Exhibit 10.58

CONFIDENTIAL TREATMENT REQUESTED UNDER

17 C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 240.24b-2.

[*****] INDICATES OMITTED MATERIAL THAT IS THE

SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST

FILED SEPARATELY WITH THE COMMISSION.

THE OMITTED MATERIAL HAS BEEN FILED

SEPARATELY WITH THE COMMISSION.

CONTRACT MANUFACTURING SERVICES AGREEMENT

1 PURPOSE: Procter & Gamble Pharmaceuticals, SARL. (“P&G”) and OSG Norwich
Pharmaceuticals, Inc. (“OSGP”) have entered into an Agreement, to provide and
P&G will purchase Contract Manufacturing Services to produce various Products,
as these terms are defined herein. This document, the “Agreement”, sets forth
the obligations of the parties and is effective upon both parties signature.

2 P&G AND OSGP:

Procter & Gamble Pharmaceuticals, SARL, with principal offices at 47, Route de
Saint-Gorges 1213 Petit-Lancy 1, Switzerland hereinafter called P&G.

OSG Norwich Pharmaceuticals, Incorporated with principal offices at 6828 State
Highway 12, Norwich, New York hereinafter called OSGP.

 

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TABLE OF CONTENTS

 

1    Purpose      1    2    P&G and OSGP      1    Table of Contents    3   
Certain Definitions      3    4    Contract Manufacturing Services      5    5
   Forecasts and Ordering      6    6    Quality Control and Testing      7    7
   Supply of Materials & Products      9    8    Change Management      9    9
   Failure To Perform      10    10    Initiatives and Projects      11    11   
Term      11    12    Price      11    13    Delivery      13    14    Payment
Terms      13    15    Invoicing      13    16    Compliance With Laws and
Safety Measures      13    17    Acceptance and Return      14    18    Access
For P&G’s Representatives      14    19    Security Precautions      14    20   
Confidentiality      14    21    Intellectual Property      14    22    OSGP’s
Indemnification Of P&G      15    23    Change in OSGP’s Ownership      15    24
   Termination For Cause      15    25    Continuation of Supply      16    26
   Assignment      16    27    Contractor Status      16    28    Reporting
Requirements      16    29    Force Majeure      16    30    Governing Law and
Language      17    31    Headings and References      17    32    Agreement
Precedence      17    33    Mutual Support      17    34    Notices      18   

 

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3 CERTAIN DEFINITIONS:

3.1 “Affiliate” means any corporation, firm, partnership or other entity, which,
at the time in question, is directly or indirectly owned by or controlled by, or
under common control with, P&G or OSGP, as the case may be. For the purposes of
this definition, “control” shall mean the ownership, directly or indirectly, of
50% or more of the voting stock or stockholders’ equity of a corporation or, in
the case of a non-corporate entity, the right to receive 50% or more of either
the profits or the assets upon dissolution.

3.2 “Calendar Year” shall mean any twelve (12) month period commencing on
January 1.

3.3 “cGMP” means current Good Manufacturing Practices as promulgated by the U.S.
FDA and as detailed in Title 21, United States Code of Federal Regulations, or
when appropriate, any corresponding statutes and/or regulations of any other
country’s prescription pharmaceuticals regulating health authority / agency in
the Territory, as the same may be amended or re-enacted from time to time. cGMP
documentation for use in the manufacture and marketing of Product will be
developed and maintained by the parties in accordance with the cGMP Guidelines.
For new Product or new SKU initiatives cGMP includes reaching an acceptable
readiness state in the Norwich Plant and the specific applicable production
operation(s) versus GMP regulations in time for a successful pre-approval
Inspection audit by the FDA and/or other appropriate health authority in the
Territory.

3.4 “Confidential Information” means all trade secrets, know how, proprietary
information, techniques, or technology, and data disclosed by one party to the
other party pursuant to this Agreement or generated pursuant to this Agreement,
except any portion thereof which:

(i) the recipient can demonstrate by its written records was known by the
recipient prior to the disclosure thereof by the disclosing party;

(ii) is disclosed to the recipient without restriction, after disclosure thereof
by the disclosing party, by a Third Party who has the right to make such
disclosure;

(iii) is or becomes part of the public domain through no breach of this
Agreement by the recipient; or

(iv) is independently developed by employees of the recipient without use of any
of the other party’s Confidential Information.

3.5 “Contract Manufacturing Services” means all operations (including but not
limited to Materials testing and release, receiving, making, picking, packaging,
quality control, testing, storage, documentation, and/or shipment) required to
produce and distribute the Products.

3.6 “Date of Manufacture” means with respect to any Product, the date of first
contact of the active substance(s) in such Products with other Materials used in
the manufacture of such Products.

3.7 “Effective Date” means the date of execution of this Agreement.

 

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3.8 “FDA” means the United States Food and Drug Administration and, when
appropriate, any corresponding regulatory agency in any other country in the
Territory.

