Exhibit 10.3
CONFIDENTIAL TREATMENT REQUESTED
Confidential Portions of This Agreement Which Have Been Redacted Are
Marked With Brackets ([***]). The Omitted Material Has Been Filed Separately
With The Securities And Exchange Commission.
MANUFACTURING AND SUPPLY AGREEMENT
THIS AGREEMENT made as of October 1, 1999; by and between SANOFI - SYNTHELABO
INC., a Delaware corporation, having offices at ▇▇ ▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇,
▇▇▇, and PATHEON INC., a corporation existing under the laws of Canada having
its registered office at ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇.
IN CONSIDERATION of the rights conferred and the obligations assumed
herein, and intending to be legally bound, the parties hereby agree as follows:
1.0 INTERPRETATION
1.1 Definitions. The following terms shall, unless the context otherwise
requires, have the following meanings, respectively:
"Affiliate" shall mean (i) with respect to Sanofi-Synthelabo Inc.,
Sanofi-Synthelabo, a societe anonyme organized under the laws of France,
and any successor thereto ("Sanofi-Synthelabo France"), and any Persons
directly or indirectly controlled by Sanofi-Synthelabo France at any time
during the period for which the determination of affiliation is being
made and (ii) with respect to any other Person, 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.
"CFR" shall have the meaning ascribed thereto in Section 4.1.
"Client" shall mean Sanofi-Synthelabo Inc.
"Components" shall mean, collectively, all packaging components, raw
materials and ingredients (including labels, product inserts and other
labeling for the Products), required to be used in order to produce the
Products in accordance with the Specifications 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 September 1, 1998 (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.
"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 of which are set forth in Exhibit A-1
hereto.
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.
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 A-1 - Specifications and Facilities
Exhibit B - Price List
Exhibit C - Previous Development Work
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[***] - CONFIDENTIAL TREATMENT REQUESTED
Exhibit D - Stability Testing Procedures/Fee Schedule
Exhibit E - Lot Numbering and Expiration Dates
1.4 Currency. - All dollar amounts in this Agreement expressed in the lawful
currency of the United States 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") on a world-wide exclusive
basis at the prices listed on Exhibit B 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 A-1 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 Schedule B, giving any guarantee of annual volume of Product.
2.2 Non-Compete. Patheon will not develop or manufacture (either for itself
or for any third party) a prescription prenatal multivitamin product for
sale or distribution in the United States market during the term of this
Agreement provided that the Client purchases from Patheon a minimum
annual volume of [***] tablets of the Products listed on the date hereof
in Exhibit A.
2.3 Capacity. Patheon represents that it has and will have during the term of
this Agreement the capacity to produce a minimum annual volume of [***]
tablets of the Products listed on the date hereof in Exhibit A. If at any
time Client's production needs exceed [***] tablets per month, Client
will promptly advise Patheon of same and Patheon will use its best
efforts to meet Client's volume requirement.
2.4 Packaging. Patheon shall package the Products with labels, product
inserts and other labeling as specified in Exhibit A-1. 1t is agreed that
the product Prenate Advance listed on Exhibit A at the date hereof is to
be supplied in bulk without packaging. Client may, in its sole
discretion, make changes to labels, product inserts and other labeling
for the Products, which changes shall be submitted by Client to all
applicable governmental agencies and other third parties responsible for
the approval of the Products, if required. Patheon's name shall not
appeal 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) all applicable laws and regulations, including
but not limited to, the U.S. Federal Food, Drug and Cosmetic Act
and the regulations promulgated thereunder (such as current Good
Manufacturing Practices ("GMPs"), as amended and in effect from
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time to time, 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 such quality control and quality assurance
testing as is required to ensure that the Products comply with all
of the Patheon Manufacturing Requirements.
(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) The parties hereto agree that Patheon shall not be liable or have
any responsibility for any deficiencies in, or other liabilities
associated with, the formulae and procedures specified by Client,
the safety, efficacy or marketability of the Products or any
distribution risk.
