I(3) International Isotopes Inc.
Section A Contract Form and Signature Page
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Contract Number: PM-801
Mod Number: Orig
Date: 2/06/98
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To: MSS Clean Technology, Inc. From: International Isotopes Inc.
0000 Xxxxxxxxx Xxxxx, Xxxxx 000 0000 Xxx Xxxxxxxx Xxxx
Xxxxxxx, XX 00000 Xxxxxx, XX 00000
This definitive contract is made and entered into by and between International
Isotopes Inc., address above, a Texas corporation, (hereinafter referred to as
I(3), or "Buyer" and MSS Clean Technology Inc., a Delaware corporation, address
above, hereinafter referred to as MSS, or "Seller".
Whereas, International Isotopes Inc. is in the business of supplying equipment,
services, pharmaceuticals, and components to the drug industry. International
Isotopes Inc. desires to obtain the services of Seller related to fabrication
and installation of clean room facilities, and Seller is willing to provide such
services. Accordingly, the parties have agreed as follows:
The Seller has represented to the Buyer that it has the capability and capacity
without any additional Buyer furnished facilities to perform all of the work
hereunder in accordance with the terms of the order, except as noted herein.
Xxxxx and Xxxxxx have negotiated and mutually agreed upon the Contract
requirements and deliveries, established a price arrangement, and other terms
and conditions as contained herein.
The Seller acceptance of this subcontract will be indicated by affixing its
authorized signature to two (2) originals of this Contract and returning one
executed original to I(3) no later than: February 6th, 1998.
ARTICLE A-1: INCLUSIVE SECTIONS
A-1
Section A Contract Form and Content
ARTICLE A-1: INCLUSIVE SECTIONS
Documents comprising this Contract are as follows:
Document Title
-------- -----
Section A Contract Form and Content
Section B Schedule of Supplies, Services, and Pricing
Section C Statement of Work and Quality Assurance Requirements
Section D Packaging, Marking, and Transportation
Section E Qualification and Acceptance Provisions
Section F Delivery and Performance Schedules
Section G Administrative Data
Section H Special Contract Requirements and Provisions
Section I General Contract Requirements and Provisions
Section J List of Documents, Exhibits, and other Attachments
Section K Representations and Certifications
ARTICLE A-2: TERMS AND CONDITIONS
The Buyer and Seller have mutually agreed upon the Contract requirements and
established a firm fixed price for items and services listed in Section B. The
terms and conditions shall be as listed in the specific sections listed above.
ARTICLE A-3: PERIOD OF PERFORMANCE
The Period of Performance (POP) of this Contract shall be from December 5th,
1997 through May 31st, 1998. The period of performance specifically includes
the design phase which was initiated by Xxxxx's letter of intent dated December
5th, 1997 and authorized by Xxxxx's letter dated December 9th, 1997.
A-2
Section B Schedule of Supplies, Services, and Pricing
ARTICLE B-1: DELIVERABLES
The following deliverable contract line items are herein established for this
Contract:
Line Description Qty Unit Price Extended
Item Price
1 Design Package Development $100,000 $100,000
2 Envelope System
3 HVAC System
4 Electrical System
5 Plumbing and Piping System
6 Steelwork System
7 Miscellaneous Items
8 Specialty Services
NOTE: Line Items 2 through 8 are
Not Separately Priced
Total $1,995,789
Add-on tasks per quote dated January 28th $19,003
Revised Total Fixed Price $2,014,792
The above table lists the general category of facilities and services to be
provided under this contract. The detailed items and services to be supplied are
listed in the MSS proposal 10694/Q5737, dated January 6th, 1998, incorporated
herein by reference. The items and services are further described in work
statements, specifications, and drawings which are incorporated into this
contract by reference in Section C and Section J.
ARTICLE B-2: COST/PRICE
B.2.1 FIRM FIXED PRICE
The Firm Fixed Price for all facilities, goods, and services to be
supplied under this contract is $2,014,792. All prices are in U.S. dollars. This
total price includes all efforts authorized and performed under pre-contract
letter authorizations issued by Xxxxx on December 5th, and December 9th, 1997,
and on January 13th, 1998.
B.2.2 FIXED PRICE OPTIONS--not applicable to this Contract.
B.2.3 UNPRICED OPTIONS--not applicable to this Contract.
B-3
Section B Schedule of Supplies, Services, and Pricing
ARTICLE B-3: PROGRESS AND MILESTONE PAYMENTS
Progress and/or Milestone payments will be made net 30 days from receipt of
properly executed invoice at the address specified below.
International Isotopes Inc.
0000 Xxx Xxxxxxxx Xxxx
Xxxxxx, XX 00000
Attn: Accounts Payable, Xx X. Xxxxxxx
B.3.1 PROGRESS PAYMENTS--not applicable to this contract.
B.3.2 MILESTONE PAYMENTS
The following billing milestones are applicable to this contract:
------------------------------ --------------------- ------------- ----------------------
Event Projected Date Event Amount
------------------------------ --------------------- ------------- ----------------------
Initial Authorization 12/9/97 $50,000
------------------------------ --------------------- ------------- ----------------------
Award and Design Approval 1/30/98 $50,000
------------------------------ --------------------- ------------- ----------------------
MSS On-Site 2/9/98 $425,000
------------------------------ --------------------- ------------- ----------------------
MSS On-Site 4 wks 3/9/98 Note 1 $425,000
------------------------------ --------------------- ------------- ----------------------
MSS On-Site 8 wks 4/6/98 Note 1 $425,000
------------------------------ --------------------- ------------- ----------------------
Satisfactory Completion 4/27/98 $519,003
------------------------------ --------------------- ------------- ----------------------
Final Certifications 6/1/98 $120,789
------------------------------ --------------------- ------------- ----------------------
------------------------------ --------------------- ------------- ----------------------
Total $2,014,792
------------------------------ --------------------- ------------- ----------------------
Payment of the above billing milestones are based on satisfactory progress
toward completion of the clean room facilities. If, in the sole opinion of
Xxxxx, satisfactory progress is not being made, formal notice will be given to
Seller as to the amount of payment being withheld, and the expected corrective
action(s) necessary to cure the deficiency and obtain release of withheld
payment.
