Exhibit 10.36


 


AMENDED
AND RESTATED


MANUFACTURING
AND SUPPLY AGREEMENT


 


THIS AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT (the “Agreement”) made as of January 1,
2004 (the “Effective Date”), by
and between FIRST HORIZON PHARMACEUTICAL CORPORATION (“First Horizon”), a Delaware corporation,
having offices at 6195 Shiloh Road, Alpharetta, Georgia, USA, 30005, and
PATHEON INC. (“Patheon”), a
corporation existing under the laws of Canada having its registered office at
7070 Mississauga Road, Suite 350, Mississauga, Ontario, L5N 7J8.


 


WHEREAS Patheon and Sanofi-Synthelabo Inc.
entered into a Manufacturing and Supply Agreement dated October 1, 1999,
which was subsequently assigned by Sanofi-Synthelabo Inc. to First Horizon on August 20,
2001 (the “Original Agreement”);
and


 


WHEREAS Patheon and First Horizon have
decided to amend and restate the Original Agreement in order to add a new
product and to revise certain of the existing terms as set forth herein;


 


NOW THEREFORE in consideration of the rights
conferred and the obligations assumed herein, and intending to be legally
bound, the parties hereby agree that the Original Agreement is amended and
restated as follows:


 


1.0                               INTERPRETATION


 


1.1                                 Definitions.  The following terms shall, unless the context
otherwise requires, have the following meanings, respectively:


 


“Active Materials”
shall mean the materials listed on Exhibit A hereto.


 


“Affiliate”
shall mean any Persons directly or indirectly controlling, controlled by, or
under common control with such other Person at any time during the period for
which the determination of affiliation is being made.  For purposes of this definition, the term “controlled”
(including the correlative meanings of the term “controlled by “and “under
common control with”), as used with respect to any Person, shall mean the
possession, directly or indirectly, of the power to direct or cause the
direction of management policies of such Person whether through ownership of
voting securities, by contract or otherwise.


 


“Client”
shall mean First Horizon Pharmaceutical Corporation.


 


“Components”
shall mean, collectively, all packaging components, raw materials and
ingredients (including labels, product inserts and other labeling for the 


 






*  Redacted
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confidential treatment.


 

















 


Products), required to be used in order to
produce the Products in accordance with the Specifications, including Active
Materials, and “Component” means
any one of the foregoing.


 


“Confidential Information”
has the meaning given to the term “Information” in the Confidentiality
Agreement between the parties dated as of March 12, 2002 (the “Confidentiality Agreement”).


 


“Deficiency Notice”
shall have the meaning ascribed thereto in Subsection 2.6(a).


 


“FDA”
shall mean the United States Food and Drug Administration.


 


“Firm Orders”
shall have the meaning ascribed thereto in Section 3.2.


 


“GMPs”
shall have the meaning ascribed thereto in Subsection 2.5(a).


 


“Inventory”
shall mean all inventories of Components and work-in-process produced or held
by Patheon in connection with the manufacture of the Products in accordance
with the Specifications.


 


“Patheon”
shall mean Patheon Inc.


 


“Patheon
Manufacturing Requirements” shall have the meaning
ascribed thereto in Subsection 2.5(a).


 


“Person”
shall mean a natural person, a corporation, a partnership, a limited liability
company, a trust, a joint venture, any governmental authority or any other
entity or organization.


 


“Products”
shall have the meaning ascribed thereto in Section 2.1.


 


“Quality Agreement”
shall mean the quality agreement dated the date hereof between the parties
hereto, a copy of which is attached as Exhibit D.


 


“Specifications”  shall mean, collectively, (i) the
product formulae, raw materials specifications, manufacturing process and
packaging specifications for the Products, (ii) the quality control
testing procedures and specifications for the Products, and (iii) the
Client incoming inspection standards, all as provided or approved by Client in
connection herewith.


 


1.2                                 Annual
Quantity.  In this Agreement for
purposes of calculating the volume of product in a calendar year or any other
period specified in this Agreement, references to “Products shipped and
delivered” or “Products purchased” shall include Products ordered in conformity
with the provisions of this Agreement for delivery within that calendar year,
whether or not delivered, unless non-delivery is a result of the actions of
Client.


 






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confidential treatment.


 


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1.3                                 Exhibits.  The following exhibits are attached hereto
and are incorporated in and are deemed to be an integral part of this
Agreement:


 


	
  Exhibit A

  	
  -

  	
  Products

  
	
  Exhibit B

  	
  -

  	
  Facilities

  
	
  Exhibit C

  	
  -

  	
  Price List

  
	
  Exhibit D

  	
  -

  	
  Quality Agreement

  
	
  Exhibit E

  	
  -

  	
  Lot Numbering and Expiration Dates

  



 


1.4                                 Currency.  All dollar amounts in this Agreement
expressed in the lawful currency of the United Sates of America.


 


2.0                               MANUFACTURE
AND SUPPLY OF PRODUCTS


 


2.1                                 Manufacture.  Patheon shall manufacture and sell to Client
the products listed on Exhibit A hereto (the “Products”) at the prices listed on Exhibit C hereto
(such prices being subject to adjustment in accordance with the terms
hereof).  The Products will be
manufactured in the Patheon facilities listed in Exhibit B and any change
to a different manufacturing facility shall be approved by the Client.  Client shall purchase its entire requirement
of Products for sale in the United States from Patheon pursuant to the terms of
this Agreement, but the parties acknowledge that Client is not hereby or
herein, including the references to volume in this Section 2.1, Article 9
and Exhibit C, giving any guarantee of annual volume of Product.  If and when Client decides that it wishes to
have Patheon manufacture the Product for countries in addition to the United
States, the Client shall inform Patheon of any additional requirements related
to such additional jurisdiction and any resulting increase in cost will be
borne by the Client.  The agreed
additional costs and change over fees shall be set out in a written amendment
to this Agreement.


 


2.2                                 ###########. 
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2.3                                 [Intentionally
deleted.]


 


2.4                                 Packaging.  It is agreed that the Products are to be
supplied in bulk without packaging.  Any
references in this Agreement to Patheon performing packaging


 






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confidential treatment.


 


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means packaging of bulk Product as opposed to
finished Product.  Client shall be
responsible for all finished Product packaging, labels, product inserts and
other labeling for the Products.  Patheon’s
name shall not appear on the label nor anywhere else on the Products unless
required by a governmental authority or applicable laws or regulations.


