Exhibit 10.1

FINAL EXECUTION COPY

CONTRACT MANUFACTURE AGREEMENT

This Agreement (“the Agreement”) is made on the 27th day of September 2010
between:

 

1. IMMUCELL CORPORATION, a corporation duly organised and existing under the
laws of the United States of America having its principal office at 56 Evergreen
Drive, Portland, Maine 04103 USA hereinafter referred to as “the Principal”;

 

2. NORBROOK LABORATORIES LIMITED, a corporation duly organised and existing
under the laws of Northern Ireland, having its principal office at Station
Works, Newry, County Down, BT35 6JP, Northern Ireland hereinafter referred to as
“the Manufacturer”.

WHEREAS:

 

(A) The Principal represents that it is the owner of the Product(s) as defined
in Schedule 1, and is desirous of entrusting the Manufacturer with their
completion and assembly, as more fully provided herein; and

 

(B) The Manufacturer represents that it has the necessary facilities, equipment,
personnel and expertise, and all appropriate or necessary permits, licenses and
certifications for the completion and assembly of the Product(s), as more fully
provided herein; and

 

(C) In furtherance thereof the parties hereto have therefore agreed to enter
into this Agreement on the terms and subject to the conditions hereinafter
contained.

NOW IT IS HEREBY AGREED in consideration of these presents as follows:

 

1. GENERAL CONDITIONS

Subject Matter of the Agreement.

 

  1.1 The Manufacturer hereby agrees to incorporate or combine the materials to
be obtained by the Manufacturer, as set forth in Schedule 2 hereof, into or with
the materials to be provided by the Principal to the Manufacturer, as set forth
in Schedule 2 hereto, in order to complete, assemble and deliver to the
Principal the Product(s) as defined in Schedule 1 hereto in conformance with the
specifications set out in Schedule 2 hereto, and in accordance with the terms of
this Agreement.

 

  1.2

The Principal hereby undertakes during the term of this Agreement to purchase
the Product(s) exclusively from the Manufacturer and not to perform the tasks
contemplated hereby to be performed by the Manufacturer on its own account, or
to have another person or entity perform such tasks, except as otherwise
provided in Sections 3.4 and 10 hereof. The Manufacturer hereby agrees that,
through the second anniversary of the Commencement Date (as hereinafter defined)
and for so long thereafter as the Principal places timely orders with the

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Manufacturer for at least xxxxxxx syringes per Contract Year (as hereinafter
defined), the Manufacturer will not assemble, complete, manufacture or otherwise
provide services, directly or indirectly, with respect to or involving Nisin to
any persons or entity other than the Principal. Such restriction shall continue
in effect xxxxxxxxxxxx following the termination or expiration of this
Agreement, other than a termination resulting from the breach by a Principal of
its obligations hereunder.

 

  1.3 The Principal hereby undertakes to ensure that the materials to be
provided by the Principal for incorporation into the Product(s), as described in
Schedule 2 hereto, will at all times comply with the standard set out for them
in the said specifications.

 

  1.4 Unless and to the extent otherwise reasonably directed by the Principal in
writing, the Manufacturer shall purchase and warehouse a maximum of twelve
(12) months (or such lesser period remaining in the term of this Agreement) raw
materials in accordance with the order forecasts provided for under Clause 2.1
hereto, provided always that the Principal shall be liable for the cost of
unused or redundant raw materials (whether arising due to any change in their
specification or on termination of this Agreement (other than termination due to
an uncured breach by the Manufacturer, in which event the Principal shall not be
so liable)) but such liability for such costs shall not exceed the cost of
twelve (12) months (or such lesser period remaining in the term of this
Agreement) raw materials. The Principal shall promptly notify the Manufacturer
in the event that its actual requirements for Products are reasonably expected
to differ by more than five (5) batches (as provided in Schedule 1), plus or
minus, from any such forecast, and the Manufacturer shall exercise commercially
reasonable efforts to adjust its raw materials inventories accordingly. Payment
in respect of any such unused or redundant packaging materials shall be made by
the Principal within thirty (30) days of the date of invoice.