(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. 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 thereof 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.
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(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, the particulars of which form part of the annexed
Exhibit D, and in accordance with the fee schedule attached as Exhibit D.
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 twelve (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 twelve (12) month period.
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[***] - CONFIDENTIAL TREATMENT REQUESTED
The first three (3) months of such forecast are to be considered firm
orders (the "Firm Orders"). Firm Orders will be accompanied by a purchase
order. Each forecast will be provided to Patheon no later than the
fifteenth (15th) of each month.
3.3 Written Orders. The Firm Orders submitted to Patheon pursuant to
Subsection 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
and may make such other purchases to meet production requirements
exceeding Firm Order requirements as may be agreed to in writing from
time to time by Client and 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 the following minimum order run quantities [***]
of [***] tablets per batch.
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;
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(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 provided such orders were made by
Patheon in reliance on Firm Orders.
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.
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(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 ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ to such Client
locations as requested by Client and 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, at Client's expense, of all shipping documents, including
customs formalities for export of the Products.
3.1l Invoices and Payment. Except as otherwise provided in this Agreement,
Patheon shall charge Client for only those Products that are shipped to
Client and shall submit to Client, with each shipment of Products, an
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 receipt 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.
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 regulations, including
the requirements of the United States Code of Federal Regulations ("CFR")
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, including the
CFR.
4.2 Product Recalls.
(a) Patheon and Client shall each maintain records as may be necessary
to permit a recall or a field correction of any 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
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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 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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(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, the manufacture of the Products, or
the premises used to process and ship 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 the CFR 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 cooperate
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) 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.
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5.0 TERM, RENEWAL AND TERMINATION
5.1 Term. This Agreement shall become effective when it has been executed by
duly authorized representatives of both parties hereto. Subject to any
extension pursuant to Section 5.2, this Agreement shall expire five (5)
years from the 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 each 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.
(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.
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.
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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 or any component thereof 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.
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;
(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; and
(iv) the Products if labelled and formulated in accordance with the
Specifications will not infringe the valid intellectual property
rights of any third party.
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(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.
7.0 INDEMNITY
7.1 Patheon. 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. 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 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 (except section 16 thereof)
are incorporated herein by reference.
9.0 PRICE
9.1 Price. The prices for the Products listed in Exhibit B are intended by
the parties to be guaranteed prices until December 31, 2000, subject to
the amendments to such prices provided for in Section 9.2. The prices for
any Products delivered pursuant to the terms of this Agreement during any
period following December 31, 2000 shall be determined in accordance with
Section 9.3.
13
[***] - CONFIDENTIAL TREATMENT REQUESTED
9.2 Purchase Price Variances. The prices set out in Exhibit B shall be
subject to adjustment in accordance with the following:
(a) If at any time and from time to time, Patheon determines, acting
reasonably and based on the forecasts and Firm Orders received
from Client, that the total annual projected volume for the
current year relating to a specific Product will constitute less
than [***] tablets ([***] tablets in the year 2000) of that
Product, Patheon shall be entitled to and may request an
adjustment to the price of that Product to reflect the increased
Component costs that Patheon will incur as a result of the reduced
volumes. In connection with such request; Patheon shall deliver to
Client a revised Exhibit B setting out the adjusted Component
costs that will be incurred based on the then anticipated volumes
for the relevant Product. Upon delivery of such a request, each of
Client and Patheon shall forthwith use all reasonable efforts to
agree on a revised price for the relevant Product that reflects
the increased Component costs being incurred by Patheon and Client
shall act in good faith and pay to Patheon the difference between
the revised price and the price charged for Products shipped prior
to the price change;
(b) If at any time, extraordinary market conditions result in
Patheon's cost of Components being greater or lesser than normal
forecasted increases or decreases, Patheon shall be entitled to
and may request an adjustment to the price of any affected Product
to reflect such increased or decreased Component costs. For the
purposes of this Subsection 9.2(b), changes greater or lesser than
normal forecasted increases or decreases shall be considered to
have occurred if (i) the cost of a Component is more or less than
ten per cent (10%) of the cost at the date hereof of Components
listed in Exhibit B or (ii) the aggregate cost for all Components
required to manufacture a Product is more or less than 5% of the
costs at the date hereof for the Component set out in Exhibit B.
