20150465 Ver 2_Modifications_20221102

Staff Review Form
NORTH CAROLINA
Envlronm¢ntcl Qvofiry
Updated September 4, 2020
Staff Review
Does this application have all the attachments needed to accept it into the review process?*
Yes No
ID# *
20150465
Version* 2
Is this project a public transportation project?*
Yes
• No
Reviewer List: * Kelsey Rowland:eads\ksrowland
Select Reviewing Office: * Central Office - [phone]
Does this project require a request for payment to be sent?*
Yes
No
How much is owed?* $240.00
$570.00

Project Submittal Form
*
Please note: fields marked with a red asterisk below are required. You will not be able to submit the form until all
mandatory questions are answered.
Project Type: *
For the Record Only (Courtesy Copy)
New Project
Modification/New Project with Existing ID
More Information Response
Other Agency Comments
Pre -Application Submittal
Re-Issuance\Renewal Request
Stream or Buffer Appeal
Pre -Filing Meeting Date Request was submitted on:
4/26/2022
Project Contact Information
Name:
Chris Huysman
Who is submitting the information?
Email Address: [e-mail]
Project Information
Existing ID #:
20150465
20170001 (no dashes)
Existing Version:
1
Project Name: Novo Nordisk Site Capacity Expansion
Is this a public transportation project?
Yes
No
Is the project located within a NC DCM Area of Environmental Concern (AEC)?
Yes No Unknown
County (ies)
Johnston
Please upload all files that need to be submited.
Click the upload button or drag and drop files here to attach document
221018 combined nn app.pdf 16.97MB
Only pdf or kmz files are accepted.
Describe the attachments or
comments:
Sign and Submit
By checking the box and signing box below, I certify that:

• I, the project proponent, hereby certifies that all information contained herein is true, accurate, and complete to the
best of my knowledge and belief.
• I, the project proponent, hereby requests that the certifying authority review and take action on this CWA 401
certification request within the applicable reasonable period of time.
• I agree that submission of this online form is a "transaction" subject to Chapter 66, Article 40 of the NC General
Statutes (the "Uniform Electronic Transactions Act");
• I agree to conduct this transaction by electronic means pursuant to Chapter 66, Article 40 of the NC General
Statutes (the "Uniform Electronic Transactions Act");
• I understand that an electronic signature has the same legal effect and can be enforced in the same way as a
written signature; AND
• I intend to electronically sign and submit the online form.
Signature:
C r. er
Submittal Date: Is filled in automatically.

U.S. ARMY CORPS OF ENGINEERS
APPLICATION FOR DEPARTMENT OF THE ARMY PERMIT
OMB APPROVAL N0. 0710-0003
EXPIRES: 28 FEBRUARY 2013
33 CFR 325 The proponent agency is CECW-CO-R.
Public reporting for this collection of information is estimated to average 11 hours per response, including the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding
this burden estimate or any other aspect of the collection of information, including suggestions for reducing this burden, to Department of Defense,
Washington Headquarters, Executive Services and Communications Directorate, Information Management Division and to the Office of Management and
Budget, Paperwork Reduction Project (0710-0003), Respondents should be aware that notwithstanding any other provision of law, no person shall be
subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. Please DO NOT
RETURN your form to either of those addresses. Completed applications must be submitted to the District Engineer having jurisdiction over the location of
the proposed activity.
PRIVACY ACT STATEMENT
Authorities: Rivers and Harbors Act, Section 10, 33 USC 403; Clean Water Act, Section 404, 33 USC 1344; Marine Protection, Research, and Sanctuaries
Act, Section 103, 33 USC 1413; Regulatory Programs of the Corps of Engineers; Final Rule 33 CFR 320-332. Principal Purpose: Information provided on
this form will be used in evaluating the application for a permit, Routine Uses: This information may be shared with the Department of Justice and other
federal, state, and local government agencies, and the public and may be made available as part of a public notice as required by Federal law. Submission
of requested information is voluntary, however, if information is not provided the permit application cannot be evaluated nor can a permit be issued. One set
of original drawings or good reproducible copies which show the location and character of the proposed activity must be attached to this application (see
sample drawings and/or instructions) and be submitted to the District Engineer having jurisdiction over the location of the proposed activity. An application
that is not completed in full will be returned.
(ITEMS 1 THRU 4 TO BE FILLED BY THE CORPS)
1. APPLICATION NO.
2. FIELD OFFICE CODE
3. DATE RECEIVED
4. DATE APPLICATION COMPLETE
(ITEMS BELOW TO BE FILLED BY APPLICANT)
5. APPLICANT'S NAME
B. AUTHORIZED AGENT'S NAME AND TITLE (agent is not required)
First - Chad Middle - Last - Henry
First - Christopher Middle - Last - Huysman
Company - Novo Nordisk Pharmaceutical Industries, LP
Company - Wetlands and Waters, Inc.
E-mail Address - CHNR(a,novonordisk.com
E-mail Address - chrishuysman(-,wetlands- waters. corn
6. APPLICANT'S ADDRESS:
9. AGENT'S ADDRESS:
Address- 3612 Powhattan Road
Address- 328 East Broad Street, Suite D
City - Clayton State - NC Zip - 27527 Country - USA
City - Statesville State - NC Zip - 2867' Country - USA
7. APPLICANT'S PHONE NOs. w/AREA CODE
10. AGENTS PHONE NOs. w/AREA CODE
a. Residence b. Business ' c. Fax
a. Residence b. Business c. Fax
919.930.7531
336.406.0906
STATEMENT OF AUTHORIZATION
11. 1 hereby authorize, Wallandn and.Wat et in m ehalf my agent in the processing of this application and to furnish, upon request,
supplemental information in support of this permit ap )'o
'
L 1My
SIGNATURE OF APPLICA T • DATE
NAME, LOCATION, AND DESCRIPTION OF PROJECT OR ACTIVITY
12. PROJECT NAME OR TITLE (see instructions)
Novo Nordisk Site Capacity Expansion
13. NAME OF WATERBODY, IF KNOWN (if applicable)
14. PROJECT STREET ADDRESS (if applicable)
UT Neuse River
Address 3612 Powhatan Road
15. LOCATION OF PROJECT
Latitude: -N 15 618979 Longitude: �W -078 40870
City - Clayton State- NC Zip- 27527
16. OTHER LOCATION DESCRIPTIONS, IF KNOWN (see instructions)
State Tax Parcel ID 05F.99010CT Municipality Tnwn of Clavton. lohnston County_ NC
Section - Township - Range -
ENG FORM 4345, OCT 2012 PREVIOUS EDITIONS ARE OBSOLETE. Page 1 of 3

17. DIRECTIONS TO THE SITE
The site is located south of the Town of Clayton. From the intersection of US Highway Business 70 W and Powhatan Road. Take
Powhatan Road 0.67 miles and the site is located on the left side of the road.
See supporting documentation for additional maps.
18. Nature of Activity (Description of project, include all features)
The project consists of buildings, parking areas, storage facilities, and supporting infrastructure. These buildings will accommodate
storage of raw materials, excipients, packaging materials, in -process and finished products, as well as aseptic production ("Al?") and
finished production ("FP") areas including new, state-of-the-art production and packaging equipment. The warehouse will utilize
automated storage and retrieval systems, providing both cold and ambient storage capacity which will meet all current GMP standards.
The AP facility construction will allow the site to expand for new capacity and existing product expansion, also allowing to better comply
with future desire of regulatory agencies using latest technology improving quality of product for patients.
See supporting documentation for additional narratives and figures related to facilities siting and other regulatory constraints.
19. Project Purpose (Describe the reason or purpose of the project, see instructions)
The applicant has stated the basic purpose of the proposed project is to expand production, packaging, and warehousing facilities at their
longest -standing injectable finished production facility in the U.S. to meet current and future demand for the production of insulin and
other pharmaceutical products while ensuring stock of both in -process and final product are maintained for their life-saving medicines.
See supporting documentation for additional narrative.
USE BLOCKS 20-23 IF DREDGED AND/OR FILL MATERIAL IS TO BE DISCHARGED
20. Reason(s) for Discharge
The construction of the proposed project will require permanent and temporary impacts to Waters of the U.S. and Waters of the State to
establish access to high -ground developable area, to grade and balance the site so that practicable development can occur, to construct
production facilities, provide parking fields and construct access roads that meet fire marshal standards.
See supporting documentation.
21. Type(s) of -Material Being Discharged and the Amount of Each Type in Cubic Yards:
Type Type Type
Amount in Cubic Yards Amount in Cubic Yards Amount in Cubic Yards
Clean fill +/- 300 cubic yards
22. Surface Area in Acres of Wetlands or Other Waters Filled (see instructions)
Acres 0.83 acres riparian wetlands
or
Linear Feet 1642 linear feet of streams (0.23 acres)
23. Description of Avoidance. Minimization, and Compensation (see instructions)
The applicant's preferred alternative is the result of multiple site designs intended to optimize the site configuration and expansion
opportunities that are detailed in the attached supporting documentation. The applicant proposes 2:1 mitigation for all wetland and stream
losses.
See supporting documentation for additional narrative.
ENG FORM 4345, OCT 2012 Page 2 of 3