Note 1: Payment event for these payments will be derived from the detailed
construction schedule available not later than February 15th, 1998. Buyer and
Seller shall mutually agree on schedule event(s) which comprise basis for
payment.
B-4
Section C Statement of Work and Quality Assurance Requirements
Statement of Work (SOW)
MSS is to perform all design, fabrication, installation and testing of the clean
room complex as described in the proposal dated January 6th, 1998, and all
related specifications and drawings. The clean room complex includes:
Envelop system
Clean Room Classified Areas
Non-Classified Areas
HVAC System
Electrical System
Plumbing and Piping System
Steelwork System
Miscellaneous and Specialty Equipment and Tasks, including:
HVAC and Power Test & Balance
Cleanroom Certification
Engineering design and drawing development
On-site Installation and Supervision
Project Management
The work shall be performed in accordance with Attachment A to this contract,
the MSS Scope of Work & Technical Specification For Cleanroom and Ancillary Area
Construction fax dated January 14th, 1998. All materials shall conform to the
specifications contained in that design package.
C-5
Section D Packaging, Marking, and Transportation
MSS is responsible for the safe packaging, transportation, and delivery of the
clean room components from MSS facilities to I(3) Denton, Texas facilities at
0000 Xxx Xxxxxxxx Xxxx.
D-6
Section E Qualification and Acceptance Provisions
Acceptance shall be at I(3) Denton, Texas facilities. Acceptance inspection and
testing shall be performed in accordance with the I(3) approved test plan and
inspection procedures.
Clean Room Certification (MSS document 15191, revised by I(3) and applied as
attachment B to this Contract) will be used as basis for the detailed acceptance
test plan.
E-7
Section F Delivery and Performance Schedules
The following scheduled milestones must be met in the performance of this
contract:
------------------------------ --------------------- ------------- ----------------------
Event Projected Date Item Completion
------------------------------ --------------------- ------------- ----------------------
Award and Design Approval 1/30/98 Contract Signature
------------------------------ --------------------- ------------- ----------------------
MSS On-Site 2/9/98 Team/Subs in Denton
------------------------------ --------------------- ------------- ----------------------
MSS On-Site 4 wks 3/9/98 See B 3.2
------------------------------ --------------------- ------------- ----------------------
MSS On-Site 8 wks 4/6/98 See B 3.2
------------------------------ --------------------- ------------- ----------------------
Satisfactory Completion 4/27/98 Successful Walk thru
------------------------------ --------------------- ------------- ----------------------
Final Certifications 6/1/98 All Certifications
------------------------------ --------------------- ------------- ----------------------
F-8
Section G Administrative Data
ARTICLE G-1: NOTICES
Formal notices under this Contract given by either party to the other shall be
in writing and transmitted via fax, followed by signed copy sent by U.S. Postal
Service, Certified Mail, Return Receipt Requested (or equivalent premium package
service) addressed as follows:
SELLER INTERNATIONAL ISOTOPES INC.
MSS Clean Technology International Isotopes Inc.
0000 Xxxxxxxxx Xxxxx, Xxxxx 000 0000 Xxx Xxxxxxxx Xxxx
Xxxxxxx, XX 00000 Xxxxxx, XX 00000
Attn: Xxxxx Xxxxxxxxx Attn: Xxxxx Xxxxxxx
ARTICLE 2: POINTS OF CONTACT
The following points of contact are designated for this contract:
Technical Issues:
SELLER INTERNATIONAL ISOTOPES INC.
Xxxx Xxxxx Xxx Xxxxxx
MSS Clean Technology International Isotopes Inc.
0000 Xxxxxxxxx Xxxxx, Xxxxx 000 0000 Xxx Xxxxxxxx Xxxx
Xxxxxxx, XX 00000 Xxxxxx, XX 00000
Phone: 000-000-0000 Phone: 000-000-0000
Fax: 000-000-0000 Fax: 000-000-0000
Contract Issues:
SELLER INTERNATIONAL ISOTOPES INC.
Xxxxx Xxxxxxxxx Xxxxx Xxxxxxx
MSS Clean Technology International Isotopes Inc.
0000 Xxxxxxxxx Xxxxx, Xxxxx 000 0000 Xxx Xxxxxxxx Xxxx
Xxxxxxx, XX 00000 Xxxxxx, XX 00000
Phone: 000-000-0000 Phone: 000-000-0000
Fax: 000-000-0000 Fax: 000-000-0000
G-9
Section H Special Contract Requirements and Provisions
ARTICLE H-1: ORDER OF PRECEDENCE
In the event of any inconsistency or conflict between or among the sections of
this contract, the following order of precedence shall be used to resolve the
conflict:
(1) This contract, specifically Articles A and B
(2) The Specifications and Drawings, as defined in Section J.
(3) The Statement of Work, as defined in Section C.
ARTICLE H-2: CHANGES AND WRITTEN AUTHORIZATION
Changes, extensions, or other modifications to this Contract may be made at any
time during the period of performance hereof. Changes affecting scope of work,
delivery schedule, or price shall require written consent of the parties hereto.
