Modification No. 24, effective August 28, 2020, to the BARDA ADM Contract

Previous edition unusable    STANDARD FORM 30 (Rev. 11/2016)

    Prescribed by GSA     FAR (48 CFR) 53.243

NSN 7540-01-152-8067    OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

Change Order Proposal    June 25, 2020

This proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed—in whole or in part—for any purpose other than to evaluate this proposal. If, however, a contract is awarded to this offeror as a result of— or in connection with—the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting contract. This restriction does not limit the Government’s right to use information contained in this data if it is obtained from another source without restriction. The data subject to this restriction are contained on all marked pages.

Emergent Manufacturing Operations Baltimore LLC (Bayview) is pleased to submit this proposal for further enhancing the ADM facility’s Core Service Capabilities for Bioreactor Infrastructure to the Biomedical Advanced Research and Development Authority (BARDA) under our current Prime Contract No. HHS01 00201200004I.

This project includes the [**]. This acquisition of additional equipment allows for the expansion of the facility with flexibility to be able to increase large scale production throughput with parallel suite capability as follows:

•Area [**] and [**]: up to [**] per area, currently up to [**] per area

•Area [**]: up to [**], currently up to [**]

[**].

This Proposal outlines and describes the resources underpinning our approach and the costs of applying those resources.

1.1 Contract Type and Period of Performance

Emergent submits this Proposal for incorporation under Contract HHS0100201200004I, awarded June 15, 2012 by BARDA to Emergent.

1.1.1.1. Cost

The Cost SLIN proposed includes only Emergent’s Total Cost (with no profit or fee) and is as follows:

1.1.1.2 Cost Share

The Cost-share SLIN proposed with this offer, and the respective share percentage, is as follows:

For the purposes of this proposal, the pricing assumes the Contract itself shall extend the end date for the period of performance for the Base Period from 06/14/2020 to 06/14/2024.

1.2 Period of Validity

This Proposal shall remain valid for a period of 60 days from the date on the cover page of this submission.

1.3 Commitment

Emergent acknowledges that there may be additional changes required under the current contract to properly incorporate the work proposed and hereby commits that Emergent shall work together in good faith with BARDA’s ADM Team to finalize an approach (and subsequent contract modification) acceptable to both parties.

Set out below is Emergent’s proposed price tables detailing the CLIN offered for the new Enhanced Core Service Capabilities for Bioreactors under an additional proposed subCLIN 0002.7 – “Core Service Capabilities – Bioreactor Infrastructure”:

2.1 CLIN Funding Realignment

Emergent is proposing the addition of this new subCLIN to the contract as a zero-dollar change order proposal assuming that the current funds allocated to existing CLIN 0002 on the contract can be re-allocated to cover the proposed subCLIN 0002.7 amount outlined in the above table. As such, no additional funding is required on the Contract under this proposed change request. The USG current cost share obligation of $[**] shall remain unchanged.

Emergent proposes that excess funds that are presently assigned to subCLIN 0002.3 - “Licensure of Pandemic Flu Vaccine at [**] Facility” be allocated to this new CLIN.

Coupled with our prior request for realignment of funds under the ADM CLINs, we request the funding be changed as follows:

Was:

Totals $[**] $[**]        $[**]

Now Read: (all proposed changes in bold font)

“The subcontractor identified in the attached proposal are approved by the government for purposes of performance of subCLIN 0002.27”

3.1 Proposed Assumptions

Pricing for the overall program is based on the following assumptions:

–Emergent’s schedule and pricing are based on the activities proposed. Any changes to the scope, quantity and type of equipment and/or services to be provided may necessitate a change to the proposed prices and schedule.

–This offer assumes that the period of performance for the Base CLINs 0001, 0002 and 0003 shall be extended as cited in Section 1.1.2, or as amended.

–As both parties have successfully done in the past on this contract, Emergent assumes that as we progress further on the scope of work under CLIN 0002, that the re-alignment of the cost share funding listed for each subCLIN under CLIN 0002s may be required to be adjusted in future.

4.1 Direct Labor

Uncompensated overtime has not been proposed for this effort.