3.9 “Materials” shall mean any raw, work-in-process, or packing materials or any
finished product needed to produce Product that meets the Specifications or
needed to perform necessary Contract Manufacturing Services.

3.10 “Norwich Plant” shall mean the North Norwich Pharmaceuticals Plant located
on Route 12 in North Norwich, New York.

3.11 “NDA” shall mean a New Drug Application filed pursuant to the requirements
of the FDA as more fully defined in 21 C.F.R. 314 as well as equivalent
submissions to the appropriate health authorities in other countries in the
Territory.

3.12 “Product(s)” means Calcium Tablets, specification 15121219 and any other
products agreed to in writing by the parties.

3.13 “SLEA” means a Service Level Execution Agreement as described in Article
5.4.

3.14 “Specification(s)” or “Release Specification(s)” means the written methods,
formulae, standards, making and packing standards, procedures, tests and/or test
protocols for Products provided by P&G to OSGP, which shall at all times conform
with the health registrations, as applicable.

3.15 “Territory” shall mean an area that consists of a country or countries
within which Contract Manufacturing Services, Product regulatory registration,
and / or Product distribution or sale are occurring or will occur.

3.16 “Third Party” shall mean any person, corporation or unincorporated body
other than OSGP and P&G and/or their Affiliates.

3.17 “Unit” means a Stock Keeping Unit (SKU), Kg or other agreed-upon measure of
Products for a specified country in the Territory.

3.18 “Within OSGP Control” means OSGP shall be deemed to have control over
(i) the timing of notifications by OSGP, but only to the extent that no other
person except Affiliates of OSGP controls the information necessary for OSGP to
give such notice, and (ii) matters relating to its employees, property,
equipment, and conduct of its business, except to the extent that Section 30,
Force Majeure, applies to or affects any of the foregoing. OSGP shall not be
deemed to have control over any other factors, including but not limited to: all
matters described in Section 30 of this Agreement; the inability of any supplier
except Affiliates of OSGP to deliver Materials as required; the failure of any
common carrier to deliver finished goods to P&G and/or P&G’s customers, except
to the extent that such failure results solely from untimely notice given or
delivery made by OSGP; and the failure of P&G to perform any obligation, whether
or not under this Agreement, which directly or indirectly impacts OSGP’s
obligations under this Agreement.

 

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4. CONTRACT MANUFACTURING SERVICES:

4.1 Manufacturing Obligation: Pursuant to the terms and conditions of this
Agreement, OSGP shall manufacture, package, distribute, and ship to P&G, and P&G
shall purchase and receive from OSGP, packaged finished goods, sample packs,
semi-finished goods, and Materials of the Products. OSGP is responsible for
Contract Manufacturing Services in the production and distribution of such
Products. OSGP’s obligation to supply Contract Manufacturing Services shall
include the obligation to use necessary efforts (including, but not limited to,
working extra hours, shifts, or days) to supply, in any three (3) month period,
Products ordered by P&G up to [*****] of volume on a Unit basis of P&G’s most
recent forecast submitted for such three (3) month period pursuant to Article
5.2, unless mutually agreed to plans documented in SLEA’s for a specific
Product(s) or Unit(s) dictate a higher percentage number is appropriate for
these Product(s) or Unit(s). All costs for such necessary effort will be at
OSGP’s expense. OSGP shall use its reasonable commercial efforts to satisfy
orders for Product quantities in any three (3) month period in excess of [*****]
of volume on a Unit basis of P&G’s most recent forecast submitted for such three
(3) month period pursuant to Article 5.2, unless mutually agreed to plans
documented in SLEA’s for a specific Product(s) or Unit(s) dictate a higher or
lower percentage number is appropriate for these Product(s) or Unit(s).

4.2 Manufacturing Standards And Warranties:

(a) OSGP hereby represents and warrants to P&G that the Products shall, at the
time of delivery to P&G for release consideration, have been manufactured to
meet Release Specifications in accordance with cGMP’s applicable to the Products
and prevailing in the applicable Territory at the time of shipment for medicinal
products for human use in the Territory, and shall not be adulterated or
misbranded within the meaning of the Specifications and cGMP’s, which include
the prevention of cross contamination by such classes of products or materials
as biologics (which contain live organisms), cytotoxins, and other highly active
or sensitizing materials; and shall be of merchantable quality suitable for
P&G’s use; provided, however, that OSGP shall not be liable for misbranding with
respect to any Product labeling or package insert text provided or used by P&G
if such Product meets the Specifications. In the event of a dispute between the
parties as to whether Product meets the Release Specifications or the
Specifications, final determination that a Product does or does not meet the
Release Specifications or the Specifications shall be made only in accordance
with the dispute resolution procedure set forth in Article 6.5 of this
Agreement.

(b) OSGP warranties shall not extend to, and hereby specifically exclude, any
alteration, misbranding or failure to meet Specifications resulting from any
work done, or activities undertaken, by P&G or its subcontractors, distributors,
wholesalers and others receiving the Product directly or indirectly from P&G
after shipment by OSGP of Product.