Changes to this Contract will be executed only by individual(s) authorized by
I(3) to make such changes. Changes will take the form of a fully executed
modification to this Contract. All risk of executing any changes not authorized
in writing by I(3) rests with the Seller.
ARTICLE H-3: BUYER FURNISHED FACILITIES, EQUIPMENT, AND DATA
The following items of facilities, equipment, material, and data shall be
supplied by I(3) to the Seller for use in the performance of work under this
subcontract:
Buyer will provide Seller with access to facilities at 0000 Xxx Xxxxxxxx Xxxx,
Xxxxxx, XX for the purpose of erecting Clean Room and supporting facility
improvements. Facility support will be provided by I(3) as listed in
EXCLUSIONS/CLARIFICATIONS section of the MSS proposal dated January 6th, 1998,
except for items 1, 2, 4, and 5, which were incorporated into this contract from
Seller's quote dated January 28th, 1998.
If items are supplied by I(3) but not consumed in the performance of work under
this Contract, they shall be returned at the end of performance in usable
condition, normal wear and tear excepted, freight prepaid. Data supplied by I(3)
shall be packaged for protection and returned to I(3) via First Class Mail at
the completion of performance.
ARTICLE H-4: WARRANTY
MSS shall provide a One-year parts, materials, and installation warranty on all
clean room elements and components provided by or installed under the
supervision of MSS. Warranty items supplied by MSS which do not pass FDA
validation must be corrected within 15 days of notice from I(3).
H-10
Section H Special Contract Requirements and Provisions
ARTICLE H-5: PROPRIETARY DATA
In the event either buyer or seller is required or finds it necessary to provide
company private or proprietary data to the other party during the performance of
this Contract, Buyer and Seller agree to afford such data with the protection
necessary to preclude its inadvertent disclosure to unauthorized parties. Such
data must be destroyed or returned to originator upon request. Should
destruction be requested, the party in possession of the data shall certify its
destruction by letter to the party who originated the data.
ARTICLE H-6: DISPUTES
In the event of a dispute arising between the parties during the performance of
this Contract, such dispute shall be resolved through arbitration as defined:
Arbitration
(a) As concluded by the parties to this Contract on the advise of their
counsel, and as evidenced by the signatures of the parties hereto, it is agreed
that all questions as to rights and obligations arising over the terms of this
Contract are subject to arbitration except disputes in which less than $50,000
is in controversy, and such arbitration shall be governed by the provisions of
the Texas General Arbitration Act.
(b) If a dispute should arise under this Contract, either party may
within 30 days after the date on which such dispute arises make a demand for
arbitration by filing a demand in writing with the other. The parties to this
Contract may agree on one arbitrator, but in the event that they cannot do so
there shall be three arbitrators, one named in writing by each of the parties
within 60 days after demand for arbitration is made, and a third to be chosen by
the two so named. Should either party fail to timely join in the appointment of
the arbitrators, the arbitrators shall be appointed in accordance with the
provisions of Texas Civil Practice and Remedies Code, Section 171.003.
(c) All arbitration hearings conducted under the terms of this Contract,
and all judicial proceedings to enforce any of the provisions of this Contract,
shall take place in Xxxxxx County, Texas.
(d) If there is only one arbitrator, his or her decision shall be
binding and conclusive on the parties. If there are three arbitrators, the
decision of any two shall be binding and conclusive. The submission of a dispute
to the arbitrators and the rendering of their decision shall be a conditions
precedent to any right of legal action on the dispute.
(e) The cost and expenses for arbitrators, including the fees of the
arbitrators, shall be borne by the losing party or in such proportions as the
arbitrators shall determine.
H-11
Section H Special Contract Requirements and Provisions
ARTICLE H-7: TERMINATION
This contract may be terminated, under any of the following circumstances, by
Xxxxx by giving 30 days formal notice to Seller.
a. Termination for Default; For any material breach by Seller; the
Default provisions in H-8 below shall apply.
b. Termination for Convenience of Buyer; Buyer to pay actual and
reasonable costs through date of termination; fee settlement will be
negotiated between Buyer and Seller.
c. Completion of the Contract; a properly executed Release of Claims may
be required by Xxxxx.
termination.
ARTICLE H-8: DEFAULT BY SELLER AND REMEDIES
The following shall constitute events of default by Seller pursuant to this
Contract:
a. Seller fails to comply with any covenant, condition, requirement or
obligation required of Seller hereunder and such failure is not cured within 5
days after written notice of such failure is provided to Seller by Buyer;
b. Xxxxxx makes an assignment of Xxxxxx's business for the benefit of creditors;
c. A petition of bankruptcy is filed by or against Seller;
d. A receiver, trustee in bankruptcy, or similar officer is appointed to take
control of all or part of Seller's property; or
e. Seller is adjudicated a bankrupt.
In the event of such default International Isotopes may terminate this agreement
and sue for damages or pursue any other remedy available to it at law or in
equity.
ARTICLE H-9: LIQUIDATED DAMAGES--not used.
H-12
Section I General Contract Requirements and Provisions
ARTICLE I-1: GOVERNING LAW AND FORM
This Contract shall in all respects be interpreted, construed, and governed by
and in accordance with the laws of the State of Texas, disregarding any conflict
of law provisions which may require the application of the law of another
jurisdiction. Any action to enforce, or which arises out of or in any way
relates to, any of the provisions of this Contract shall be brought and
prosecuted in such court or courts located within the State of Texas as provided
by law; and the parties consent to the jurisdiction of said court or courts
located within the State of Texas, and to service or process by registered mail,
return receipt requested, or by any other manner provided by the law of the
State of Texas.