 

2. FORECAST AND ORDERS

 

  2.1 In order that the Manufacturer can plan its production and delivery
program for the Product(s) the Principal shall provide every six (6) months a
good faith estimate of its requirements for the Product(s) for the subsequent
twelve (12) months, such estimates to be broken down on a month by month basis.

 

  2.2 The Principal shall place orders with the Manufacturer subject to a
delivery time of at least one hundred and twenty (120) days and provided proper
notice has been given and the Manufacturer is in possession of all information
and documents necessary to permit it to proceed to fulfil such order on a timely
basis and without interruption, then the Manufacturer shall deliver the Products
so ordered to the Principal, meeting the specifications set forth in Schedule 2,
on or prior to the delivery date designated by the Principal in such order. The
Manufacturer’s delivery obligation shall be subject to the Principal having
delivered to the Manufacturer, not more than thirty (30) days following the
submission of such order, sufficient quantities of the materials to be provided
by the Principal for incorporation into such quantity of Products, meeting the
specifications for such materials set forth in Schedule 2 hereto. Such delivery
date shall be extended day-for-day by each day beyond such thirty (30) day
period that elapses before the Principal has delivered such materials to the
Manufacturer.

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  2.3 Any order placed by the Principal will be subject to the minimum order
size as set out in Schedule 1 hereto.

 

3. DELIVERY

 

  3.1 Each Order of the Product(s) shall be delivered by the Manufacturer to the
Principal at Manufacturer’s premises as identified in Schedule 1 hereto. All
deliveries for the Product(s) shall be based on Free On Board (FOB),
Manufacturer’s facility in Newry, Northern Ireland.

 

  3.2 The Manufacturer may at its discretion deliver the Product(s) ordered by
the Principal by installments in any sequence, provided that all such
installments must be delivered on or prior to the delivery date established in
accordance with Section 2.2 hereof. The Manufacturer shall notify the Principal
as soon as practicable as to the dates and quantities of all such installment
deliveries. Where the Product(s) are delivered by installments, each installment
shall be deemed to be the subject of a separate contract and no default or
failure by the Manufacturer in respect in any one or more installments shall
vitiate the Order in respect of the Product(s) previously delivered or
undelivered Product(s).

 

  3.3 If the Principal fails to take delivery of any ordered Product(s) or any
part of them and fails to provide any instructions, documents, licences,
consents or authorisations required to enable the Product(s) to be delivered by
the Manufacturer, the Manufacturer shall be entitled upon giving written notice
to the Principal to store or arrange for the storage of the Product(s) and then
risk in the Product(s) shall pass to the Principal, delivery shall be deemed to
have taken place and the Principal shall pay to the Manufacturer all reasonable
costs and expenses including storage and insurance charges arising from its
failure.

 

  3.4 In the event that the Manufacturer fails to deliver any Products on the
delivery schedule established in accordance with Section 2 hereof, the
Manufacturer shall (a) deliver such Products as promptly as practicable (unless
the Principal has theretofore elected to obtain such Products otherwise and has
so notified the Manufacturer in writing, in which event the Manufacturer shall
not assemble or ship such Products to the Principal), and (b) reimburse the
Principal for any costs incurred by it arising out of such failure to timely
deliver, including without limitation any additional expedited shipping costs
incurred by the Principal for delivery of such Products to customers, or any
costs of obtaining replacement Products in excess of the amount payable to the
Manufacturer for such Products pursuant to this Agreement.

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4. NON-COMPLIANCE

Where tests on a batch of the finished goods supplied under this Agreement
carried out at the Principal’s laboratory shows that the quality of the batch of
the Products does not meet the agreed specification, the Principal may reject
such batch, which the Manufacturer shall replace with Products acceptable to the
Principal to be delivered to the Principal within thirty (30) days free of
charge, and the Manufacturer shall bear the expense of replacing the raw
materials and other components included in the rejected Products. If the
Manufacturer disagrees with the Principal’s determination with respect to such
Products’ conformity to specifications, the Manufacturer may have the sealed
samples held by the Manufacturer for the Principal in respect of that particular
batch of the Products tested by any independent laboratory as mutually agreed
between the parties, whose analysis results shall be final and binding. In the
event that such arbitral analysis shows the relevant batch did comply with the
agreed specification as set out in the relevant Certificate of Analysis to be
supplied by the Manufacturer in respect of every batch of the Products, the
Principal shall reimburse the Manufacturer for the additional costs incurred by
the Manufacturer pursuant to the immediately preceding sentence. The costs
incidental to any arbitral analysis will be borne by the Principal if an
independent analysis confirms the validity of the Manufacturer’s certificate and
shall be borne by the Manufacturer if the batch is confirmed to be outside the
specification as set out in the relevant certificate. The Manufacturer shall
carry out all tests on delivered Product within one (1) month of delivery time
(time being of the essence) to satisfy compliance with the relevant Certificate
of Analysis. No query or complaint in respect of the Principal’s determination
as to Products’ compliance with the specification shall be considered after such
period has elapsed.