(c) OSGP has been provided by P&G with all necessary processes, trade secrets,
manufacturing know-how, and trademark rights to manufacture the Products (herein
collectively referred to as “Intellectual Property”) for use in the Territory in
accordance with this Agreement, and the Norwich Plant, the facilities and
equipment used by OSGP to manufacture the Products are licensed and/or qualified
under cGMP’s, are in good condition.

 

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4.3 Exclusivity: OSGP’s right and obligation in Article 4 to manufacture
Products shall be exclusively for P&G unless otherwise mutually agreed upon in
writing by the parties. P&G hereby covenants that during the term of this
Agreement it shall not institute any action or suit at law or equity against
OSGP alleging the infringement of any of P&G’s Intellectual Property by OSGP in
its making of Product for P&G. Any improvements made by OSGP to P&G registered
Products or processes whether or not patentable shall be owned by P&G.
Intellectual property from other OSGP initiated improvements shall be owned by
OSGP.

4.4 Labeling and Packaging of Products: It is intended that for existing
Products P&G’s artwork will be consistent with OSGPs manufacturing equipment.
P&G shall, at its own cost and expense, supply OSGP with the mechanical design
of artwork for all Printed Matter except shipper case labels. A technical
standards document will be used to state the requirements for shipper case
labels. The mechanical design for shipper case labels will be the responsibility
of OSGP. P&G artwork for labeling will be subject to OSGP approval solely for a
determination of manufacturing feasibility. As used herein, “Printed Matter”
means all printed materials, including labeling and leaflets, required to be
affixed to and/or packaged with or accompanying Products distributed for or
delivered to P&G. Each set of such artwork, and each partial set and/or
alteration or amendment thereto, for each piece of Printed Matter shall be
identified by a unique item control number or code which is consistent with
P&G’s control numbering system and quality control requirements. P&G shall
specify the Code for each item of Printed Matter to be supplied with each order
for Products. Such Code shall be specified on the purchase order for such
Products.

4.5 Maintenance of Equipment: All equipment and tooling required to manufacture
P&G’s Products will be maintained in good operating condition by OSGP. OSGP
agrees to assume complete responsibility for all maintenance. This includes (but
not limited to) preventive and predictive maintenance; and replacement of worn
or broken parts and tooling for all equipment and facilities, including major
components, utilized in the contract manufacturing of P&G’s Product. OSGP
further agrees to maintain adequate insurance coverage and to replace said
equipment should equipment for any reason be destroyed by fire, vandalism or
perils otherwise covered by an extended coverage endorsement or otherwise
rendered unusable for the purpose intended by this Agreement.

5. FORECASTS AND ORDERING:

5.1 Firm Orders: P&G shall give OSGP a firm order of its requirements of the
Products at least ninety (90) days before it requires shipment of such Products.
Such orders shall be in minimum order quantities, as set forth in Schedule B.
OSGP shall use necessary efforts to fulfill orders properly made hereunder by
completing Contract Manufacturing Services of the Products on or prior to the
date specified on the order as received. A process for handling firm order
changes shall be developed and agreed between the parties promptly after
execution of this Agreement and documented in SLEA’s.

5.2 Forecasting: Within thirty (30) days of completion of this Agreement and
then, at least one (1) month prior to the start of each calendar quarter during
the Term, P&G shall

 

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give to OSGP a forecast of P&G’s estimated requirements of Products starting
with the start of such quarter (or the start of the Term). Each such forecast
shall be broken down by SKU by month in respect of the first three quarters and
by SKU by quarter in respect of the remaining period.

5.3 Customer Service: OSGP shall maintain systems, staffing, and procedures in
place to consistently maintain “excellent” customer service for P&G customers,
as defined herein. “Excellent” customer service shall be measured by the
following P&G defined measures: Shipped On Time, Orders Shipped Complete,
Product Availability, Same Day / Next Day Shipments, and Supplier Delivery
Performance.

Levels for “excellence” customer service are:

Shipped On Time > 98%

Shipped Complete > 98.5%

Product Availability = 100%

Same Day Shipments > 95% & 100% Within 48 Hours

Supplier Delivery Performance > 95%

OSGP will track their actual monthly performance versus the above targets (the
“Monthly Targets”) and report these results to P&G monthly. If any one Monthly
Target is not met and the cause / correction of this below target performance is
Within OSGP Control, then within two weeks OSGP will develop a plan, (the
“Action Plan”), agreed to by P&G which in P&G’s reasonable assessment is
feasible to improve performance to meet or exceed target. All costs associated
with any such Action Plan will be the responsibility of OSGB. P&G has the right
to audit OSGP’s books and records for the purpose of determining accuracy of
customer service results reported.

OSGP shall be construed to have failed to perform, as described in Article 11,
its customer service obligations to P&G if any of the following events occur:

(a.) OSGP fails to meet one particular Monthly Target for three (3) consecutive
months.

(b.) OSGP’s actual performance in any two (2) consecutive months falls below
two-thirds ( 2/3) of a Monthly Target.