ARTICLE I-2: CONFIDENTIALITY AGREEMENT
Sellers performing work for I(3) are required to sign the company's
Confidentiality Agreement, which is attached hereto and incorporated into this
Contract by this reference.
ARTICLE I-3: PUBLICITY Neither party to this Contract may use the name of the
other in news releases, publicity, advertising, or product/service promotions
without the prior written consent of the other. I(3) reserves the right to
review and approve the content of any publicity materials prepared for release
by the Seller wherein that material refers to I(3) or the work covered by this
Contract.
ARTICLE I-4: COUNTERPARTS
This Contact may be executed simultaneously in two or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute
and be the same instrument. All schedules, exhibits and documents referred to
Article A-1 hereof, are incorporated herein and expressly made a part of this
Contract as though completely set forth herein. All references to this Contract
herein or in any of the schedules, exhibits or documents referred to in Article
A-1 and attached hereto shall be deemed to refer to this entire Contract,
including all schedules, exhibits and attachments.
ARTICLE I-5: INDEMNIFICATION
Seller shall defend, indemnify and hold harmless Buyer and its directors,
shareholders, officers, employees, agents, consultants, representatives,
affiliates, successors and assigns from and against any and all claims,
liabilities, obligations, losses, costs, expenses (including without limitation,
reasonable legal expenses), litigation, proceedings, fines, taxes, levies,
duties, deficiencies, assessments, charges, penalties, allegations, demands,
damages (including by not limited to actual, punitive or consequential, foreseen
or unforeseen, known or unknown, fixed or contingent, and matured or unmatured),
civil and criminal violations of law, settlements and judgments of any kind or
nature whatsoever, which may incur or arise out of the performance of Seller's
duties and obligations hereunder.
I-13
Section I General Contract Requirements and Provisions
ARTICLE I-6: ASSIGNABILITY
This Contract shall not be assignable by either party without the express
written consent of the other except for assignments to subsidiaries or
affiliates of the parties hereto, provided that such assignment or assignments
shall not relieve the assigning party of any obligation or liability under this
Contract.
ARTICLE I-7: HEADINGS
The headings and subheadings hereof are inserted for the convenience of
reference only and shall not affect the interpretation of this Contract.
ARTICLE I-8: BINDING EFFECT
This Contract shall be binding upon, inure to the benefit of, and be enforceable
by the successors and permitted assigns to the parties hereto.
ARTICLE I-9: WAIVERS
Any waiver of rights hereunder must be set forth in writing. A waiver of any
breach or failure to enforce any of the terms or conditions of this Contract
shall not in any way affect, limit or waive either party's rights at any time to
enforce strict compliance thereafter with every term or condition of this
Agreement.
ARTICLE I-10: SEVERABILITY
If and to the extent that any court of competent jurisdiction holds any
provisions, or any part thereof, of this Contract to be invalid or enforceable,
such holdings shall in no way affect the validity of the remainder of this
Contract.
ARTICLE I-11: ENTIRE AGREEMENT
This Contract constitutes the entire agreement of the parties with respect to
the subject matter hereto and supersedes all previous agreements, understandings
or discussions with respect to the subject matter hereof.
I-14
Section J List of Documents, Exhibits, and other Attachments
The following table of drawings (issue in effect at time of award unless changed
below) shall define the facility to be designed, built, installed, and delivered
under this contract:
For plumbing and electrical requirements, the provisions of the Conceptual
Design Summary shall apply until the formal drawings are received and approved
by Xxxxx.
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Sheet Title Date Rev
----------------- ---------------------------------- -------------- --------------
M-1 Symbols & Abbreviations 1/14/98
----------------- ---------------------------------- -------------- --------------
M-2 Flow Schematic 1/14/98
----------------- ---------------------------------- -------------- --------------
M-3 Flow Schematic 1/14/98
----------------- ---------------------------------- -------------- --------------
M-4 Equipment Schedules 1/14/98
----------------- ---------------------------------- -------------- --------------
M-5 Make Up Air Duct Plan 1/14/98
----------------- ---------------------------------- -------------- --------------
M-6 Recirc Ductwork Plan 1/14/98
----------------- ---------------------------------- -------------- --------------
M-7 Exhaust Ductwork Plan 1/14/98
----------------- ---------------------------------- -------------- --------------
M-8 HVAC Piping Plan 1/14/98
----------------- ---------------------------------- -------------- --------------
M-9 Mechanical Sections To Be
Produced
----------------- ---------------------------------- -------------- --------------
M-10 Mechanical Sections To Be
Produced
----------------- ---------------------------------- -------------- --------------
M-11 Mechanical Details 1/14/98
----------------- ---------------------------------- -------------- --------------
M-12 Mechanical Details 1/14/98
----------------- ---------------------------------- -------------- --------------
P-1 Process Piping Plan TBP
----------------- ---------------------------------- -------------- --------------
P-2 Drain Systems Plan TPB
----------------- ---------------------------------- -------------- --------------
P-3 Plumbing Details TBP
----------------- ---------------------------------- -------------- --------------
P-4 Plumbing Details TBP
----------------- ---------------------------------- -------------- --------------
P-5 Plumbing Details TBP
----------------- ---------------------------------- -------------- --------------
E-1 One Line Diagram 1/14/98
----------------- ---------------------------------- -------------- --------------
E-2 Electrical Floor Plan TBP
----------------- ---------------------------------- -------------- --------------
E-3 Lighting Plan TBP
----------------- ---------------------------------- -------------- --------------
E-4 Power Plan TBP
----------------- ---------------------------------- -------------- --------------
E-5 Electrical Details TBP
----------------- ---------------------------------- -------------- --------------
E-6 Panel Schedules TBP
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J-15
Section J List of Documents, Exhibits, and other Attachments
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Sheet Title Date Rev
----------------- ---------------------------------- -------------- --------------
5737-0601 Cleanroom Ceiling Interface 1/8/98
Detail
----------------- ---------------------------------- -------------- --------------
5737-0602 Ancillary Area Ceiling Interface 1/8/98
Detail
----------------- ---------------------------------- -------------- --------------
5737-0603 Cleanroom Flooring Interface 1/13/98
Detail
----------------- ---------------------------------- -------------- --------------
5737-0604 Ancillary Area Flooring 1/13/98
Interface Detail
----------------- ---------------------------------- -------------- --------------
7384-98 Steel Systems Mezzanine 1/13/98
----------------- ---------------------------------- -------------- --------------
M-4, Equipment Schedules, provides the list and specifications of major
equipment items.
