Document:

exhibit10-1.htm

Exhibit 10.1

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

  

  

  

The purpose of this modification is to:

	
a)  

	
Update the Contractor’s name from Emergent BioDefense Operations Lansing Inc. to Emergent BioDefense Operations Lansing LLC in accordance with the change of name agreement (attachment 1) and letter dated February 28, 2011 (attachment 2);

	
b)  

	
Incoporate FAR Clause 52-217.6, Option to Increase Quantity to Section I.2 as shown in full text below;

	
c)  

	
Increase and fund CLIN 0005 by [**] doses at the contracted price of $[**];

	
d)  

	
As a result of this modification, total doses for CLIN 0005 is now [**] as Section B below;

	
e)  

	
Increase and fund CLIN 0008 by [**] trucks at the contracted price of $[**];

	
f)  

	
As a result of this modification, total truckloads for CLIN 0008 is now [**] as shown in Section B below;

	
g)  

	
As a result of this modification, total contract value and total funding are increased by $100,609,440.00 from $405,685,512.00 to $506,294,952.00;

	
h)  

	
Incorporate the following dose pricing structure for 4 year dated lots with less than [**] months expiration at the time of delivery:

[**]-year product (≥ [**] months to <[**] months) - $[**] per dose

[**]-year product ( ≥ [**] months to <[**] months) - $[**] per dose

	
i)  

	
Update the Forecasted Delivery Schedule as shown in J.7 (attachment 3).

 

Section B:

 

 

	

ITEM

	

SUPPLIES / SERVICES

	

QTY/UNIT

	

UNIT PRICE

	

EXTENDED PRICE

	

0005

	

BioThrax

	

[**]

	

$[**]

	

$[**]

	  	

Line(s) Of Accounting: 921ZFXP 2642 2011 75-X-0943 5664311101 $[**] 9390110 2642 2011 75 -X-0943 5664311101 $[**] 939ZFCF 2642 2011 75-X-0943 5664311101 $[**] 939ZKZY 2642 2011 75-11-0943 5623RF1101 $[**] 939ZKZZ 2642 2011 75-11-0943 5623RF1101 $[**] 939ZLRW 2642 2011 75-11-0943 5623RF1101 $[**]

	  	  	  
	

0008

	

Shipping to SNS shipping tc SNS for CLIN 0005

	

[**]

	

$[**]

	

$[**]

	  	

Line(s) Of Accounting: 939ZFCF2642 201I 75-X-0943 5664311101 $[**] 939ZKZZ 2642 2011 75-11-0943 5623RF1101 $[**] 939ZLRW 2642 2011 75-11 -0943 5623RF1101 $[**]

	  	  	  

 

I.2

 

52.217-6 Option for Increased Quantity (Mar 1989)

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor at any time during contract performance. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

 

  

  

  

Attachment 1

 

Change of Name Agreement

 

  

  

  

Change-of-Name Agreement

 

Emergent BioDefense Operations Lansing Inc. (“Contractor”), a corporation duly organized and existing under the laws of Michigan, and the United States of America (“Government”), enter into this Agreement as of December 1, 2010.

 

	
(a)  

	
The parties agree to the following facts:

 

(1) The Government, represented by various Contracting Officers of the Centers for Disease Control and Prevention (PGO), has entered into a contract with Emergent BioDefense Operations Lansing Inc., namely Contract Number 200-2009-30162. The term “the contracts” as used in this Agreement, means the above contracts and all other contracts, including all modifications, made by the Government and the Contractor before the effective date of this Agreement (whether or not performance and payment have been completed and releases executed if the Government or the Contractor has any remaining rights, duties, or obligations under these contracts).

 

(2) Emergent BioDefense Operations Lansing Inc. filed a Certificate of Conversion with the Michigan Department of Energy, Labor & Economic Growth, Bureau of Commercial Services, Corporation Division dated November 22, 2010 and has changed its corporate name to Emergent BioDefense Operations Lansing LLC effective December 1, 2010.

 

(3) This amendment accomplishes a change of corporate name only and all rights and obligations of the Government and of the Contractor under the contracts are unaffected by this change.