The productive man-year proposed for this effort is 2,080. The calculation is based on the available hours in a calendar year (52 weeks x 40 hours per week).

The LOE proposed for each position was estimated based on the work requirements and Emergent’s experience with similar tasks.

Direct labor rates have been escalated by [**]% commencing January 1st of each contract year which is consistent with industry standard. Emergent issues annual merit/cost of living adjustments to its employees and takes account of any anticipated promotions for proposed personnel on January 1st. Emergent does not always award a [**]% annual merit/cost of living adjustments.

4.2 Other Direct Costs

Proposed subcontractors and subcontractor costs for the following are based on estimated pricing used as a basis of estimate for tasks similar in scope. Breakdowns of Subcontractor costs with task description are included in Table 1, below.

Table 1 – “Emergent’s Proposed Subcontractors” below, lists our proposed subcontractors and provides the following information: Subcontractor name, SLIN, basis of selection, and total cost and summary of the source used:

Subcontractor costs are based on estimates from similar work performed by existing or anticipated vendors.

Emergent is not proposing any costs for travel in this offer.

Emergent is not proposing any costs for materials or supplies in this offer.

Emergent shall require the acquisition of certain equipment in the fulfillment of the work proposed. We have included Table 2 below detailing the equipment and the direct cost proposed. Quotes for this equipment is on file at Emergent.

Equipment cost share assumes that Emergent will own and have title to the equipment purchased as part of this proposed effort.

4.3 Indirect Costs

The methodology used to calculate Emergent’s proposed Total Cost/Cost Share pricing utilized indirect costs detailed in the sections below and are based on rates from the 2019 Forward Pricing Rates for Emergent BioSolutions – Federal Segment submitted to the National Institute of Health (NIH) Division of Financial Services (DFAS) on July 22, 2019. This Forward Pricing Indirect rate proposal provides forward pricing to be used from the date of submittal onward and provides rates for our indirect cost elements (Fringe, OH, Material & Subcontractor Handling and G&A). A pdf copy is embedded in this submission for your reference, as follows:

[**]

Emergent’s fringe rate is [**]%. The fringe rate is applied to all direct labor costs. This fringe rate as calculated by dividing the projected cost of fringe benefits by the projected salary base.

Emergent has utilized its overhead rate titled “R&D Overhead (Bayview)” for this effort in concert with our disclosed practices, which is [**]% and has been applied to all direct labor and fringe benefit costs. This rate was calculated by dividing the projected cost of overhead expenses by the projected salary base plus applicable fringe benefits.

Emergent’s General and Administrative (G&A) rate is [**]% and has been applied to all direct costs and equipment costs proposed herein (excluding Subcontractor and material costs, which are not part of the basis of allocation). This rate was calculated by dividing projected

G&A costs by a base composed of direct project cost (excluding subcontracts and materials) and Federal Acquisition Regulation (FAR) unallowable costs.

Emergent’s Material and Subcontractor Handling (M&SH) rate is [**]% and has been applied to subcontractor and material costs proposed herein. This rate includes the costs associated with personnel responsible for aspects of purchasing materials, issuing solicitations, processing subcontractor’s agreements and purchase orders. The base used to calculate this rate consists of materials and subcontractor cost (except for subcontractor cost related to capital assets).

Emergent has straight-lined the indirect ceiling rates and as such, there is no variance in the indirect cost rates proposed for each contract year.

1.Cost Summary

The following tables shows the total for the subCLIN 0002.7, by Element of Cost proposed, and broken down per the proposed Cost Share percentages;

2. Labor Detail – The following tables shows the calculations for labor costs proposed, by labor category:

3. Subcontractor Cost Detail

The following tables is a list of the subcontractor costs included in the proposed prices:

Emergent is submitting as an embedded file, to this volume in MS EXCEL format, the costing buildup worksheet from which the proposed price is generated. Each table displayed in Section

5.0 of this offer is a separate tab within the file.

[**]

The bioreactors are designed to be [**].

This SOW also includes estimates for labor associated with installation, engineering and qualification activities as well as contract automation support. Additional miscellaneous costs include required bioreactor support equipment