J-16
Section J List of Documents, Exhibits, and other Attachments
This West Building Conceptual Design Summary provides a summary of the facility
design requirements/specifications which must be met:
--------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
Room No. Room Name Cleanroom Dimensions Area Temp Humidity Velocity ACPH
Classification (LxWxH) SqFt F +/- %RH +/- FPM
--------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
1 Process Materials Storage N/A 12x11x8 132 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
2 Airlock #1 100,000 12x11x8 132 70 +/-2 <60 20
--------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
3 RadioPharm Lab #1 10,000 12x15x9 180 70 +/-2 <60 60
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
4 RadioPharm Lab #2 10,000 12x15x9 180 70 +/-2 <60 30
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
5 RadioPharm Lab #3 10,000 12x15x9 180 70 +/-2 <60 30
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
6 RadioPharm Lab #4 10,000 12x15x9 180 70 +/-2 <60 60
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
7 RadioPharm Lab #5 10,000 12x15x9 180 70 +/-2 <60 30
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
8 RadioPharm Lab #6 10,000 12x15x9 180 70 +/-2 <60 30
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
9 Hallway 10,000 12x5.5x9 66 70 +/-2 <60 30
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
10 Airlock #2 100,000 24x5.5x9 132 70 +/-2 <60 20
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
11 Autoclave & Storage N/A 16x20.5x8 328 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
12 Assay N/A 16x15x8 240 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
13 Lead Pig Storage N/A 11x10x8 110 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
14 Radiological Control Area N/A 11x10x8 110 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
15 Hallway N/A 271x6.5x8 1762 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
16 QC Analytical Lab N/A 355.5 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
17 Pre Package 1 N/A 12x15x8 180 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
18 Vial Fill #1 1,000 12x18x8 216 70 +/-2 <60 40
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
19 Airlock 100K 100,000 45 70 +/-2 <60 20
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
20 Airlock 10K 10,000 70 +/-2 <60 30
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
21 Vial Fill #2 1,000 12x18x8 216 70 +/-2 <60 40
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
22 Cold Chemistry 100,000 278.5 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
23 Pre Package 2 N/A 12x18x8 216 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
24 Airlock 100K 100,000 7.5x6x8 45 70 +/-2 <60 20
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
25 Airlock 10K 10,000 7.5x6x8 45 70 +/-2 <60 30
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
26 Airlock 1K 1,000 8x8x8 64 70 +/-2 <60 40
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
27 Aseptic Vials Receiving 100 16x8x8 128 70 +/-2 <60 90+/-18 60
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
28 Records N/A 16x10x8 160 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
29 QC Radiometric N/A 16x10x8 160 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
30 Radio Assay N/A 16x10x8 160 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
31 Glass Washing Vial N/A 483.5 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
32 Quarantine N/A 12x7x8 84 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
33 Label Storage N/A 12x7x8 84 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
34 Stability N/A 16x9x8 144 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
35 HP Lab N/A 16x9x8 144 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
36 Label Room N/A 16x9x8 144 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
37 Radiological Control Area N/A 9x9x8 81 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
38 Xxxxx Room N/A 5x8x8 40 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
39 Men's Lockers N/A 198 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
40 Men's Sinks N/A 112 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
41 Men's Toilets N/A 115 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
42 Rad Gowning N/A 13.5x11x8 148.5 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
43 cGMP Cleaning Materials N/A 5x8x8 40 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
44 Women's Lockers N/A 198 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
45 Women's Sinks N/A 104 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
46 Women's Toilets N/A 109 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
47 Airlock 100K 100,000 5x9x8 45 70 +/-2 <60 20
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
48 Airlock 10K 10,000 5x9x8 45 70 +/-2 <60 30
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
49 Sterility Lab 1,000 15x9x8 135 70 +/-2 <60 40
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
50 Micro Prep N/A 25x9x8 225 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
9,032
--------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
J-17
Section J List of Documents, Exhibits, and other Attachments
--------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
Room No. Room Name Cleanroom Dimensions Area Temp Humidity Velocity ACPH
Classification (LxWxH) SqFt F +/- %RH +/- FPM
--------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
51 Chemistry Records N/A 18x17x8 306 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
52 Micro Lab N/A 15x9x8 135 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
53 Incubator N/A 9x25x8 225 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
54 QA Records N/A 18x27x8 486 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
59 Hallway N/A 25x6.5x8 163 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
60 Unpacking Room N/A 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- --------- --------- -------
61 Autoclave Tech Room N/A 70 +/-2 <60 10
--------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
Total - Rooms 51-54 1,446
--------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
Total - Rooms 1-50 9,032
--------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
Total Square Footage 10,478
--------- -------------------------- ------------- -------------- ------- -------- ---------- --------- -------
J-18
Section J List of Documents, Exhibits, and other Attachments
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
Room No. Room Name Number Light Diff. Exhaust Heat Gain Air Flow Supply
of People Level (FC) Pressure (CFM) (KW)
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
1 Process Materials Storage 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
2 Airlock #1 1 75 OT DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
3 RadioPharm Lab #1 1 75 1315 OT DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
4 RadioPharm Lab #2 1 75 350 OT DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
5 RadioPharm Lab #3 1 75 350 OT DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
6 RadioPharm Lab #4 1 75 1315 OT DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
7 RadioPharm Lab #5 1 75 350 OT DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
8 RadioPharm Lab #6 1 75 350 OT DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
9 Hallway 0 75 OT DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
10 Airlock #2 1 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
11 Autoclave & Storage 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
12 Assay 3 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
13 Lead Pig Storage 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
14 Radiological Control Area 1 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
15 Hallway 2 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
16 QC Analytical Lab 1 75 965 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
17 Pre Package 1 2 75 965 OT DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
18 Vial Fill #1 1 75 350 OT DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