 

(4) Documentary evidence of this change of corporate name has been filed with the Government,

 

	
(b)  

	
In consideration of these facts, the parties agree that:

 

(1) The contracts covered by this Agreement are amended by substituting the name “Emergent BioDefense Operations  Lansing LLC” for the name “Emergent BioDefense Operations Lansing Inc.” wherever it appears in the contracts; and

 

(2) Each party has executed this Agreement as of the day and year first written above.

 

  

  

  

United States of America:

 

 

By:                                                       

 

Name:                                                       

 

Title:                                                       

 

Emergent BioDefense Operations Lansing LLC:

 

 

By:  /s/ R. Don Elsey

 

Name:  R. Don Elsey

 

Title:  Treasurer

 

Certificate

 

I, Jay G. Reilly, certify that I am the Secretary of Emergent BioDefense Operations Lansing LLC; that R. Don Elsey, who signed this Agreement for this corporation, was then the Treasurer of this corporation; and that this Agreement was duly signed for and on behalf of this corporation by authority of its governing body and within the scope of its corporate powers.  Witness my hand and the seal of this corporation this 3rd day of March 2011.

 

By:  /s/ Jay G. Reilly                                                      

 

  

  

  

Attachment 2

 

Emergent Letter Dated February 28, 2011

 

  

  

  

	
February 28, 2011

	
Emergent BioSolutions Inc.

2273 Research Blvd., Suite 400

Rockville, MD 20850

	  	
t   301 795 1800

f   301 795 1899

www.emergentbiosloutions.com

Christine N. Godfrey

 

Contracting Officer

 

Centers for Disease Control and Prevention (PGO)

 

Building & Facilities Contracts Branch

 

2920 Brandywine Road, MS-K71

 

Atlanta, GA 30341-5539

 

RE:           Contract No.: 200-2009-30162 (the “Contract”)

Emergent BioDefense Operations Lansing LLC

 

Dear Ms. Godfrey:

 

As General Counsel for Emergent BioSolutions Inc. (the “Company”), the parent company of Emergent BioDefense Operations Lansing LLC (“EBOL”), I have been requested to furnish you an opinion with respect to the conversion of Emergent BioDefense Operations Lansing Inc., a Michigan corporation, to Emergent BioDefense Operations Lansing LLC, a Delaware limited liability company (the “Conversion”) effective December 1, 2010.

 

As a basis for this opinion, I have received and reviewed the following documents related to the Conversion: the Limited Liability Company Agreement of Emergent BioDefense Operations Lansing LLC; the Certificate of Conversion filed with the Delaware Department of State, Division of Corporations; the Certificate of Formation for “Emergent BioDefense Operations Lansing LLC” filed with the Delaware Department of State, Division of Corporations; the Certificate of Conversion filed with the Michigan Department of Energy, Labor & Economic Growth, Bureau of Commercial Services, Corporation Division; and the Application for Certificate of Authority to Transact Business in Michigan with respect to “Emergent BioDefense Operations Lansing LLC” filed with the Michigan Department of Energy, Labor & Economic Growth, Bureau of Commercial Services, Corporation Division. The opinion expressed herein as to the valid existence and good standing of the Company is based solely on a certificate of legal existence and good standing issued by the Secretary of State of the State of Delaware, dated as of December 1, 2010, and the opinion with respect to such matters is rendered as of the date of such certificate and limited accordingly.

 

Based upon and subject to the foregoing, I am of the opinion that EBOL is a limited liability company validly existing and in good standing under the laws of the State of Delaware and has the corporate power and authority to conduct its business as it is, to my knowledge, currently conducted.

 

This opinion is provided to you as a legal opinion only and not as a guaranty or warranty of the matters discussed herein. This opinion is based upon currently existing statutes, rules, regulations and judicial decisions and is rendered as of the date hereof, and I disclaim any obligation to

 

  

  

  

Christine N. Godfrey

 

February 28, 2011

 

Page 2 of 2

 

advise you of any change in any of the foregoing sources of law or subsequent developments in law or changes in facts or circumstances which might affect any matters or opinions set forth herein.