 

5. PRICES

 

  5.1 The initial purchase price for the Product(s) shall be as set out in
Schedule 1 hereto which said prices shall, subject as hereinafter provided, be
applicable until the second anniversary of the Commencement Date. The parties
hereto agree to commence discussions at least three (3) calendar months before
such second anniversary and the end of each subsequent Contract Year for the
purpose of agreeing upon prices for the subsequent Contract Year. In the event
that the parties are unable to agree upon a price for each Product by the
beginning of the next applicable Contract Year, then the price for any such
Product will be increased (or decreased, as applicable).

 

  5.1.1   by an amount equal to the vouched percentage increase (or decrease, as
applicable) in the cost of raw materials or other Product components purchased
by the Manufacturer as provided in Schedule 2; and

 

  5.1.2   an inflationary price based on increases (or decreases, as applicable)
in the (RPI) Retail Price Index as published by the UK Government for the
remaining portion of the relevant price,

In both cases calculated from the date of the last price change for the said
Product until the beginning of the next applicable Contract Year. Should either
party wish to implement any price increase or decrease under this Clause 5.1
then it shall, at its own cost, produce to the other party a certificate
certifying that the amount of the proposed increase or decrease has been
properly calculated in accordance with the requirements of this Clause 5.1. The
price calculated in accordance with this sub-clause would apply to all orders
placed by the Principal and accepted by the

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Manufacturer during the following Contract Year. Each party shall cooperate with
the other in determining any such price adjustment (or the adjustments
contemplated by Section 5.3 hereof), including, but not limited to, sharing such
party’s cost data to the extent relevant to any such calculation.

 

  5.2 All the orders for the Product(s) as supplied by the Manufacturer shall be
paid by the Principal in English pounds sterling within thirty (30) days from
the date of the relevant invoice, which shall be delivered upon shipment of such
Products. The Manufacturer reserves the right to charge interest on all late
payments at a rate of two (2%) percent per annum over Bank of Ireland base rate
for sterling, such interest to be compounded on a weekly basis.

 

  5.3 The Manufacturer reserves the right to increase its prices, subject to
providing appropriate documentation thereof to the Principal, at any time to
take account of any sudden increase in any production cost outside its control
including the cost of active ingredients, packaging, energy, transport, raw
materials or exchange rate fluctuations which may increase the relevant
production cost to the Manufacturer by more than five (5%) percent. The
Manufacturer agrees to reduce its prices at any time to take account of any
decreases in any of the costs or other factors set forth in the preceding
sentence, which may decrease the relevant production cost to the Manufacturer by
more than five percent (5%).

 

6. SUPPLY OF PACKAGING MATERIAL

 

  6.1 The Manufacturer is responsible on his own account for the procurement of
all packaging materials used for the manufacturing of the Product(s), in
accordance with Schedule 2 hereof.

 

  6.2 The Principal will supply all artwork and repro film for the making of the
packaging materials. All text and art work for the labels, carton and containers
to be used for the Products shall be the sole responsibility of the Principal.
The Principal warrants that the text and art work as specified by it complies
with the requirements of all the relevant marketing authorisations under which
it sells the Products and the statutory and other legal requirements of each
country in which the Products are marketed and sold and furthermore does not
infringe any third party intellectual or industrial property rights and hereby
indemnifies and shall hold the Manufacturer harmless against all claims,
liabilities and costs accordingly.