19 Airlock 100K 1 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
20 Airlock 10K 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
21 Vial Fill #2 1 75 350 OT DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
22 Cold Chemistry Lab 1 75 1930 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
23 Pre Package 2 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
24 Airlock 100K 1 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
25 Airlock 10K 1 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
26 Airlock 1K 1 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
27 Aseptic Vials Receiving 1 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
28 Records 1 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
29 QC Radiometric 75 1930 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
30 Radio Assay 1 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
31 Glass Washing Vial 1 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
32 Quarantine 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
33 Label Storage 0 50 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
34 Stability 0 50 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
35 HP Lab 0 50 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
36 Label Room 0 50 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
37 Radiological Control Area 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
38 Xxxxx Area 0 50 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
39 Men's Lockers 3 50 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
40 Men's Sinks 2 50 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
41 Men's Toilets 2 50 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
42 Rad Gowning 1 100 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
43 cGMP Cleaning Materials 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
44 Women's Lockers 3 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
45 Women's Sinks 2 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
46 Women's Toilets 2 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
47 Airlock 100K 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
48 Airlock 10K 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
49 Sterility Lab 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
50 Micro Prep 1 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
J-19
Section J List of Documents, Exhibits, and other Attachments
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
Room No. Room Name Number Light Diff. Exhaust Heat Gain Air Flow Supply
of People Level (FC) Pressure (CFM) (KW)
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
51 Chemistry Records 2 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
52 Micro Lab 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
53 Incubator 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
54 QA Records 2 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
59 Hallway 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
60 Unpacking 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
61 Autoclave Tech Room 0 75 RECIRC DUCTED
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
J-20
Section J List of Documents, Exhibits, and other Attachments
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
Room No. Room Name Return HVAC Floor Wall Ceiling Fire Other
Type Zone Type Type Type Protect
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
1 Process Materials Storage DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
2 Airlock #1 DUCTED 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
3 RadioPharm Lab #1 DUCTED 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
4 RadioPharm Lab #2 DUCTED 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
5 RadioPharm Lab #3 DUCTED 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
6 RadioPharm Lab #4 DUCTED 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
7 RadioPharm Lab #5 DUCTED 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
8 RadioPharm Lab #6 DUCTED 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
9 Hallway DUCTED 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
10 Airlock #2 DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
11 Autoclave & Storage DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
12 Assay DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
13 Lead Pig Storage DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
14 Radiological Control Area DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
15 Hallway DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
16 QC Analytical Lab DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
17 Pre Package 1 DUCTED 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
18 Vial Fill #1 DBWALL 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
19 Airlock 100K DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
20 Airlock 10K DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
21 Vial Fill #2 DBWALL 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
22 Cold Chemistry Lab DUCTED 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
23 Pre Package 2 DUCTED 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
24 Airlock 100K DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
25 Airlock 10K DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
26 Airlock 1K DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
27 Aseptic Vials Receiving DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
28 Records DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
29 QC Radiometric DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
30 Radio Assay DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
31 Glass Washing Vial DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
32 Quarantine DUCTED 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
33 Label Storage DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
34 Stability DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
35 HP Lab DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
36 Label Room DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
37 Radiological Control Area DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
38 Xxxxx Room DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
39 Men's Lockers DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
40 Men's Sinks DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
41 Men's Toilets DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
42 Decontamination DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
43 Women's Restroom DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
44 Women's Lockers DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
45 Women's Sinks DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
46 Women's Toilets DBWALL 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
47 Airlock 100K DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
48 Airlock 10K DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
49 Sterility Lab DUCTED 1 Piece Smooth T-Grid SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
50 Micro Prep DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
J-21
Section J List of Documents, Exhibits, and other Attachments
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
Room No. Room Name Return HVAC Floor Wall Ceiling Fire Other
Type Zone Type Type Type Protect
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
51 Chemistry Records DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
52 Micro Lab DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
53 Incubator DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
54 QA Records DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
59 Hallway DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
60 Unpacking Room DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
61 Autoclave Tech Room DUCTED 1 Piece Smooth SUSP SPRNK
--------- -------------------------- ---------- ---------- --------- ---------- ----------- --------- ----------
J-22
Section J List of Documents, Exhibits, and other Attachments