To the extent Product prices have been previously adjusted
pursuant to this Subsection 9.2(b) to reflect an increase or
decrease 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 price
adjustment request pursuant to this Subsection 9.2(b), Patheon
shall deliver to Client a revised Exhibit B setting out the
Components, their respective costs at the date hereof and the
adjusted Component costs that will be incurred as a result of the
greater or lessor than normal forecasted increases together with
evidence of the cost change satisfactory to Client acting
reasonably. Upon delivery of such a request, each of Client and
Patheon shall forthwith use all reasonable efforts to agree on a
revised price for each affected Product that reflects the changed
Component costs being incurred by Patheon.
14
[***] - CONFIDENTIAL TREATMENT REQUESTED
9.3 Pricing after December 31. 2000. Costing for January 1, 2001 through
December 31, 2001 will be negotiated no later than August 31, 2000 based
on annual forecasts provided by Sanofi no later than July 1, 2000.
Patheon acknowledges Sanofi's target price is US $[***] per thousand
tablets plus the relevant inflation factor assuming a minimum volume of
[***] tablets purchased during 2001. Patheon also agrees that Sanofi's
maximum price is US $[***] per thousand tablets plus the relevant
inflation factor based on [***] tablets annual volume and subject to the
other terms and conditions of this Agreement. The prices for each Product
during each additional year subsequent to December 31, 2001 that this
Agreement remains in force shall be agreed to between the parties prior
to the commencement of each such year. In such circumstances, Client
shall provide Patheon with the yearly volume forecasts contemplated by
Section 3.2 at least one hundred and twenty (120) days prior to the first
day of each such additional year. Based on those projections, Patheon
will deliver to Client, no later than sixty (60) days after receipt of
such yearly forecast, a revised Exhibit B and such other budgetary
pricing information as it deems necessary to allow the parties to
effectively settle all prices for the relevant year. Thereafter, the
parties shall use all reasonable efforts to come to agreement with
respect to the applicable price for each Product during the relevant
year, based on the anticipated changes in Product volumes, Component
costs and other relevant market conditions. Such revised prices shall
become effective as of the first day of the subject year. The relevant
inflation factor is the Consumer Price Index for All Urban Consumers as
published by the Bureau of Labor Statistics of the U.S. Department of
Labour, for the most recent 12 month period.
9.4 Tooling Costs. Sanofi 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 Sanofi prior to incurring these
costs.
9.5 Rebate. If Patheon does not during the term of this Agreement purchase a
high speed double sided tablet printing machine for use in producing the
Products, Patheon shall rebate to Client the US$40,000 discount described
in Patheon's letter to Client dated December 9, 1998 related to the cost
of the analytical method validation work for this project, which discount
Client waived to support the printer acquisition.
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 5.3(d), have no
further liability hereunder in respect of such discontinued Product.
15
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, testing,
export and supply 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 Trademark. 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 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. 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. Each party shall cause its insurance policy to name
the other party hereto as an additional insured and a loss payee. Each
party's general liability insurance policy shall contain a waiver of
subrogation rights which that party's insurer(s) may have against the
other party.
10.7 Independent Contractors. The parties shall be deemed to be independent
contractors, and this Agreement shall not be construed to create between
Pathcon 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.
16
10.8 No Waiver. Either 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. 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 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 Development Work.
(a) Subject to the terms set out in this Section 10.11, Patheon shall
perform certain research and development work related to the
Products listed at the date hereof on Exhibit A or any other
Prenate line of products on an exclusive basis for Client or such
other products as Client shall from time to time require (the
"Development Work"). The Development Work may include the
following:
(i) process development;
(ii) formulation development (present and future formulations);
(iii) analytical method development;
(iv) analytical method validation and qualification;
(v) process validation;
(vi) stability studies;
(vii) packaging; and
17
[***] - CONFIDENTIAL TREATMENT REQUESTED
(viii) documentation (such as documentation for validation
and stability protocols, batch records and
monographs, etc.)
