Document:

emergentbiosolutionshb43

Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of  information that the registrant treats as private or confidential. Double asterisks denote omissions.  Exhibit 10.10    AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE    PAGE OF PAGES  1 2  2. AMENDMENT/MODIFICATION NO.   P00007  3.  EFFECTIVE DATE  See Block 16C  4. REQUISITION/PURCHASE REQ. NO.   OS251972  5. PROJECT NO. (If applicable)  6. ISSUED BY CODE ASPR-BARDA 7. ADMINISTERED BY (If other than Item 6)    CODE ASPR-BARDA02  ASPR-BARDA   200 Independence Ave., S.W.  Room 640-G  Washington DC 20201   AS PR-BARDA   330 Independence Ave, SW, Rm G640  Washington DC 20201   8.  NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)  (x) 9A. AMENDMENT OF SOLICITATION NO.  EMERGENT MANUFACTURING OPERATIONS BALTIMORE LLC  EMERGENT MANUFACTURING OPERATIONS B  5901 E LOMBARD ST  BALTIMORE MD 212246824      9B. DATED (SEE ITEM 11)     x 10A. MODIFICATION OF CONTRACT/ORDER NO.   HHSO100201200004I  75A50120F33007   10B. DATED (SEE ITEM 13)  CODE    1410445 FACILITY CODE     05/24/2020  11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS   The above numbered solicitation is amended as set forth in Item 14.  The hour and date specified for receipt of Offers  is extended,  is not extended.  Offers  must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing Items  8 and 15, and returning _________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or   (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers.  FAILURE OF YOUR ACKNOWLEDGMENT TO  BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR  OFFER.  If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each  letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.  12. ACCOUNTING AND APPROPRIATION DATA (If required)  See Schedule  13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.   IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.  CHECK ONE  A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT  ORDER NO. IN ITEM 10A.     B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office,  appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).    C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:    FAR 43.103 (a) (3) MUTUAL AGREEMENT OF THE PARTIES.    D. OTHER (Specify type of modification and authority)      E. IMPORTANT:  Contractor    is not,  is required to sign this document and return ____1____ copies to the issuing office.  14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)  Tax ID Number:  [**]  DUNS Number:  [**]  The purpose of this modification is to:    A. Incorporate language under H.1.13 to reflect Third Party batch production and the associated credit to BARDA.    B. Update Contractor's Key Personnel.    See attached page for full details.    Continued ...  Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.  15A. NAME AND TITLE OF SIGNER (Type or print).  Catherine Hanley VP, Interim Head of CDMO Business Unit  16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)  JEFFREY R. SCHMIDT  15B. CONTRACTOR/OFFEROR      /s/ Catherine Hanley   (Signature of person authorized to sign)  15C. DATE  SIGNED    May 24, 2021  16B. UNITED STATES OF AMERICA  /s/ Jeffrey R, Schmidt      (Signature of Contracting Officer)  16C. DATE SIGNED   Electronically signed by Catherine Hanley  Reason: I approve this document  Date: May 24, 2021 09:00 EDT  Digitally signed by Jeffrey R, Schmidt  Date: 2021.05.24 14:25:18 -04’00’  

 

     STANDARD FORM 30 (Rev. 11/2016)  Previous edition unusable Prescribed by GSA   FAR (48 CFR) 53.243  

 

      CONTINUATION  SHEET  REFERENCE NO. OF DOCUMENT BEING CONTINUED  HHSO100201200004I/75A50120F33007/P00007  PAGE OF   2 3  NAME OF OFFEROR OR CONTRACTOR  EMERGENT MANUFACTURING OPERATIONS BALTIMORE LLC 1410445  ITEM No.  (A)  SUPPLIES/SERVICES  (B)  QUANTITY  (C)  UNIT  (D)  UNIT  PRICE  (E)  AMOUNT  (F)   All other terms and conditions  remain in full force and effect.     Period of Performance: 05/13/2020 to  12/31/2021                                                                     NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)   Sponsored by GSA    FAR (48 CFRl 53.110  

 

      Contract Number HHSO100201200004I, Task Order 75A50120F33007, P00007  On the effective date of this modification, the following changes are made to, Contract Number  HHSO100201200004I, Task Order 75A50120F33007.  A. The purpose of this modification is to incorporate language under H.1.13. Accordingly, the following  language is being added to the contract.  1.  "H.1.13 The Contractor, after entering into a separate agreement with a third-party [**] agrees to  reduce the total payments in Paragraph B.2. Task 1 Payment Schedule by $[**] per batch, up to [**] batches a  month and estimated not-to-exceed [**] batches, or $[**], as a credit for reallocating a portion of the current  monthly reserve capacity from BARDA to the third-party.  The Contractor will reduce the monthly Unit Price billings accordingly upon completion of all third-party batch  production, release, and receipt of payment by Emergent from the third party or as otherwise agreed upon by  the Government and Contractor in good faith, for the Reporting Periods in which the third-party batches occur.  For avoidance of doubt, the third-party batch production and associated Unit Price reductions are limited to the  calendar month in which such production actually occurs and credit for batches in excess of [**] for any  calendar month do not carryover to future Reporting Periods.  Any reduction to the monthly Unit Price will result in a corresponding reduction to the total fixed price of Task 1:  Capacity Reservation listed in Paragraph B.1.2 and the total fixed price of this task order listed in Paragraph  B.1.1.  B. Update Contractor's Key Personnel in Section G.3 as follows:  1. Replace [**] as Principal Investigator with [**] as Principal Investigator.    C. Current Status Revision required  [**] [**] [**] [**] [**]  [**] [**] [**] [**]  [**] [**] [**] [**]  [**] [**] [**] [**]      All other terms and conditions remain in full force and effect.emergentbiosolutionsazch