--------- -------------------------- ------------------------------------------------------------------------
Room No. Room Name Equipment
--------- -------------------------- ------------------------------------------------------------------------
1 Process Materials Storage
--------- -------------------------- ------------------------------------------------------------------------
2 Airlock #1
--------- -------------------------- ------------------------------------------------------------------------
3 RadioPharm Lab #1 Controlled Process Box (Class 100), Filling Machine, Movable Clean Air
Projector
--------- -------------------------- ------------------------------------------------------------------------
4 RadioPharm Lab #2 Controlled Process Box (Class 100), Filling Machine, Movable Clean Air
Projector
--------- -------------------------- ------------------------------------------------------------------------
5 RadioPharm Lab #3 Controlled Process Box (Class 100), Filling Machine, Movable Clean Air
Projector
--------- -------------------------- ------------------------------------------------------------------------
6 RadioPharm Lab #4 Controlled Process Box (Class 100), Filling Machine, Movable Clean Air
Projector
--------- -------------------------- ------------------------------------------------------------------------
7 RadioPharm Lab #5 Controlled Process Box (Class 100), Filling Machine, Movable Clean Air
Projector
--------- -------------------------- ------------------------------------------------------------------------
8 RadioPharm Lab #6 Controlled Process Box (Class 100), Filling Machine, Movable Clean Air
Projector
--------- -------------------------- ------------------------------------------------------------------------
9 Hallway
--------- -------------------------- ------------------------------------------------------------------------
10 Airlock #2
--------- -------------------------- ------------------------------------------------------------------------
11 Autoclave & Storage Autoclave, Pyrogen Oven
--------- -------------------------- ------------------------------------------------------------------------
12 Assay 4 Dose Calibrator Ionization Xxxxxxxx, Computer
--------- -------------------------- ------------------------------------------------------------------------
13 Lead Pig Storage
--------- -------------------------- ------------------------------------------------------------------------
14 Radiological Control Area
--------- -------------------------- ------------------------------------------------------------------------
15 Hallway
--------- -------------------------- ------------------------------------------------------------------------
16 QC Analytical Lab
--------- -------------------------- ------------------------------------------------------------------------
17 Pre Package 1
--------- -------------------------- ------------------------------------------------------------------------
18 Vial Fill #1
--------- -------------------------- ------------------------------------------------------------------------
19 Airlock 100K
--------- -------------------------- ------------------------------------------------------------------------
20 Airlock 10K
--------- -------------------------- ------------------------------------------------------------------------
21 Vial Fill #2
--------- -------------------------- ------------------------------------------------------------------------
22 Cold Chemistry
--------- -------------------------- ------------------------------------------------------------------------
23 Pre Package 2 Crimping Machine, Moveable Clean Air Projector
--------- -------------------------- ------------------------------------------------------------------------
24 Airlock 100K
--------- -------------------------- ------------------------------------------------------------------------
25 Airlock 10K
--------- -------------------------- ------------------------------------------------------------------------
26 Airlock 1K
--------- -------------------------- ------------------------------------------------------------------------
27 Aseptic Vials Receiving Stoppering Machine
--------- -------------------------- ------------------------------------------------------------------------
28 Quarantine
--------- -------------------------- ------------------------------------------------------------------------
29 QC Radiometric
--------- -------------------------- ------------------------------------------------------------------------
30 Radio Assay HPGe Gamma Detector
--------- -------------------------- ------------------------------------------------------------------------
31 Glass Washing Vial Vial Washer, Stopper Washer, Dbl Door Autoclave, Dbl Door Hot Air
Sterilizer
--------- -------------------------- ------------------------------------------------------------------------
32 Quarantine
--------- -------------------------- ------------------------------------------------------------------------
33 Label Storage Labeling Machine
--------- -------------------------- ------------------------------------------------------------------------
34 Stability Stability Xxxxxxxx
--------- -------------------------- ------------------------------------------------------------------------
35 HP Lab Misc HP Equipment/Detectors
--------- -------------------------- ------------------------------------------------------------------------
36 Label Room Computer/Printer
--------- -------------------------- ------------------------------------------------------------------------
37 Radiological Control Area
--------- -------------------------- ------------------------------------------------------------------------
38 Xxxxx Room Survey Instruments
--------- -------------------------- ------------------------------------------------------------------------
39 Men's Lockers
--------- -------------------------- ------------------------------------------------------------------------
40 Men's Sinks
--------- -------------------------- ------------------------------------------------------------------------
41 Men's Toilets
--------- -------------------------- ------------------------------------------------------------------------
42 Gowning
--------- -------------------------- ------------------------------------------------------------------------
43 cGMP Cleaning Materials
--------- -------------------------- ------------------------------------------------------------------------
44 Women's Lockers
--------- -------------------------- ------------------------------------------------------------------------
45 Women's Sinks
--------- -------------------------- ------------------------------------------------------------------------
46 Women's Toilets
--------- -------------------------- ------------------------------------------------------------------------
47 Airlock 100K
--------- -------------------------- ------------------------------------------------------------------------
48 Airlock 10K
--------- -------------------------- ------------------------------------------------------------------------
49 Sterility Lab
--------- -------------------------- ------------------------------------------------------------------------
50 Micro Prep
--------- -------------------------- ------------------------------------------------------------------------
J-23
Section J List of Documents, Exhibits, and other Attachments
--------- -------------------------- ------------------------------------------------------------------------
Room No. Room Name Equipment
--------- -------------------------- ------------------------------------------------------------------------
51 Chemistry Records
--------- -------------------------- ------------------------------------------------------------------------
52 Micro Lab
--------- -------------------------- ------------------------------------------------------------------------
53 Inclubator Incubators
--------- -------------------------- ------------------------------------------------------------------------
54 QA Records
