Party as shall  be specified by like notice, provided, however, that notices of a change of address shall be effective  only upon receipt thereof):  All correspondence to Pfizer shall be addressed as follows:  Pfizer Inc.  Notices: R&D Business Development  235 East 42nd Street  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  61    New York, NY 10017  Attn.: R&D BD Contract Notice  with a copy to:  Pfizer Inc.  Notices: Pfizer Legal Division  235 East 42nd Street  New York, NY 10017  Attn.: Chief Counsel, R&D   Fax: [***]  and electronic copies to:  [***]  All correspondence to Codex shall be addressed as follows:  CODEX DNA, Inc.  9535 Waples St, Suite 10  San Diego, CA 92121  Attention: Legal Department  12.6. Amendment.  No amendment, modification or supplement of any provision of this  Agreement shall be valid or effective unless made in writing and signed by a duly authorized  officer of each Party.  12.7. Waiver.  No provision of this Agreement shall be waived by any act, omission or  knowledge of a Party or its agents or employees except by an instrument in writing expressly  waiving such provision and signed by a duly authorized officer of the waiving Party.  The waiver  by either of the Parties of any breach of any provision hereof by the other Party shall not be  construed to be a waiver of any succeeding breach of such provision or a waiver of the provision  itself.  12.8. Severability.  If any clause or portion thereof in this Agreement is for any reason  held to be invalid, illegal or unenforceable, the same shall not affect any other portion of this  Agreement, as it is the intent of the Parties that this Agreement shall be construed in such fashion  as to maintain its existence, validity and enforceability to the greatest extent possible.  In any such  event, this Agreement shall be construed as if such clause of portion thereof had never been  contained in this Agreement, and there shall be deemed substituted therefor such mutually agreed  provision as will most nearly carry out the intent of the Parties as expressed in this Agreement to  the fullest extent permitted by applicable Law.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  62    12.9. Descriptive Headings.  The descriptive headings of this Agreement are for  convenience only and shall be of no force or effect in construing or interpreting any of the  provisions of this Agreement.  12.10. Global Trade Control Laws.  The Parties acknowledge that certain activities  covered by or performed under this Agreement may be subject to laws, regulations or orders  regarding economic sanctions, import controls or export controls (“Global Trade Control  Laws”).  Each of the Parties will perform all activities under this Agreement in compliance with  all applicable Global Trade Control Laws.  Furthermore, with respect to the activities performed  under this Agreement, each of the Parties represents, warrants and covenants that:  12.10.1. Each Party will not, for activities under this Agreement, (i) engage in any  such activities in a Restricted Market; (ii) involve individuals ordinarily resident in a  Restricted Market; or (iii) include companies, organizations, Governmental Authorities or  Government Officials from or located in a Restricted Market.  “Restricted Market” for  purposes of this Agreement means the Crimean Peninsula, Cuba, the Donbass Region, Iran,  North Korea, Sudan, and Syria, or any other country or region sanctioned by the United  States or European Union.  12.10.2. Each Party represents and warrants that it is not a Restricted Party and is  not owned or controlled by a Restricted Party.  With respect to activities performed under  this Agreement, neither Party will engage or delegate to any Restricted Parties for any  activities under this Agreement.  Each Party will screen all relevant Third Parties involved  by such Party in the activities under this Agreement under the relevant Restricted Party  Lists.  “Restricted Parties” for purposes of this Agreement means any individual or entity  on any of the following “Restricted Party Lists”: the list of sanctioned entities maintained  by the United Nations; the Specially Designated Nationals List and the Sectoral Sanctions  Identifications List of the U.S. Treasury Department’s Office of Foreign Assets Control;  the U.S. Denied Persons List, the U.S. Entity List, and the U.S. Unverified List of the U.S.  Department of Commerce; entities subject to restrictive measures and the Consolidated  List of Persons, Groups and Entities Subject to E.U. Financial Sanctions, as implemented  by the E.U. Common Foreign & Security Policy; the List of Excluded Individuals / Entities  published by the U.S. Health and Human Services’ Office of Inspector General; any lists  of prohibited or debarred parties established under the U.S. Federal Food Drug and  Cosmetic Act; the list of parties suspended or debarred from contracting with the U.S.  government; and similar lists of restricted parties maintained by the Governmental  Authorities of the countries that have jurisdiction over the activities conducted under this  Agreement.  12.10.3. Neither Party will knowingly transfer to the other Party any goods,  software, technology or services that are (i) controlled under the U.S. International Traffic  in Arms Regulations or at a level other than EAR99 under the U.S. Export Administration  Regulations; or (ii) specifically identified as an E.U. Dual Use Item or on an applicable  export control list of another country.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  63    12.11. Export Control.  This Agreement is made subject to any restrictions concerning  the export of products or technical information from the United States of America or other  countries which may be imposed upon or related to Codex or Pfizer from time to time.  Each Party  agrees that it will not export, directly or indirectly, any technical information acquired from the  other Party under this Agreement or any products using such technical information to a location  or in a manner that at the time of export requires an export license or other governmental approval,  without first obtaining the written consent to do so from the appropriate agency or other  governmental entity.  12.12. Dispute Resolution.  If any dispute or disagreement arises between Pfizer and  Codex in respect of this Agreement that is not within the scope of the JRC’s decision-making  authority as provided in Section 4.4 (all such disputes that are not within the scope of the JRC’s  decision-making authority would include disputes arising with respect to the interpretation,  enforcement, termination or invalidity of this Agreement), they shall follow the following  procedures in an attempt to resolve the dispute or disagreement:  12.12.1. The 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.  12.12.2. Within [***] of receipt of a Notice of Dispute, the Pfizer Program Director  and the Codex Program Director shall meet in person or by teleconference and exchange  written summaries reflecting, in reasonable detail, the nature and extent of the dispute, and  at this meeting they shall use their reasonable endeavors to resolve the dispute.  12.12.3. If the Program Directors are unable to resolve the dispute during the  meeting described in Section 12.12.2 or if for any reason such meeting does not take place  within the period specified in Section 12.12.2, then the Chief Scientific Officer of Viral  Vaccines Research of Pfizer and the Chief Executive Officer of Codex shall meet at a  mutually agreed-upon time and location for the purpose of resolving such dispute.  12.12.4. If, within a further period of [***], or if in any event within [***] of initial  receipt of the Notice of Dispute, the dispute has not been resolved, or if, for any reason,  the meeting described in Section 12.12.3 has not been held within [***] of initial receipt  of the Notice of Dispute, then the Parties agree that either Party may initiate litigation to  resolve the dispute.  Notwithstanding any provision of this Agreement to the contrary, either Party may immediately  initiate litigation in any court of competent jurisdiction seeking any remedy at law or in equity,  including the issuance of a preliminary, temporary or permanent injunction, to preserve or enforce  its rights under this Agreement.  The provisions of this Section 12.12 will survive the termination  or expiration of this Agreement.  12.13. Governing Law.  This Agreement, and all claims arising under or in connection  therewith, shall be governed by and interpreted in accordance with the substantive laws of the State  of New York, without regard to conflict of law principles thereof.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  64    12.14. Consent to Jurisdiction.  Each Party to this Agreement hereby (a) irrevocably  submits to the exclusive jurisdiction of the state courts of the State of New York or the United  States District Court for the Southern District of New York for the purpose of any and all actions,  suits or proceedings arising in whole or in part out of, related to, based upon or in connection with  this Agreement or the subject matter hereof, (b) waives to the extent not prohibited by applicable  Law, and agrees not to assert, by way of motion, as a defense or otherwise, in any such action, any  claim that it is not subject personally to the jurisdiction of the above-named courts, that its property  is exempt or immune from attachment or execution, that any such action brought in one of the  above-named courts should be dismissed on grounds of forum non conveniens, should be  transferred to any court other than one of the above-named courts, or should be stayed by reason  of the pendency of some other proceeding in any other court other than one of the above-named  courts, or that this Agreement or the subject matter hereof may not be enforced in or by such court,  and (c) agrees not to commence any such action other than before one of the above-named courts  nor to make any motion or take any other action seeking or intending to cause the transfer or  removal of any such action to any court other than one of the above-named courts whether on the  grounds of inconvenient forum or otherwise.  12.15. Entire Agreement.  This Agreement constitutes and contains the complete, final  and exclusive understanding and agreement of the Parties and cancels and supersedes any and all  prior negotiations, correspondence, understandings and agreements, whether oral or written,  between the Parties respecting the subject matter hereof and thereof, including that certain Non- Disclosure Agreement between the Parties [***], which is hereby terminated effective as of the  Effective Date, provided that all confidential or proprietary information exchanged between the  Parties under such Non-Disclosure Agreement will be deemed to have been disclosed under this  Agreement and shall be subject to the terms and conditions of this Agreement.  12.16. Independent Contractors.  Both Parties are independent contractors under this  Agreement.  Nothing herein contained shall be deemed to create an employment, agency, joint  venture or partnership relationship between the Parties hereto or any of their agents or employees,  or any other legal arrangement that would impose liability upon one Party for the act or failure to  act of the other Party.  Neither Party shall have any express or implied power to enter into any  contracts or commitments or to incur any liabilities in the name of, or on behalf of, the other Party,  or to bind the other Party in any respect whatsoever.  12.17. Counterparts.  This Agreement may be executed in two counterparts, each of  which shall be an original and both of which shall constitute together the same document.   Counterparts may be signed and delivered by facsimile or digital (e.g., PDF) file, each of which  shall be binding when received by the applicable Party.  12.18. No Third Party Rights or Obligations.  No provision of this Agreement shall be  deemed or construed in any way to result in the creation of any rights or obligation in any Person  not a Party to this Agreement.  However, Pfizer may decide, in its sole discretion, to use one or  more of its Affiliates to perform its obligations and duties hereunder, provided that Pfizer shall  remain liable hereunder for the performance by any such Affiliates of any such obligations.  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  65    (Signature page follows.)     