 

  6.3

Unless and to the extent otherwise reasonably directed by the Principal in
writing, the Manufacturer shall purchase and warehouse a maximum of twelve
(12) months (or such lesser period remaining in the term of this Agreement)
packaging materials in accordance with the order forecasts provided for under
Clause 2.1 hereto, provided always that the Principal shall be liable for the
cost of unused or redundant dedicated labels and packaging materials (whether
arising due to any change in their specification or on termination of this
Agreement) (other than termination due to an uncured breach by the Manufacturer,
in which event the Principal shall not be so liable) but such liability for such
costs shall not exceed the cost of twelve (12) months (or such lesser period
remaining in the term of this Agreement) materials. The Principal shall promptly
notify the

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Manufacturer in the event that its actual requirements for Products are
reasonably expected to differ by more than five (5) batches (as provided in
Schedule 1), plus or minus, from any such forecast, and the Manufacturer shall
exercise commercially reasonable efforts to adjust its packaging materials
inventories accordingly. Payment in respect of any such unused or redundant
packaging materials shall be made by the Principal within thirty (30) days of
the date of invoice.

 

7. LIABILITY

 

  7.1 The Manufacturer agrees to:

 

  7.1.1   indemnify the Principal against all loss damage or liability suffered
by the Principal in relation to any defective Product(s) supplied by the
Manufacturer primarily resulting from any proven negligence or default on the
part of the Manufacturer, provided that the Principal shall notify the
Manufacturer in writing without delay of any claims made or threatened, give all
required information and prompt assistance and fully co-operate with the
Manufacturer in the defence of any action and not take any action nor omit to do
anything the result of which may be prejudicial to the Manufacturer in relation
to any such matter without first obtaining the Manufacturer’s written consent,
which shall not be unreasonably withheld, delayed or conditioned.

 

  7.1.2   maintain its own product liability insurance, subject to such
insurance being available to it at commercially reasonable rates and terms, in
an amount of Sterling £8,000,000 (eight million British Pounds) (or such other
sum as the parties hereto from time to time agree) to cover all loss damage or
liability suffered by the Principal in relation to Products resulting from
proven negligence or default of the Manufacturer, provided such liability has
not been incurred by the Principal in breach of its obligations under this
Agreement.

 

  7.2 The Principal undertakes that it will indemnify and keep indemnified the
Manufacturer against all proceedings, costs, liabilities, injury, loss or damage
arising primarily out of the breach or negligent performance or failure of
performance by the Principal of the terms of this Agreement, or any defect in
the Specifications or other documentation supplied by the Principal to the
Manufacturer.

 

  7.3 Except as otherwise expressly provided in this Agreement, in no
circumstances shall either party be liable in contract, tort (including
negligence or breach of Statutory Duty), or otherwise, and whatever the cause
thereof whether reasonably foreseeable or not (a) for any increased costs or
expenses, (b) for any loss of profit, business, contracts, revenue, or
anticipated savings (c) for any special indirect or consequential damage of any
nature whatsoever.

 

  7.4 Notwithstanding anything contained in this Agreement, under no
circumstances shall the Manufacturer be liable to the Principal for any loss or
damage whatsoever suffered by the Principal should the Product licence held by
the Principal be suspended, withdrawn or other similar action occurring for
whatever reason by the relevant governmental authorities.

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  7.5 The Principal hereby indemnifies and shall keep the Manufacturer
indemnified against any liability arising on the part of the Manufacturer as a
“Producer” of goods for the purposes of the Consumer Protection Act 1987.

 

  7.6 Where the Manufacturer is required to supply the Principal with
replacement product arising out of any breach of this Agreement by the
Manufacturer in respect of which any active ingredient, excipient or packaging
materials have been supplied by the Principal, then the Manufacturer shall be
required to purchase replacement materials from the Principal at the cost for
such materials to the Principal.

 

8. REGULATORY REQUIREMENTS

 

  8.1 The Manufacturer agrees to assist the Principal by providing access to any
necessary document or dossier in its ownership or possession to enable the
Principal to make application to any Regulatory Authority for the Manufacturer
to be appointed as Manufacturer of the Product(s) under any marketing
authorisation held by the Principal.

 

  8.2 Both parties agree that should any provision in this Agreement be held not
to comply with any applicable law regulating the pharmaceutical industry then
the parties hereto shall discuss in good faith such modification to this
Agreement to ensure compliance with the relevant laws within the shortest
possible time.