24. is Any Portion of the Work Already Complete? ElYes nXX No IF YES, DESCRIBE THE COMPLETED WORK
25, Addresses of Adjoining Property owners, Lessees, Etc., Whose Property Adjoins the Waterbady (ir mwe ihan can he entered hare. Please attach a suppiemen tal list)
a. Address- Grifols Therapeutics, LLC, 4201 Research Commons
City- Durham state- NC
Zip - 27704
b. Address- Powhatan Free Will Baptist, 3468 Powhatan Rd
City - Clayton State - NC Zip _ 27527
o- Address- Town of Clayton, PO Box 777
City - Clayton State - NC zip _ 27528
d- Address -
City - State - Zip _
e. Address -
City - State - Zip _
26- List of Other Certificates or Approvals)Deniais received from other Federal, State, or Local Agencies for Work Described in This Application.
AGENCY TYPE APPROVAL* IDENTIFICATION DATE APPLIED DATE APPROVED DATE DENIED
NUMBER
NC DOT ENCROACHMENT PENDING
TOWN OF CLAYTO ZONINGIBUILDIN PENDING
NC DWR 401 WQC CONCURRENT —
NC DWR — BUFFER CONCURRENT _.
" Would include but is not restricted to zoning, building, and flood plain permits
27- Appli I on is hereby made for permit or permits to authorize the work described in this application. I certify that this information in this application is
compie a accurat urther certify that I possess the authority to undertake the work descrlbed herein or am acting as the duly authorized agent of the
applic nt.
Alt'T2V
URE ❑F APPLI NT � DATE &NATV—RE AOF4NT
The Application must be signed ythe person who desires to undertake the proposed activity (applicant) or it maybe signed by a.duly
authorized agent if the statement in block 11 has been filled out and signed.
18 U.S.C. Section 1001 provides that; Whoever, in any manner within the jurisdiction of any department or agency of the United States
knowingly and willfully falsifies, conceals, or covers up any trick, scheme, or disguises a material fact or makes any false, fictitious or
fraudulent statements or representations or makes or uses any false writing or document knowing same to contain any false, fictitious or
fraudulent statements or entry, shall be fined not more than $10,000 or imprisoned not more than five years or both,
_+.� ra.rrcm Lit,r ru7,d Page 3 of 3

1. INTRODUCTION
1.1. Background
Novo Nordisk is a global healthcare company and a world leader in diabetes care with
almost 100 years of translating unmet medical needs of people living with a serious and
chronic disease into innovative medicines and delivery systems. With headquarters in
Denmark, Novo Nordisk employs approximately 40,000 employees in over 80 countries
and markets its products in 180 countries.
Novo Nordisk has strategic production facilities in five countries, including the United
States. In the U.S., the facility in Clayton, NC is a critical element of the company's
global supply chain necessary for the manufacturing and packaging of life saving and life
sustaining medicines marketed in North America, Europe, Australia and New Zealand.
Operating 24 hours a day, 7 days a week, impacts to operations at the Clayton facility
have direct impact on global supply.
Novo Nordisk purchased the facility in Clayton in 1991 from Locke Pharmaceuticals,
establishing U.S. operations, and launched its first product for global distribution in
1996. The site was selected based on a licensed pharmaceutical operation previously
established, availability of basic site utilities including water, sewer, power, etc.,
proximity to the Research Triangle Park, availability of trained, technical resources, and,
the site offered opportunity for expansion in the future.
Between 1996 and 2014, this facility has undergone six expansions, including an
expansion in 2004 that included a Major Variance approval (DWQ Project No. 04-1660)
for the same subject area of this application. Today, the facility is approximately
457,000 square feet, employs over 850 employees and operates 24/7, producing and
packaging medicines. Future expansion will increase production and warehouse space
as well as employee headcount by at least 250 employees, requiring additional parking
to accommodate.

The proposed facilities expansion is necessary to meet current and forecasted
production needs for life-saving medications. These buildings will accommodate
storage of raw materials, excipients, packaging materials, in -process and finished
products, as well as aseptic production ("AP") and finished production ("FP") areas
including new, state-of-the-art production and packaging equipment. The warehouse
will utilize automated storage and retrieval systems, providing both cold and ambient
storage capacity which will meet all current GMP standards. The AP facility construction
will allow the site to expand for new capacity and existing product expansion, also
allowing to better comply with future desire of regulatory agencies using latest
technology improving quality of product for patients.
In addition, the company experienced significant disruption on their supply chain during
the Covid-19 pandemic this expansion will ensure that inventory levels of both raw
materials, as well as finished product, are maintained at sufficient levels to greatly
reduce any potential disruption in providing life-saving medications to our customers.
1.2. Project Location and Description
The Project site is located immediately east of State Highway 70 in the Town of
Clayton, Johnston County, NC. The total property (NC PIN: 05E99010G) is
approximately 54 acres and is bordered on the south by the North Carolina
Railroad/Norfolk Southern rail line and to the east by Powhatan Road (SR 1901). The
north side of the property is bordered by a state roadway allowing emergency access
to another pharmaceutical company in Clayton. In addition, the site is bordered on
both the north and west sides by streams.
This project will construct +400,000 square foot of new buildings that will enable the
company to continue to meet global production needs of life-saving medicines.

2. Design Alternatives Evaluated
The production of biologic medications is strictly regulated by the U.S. Food and Drug
Administration ("FDA") under requirements defined as Good Manufacturing Practices
("GMP") in 21 CFR Parts 210 and 211. According to GMP requirements the flow of
components, drug products, and personnel through the building or buildings shall be
designated to prevent contamination.
Novo Nordisk medicines have increased in demand and therefore the company needs to
expand its production capacity globally. As a part of this major global expansion, the site in
Clayton, NC must undergo a significant expansion to ramp -up production capacity to meet
this overwhelming patient demand and business growth while also providing increased
safety stock of both raw materials and finished products.
Master Planning efforts for the site have been ongoing since early 2021 and Novo Nordisk
has engaged with Hanbury Architects, HIPP Engineering, Stewart Engineering, and Wetlands
& Waters to provide professional architectural, engineering and environmental consulting
and design services.
As previously stated, there are limitations within our current site that prevent us from
expanding without impact to the existing stream and wetlands located on the site. Multiple
potential on -site and off -site options were prepared and evaluated by Novo Nordisk and our
design team prior to selecting our preferred option.
Off -site alternatives considered included the purchase of additional parcels which were
directly adjacent and contiguous to the existing site. Being directly adjacent and contiguous
to the existing site was a primary consideration as it relates to licensure by the FDA for any
new facilities. A new site approval by the FDA would require substantial additional time to
obtain. Offers for these parcels was made but unfortunately, the seller declined to proceed
with the transaction.