5.4 Service Level Execution Agreement (SLEA) between the Parties: As soon as
practicable after execution of this Agreement, the parties shall develop Service
Level Execution Agreement(s) (SLEA’s) covering the details of production
planning, customer service, quality assurance, cGMP, problem solving procedures,
and similar activities as between the Norwich Plant and each P&G site; and
between the Norwich Plant and the P&G European pharmaceuticals business.

6 QUALITY CONTROL AND TESTING:

6.1 Testing and Certificate of Analysis: Before releasing any batch of the
Materials, OSGP shall test for the compliance of such batch with all Registered
tests for their site and cGMP’s. OSGP’s Quality Assurance department at the
Norwich Plant shall oversee and assure the testing is completed by the OSGP
Quality Control laboratory at the Norwich Plant. Copies of raw material,
manufacturing, and inspection records will be made available for review by P&G
representatives. Copies of manufacturing records and

 

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certificates of analysis incorporating such certification, in the form attached
hereto as Schedule E, shall be provided to P&G with each shipment of Product(s)
for each batch and/or partial batch contained in the shipment. All such copies
shall be sent to the addressees specified by P&G.

6.2 Preservation Samples and Retained Samples: OSGP shall take from each batch
of the Products pursuant to this Agreement preservation samples/retained samples
which OSGP shall retain for the shelf life of the particular batch and dosage
forms of the Products plus one year or longer as required by relevant
regulations. For the avoidance of doubt, preservation samples/retained samples,
as referred to herein, do not include samples retained for purposes of stability
testing. OSGP shall take preservation samples of raw materials and
work-in-process materials as designated in writing by P&G. OSGP shall maintain
these samples under cGMP conditions and review samples annually according to
applicable regulations.

6.3 Stability Testing: OSGP shall conduct stability-testing studies for the
agreed Products, which include: all stability studies required to support
material changes (e.g. packaging, new suppliers, etc.); changes in the processes
to produce items included in then-current stability program (i.e., those cases
where only concurrent stability studies are needed, and/or which are initiated
after the decision to release batches involved in studies); and any new studies
required as a result of manufacturing deviation(s) and any stability studies
required as a result of manufacturing deviation(s). The results of this testing
program shall be available to P&G, without charge, upon request.

6.4 P&G Testing Rights: P&G shall have the right (but not the obligation) to
perform analytical testing on the Products manufactured by OSGP pursuant to this
Agreement.

6.5 Quality Disputes: Any claim by P&G that any of the Products at the time of
delivery to P&G did not meet the Release Specifications or during their shelf
life did not meet the Specifications must be made in writing to OSGP within
thirty (30) days after discovery by P&G of the problem. In the event that P&G
claims that any of the Products failed to meet the Release Specifications or the
Specifications and OSGP disagrees with P&G’s findings, OSGP shall test In OSGP’s
Norwich Plant testing facilities a retained sample from the same batch as the
contested Product. P&G may, at its option and cost, have one of its personnel
present for and actively participate in such testing. At P&G’s discretion the
testing may be done at a Third Party laboratory mutually agreed upon by the
parties. The results of such Third Party testing shall be accepted by the two
parties as final and binding. The cost of such analysis, and the cost of
testing, shipment, replacement or disposal of disputed Product, shall be borne
by the party whose position is not substantiated by the testing.

6.6 Customer Complaints: P&G shall, without delay, inform OSGP of any customer
complaints of which it becomes aware which may relate to the manufacturing or
packaging of the Products. OSGP shall provide P&G, at OSGP’s expense, with all
reasonable assistance in investigating complaints that are alleged to have
arisen from manufacture or packaging of the Products hereunder.

 

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6.7 Health Authority Inquiries: OSGP shall be responsible for responding to any
inquiry from any legally competent health authority in the Territory regarding
the Norwich Plant. For any such responses regarding or related to the Products,
P&G shall review and approve the response prior to filing. OSGP shall without
delay, at its own expense, make available to P&G a copy of pertinent sections of
any inspection report resulting from any inspection of the Norwich Plant by such
health authority to the extent such report relates to the Products, the
manufacture of the Products, or Norwich Plant facilities used to manufacture the
Products as well as a copy of any response(s) thereto. P&G shall provide OSGP
with all reasonable assistance in responding to such inquiries and in handling
inspections of the Norwich Plant for the Products by such authorities. OSGP
shall without delay inform P&G of any such inquiries and any requests for
inspections of which it becomes aware.

6.8 Quality Assurance Key Elements OSGP agrees to comply with P&G Quality
Standards as described in P&G’s Quality Assurance Key Elements (QAKE) Assessment
and all future revisions thereto. P&G shall use said QAKE Assessment
periodically to audit OSGP’s Norwich Plant and shall provide OSGP a written
report following said audit. For all Products that OSGP produces for P&G and all
facilities and systems supporting such production, should OSGP’s audit result in
a score less than 100%, OSGP shall develop and implement, and P&G shall approve
in writing, a detailed plan to improve OSGP’s systems. P&G will provide a copy
of the QAKE manual to OSGP, which shall be incorporated as appropriate into
OSGP’s operating procedures used for production of Products covered by this
Agreement. Should OSGP fail to meet the agreed-upon success criteria on a
mutually acceptable time schedule, or fall below a QAKE score of 100% P&G shall
have the right to notify OSGP of OSGP’s failure to perform per Article 11.