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.  66        IN WITNESS WHEREOF, an authorized representative of each Party duly executed this  Agreement as of the Effective Date to be effective as of the Effective Date.  PFIZER INC.    CODEX DNA, Inc.      By___[***]________________________      By_[***]____    Name:  Title:    Name:  Title:  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it is  not material and is of the type that the registrant treats as private and confidential.  67       Exhibit A  Codex Patent Rights Existing as of the Effective Date    [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it is  not material and is of the type that the registrant treats as private and confidential.  68    [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]    [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it is  not material and is of the type that the registrant treats as private and confidential.  69    [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]    [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it is  not material and is of the type that the registrant treats as private and confidential.  70    [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]    [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it is  not material and is of the type that the registrant treats as private and confidential.  71    [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]          [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it is  not material and is of the type that the registrant treats as private and confidential.  72    [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]    [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***]  [***] [***]  [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***]  [***]  [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it is  not material and is of the type that the registrant treats as private and confidential.  73    [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***]  [***]  [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***]  [***]  [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]     [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** [***] [***] [***] [***]  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it is  not material and is of the type that the registrant treats as private and confidential.  74    *]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it is  not material and is of the type that the registrant treats as private and confidential.  75    [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]        [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it is  not material and is of the type that the registrant treats as private and confidential.  76    [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]           [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it is  not material and is of the type that the registrant treats as private and confidential.  77    [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]           [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it is  not material and is of the type that the registrant treats as private and confidential.  78    [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]            [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it is  not material and is of the type that the registrant treats as private and confidential.  79    [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it is  not material and is of the type that the registrant treats as private and confidential.  80    [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]      [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  