On -site alternatives included dozens of possible siting and material flow arrangements
generated by the project team including our architects, engineers and wetlands consultants.
The evaluation process was extensive, and a summary of those results are contained in the
attached document titled "AP Filling + Warehouse Expansion Site Master Plan Options —
Wetland and Stream Alternatives" dated October 13, 2022.
Established regulations and guidance for the design, layout and operation of a
pharmaceutical manufacturing facility, providing aseptically produced medicines, were a
key factor in evaluating all options. The criteria for decision making included areas such as
material flows in the facility and site, intended to establish clearly defined pathways for raw
materials, personnel, waste, etc., minimize handling and transportation of in -process and
finished drug products, ensuring appropriate sizing of manufacturing, support, laboratory,
gowning, etc. areas to allow for proper operation, maintenance, material flows, etc.
In addition, each option was evaluated for impacts to streams, buffers and wetlands while
ensuring site circulation for emergency access, shipping and receiving heavy truck traffic
and personnel vehicle and foot traffic. Other significant aspects considered were phasing
and constructability, location and setbacks required for utility services, as well as schedule
implications. Novo Nordisk has defined cost to construct each option as the least significant
factor in the overall decision during evaluation, focusing mainly on patient supply, quality
and environment.

M
US Army Corps
Of Engineers
Wilmington District
PUBLIC NOTICE
Issue Date:
Comment Deadline:
Corps Action ID Number: SAW -
The Wilmington District, Corps of Engineers (Corps) received an application from Novo
Nordisk Pharmaceutical Industries, LP seeking Department of the Army authorization to
associated with in Johnston County, North Carolina.
Specific plans and location information are described below and shown on the attached plans.
This Public Notice and all attached plans are also available on the Wilmington District Web Site
at: https://www.saw.usace.army.mil/Missions/Regulatory-Permit-Program/Public-Notices/
Applicant: Chad Henry, Corporate Vice President
Novo Nordisk Pharmaceutical Industries, LP
3612 Powhatan Rd
Clayton, NC 27527
AGENT (if applicable):
Authority
Chris Huysman
Wetlands & Waters, Inc.
328 East Broad Street, Suite D
Statesville, NC 28677
The Corps evaluates this application and decides whether to issue, conditionally issue, or deny
the proposed work pursuant to applicable procedures of the following Statutory Authorities:
® Section 404 of the Clean Water Act (33 U.S.C. 1344)
❑ Section 10 of the Rivers and Harbors Act of 1899 (33 U. S.C. 403)
❑ Section 103 of the Marine Protection, Research and Sanctuaries Act of 1972 (33 U.S.C.
1413)
Version 6.15.2017 Page 1

Location
Location Description:
Project Area (acres): —53 acres Nearest Town: Clayton
Nearest Waterway: Unnamed Tributary River Basin: Neuse River
Latitude and Longitude: 35.618972N,-78.408763W
Existing Site Conditions
The Review Area is characterized by existing industrial development, parking fields, forested
areas, and riparian and aquatic habitat. Land use is primarily active industrial land with
supporting infrastructure such as stormwater BMP's, parking fields, and laydown yards. Natural
areas are comprised of mixed mesic forest, riparian buffers and passive use open fields. Mesic
forests are comprised of pines, softwoods, and hardwoods including Loblolly Pine, White and
Red Oaks, Sweet Gum and Tulip Poplar. The site topography is generally rolling hills, with two
natural valleys; one along the northern boundary and the other within the central portion of the
site. The site is underlain by several unique soil map units, including Varina loam, Pacolet loam,
Gilead sandy loam, Cowarts loamy sand, Faceville sandy loam, Uchee sandy loam, and
Goldsboro sandy loam. An unnamed tributary to the Neuse River forms the northern boundary of
the site and an unnamed tributary bisects the site; they are the primary receiving water of the
Review Area. Other on -site riparian and aquatic communities include streams and wetlands. The
project area lies in a drainage basin subject to the Neuse River Riparian Buffer rules.
404/401 Permit History
An aquatic resources delineation was completed within the project area by Wetlands & Waters,
Inc. The aquatic resources delineation was field -verified by USACE in February 2022. The
project area contains approximately 3642 linear feet of streams (totaling 0.409 acres), and 0.83
acres of vegetated wetlands. There are approximately 4 acres of stormwater ponds that are not
subject to Clean Water Act jurisdiction. Table 1 illustrates aquatic resources within the project
boundary.
Impacts streams and wetlands were previously authorized by the USACE under actions SAW
2005-20153 and SAW 2015-00471. These impacts were subsequently certified by the NC
Division of Water Resources as projects DWR 20041660, DWR 20150465 and DWR 20150715.
Based on a review of project files the prior approved impacts total 299 linear feet of streams
(0.27 ac) and no impacts to vegetated wetlands. Approved impacts to Neuse River Riparian
Buffers total 16,842 square feet (0.386 ac). Impacts authorized by USACE 2015-00471 and
DWR 20150715 were not constructed. The prior approved impacts were authorized for the
construction of the facility and were mitigated at then applicable standards.
Table 1: Aquatic Resources
Waters Name Amount
Tributary 1 2000
Tributary 2 1340
Waters Name Amount
JdL
Tributary 3 302
Wetland 1 0.80
Units AL
FOOT
ACRE
Version 6.15.2017 Page 2

Waters Name
L
Amount
Units
Waters Name L Amount
Wetland
0.03
ACRE
7r
Applicant's Stated Purpose
The applicant has stated the basic purpose of the proposed project is to expand production,
packaging, and warehousing facilities at their longest -standing injectable finished products
facility in the U.S. to meet current and future demand for the production of insulin and other
pharmaceutical products while ensuring stock of both in -process and final product are
maintained for their life-saving medicines.
Project Description
Factors considered in determining the ideal project configuration for the proposed project
included (but were not limited to):
• Food and Drug Administration compliance: The proposed expansion must comply with
current rules and regulations related to facilities certification and licensure.
• Material flows and waste stream management: The proposed expansion must allow for
defined material, personnel and waste flows that will minimize the risk to final product
for contamination/cross-contamination.
• Process engineering and materials handling: The proposed expansion must allow for
logical uninterrupted product manufacturing, packaging, storage and distribution at one
finished floor elevation.
• Contiguous acreage: The proposed expansion must be proximate to the existing
production facilities which operate continuously to meet current market needs.
• Zoning: The selected site must be able to be able to secure all local approvals and the
current site has the appropriate zoning for the proposed expansion.
• Utilities: Access to utilities, including (but not limited to) electric, water, and sanitary
sewer must be available to serve the site.
Construction of the proposed project will require permanent and temporary impacts to Waters of
the U.S. and Waters of the State to establish access to high -ground developable area, to grade
and balance the site so that practicable development can occur, to construct production facilities,
provide parking fields and construct access roads that meet fire marshal standards. Proposed
impacts associated with the development are itemized below.
The proposed project impacts 1642 linear feet of stream associated with tributary 2 and 3 as
depicted on the site construction plans. Additionally, the site development proposes impacts to
0.83 acres of vegetated wetlands associated with tributary 2 and 3.
Endangered Species and Designated Critical Habitat
Potentially suitable habitat for threatened and endangered species protected under the
Endangered Species Act is present in the project area. The applicant conducted aquatic species
surveys and vegetation surveys and found no protected species within the project area. The
Version 6.15.2017 Page 3

project is located more than 10 miles upstream of any designated critical aquatic habitat for the
Neuse River Waterdog.
Essential Fish Habitat
The proposed project does not occur in or near an area designated as essential fish habitat.
Historic or Prehistoric Cultural Resources
Previous consultation with the North Carolina State Historic Preservation Office (SHPO) during
the permitting activities in 2015 resulted in no comments from the SHPO.
Flood Zone Designation
No portions of the project site occur in FEMA-designated 100-year floodplain.
Avoidance and Minimization Efforts
The applicant's preferred alternative is the result of multiple site designs intended to optimize the
site configuration and expansion opportunities.
Avoidance Efforts
On -site Option 1
The applicant considered multiple designs locating production facilities on the south side of the
channel and warehouse facilities on the north side of the channel in an effort to minimize impacts
to the central channel (Tributary 2) and associated buffers. This configuration did not result in
meeting expansion requirements, disrupted the existing manufacturing process, and generated
significant additional product handling, both in -process and finished product which is
undesirable. The location of the warehouse, towards the northern boundary, is somewhat fixed
because of tractor trailer circulation on the Grifols Access Road. The applicant determined that
this alternative would not meet base project requirements and would result in a non -viable
project, therefore this alternative was eliminated from consideration.
On -site Option 2
The applicant considered a configuration that provided continuity of production and warehousing
by impacting approximately 1,100 linear foot segment of the stream that bisects the site
(Tributary 2). This alternative allowed for the production and packaging facilities to abut the
warehousing facilities and comply with best manufacturing practices. The option functions well
from a production, storage and distribution perspective but was eliminated because it resulted in
waste and production streams being comingled which compromises FDA licensure. This
alternative, while it avoids and minimizes impacts, does not meet minimum material segregation
requirements, making it impractical from a regulatory perspective.
On -site Option 3
The applicant considered multiple designs locating production facilities on the south side of the
channel and warehouse facilities on the north side of the channel in an effort to avoid impacts to
Tributary 1 and associated buffers but impacted the totality of Tributary 2. This configuration
met expansion requirements but disrupted the existing manufacturing process, and generated
significant additional product handling, both in -process and finished product which is
Version 6.15.2017 Page 4