 


2.5                                 Quality
Control and Assurance.


 


(a)                                  Patheon
shall manufacture, package, test and ship the Products in accordance with (i) the
current good manufacturing practices as described in Division 2 of Part C
of the Food and Drug Regulations (Canada)
and Parts 210 and 211 of Title 21 of the United States Code of Federal
Regulations, together with the latest Health Canada and FDA guidance documents
pertaining to manufacturing and quality control practices all as updated,
amended and revised from time to time (collectively “GMPs”), and (ii) the Specifications.  Patheon’s responsibilities and obligations
described in the foregoing sentence are hereinafter referred to as the “Patheon Manufacturing Requirements”.


 


(b)                                 Patheon
shall perform the quality control and quality assurance testing specified in
the Quality Agreement.


 


(c)                                  If
the Products as manufactured by Patheon do not satisfy Patheon’s quality
control and quality assurance testing due to Patheon’s failure to produce the
Products in accordance with the Patheon Manufacturing Requirements, Patheon
shall, at its sole cost and expense, manufacture additional Products to replace
such defective Products.  In such circumstances,
Client shall have no obligation to purchase or pay for any rejected Products.


 


(d)                                 Notwithstanding
any provisions of this Agreement to the contrary, the parties agree that
Patheon shall not be liable or have any responsibility for any deficiencies in,
or other liabilities associated with: (i) the formulae and procedures
specified by Client; (ii) the safety (except to the extent due to the
fault of Patheon as determined in accordance with the provisions of this
Agreement), efficacy or marketability of the Products; (iii) distribution
risk; (iv) Components, provided that any such deficiency was not
reasonably discoverable using the test methods detailed in the Specifications
and applying such test methods in accordance with GMP; or (v) services
provided by third parties in connection with the packaging of the bulk Product.


 


(e)                                  Each
time Patheon ships Products to Client, it shall provide Client with a
certificate of analysis that sets out the actual test results for each lot of
Products and which certifies that the Products shipped to Client have been
evaluated by Patheon’s Quality Control/Quality Assurance department and that
the Products comply with the Patheon Manufacturing Requirements.


 






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confidential treatment.


 


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Patheon shall not under any circumstances
ship Non-Conforming Products (as defined in Section 2.6(a)) to Client.


 


2.6                                 Rejection
of Products.


 


(a)                                  Client
shall inspect the Products manufactured by Patheon within thirty (30) business
days after receipt at Client’s warehouse and shall give Patheon written notice
(a “Deficiency Notice”) of all
claims for (i) Products which do not conform to the Patheon Manufacturing
Requirements or the tests results as shown on the certificate of analysis (such
Products being referred to herein as “Non-Conforming
Products”), or (ii) shortages in the amount of delivered
Products, in each case prior to the expiry of such thirty (30) day period.  Except as set out in Sections 4.2 and 4.3
below, Patheon shall have no liability for any deviations or shortages for
which it has not received notice within such thirty (30) day period.  Client shall return, at Patheon’s expense,
any Non-Conforming Product.  Cost and
method of returned Non-Conforming Product disposal shall be Patheon’s
responsibility.


 


(b)                                 Upon
receipt of a Deficiency Notice relating to claims under 2.6(a)(i) above,
Patheon shall have 10 business days to notify Client in writing as to whether
it agrees that the subject Products are Non-Conforming Products.  If Client and Patheon fail to agree within 10
business days after Patheon’s notice to Client as to whether any Products
identified in the Deficiency Notice are Non-Conforming Products, the parties
shall mutually determine an independent laboratory to evaluate whether the
Products are Non-Conforming Products.  If
such evaluation certifies that any Products are Non-Conforming Products, Client
may have those Products replaced in the manner contemplated by Subsection 2.6(d).


 


(c)                                  Claims
for shortages set out in a Deficiency Notice delivered to Patheon pursuant to
Subsection 2.6(a)(ii) shall be dealt with in accordance with normal
commercial practices.


 


(d)                                 All
fees and disbursements incurred in connection with the independent
determination by the laboratory as described in Section 2.6(b) above
shall be borne by the party which determined incorrectly that the relevant
Product was or was not a Non-Conforming Product.  Within 15 days of the determination by the
independent laboratory that the Product is a Non-Conforming Product, Patheon
shall replace such returned Non-Conforming Product at its expense or if it is
unable to make prompt replacement, shall either credit Client’s account or
refund any payment made on the rejected Product, depending on Client’s account
balance.


 


2.7                                 Stability
Testing.  Patheon shall conduct
stability testing on the Products as required by GMPs and in accordance with
the protocols approved by Client from time to time and executed by the Client
and Patheon.  The fee proposal for such


 






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stability testing shall be prepared by Patheon
and approved by the Client, such approval to be evidenced by the Client’s
execution of such proposal.  Patheon
shall not make any changes to these testing procedures without prior written
approval from Client.  In the event that
any lot of Products fails stability testing, Patheon and Client shall jointly
determine the proceedings and methods to be undertaken to investigate the
causes of such failure, including which party shall bear the cost of such
investigation.  Patheon will provide any
and all data and results relating to the stability testing upon request by
Client.  From time to time, Patheon
shall, at the request of Client, also provide stability testing services with
respect to products not manufactured by Patheon, the cost of such services to
be agreed to between the parties prior to such services being undertaken.


 


3.0                               ORDERS,
DELIVERY, INVOICING AND PAYMENT


 


3.1                                 Yearly
Forecast.  On the execution of this
Agreement, Client shall provide Patheon with a forecast of the volume of each
Product required during the first year of this Agreement.


 


3.2                                 Orders/Forecasts.  During the term of this Agreement, Client
shall, on a monthly basis, submit to Patheon a 12 month rolling forecast that
sets forth the total quantity of Product that the Client has ordered and
expects to order from Patheon within the 12 month period.  The first two months of such forecast are to
be considered firm orders (the “Firm Orders”).  Firm Orders in respect of batches of Product
of not more than 24 per month will be accompanied by a purchase order for the
Product to be produced and delivered to the Client on a date not less than 75
days from the date Patheon receives the purchase order.  Each forecast and purchase order will be
provided to Patheon no later than the 15th of each month.  The parties shall mutually agree on an
acceptable delivery schedule in the event the forecasted requirements
exceed 24 batches.


 


In addition, in January and June of
each year, the Client shall provide Patheon with a written non-binding three
year forecast (broken down by quarters for the second and third years of the
forecast) of the volume of each Product the Client then anticipates will be
required to be produced and delivered to the Client during such three-year
period.


 


3.3                                 Written
Orders.  The Firm Orders submitted to
Patheon pursuant to Section 3.2 shall specify Client’s purchase order
number, quantities by Product type, monthly delivery schedule and any
other elements necessary to ensure the timely production and delivery of the
Products.  The quantities of Products
ordered in such Firm Orders shall be firm and binding on Client and shall not
be subject to reduction.  Patheon shall
provide written confirmation of receipt of Firm Orders to the Client within ten
(10) calendar days of receipt thereof.