In the event that the parties agree on changes to quality assurance and
manufacturing systems, and such changes require capital or increased staffing to
implement, the parties shall negotiate in good faith to determine the extent to
which each party shall bear the costs of such changes.

7 SUPPLY OF PRODUCTS:

7.1 Approval & Disposition of Scrap: OSGP may not scrap or otherwise destroy any
of P&G’s Products without P&G’s prior written authorization. In situations where
scrapping is authorized, OSGP agrees to provide to P&G written documentation
assuring that the Products have been scrapped in a timely manner and by a means
approved by P&G. In such approved scrapping situations the Materials cost of
Product scrapped and the physical disposition costs are for P&G’s account. The
manufacturing expense cost of Product scrapped due to a problem Within OSGP
Control is for OSGP’s account.

8 CHANGE MANAGEMENT

8.1 Non-Discretionary Changes: With respect to changes to the Specifications
and/or the Printed Matter which are required by applicable law, rule or
regulation (including but not limited to changes required by the FDA or other
legally competent authority) (collectively, “Non-Discretionary Changes”), the
parties shall co-operate in making such changes promptly and, unless otherwise
agreed, the costs of making and/or implementing

 

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such changes and the costs of the scrapping of Materials and Product
necessitated by any such changes shall be the responsibility of P&G. Any such
changes shall be evaluated using P&G’s Change Control process for conformance to
cGMP and other applicable health authority regulations. OSGP may not implement
any Non-Discretionary Change without receiving written agreement in advance from
P&G.

8.2 Discretionary Changes: With respect to changes to the Specifications and/or
the Printed Matter which are not required by applicable law, rule or regulation
(including but not limited to changes not initially proposed or required by the
FDA or other legally competent authority) (collectively, “Discretionary
Changes”), the parties shall, to the extent commercially reasonable under the
circumstances, cooperate in making such changes and the party initiating such
change(s) shall bear the costs of making and/or implementing such changes and
the costs of the scrapping of Materials (including but not limited to raw and
packaging Materials, work in process, inventory and labeling materials)
necessitated by any such changes. Any such changes shall be evaluated using
P&G’s Change Control process for conformance to cGMP and other applicable health
authority regulations. OSGP may not implement any Discretionary Change without
receiving written agreement in advance from P&G. Costs associated with complying
with applicable cGMP shall be the responsibility of OSGP. Cost reduction savings
that result from Discretionary Changes shall be shared to the extent that the
total costs to develop and implement the changes are shared.

8.3 Disclaimer of Incidental Damages: Notwithstanding anything herein to the
contrary, neither party shall be liable to the other for any consequential or
special damages and/or lost profits resulting from a change to the
Specifications and/or to the printed matter as a result of any change thereto
pursuant to this Article 10.

8.4 Authorizations: During the Term of this Agreement OSGP shall obtain and
maintain in force all licenses and authorizations necessary for OSGP to Contract
Manufacture Product as contemplated herein. OSGP shall bear the full cost and
expense of so obtaining and maintaining such licenses and authorizations. P&G
shall give OSGP all help reasonably necessary to assist OSOP in so obtaining and
maintaining such licenses and authorizations and shall bear the full cost and
expense of so assisting OSGP.

9 [*****]

 

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10 INITIATIVES AND PROJECTS: P&G will communicate to OSGP product initiatives or
projects that P&G desires to conduct at OSGP’s Norwich Plant. Planning for
implementation of such project activity will be included as part of production
planning for P&G requirements at OSGP’s Norwich Plant. P&G may require the
participation of other outside contractors in initiatives or project work
conducted at OSGP’s Norwich Plant. Access to the Norwich Plant and participation
by such contractors will not be prohibited by OSGP subject to execution of
appropriate confidential disclosure agreement(s) and P&G providing OSGP
reasonable notice of such contractor(s).

11 TERM

11.1 Initial Term: The initial term of this Agreement, “Initial Term”, begins
July 1, 2005 and ends June 30, 2008, unless terminated earlier pursuant to terms
contained in this Agreement.

11.2 Extension: P&G may, at its option, extend this Agreement for any or all of
the Contract Manufacturing Services, up to OSGP’s production capacity, under the
terms and conditions of this Agreement for successive periods of one year each
up to a maximum period of five (5) years by notifying OSGP in writing of the
extension within at least three hundred sixty (360) days prior to the expiration
of the Initial Term or any extension thereof, (the Initial Term plus any such
extensions, the “Term”).

11.3 Termination: Upon termination of this Agreement OSGP shall cease all and
any use of Intellectual Property acquired from P&G, return to P&G or its
designee without delay all Intellectual Property belonging to P&G, and shall
refrain for five years thereafter from the manufacture of products which are the
same as or directly competitive to P&G Products, for themselves or for any Third
Party without P&G’s prior written agreement.

