**Exhibit 10.36**

 

**AMENDEDAND RESTATED**

**MANUFACTURINGAND SUPPLY AGREEMENT**

 

THIS AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT (the **“Agreement”**) made as of January 1,2004 (the **“Effective Date”**), byand between FIRST HORIZON PHARMACEUTICAL CORPORATION (**“First Horizon”**), a Delaware corporation,having offices at 6195 Shiloh Road, Alpharetta, Georgia, USA, 30005, andPATHEON INC. (**“Patheon”**), acorporation existing under the laws of Canada having its registered office at7070 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 havedecided to amend and restate the Original Agreement in order to add a newproduct and to revise certain of the existing terms as set forth herein;

 

NOW THEREFORE in consideration of the rightsconferred and the obligations assumed herein, and intending to be legallybound, the parties hereby agree that the Original Agreement is amended andrestated as follows:

 

**1.0****                               INTERPRETATION**

 

1.1                                 Definitions.  The following terms shall, unless the contextotherwise 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, orunder common control with such other Person at any time during the period forwhich 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 “undercommon control with”), as used with respect to any Person, shall mean thepossession, directly or indirectly, of the power to direct or cause thedirection of management policies of such Person whether through ownership ofvoting securities, by contract or otherwise.

 

**“Client”**shall mean First Horizon Pharmaceutical Corporation.

 

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

 

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Products), required to be used in order toproduce the Products in accordance with the Specifications, including ActiveMaterials, and **“Component”** meansany one of the foregoing.

 

**“Confidential Information”**has the meaning given to the term “Information” in the ConfidentialityAgreement 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 heldby Patheon in connection with the manufacture of the Products in accordancewith the Specifications.

 

**“Patheon”**shall mean Patheon Inc.

 

**“PatheonManufacturing Requirements”** shall have the meaningascribed thereto in Subsection 2.5(a).

 

**“Person”**shall mean a natural person, a corporation, a partnership, a limited liabilitycompany, a trust, a joint venture, any governmental authority or any otherentity 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 partieshereto, a copy of which is attached as Exhibit D.

 

**“Specifications”**  shall mean, collectively, (i) theproduct formulae, raw materials specifications, manufacturing process andpackaging specifications for the Products, (ii) the quality controltesting procedures and specifications for the Products, and (iii) theClient incoming inspection standards, all as provided or approved by Client inconnection herewith.

 

1.2                                 AnnualQuantity.  In this Agreement forpurposes of calculating the volume of product in a calendar year or any otherperiod specified in this Agreement, references to “Products shipped anddelivered” or “Products purchased” shall include Products ordered in conformitywith the provisions of this Agreement for delivery within that calendar year,whether or not delivered, unless non-delivery is a result of the actions ofClient.

 

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1.3                                 Exhibits.  The following exhibits are attached heretoand are incorporated in and are deemed to be an integral part of thisAgreement:

 
| 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 Agreementexpressed in the lawful currency of the United Sates of America.

 

**2.0****                               MANUFACTUREAND SUPPLY OF PRODUCTS**

 

2.1                                 Manufacture.  Patheon shall manufacture and sell to Clientthe 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 termshereof).  The Products will bemanufactured in the Patheon facilities listed in Exhibit B and any changeto a different manufacturing facility shall be approved by the Client.  Client shall purchase its entire requirementof Products for sale in the United States from Patheon pursuant to the terms ofthis Agreement, but the parties acknowledge that Client is not hereby orherein, including the references to volume in this Section 2.1, Article 9and Exhibit C, giving any guarantee of annual volume of Product.  If and when Client decides that it wishes tohave Patheon manufacture the Product for countries in addition to the UnitedStates, the Client shall inform Patheon of any additional requirements relatedto such additional jurisdiction and any resulting increase in cost will beborne by the Client.  The agreedadditional costs and change over fees shall be set out in a written amendmentto this Agreement.

 

2.2                                 ###########. ######################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################################

 

2.3                                 [Intentionallydeleted.]

 

2.4                                 Packaging.  It is agreed that the Products are to besupplied in bulk without packaging.  Anyreferences in this Agreement to Patheon performing packaging

 

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means packaging of bulk Product as opposed tofinished Product.  Client shall beresponsible for all finished Product packaging, labels, product inserts andother labeling for the Products.  Patheon’sname shall not appear on the label nor anywhere else on the Products unlessrequired by a governmental authority or applicable laws or regulations.