 


3.4                                 Reliance
by Patheon.  Client agrees that
purchases may be made by Patheon of the Components to satisfy the production
requirements for Firm Orders.  In
addition, the Client authorizes Patheon to purchase Components in order to
satisfy


 






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confidential treatment.


 


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the production requirements for Products for
the first six months contemplated in the most recent forecast provided by the
Client pursuant to Section 3.2, and agrees that Patheon may make such
other purchases of Components to meet production requirements during such
longer periods as may be agreed to in writing from time to time by the Client
at the request of Patheon.  In such
circumstances, if such Components are not included in finished Products
purchased by Client within six months after such purchases have been made (or
such longer period as the parties may have agreed to), Client will pay to
Patheon its costs thereof and, in the event such Components are incorporated
into Products subsequently purchased by Client, Client will receive credit for
any of such costs previously paid to Patheon by Client.


 


3.5                                 Minimum
Orders.  The Products to be
manufactured and packaged by Patheon may only be ordered in quantities equal to
or greater than the minimum order quantities specified in Exhibit C.


 


3.6                                 Late
Shipments.  Patheon agrees that time
is of the essence of this Agreement.  If
Patheon becomes aware that it will not meet a scheduled delivery date, Patheon
will promptly communicate this to Client. 
In the event of repeated late deliveries, Patheon and Client shall meet
to determine a mutually satisfactory solution to this problem.  If after such meetings, there are continued
late deliveries, Client shall be entitled to treat same as a material breach of
this Agreement and the provisions of Section 5.3(a) hereof shall
apply and the time period specified in Section 5.3(a) shall commence.


 


3.7                                 Termination.  If this Agreement expires or is terminated in
whole or in part for any reason other than a default by Patheon as set out in
subsection 5.3(a) or (b), Client shall (in addition to any other
remedies Patheon may have in the event of default by Client):


 


(a)                                  purchase,
at Patheon’s cost, the Inventory applicable to the Products which were
purchased, produced or maintained by Patheon in contemplation of filling Firm
Orders, or in accordance with Section 3.4, prior to notice of termination
being given. Client’s obligation under this section shall not exceed
Patheon’s actual costs of Components and Inventory in order to manufacture a six
month supply of Product based upon the most recent forecast unless the purchase
of such Components and Inventory was authorized by the Client pursuant to Section 3.4;


 


(b)                                 purchase
all undelivered Products which were manufactured and/or packaged pursuant to a
Firm Order, at the price in effect at the time the order was placed; and


 


(c)                                  satisfy
the purchase price payable pursuant to Patheon’s orders with suppliers of
Components, or in accordance with Section 3.4, provided such orders were
made by Patheon in reliance on Firm Orders.


 






*  Redacted
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confidential treatment.


 


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If this Agreement is terminated as a result
of a default by Patheon, Client shall have the option to purchase such of the
items referred to in (a), (b) and (c) above if it determines in its
absolute discretion that the items can be used by it.


 


3.8                                 Specifications.  All Components shall be purchased and tested
by Patheon at Patheon’s expense in accordance with Patheon Manufacturing
Requirements.  Patheon will not change
the Specifications used to manufacture, test, package and ship the Products
without the written consent of Client. 
Amendments to Specifications requested by Client will only be
implemented following a technical and cost review, subject to Client and Patheon
reaching agreement as to price revisions necessitated by any such amendment in
accordance with Section 3.9 below.


 


3.9                                 Change
in Specifications.


 


(a)                                  If
Client requests a change in the Specifications which would result in an
increase or decrease in Patheon’s costs for Components or would cause Patheon
to incur other costs as a result of the change in Specifications, the parties
shall discuss, each acting reasonably and based on satisfactory documentation
provided by Patheon indicating the cause of the price change, what impact, if
any, such change should have on the price of the Products and payment to
Patheon of the related costs.  If Client,
acting reasonably, accepts a proposed price change, the proposed change in the
Specifications shall be implemented, and the price change shall become effective
only with respect to those orders of Products which are manufactured in
accordance with the revised Specifications.


 


(b)                                 Notwithstanding
any change in the Specifications implemented in accordance with the terms of (a) above,
Client agrees to purchase all Products manufactured by Patheon based upon any “old”
Specifications at the then-current price for those Products.  In addition, Client agrees to purchase, at
Patheon’s cost, all Inventory, utilized under the “old” Specifications and
purchased or maintained by Patheon in order to fill Firm written Orders to the
extent that such Inventory can no longer be utilized under the revised
Specifications.  Open purchase orders for
Components no longer required under any revised Specifications which were
placed by Patheon with suppliers in order to fill Firm Orders or in accordance
with Section 3.4 shall be cancelled where possible, and where such orders
are not subject to cancellation without penalty, shall be assigned to and
satisfied by Client.


 


(c)                                  If
a change in Specifications must be made by Client solely as a result of Patheon’s
acts or omissions, the parties will meet to determine who will bear any costs
arising from such change in the Specifications.


 


3.10                           Shipments.  Patheon shall ship and deliver the Products
at Patheon’s premises at the facilities listed in Exhibit B to such Client
locations as requested by Client and


 






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confidential treatment.


 


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at Client’s expense.  Client shall select the freight carrier used
by Patheon to ship the Products and may monitor Patheon’s shipping/freight
practices as they pertain to this Agreement. 
Risk of loss and title shall pass to Client upon delivery by Patheon to
the freight carrier selected by Client at Patheon’s premises.  For greater certainty, Patheon agrees that it
will be responsible for preparation, on Client’s behalf and at Client’s
expense, of all shipping documents, including customs formalities for export of
the Products.


 


3.11                           Invoices
and Payment.  Except as otherwise
provided in this Agreement, Patheon shall charge Client for only those Products
that are shipped to Client.  Invoices
shall be sent by fax or email to such fax number or email address as may be
provided by the Client in writing from time to time.  Patheon shall also submit to the Client, with
each shipment of Products, a duplicate copy of the invoice covering such
shipment.  Each such invoice shall, to
the extent applicable, identify the Client purchase order number, Product
numbers, names and quantities, unit price, freight charges and the total amount
to be remitted by Client.  Client shall
pay all such invoices within thirty (30) days of the date thereof.