undesirable. The location of the warehouse, towards the northern boundary, is somewhat fixed
because of tractor trailer circulation on the Grifols Access Road. The applicant determined that
this alternative would not meet base project requirements and would result in a non -viable
project, therefore this alternative was eliminated from consideration.
On -site Option 4 Applicant's Preferred)
The applicant's preferred alternative is to impact the totality of the central drainage feature to
construct the above -described facilities, additional parking fields, and additional materials
storage sites. The additional materials storage facilities are beneficial in light of supply chain
complications that can occur. This layout creates separate pathways for personnel, finished
product and waste. The preferred layout provides for additional facilities and parking for future
expansion by removing all obstacles to accommodate projected product needs and facilities
growth over the next 10 years. The site plan avoids approximately 2,000 linear feet (0.229 acres)
of streams and associated Neuse River Riparian Buffers along the northern property line.
Off -site Alternatives
New facilities on new locations are subject to additional licensing under Food and Drug
Administration requirements. Two proximate parcels were considered for the expansion at new
locations but were determined to be ineligible for licensure in the near term. To be truly
practicable, new off -site alternatives need to be adjacent to the existing facility to be efficient and
viewed by the FDA as the same site for licensing of operations. A new off -site alternative is not
logical from a production perspective, timing of licensure nor economically practicable.
One off site parcel (approximately 37 acres) of land adjoining the manufacturing facility was
evaluated for the proposed expansion. The site contained sufficient high ground to accommodate
some of the proposed facilities and therefore lessen impacts to waters of the US at the existing
facility. The applicant contemplated a few road crossings to provide connectivity that would
allow for production with acceptable disruptions. This off -site alternative is not viable because
the owner of the parcel declined the offer to purchase after months of negotiations, engineering
evaluation and appraisals were performed.
Minimization Efforts
The applicant has minimized direct impacts to the riparian buffers and the stream on the northern
property line. Tributary 1, totaling approximately 2000 linear feet, will be avoided during the
expansion contemplated at this time. Indirect impacts to surface waters are minimized through
an extensive stormwater management program. Stormwater outlets will be located as high as
practicable in the receiving streams as practicable and the pre and post drainage areas will be
modeled to have the least environmentally damaging effect.
Compensatory Mitigation
The applicant offered the following compensatory mitigation plan to offset unavoidable
functional loss to the aquatic environment:
The applicant has attempted to avoid and minimize impacts where possible and will compensate
to the extent practicable for the remaining mitigatable unavoidable losses with compensatory
Version 6.15.2017 Page 5

mitigation. The applicant proposes to compensate for 1642 linear feet of permanent streambed
loss due to construction at a 2:1 mitigation ratio, 0.83 acres of riparian wetland loss of forested
wetlands at a 2:1 mitigation ratio, and 144,720 square feet of Zone 1 and Zone 2 riparian buffer
impacts.
To offset unavoidable impacts to the riparian buffer, the applicant proposes to purchase
mitigation credits through a combination of private commercial mitigation bankers and the NC
Division of Mitigation Services in accordance with state and federal law. Specifically, stream
mitigation credits will be satisfied at Restoration System's Milburnie Dam Mitigation Bank and
wetlands mitigation credits will be satisfied at Wildlands Holding's Falling Creek Umbrella
Mitigation Bank. Mitigation needs that are not met by commercial providers will be satisfied
through the Division of Mitigation Services.
The project proponent proposes to complete the mitigation payment within 90 days of the permit
issuance.
Essential Fish Habitat
The Corps' determination is that the proposed project may adversely affect EFH or associated
fisheries managed by the South Atlantic or Mid Atlantic Fishery Management Councils or the
National Marine Fisheries Service.
❑ This notice initiates the Essential Fish Habitat (EFH) consultation requirements of the
Magnuson -Stevens Fishery Conservation and Management Act. Implementation of the
proposed project would impact (CHOOSE ALL THAT APPLY- marine substrate,
estuarine substrate, water columns, emergent wetlands, submerged aquatic vegetation,
artificial reefs, hardbottoms) (see project description) utilized by various life stages of the
following species: (CHOOSE ALL THAT APPLY — coastal migratory pelagics, corals,
golden crab, shrimp, snapper grouper, spiny lobster, Atlantic highly migratory species).
Our initial determination is that the proposed action would not have a substantial
individual or cumulative adverse impact on EFH or fisheries managed by Fishery
Management Councils and the National Marine Fisheries Service (NMFS). Our final
determination relative to project impacts and the need for mitigation measures is subject
to review by and coordination with the NMFS.
❑ The Corps will consult under the Magnuson -Stevens Act and will not make a permit
decision until the consultation process is complete.
❑ The Corps has initiated consultation the Magnuson -Stevens Act and will not make a
permit decision until the consultation process is complete.
Cultural Resources
Pursuant to Section 106 of the National Historic Preservation Act of 1966, Appendix C of 33
CFR Part 325, and the 2005 Revised Interim Guidance for Implementing Appendix C, the
Version 6.15.2017 Page 6

District Engineer consulted district files and records and the latest published version of the
National Register of Historic Places and initially determines that:
❑ Should historic properties, or properties eligible for inclusion in the National Register, be
present within the Corps' permit area; the proposed activity requiring the DA permit (the
undertaking) is a type of activity that will have no potential to cause an effect to an
historic properties.
❑ No historic properties, nor properties eligible for inclusion in the National Register, are
present within the Corps' permit area; therefore, there will be no historic properties
affected. The Corps subsequently requests concurrence from the SHPO (or THPO).
❑ Properties ineligible for inclusion in the National Register are present within the Corps'
permit area; there will be no historic properties affected by the proposed work. The Corps
subsequently requests concurrence from the SHPO (or THPO).
❑ Historic properties, or properties eligible for inclusion in the National Register, are
present within the Corps' permit area; however, the undertaking will have no adverse
effect on these historic properties. The Corps subsequently requests concurrence from the
SHPO (or THPO).
❑ Historic properties, or properties eligible for inclusion in the National Register, are
present within the Corps' permit area; moreover, the undertaking may have an adverse
effect on these historic properties. The Corps subsequently initiates consultation with the
SHPO (or THPO).
❑ The proposed work takes place in an area known to have the potential for the presence of
prehistoric and historic cultural resources; however, the area has not been formally
surveyed for the presence of cultural resources. No sites eligible for inclusion in the
National Register of Historic Places are known to be present in the vicinity of the
proposed work. Additional work may be necessary to identify and assess any historic or
prehistoric resources that may be present.
The District Engineer's final eligibility and effect determination will be based upon coordination
with the SHPO and/or THPO, as appropriate and required, and with full consideration given to
the proposed undertaking's potential direct and indirect effects on historic properties within the
Corps-indentified permit area.
Endangered Species
Pursuant to the Endangered Species Act of 1973, the Corps reviewed the project area, examined
all information provided by the applicant and consulted the latest North Carolina Natural
Heritage Database. Based on available information:
❑ The Corps determines that the proposed project would not affect federally listed
endangered or threatened species or their formally designated critical habitat.
Version 6.15.2017 Page 7