 

2.5                                 QualityControl and Assurance.

 

(a)                                  Patheonshall manufacture, package, test and ship the Products in accordance with (i) thecurrent good manufacturing practices as described in Division 2 of Part Cof the *Food and Drug Regulations*(Canada)and Parts 210 and 211 of Title 21 of the United States Code of FederalRegulations, together with the latest Health Canada and FDA guidance documentspertaining 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 obligationsdescribed in the foregoing sentence are hereinafter referred to as the **“Patheon Manufacturing Requirements”**.

 

(b)                                 Patheonshall perform the quality control and quality assurance testing specified inthe Quality Agreement.

 

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

 

(d)                                 Notwithstandingany provisions of this Agreement to the contrary, the parties agree thatPatheon shall not be liable or have any responsibility for any deficiencies in,or other liabilities associated with: (i) the formulae and proceduresspecified by Client; (ii) the safety (except to the extent due to thefault of Patheon as determined in accordance with the provisions of thisAgreement), efficacy or marketability of the Products; (iii) distributionrisk; (iv) Components, provided that any such deficiency was notreasonably discoverable using the test methods detailed in the Specificationsand applying such test methods in accordance with GMP; or (v) servicesprovided by third parties in connection with the packaging of the bulk Product.

 

(e)                                  Eachtime Patheon ships Products to Client, it shall provide Client with acertificate of analysis that sets out the actual test results for each lot ofProducts and which certifies that the Products shipped to Client have beenevaluated by Patheon’s Quality Control/Quality Assurance department and thatthe Products comply with the Patheon Manufacturing Requirements.

 

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

 

2.6                                 Rejectionof Products.

 

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

 

(b)                                 Uponreceipt 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 whetherit agrees that the subject Products are Non-Conforming Products.  If Client and Patheon fail to agree within 10business days after Patheon’s notice to Client as to whether any Productsidentified in the Deficiency Notice are Non-Conforming Products, the partiesshall mutually determine an independent laboratory to evaluate whether theProducts are Non-Conforming Products.  Ifsuch evaluation certifies that any Products are Non-Conforming Products, Clientmay have those Products replaced in the manner contemplated by Subsection 2.6(d).

 

(c)                                  Claimsfor shortages set out in a Deficiency Notice delivered to Patheon pursuant toSubsection 2.6(a)(ii) shall be dealt with in accordance with normalcommercial practices.

 

(d)                                 Allfees and disbursements incurred in connection with the independentdetermination by the laboratory as described in Section 2.6(b) aboveshall be borne by the party which determined incorrectly that the relevantProduct was or was not a Non-Conforming Product.  Within 15 days of the determination by theindependent laboratory that the Product is a Non-Conforming Product, Patheonshall replace such returned Non-Conforming Product at its expense or if it isunable to make prompt replacement, shall either credit Client’s account orrefund any payment made on the rejected Product, depending on Client’s accountbalance.

 

2.7                                 StabilityTesting.  Patheon shall conductstability testing on the Products as required by GMPs and in accordance withthe protocols approved by Client from time to time and executed by the Clientand Patheon.  The fee proposal for such

 

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stability testing shall be prepared by Patheonand approved by the Client, such approval to be evidenced by the Client’sexecution of such proposal.  Patheonshall not make any changes to these testing procedures without prior writtenapproval from Client.  In the event thatany lot of Products fails stability testing, Patheon and Client shall jointlydetermine the proceedings and methods to be undertaken to investigate thecauses of such failure, including which party shall bear the cost of suchinvestigation.  Patheon will provide anyand all data and results relating to the stability testing upon request byClient.  From time to time, Patheonshall, at the request of Client, also provide stability testing services withrespect to products not manufactured by Patheon, the cost of such services tobe agreed to between the parties prior to such services being undertaken.

 

**3.0****                               ORDERS,DELIVERY, INVOICING AND PAYMENT**

 

3.1                                 YearlyForecast.  On the execution of thisAgreement, Client shall provide Patheon with a forecast of the volume of eachProduct required during the first year of this Agreement.