 

This opinion is rendered only to you and is solely for your benefit in connection with the administration of the Contract. This opinion may not be relied upon by you for any other purpose, nor may this opinion be provided to, quoted to or relied upon by any other person or entity for any purpose without my prior written consent.

 

Any questions concerning the foregoing opinion should be communicated to me at 301-795-1873.

 

Very truly yours,

 

/s/ Jay G. Reilly

 

Jay G. Reilly

 

Vice President, Legal Affairs and

 

General Counsel

 

  

  

  

Attachment 3

 

Forecasted Delivery Schedule

 

  

  

  

J.7 Forecasted Delivery Schedule

 

	
CLIN

	
Delivery #

	
Lot

	
Ship Date

	
Expected Doses

	
Delivered Doses

	
Cum Doses

	
Date Accepted

	  	  	  	  	  	  	  	  
	
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Remaining in CLIN 1 to Deliver

	  	
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Delivered CLIN 1

	  	  	  	  	  	  	  
	
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Delivered CLIN 2

	  	  	  	  	  	  	  
	
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Added Doses

	  	
Remaining in CLIN 5 to Deliver

	
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Delivered CLIN 5

	  	
for Mod # 12

	  	  	  	  	  
	  	
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Delivered total contract

	  	  	  	  	  	  	  
	  	  	  	
~Number of lots Remaining (~[**]k/lot)

	
[**]exhibit10-2.htm

CONFIDENTIAL

EXECUTION VERSION

 

Exhibit 10.2

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission.  Asterisks denote omissions.

 

WYETH LLC

 

ACTING THROUGH ITS

 

WYETH PHARMACEUTICALS DIVISION

 

500 Arcola Road

 

Collegeville, Pennsylvania 19426 USA

 

May 18, 2011

 

 

Emergent Product Development Seattle, LLC.

 

2401 4th Avenue, Suite 1050

 

Seattle, Washington 98121

 

Re: Amendment No. 3 to the Collaboration and License Agreement dated as of December 19, 2005 (as previously amended, the “Agreement”) by and between Emergent Product Development Seattle, LLC (successor to Trubion Pharmaceuticals, Inc. (“Trubion”)) (“EPDS”) and Wyeth LLC (formerly known as Wyeth), acting through its Wyeth Pharmaceuticals Division (“Wyeth”)

 

 

Ladies and Gentlemen:

 

This letter agreement (the “Letter Agreement”) constitutes Amendment No. 3 to the Agreement referred to above.  Capitalized terms used but not defined herein shall have the meanings set forth in the Agreement.  EPDS and Wyeth desire to amend the Agreement with respect to the restrictions on Development and Commercialization of CD20 Antigens and CD20 Products.  This Letter Agreement sets forth the agreement of EPDS and Wyeth with respect to such amendment.

 

Each of EPDS and Wyeth agrees as follows:

 

	
1.  

	
Amendments to Article 1.  Article 1 of the Agreement is hereby amended by inserting the following new definitions in alphabetical order therein:

 

  

  

  

CONFIDENTIAL

 “‘Biosimilar Combination Product’ shall mean any product containing as active ingredients both (a) a CD 20 Biosimilar Product and (b) one or more other pharmaceutically active compounds or substances.”

 

“‘Biosimilar Product’ shall mean a biological product other than a SMIP which, through reference to a biological product that has already received approval from the applicable regulatory authority (the “reference product”), is eligible for approval pursuant to an abbreviated follow-on biological approval pathway established by either the US FDA, the EMEA (currently Similar Biological Medicinal Product as described in CHMP/437/04, issued 30 October 2005, as amended from time to time) or the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, as such regulations may be amended from time to time.  A product which qualifies as a Biosimilar Product under the regulatory pathway of any one such jurisdiction shall constitute a Biosimilar Product for purposes of this Agreement in all jurisdictions, even if the marketing approval for such product in other jurisdictions requires a more restrictive regulatory pathway.”