 


3.12                           Lot
Numbering/Expiration Dates.  Patheon
shall make arrangements for and implement the imprinting of lot numbers,
expiration dates, retest dates or “package-by” dates, as applicable, on each
Product container as required by GMPs for each Product shipped.  Such lot numbers and dates shall be affixed
on the Products and/or on the shipping carton of each Product as is required by
GMPs.  The system used by Patheon for lot
numbering and expiration dates is detailed on Exhibit E hereto.  Except in circumstances constituting force
majeure pursuant to Section 10.10 or an inability of Patheon to obtain
Components due to no fault of Patheon or circumstances beyond Patheon’s
reasonable control (including, without limitation, where Product is undergoing
an investigation in respect of quality matters), Patheon shall take best
efforts to ensure that Product shall have not less than 21 months remaining
before expiration at the time of shipment of such Product by Patheon; provided,
however, in the event that Product will have less than 21 months remaining
before expiration at the time of shipment of such Product by Patheon, Patheon
shall promptly notify the Client and Patheon and the Client shall endeavor to
mutually agree on a resolution in respect of such shipment.


 


3.13                           Technical Transfer Costs.  In accordance with the terms of the Technical
Transfer Proposal between the parties dated as of September 15, 2003,
Patheon has agreed to absorb a portion of the technical transfer costs
associated with transferring the Prenate Elite (Metafolin Formulation) to
Patheon’s Niagara Region Operations facility, provided that the Client orders
and pays for a minimum volume of ########## tablets of such Product within 24
months after the completion of the process validation batch of Prenate Elite
(Metafolin Formulation).  Notwithstanding
any provision to the contrary in this Agreement, the parties agree that the
Client will reimburse Patheon for the full amount of the technical transfer
costs incurred by Patheon in the event that: (a) the Prenate Elite
(Metafolin 


 






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confidential treatment.


 


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Formulation) Product, or any line extension
thereof containing Metafolin, ceases to be produced by Patheon for any reason
within 24 months after the completion of the process validation batch of such
Product; or (b) a minimum volume of ########## tablets of the Prenate
Elite (Metafolin Formulation) Product, or any line extension thereof containing
Metafolin, is not ordered by the Client and paid for by the Client within 24
months after the completion of the process validation batch of such Product.


 


3.14                           Risk Allocation of Metafolin.  
Client recognizes that certain financial risk exists in Patheon’s
procurement of the Active Material Metafolin. 
If there is any loss of Metafolin due to reasons other than Patheon’s
negligence or willful misconduct, then Client shall be solely liable for the
cost of such loss of Metafolin; provided, however, that Patheon shall take
reasonable actions to mitigate such losses. 
If there is any loss of Metafolin due to Patheon’s negligence or willful
misconduct and Client fails to meet the minimum purchase volume of ###########
tablets of Product during the calendar year, then Client shall be responsible
for the cost of such loss of Metafolin to a maximum of ######## of that
calendar year.  If there is any loss of
Metafolin due to Patheon’s negligence or willful misconduct and Client meets or
exceeds the minimum purchase volume of ########## tablets of Prenate Elite
Product during the calendar year, then Client shall be responsible for the cost
of such loss of Metafolin to a maximum of ####### of that calendar year.  Amounts owing from each party under this Section 3.14
shall be reconciled at the end of each calendar year.


 


4.0                               CO-OPERATION


 


4.1                                 Records
and Accounting by Patheon.  Patheon
shall keep records of the manufacture, testing and shipping of the Products,
and retain samples of such Products in order to comply with applicable GMPs as
well as to assist with resolving Product complaints and other similar
investigations.  Copies of such records
and samples shall be made available to Client upon its request and shall be
retained by Patheon and be available to Client for a period of one (1) year
after the expiration dates of the packaged batch, or longer if required by law.


 


4.2                                 Product
Recalls.


 


(a)                                  Patheon
and Client shall each maintain such records as may be necessary to permit a
recall or a field correction of any of the Products delivered to Client or
customers of Client, effected voluntarily or under a threat of, or a directive
by, any governmental agency.  Each party
shall give notice within 24 hours by telephone (to be confirmed in writing) to
the Director of Quality Control/Quality Assurance of the other party upon
discovery that any Products should be recalled or corrected, or may be required
to be recalled or corrected, and, each party upon receiving any such notice or
upon any such discovery, shall cease and desist from further shipments of such
Products in its possession or control until a decision has been made whether a
recall or some other corrective action is necessary.  The


 






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decision to initiate a recall or to take some
other corrective action, if any, shall be made and implemented by Client.  Patheon will co-operate as reasonably required
by Client, having regard to all applicable laws and regulations.  Each party shall co-operate with the other in
developing any necessary recall plan, and the manner and extent of such plan
shall be subject to prior consultation, which consultation shall not
unreasonably delay such plan.


 


(b)                                 To
the extent that a recall results from, or arises out of, any breach by Patheon
of the Patheon Manufacturing Requirements then (i) such recall and all
reasonable expenses associated with the recall shall be made at Patheon’s cost
and expense, and (ii) Patheon shall use its best efforts to replace the
recalled Products with new Products within sixty (60) days from the date that
Client notifies Patheon about the recalled Products.  In the event that (i) Patheon is unable
to replace the recalled Products within this sixty (60) day period (except
where such inability results from a failure to receive the required Active
Materials), or (ii) such new Products are also recalled or returned due to
a breach by Patheon of the Patheon Manufacturing Requirements, then Client may
request Patheon to reimburse Client for the purchase price that Client paid
Patheon for the affected Products.  In
all other circumstances, recalls shall be made at Client’s cost and expense.


 


4.3                                 Product
Returns.  Client shall have the
responsibility for handling customer returns of the Products.  Patheon shall provide Client with such
assistance as Client may reasonably need to handle such returns.  To the extent that such return results from,
or arises out of, any breach by Patheon of the Patheon Manufacturing
Requirements, Patheon shall use all reasonable best efforts to replace the
returned Products with new Products within sixty (60) days from the date that
Client notifies Patheon about the returned Products or sooner if reasonably
possible.  In the event that (i) Patheon
is unable to replace the returned Products within this sixty (60) day period or
(ii) such new Products are also returned or recalled due to a breach by
Patheon, then Client may request Patheon to reimburse Client the purchase price
that Client paid Patheon for the affected Products.  In all other circumstances, customer returns
shall be made at Client’s cost and expense.


 


4.4                                 Audits.


 


(a)                                  During
the term of this Agreement, Client shall have the right, at Client’s sole cost
and expense, during normal business hours and upon reasonable request and
notice, to inspect the facilities, sanitation procedures and equipment used to
manufacture, test and package the Products, provided, however, that there shall
be no undue interference by Client’s representatives with the operations at
Patheon’s facilities.


 






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confidential treatment.


