Document:

dvax-ex101_313.htm

Exhibit 10.1

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

 

First Amendment to Agreement

 

This First Amendment to Agreement (“First Amendment”) is entered into as of the date of last signature by and between Coalition for Epidemic Preparedness Innovations, having an address of PO Box 123, Torshov, N-0412 Oslo, Norway (“CEPI”), and Dynavax Technologies Corporation, having an address of 2100 Powell Street, Suite 900, Emeryville, CA 94608, USA (“Dynavax”).  Each of CEPI and Dynavax is referred to herein individually as a “Party” and are collectively referred to herein as the “Parties.”

Recitals

Whereas, CEPI and Dynavax are parties to that certain Agreement dated January 29, 2021 (the “Agreement”), pursuant to which, among other things, CEPI agreed to advance an interest-free, forgivable, unsecured loan to Dynavax to cover the costs of at risk manufacture of specified quantities of the CpG 1018 adjuvant and to reserve such quantities for purchase by CEPI Partners for use in development and manufacturing of vaccines against COVID‐19; 

Whereas, CEPI has exercised the Option and the First Right (as such terms are defined in the Agreement); and

Whereas, the Parties now wish to amend the Agreement to provide for an increase to the Loan Amount (as defined herein) and to reserve specified additional quantities of the CpG 1018 adjuvant for purchase by CEPI Partners; in each case, on the terms and subject to the conditions set forth in the Agreement, as amended by this First Amendment. 

Agreement

Now, Therefore, in consideration of the foregoing premises and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

1.Defined Terms.  Capitalized terms used but not otherwise defined in this First Amendment shall have the meanings set forth in the Agreement.  As used in the Agreement and this First Amendment, the following terms shall have the meanings set forth below. 

(a)“Amended Agreement” shall mean the Agreement, as amended by this First Amendment.

(b)“Dynavax CMO” shall mean (a) the third party contract manufacturer engaged by Dynavax to manufacture Dynavax Adjuvant as of the Effective Date (“CMO 1”) or (b) the additional third party contract manufacturer engaged by Dynavax to manufacture Dynavax Adjuvant as of the First Amendment Date (“CMO 2”). 

(c)“Extra Loan Amount” shall have the meaning set forth in Section 3.1(b) of the Agreement, as such Section 3.1(b) has been amended by this First Amendment. 

 

 

(d)“Extra Manufacturing Cost” shall mean the total manufacturing cost of the Extra Reserved Material, based on an Extra Manufacturing Cost per kilogram of US$[***]. 

(e)“Extra Reserved Material” shall have the meaning set forth in paragraph 3 of this First Amendment. 

(f)“First Amendment Date” shall mean the date when this First Amendment has been signed by both Parties or, if both Parties signed this First Amendment on different dates, the date on which the last Party has signed this First Amendment.

(g)“Loan Amount” shall mean the sum of (i) the Initial Loan Amount, (ii) the Additional Loan Amount, and (iii) the Extra Loan Amount. 

(h)“Reserved Material” shall mean the Initial Reserved Material, the Additional Reserved Material and the Extra Reserved Material. 

2.Exercise of Option.  The Parties acknowledge that CEPI exercised the Option in accordance with Section 2.1(b) of the Agreement.  Subject to the terms and conditions of the Amended Agreement, and in consideration for CEPI advancing the Additional Loan Amount in accordance with Section 3.1(a) of the Agreement, Dynavax shall use commercially reasonable efforts to have manufactured the Additional Reserved Material for release during Q4 2021.  CEPI’s obligation to advance the Additional Loan Amount in accordance with Section 3.1(a) of the Agreement is firm as of the First Amendment Date and shall not be subject to termination or cancellation.  

3.Exercise of First Right.  The Parties acknowledge that CEPI has exercised the First Right in accordance with Section 2.1(c) of the Agreement.  Subject to the terms and conditions of the Amended Agreement, and in consideration for CEPI advancing the Extra Loan Amount in accordance with Section 3.1(b) of the Agreement (as such Section 3.1(b) has been amended by this First Amendment), Dynavax shall use commercially reasonable efforts to have manufactured an extra [***] kg of Dynavax Material (the “Extra Reserved Material”) for release in Q4 2021.  CEPI’s obligation to advance the Extra Loan Amount in accordance with Section 3.1(b) of the Agreement (as such Section 3.1(b) has been amended by this First Amendment) is firm as of the First Amendment Date and shall not be subject to termination or cancellation.  