 

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

 

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

 

3.3                                 WrittenOrders.  The Firm Orders submitted toPatheon pursuant to Section 3.2 shall specify Client’s purchase ordernumber, quantities by Product type, monthly delivery schedule and anyother elements necessary to ensure the timely production and delivery of theProducts.  The quantities of Productsordered in such Firm Orders shall be firm and binding on Client and shall notbe subject to reduction.  Patheon shallprovide written confirmation of receipt of Firm Orders to the Client within ten(10) calendar days of receipt thereof.

 

3.4                                 Relianceby Patheon.  Client agrees thatpurchases may be made by Patheon of the Components to satisfy the productionrequirements for Firm Orders.  Inaddition, the Client authorizes Patheon to purchase Components in order tosatisfy

 

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the production requirements for Products forthe first six months contemplated in the most recent forecast provided by theClient pursuant to Section 3.2, and agrees that Patheon may make suchother purchases of Components to meet production requirements during suchlonger periods as may be agreed to in writing from time to time by the Clientat the request of Patheon.  In suchcircumstances, if such Components are not included in finished Productspurchased by Client within six months after such purchases have been made (orsuch longer period as the parties may have agreed to), Client will pay toPatheon its costs thereof and, in the event such Components are incorporatedinto Products subsequently purchased by Client, Client will receive credit forany of such costs previously paid to Patheon by Client.

 

3.5                                 MinimumOrders.  The Products to bemanufactured and packaged by Patheon may only be ordered in quantities equal toor greater than the minimum order quantities specified in Exhibit C.

 

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

 

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

 

(a)                                  purchase,at Patheon’s cost, the Inventory applicable to the Products which werepurchased, produced or maintained by Patheon in contemplation of filling FirmOrders, or in accordance with Section 3.4, prior to notice of terminationbeing given. Client’s obligation under this section shall not exceedPatheon’s actual costs of Components and Inventory in order to manufacture a sixmonth supply of Product based upon the most recent forecast unless the purchaseof such Components and Inventory was authorized by the Client pursuant to Section 3.4;

 

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

 

(c)                                  satisfythe purchase price payable pursuant to Patheon’s orders with suppliers ofComponents, or in accordance with Section 3.4, provided such orders weremade by Patheon in reliance on Firm Orders.

 

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

 

3.8                                 Specifications.  All Components shall be purchased and testedby Patheon at Patheon’s expense in accordance with Patheon ManufacturingRequirements.  Patheon will not changethe Specifications used to manufacture, test, package and ship the Productswithout the written consent of Client. Amendments to Specifications requested by Client will only beimplemented following a technical and cost review, subject to Client and Patheonreaching agreement as to price revisions necessitated by any such amendment inaccordance with Section 3.9 below.

 

3.9                                 Changein Specifications.

 

(a)                                  IfClient requests a change in the Specifications which would result in anincrease or decrease in Patheon’s costs for Components or would cause Patheonto incur other costs as a result of the change in Specifications, the partiesshall discuss, each acting reasonably and based on satisfactory documentationprovided by Patheon indicating the cause of the price change, what impact, ifany, such change should have on the price of the Products and payment toPatheon of the related costs.  If Client,acting reasonably, accepts a proposed price change, the proposed change in theSpecifications shall be implemented, and the price change shall become effectiveonly with respect to those orders of Products which are manufactured inaccordance with the revised Specifications.

 

(b)                                 Notwithstandingany 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, atPatheon’s cost, all Inventory, utilized under the “old” Specifications andpurchased or maintained by Patheon in order to fill Firm written Orders to theextent that such Inventory can no longer be utilized under the revisedSpecifications.  Open purchase orders forComponents no longer required under any revised Specifications which wereplaced by Patheon with suppliers in order to fill Firm Orders or in accordancewith Section 3.4 shall be cancelled where possible, and where such ordersare not subject to cancellation without penalty, shall be assigned to andsatisfied by Client.

 

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

 

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

 

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

 

3.11                           Invoicesand Payment.  Except as otherwiseprovided in this Agreement, Patheon shall charge Client for only those Productsthat are shipped to Client.  Invoicesshall be sent by fax or email to such fax number or email address as may beprovided by the Client in writing from time to time.  Patheon shall also submit to the Client, witheach shipment of Products, a duplicate copy of the invoice covering suchshipment.  Each such invoice shall, tothe extent applicable, identify the Client purchase order number, Productnumbers, names and quantities, unit price, freight charges and the total amountto be remitted by Client.  Client shallpay all such invoices within thirty (30) days of the date thereof.