 


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(b)                                 Client
shall have the right, upon prior reasonable notice to Patheon and during normal
business hours, to examine all technical records related to the Products (or to
examine any portions of any technical records related to the Products, as the
case may be) kept by Patheon and to request and receive reasonable samples of
raw materials, packaging materials and finished Products.


 


(c)                                  During
the term of this Agreement, Patheon shall promptly notify Client of any
inspections by the FDA, or any other federal, state, local or foreign
government agency, of the facilities where the Products are manufactured and
packaged, and shall thereupon furnish Client with copies of all reports,
analyses and other documents (including responses to the FDA) relating to such
inspections, where the inspections involve or may involve the Products, the
Components of the Products or the manufacture of the Products.  If such inspections are scheduled or
conducted with advance notice, Patheon shall so advise Client and unless there
is a legal prohibition against doing so, Client shall have the option to be
present during the inspections. 
Duplicate samples of the Products given to government agencies and
duplicates of the photographs taken during the inspection shall be provided to
Client.  Any Patheon correspondence
relating to the Products shall be approved by Client prior to submission to any
government agency.


 


(d)                                 During
the term of this Agreement, each party shall report promptly to the other any
significant information it may receive concerning any defects, adverse
reactions and unexpected side effects, if reasonably believed to be related to
the Products.


 


(e)                                  Patheon
shall support the annual reporting requirements of Client under GMPs by
providing Client with updated stability data for its ongoing studies for the
Products.


 


4.5                                 Customer
Questions and Complaints.  Client
shall have the sole responsibility for responding to questions and complaints
from Client customers.  Questions or
complaints received by Patheon from Client customers shall be promptly referred
to Client.  Patheon shall co-operate as
required to allow Client to resolve any customer questions and complaints.  Such assistance shall include follow-up
investigations including testing.  In
addition, within ten (10) business days from the date of request, or
sooner if reasonably possible Patheon shall provide Client with all necessary
information that will enable Client to respond properly to questions or
complaints relating to the Products. 
Unless it is determined that the cause of any customer complaint
resulted from a breach by Patheon of the Patheon Manufacturing Requirements or
its representations in Section 6.2 hereof, all costs incurred in respect
of this Section 4.5 shall be borne by Client.


 






*  Redacted
text has been omitted and filed separtely pursuant to a request for
confidential treatment.


 


12

















 


5.0                               TERM,
RENEWAL AND TERMINATION


 


5.1                                 Term.  This Agreement shall become effective on the
Effective Date hereof.  Subject to any
extension pursuant to Section 5.2, this Agreement shall expire five (5) years
from the Effective Date hereof, unless terminated by one of the parties as
provided herein.


 


5.2                                 Extension.  This Agreement shall continue after the
initial term for successive terms of one year unless either party gives written
notice to the other party of its intention to terminate this Agreement at least
three hundred and sixty-five (365) days prior to the end of the then current
term.


 


5.3                                 Termination.


 


(a)                                  Upon
failure of either party to remedy its material breach of any of the obligations
or provisions of this Agreement within forty-five (45) days following receipt
of written notice of said breach, the aggrieved party shall have the right to
terminate this Agreement immediately by written notice.  For certainty, failure to purchase the
minimum order quantities set forth in Exhibit C shall not constitute a
breach of this Agreement.


 


(b)                                 Either
party at its sole option may immediately terminate this Agreement upon written
notice, but without prior advance notice, to the other party in the event that (i) the
other party is declared insolvent or bankrupt by a court of competent
jurisdiction; (ii) a voluntary petition of bankruptcy is filed in any
court of competent jurisdiction by such other party; or (iii) this
Agreement is assigned by such other party for the benefit of creditors.


 


(c)                                  Client
may terminate this Agreement as to any Products upon thirty (30) days’ written
notice in the event that any governmental agency takes any action, or raises
any objection, that prevents Client from importing, exporting, purchasing or
selling such Products.


 


(d)                                 Any
termination or expiration of this Agreement shall not affect any outstanding
obligations or payments due hereunder prior to such termination or expiration,
nor shall it prejudice any other remedies that the parties may have under this
Agreement.


 


(e)                                  Customer may
terminate it’s obligation to purchase Product, by giving written notice to
Patheon at least one hundred eighty (180) days prior to the effective date
of such termination.  Customer may not
terminate this Agreement in accordance with this paragraph prior to the second
anniversary date from the Effective Date.


 






*  Redacted
text has been omitted and filed separtely pursuant to a request for
confidential treatment.


 


13

















 


6.0                               REPRESENTATIONS
AND WARRANTIES


 


6.1                                 Authority.  Each party represents and warrants that it
has the full right and authority to enter into this Agreement, and that it is
not aware of any impediment that would inhibit its ability to perform its
obligations hereunder.


 


6.2                                 Patheon.  Patheon represents and warrants that:


 


(i)                                     the
work it performs hereunder will be in accordance with Subsections 2.5(a) and
(b);


 


(ii)                                  the
Products supplied to Client and the packaging and testing for the Products will
comply in all respects with Patheon Manufacturing Requirements;


 


(iii)                               upon
delivery, the Products will be free and clear from all liens and encumbrances,
other than liens and encumbrances that are a result of actions taken by Client;


 


(iv)                              the
Products will be manufactured at an FDA approved facility and in compliance
with applicable regulatory requirements;


 


(v)                                 the
manufacture of the Products, other than the manufacture in accordance with the
Specifications or the Client’s instructions, will not as a result solely of the
acts or omissions of Patheon or Patheon’s agents, representatives or
independent contractors infringe any valid rights of third parties; and


 


(vi)                              Products
delivered to Client under this Agreement shall not, at the time of delivery, be
adulterated or misbranded within the meaning of the Federal Food, Drug and Cosmetic Act, as amended, or within
the meaning of any applicable law in which the definition of adulteration and
misbranding is substantially the same as that contained in the Federal Food, Drug and Cosmetic Act, as
such act and such laws are effective at the time of delivery.


 


PATHEON MAKES NO WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY
FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT.  PATHEON MAKES NO WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE OR WARRANTY OF MERCHANTABILITY IN RESPECT OF THE CLIENT’S
PRODUCT.


 


6.3                                 Client:  Client represents and warrants that:


 


(i)                                     the
Specifications for each of the Products are its property or are licensed to it
and that Client may lawfully disclose the Specifications to Patheon;


 






*  Redacted
text has been omitted and filed separtely pursuant to a request for
confidential treatment.