(b) The parties shall endeavour to jointly define in good faith the
specific Development Work to be performed, the scope of the
project, the price (subject to (d) below) to be paid and the
associated timelines for such activities. If the foregoing is
agreed to by the parties, it shall be reflected in an exhibit to
this Agreement.
(c) If Client, in its sole discretion, decides to commercialize a
product related to Development Work performed by Patheon
hereunder, Client will notify Patheon thereof. Patheon will have
60 days from the receipt of such notice to submit to Client
pricing for the commercial production of the relevant product.
Promptly thereafter the parties shall commence negotiations with
respect to price and any other remaining terms and conditions
(collectively, "Terms and Conditions"). If the parties reach an
agreement on the Terms and Conditions of commercial supply, the
product will be added to this Agreement pursuant to section 10.12
and such additional product shall be governed by the general
conditions hereof with any special terms (including, without
limitation, price) governed by an addendum hereto. If the parties
are unable to reach an agreement on such Terms and Conditions
within 60 days after the commencement of the negotiations, then
Client may terminate negotiations and thereafter Client may enter
into an agreement with any third party for the commercialization
of the product. Patheon will only be entitled to bid on providing
commercial production services if it has adequate production and
technical capacity to meet Client's standards and timeline
requirements, and can satisfy all applicable regulatory standards.
(d) Client shall pay Patheon for the Development Work at Patheon's
agreed rates stated in U.S. dollars, which are at the date hereof:
o Formulation Scientist: $[***]
o Formulation Technician: $[***]
o Analytical Chemist: $[***]
o Formulation Chemist: $[***]
o Project Manager: $[***]
o Documentation Specialist: $[***]
It is understood by the parties that the price for the Development
Work for Prenate products in tablet form shall be calculated in a
manner consistent with the development work previously performed
by Patheon in connection with the Prenate Products in tablet form
covered under this Agreement and Patheon agrees that the foregoing
rates shall remain unchanged during the first year of this
Agreement. Thereafter such rates shall not exceed Patheon's
standard rates for such services. Such development work, together
with the related pricing, is described in Exhibit C hereto.
18
(e) All information, data, results, inventions or discoveries (whether
patentable or not), formulations, manufacturing processes,
reports, records (including batch records), and formulas
(collectively, "Data") related to the Development Work shall be
the property of the Client, and Patheon shall assign to Client any
interests it may have in such Data, including any copyright rights
therein. Patheon shall treat such Data as Confidential
Information.
(f) All information, data, results, inventions or discoveries (whether
patentable or not), formulations, manufacturing processes,
reports, records (including batch records), and formulas
(collectively, "Data") related to development work performed by
Patheon for Client prior to the date of this Agreement shall be
the property of the Client, and Patheon shall also assign to
Client any interests it may have in such Data, including any
copyright rights therein. Patheon shall treat such Data as
Confidential Information. For the avoidance of doubt, Patheon
hereby acknowledges and agrees that the Products and
Specifications set forth in Exhibits A, A-1 and C are the
exclusive property of the Client.
10.12 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.
10.13 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.
10.14 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:
Sanofi-Synthelabo Inc.
▇▇ ▇▇▇▇ ▇▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇▇▇ ▇▇▇▇▇, Vice-President and Chief Financial Officer
Telecopier No.: (▇▇▇) ▇▇▇-▇▇▇▇
19
With a copy to ▇▇▇▇ ▇▇▇▇▇▇▇▇, Senior Vice President and General Counsel
(same address) and ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ (same address)
If to Patheon:
Patheon Inc.
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇
▇▇▇ ▇▇▇
Attention: President
Telecopier No.: (▇▇▇) ▇▇▇-▇▇▇▇
or to such other addresses or telecopier number provided to the other
party in accordance with the terms of this Section 10.14. 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.