 

3.12                           LotNumbering/Expiration Dates.  Patheonshall make arrangements for and implement the imprinting of lot numbers,expiration dates, retest dates or “package-by” dates, as applicable, on eachProduct container as required by GMPs for each Product shipped.  Such lot numbers and dates shall be affixedon the Products and/or on the shipping carton of each Product as is required byGMPs.  The system used by Patheon for lotnumbering and expiration dates is detailed on Exhibit E hereto.  Except in circumstances constituting forcemajeure pursuant to Section 10.10 or an inability of Patheon to obtainComponents due to no fault of Patheon or circumstances beyond Patheon’sreasonable control (including, without limitation, where Product is undergoingan investigation in respect of quality matters), Patheon shall take bestefforts to ensure that Product shall have not less than 21 months remainingbefore expiration at the time of shipment of such Product by Patheon; provided,however, in the event that Product will have less than 21 months remainingbefore expiration at the time of shipment of such Product by Patheon, Patheonshall promptly notify the Client and Patheon and the Client shall endeavor tomutually agree on a resolution in respect of such shipment.

 

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

 

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Formulation) Product, or any line extensionthereof containing Metafolin, ceases to be produced by Patheon for any reasonwithin 24 months after the completion of the process validation batch of suchProduct; or (b) a minimum volume of ########## tablets of the PrenateElite (Metafolin Formulation) Product, or any line extension thereof containingMetafolin, is not ordered by the Client and paid for by the Client within 24months 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’sprocurement of the Active Material Metafolin. If there is any loss of Metafolin due to reasons other than Patheon’snegligence or willful misconduct, then Client shall be solely liable for thecost of such loss of Metafolin; provided, however, that Patheon shall takereasonable actions to mitigate such losses. If there is any loss of Metafolin due to Patheon’s negligence or willfulmisconduct and Client fails to meet the minimum purchase volume of ###########tablets of Product during the calendar year, then Client shall be responsiblefor the cost of such loss of Metafolin to a maximum of ######## of thatcalendar year.  If there is any loss ofMetafolin due to Patheon’s negligence or willful misconduct and Client meets orexceeds the minimum purchase volume of ########## tablets of Prenate EliteProduct during the calendar year, then Client shall be responsible for the costof such loss of Metafolin to a maximum of ####### of that calendar year.  Amounts owing from each party under this Section 3.14shall be reconciled at the end of each calendar year.

 

**4.0****                               CO-OPERATION**

 

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

 

4.2                                 ProductRecalls.

 

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

 

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decision to initiate a recall or to take someother corrective action, if any, shall be made and implemented by Client.  Patheon will co-operate as reasonably requiredby Client, having regard to all applicable laws and regulations.  Each party shall co-operate with the other indeveloping any necessary recall plan, and the manner and extent of such planshall be subject to prior consultation, which consultation shall notunreasonably delay such plan.

 

(b)                                 Tothe extent that a recall results from, or arises out of, any breach by Patheonof the Patheon Manufacturing Requirements then (i) such recall and allreasonable expenses associated with the recall shall be made at Patheon’s costand expense, and (ii) Patheon shall use its best efforts to replace therecalled Products with new Products within sixty (60) days from the date thatClient notifies Patheon about the recalled Products.  In the event that (i) Patheon is unableto replace the recalled Products within this sixty (60) day period (exceptwhere such inability results from a failure to receive the required ActiveMaterials), or (ii) such new Products are also recalled or returned due toa breach by Patheon of the Patheon Manufacturing Requirements, then Client mayrequest Patheon to reimburse Client for the purchase price that Client paidPatheon for the affected Products.  Inall other circumstances, recalls shall be made at Client’s cost and expense.

 

4.3                                 ProductReturns.  Client shall have theresponsibility for handling customer returns of the Products.  Patheon shall provide Client with suchassistance 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 ManufacturingRequirements, Patheon shall use all reasonable best efforts to replace thereturned Products with new Products within sixty (60) days from the date thatClient notifies Patheon about the returned Products or sooner if reasonablypossible.  In the event that (i) Patheonis 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 byPatheon, then Client may request Patheon to reimburse Client the purchase pricethat Client paid Patheon for the affected Products.  In all other circumstances, customer returnsshall be made at Client’s cost and expense.