12 PRICE:

12.1 Charges And Prices: OSGP will charge P&G [*****] USD per kg for Contract
Manufacturing Services performed at forecast production volume for the term of
the Agreement.

12.2 PRICE (S) shall be firm through June 30, 2006. SELLER may reduce PRICES at
any time.

 

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SELLER has the right to increase any PRICE specified herein due to raw,
packaging or miscellaneous material costs on July 1st each year, provided SELLER
has given BUYER at least thirty (30) calendar days’ advance written notice of
such change.

These revised PRICES shall become effective on 30 calendar days after BUYER’s
receipt of such notice (“PRICE CHANGE DATE”) unless BUYER provides SELLER with a
written objection prior to the PRICE CHANGE DATE (“PRICE CHANGE OBJECTION”). If
BUYER provides a PRICE CHANGE OBJECTION prior to the PRICE CHANGE DATE, the
PARTIES shall promptly discuss the reason for the PRICE CHANGE OBJECTION and
attempt to resolve the same per Paragraph 14.3. If the PARTIES cannot resolve
the PRICE CHANGE OBJECTION within 30 calendar days, BUYER may (i) purchase the
GOODS from any other supplier in which case the obligations, including, but not
limited to, any purchase and sale requirements and/or commitments, if any, of
BUYER and SELLER hereunder shall be reduced accordingly; or (ii) terminate this
AGREEMENT without any penalty, liability or further obligation.

12.3 Price Change Audit: Buyer shall have the right to initiate an audit to
verify the adjustments to price and/or data pertaining to the adjustments as
used by Seller in revising the price. The intent of the audit would be to insure
that market-based pricing adjustments are passed through to Buyer in the amounts
actually incurred by Seller. The audit is not intended to verify absolute price
or to force pass-through of non-market-based pricing adjustments.

In order to initiate such an audit, Buyer shall provide written notice to Seller
of its desire to audit price adjustments in accordance with the terms of this
Paragraph. Buyer shall initiate such audits not more frequently than once every
twelve (12) months. In the event Buyer initiates such an audit, the firm of
independent certified public accountants which is regularly retained by Seller
to audit its finances shall conduct such audit.

The auditing firm will maintain the confidentiality of the data reviewed and
will either verify the correctness of such price adjustment or advise the
parties of the composite adjustment required to make a correction. If a
correction is warranted, the price will thereafter be adjusted by the parties in
accordance with such corrected data and calculations, and any deficiency or
overage in past payments for the goods sold and purchases under this Agreement
resulting from such incorrect cost data or calculations shall be corrected by
payment, within thirty (30) days, of the amount of such deficiency or average.
In all events, Buyer shall pay any and all costs associated in any way
whatsoever with the audit procedure.

12.4 Extra Charges: Any charges that OSGP proposes to charge P&G beyond those
included in the prices agreed to in this Agreement, its extensions, Supplemental
Agreements or amendments, or related purchase orders, must be approved in
writing by P&G prior to OSGP incurring or accepting such charges.

 

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13 DELIVERY:

13.1 Delivery Terms: Delivery terms shall be Ex-works, the OSGP Norwich Plant.
OSGP will be responsible for loading the carrier for shipment. OSGP shall ship
Products on a carrier or carriers specified by P&G in accordance with P&G’s
purchase order form or as otherwise directed by P&G in writing. OSGP shall
assist P&G in selecting appropriate carriers as requested. All such Products
shipped hereunder shall have at least twelve (12) months from their original
expiration date remaining at the time of shipment to P&G customers unless
mutually agreed to plans documented in appropriate SLEA’s for specific
Product(s) or Unit(s) indicate a different minimum number of months remaining
until the expiration date at the time of shipment is acceptable.

13.2 Alternate Shipping: OSGP may use alternate shipping methods to expedite
delivery to P&G if both parties agree. In such cases, OSGP must receive P&G’s
approval prior to the use of any carrier other than those on P&G’s approved
carrier list. Additional shipping costs resulting from expedited deliveries or
use of alternate carriers will be at OSGP’s expense where the cause was Within
OSGP Control or will be at P&G’s expense where required by P&G for reasons not
Within OSGP Control.

13.3 Refused Entry: In the event that the customs authorities of the destination
country refuse entry of any Products for reasons Within OSGP Control hereunder,
except where appropriate for P&G’s failure to obtain the necessary import
license or pay duty, P&G will not be responsible to pay for the same and, if
payment has already been made, OSGP will reimburse P&G in full. OSGP will be
responsible for the repatriation of such Products at OSGP’S own cost.

14. PAYMENT TERMS: Net thirty (30) days from receipt by P&G of a complete and
correct invoice.

15 INVOICING: OSGP shall include with each invoice required information as
agreed and documented in the Service Level Execution Agreements (SLEA’s). P&G
may withhold payment of OSGP’S invoice until the provisions of this paragraph
have been fulfilled. Payment to OSGP shall be in United States dollars.