2.

 

4.Extra Loan Amount.  Section 3.1(b) of the Agreement is hereby amended and restated to read in its entirety as follows:

“Extra Loan Amount.  Effective as of the First Amendment Date, CEPI shall make available to Dynavax an interest-free, forgivable, unsecured loan for a sum equivalent to the Extra Manufacturing Cost (the “Extra Loan Amount”), which shall be advanced by CEPI to Dynavax in two installments, upon receipt of a Loan Drawdown Notice for each such installment, as follows:  

						
	
Quantity
	
Total Manufacturing Cost
	
First Installment
	
Due Date for First Installment
	
Second Installment
	
Due Date for Second Installment

	
Extra Reserved Material - CMO 1 ([***]kg)
	
[***]
	
[***]

 

 

 

 

 

 
	
First Amendment Date
	
[***]
	
Release Date*

	
Extra Reserved Material - CMO 2 ([***] kg)
	
[***]
	
[***]

 

 

 

 
	
First Amendment Date
	
[***]
	
Release Date*

	
Total – [***] kg
	
[***]
	
[***]
	
 
	
[***]
	
 

 

	
 
	
*
	
The second installment of the Manufacturing Cost shall be payable on a kilogram-by-kilogram basis upon the applicable Release Date for a particular quantity of Extra Reserved Material, written notice of which shall be provided by Dynavax to CEPI, and shall be based on (i) in the case of Extra Reserved Material manufactured by CMO 1, [***]% of the Manufacturing Cost per kilogram (i.e., US$[***]per kilogram), and (ii) in the case of Extra Reserved Material manufactured by CMO 2, [***]% of the Manufacturing Cost per kilogram (i.e., US$[***] per kilogram). 

Loan Drawdown Notices pursuant to Section 3.1(a) and this Section 3.1(b) shall specifically refer to this Agreement and shall be delivered by Dynavax to CEPI via email to [***] with a copy to [***] fifteen (15) Business Days in advance of the due date except for: (i) the first advance which will be made as soon as reasonably practicable after the first Loan Drawdown Notice; and (ii) the first advance of the Extra Loan Amount (i.e., US$[***]) which will be made as soon as reasonably practicable after the First Amendment Date, provided that the Loan Drawdown Notice for such amount is provided on or about the First Amendment Date.” 

5.Regulatory Information.  Dynavax shall, promptly upon request by any CEPI Partner to which Dynavax supplies Reserved Material, file with applicable regulatory authorities such letters of cross-reference to such CMC data or other manufacturing information of Dynavax with respect 

3.

 

to the Dynavax Adjuvant on file with any regulatory authority (collectively, “Dynavax Manufacturing Information”) as may be necessary for such CEPI Partner to apply for, obtain or maintain regulatory approval for such CEPI Partner’s Product; provided, however, that: 

(a)if a regulatory authority requires [***], then, to the maximum extent permissible by applicable laws, rules and regulations, [***]; and

(b)if a regulatory authority requires [***], then Dynavax will [***].  

6.[***].  Dynavax shall, promptly upon request by [***] as may be necessary for [***].  

7.Effectiveness of Agreement.  Except as expressly amended by this First Amendment, the Agreement shall remain in full force and effect in accordance with its terms. 

8.Counterparts.  This First Amendment may be executed in counterparts, including electronic counterparts, but shall not be effective until each Party has executed at least one counterpart.  Each counterpart shall constitute an original of this First Amendment, but all the counterparts shall together constitute one and the same instrument.

[Signature page follows.]

4.

 

 

In Witness Whereof, the Parties hereto have caused this First Amendment to Agreement to be executed and entered into by their duly authorized representatives as of the date(s) specified below.

Signed for and on behalf of COALITION FOR EPIDEMIC PREPAREDNESS INNOVATIONS by:

Signature: /s/ Dr. Richard Hatchett

	
Name:  Dr. Richard Hatchett
	

	
Title:    Chief Executive Officer
	

Date: 2021-05-03

 

 

Signed for and on behalf of DYNAVAX TECHNOLOGIES CORPORATION by:

Signature: /s/ Ryan Spencer

	
Name:  Ryan Spencer
	

	
Title:    Chief Executive Officer
	

Date: 2021-05-03

 

 

5.dvax-ex102_261.htm

Exhibit 10.2

AMENDMENT NO. 5 TO TERM LOAN AGREEMENT

THIS AMENDMENT NO. 5 TO TERM LOAN AGREEMENT, dated as of [May 1], 2021 (this “Agreement”), is made among Dynavax Technologies Corporation, a Delaware corporation (the “Borrower”), the Subsidiary Guarantors party hereto, the Lenders party hereto and CRG Servicing LLC, as administrative agent and collateral agent (in such capacities, “Agent”), with respect to the Loan Agreement referred to below.