❑ The Corps determines that the proposed project may affect federally listed endangered or
threatened species or their formally designated critical habitat.
❑ By copy of this public notice, the Corps initiates consultation under Section 7 of the
ESA and will not make a permit decision until the consultation process is complete.
❑ The Corps will consult under Section 7 of the ESA and will not make a permit
decision until the consultation process is complete.
❑ The Corps has initiated consultation under Section 7 of the ESA and will not make a
permit decision until the consultation process is complete.
❑ The Corps determines that the proposed project may affect federally listed endangered or
threatened species or their formally designated critical habitat. Consultation has been
completed for this type of activity and the effects of the proposed activity have been
evaluated and/or authorized by the National Marine Fisheries Service (NMFS) in the
South Atlantic Regional Biological Opinion or its associated documents, including
7(a)(2) & 7(d) analyses and Critical Habitat assessments. A copy of this public notice
will be sent to the NMFS.
❑ The Corps is not aware of the presence of species listed as threatened or endangered or
their critical habitat formally designated pursuant to the Endangered Species Act of 1973
(ESA) within the project area. The Corps will make a final determination on the effects of
the proposed project upon additional review of the project and completion of any
necessary biological assessment and/or consultation with the U.S. Fish and Wildlife
Service and/or National Marine Fisheries Service.
Other Required Authorizations
The Corps forwards this notice and all applicable application materials to the appropriate State
agencies for review.
North Carolina Division of Water Resources (NCDWR):
❑ The applicant did not provide or satisfy all 9 elements required for a complete 401
certification request. Therefore, the 401 Certification process has not started. The Corps
will generally not make a final permit decision until the NCDWR issues, denies, or
waives the state Certification as required by Section 401 of the Clean Water Act (PL 92-
500).
❑ The Corps will generally not make a final permit decision until the NCDWR issues,
denies, or waives the state Certification as required by Section 401 of the Clean Water
Act (PL 92-500). The receipt of the application and this public notice, combined with
the appropriate application fee, at the NCDWR Central Office in Raleigh constitutes
Version 6.15.2017 Page 8

initial receipt of an application for a 401 Certification. Unless NCDWR is granted a time
review extension, a waiver will be deemed to occur if the NCDWR fails to act on this
request for certification within 120 days of the date of this public notice. Additional
information regarding the 401 Certification may be reviewed at the NCDWR Central
Office, 401 and Buffer Permitting Unit, 512 North Salisbury Street, Raleigh, North
Carolina 27604-2260. All persons desiring to make comments regarding the application
for a 401 Certification should do so, in writing, by 60 DAYS From PN Issue Date to:
NCDWR Central Office
Attention: Mr. Paul Wojowski, 401 and Buffer Permitting Unit
(LISPS mailing address): 1617 Mail Service Center, Raleigh, NC 27699-1617
Or,
(physical address): 512 North Salisbury Street, Raleigh, North Carolina 27604
North Carolina Division of Coastal Management (NCDCM):
❑ The application did not include a certification that the proposed work complies with and
would be conducted in a manner that is consistent with the approved North Carolina
Coastal Zone Management Program. Pursuant to 33 CFR 325.2 (b)(2) the Corps cannot
issue a Department of Army (DA) permit for the proposed work until the applicant
submits such a certification to the Corps and the NCDCM, and the NCDCM notifies the
Corps that it concurs with the applicant's consistency certification. As the application
did not include the consistency certification, the Corps will request, upon receipt„
concurrence or objection from the NCDCM.
❑ Based upon all available information, the Corps determines that this application for a
Department of Army (DA) permit does not involve an activity which would affect the
coastal zone, which is defined by the Coastal Zone Management (CZM) Act (16 U.S.C.
1453).
Evaluation
The decision whether to issue a permit will be based on an evaluation of the probable impacts
including cumulative impacts of the proposed activity on the public interest. That decision will
reflect the national concern for both protection and utilization of important resources. The benefit
which reasonably may be expected to accrue from the proposal must be balanced against its
reasonably foreseeable detriments. All factors which may be relevant to the proposal will be
considered including the cumulative effects thereof, among those are conservation, economics,
aesthetics, general environmental concerns, wetlands, historic properties, fish and wildlife
values, flood hazards, flood plain values (in accordance with Executive Order 11988), land use,
navigation, shoreline erosion and accretion, recreation, water supply and conservation, water
quality, energy needs, safety, food and fiber production, mineral needs, considerations of
property ownership, and, in general, the needs and welfare of the people. For activities involving
the discharge of dredged or fill materials in waters of the United States, the evaluation of the
Version 6.15.2017 Page 9

impact of the activity on the public interest will include application of the Environmental
Protection Agency's 404(b)(1) guidelines.
Commenting Information
The Corps of Engineers is soliciting comments from the public; Federal, State and local agencies
and officials, including any consolidated State Viewpoint or written position of the Governor;
Indian Tribes and other interested parties in order to consider and evaluate the impacts of this
proposed activity. Any comments received will be considered by the Corps of Engineers to
determine whether to issue, modify, condition, or deny a permit for this proposal. To make this
decision, comments are used to assess impacts on endangered species, historic properties, water
quality, general environmental effects and the other public interest factors listed above.
Comments are used in the preparation of an Environmental Assessment (EA) and/or an
Environmental Impact Statement (EIS) pursuant to the National Environmental Policy Act
(NEPA). Comments are also used to determine the need for a public hearing and to determine the
overall public interest of the proposed activity.
Any person may request, in writing, within the comment period specified in this notice, that a
public hearing be held to consider the application. Requests for public hearings shall state, with
particularity, the reasons for holding a public hearing. Requests for a public hearing will be
granted, unless the District Engineer determines that the issues raised are insubstantial or there is
otherwise no valid interest to be served by a hearing.
The Corps of Engineers, Wilmington District will receive written comments pertinent to the
proposed work, as outlined above, until 5pm, . Comments should be submitted to
Asheville Regulatory Field Office, 151 Patton Avenue, Room 208,
Asheville, North Carolina 28801-5006, at ( ) -
Version 6.15.2017 Page 10

State of North Carolina
DWR Department of Environment and Natural Resources
Division of Water Resources
Vivisicn of Water Resources
15A NCAC 02B .0233 (8)(b), .0243 (8)(b), .0250 (11)(b), .0259 (8)(b), .0267 (11)(c), .0607 (e)(2)
Protection and Maintenance of Riparian Areas Rules - Variance Application
FORM: VAR 10-2013
PLEASE IDENTIFY WHICH RIPARIAN AREA PROTECTION RULE APPLIES:
❑ Neuse River Basin (15A NCAC 02B.0233)
❑ Major Variance ❑ Minor Variance
❑ Catawba River Basin (15A NCAC 02B.0243)
❑ Randleman Lake Water Supply Watershed (15A NCAC 02B.0250)
❑ Major Variance ❑ Minor Variance
❑ Tar -Pamlico River Basin (15A NCAC 02B.0259)
❑ Major Variance ❑ Minor Variance
❑ Jordan Lake Water Supply Nutrient Strategy (15A NCAC 02B.0267)
❑ Major Variance ❑ Minor Variance
❑ Goose Creek Watershed (15A NCAC 02B.0606 & 15A NCAC 02B.0607)
A. General Information
1. Applicant's Information(if other than the current property owner):
Name: Novo Nordisk Pharmaceutical Industries. LP
Title: Chad Henry, Corporate Vice President
Street Address: 3612 Powhatan Rd
City, State & Zip: Clayton, NC 27527
Telephone: [phone]
Email: [e-mail]
2. Property Owner/Signing Official (person legally responsible for the property and its compliance):
Name: Chad Henry
Title:
Corporate Vice President
Street Address:
3612 Powhatan Rd
City, State & Zip:
Clayton, NC 27527
Telephone:
[phone]
Email:
[e-mail]
FORM: VAR 10-2013