 

“‘CD20 Biosimilar Product’ shall mean a Biosimilar Product with respect to which Development or Commercialization is first commenced or conducted by Wyeth during the CD20 Biosimilar Product Applicability Period, and such Biosimilar Product contains a protein directed against or that Specifically Binds to the CD20 Antigen or any portion thereof.  A CD20 Biosimilar Product shall not be considered to be a CD20 Product for the purposes of this Agreement.”

 

“‘CD20 Biosimilar Product Applicability Period’ shall mean any time that occurs both (a) during the term of this Agreement and (b) prior to the later of (i) the date which is ninety (90) days after the date of expiration or termination of Wyeth’s obligations under Section 2.3.1 of this Agreement and (ii) May 26, 2012.”

 

“‘CD20 Biosimilar Royalty Period’ shall mean the period of time beginning on the date of the first commercial sale by Wyeth or any sublicensee of the first CD20 Biosimilar Product anywhere in the Territory and ending on the seventh (7th) anniversary of the first commercial sale by Wyeth or any sublicensee of the first CD20 Biosimilar Product in any Major Market Country; provided, however, that if the first commercial sale by Wyeth or any sublicense of the first CD20 Biosimilar Product in a Major Market Country occurs in a Major Market Country that is not the United States, then (a) the “CD20 Biosimilar Royalty Period” for all countries in the Territory other than the United States shall end on the seventh (7th) anniversary of the first commercial sale by Wyeth or any sublicensee of the first CD20 Biosimilar Product in such Major Market Country and (b) the “CD20 Biosimilar Royalty Period” for the United States shall end on the seventh (7th) anniversary of the first commercial sale by Wyeth or any sublicensee of the first CD20 Biosimilar Product in the United States.  For the avoidance of doubt, if the first commercial sale by Wyeth or any sublicense of the first CD20 Biosimilar Product in a Major Market Country occurs in the United States, then the “CD20 Biosimilar Royalty Period” for all countries in the Territory shall end on the on the seventh (7th) anniversary of the first commercial sale by Wyeth or any sublicensee of the first CD20 Biosimilar Product in the United States.”

 

“‘CD20 Biosimilar Product Net Sales’ shall mean the gross amounts charged for sales of CD20 Biosimilar Products by Wyeth or its sublicensees to Third Parties, less the sum of (a) and (b) where (a) is a provision, determined under Generally Accepted Accounting Principles in the United States and in accordance with Wyeth’s customary and usual accrual procedures, consistently applied, for the accrual of (i) trade, cash, quantity and wholesaler discounts or rebates (other than price discounts granted at the time of sale), if any, allowed or paid, (ii) credits or allowances given or made for rejection or return of, previously sold CD20 Biosimilar Products or for retroactive price reductions (including Medicaid, managed care and similar types of rebates), (iii) taxes, duties or other governmental charges levied on or measured by the billing amount (excluding income and franchise taxes), as adjusted for rebates and refunds, and (iv) charges for packing, freight, and shipping to the extent included in the invoice price and (b) is a periodic adjustment (positive or negative, as applicable), determined under Generally Accepted Accounting Principles in the United States and in accordance with Wyeth’s customary and usual adjustment procedures, consistently applied, of the provision determined in (a) to reflect amounts actually incurred for (i), (ii), (iii) and (iv) based on amounts actually invoiced or as separately set forth in agreements with Third Parties or as deducted or paid as required by applicable law or regulations.  (The deductions described in (i), (ii), (iii) and (iv) are also referred to herein as “Permitted Deductions.”)  In the case of any sale of CD20 Biosimilar Products for consideration other than cash, CD20 Biosimilar Product Net Sales shall be calculated on the fair market value of the consideration received.

 

Notwithstanding the foregoing, if a CD20 Biosimilar Product is sold as a Biosimilar Combination Product (also a “Combination Sale”), the Net Sales for such Biosimilar Combination Product shall be the portion of such Combination Sale allocable to the CD20 Biosimilar Product determined as follows:

 

Except as provided below, the CD20 Biosimilar Product Net Sales amount for a Combination Sale shall equal the gross amount invoiced for the Combination Sale, reduced by the Permitted Deductions (also the “Net Combination Sale Amount”), multiplied by the fraction A/(A+B), where:

 

A is the invoice price, in the country where such Combination Sale occurs, of the CD20 Biosimilar Product contained in the Biosimilar Combination Product, if sold as a separate product in such country by Wyeth or its sublicensees, as the case may be, and B is the aggregate of the invoice price or prices, in such country, of products which collectively contain as their respective sole active ingredient such other pharmaceutically active compounds or substances, as the case may be, included in the Biosimilar Combination Product, if sold separately in such country by Wyeth or its sublicensees, as applicable.