 


14

















 


(ii)                                  any
trademarks utilized in connection with any of the Products are its property or
are licensed to it and may be lawfully used as directed by Client;


 


(iii)                               the
Specifications for all Products conform to all applicable laws and regulations;


 


(iv)                              the
Products if labeled and formulated in accordance with the Specifications will
not infringe the valid intellectual property rights of any third party;


 


(v)                                 the
Specifications will not in and of themselves result in production of Products
which are unfit for human consumption or adulterated or misbranded within the
meaning of any applicable law;


 


(vi)                              the
Products, if labeled and manufactured in accordance with the Specifications and
in compliance with applicable GMPs (a) may be lawfully sold and
distributed in every jurisdiction in which the Client markets such Products, (b) will
be fit for the purpose intended, and (iii) will be safe for human
consumption; and


 


(vii)                           the provision
of the manufacturing service by Patheon in respect of any Product pursuant to
this Agreement or use or other disposition of any Product by Patheon as may be
required to perform its obligations under this Agreement does not and will not
infringe any intellectual property rights of any third party.


 


7.0                               INDEMNITY


 


7.1                                 Patheon.  Subject to Sections 2.5(d) and 7.3,
Patheon agrees to defend, indemnify and hold harmless Client, its Affiliates,
officers, directors, employees and agents against any and all losses, damages,
costs, claims, demands, judgments and liability of any kind (including
attorneys’ fees) (collectively, “Liabilities”)
arising out of or attributable to (i) Patheon’s breach of its
representations or warranties under this Agreement or its obligation to
manufacture, package, test and ship Products in accordance with the Patheon
Manufacturing Requirements, or (ii) any negligent or wrongful act or
omission on the part of Patheon, its employees, agents or representatives
except, in each case, to the extent that any such Liabilities are due to the
negligence or wrongful act(s) of Client, its Affiliates, officers, directors,
employees or agents.


 


7.2                                 Client.  Subject to Section 7.3, Client agrees to
defend, indemnify and hold harmless Patheon, its Affiliates, officers,
directors, employees and agents against any and all Liabilities arising out of
or attributable to, (i) Client’s breach of its representations or
warranties under this Agreement, or (ii) any negligent or wrongful act or
omission on the part of Client, its Affiliates, officers, directors, employees,
agents or representatives except, in each case, to the extent that any


 






*  Redacted
text has been omitted and filed separtely pursuant to a request for
confidential treatment.


 


15

















 


such Liabilities are due to the negligence or
wrongful act(s) of Patheon, its officers, directors, employees or agents.


 


7.3                                 Consequential
Damages.  A party shall not be liable
to the other party for that other party’s consequential damages, but for
greater certainty nothing in this Section 7.3 shall limit the liability of
a party under its indemnity of the other party in this Article 7 in
respect of damages suffered by the other party which include consequential damages
of a third party.


 


8.0                               CONFIDENTIALITY


 


8.1                                 During
and in furtherance of this Agreement, each of the parties hereto may disclose
certain of its Confidential Information to the other party.  The parties agree that for the term of this
Agreement (including any renewals) and for a period of five years after the
termination of this Agreement, such Confidential Information shall be subject
to the terms of the Confidentiality Agreement, which terms are incorporated
herein by reference.


 


9.0                               PRICE


 


9.1                                 Annual
Price Adjustments.  The fees for the
Products listed in Exhibit C during any period following the first
anniversary of this Agreement shall be determined in accordance with the
following:


 


(a)                                  Annual
Price Adjustment.  On January 1st
of each calendar year of this Agreement, Patheon shall be entitled to an
adjustment to the fees (i) for manufacturing services in respect of the
Products to reflect inflation, which adjustment shall be based on the increase
in the Consumer Price Index, Canada (All Items) published by Statistics Canada
in September of the then current year compared to the same month of the preceding year which shall not
exceed four percent (4%) of the then current year’s costs associated with manufacturing
services, unless the parties otherwise agree in writing; and (ii) for
Component costs to pass on the actual amount of any increase or decrease in
such costs.  Such annual price increases
shall be effective on January 1st of each calendar year.


 


(b)                                 Annual
Forecast. To the extent that Patheon determines that the projections
contained in the Client’s most recent forecast provided in accordance with Section 3.2
necessitate that an adjustment be made to the fees in respect of any Product
for such year, Patheon shall, within 30 days of receipt by Patheon of the
yearly forecast, be entitled to request an appropriate price adjustment.


 


(c)                                  Pricing
Basis.  The Client acknowledges that
the fee in respect of a Product in any year is quoted based upon the minimum
order quantity and minimum annual quantity per Product specified in Exhibit C
or thereafter specified in the forecast provided pursuant to Section 9.1(b) for
the year and is subject to change if the specified minimum order quantity and


 






*  Redacted
text has been omitted and filed separtely pursuant to a request for
confidential treatment.


 


16

















 


minimum annual quantity is not met.  For greater certainty, if Patheon and the
Client agree that the minimum order quantity in respect of a Product shall be
reduced whether as a result of a decrease in minimum annual quantity or
otherwise and, as a result of such reduction, Patheon’s fees for services
relating to such Product increase on a per unit basis, then Patheon shall be
entitled to an increase in the fee in respect of such Product by an amount
sufficient to absorb such increase.


 


In connection with a fee adjustment pursuant
to Section 9.1(a), Patheon shall deliver to the Client a revised Exhibit C
and a statement outlining the percentage increase in the Consumer Price Index,
Canada (All Items) upon which such fee adjustment is based.  In connection with all fee adjustment
requests pursuant to this Section 9.1(b) and 9.1(c), Patheon shall
deliver to the Client a revised Exhibit C and such budgetary pricing information
or other documentation reasonably sufficient to demonstrate that a fee
adjustment is justified, provided that Patheon shall have no obligation to
provide any supporting documents to the extent such documents are subject to
obligations of confidentiality between Patheon and its suppliers. Upon delivery
of such a request, each of the Client and Patheon shall forthwith use all
reasonable efforts to agree on a revised fee in respect of each affected
Product.


 


9.2                                 Mid-Year
Price Adjustments.  During any year
of this Agreement, the fees set out in Exhibit C shall be subject to
adjustment in accordance with the following:


 


(a)                                  Volume
Reduction.  If at any time and from
time to time Patheon determines, acting reasonably and based on the forecasts
and Firm Orders received from the Client, that the current yearly run-rate
volumes (including, without limitation, any permanent reductions in volumes)
relating to a specific Product will constitute no more than 85% of the minimum
annual quantities for that Product specified in Exhibit C hereto or, if
applicable, any revised minimum annual quantity hereinafter agreed to by the
parties, then Patheon shall be entitled to request an adjustment to the fee in
respect of that Product to reflect the increased costs that Patheon will incur
as a result of the reduced volumes.