3. Agent Information:
3a. Name: Christopher Huysman
Company Affiliation: Wetlands and Waters, Inc
Street Address: 328 East Broad Street, Suite D
City, State & Zip: Statesville, NC 28677
Telephone: [phone]
E-mail: [e-mail]
3b. Attach a signed and dated copy of the Agent Authorization letter if the Agent has signatory authority for the owner.
4. Project Name (Subdivision, facility, or establishment name):
Novo Nordisk Site Capacity Expansion
5. Project Location:
5a. Street Address: 3612 Powhatan Rd
City, State & Zip: Clayton, NC 27527
5b. County: Johnston County
5c. Site Coordinates (in decimal degrees): _
Latitude
Longitude
5d. Attach an 8'Y, x 11 excerpt from the most recent version of the USGS topographic map indicating the location of the site.
5e. Attach an 8'Y, x 11 excerpt from the most recent version of the published County NRCS Soil Survey Map depicting the
project site.
6. Property Information:
6a. Property identification number (parcel ID): 05E99010G
6b. Date property was purchased: Purchased 1991, Entity Name Change April 16, 2010
6c. Deed book 03834 and page number 0904
6d. Map book and page number
6e. Attach a copy of the recorded map that indicates when the lot was last platted.
7. Is your project in one of the 20 Coastal Counties covered under the Coastal Area Management Act (CAMA)?
❑ YES ❑ NO
7a. If you answered yes above, in which AEC do you fall (30 ft or 75 ft)?
7b. If you answered yes above, what is the total percent of impervious cover that you have proposed within the AEC?
FORM: VAR 10-2013 Page 2 of 6

8. Directions to site from nearest major intersection:
The site is located south of the Town of Clayton. From the intersection of US Highway Business 70 W and Powhatan Road. Take
Powhatan Road 0.67 miles and the site is located on the left side of the road.
9. Stream associated with riparian buffer to be impacted by the proposed activity:
Name Water Quality Classification
UT Neuse River WS-IV;NSW
9a. For Goose Creek only: Is the buffer in the 100-year floodplain? ❑ YES ❑ NO
10. List any permits/approvals that have been requested or obtained for this project in the past (including all prior phases).
Date Applied: Date Received: Permit Type:
DWR 20041660 (401/404)
DWR 20150465 (401/404)
DWR 20150715 (Neuse River Buffers
B. Proposed Activity
1. Project Description
1a. Provide a detailed description of the proposed activity including its purpose:
The proposed activity is the expansion of an existing pharmaceutical manufacturing facility. The facility includes
manufacturing, packaging, and warehousing facilities for specialty products. Further details are included in the USACE
Individual Permit application for this project.
1b. Attach a site plan showing the following items as applicable to the project:
0 Development/Project name
0 Revision number & date
0 North arrow
0 Scale (1" = 50' is preferred)
0 Property/project boundary with dimensions
0 Adjacent streets and roads labeled with names and/or NC State Road numbers
0 Original contours and proposed contours
0 Perennial and intermittent streams, ponds, lakes, rivers and estuaries
0 Mean high water line (if applicable)
0 Wetlands delineated, or a note on plans that none exist
0 Location of forest vegetation along the streams, ponds, lakes, rivers and estuaries
0 Extent of riparian buffers on the land including Zone 1 and Zone where applicable
0 Location and dimension of the proposed buffer impact (label the area of buffer impact in ftz on the plan)
0 Details of roads, parking areas, cul-de-sacs, sidewalks, and curb and gutter systems
0 Footprint of any proposed buildings or other structures
0 Discharge points of gutters on existing structures and proposed buildings
0 Existing drainage (including off -site), drainage easements, and pipe dimensions
0 Drainage areas delineated
FORM: VAR 10-2013 Page 3 of 6

C. Proposed Impacts and Mitigation
1. Individually list the square footage of each proposed impact to the protected riparian buffers:
Buffer Impact
Number'—
Permanent (P) or
Temporary (T)
Reason for Impact
Buffer
Mitigation
Required
Zone 1 Impact
(square feet)
Zone 2 Impact
(square feet)
B1 - ❑ P ❑ T
Structural fill
❑ Yes ❑ No
95793.6
63862.4
B2 -❑P ❑T
❑ Yes ❑No
B3 -❑P ❑T
❑ Yes ❑No
Total Buffer Impacts
159656
'Label on site plan
2. Identify the square feet of impact to each zone of the riparian buffer that requires mitigation from the table above. Calculate
the amount of mitigation required.
Required
Zone
Total Impact
Multiplier
Mitigation
(square feet)
(square feet)
Zone 1'
3
287380.8
(2 for Catawba only)
Zone 2
1.5
95793.6
Total Buffer Mitigation Required:
383174.4
'For projects in the Goose Creek Watershed, list all riparian buffer impacts as Zone 1
and use Zone 1 multiplier.
3. Provide a description of how mitigation will be achieved at your site pursuant to the mitigation requirements of the applicable
river basin/watershed.
Mitigation will be achieved through the purchase of credits from either private mitigation banker or the states in lieu fee
program according to state regulations..
3a. Is buffer restoration or enhancement proposed? ❑ Yes ❑ No
If yes, attach a detailed planting plan to include plant type, date of plantings, the date of the one-time fertilization in the
protected riparian buffers, and a plan sheet showing the proposed location of the plantings.
3b. Is payment into a buffer restoration fund proposed? ❑ Yes ❑ No
If yes, attach an acceptance letter from the mitigation bank you propose to use or the NC Ecosystem Enhancement
Program stating they have the mitigation credits available for the mitigation requested.
FORM: VAR 10-2013 Page 4 of 6

D. Stormwater
1. Provide a description of how diffuse flow will be maintained through the protected riparian buffers (e.g., re -planting vegetation
or enhancement of existing vegetation, gutter splash pads, level spreader to control of runoff from impervious surfaces, etc.).
1a. Show the location of diffuse flow measure(s) on your site plan.
1b. Attach a completed Level Spreader Supplement Form or BMP Supplement Form with all required items for each proposed
measure.
1c. Attach an Operation and Maintenance (O&M) Form for each proposed level spreader or BMP.
2. For Major, Catawba, and Goose Creek variance requests, provide a description of all best management practices (BMPs) that
will be used to minimize disturbance and control the discharge of nutrients and sediments from stormwater.
2a. Show the location of BMPs on your site plan.
2b. Attach a Supplement Form for each structural BMP proposed.
2c. Attach an Operation and Maintenance (O&M) Form for each structural BMP proposed.
E. Demonstration of Need for a Variance
The variance provision of the riparian buffer rules allows the Division or the Environmental Management Commission to grant a
variance when there are practical difficulties or unnecessary hardships that prevent compliance with the strict letter of riparian
buffer protection.
1. Explain how complying with the provisions of the applicable rule would prevent you from securing a reasonable return from or
make reasonable use of your property. Merely proving that the variance would permit a greater profit from the property shall
not be considered adequate justification for a variance. The Division will consider whether the variance is the minimum possible
deviation from the terms of the applicable Buffer Rule that shall make reasonable use of the property possible.
Please see the attached cover letter from Novo Nordisk. Complete adherence to the rule will prevent the reasonable use of the
property to manufacture, store and distribute drug products. The project is being reviewed by the US Army Corps of Engineers
and the NC Division of Water Resources for an Individual Permit. The applicant conducted a thorough alternatives analysis
trying to avoid impacting aquatic resources and their associated buffers. The exception ensures that the facility will continue to
reliably produce life-saving products to meet market demands.
FORM: VAR 10-2013 Page 5 of 6