16 COMPLIANCE WITH LAWS AND SAFETY MEASURES: OSGP represents and warrants that
it is and will, and that the Products and Contract Manufacturing Services
(including after being incorporated into any finished products) are and will, at
all times, be in full compliance with all applicable laws, regulations, rules,
judgments, orders and decrees, including, without limitation, those related to
intellectual property, customs, labor, employment, working conditions, board of
health, environmental matters, and Good Manufacturing Practices (GMP’s). OSGP
also represents and warrants that it has obtained and will maintain all
licenses, consents and permits required to perform lawfully this Agreement. OSGP
assumes sole responsibility for taking all necessary health and safety
precautions for producing Products on behalf of P&G pursuant to this Agreement.
These precautions include, without limitation, such things as proper control of
ventilation, the wearing of adequate protective clothing, installation, and
proper utilization of appropriate environmental control equipment. OSGP will
inform P&G of any regulatory agency inspection, such as an OSHA inspection,
which involves P&G Products or the Contract Manufacturing Services to produce
these Products. OSGP is responsible for any audit follow-up or response. P&G
Will provide OSGP information P&G possesses which is needed by OSGP to respond
to such audits.

 

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17 ACCEPTANCE AND RETURN: Any Products manufactured by OSGP on behalf of P&G
that do not comply with the Specifications at any time during the shelf-life for
such Products may, at P&G’s option, be (i) returned to OSGP at OSGP’s expense
for credit to P&G at the full price as defined by the Unit pricing plus expenses
associated with such return, including, without limitation payment or
reimbursement of customs duties and freight charges, (ii) scrapped by P&G, at
OSGP’s expense, in which case P&G will be relieved of any payment obligations
with respect thereto or (iii) reworked by P&G or OSGP, at OSGP’s expense. P&G
will also have the remedies set forth in subparts (ii) and (iii) above with
respect to any of P&G’S finished Products involving Contract Manufacturing
Services performed by OSGP that do not comply with the representations and
warranties set forth in this Agreement. Additionally, when numbers ii) or iii)
above are applicable, the expenses for which OSGP will be responsible include,
without limitation, P&G’S cost of inspecting, recovering, and sorting the
Products produced hereunder and P&G’S cost of obtaining replacement Products
(including raw and packaging materials, scrapping Products produced for P&G, and
manufacturing additional Products on behalf of P&G). The rights and remedies set
forth in this Agreement are not exclusive and nothing herein will be interpreted
to limit in any manner the rights and remedies the parties will have available
to them pursuant to the relevant governing law.

18 ACCESS FOR P&G’S REPRESENTATIVES: OSGP will permit P&G’s representatives
access to any area of OSGP’s facilities and records having to do with the
fulfillment of this Agreement upon reasonable notice by P&G. Should security
requirements of other customers of OSGP create conflict with this right, P&G
shall be so informed and compatible scheduling arranged.

19 SECURITY PRECAUTIONS: OSGP agrees to take appropriate security precautions
requested by P&G including, but not limited to, prohibiting Third Parties from
being present during production of P&G’s Products unless authorized in writing
by P&G. P&G reserves the right to reduce or discontinue its purchases under this
Agreement, its extensions or related purchase orders, without further
obligation, for violations of security practices agreed to by P&G and OSGP.

20 CONFIDENTIALITY: Neither party will use (other than for the performance of
this Agreement) or disclose to any Third Party any Confidential Information.
This obligation shall survive the expiration or termination of this Agreement.

21 INTELLECTUAL PROPERTY. All right, title and interest in the Intellectual
Property and other proprietary information to be used in connection with the
Products are owned by P&GP and shall remain so at all times. P&GP has the right
at all reasonable times to inspect the services and goods sold or otherwise
provided by OSGP using any of the Intellectual Property, as well as the
facilities and methods of production and delivery of such goods and services.

By acceptance of this Agreement and in consideration thereof, OSGP warrants and
agrees that with respect to any article(s), chemical component(s) or
composition(s)

 

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furnished by OSGP to any Third Party (excluding the Contract Manufacturing
Services provided to or on behalf of P&G), OSGP will not use any P&G patents,
copyrights, or similar intellectual property rights without P&G’s prior written
consent and will not infringe on any such P&G patents, copyrights or similar
intellectual property rights.

If P&G is unknowingly benefiting from a Third Party’s patent, copyrights or
similar intellectual property, OSGP will indemnify and save P&G harmless from
and against claims by a Third Party that P&G is infringing on such Third Party’s
patents, copyrights or intellectual property with respect to products
manufactured for a Third Party by OSGP.

P&G agrees to hold OSGP harmless with respect to liability for infringement,
which OSGP may incur because of any allegations that the Products produced
hereunder, the formula(e) or the specifications of P&G violate or infringe any
patents. OSGP agrees that P&G or P&G’s other suppliers (with respect to their
activities on behalf of P&G) shall have immunity from suit by OSGP under any
patents arising out of the performance of this Agreement.