 


(b)                                 Extraordinary
Increases in Component Costs. If at any time market conditions result in
Patheon’s cost of Components being materially greater than normal forecasted
increases, then Patheon shall be entitled to request an adjustment to the fee
in respect of any affected Product to compensate it for such increased
Component costs.  For the purposes of
this Section 9.2(b), changes materially greater than normal forecasted
increases shall be considered to have occurred if: (i) the cost of a
Component increases by 10% of the cost for that Component upon which the fee
quote was based; or (ii) the aggregate cost for all Components required to
manufacture a Product increases by 5% of the total Component costs for such
Product upon which the fee quote was based. 
To the extent that fees have been previously adjusted pursuant to Section 9.1(a) or
this Section 9.2(b) to


 






*  Redacted
text has been omitted and filed separtely pursuant to a request for
confidential treatment.


 


17

















 


reflect an increase in the cost of one or
more Components, the adjustments provided for in (i) and (ii) above
shall operate based on the costs attributed to such Component (or Components)
at the time the last of such adjustments were made.


 


In connection with a fee adjustment request
pursuant to this Section 9.2, Patheon shall deliver to the Client a
revised Exhibit C and such budgetary pricing information, adjusted
Component costs or other documentation reasonably sufficient to demonstrate
that a fee adjustment is justified, provided that Patheon shall have no
obligation to provide any supporting documents to the extent such documents are
subject to obligations of confidentiality between Patheon and its suppliers.
Upon delivery of such a request, each of the Client and Patheon shall forthwith
use all reasonable efforts to agree on a revised fee in respect of each
affected Product.


 


Notwithstanding anything to the contrary in
Sections 9.1 and 9.2 hereof, Patheon shall not be entitled to a price increase
pursuant to Section 9.1(a) to the extent that such price increase was
reflected in a price increase already taken pursuant another provision of Section 9.1
or 9.2.


 


9.3                                 Tooling
Costs.  Client shall reimburse
Patheon promptly upon request for any costs related to tablet press tooling and
printing press change parts specific to the Prenate logo required for the
production of the Products.  These
charges are to be approved by Client prior to incurring these costs.


 


10.0                        MISCELLANEOUS


 


10.1                           Product
Discontinuation.  During the term of
this Agreement or any extension, Client shall provide at least six (6) months
advance notice if it intends to no longer order a Product due to its
discontinuance.  In such event, Client
shall have the right to terminate this Agreement as it relates to the
discontinued Product and shall, subject to Sections 3.7 and 5.3(d), have no
further liability hereunder in respect of such discontinued Product.


 


10.2                           Compliance
with Laws.  Each party, in connection
with its performance under this Agreement, shall comply with all applicable
laws, rules, regulations, and orders including maintaining all insurance
coverage required by state, federal, provincial or other applicable laws.


 


10.3                           Permits.  Patheon shall, at its own expense, obtain and
maintain the necessary permits required for the manufacture, packaging and
testing of the Products, provided that Patheon shall not be responsible for
obtaining or maintaining any permits or other regulatory approvals in respect
of the Products or the Specifications, which shall be the sole responsibility
of Client.


 


10.4                           Trademarks.  Client and Patheon hereby acknowledge that
neither party has, nor shall it acquire, any interest in any of the other party’s
trademarks or trade names unless otherwise expressly agreed to in writing.  The parties agree not to use any


 






*  Redacted
text has been omitted and filed separtely pursuant to a request for
confidential treatment.


 


18

















 


trademark or trade name of the other party,
except as specifically authorized by the other party.


 


10.5                           Reports.  Patheon will on an annual basis supply
Product data, including release test results, complaint test results, all
investigations (in manufacturing, testing and storage), and the like, which
Client reasonably requires in order to complete the Annual Product Review
report that is required to be filed by Client with the FDA.


 


10.6                           Insurance.  Each party shall maintain comprehensive
general liability insurance, including blanket contractual liability insurance
covering the obligations of that party under this Agreement through the term of
this Agreement and for five (5) years thereafter, which insurance shall
afford limits of not less than $2,000,000  for each occurrence for bodily injury
liability, personal injury liability, products liability, property damage
liability, contractual liability and completed operations liability.  If requested, each party will provide the
other with a certificate of insurance evidencing the above and showing the name
of the issuing company, the policy number, the effective date, the expiration
date and the limits of liability.  The
insurance certificate shall further provide for a minimum of thirty (30) days
written notice to the recipient of a cancellation of, or material change in,
the insurance, subject to the insurer’s agreement to so state on the
certificate.


 


10.7                           Independent
Contractors.  The parties shall be
deemed to be independent contractors, and this Agreement shall not be construed
to create between Patheon and Client any other relationship such as, by way of
example only, that of employer-employee, principal agent, joint-venturer,
co-partners or any similar relationship, the existence of which is expressly
denied by the parties hereto.


 


10.8                           No
Waiver.  Each party’s failure to
require the other party to comply with any provision of this Agreement shall
not be deemed a waiver of such provision or any other provision of this
Agreement.


 


10.9                           Assignment.  Patheon may not assign this Agreement or any
of its rights or obligations hereunder except with the written consent of
Client, such consent not to be unreasonably withheld, provided, however, that
Patheon may arrange for subcontractors to perform specific testing services
arising under this Agreement without the consent of the Client.  Client may assign this Agreement or any of
its rights or obligations hereunder without approval from Patheon provided that
the proposed assignee is credit-worthy in the opinion of Patheon acting
reasonably, Client shall give prior written notice of any assignment to Patheon
and any assignee shall covenant in writing with Patheon (and Patheon shall be
reasonable in connection therewith) to be bound by the terms of this
Agreement.  Notwithstanding the foregoing
provisions of this Section 10.9, either party may assign this Agreement to
any of its Affiliates or to a successor to all or substantially all of its
business and, in the case of Client, all or substantially all of the business
related to the Products covered by this Agreement, provided that the proposed
assignee is credit-worthy in the opinion of the non-assigning party


 






*  Redacted
text has been omitted and filed separtely pursuant to a request for confidential
treatment.


 


19

















 


acting reasonably and that such assignee
executes an agreement with the non-assigning party hereto whereby it agrees to
be bound hereunder


 


10.10                     Force
Majeure.  Neither party shall be liable
for the failure to perform its obligations under this Agreement if such failure
is occasioned by a contingency beyond such party’s reasonable control,
including, but not limited to, strikes or other labour disturbances, lockouts,
riots, wars, fires, floods or storms.  A
party claiming a right to excused performance under this Section 10.10
shall immediately notify the other party in writing of the extent of its
inability to perform, which notice shall specify the occurrence beyond its
reasonable control that prevents such performance.  Such other party shall have the right to
receive alternative arrangements during the period of the force majeure and,
after 3 months, shall have the right to terminate this Agreement.