10.15 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.
Any modification, amendment or supplement to this Agreement must be in
writing and signed by authorized representatives of both parties.
10.16 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.
10.17 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.
10.18 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.
10.19 Governing Law. This Agreement shall be construed and enforced in
accordance with the laws of New York.
20
IN WITNESS WHEREOF, the duly authorized representatives of the parties
have executed this Agreement as of the dates set forth below.
SANOFI-SYNTHELABO INC. PATHEON INC.
By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇ By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
--------------------------- ----------------------------
Name: ▇▇▇▇▇▇▇ ▇▇▇▇▇ Name: ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
Title: Vice President and CFO Title: President and
Chief Operating Officer
Date: October 14, 1999 Date: October 21, 1999
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
----------------------------
Name: ▇▇▇▇. ▇. ▇▇▇▇▇▇▇▇
Title: Sr. V.P. and General Counsel
Date: October 14, 1999
21
EXHIBIT A
PRODUCTS
Prenate Advance(TM) tablets in bulk
EXHIBIT 1A
SPECFICATIONS
[***] - CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT B
PRICE LIST
Commercial Costing (please see below for terms and conditions integral to
this costing):
-------------------------------------------------------------------------
Sept. 1999 - June 2000 -
May 2000 Dec. 2000
In U.S. Dollars Price Price
-------------------------------------------------------------------------
Key Assumptions:
-------------------------------------------------------------------------
Minimum Annual Quantity (000's) [***] [***]
-------------------------------------------------------------------------
Run Quantity (000's) [***] [***]
-------------------------------------------------------------------------
Batch Size (kg) [***] [***]
-------------------------------------------------------------------------
Tablet Size (mg) [***] [***]
-------------------------------------------------------------------------
Total Cost per Thousand Tablets: $[***] $[***]
-------------------------------------------------------------------------
Commercial Costing Terms and Conditions:
1. Stability testing, validation costs and additional development costs are
not included in the above commercial pricing.
2. Costs for final blister packaging are not included.
3. Prices for September, 1999 through May 31, 2000 arc based on a minimum of
[***] tablets shipped to Sanofi during this time period (inclusive of
Product shipped prior to execution of this Agreement). Prices for any
quantity shipped above this [***] tablet threshold during this period
will not be subject to review.
4. Prices for June 1, 2000 through December 31, 2000 are conditional on a
minimum annual quantity of [***] tablets forecasted for the calendar year
2000 provided that such price shall not become available until after (i)
June 1, 2000 and (ii) [***] tablets in commercial batches of Product
having been shipped during 1999 through 2000. The price for volume
between [***] and [***] tablets shipped during calendar year 2000 is
$[***]. Any total quantity shipped below [***] in calendar 2000 will
result in a change in pricing for the entire shipped quantity during
calendar year 2000. If [***] tablets are not shipped between September,
1999 and May 31, 2000 then for the remainder of the year 2000 the price
of [***] remains in effect until [***] tablets have been shipped. Once
the [***] tablets volume price is achieved, there will be no change in
prices for volume greater than [***] tablets.
5. Sanofi estimates an incremental US$[***] for use in new product
development for 2000 but such estimate is not a condition of pricing
above.
[***] - CONFIDENTIAL TREATMENT REQUESTED
For greater clarity, examples of the above pricing conditions in
operation are set out below.
1. If Client does not purchase [***] tablets for delivery by 5/31/00, the
$[***] price remains in effect for calendar year 2000 as long as [***]
volume has not been reached.
2. If shipments are greater than [***] tablets by 5/31/2000, the $[***]
price applies to the quantity in excess of [***] provided that the $[***]
price is not available before 5/31/00. E.g. [***] tablets or more shipped
by 5/31/00, the price for all [***] or more is $[***].