Explain how the hardship results from application of the Buffer Rule to the property rather from other factors such as deed
restrictions or other hardships (e.g. zoning setbacks, floodplains, etc).
Adherence to the buffer rule will prevent the expansion of the proposed facility according to current good manufacturing
practices. Food and Drug Administration rules and regulations dictate procedural processes to keep products aseptic which
include storing and managing raw products, managing waste stream, and ensuring reliable manufacturing processes. The
central drainage effectively cuts the site in two which, if it remains unimpacted, results in disrupted production flow, capacity
and handling.
3. Explain how the hardship results from physical nature of the property, such as its size, shape, or topography, which is different
from that of neighboring property.
The site is an FDA licensed pharmaceutical manufacturing facility that is bounded on three sides by established transportation
corridors. Two streams subject to the rule are present on the site: one bisects it and the other forms a boundary. The
topography of the site requires that mass grading be completed to provide a uniform elevation for the manufacturing processes.
4. Explain whether the hardship was caused by the applicant knowingly or unknowingly violating the applicable Buffer Rule.
The applicant has not violated the applicable buffer rules
5. For Neuse, Tar -Pamlico, Jordan Lake and Goose Creek only: Did the applicant purchase the property after the effective date of
the applicable Buffer Rule and then request a variance?
The applicant purchased the property before the effective date of the rule.
6. Explain how the hardship is rare or unique to the applicant's property, rather than the result of conditions that are widespread.
The site is bound on three sides by transportation infrastructure which limits expansion opportunities. The expansion must be
logical and adhere to good manufacturing practices for pharmaceutical products and comply with FDA rules and regulations.
F. Deed Restrictions
By your signature in Section G of this application, you certify that all structural stormwater BMPs required by this variance shall
be located in recorded drainage easements, that the easements will run with the land, that the easements cannot be changed
or deleted without concurrence from the State, and that the easements will be recorded prior to the sale of any lot.
G. Applicant's Certification
I, (print or type name of person listed in Section A, Item 2), certify that
the information included on this permit application form is correct, that the project will be constructed in conformance with the
approved plans and that the deed restrictions in accordance with Section F of this form will be recorded with all required permit
conditions.
Signature:
Date
FORM: VAR 10-2013 Page 6 of 6

October 13, 2022
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a4fWETLANDS
ea-1 WATERS, I N r-
Vicinity Map
i-rojeci i,4arne:
Owner/ Developer:
City / County:
Tax PIN(s):
Coordinates:
Lat: 36.62029 Long: -78.41109
Novo Nordisk
Stewart
Clayton/Johnston
05E9901OG
Scale: Date:
Graphic I
12-09-2021

POTENTIALLY JURISC
NON -WETLAND WATERS OI
TRIBUTARY 3 +/- 302 LF (+
POTEr
WETLA
POTENTIALLY JURISDICTIONAL
`-�- � NON -WETLAND WATERS OF THE U.S.
POTENTIALLY JURISDICTIONAL
NON -WETLAND WATERS OF THE U.S.
TRIBUTARY 2+/- 1340 LF (+/-0.153 ac) A
kL
1 r
ly �
ITIALLY JURISDICTIONAL
VD WATERS OF THE U.S. S
WETLAND 2+/-0.03 ac /
S
�� POTENTIALLY JURISDICTIONAL
WETLAND WATERS OF THE U.S.
WETLAND 1 +/- 0.80 ac ,.
AVERAGE OHWM f
4 AVERAGE OHWM
*Wetland Sketch provided for illustrative purposes for preliminary planning use only. Not intended
to be relied upon for exact location, dimensions, or orientation. All findings and assessments made
by wetland consultants regarding limits ofjurisdiction or permitting requirements are subject to
verification by the US Army Corps of Engineers and other appropriate state and local authorities.
Project Name: Novo Nordisk
Owner / Developer: Stewart
WETLANDS City / County: Clayton/Johnston
& WATERS, INC.
Tax PiN(s): 05E99010G
Figure 1: Approximate Delineation Coordinates: Scale: Date:
of Surface Waters and Wetlandsb Lat: 36.62029 Long:-78.41109 Graphic 12-09-2021

.'T. ' IWETLANDS
WATERS, IfVC.
Figure 2: County GIS
rojeci ivame:
Novo Nordisk
Owner / Developer:
City / County:
Tax PIN(s):
Coordinates: Scale:
Lat: 36.62029 Long:-78.41109
Stewart
Clayton/Johnston
05E99010G
Date:
Graphic 12-09-2021

Nrojeci ivame:
Novo Nordisk
Owner / Developer: Stewart
' WETLANDS City/County:
. & WATERS, INC. Clayton/Johnston
Tax PiN(s): O5E99O1OG
Figure 3: USGS Topographic Coordinates: Scale: Date:
Quadrangle 0 Lat: 36.62029 Long:-78.41109 Graphic 12-09-2021

Map Unit Symbol
Map Unit Name
Acres in AOI
Percent of AOI
CoB
Cowarts loamy sand, 2 to 6
percent slopes
6.0
11.3 %
FaB
Faceville sandy loam, 2 to 6
percent slopes
5.3
10.0 %
GeB
Gilead sandy loam, 2 to B
percent slopes
8.7
16.4 %
GoA
Goldsboro sandy loam, 0 to 2
percent slopes
2.6
4.9 %
PaE
Pacolet loam, 15 to 25 percent
slopes
12.9
24.3 %
Ra
Rains sandy loam, 0 to 2
percent slopes
0.0
0.0 %
UcB
Uchee loamy coarse sand, 2 to
6 percent slopes
3.4
6.4 %
Utl
Utlorthents, loamy
0.8
1.5 %
VrA
Varina loamy sand, 0 to 2
percent slopes
13.4
25.3 %
Totals for Area of Interest
63.1
100.0
Soil Map —Johnston County, North Carolina
(project_shapefile_novo_nordisk_west_facili_33092_33092) _
734100 734200 734300 734400 734500 734600 734700
35- 37'27"N 35- 37'27"N
g
W
V
I !
Y
Map Unit Legend
.A
rig
r,
„k r
C
T
35- 36' 57" N
734200 734300 734400 734500 734600 734700 734800
N Meters
Map Scale: 1:4,480 if printed on A portrait (8.5" x 11") sheet.
a -
0 50 100 200 300
Feet
0 200 40D 800 1200
Map projection: Web Mercator Comer coordinates: WGS84 Edge tics: UTM Zone 17N WGS84
Project Name: Novo Nordisk
n
IN\
Owner / Developer: Stewart
WETLANDS City/County:
WATERS, I N c. Clayton/Johnston Tax PIN(s): 05E99010G
Figure 4: NRCS Soil Survey Coordinates: Scale: Date:
Lat: 36.62029 Long:-78.41109 Graphic 12-09-2021

National Wetlands Inventory Wetlands
1:9,470
0 0.075 0.15 0.3 mi
0 0.125 0.25 0.5 km
December 9, 2021
Wetlands
❑
Freshwater Emergent Wetland Lake
Estuarine and Marine Deepwater
r
Freshwater Forested/Shrub Wetland Other
❑ Estuarine and Marine Wetland
❑
Freshwater Pond Riverine
This map is for general reference only. The US Fish and Wildlife
Service is not responsible for the accuracy or currentness of the
base data shown on this map. All wetlands related data should
be used in accordance with the layer metadata found on the
Wetlands Mapper web site.
rrojeci ivame:
Novo Nordisk
Owner / Developer: Stewart
I WETLANDS City /County:
i s WATERS, INC. Clayton/Johnston
Tax PIN(s): 05E99010G
Figure 5: National Wetland Coordinates: Scale: Date:
Inventory 0 Lat: 36.62029 Long:-78.41109 Graphic 12-09-2021

600ft
wWETLANDS
a4 WATERS} INC.
%{
r
PANEL
3721D16770010
78.404 35.620 Degrees
�I
Project Name:
Novo Nordisk
Owner / Developer:
Stewart
City / County:
Clayton/Johnston
Tax PiN(s):
05E99010G
Figure 6: FEMA Floodplain Panel Coordinates: Scale: Date:
Lat: 36.62029 Long:-78.41109 Graphic 12-09-2021

Novo Nordisk, Clayton Site
Adjacent Property Owners
GRIFOLS THERAPEUTICS LLC
ATTN: CLAYTON FACILITIES MANAGER
4201 RESEARCH COMMONS
79 TW ALEXANDER DR
DURHAM, NC 27709
TOWN OF CLAYTON
ATTN: TOWN MANAGER
PO BOX 777
CLAYTON, NC 27528-0777
POWHATAN FREE WILL BAPTIST
ATTN: PROPERTY COMMITTEE
3468 POWHATAN RD
CLAYTON, NC 27527