 

Exhibit 10.21  Certain identified information marked with [***] has been excluded from this exhibit because it is  not material and is of the type that the registrant treats as private and confidential.  81    [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]  [***] [***] [** *]  [***] [***] [***] [***]    [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***] [***]  

 

Exhibit 10.21    Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.    Exhibit B  Research Plan  • [***].    [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***]  [***] [***] [***] [***] [***] [***]      Exhibit C   Pfizer Anti-Bribery and Anti-Corruption Principles   Pfizer has a longstanding corporate policy that prohibits colleagues or anyone acting on  our behalf from providing any payment or benefit to any person or entity in order to improperly  influence a government official or to gain an unfair business advantage.  Pfizer is committed to  performing with integrity, and acting ethically and legally in accordance with all applicable laws  and regulations, including, but not limited to, anti-bribery and anti-corruption laws.  We expect  the same commitment from the consultants, agents, representatives or other companies and  individuals acting on our behalf (“Business Associates”), as well as those acting on behalf of  Business Associates, in connection with work for Pfizer.  Bribery of Government Officials  Most countries have laws that forbid making, offering or promising any payment or  anything of value (directly or indirectly) to a government official when the payment is intended to  influence an official act or decision to award or retain business.  Under Pfizer’s policies,  

 

Exhibit 10.21    Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.    “government official” is broadly interpreted and includes:(i) any elected or appointed government  official (e.g., a member of a ministry of health); (ii) any employee or person acting for or on behalf  of a government official, agency, or enterprise performing a governmental function; (iii) any  political party, candidate for public office, officer, employee, or person acting for or on behalf of  a political party or candidate for public office; or (iv) an employee or person acting for or on behalf  of a public international organization (e.g., the United Nations).  “Government” is meant to include  all levels and subdivisions of governments (i.e., local, regional, or national and administrative,  legislative, or executive).  Because this definition of “government official” is so broad, it is likely  that Business Associates will interact with a government official in the ordinary course of their  business on behalf of Pfizer.  For example, doctors employed by government-owned hospitals  would be considered “government officials” under Pfizer’s policies.  The U.S. Foreign Corrupt Practices Act of 1977 (the “FCPA”) prohibits making,  promising, or authorizing the making of a payment or providing anything of value to a non-U.S.  government official to improperly or corruptly induce that official to make any governmental act  or decision to assist a company in obtaining or retaining business, or to otherwise obtain an  improper advantage.  The FCPA also prohibits a company or person from using another company  or individual to engage in any of the foregoing activities.  As a U.S. company, Pfizer must comply  with the FCPA and could be held liable as a result of acts committed anywhere in the world by a  Business Associate.  Anti-Bribery and Anti-Corruption Principles Governing Interactions with Governments  and Government Officials   Business Associates must communicate and abide by the following principles with regard  to their interactions with governments and government officials:  • Business Associates, and those acting on their behalf in connection with work for  Pfizer, may not directly or indirectly make, promise, or authorize the making of a  corrupt payment or provide anything of value to any government official to induce  that government official to make any governmental act or decision to help Pfizer  obtain or retain business.  Business Associates, and those acting on their behalf in  connection with work for Pfizer, may never make a payment to or offer a  government official any item or benefit, regardless of value, as an improper  inducement for such government official to approve, reimburse, prescribe, or  purchase a Pfizer product, to influence the outcome of a clinical trial, or otherwise  improperly to benefit Pfizer’s business activities.  • Business Associates, and those acting on their behalf in connection with work for  Pfizer, need to understand whether local laws, regulations, or operating procedures  (including requirements imposed by government entities such as government- owned hospitals or research institutions) impose any limits, restrictions, or  disclosure requirements on compensation, financial support, donations, or gifts that  may be provided to government officials.  Business Associates, and those acting on  their behalf in connection with work for Pfizer, must take into account and comply  with any applicable restrictions in conducting their Pfizer-related activities.  If a  Business Associate is uncertain as to the meaning or applicability of any identified  