 

4.4                                 Audits.

 

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

 

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(b)                                 Clientshall have the right, upon prior reasonable notice to Patheon and during normalbusiness hours, to examine all technical records related to the Products (or toexamine any portions of any technical records related to the Products, as thecase may be) kept by Patheon and to request and receive reasonable samples ofraw materials, packaging materials and finished Products.

 

(c)                                  Duringthe term of this Agreement, Patheon shall promptly notify Client of anyinspections by the FDA, or any other federal, state, local or foreigngovernment agency, of the facilities where the Products are manufactured andpackaged, and shall thereupon furnish Client with copies of all reports,analyses and other documents (including responses to the FDA) relating to suchinspections, where the inspections involve or may involve the Products, theComponents of the Products or the manufacture of the Products.  If such inspections are scheduled orconducted with advance notice, Patheon shall so advise Client and unless thereis a legal prohibition against doing so, Client shall have the option to bepresent during the inspections. Duplicate samples of the Products given to government agencies andduplicates of the photographs taken during the inspection shall be provided toClient.  Any Patheon correspondencerelating to the Products shall be approved by Client prior to submission to anygovernment agency.

 

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

 

(e)                                  Patheonshall support the annual reporting requirements of Client under GMPs byproviding Client with updated stability data for its ongoing studies for theProducts.

 

4.5                                 CustomerQuestions and Complaints.  Clientshall have the sole responsibility for responding to questions and complaintsfrom Client customers.  Questions orcomplaints received by Patheon from Client customers shall be promptly referredto Client.  Patheon shall co-operate asrequired to allow Client to resolve any customer questions and complaints.  Such assistance shall include follow-upinvestigations including testing.  Inaddition, within ten (10) business days from the date of request, orsooner if reasonably possible Patheon shall provide Client with all necessaryinformation that will enable Client to respond properly to questions orcomplaints relating to the Products. Unless it is determined that the cause of any customer complaintresulted from a breach by Patheon of the Patheon Manufacturing Requirements orits representations in Section 6.2 hereof, all costs incurred in respectof this Section 4.5 shall be borne by Client.

 

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**5.0****                               TERM,RENEWAL AND TERMINATION**

 

5.1                                 Term.  This Agreement shall become effective on theEffective Date hereof.  Subject to anyextension pursuant to Section 5.2, this Agreement shall expire five (5) yearsfrom the Effective Date hereof, unless terminated by one of the parties asprovided herein.

 

5.2                                 Extension.  This Agreement shall continue after theinitial term for successive terms of one year unless either party gives writtennotice to the other party of its intention to terminate this Agreement at leastthree hundred and sixty-five (365) days prior to the end of the then currentterm.

 

5.3                                 Termination.

 

(a)                                  Uponfailure of either party to remedy its material breach of any of the obligationsor provisions of this Agreement within forty-five (45) days following receiptof written notice of said breach, the aggrieved party shall have the right toterminate this Agreement immediately by written notice.  For certainty, failure to purchase theminimum order quantities set forth in Exhibit C shall not constitute abreach of this Agreement.

 

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

 

(c)                                  Clientmay terminate this Agreement as to any Products upon thirty (30) days’ writtennotice in the event that any governmental agency takes any action, or raisesany objection, that prevents Client from importing, exporting, purchasing orselling such Products.

 

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

 

(e)                                  Customer mayterminate it’s obligation to purchase Product, by giving written notice toPatheon at least one hundred eighty (180) days prior to the effective dateof such termination.  Customer may notterminate this Agreement in accordance with this paragraph prior to the secondanniversary date from the Effective Date.

 

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**6.0****                               REPRESENTATIONSAND WARRANTIES**

 

6.1                                 Authority.  Each party represents and warrants that ithas the full right and authority to enter into this Agreement, and that it isnot aware of any impediment that would inhibit its ability to perform itsobligations hereunder.

 

6.2                                 Patheon.  Patheon represents and warrants that:

 

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

 

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

 

(iii)                               upondelivery, 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)                              theProducts will be manufactured at an FDA approved facility and in compliancewith applicable regulatory requirements;

 

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

 

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

 

PATHEON MAKES NO WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BYFACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT.  PATHEON MAKES NO WARRANTY OF FITNESS FOR APARTICULAR PURPOSE OR WARRANTY OF MERCHANTABILITY IN RESPECT OF THE CLIENT’SPRODUCT.