--------- -------------------------- ------------------------------------------------------------------------
59 Hallway
--------- -------------------------- ------------------------------------------------------------------------
60 Unpacking Room
--------- -------------------------- ------------------------------------------------------------------------
61 Autoclave Tech Room Autoclave
--------- -------------------------- ------------------------------------------------------------------------
J-24
Section J List of Documents, Exhibits, and other Attachments
Utilities Schedule
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
Room No. Room Name TW PW SD FD HD IC WFI CA N(2) VAC
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
1 Process Materials
Storage
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
2 Airlock #1 x . x
+sink
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
3 RadioPharm Lab #1 . . x-GB x x-GB x-GB x-GB
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
4 RadioPharm Lab #2 . x-GB x x-GB x-GB x-GB
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
5 RadioPharm Lab #3 . x-GB x x-GB x-GB x-GB
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
6 RadioPharm Lab #4 . x x-GB x x x-GB x-GB x-GB
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
7 RadioPharm Lab #5 . x-GB x x-GB x-GB x-GB
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
8 RadioPharm Lab #6 . x-GB x x-GB x-GB x-GB
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
9 Hallway
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
10 Airlock #2
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
11 Autoclave & Storage x x x x x x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
12 Assay
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
13 Lead Pig Storage x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
14 Radiological Control
Area
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
15 Hallway
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
16 QC Analytical Lab x x x x x x x-
-xxxx -xxxx hood
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
17 Pre Package Lab x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
18 Vial Fill #1 x x x x x-GB x-GB x-GB
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
19 Airlock 100K x+sink
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
20 Airlock 10K
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
21 Vial Fill #2 x x x x-GB x-GB x-GB
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
22 Cold Chemistry Lab x x x x x-GB x-GB
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
23 Pre Package 2 x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
24 Airlock 100K x x+sink
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
25 Airlock 10K
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
26 Airlock 1K
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
27 Aseptic Vials x
Receiving
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
28 Quarantine
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
29 QC Radiometric x x x x x x
-xxxx -xxxx -hood
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
30 Radio Assay
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
31 Glass Washing Vial x x x+sink 3x x x x x x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
32 Quarantine
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
33 Label Storage x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
34 Stability x x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
35 HP Lab x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
36 Label Room
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
37 Radiological Control
Area
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
38 Xxxxx Room x x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
39 Men's Lockers x x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
40 Men's Sinks x x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
41 Men's Toilets x x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
42 Degowning . .
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
43 cGMP Closet x x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
44 Women's Lockers x x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
45 Women's Sinks x x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
46 Women's Toilets x x
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
47 Airlock 100k x x+sink
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
48 Airlock 10K
--------- ----------------------- ------ ------- ------- ------ ------- ------ ------- ------ ------- ------
49 Sterility Lab 1k
--------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
50 Micro Prep x x x
--------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
51 Chemistry Records
--------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
52 Micro Lab x x x x x
--------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
53 Incubator x x
--------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
54 QA Records
--------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
59 Hallway
--------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
60 Unpacking Room
--------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
61 Autoclave Tech Room x
--------- ----------------------- ------ ------ ------- ------ ------ ------ ------- ------- ------ ------
TW=Hot and Cold Tap Water PW=Purified Water USP SD=Sink Drain FD=Floor Drain
VAC=Vacuum N2 =Nitrogen HD=Drain for radioactive liquids IC=Intercom System
SCS=Safety Communication System CA=Compressed Air GB=Glove Box -Provide Valved
Connection 4' from corner/ 8' above FFL
J-25
Section K Representations and Certifications
ARTICLE K-1: CORPORATE STATUS Seller is a Sole Proprietorship __N/A___.
Seller is a Partnership duly organized, valid and existing and in good standing
under the laws of ______N/A_________.
Seller is a Corporation duly organized, valid and existing and in good standing
under the laws of Delaware.
ARTICLE K-2: AUTHORITY
The execution, delivery and performance of this Contract and all other
agreements, instruments and documents to be delivered hereunder have been duly
and validly authorized by the Board of Directors of Seller or other appropriate
authority. No other action must be taken to make this Contract and all other
agreements, instruments and documents to be executed and delivered hereunder,
valid and legally binding upon Seller in accordance with their respective terms,
subject to general principles of equity and accept as enforceability thereof may
be limited by applicable bankruptcy, insolvency, reorganization or other similar
laws of general application relating to creditors' rights.
ARTICLE K-3: COMPLIANCE WITH LAW
Seller has complied with and is not in violation of applicable statutes, laws
and regulations which would affect its ability to perform its respective
obligations hereunder.
ARTICLE K-4: XXXXXXX'X COMPENSATION INSURANCE
Seller certifies that during the term of this contract that he will maintain, at
his expense workmen's compensation insurance and comprehensive liability
insurance, providing coverage against liability for bodily injury, death, and
property damage, in the minimum amount of $1,000,000 per occurrance.
Certificates regarding such coverage are available upon request.
K-31
Signature Page
--------------------------------------------------------------------------------
Contract Number: PM-801
Mod Number: Orig
Date: 2/06/98
--------------------------------------------------------------------------------
The above pages, through this page and including any attachments referenced
herein, constitute the full content of this contract between International
Isotopes Inc. and MSS Technologies.
SIGNATURES
Executed as of February 5, 1998
SELLER INTERNATIONAL ISOTOPES INC.
By: /s/ Xxxxx Xxxxxxxx By: /s/ Xxx Xxx Xxxxxx By: /s/ Xxxx Xxxxxxxx
------------------ -------------------- ------------------
Name: Xxxxx Xxxxxxxx Name: Xxx Xxx Xxxxxx Name: Xxxxx Xxxxxxxx
Title: Vice-President Title: Chairman Title: Exec. Vice President
Date: 2/5/98 Date: 2/5/98 Date: 2/5/98