 

In the event that Wyeth or its sublicensees sell the CD20 Biosimilar Product included in a Biosimilar Combination Product as a separate product in a country, but do not separately sell all of the other pharmaceutically active compounds or substances, as the case may be, included in such Biosimilar Combination Product in such country, the calculation of the CD20 Biosimilar Product Net Sales amount for such Combination Sale shall be determined by multiplying the Net Combination Sale Amount by the fraction A/C where:

 

A is the average wholesale price, in such country, charged by Wyeth or its sublicensees, as the case may be, for the CD20 Biosimilar Product contained in such Biosimilar Combination Product, when sold as a separate product by Wyeth or its sublicensees, as applicable, and C is the average wholesale price, in such country, charged by Wyeth or its sublicensees, as applicable, for the entire Biosimilar Combination Product.

 

In the event that Wyeth or its sublicensees do not sell the CD20 Biosimilar Product included in a Biosimilar Combination Product as a separate product in a country where such Combination Sale occurs, but do separately sell products which collectively contain as their respective sole active ingredient all of the other pharmaceutically active compounds or substances, as the case may be, included in the Biosimilar Combination Product in such country, the calculation of CD20 Biosimilar Product Net Sales resulting from such Combination Sale shall be determined by multiplying the Net Combination Sale Amount by the fraction (C-D)/C, where:

 

C is the average wholesale price, in such country, charged by Wyeth or its sublicensees, as the case may be, for the entire Biosimilar Combination Product, and D is the average wholesale price charged by Wyeth or its sublicensees, as the case may be, for the products which collectively contain as their sole active ingredient such other pharmaceutically active compounds or substances, as the case may be, included in the Biosimilar Combination Product.

 

Where active ingredient portions of a Biosimilar Combination Product are sold separately as other products but in different dosage strengths than are in the Biosimilar Combination Product, the calculation of the Net Sales amount for such Biosimilar Combination Product shall be based on appropriate proration of the amounts of each active ingredient component included therein when applying the formulas set forth above.

 

Where the calculation of CD20 Biosimilar Product Net Sales resulting from a Combination Sale in a country cannot be determined by any of the foregoing methods, the calculation of CD20 Biosimilar Product Net Sales for such Combination Sale shall be that portion of the Net Combination Sale Amount reasonably determined in good faith by the Parties as properly reflecting the value of the CD20 Biosimilar Product included in the Biosimilar Combination Product.

 

Notwithstanding the foregoing, CD20 Biosimilar Product Net Sales shall not include any reimbursement received by Wyeth or its sublicensees in respect of the use of a CD20 Biosimilar Product in a country solely as part of a clinical trial prior to the receipt of marketing authorization required to commence commercial sales of such CD20 Biosimilar Product in such country.”

 

	
2.  

	
Amendment to Section 2.3.1.  Section 2.3.1 of the Agreement is hereby amended by adding the following new paragraph at the end thereof:

 

“The foregoing provisions of this Section 2.3.1 shall not, and shall not be deemed to, prohibit Wyeth from Developing or Commercializing any CD20 Biosimilar Product.  For clarity, no rights or licenses are granted to Wyeth under the Trubion Technology with respect to any CD20 Biosimilar Products.”

 

	
3.  

	
Amendment to Section 5.4.  In partial consideration for EPDS agreeing to amend Section 2.3.1 of the Amendment as set forth above, Section 5.4 of the Agreement is hereby amended by adding the following new Section at the end thereof:

 

“5.4.7. CD20 Biosimilar Product Payments.  Wyeth shall pay to Trubion an amount equal to [**] percent ([**]%) multiplied by the aggregate CD20 Biosimilar Product Net Sales collectively obtained by Wyeth and its sublicensees from the sale of CD20 Biosimilar Products during each calendar year.  Such payments shall be made during the CD20 Biosimilar Royalty Period.  Sections 5.5 (excluding clause (c) of Section 5.5.2) and 5.6 shall apply to the payments to be made pursuant to this Section 5.4.7 on CD20 Biosimilar Products.