 

6.3                                 Client:  Client represents and warrants that:

 

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

 

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

 

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

 

(iv)                              theProducts if labeled and formulated in accordance with the Specifications willnot infringe the valid intellectual property rights of any third party;

 

(v)                                 theSpecifications will not in and of themselves result in production of Productswhich are unfit for human consumption or adulterated or misbranded within themeaning of any applicable law;

 

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

 

(vii)                           the provisionof the manufacturing service by Patheon in respect of any Product pursuant tothis Agreement or use or other disposition of any Product by Patheon as may berequired to perform its obligations under this Agreement does not and will notinfringe 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 (includingattorneys’ fees) (collectively, **“Liabilities”**)arising out of or attributable to (i) Patheon’s breach of itsrepresentations or warranties under this Agreement or its obligation tomanufacture, package, test and ship Products in accordance with the PatheonManufacturing Requirements, or (ii) any negligent or wrongful act oromission on the part of Patheon, its employees, agents or representativesexcept, in each case, to the extent that any such Liabilities are due to thenegligence or wrongful act(s) of Client, its Affiliates, officers, directors,employees or agents.

 

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

 

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

 

7.3                                 ConsequentialDamages.  A party shall not be liableto the other party for that other party’s consequential damages, but forgreater certainty nothing in this Section 7.3 shall limit the liability ofa party under its indemnity of the other party in this Article 7 inrespect of damages suffered by the other party which include consequential damagesof a third party.

 

**8.0****                               CONFIDENTIALITY**

 

8.1                                 Duringand in furtherance of this Agreement, each of the parties hereto may disclosecertain of its Confidential Information to the other party.  The parties agree that for the term of thisAgreement (including any renewals) and for a period of five years after thetermination of this Agreement, such Confidential Information shall be subjectto the terms of the Confidentiality Agreement, which terms are incorporatedherein by reference.

 

**9.0****                               PRICE**

 

9.1                                 AnnualPrice Adjustments.  The fees for theProducts listed in Exhibit C during any period following the firstanniversary of this Agreement shall be determined in accordance with thefollowing:

 

(a)                                  AnnualPrice Adjustment.  On January 1stof each calendar year of this Agreement, Patheon shall be entitled to anadjustment to the fees (i) for manufacturing services in respect of theProducts to reflect inflation, which adjustment shall be based on the increasein the Consumer Price Index, Canada (All Items) published by Statistics Canadain September of the then current year compared to the same month of the preceding year which shall notexceed four percent (4%) of the then current year’s costs associated with manufacturingservices, unless the parties otherwise agree in writing; and (ii) forComponent costs to pass on the actual amount of any increase or decrease insuch costs.  Such annual price increasesshall be effective on January 1st of each calendar year.

 

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

 

(c)                                  PricingBasis.  The Client acknowledges thatthe fee in respect of a Product in any year is quoted based upon the minimumorder quantity and minimum annual quantity per Product specified in Exhibit Cor thereafter specified in the forecast provided pursuant to Section 9.1(b) forthe year and is subject to change if the specified minimum order quantity and

 

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minimum annual quantity is not met.  For greater certainty, if Patheon and theClient agree that the minimum order quantity in respect of a Product shall bereduced whether as a result of a decrease in minimum annual quantity orotherwise and, as a result of such reduction, Patheon’s fees for servicesrelating to such Product increase on a per unit basis, then Patheon shall beentitled to an increase in the fee in respect of such Product by an amountsufficient to absorb such increase.

 

In connection with a fee adjustment pursuantto Section 9.1(a), Patheon shall deliver to the Client a revised Exhibit Cand 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 adjustmentrequests pursuant to this Section 9.1(b) and 9.1(c), Patheon shalldeliver to the Client a revised Exhibit C and such budgetary pricing informationor other documentation reasonably sufficient to demonstrate that a feeadjustment is justified, provided that Patheon shall have no obligation toprovide any supporting documents to the extent such documents are subject toobligations of confidentiality between Patheon and its suppliers. Upon deliveryof such a request, each of the Client and Patheon shall forthwith use allreasonable efforts to agree on a revised fee in respect of each affectedProduct.