 

9. INTELLECTUAL PROPERTY

 

  9.1 It is agreed that all rights to the Product(s) and to any trade or brand
name and design used by the Principal in respect of the Product(s) are and shall
remain the exclusive property of the Principal.

 

  9.2 The Principal hereby indemnifies and shall keep indemnified the
Manufacturer against all proceedings, costs (including legal costs),
liabilities, injury, loss or damage arising out of any third party claims
(whether successful or unsuccessful) relating to ownership of any intellectual
or industrial property rights relating to the Product(s) and any trade or brand
name or design used by the Principal in respect of the Product(s).

 

10. FORCE MAJEURE

Neither party hereto shall be liable to the other for any failure to perform or
delay in performance of its obligations hereunder (other than an obligation to
pay monies) caused by any of the following to the extent beyond the reasonable
control of the party seeking to be excused from performance pursuant to this
Section 10: (i) act of God, (ii) outbreak of hostilities, riot, civil
disturbance, acts of terrorism, (iii) the act of

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any government or authority (including but not limited to revocation or
suspension of any licence or consent), (iv) fire, explosion, flood, fog or bad
weather, (v) default of suppliers or sub-contractors, (vi) theft, malicious
damage, strike, lockout or industrial action of any kind, (vii) inability to
obtain supplies of active ingredients, raw materials or packaging (other than
due to the cost thereof), or (viii) machinery breakdown, provided the party so
affected shall give prompt written notice to the other party. The party so
affected shall exercise diligent, commercially reasonable efforts to mitigate
the duration and extent of any such event, condition or circumstance, shall keep
the other party promptly informed as to all developments affecting or relevant
to such force majeure, including but not limited to promptly notifying the other
party when the cause or causes preventing, restricting or interfering with its
performance hereunder have been eliminated. If the failure or delay occasioned
by force majeure subsists for more than one hundred twenty (120) days, either
party can terminate this Agreement immediately by notice in writing to the other
party, and, save in respect of any payment due, neither party shall have any
liability to the other in respect of the termination of this Agreement as a
result of an event of force majeure. During the continuation of any force
majeure event affecting the Manufacturer’s performance under this Agreement, the
Principal shall be entitled to take reasonable steps to assure continued supply
of the Products, including but not limited to the entry into agreements with
other parties to provide the goods and services to be provided by the
Manufacturer hereunder, which agreements may need to extend beyond the
termination of the force majeure. In such event, the Principal shall be excused
from its obligation to purchase Products hereunder from the Manufacturer to the
extent of the remainder of its obligations under such alternative agreement,
notwithstanding the cessation of such force majeure; however, Manufacturer’s
obligations under Section 1.2 hereof shall remain in full force and effect if,
but for such force majeure event, Principal would have purchased sufficient
quantities hereunder in order for such exclusivity obligations to remain in
effect.

 

11. CONFIDENTIALITY

 

  11.1 The parties agree that all rights to any information supplied by the
Disclosing Party to the Receiving Party (“Information”) are reserved to the
Disclosing Party and the Receiving Party shall use such Information only for the
purpose (hereinafter called “the Purpose”) of exploiting its rights and
fulfilling its obligations under this Agreement including without limitation the
marketing and sale of the Products.

 

  11.2 The Receiving Party shall not use such Information except in connection
with the Purpose to benefit itself or others and will not communicate such
Information to others except as specifically permitted by this Agreement in
connection with the Purpose or if expressly authorised in writing prior to its
disclosure to do so in any instance by the Disclosing Party or except as
required by applicable law or court order (of which the Receiving Party shall
promptly notify the Disclosing Party).

 

  11.3 The Receiving Party undertakes that such Information will be made
available in confidence only to such of its employees and sub-contractors as
need to know the same for the Purpose and such employees are bound by their
contracts of employment and such sub-contractors are bound by confidentiality
undertakings identical to those contained in this clause not to use or disclose
such Information transmitted to them by the Receiving Party.

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  11.4   The Receiving Party undertakes at its own expense to enforce the
obligations of confidentiality imposed upon its employees and sub-contractors in
accordance with this clause 11 in so far as they relate to the disclosure of
such Information by such employees or sub-contractors.