RECITALS

WHEREAS, the Borrower, the Subsidiary Guarantors from time to time party thereto, the Lenders from time to time party thereto and the Agent are parties to that certain Term Loan Agreement, dated as of February 20, 2018, as amended by that certain Waiver and Amendment, dated as of November 20, 2018, that certain Amendment No. 2 to Term Loan Agreement and Fee Letter, dated as of August 7, 2019 and effective as of August 7, 2019, that certain Consent, dated as of April 21, 2020, that certain Consent, dated as of July 31, 2020, that certain Amendment No. 3 to Term Loan Agreement, dated as of November 2, 2020 and that certain Amendment No. 4 to Term Loan Agreement, dated as of January 29, 2021 (as further amended, amended and restated, modified or otherwise supplemented from time to time, the “Loan Agreement”); and

WHEREAS, the parties hereto desire to amend the Loan Agreement on the terms and subject to the conditions set forth herein; 

NOW, THEREFORE, in consideration of the mutual agreements, provisions and covenants contained herein, the parties agree as follows:

SECTION 1.Definitions; Interpretation.

(a)Terms Defined in Loan Agreement. All capitalized terms used in this Agreement (including in the recitals hereof) and not otherwise defined herein shall have the meanings assigned to them in the Loan Agreement.

(b)Interpretation. The rules of interpretation set forth in Section 1.03 of the Loan Agreement shall be applicable to this Agreement and are incorporated herein by this reference.

SECTION 2.Amendments. Subject to Section 3, the Loan Agreement is hereby amended as follows:

(a)Section 1.01 of the Loan Agreement is hereby amended by inserting the following new definition in the appropriate alphabetical order:

 

“Fifth Amendment Effective Date” means [May 1], 2021.

 

(b)Section 1.01 of the Loan Agreement is hereby amended by amending and restating the definition of “CEPI Agreement” to read as follows:

 

 

 

 

“CEPI Agreement” means that certain Agreement dated as of January 29, 2021 between CEPI and the Borrower, as amended by that certain First Amendment to Agreement dated as of the Fifth Amendment Effective Date and as further amended, modified, extended, restated, replaced or supplemented from time to time in accordance with the terms and provisions of this Agreement.

 

(c)Section 9.01(w) of the Loan Agreement is hereby amended by replacing the text “the Fourth Amendment Effective Date” with the text “the Fifth Amendment Effective Date”.

 

(d)Section 9.07(vi) of the Loan Agreement is hereby amended by replacing the text “the Fourth Amendment Effective Date” with the text “the Fifth Amendment Effective Date”.

 

SECTION 3.Conditions to Effectiveness. The effectiveness of Section 2 shall be subject to the satisfaction of each of the following conditions precedent:

(a)Agent shall have received, in form and substance reasonably satisfactory to it and Lenders, counterparts of this Agreement duly executed by Borrower, Agent and the Majority Lenders.

(b)The representations and warranties in Section 5 shall be true in all material respects on the date hereof and on the date on which the foregoing condition is satisfied.

SECTION 4.Expenses. The Obligors agree to reimburse the Agent for all reasonable fees, charges and disbursements of the Agent in connection with the preparation, execution and delivery of this Agreement, including the reasonable fees, charges and disbursements of Moore & Van Allen PLLC.

SECTION 5.Representations and Warranties. Each Obligor hereby represents and warrants to Agent and each Lender as follows:

(a)Such Obligor has full power, authority and legal right to make and perform this Agreement and the Loan Agreement, as modified by this Agreement (the “Amended Loan Agreement”). Each of this Agreement and the Amended Loan Agreement is within such Obligor’s corporate or equivalent powers and has been duly authorized by all necessary corporate or equivalent action and, if required, by all necessary shareholder action. This Agreement has been duly executed and delivered by such Obligor and each of this Agreement and the Amended Loan Agreement constitutes legal, valid and binding obligations of such Obligor, enforceable against such Obligor in accordance with its terms, except as such enforceability may be limited by (i) bankruptcy, insolvency, reorganization, moratorium or similar laws of general applicability affecting the enforcement of creditors’ rights and (ii) the application of general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law). Each of this Agreement and the Amended Loan Agreement (x) does not require any consent or approval of, registration or filing with, or any other action by, any Governmental Authority or any third party, except for such as have been obtained or made and are in full force and effect, (y) 