 

9.2                                 Mid-YearPrice Adjustments.  During any yearof this Agreement, the fees set out in Exhibit C shall be subject toadjustment in accordance with the following:

 

(a)                                  VolumeReduction.  If at any time and fromtime to time Patheon determines, acting reasonably and based on the forecastsand Firm Orders received from the Client, that the current yearly run-ratevolumes (including, without limitation, any permanent reductions in volumes)relating to a specific Product will constitute no more than 85% of the minimumannual quantities for that Product specified in Exhibit C hereto or, ifapplicable, any revised minimum annual quantity hereinafter agreed to by theparties, then Patheon shall be entitled to request an adjustment to the fee inrespect of that Product to reflect the increased costs that Patheon will incuras a result of the reduced volumes.

 

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

 

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reflect an increase in the cost of one ormore Components, the adjustments provided for in (i) and (ii) aboveshall 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 requestpursuant to this Section 9.2, Patheon shall deliver to the Client arevised Exhibit C and such budgetary pricing information, adjustedComponent costs or other documentation reasonably sufficient to demonstratethat a fee adjustment is justified, provided that Patheon shall have noobligation to provide any supporting documents to the extent such documents aresubject to obligations of confidentiality between Patheon and its suppliers.Upon delivery of such a request, each of the Client and Patheon shall forthwithuse all reasonable efforts to agree on a revised fee in respect of eachaffected Product.

 

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

 

9.3                                 ToolingCosts.  Client shall reimbursePatheon promptly upon request for any costs related to tablet press tooling andprinting press change parts specific to the Prenate logo required for theproduction of the Products.  Thesecharges are to be approved by Client prior to incurring these costs.

 

**10.0****                        MISCELLANEOUS**

 

10.1                           ProductDiscontinuation.  During the term ofthis Agreement or any extension, Client shall provide at least six (6) monthsadvance notice if it intends to no longer order a Product due to itsdiscontinuance.  In such event, Clientshall have the right to terminate this Agreement as it relates to thediscontinued Product and shall, subject to Sections 3.7 and 5.3(d), have nofurther liability hereunder in respect of such discontinued Product.

 

10.2                           Compliancewith Laws.  Each party, in connectionwith its performance under this Agreement, shall comply with all applicablelaws, rules, regulations, and orders including maintaining all insurancecoverage required by state, federal, provincial or other applicable laws.

 

10.3                           Permits.  Patheon shall, at its own expense, obtain andmaintain the necessary permits required for the manufacture, packaging andtesting of the Products, provided that Patheon shall not be responsible forobtaining or maintaining any permits or other regulatory approvals in respectof the Products or the Specifications, which shall be the sole responsibilityof Client.

 

10.4                           Trademarks.  Client and Patheon hereby acknowledge thatneither party has, nor shall it acquire, any interest in any of the other party’strademarks or trade names unless otherwise expressly agreed to in writing.  The parties agree not to use any

 

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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 supplyProduct data, including release test results, complaint test results, allinvestigations (in manufacturing, testing and storage), and the like, whichClient reasonably requires in order to complete the Annual Product Reviewreport that is required to be filed by Client with the FDA.

 

10.6                           Insurance.  Each party shall maintain comprehensivegeneral liability insurance, including blanket contractual liability insurancecovering the obligations of that party under this Agreement through the term ofthis Agreement and for five (5) years thereafter, which insurance shallafford limits of not less than $2,000,000  for each occurrence for bodily injuryliability, personal injury liability, products liability, property damageliability, contractual liability and completed operations liability.  If requested, each party will provide theother with a certificate of insurance evidencing the above and showing the nameof the issuing company, the policy number, the effective date, the expirationdate and the limits of liability.  Theinsurance certificate shall further provide for a minimum of thirty (30) dayswritten notice to the recipient of a cancellation of, or material change in,the insurance, subject to the insurer’s agreement to so state on thecertificate.

 

10.7                           IndependentContractors.  The parties shall bedeemed to be independent contractors, and this Agreement shall not be construedto create between Patheon and Client any other relationship such as, by way ofexample only, that of employer-employee, principal agent, joint-venturer,co-partners or any similar relationship, the existence of which is expresslydenied by the parties hereto.

 

10.8                           NoWaiver.  Each party’s failure torequire the other party to comply with any provision of this Agreement shallnot be deemed a waiver of such provision or any other provision of thisAgreement.