 

  11.5   The Receiving Party agrees that such Information shall not be copied or
reproduced by it without the express written permission of the Disclosing Party
except for such copies as may be reasonably required for the Purpose of the
Receiving Party.

 

  11.6   The Receiving Party undertakes to prevent disclosure of such
Information and the access of unauthorised persons to the Information, and shall
be responsible for any violation of this Section 11 by any of its employees,
agents or other persons to whom it makes any of such Information available.

 

  11.7   The Receiving Party shall in the discharge of its obligations under
this clause arrange proper and secure storage for such Information in the form
of documents, paper, computer discs, magnetic tapes or in any other material
form.

 

  11.8   The obligations imposed under this clause 11 shall not apply to such
Information if the same:

 

  11.8.1   was in the public domain at the time it was disclosed or thereafter
shall fall in to the public domain except through the default of the Receiving
Party its employees, agents or sub-contractors; or

 

  11.8.2   was known to and recorded by the Receiving Party prior to its
disclosure to the Receiving Party by the Disclosing Party; or

 

  11.8.3   was disclosed after the express prior authorisation of the Disclosing
Party; or

 

  11.8.4   becomes known to the Receiving Party from a source other than the
Disclosing Party without breach of this Agreement the Receiving Party; or

 

  11.8.5   was independently developed by the Receiving Party without the
benefit of any of the Information; or

 

  11.8.6   is disclosed fifteen (15) years from the time of receipt thereof.

 

  11.9   If only a portion of such Information falls in any one of the sections
under the above clause 11.8 the remainder shall continue to be subject to the
prohibitions and restrictions of this clause 11.

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  11.10   No licence or conveyance of any rights to the Receiving Party under
any discoveries inventions or patents or to use the Information other than for
the Purpose is granted or implied by the transmission of such Information to the
Receiving Party under this Agreement.

 

  11.11   Notwithstanding anything contained elsewhere in this Agreement the
provisions of this clause 11 shall survive the termination or expiry of this
Agreement.

 

12. ASSIGNMENT AND TRANSFER

Neither party may assign or transfer its rights or obligations under this
Agreement without the prior written agreement of the other, such agreement not
to be unreasonably withheld, other than (a) in connection with the sale or other
transfer of all or substantially all of the assignor’s assets, or (b) as
collateral in connection with a bona fide debt financing transaction effectuated
by such assignor, as to which no such consent shall be required. Upon any such
assignment pursuant to clause (a) under which such assignee agrees to assume all
of assignor’s obligations under this Agreement arising subsequent to the
effective date of such assignment, the assignor shall be relieved of any further
obligations arising under this Agreement subsequent to the effective date of
such assignment.

 

13. TERM AND TERMINATION

 

  13.1   This Agreement will come into effect on the date first before written
and will continue in effect for a period of five (5) years, commencing on the
date on which the Principal submits its first order for Products under
Section 2.2 hereof (the “Commencement Date”). Each one (1) year period beginning
on the Commencement Date or an anniversary thereof shall be referred to herein
as a “Contract Year.” The parties hereto agree that at least twelve (12) months
before the said termination date they shall enter into good faith negotiations
for a period of three (3) months with a view to seeking to agree terms for a new
agreement between the parties and having any resultant agreement executed by the
parties.

 

  13.2   In the event of one of the parties being in breach of this Agreement,
the non-defaulting party may give written notice to the defaulting party of the
breach and indicate its intention to terminate the Agreement if the breach is
not remedied to its reasonable satisfaction within thirty (30) days after
receipt for the notice. It shall, at the Principal’s option, constitute a
default hereunder which shall not be subject to remedy or cure if the
Manufacturer fails to timely deliver Products hereunder, or delivers Products
that do not meet the specifications set forth in Schedule 2 hereto, on three
(3) or more occasions, in which event the Principal shall also be entitled to
receive from the Manufacturer whatever damages may be legally available to it,
including but not limited to any costs incurred by the Principal in excess of
the price payable under this Agreement to obtain goods and services to replace
those to have been provided by the Manufacturer under this Agreement for the
remainder of the term of this Agreement in the absence of such termination.