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will not violate any applicable law or regulation or the charter, bylaws or other organizational documents of such Obligor and its Subsidiaries or any order of any Governmental Authority, other than any such violations that, individually or in the aggregate, could not reasonably be expected to have a Material Adverse Effect, and (z) will not violate or result in an event of default under any material indenture, agreement or other instrument binding upon any Obligor or any of its Subsidiaries or assets, or give rise to a right thereunder to require any payment to be made by any such Person.

(b)No Default has occurred and is continuing or will result after giving effect to this Agreement.

(c)There has been no Material Adverse Effect since the date of the Loan Agreement.

(d)The representations and warranties made by or with respect to such Obligor in Section 7 of the Loan Agreement are true in all material respects (and, in all respects, for such representations and warranties that are by their terms already qualified as to materiality, material adverse effect or similar language), taking into account any changes made to schedules updated in accordance with Section 7.20 of the Loan Agreement, except that such representations and warranties that refer to a specific earlier date were true in all material respects on such earlier date (and, in all respects, for such representations and warranties that are by their terms already qualified as to materiality, material adverse effect or similar language).

SECTION 6.Reaffirmation. Each Obligor hereby ratifies, confirms, reaffirms, and acknowledges its obligations under the Loan Documents to which it is a party and agrees that the Loan Documents remain in full force and effect, undiminished by this Agreement, except as expressly provided herein. By executing this Agreement, each Obligor acknowledges that it has read, consulted with its attorneys regarding, and understands, this Agreement.

SECTION 7.Governing Law; Submission to Jurisdiction; Waiver of Jury Trial.

(a)Governing Law. This Agreement and the rights and obligations of the parties hereunder shall be governed by, and construed in accordance with, the law of the State of New York, without regard to principles of conflicts of laws that would result in the application of the laws of any other jurisdiction; provided that Section 5-1401 of the New York General Obligations Law shall apply.

(b)Submission to Jurisdiction. Each Obligor agrees that any suit, action or proceeding with respect to this Agreement or any other Loan Document to which it is a party or any judgment entered by any court in respect thereof may be brought initially in the federal or state courts in Houston, Texas or in the courts of its own corporate domicile and irrevocably submits to the nonexclusive jurisdiction of each such court for the purpose of any such suit, action, proceeding or judgment. This Section 7 is for the benefit of Lenders and the Agent only and, as a result, neither the Agent nor any Lender shall be prevented from taking proceedings in any other courts with jurisdiction. To the extent 

3

 

allowed by applicable Laws, Agent and Lenders may take concurrent proceedings in any number of jurisdictions.

(c)Waiver of Jury Trial. EACH OBLIGOR, THE AGENT AND EACH LENDER HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY SUIT, ACTION OR PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT, THE OTHER LOAN DOCUMENTS OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY.

SECTION 8.No Actions, Claims, Etc. Each Obligor acknowledges and confirms that it has no knowledge of any actions, causes of action, claims, demands, damages or liabilities of whatever kind or nature, in law or in equity, against any Secured Party, in any case, arising from any action or failure of any Secured Party to act under any Loan Document on or prior to the date hereof, or of any offset right, counterclaim or defense of any kind against any of its respective obligations, indebtedness or liabilities to Secured Party under any Loan Document. Each Obligor unconditionally releases, waives and forever discharges (a) any and all liabilities, obligations, duties, promises or indebtedness of any kind of Agent or any Lender to such Obligor, except the obligations required to be performed by Agent or any Lender under the Loan Documents on or after the date hereof, and (b) all claims, offsets, causes of action, suits or defenses of any kind whatsoever (if any), whether arising at law or in equity, whether known or unknown, which such Obligor might otherwise have against any Secured Party in connection with the Loan Documents or the transactions contemplated thereby, in the case of each of clauses (a) and (b), on account of any past or presently existing condition, act, omission, event, contract, liability, obligation, indebtedness, claim, cause of action, defense, circumstance or matter of any kind. Each Obligor acknowledges that it may discover facts or law different from, or in addition to, the facts or law that it knows or believes to be true with respect to the claims released in this Section 8 and agrees, nonetheless, that this release shall be and remain effective in all respects notwithstanding such different or additional facts or the discovery of them. Each Obligor expressly acknowledges and agrees that all rights under Section 1542 of the California Civil Code are expressly waived. That section provides:

“A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM MUST HAVE MATERIALLY AFFECTED HIS SETTLEMENT WITH THE DEBTOR.”