 

10.9                           Assignment.  Patheon may not assign this Agreement or anyof its rights or obligations hereunder except with the written consent ofClient, such consent not to be unreasonably withheld, provided, however, thatPatheon may arrange for subcontractors to perform specific testing servicesarising under this Agreement without the consent of the Client.  Client may assign this Agreement or any ofits rights or obligations hereunder without approval from Patheon provided thatthe proposed assignee is credit-worthy in the opinion of Patheon actingreasonably, Client shall give prior written notice of any assignment to Patheonand any assignee shall covenant in writing with Patheon (and Patheon shall bereasonable in connection therewith) to be bound by the terms of thisAgreement.  Notwithstanding the foregoingprovisions of this Section 10.9, either party may assign this Agreement toany of its Affiliates or to a successor to all or substantially all of itsbusiness and, in the case of Client, all or substantially all of the businessrelated to the Products covered by this Agreement, provided that the proposedassignee is credit-worthy in the opinion of the non-assigning party

 

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acting reasonably and that such assigneeexecutes an agreement with the non-assigning party hereto whereby it agrees tobe bound hereunder

 

10.10                     ForceMajeure.  Neither party shall be liablefor the failure to perform its obligations under this Agreement if such failureis 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.  Aparty claiming a right to excused performance under this Section 10.10shall immediately notify the other party in writing of the extent of itsinability to perform, which notice shall specify the occurrence beyond itsreasonable control that prevents such performance.  Such other party shall have the right toreceive alternative arrangements during the period of the force majeure and,after 3 months, shall have the right to terminate this Agreement.

 

10.11                     NewProducts.  The parties covenant andagree that additional products may be added to this Agreement and suchadditional products shall be governed by the general conditions hereof with anyspecial terms (including, without limitation, price) governed by an addendumhereto.

 

10.12                     Debarment.  Patheon represents and warrants that it andits employees, Affiliates and agents have never been (i) debarred or (ii) convictedof a crime for which a person can be debarred, under Section 306(a) ofthe Generic Drug Enforcement Act of 1992 (Section 306 (a) or(b)).  Patheon represents and warrantsthat 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) threatenedto be debarred or (2) indicted for a crime or otherwise engaged in conductfor which a person can be debarred, under Section 306(a) or (b).  Patheon agrees that it will promptly notifyClient upon learning of any such debarment, conviction, threat or indictment.

 

10.13                     Notices.  Any notice, approval, instruction or otherwritten communication required or permitted hereunder shall be sufficient ifmade or given to the other party by personal delivery, by telecopiercommunication or by sending the same by first class mail, postage prepaid tothe 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

 

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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 telecopiernumber provided to the other party in accordance with the terms of this Section 10.13.  Notices or written communications made orgiven by personal delivery or by telecopier shall be deemed to have beensufficiently 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                     EntireAgreement.  The ConfidentialityAgreement and this Agreement constitute the full, complete, final andintegrated agreement between the parties hereto relating to the subject matterhereof and supersedes all previous written or oral negotiations, commitments,agreements, transactions or understandings with respect to the subject matterhereof, including, without limitation, the Original Agreement.  Any modification, amendment or supplement tothis Agreement must be in writing and signed by authorized representatives ofboth parties.

 

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

 

10.16                     SingularTerms.  Except as otherwise expresslyprovided herein or unless the context otherwise requires, all references to thesingular shall include the plural as well.

 

10.17                     Executionin Counterparts.  This Agreement maybe executed in two (2) counterparts, each of which shall be deemed anoriginal, but all of which together shall constitute one and the sameinstrument.

 

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10.18                     GoverningLaw.  This Agreement shall beconstrued and enforced in accordance with the laws of New York.

 

 

IN WITNESS WHEREOF, the duly authorizedrepresentatives of the parties have executed this Agreement as of the datefirst 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 |

 

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**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           |

 

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**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

 

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**EXHIBIT C**

 

**PRICELIST**

 

| **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 |

 

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**EXHIBIT D**

 

**QUALITYAGREEMENT**

 

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**EXHIBIT E**

 

**LOTNUMBERING AND EXPIRATION DATES**

 

Patheon Niagara Region Operations:

 

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

 

Patheon York Mills Operations:

 

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

 

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