 

  13.3   The Principal shall be entitled to terminate this Agreement in the
event that it has not received from the United States Food and Drug
Administration all approvals necessary in order for the Principal to sell the
Products in the United States with no milk discard requirement and the Principal
notifies the Manufacturer that it is abandoning its efforts to obtain such
approvals.

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14. AMENDMENTS; ENTIRE AGREEMENT

No amendment of this Agreement shall be valid or binding upon the parties hereto
unless made in writing and duly executed on behalf of each party hereto. This
Agreement constitutes the entire agreement between the parties with respect to
the performance by the Manufacturer of the types of services contemplated by
this Agreement, and supersedes any and all prior oral or written agreements,
understandings or expressions with respect thereto, which shall be of no further
force or effect.

 

15. NOTICES AND OTHER COMMUNICATIONS

 

  15.1  Any notice to be served upon or given or communicated to one party
hereto by the other (and this clause called “Communication”) shall be in the
form of a document in writing including without limitation facsimile.

 

  15.2  All communications shall be made to the Manufacturer at the following
address:

 

Address:

   Norbrook Laboratories Limited    Station Works    Newry    County Down   
BT35 6JP    Northern Ireland   

Fax: 28 3026 0279

 

Attention:

   Lord Ballyedmond – Chairman

and to the Principal at the following address:

 

Address:

   ImmuCell Corporation    56 Evergreen Drive    Portland    Maine 04103    USA
   Fax: (207) 878-2117

 

Attention:

   Michael Brigham – President and CEO

 

  15.3   All Communications shall be delivered by hand during normal business
hours or sent by facsimile or sent by registered post (where possible by
airmail).

 

  15.4   A Communication shall have effect for the purposes of this Agreement
and shall be deemed to have been received by the party to whom it was made:

 

  15.4.1   If delivered by hand upon receipt by the relevant person for whose
attention it should be addressed under Clause 15.2 or upon receipt by any other
person then upon the premises at the relevant time who reasonably appears to be
authorised to receive post or other messages on behalf of the relevant party;
and

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  15.4.2   If sent by facsimile upon the transmission of the Communication to
the relevant facsimile number and the receipt by the transmitting facsimile
machine of an answer back code showing that the facsimile message has been
received properly by the facsimile machine to which it was transmitted; and

 

  15.4.3   If sent by registered post seven (7) days after the date upon the
registration receipt provided by the relevant postal authority.

 

  15.5   Each party shall be obliged to send a notice to the other (in
accordance with this clause) of any change in the details for it recorded in
clause 15.2 which details shall be deemed to have been amended accordingly.

 

16. REASONABLENESS

The provisions of this Agreement are considered by the parties hereto to be
reasonable in all the circumstances and accordingly it is hereby agreed that if
any restriction herein contained shall be judged to be void as going beyond what
is reasonable in all circumstances but would be valid if part of or all of the
wording were deleted or modified or the periods thereof reduced or the extent of
the restriction reduced in scope the same restrictions shall apply with such
deletions or modifications and shall be necessary to make them valid or
effective.

 

17. SEVERABILITY

In the event that any one or more of the provisions contained in this Agreement
shall for any reason be held to be unenforceable illegal or otherwise invalid in
any respect under the laws governing this Agreement or its performance and
cannot be modified in accordance with Clause 16 hereto, such unenforceability,
illegality or invalidity shall not affect any other provisions of this Agreement
and this Agreement shall then be construed as if such unenforceable illegal or
invalid provisions had never been contained herein.

 

18. NOTIFICATION OF AGREEMENT

In so far as this Agreement or any matters relating to it may be notifiable to
the EC Commission for the purposes of obtaining an exemption under Article 85(3)
of the EEC Treaty or for any other reason, the parties hereto agree that the
Principal shall be responsible for any such notification and the Manufacturer
authorises the Principal to conduct any such notification and any matters
relating to it for that purpose, subject to the Principal being obliged to
consult with the Manufacturer at each stage relating to the preparation for
notification, the actual notification and any matters arising therefrom.

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19. DISPUTES, PROPER LAW AND JURISDICTION

The parties hereto shall strive to resolve on an amicable basis any dispute that
may arise between them relating to the terms of this Agreement failing which the
parties shall agree to submit any dispute to the exclusive jurisdiction of the
High Court of Northern Ireland. The Agreement shall be subject to the laws of
Northern Ireland.