SECTION 9.Miscellaneous.

(a)No Waiver. Nothing contained herein shall be deemed to constitute a waiver of compliance with any term or condition contained in the Loan Agreement or any of the other Loan Documents or constitute a course of conduct or dealing among the parties. Except as expressly stated herein, Agent and Lenders reserve all rights, privileges and remedies under the Loan Documents (including, without limitation, all such rights, privileges and remedies with respect to any Default, Event of Default or Material Adverse Effect, whether or not communicated to Lenders or Agent). Except as amended hereby, the 

4

 

Loan Agreement and other Loan Documents remain unmodified and in full force and effect.  All references in the Loan Documents to the Loan Agreement shall be deemed to be references to the Loan Agreement as modified hereby.

(b)Severability. In case any provision of or obligation under this Agreement shall be invalid, illegal or unenforceable in any jurisdiction, the validity, legality and enforceability of the remaining provisions or obligations, or of such provision or obligation in any other jurisdiction, shall not in any way be affected or impaired thereby.

(c)Headings. Headings and captions used in this Agreement (including the Exhibits, Schedules and Annexes hereto, if any) are included for convenience of reference only and shall not be given any substantive effect.

(d)Integration. This Agreement constitutes a Loan Document and, together with the other Loan Documents, incorporates all negotiations of the parties hereto with respect to the subject matter hereof and is the final expression and agreement of the parties hereto with respect to the subject matter hereof.

(e)Counterparts. This Agreement may be executed in any number of counterparts, all of which taken together shall constitute one and the same instrument and any of the parties hereto may execute this Agreement by signing any such counterpart.  Receipt by facsimile or other electronic transmission of any executed signature page to this Agreement shall constitute delivery of such signature page.

(f)Controlling Provisions. In the event of any inconsistencies between the provisions of this Agreement and the provisions of any other Loan Document, the provisions of this Agreement shall govern and prevail.

(g)Loan Document. This Agreement is a Loan Document. 

[Remainder of page intentionally left blank]

 

 

5

 

 

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed and delivered as of the day and year first above written.

 

	
BORROWER:

	
 
	
 
	
 

	
DYNAVAX TECHNOLOGIES CORPORATION

	
 
	
 
	
 

	
By:
	
 
	
/s/ Ryan Spencer

	
Name:
	
 
	
Ryan Spencer

	
Title:
	
 
	
Chief Executive Officer

	
 
	
 
	
 

 

 

 

 

[Signature Page to Amendment No. 5]

 

 

 

AGENT:

 

CRG SERVICING LLC 

 

	
By:
	
 
	
/s/ Nathan Hukill

	
Name:
	
 
	
Nathan Hukill

	
Title:
	
 
	
Authorized Signatory

 

 

LENDERS:

 

CRG ISSUER 2017-1

 

By: CRG SERVICING LLC,

acting by power of attorney 

 

	
By:
	
 
	
/s/ Nathan Hukill

	
Name:
	
 
	
Nathan Hukill

	
Title:
	
 
	
Authorized Signatory

 

CRG PARTNERS III (CAYMAN) UNLEV AIV 1 L.P.

 

By: CRG PARTNERS III (CAYMAN) GP L.P., 

its General Partner

 

By: CRG PARTNERS III GP LLC, 

its General Partner

 

	
By:
	
 
	
/s/ Nathan Hukill

	
Name:
	
 
	
Nathan Hukill

	
Title:
	
 
	
Authorized Signatory

 

	
Witness:
	
 
	
/s/ Nicole Nesson

	
Name:
	
 
	
Nicole Nesson

 

[Signature Page to Amendment No. 5]

 

 

 

CRG PARTNERS III-PARALLEL FUND “A” L.P.

 

By: CRG PARTNERS III-PARALLEL FUND “A” GP L.P., 

its General Partner

 

By: CRG PARTNERS III GP LLC, 

its General Partner

 

 

	
By:
	
 
	
/s/ Nathan Hukill

	
Name:
	
 
	
Nathan Hukill

	
Title:
	
 
	
Authorized Signatory

 

[Signature Page to Amendment No. 5]

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