ROY COOPER
Governor
ELIZABETH S. BISER
Secretary
MARC RECKTENWALD
Director
Chad Henry
Novo Nordisk
3612 Powhatan Road
Clayton, NC 27520-9217
Project: Novo Nordisk Expansion
NORTH CAROLINA
Environmental Quality
October 11, 2022
Expiration of Acceptance: 4/11/2023
County: Johnston
The purpose of this letter is to notify you that the NCDEQ Division of Mitigation Services (DMS) is willing to
accept payment for compensatory mitigation for impacts associated with the above referenced project as
indicated in the table below. Please note that this decision does not assure that participation in the DMS in -
lieu fee mitigation program will be approved by the permit issuing agencies as mitigation for project impacts.
It is the responsibility of the applicant to contact permitting agencies to determine if payment to the DMS will
be approved. You must also comply with all other state, federal or local government permits, regulations or
authorizations associated with the proposed activity including G.S. § 143-214.11.
This acceptance is valid for six months from the date of this letter and is not transferable. If we have not
received a copy of the issued buffer approval within this time frame, this acceptance will expire. It is
the applicant's responsibility to send copies of the permits to DMS. Once DMS receives a copy of the
permit(s) an invoice will be issued based on the required mitigation in that permit and payment must be
made prior to conducting the authorized work. The amount of the in -lieu fee to be paid by an applicant is
calculated based upon the Fee Schedule and policies listed on the DMS website.
Based on the information supplied by you in your request to use the DMS, the impacts for which you are
requesting compensatory mitigation credit are summarized in the following table. The amount of mitigation
required and assigned to DMS for this impact is determined by permitting agencies and dependent
on the availability of bank credits and may differ from the amounts shown below.
River Basin
Impact Location
8-di it HUC
Impact Type
Impact Quantity
Neuse
03020201
Riparian Buffer
Up to 65,000 @3:1
Neuse
03020201
Riparian Buffer
Up to 85,000 @ 1.5:1
Upon receipt of payment, DMS will take responsibility for providing the compensatory mitigation. The
mitigation will be performed in accordance with the In -Lieu Fee Program instrument dated July 28, 2010 and
15A NCAC 02B .0295 as applicable. Thank you for your interest in the DMS in -lieu fee mitigation program.
If you have any questions or need additional information, please contact [e-mail].
Sincerely,
A_�t-
FOR James. B Stanfill
Deputy Director
cc: Chris Huysman, agent
North Carolina Department of Environmental Quality I Division of Mitigation Services
RE IQ 217 west Jones Street 1 1652 Mail Service Center I Raleigh, North Caro€Ina 27699-1652
919.747.8976

Statement of Mitigation Credit Availability
Milburnie Dam Mitigation Bank
October 11, 2022
Re: Availability of Compensatory Stream Mitigation Credits
Project: Novo Nordisk Expansion
This document confirms that 5,432 Stream Credits (Credits) from the Milburnie Dam Mitigation
Bank (Bank) are currently available and all or a portion may be used, once transferred, for
compensatory mitigation relative to the Novo Nordisk Expansion project, and as proposed by Novo
Nordisk Pharmaceuticals Industries, LP (Applicant).
The Applicant may ultimately purchase the Credits, if they are available, following Permit issuance.
Should the Applicant purchase the Credits at that time, we will complete and execute the Mitigation
Credit Transfer Certificate (Certificate) within five (5) days of receipt of the full purchase price.
We will additionally provide copies of the completed and executed Certificate to the Applicant, the
U.S. Army Corp of Engineers (USACE) and, if needed, other regulatory agencies. In addition, we will
provide USACE with an updated copy of the Bank's Ledger, reflecting the transaction. Transaction
information in the updated Bank Ledger will include relevant Permit and Applicant information as
well as the number and resource type of the debited Credits.
Should your office have any questions, please contact me at 919.334.9118.
Sincerely,
BARRETT JENKINS
Restoration Systems, LLC
1101 Haynes St., Suite 211 • Raleigh, NC 27604 • www.restorationsystems.com • Ph 919.755.9490 • Fx 919.755.9492

HWILDLANDSoi�
Neuse Wetland Credits Statement of Availability
October 13, 2022
Novo Nordisk
Attn: Chad Henry
3612 Powhatan Rd
Clayton, NC 27528
RE: Availability of Stream and Riparian Wetland Credits for the "Novo Nordisk Site Capacity Expansion"
project
Bank Name: Falling Creek Umbrella Mitigation Bank
Bank Sites: Falling Creek Mitigation Site / Grantham Branch Mitigation Site / McClenny Acres II
Mitigation Site
Bank Sponsor: Wildlands Holdings III, LLC
USACE Action ID No.: SAW-2015-00940 / SAW-2017-00549 / SAW-2017-00552
Permittee: Novo Nordisk
Riparian Wetland Credits Needed: 1.86 acres
Riparian Wetland Credits Available: 5.69 acres
Neuse 03020201 River Basin
Dear Mr. Henry,
Wildlands Holdings III, LLC, owned and operated by Wildlands Engineering, Inc., currently has sufficient stream
and/or riparian wetland credits from the Falling Creek Umbrella Mitigation Bank: Falling Creek Mitigation Site,
Grantham Branch Mitigation Site, and McClenny Acres II Mitigation Site to satisfy the stream and/or wetland
mitigation requirements related to the above -mentioned project. The project is located within the Neuse River
Basin of the service area (HUC 03020201) of the Bank.
This letter is simply a statement of availability of credits as of the date written. We have the inventory as shown
above, however, this letter is not a guarantee of availability as credits will be sold on a first come, first serve
basis. An invoice for this transaction will be sent upon your request and we will formally reserve both the
credits and price quoted for a period of 30-days from the invoice.
Final transfer of the credits will be made upon receipt of a copy of the 401 Water Quality Certification and
Authorization Certificate from the NC Department of Environmental Quality -Division of Water Resources
approving the Stream mitigation purchase from the Bank and upon receipt of your payment to Wildlands
Holdings III, LLC (depending on availability at the time of permit issuance). We will then issue a credit transfer
certificate verifying your credit purchase to the North Carolina Division of Water Resources and to you for your
records.
We appreciate the opportunity to assist you with your mitigation requirements. Please contact me at (704) 332-
7754 x114 or [e-mail] if you have any questions or need any additional information.
Wildlands Holdings III, LLC • Wildlands Engineering, Inc • 1430 South Mint Street, Suite 104, Charlotte, INC 28203

HWILDLANDSoi�
Sincerely,
Camden M. Brunick
Wildlands Engineering, Inc.
Mitigation Credit Sales
[e-mail]
0: [phone] ext. 114
M: [phone]
Cc: Mr. Chris Huysman, Project Manager I Wetlands & Waters, Inc
Mr. Chris Hopper, Regulatory Agent I USACE
Wildlands Holdings III, LLC • Wildlands Engineering, Inc • 1430 South Mint Street, Suite 104, Charlotte, NC 28203

10/18/22, 1:52 PM wetlands-waters.com Mail - Fwd: Pre -File Notification, NWP 39, Johnston County NC (Novo Nordisk)
WWLAND5 Chris Huysman <[e-mail]>
,W1A_TE:R5, INC.
Fwd: Pre -File Notification, NWP 39, Johnston County NC (Novo Nordisk)
1 message
Meagan Jolly <[e-mail]>
To: "Chris. Huysman" <[e-mail]>
Meagan Jolly
[phone]
Sent from mobile
---------- Forwarded message ---------
From: Meagan Jolly <[e-mail]>
Date: Tue, Apr 26, 2022, 2:38 PM
Subject: Pre -File Notification, NWP 39, Johnston County NC (Novo Nordisk)
To: <401 PreF![e-mail]>
Applicant: Novo Nordisk
NWP 39
Johnston County, NC (Clayton)
Project contact Meagan Jolly, 704-681-3479
Meagan Jolly
704.681.3479
www.wetiands-waters.com
44WETLANDS
S� WATERS, INC.
Tue, Oct 18, 2022 at 1:49 PM
The information contained in this email message is confidential and may be legally privileged and is intended only for the use of the
individual or entity named above. If you are not an intended recipient or if you have received this message in error, you are hereby
notified that any dissemination, distribution or copy of this email is strictly prohibited. If you have received this email in error, please
immediately notify us by return email or telephone if the sender's phone number is listed above, then promptly and permanently delete
this message. Thank you for your cooperation and consideration.
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