SIGNED by duly authorised representatives of each of the parties hereto on the
date first before written.

SIGNED on behalf of NORBROOK LABORATORIES LIMITED:

/s/ Ballyedmond Signature   Name   Position

SIGNED on behalf of IMMUCELL CORPORATION:

 

/s/ Michael F. Brigham Signature Michael F. Brigham Name President and CEO
Position

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SCHEDULE 1

 

Products

  

Minimum Order Size

  

Initial Purchase Price

  

Destination

Mast Out ®    Minimum Annual Order Quantity    See table below    Manufacturer’s
   xxxxxxxxxxxxxxxxxxxxxx for the       facility in Newry,    first Contract
Year; all of       Northern Ireland    Principal’s requirements for         
Products in subsequent Contract          Years          Minimum Batch
xxxxxxxxxxx          xxxxxxxxxx (each, a “batch”)      

FOB Newry, Northern Ireland

PURCHASE PRICE (U.S. DOLLARS)

 

Order Volume

  

Cost per Syringe

xxxxxxx

xxxxxxxxxxxxx

xxxxxxxxxxxxxx

xxxxxxxxxxx

  

xxxxx

xxxxx

xxxxx

xxxxx

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SCHEDULE 2

Responsibilities of the Parties

 

ITEM

 

RESPONSIBILITY

Section A. Formulation and Chemical Raw Materials

 

Norbrook

 

ImmuCell

A1   

(Active ingredients and excipients)

Unit Formulation for Product

    ü A2    Quality Specification of Raw Materials in Product Formulation     ü
A3    Analytical Methods for Testing of Raw Materials     ü A4    Purchase and
supply of Nisin API to Norbrook Free of Charge     ü A5    Purchase of Raw
Materials for Manufacture of Product   ü   A6    Inspection and Release of Raw
Materials for Manufacture of Product   ü   A7    Retention of Reference Samples
of Raw Materials   ü   A8    Retention of Analytical Testing Records   ü  

Section B. Manufacture of Product

 

Norbrook

 

ImmuCell

B1    Manufacture of Product   ü   B2    Quality Control Specifications for Bulk
Product     ü B3    Analytical Methods for Testing of Product     ü B4   
Retention of Batch Manufacturing Records   ü   B5    Manufacturing instructions
including in-process controls   ü  

Section C. Packaging for the Product

 

Norbrook

 

ImmuCell

C1    Master Filling and Packaging Instructions     ü C2    Quality Control
Stipulations for Packaging Components     ü C3    Purchase and Supply of
Packaging Components   ü   C4    Inspection and Release of Packaging Materials
for Use   ü   C5    Retention of Samples of Packaging Components   ü   C6   
Filling, Labelling and Packaging of Product Including In-Process Controls and
Inspections   ü   C7    Retention of Batch Packaging Records   ü  

Section D. Finished Product

 

Norbrook

 

ImmuCell

D1    Finished Product Specifications and Analytical Methods     ü D2   
Inspection of Product and Release for Shipment to Customer   ü   D3   
Inspection and Final Release of Product for Sale     ü D4    Retention of
Reference Samples of Finished Product   ü   D5    Retention of Analytical
Testing Records   ü   D6    Contents of Certificate of Analysis   ü   D7   
Finished Product Sample Requirements     ü

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ITEM

 

RESPONSIBILITY

Section E. Quality control

 

Norbrook

 

ImmuCell

E1    Pharmacovigilance     ü E2    Investigation of complaints   ü   ü E3   
Action of complaints   ü   E4    Recording of complaints   ü   ü E5    Product
Recall   ü   ü E6    Annual product quality review   ü   ü E7    Follow-up
stability studies     ü

Section F. Operations to be Carried Out by Third Parties

 

Norbrook

 

ImmuCell

H1    Analytical Product Testing to be Performed by Third Parties   N/A   N/A H2
   Manufacturing Operations to be Performed by Third Parties   N/A   N/A

Section G. Miscellaneous

 

Norbrook

 

ImmuCell

I1    Supply of Safety Data     ü I2    Retention of Product Distribution
Records   ü