 


10.11                     New
Products.  The parties covenant and
agree that additional products may be added to this Agreement and such
additional products shall be governed by the general conditions hereof with any
special terms (including, without limitation, price) governed by an addendum
hereto.


 


10.12                     Debarment.  Patheon represents and warrants that it and
its employees, Affiliates and agents have never been (i) debarred or (ii) convicted
of a crime for which a person can be debarred, under Section 306(a) of
the Generic Drug Enforcement Act of 1992 (Section 306 (a) or
(b)).  Patheon represents and warrants
that it has never been and, to the best of its knowledge after due inquiry,
none of its employees, affiliates or agents has ever been (1) threatened
to be debarred or (2) indicted for a crime or otherwise engaged in conduct
for which a person can be debarred, under Section 306(a) or (b).  Patheon agrees that it will promptly notify
Client upon learning of any such debarment, conviction, threat or indictment.


 


10.13                     Notices.  Any notice, approval, instruction or other
written communication required or permitted hereunder shall be sufficient if
made or given to the other party by personal delivery, by telecopier
communication or by sending the same by first class mail, postage prepaid to
the mailing address, or telecopier number set forth below:


 


If to Client:


 


First Horizon Pharmaceutical Corporation


6195 Shiloh Road


Alpharetta, Georgia


USA 
30005


 


Attention: 
Vice President of Operations


 


Telecopier No.:  770-442-9594


 






*  Redacted
text has been omitted and filed separtely pursuant to a request for
confidential treatment.


 


20

















 


With a copy to:


 


First Horizon Pharmaceutical Corporation


6195 Shiloh Road


Alpharetta, Georgia


USA 
30005


 


Attention: 
General Counsel


 


If to Patheon:


 


Patheon Inc.


7070 Mississauga Road, Suite 350


Mississauga, Ontario


Canada L5N 7J8


 


Attention: 
President


 


Telecopier No.:  (905) 812-6705


 


or to such other addresses or telecopier
number provided to the other party in accordance with the terms of this Section 10.13.  Notices or written communications made or
given by personal delivery or by telecopier shall be deemed to have been
sufficiently made or given when sent (receipt acknowledged), or if mailed, five
(5) days after being deposited in the United States or Canadian mail,
postage prepaid or upon receipt, whichever is sooner.


 


10.14                     Entire
Agreement.  The Confidentiality
Agreement and this Agreement constitute the full, complete, final and
integrated agreement between the parties hereto relating to the subject matter
hereof and supersedes all previous written or oral negotiations, commitments,
agreements, transactions or understandings with respect to the subject matter
hereof, including, without limitation, the Original Agreement.  Any modification, amendment or supplement to
this Agreement must be in writing and signed by authorized representatives of
both parties.


 


10.15                     Headings.  The titles and headings herein are for
convenience only and shall not be used to interpret or construe the terms and
conditions of this Agreement.


 


10.16                     Singular
Terms.  Except as otherwise expressly
provided herein or unless the context otherwise requires, all references to the
singular shall include the plural as well.


 


10.17                     Execution
in Counterparts.  This Agreement may
be executed in two (2) counterparts, each of which shall be deemed an
original, but all of which together shall constitute one and the same
instrument.


 






*  Redacted
text has been omitted and filed separtely pursuant to a request for confidential
treatment.


 


21

















 


10.18                     Governing
Law.  This Agreement shall be
construed and enforced in accordance with the laws of New York.


 


 


IN WITNESS WHEREOF, the duly authorized
representatives of the parties have executed this Agreement as of the date
first written above.


 


 


	
   

  	
  Patheon Inc.

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
   

  	
  /s/ Clive V. Bennett

  	
   

  
	
   

  	
  Title 

  	
  President Patheon North America

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  First Horizon Pharmaceutical Corporation

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
   

  	
  /s/ Leslie B. Zacks

  	
   

  
	
   

  	
  Title

  	
  VP, Legal & Administration

  



 






*  Redacted
text has been omitted and filed separtely pursuant to a request for
confidential treatment.


 


22

















 


EXHIBIT A


 


PRODUCTS


 




	
  PRODUCT

  	
   

  	
  ACTIVE MATERIAL

  
	
   

  	
   

  	
   

  
	
  Prenate EliteTM
  (Metafolin formulation) Tablets
  in Bulk

  	
   

  	
  Metafolin

  
	
   

  	
   

  	
   

  
	
  OptinateTM (Prenate Elite formulation
  and DHA 250 mg L-V capsule packaged together as one pharmaceutical drug
  product)

  	
   

  	
  Metafolin

  






 






*  Redacted
text has been omitted and filed separtely pursuant to a request for
confidential treatment.


 

















 


EXHIBIT B


 


FACILITIES


 


The Products may be manufactured at the following Patheon facilities:


 


Patheon Niagara Region Operations:


333 Jarvis Street


Fort Erie, Ontario


L2A 5M9


Canada


 


Patheon York Mills Operations:


865 York Mills Road


Toronto, Ontario


M3B 1Y5


Canada


 






*  Redacted
text has been omitted and filed separtely pursuant to a request for
confidential treatment.


 

















 


EXHIBIT C


 


PRICE
LIST


 




	
  TOTAL VOLUME OF PRODUCTS

  DURING A CALENDAR YEAR

  	
   

  	
  PRICE

  
	
  65 million tablets or less

  	
   

  	
  ###### per 1000 tablets

  
	
  65 million to 130 million tablets

  	
   

  	
  ###### per 1000 tablets in excess of 65
  million

  
	
  All volumes over 130 million tablets

  	
   

  	
  ###### per 1000 tablets in excess of 130
  million

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Minumum order quanity: 6 batches
  representing an aggregate of 7,182,000 tablets 

  






 






*  Redacted
text has been omitted and filed separtely pursuant to a request for
confidential treatment.


 

















 


EXHIBIT D


 


QUALITY
AGREEMENT


 






*  Redacted
text has been omitted and filed separtely pursuant to a request for confidential
treatment.


 

















 


EXHIBIT E


 


LOT
NUMBERING AND EXPIRATION DATES


 


Patheon Niagara Region Operations:


 


Products manufactured at Patheon will bear
lot numbers and will have expiry dates as described in Patheon SOP NROQ009.


 


Patheon York Mills Operations:


 


Products manufactured at Patheon will bear
lot numbers as described in Patheon SOP #MMG011 and will have expiry dates as
described in Patheon SOP #MCT 154.


 






*  Redacted
text has been omitted and filed separtely pursuant to a request for confidential
treatment.