 

Exhibit 10.21    Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.    limits, restrictions, or disclosure requirements with respect to interactions with  government officials, that Business Associate should consult with his or her  primary Pfizer contact before undertaking their activities.  • Business Associates, and those acting on their behalf in connection with work for  Pfizer, are not permitted to offer facilitation payments.  A “facilitation payment” is  a nominal, unofficial payment to a government official for the purpose of securing  or expediting the performance of a routine, non-discretionary governmental action.   Examples of facilitation payments include payments to expedite the processing of  licenses, permits or visas for which all paperwork is in order.  In the event that a  Business Associate, or someone acting on their behalf in connection with work for  Pfizer, receives or becomes aware of a request or demand for facilitation payment  or bribe in connection with work for Pfizer, the Business Associate shall report such  request or demand promptly to his or her primary Pfizer contact before taking any  further action.  Commercial Bribery  Bribery and corruption can also occur in non-government, business to business  relationships.  Most countries have laws which prohibit offering, promising, giving, requesting,  receiving, accepting, or agreeing to accept money or anything of value in exchange for an improper  business advantage.  Examples of prohibited conduct could include, but are not limited to, the  provision of inappropriate gifts or hospitality, kickbacks, or investment opportunities offered to  improperly induce the purchase of goods or services.  Pfizer colleagues are not permitted to offer,  give, solicit or accept bribes, and we expect our Business Associates, and those acting on their  behalf in connection with work for Pfizer, to abide by the same principles.  Anti-Bribery and Anti-Corruption Principles Governing Interactions with Private Parties  and Pfizer Colleagues  Business Associates, and those acting on their behalf in connection with work for Pfizer,  may not directly or indirectly make, promise, or authorize the making of a corrupt payment or  provide anything of value to any person to induce that person to provide an unlawful business  advantage for Pfizer.  • Business Associates, and those acting on their behalf in connection with work for  Pfizer, may not directly or indirectly make, promise, or authorize the making of a  corrupt payment or provide anything of value to any person to induce that person  to provide an unlawful business advantage for Pfizer.  • Business Associates, and those acting on their behalf in connection with work for  Pfizer, may not directly or indirectly, solicit, agree to accept or receive a payment  or anything of value as an improper inducement in connection with their business  activities performed for Pfizer.  Pfizer colleagues are not permitted to receive gifts, services, perks, entertainment, or other  items of more than token or nominal monetary value from Business Associates, and those acting  

 

Exhibit 10.21    Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.    on their behalf in connection with work for Pfizer.  Moreover, gifts of nominal value are only  permitted if they are received on an infrequent basis and only at appropriate occasions.  Reporting Suspected or Actual Violations  Business Associates, and those acting on their behalf in connection with work for Pfizer,  are expected to raise concerns related to potential violations of these International Anti-Bribery  and Anti-Corruption Principles or the law.  Such reports can be made to a Business Associate’s  primary point of contact at Pfizer, or if a Business Associate prefers, to Pfizer’s Compliance Group  by e-mail at corporate.compliance@pfizer.com or by phone at 1-212-733-3026.     

 

Exhibit 10.21    Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.    Schedule 3.7  Sample Royalty Calculation    [***]     

 

Exhibit 10.21    Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.    Schedule 7.5.1  Press Release  [***]               

 

Exhibit 10.21    Certain identified information marked with [***] has been excluded from this exhibit because it  is not material and is of the type that the registrant treats as private and confidential.    Schedule 8.3  [***] [***]

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