3. If a minimum of [***] tablets are shipped by 5/31/00 so that client is
entitled to reduced price of $[***] and then only [***] tablets are
shipped from 6/1/00 to 12/31/00, the $[***] price will be in effect for
calendar 2000 and the difference between $[***] and $[***] price to be
reimbursed by Sanofi to Patheon at the end of the year.
e.g. $[***] shipped in 1999, [***] shipped between Jan-May 31, 2000 and
only [***] between June-Dec. 31, 2000 results in volume of [***] tablets
for calendar year 2000 and Client must reimburse using formula for
reimbursement: (Actual volume - [***].
4. If calendar 2000 volumes are less than [***] tablets then Section 9.2(a)
is in effect and price to be negotiated in good faith and difference
reimbursed to Patheon.
5. If in calendar year 2000 volumes are greater than [***] tablets then the
price is $[***] for excess of volume over the first [***] tablets ([***]
includes shipments made beginning September 1999), provided that there is
no retroactive price decrease for any volume of Product shipped prior to
June 1, 2000.
[***] - CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT C
PREVIOUS DEVELOPMENT WORK
All Prices Listed are in U.S. Dollars
1. Formulation Development
[***] Prototype Lots $[***] per lot
[***] Prototype Lots $[***] per lot
Assumptions:
o This is relevant for direct compression tablets of Prenate
products only
o Client to identify target direct compression tablet formula
o Raw material and finished product testing services are not
included
2. Process Development
Not Included
3. Analytical Method Verification and Qualification
USP/NF Mehtod Verification:
Protocol & Reports (40 hours) $ [***]
Analytical Benchwork Total (860 hours) $ [***]
Raw Materials Testing Methods Verification (320 hours)
Finished Product Testing Methods Verification (460 hours)
USP & Data Review (80 hours)
Project Management (80 hours) $ [***]
USP Standards $ [***]
Total Analytical Methods Verification Cost $ [***]
Assumptions:
o Cost does not include cost of outside laboratory services, if
required
o Cost of method development and validation activities are not
included
4. Process Validation
Product Price + $[***] per commercial lot premium, three (3) validation
lots required
Assumptions:
o Assay and content uniformity testing of validation samples will be
completed for two indicator ingredients (eg. [***])
o Dissolution testing will also be performed on uncoated and coated
tablets as requested by Sanofi.
[***] - CONFIDENTIAL TREATMENT REQUESTED
o Process validation activities will include:
o Prenate Tablets Validation Protocol preparation, execution
and approval
o Prenate Tablets Validation Report preparation, execution
and approval
o Validation sampling during manufacturing ([***] samples)
5. Stability Studies
Patheon can perform stability storage and testing of Prenate Tablets as
per information obtained from Sanofi. It has been assumed that the
product stability for Prenate Tablets will be monitored using the
following tests:
[***]
Patheon will prepare stability protocols and reports that will be
approved by Sanofi. Stability work and related costs are a separate and
distinct service Patheon provides and the costs of these stability
services are not included in any other categories of services quoted by
Patheon.
Prenate Tablets Stability Testing Cost (as previously quoted):
Price/Interval: $[***]
Studies to be Conducted: 25(degree)C, +/- 2(degree)C / 60% RH
40(degree)C, +/- 2(degree) C / 75% RH
30(degree)C +/- 2(degree) C / 60% RH
Total Cost of Stability Program: $[***]
Sanofi will be responsible for any reasonable additional fees resulting
from changes to the scope of work outlined in any proposal. Sanofi must
approve changes to the scope of work and associated costs prior to
incurring additional fees.
EXHIBIT D
STABILITY TESTING PROCEDURES/FEE SCHEDULE
EXHIBIT E
LOT NUMBERING AND EXPIRATION DATES
Lot Numbering:
-------------
Sequential lot numbers are assigned by Patheon Niagara Region Operations at the
time of manufacture of uncoated bulk tablets. Film-coated and printed bulk
tablets are assigned the same sequential lot number by Patheon Toronto Region
Operations.
Expiry Dating:
-------------
Patheon shall not assign expiration dates. Expiration dates are calculated by
the Client exclusively.
1413415v1