 

	
4.  

	
Amendment to Section 9.7.10.  In further consideration for Trubion agreeing to amend Section 2.3.1 of the Agreement as set forth above, Section 9.7.10 of the Agreement is hereby amended and replaced by the following text:

 

“9.7.10. Continuation of Certain Rights and Licenses.

 

	
(a)  

	
Notwithstanding anything in this Section 9.7 to the contrary, the Parties’ rights and licenses set forth in Sections 6.1.1 and 6.1.2 shall survive any expiration or termination of this Agreement.

 

	
(b)  

	
Notwithstanding anything in this Section 9.7 to the contrary, Trubion’s right to receive CD20 Biosimilar Product Payments in accordance with Section 5.4.7 shall survive any expiration or termination of this Agreement and continue until the end of the CD20 Biosimilar Royalty Period.”

 

	
5.  

	
Amendment Payment.  Wyeth shall pay to EPDS Two Million Five Hundred Thousand Dollars ($2,500,000.00) within thirty (30) days after the effective date set forth below, which payment shall be non-refundable and non-creditable.

 

	
6.  

	
Assignment.  Wyeth hereby assigns the Agreement, as amended hereby, and all of its rights, obligations and interests thereunder, to Pfizer Inc. Pfizer Inc. hereby accepts such assignment and assumes the rights, obligations and interests of Wyeth under the Agreement.

 

	
7.  

	
Continuity of Royalty Obligation.  In the event that Wyeth or Pfizer Inc. sells, transfers, licenses or otherwise assigns its rights and interests in any CD20 Biosimilar Product for which royalties are or will become due and payable as provided for in the amendments to the Agreement set forth in Paragraph 3 above, Pfizer Inc. shall remain responsible for the obligation to pay such royalties with respect to such CD20 Biosimilar Product unless the successor to such rights and interests confirms in writing to EPDS that such successor assumes the obligations to pay such royalties to EPDS.

 

	
8.  

	
Notice.

 

	
(a)  

	
On or prior to January 15, 2012 and thereafter on or prior to each January 15 and July 15 that occurs during the CD20 Biosimilar Product Applicability Period, Wyeth or Pfizer Inc. shall provide EPDS with a written report with respect to whether the Development or Commercialization of any CD20 Biosimilar Product was first commenced or conducted by Wyeth since the date of the last such report.

 

	
(b)  

	
Wyeth or Pfizer Inc. shall provide EPDS with notice of the consummation of any transaction contemplated pursuant to Section 7 of this Letter Agreement within thirty (30) days after consummation thereof and such notice shall indicate whether the obligations set forth in Section 7 remain with Pfizer Inc or were transferred to the successor.

 

This Letter Agreement shall be deemed entered into and effective as of May 26, 2011.  As modified by this Amendment No. 3, the Parties confirm that the Agreement is in full force and effect.

 

Please indicate your acknowledgement of and agreement with the foregoing by having each counterpart of this Letter Agreement executed on behalf of EPDS and returning one fully executed original counterpart to me.

 

Very truly yours,

 

 

WYETH LLC, acting through its

 

WYETH PHARMACEUTICALS DIVISION

 

By:           /s/ Mikael Dolsten                                           

 

Name:       Mikael Dolsten                                           

 

Title:         President – Worldwide Research and Development                                                                                     

 

 

By:           /s/ Mikael Dolsten                                           

 

Name:      Mikael Dolsten                                           

 

Title:        President – Worldwide Research and Development                                                                                     

 

  

  

  

 

ACKNOWLEDGED AND AGREED:

 

EMERGENT PRODUCT DEVELOPMENT SEATTLE, LLC

 

By:           /s/ Kyle W. Keese                                           

 

Name:      Kyle W. Keese                                           

 

Title:           

 

Title:           18 May 11

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