Certain identified information has been excluded from the exhibit because it is both (i) not  material and (ii) is the type of information that the registrant treats as private or confidential.  Double asterisks denote omissions.  Exhibit 10.11      CHANGE ORDER NO. 1 TO WORK ORDER #5997-01 – [**] STUDY AND [**]  This Change Order No. 1 entitled – [**] STUDY AND [**] (“Change Order”) effective as  of July 31, 2020 (“Change Order Effective Date”) to Work Order #5997-01 by and between  AstraZeneca Pharmaceuticals LP (“Astrazeneca”) and Emergent Manufacturing Operations  Baltimore LLC (“Service Provider”) hereby adds to the scope of Services set forth in Work Order  #5997-01 entered into by the Parties pursuant to the Master Services Agreement dated July 24,  2020 (the “Master Services Agreement”).  Capitalized terms used in this Change Order that are  not otherwise defined herein have the meanings given to them in the Master Services Agreement.  In consideration of the mutual promises contained therein and herein and for other good  and valuable consideration the receipt and adequacy of which each of the Parties does hereby  acknowledge, the Parties hereby agree as follows:  1. Purpose and Description of Change.  The purpose of this Change Order is to add to the  Services set forth in Work Order #5997-01.  In addition to the Services set forth in Work Order  #5997-01, Service Provider will render to Astrazeneca the following Services:  1.1 Stage 1 Development Study.  The goal is to evaluate [**] storage solutions for [**] of the  [**] used for [**] of the Product bulk drug substance, and determine a [**] for [**].  The study  will utilize [**]. The detailed study design will be approved in writing by both Service Provider  and AstraZeneca.  The experiment will be documented in the lab notebook.  1.2 [**] Study.  The goal is to demonstrate the suitability of the selected [**] for [**] of the  [**] over a predefined [**] and [**] will be determined [**].  The [**] study will be performed under quality assurance approved protocol to support validation.   The process parameters will be based on the finalized process parameter selected for the process  performance qualification campaign.  Detailed study design and batch records will be approved in  writing by both Service Provider and Client.  All results will be reviewed by quality and the study  report will be approved, in writing, by the appropriate Service Provider and Astra Zeneca quality  representative.  2. Deliverables.  2.1 Data summary for [**]  2.2 [**]   2.3 [**]   

 

CONFIDENTIAL AND PROPRIETARY    3. Service Fees  3.1 In addition to fees set forth in Work Order 5997-01, the additional fees due to Service  Provider for Services included under this Change Order shall be as follows:  [**]  Qty Task Deliverable Direct  Fees  Est. Pass  Through  Costs  Line  Total  [**] [**] [**] [**] [**] [**]  [**] [**] [**] [**] [**] [**]  [**] [**] [**] [**] [**] [**]  [**] [**] [**] [**] [**] [**]  Subtotal [**] [**] [**]    3.2 Astrazeneca shall pay Service Provider all fees and costs set forth in this Change Order in  accordance with the following payment schedule: (a) all fees are payable [**]% upfront upon  initiation of the specified activity or task, with the remaining [**]% payable upon completion of  the applicable activity or task; and (b) all pass-through costs plus the administrative fee of [**]%  are payable [**]% upon order placement for the materials or services, with the remaining [**]%  payable upon Service Provider’s receipt of the materials or services.  Late payments shall bear  interest at the lesser of [**]% per month or the maximum rate allowed by law until such time as  paid in full.  4. Estimated Timeline  Service Provider presents the following non-binding estimated timeline to represent the currently  expected duration of activities set forth in this Change Order which is subject to change at Service  Provider’s sole discretion due to the timing of events beyond Service Provider’s control, including  but not limited to timing of receipt of this executed Change Order.  All timelines set forth in this  Change Order are estimated and based on a number of assumptions and currently known  information.  Astrazeneca acknowledges that portions of the work to be performed are  experimental in nature and may not have been fully validated within generally accepted standards  of the pharmaceutical industry.  To the extent assumptions or information change, or there are  unexpected results or events or delays, including but not limited to delays in receipt of materials  or information from Astrazeneca, timelines may be impacted.  [**]    5. All other terms and conditions of Work Order 5997-01 remain unchanged and in full force  and effect.        

 

CONFIDENTIAL AND PROPRIETARY    [Signature Page Follows]     

 

CONFIDENTIAL AND PROPRIETARY    IN WITNESS THEREOF, the authorized representatives of the Parties have executed this  Change Order as of the Change Order Effective Date.  ASTRAZENECA PHARMACEUTICALS LP  BY: /s/ Michelle Vincent    Name: Michelle Vincent   Title: Supplier Relationship Manager, BES   Date: 11 August 2020    EMERGENT MANUFACTURING OPERATIONS   BALTIMORE, LLC  BY: /s/ Jon Lenihan    Name: Jon Lenihan   Title: Sr. Dir., Head of Sales & BD   Date: Aug 4, 2020

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