22 OSGP’S INDEMNIFICATION OF P&G: OSGP will indemnify, defend and hold P&G
harmless from and against all claims, losses, damages, costs and expenses
(including without limitation reasonable fees and expenses of attorneys incurred
in investigation or defense of any third-party claim or action, (collectively
“Damages”) arising out of or related to (i) OSGP’S breach of any representation,
warranty, covenant or other obligation pursuant to this Agreement, including,
without limitation, the failure of any Contract Manufacturing Services to be in
compliance with the Specifications where such failure was Within OSGP Control,
(ii) any manufacturing defect of Products produced hereunder, or (iii) the
negligence, gross negligence, bad faith or willful misconduct of OSGP, its
employees or other representatives. OSGP agrees to provide at least $5,000,000
of commercial liability insurance in support of this indemnity with companies
reasonably acceptable to P&G, which insurance will carry an endorsement naming
P&G and its affiliates as co-insured.

23 CHANGE IN OSGP’S OWNERSHIP: If for any reason OSGP decides to sell or
transfer voluntarily any or all the Norwich Plant facilities used in the
fulfillment of this Agreement to any Third Party, OSGP will provide P&G with at
least six (6) months or with as much notice as legally possible prior written
notice of its intent to transfer or sell such operation. P&G reserves the right
to reduce or discontinue purchases under this Agreement, or terminate this
Agreement, without obligation, if any new entity or person obtains whole or
greater than 50% corporate ownership of OSGP without P&G’s consent. Such an
agreement not to be unreasonably withheld by P&G.

24 TERMINATION FOR CAUSE: In the event (i) a party (the “Defaulting Party”)
breaches any representation, warranty, covenant or other obligation of this
Agreement, or ii) the Defaulting Party becomes unable to pay its bills as they
become due in the ordinary course, a trustee or receiver of such party’s
property is appointed, the Defaulting Party makes an assignment for the benefit
of creditors, a petition in bankruptcy is filed by or against the Defaulting
Party or the Defaulting Party terminates or liquidates its business, the other
party (the “Non-Defaulting Party”) will have the option to terminate this

 

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Agreement, without further obligation, immediately upon notice of such
termination to the Defaulting Party. If the Defaulting Party is OSGP, then OSGP
will make available for P&G’s removal any finished Products, Materials, or other
of P&G’S property then under OSGP’s control. OSGP further agrees not to encumber
such Products or Materials in any way. Termination or expiration of this
Agreement will not relieve either party of any liability it may have to the
other arising out of or related to acts or omissions prior to such termination
or expiration.

25 CONTINUATION OF SUPPLY: If either party terminates this Agreement pursuant to
either paragraph 23 or 24 hereof, then the parties’ obligations with respect to
manufacturing and supply of PRODUCTS hereunder shall continue, unless earlier
terminated by P&G, for a period of eighteen (18) months from the initial
termination date, or until P&G can obtain commercial supply from another source,
whichever is earlier at which point OSGP shall have no further obligation to
continue to Manufacture the PRODUCTS. In addition, OSGP agrees to use best
efforts to transition the manufacturing process to a P&G-designated third party
prior to cessation of supply by OSGP. For the avoidance of doubt the costs for
any transfer of PRODUCTS shall be borne solely by P&G, unless specified
otherwise in this Agreement.

26 ASSIGNMENT: Not withstanding the provisions of Article 25 neither OSGP nor
P&G may assign its rights or delegate or subcontract this Agreement or its
obligations pursuant hereto to any Third Party without the prior written consent
of the other; provided, however, P&G may so assign or delegate to any of its
Affiliates without OSGP’S prior consent, and provided that if all or
substantially all of the assets of P&G are sold to a Third Party, P&G may assign
its rights and obligations under this Agreement to such Third Party.

27 CONTRACTOR STATUS: OSGP is an independent contractor and nothing herein
contained and no course of dealing between the parties will create or be deemed
to create an agency, partnership, joint venture or any other relationship,
fiduciary or otherwise between the parties hereto. OSGP assumes sole
responsibility for the direction and control of its employees involved in
performing Contract Manufacturing Services and such employees shall for all
purposes remain employees of OSGP. Except as otherwise expressly indicated
herein, OSGP is not granted any right or authority to assume or to create an
obligation or responsibility, express or implied, on behalf of or in the name of
P&G or bind P&G in any manner whatsoever.

28 REPORTING REQUIREMENTS: OSGP agrees to provide to P&G information and
reports, in a format and on a frequency requested by P&G and agreed to by OSGP.
Costs for such services will be included in OSGP’s price as referenced in
Article 14.2. P&G shall have the right to withhold payment if OSGP fails to
provide information or reports as mutually agreed. P&G reserves the right to
reduce or discontinue its purchases under this Agreement, its extensions or
related purchase orders, if OSGP fails to meet information or reporting
requirements on a recurring basis.

29 FORCE MAJEURE:

29.1 Force Majeure: P&G or OSGP shall not be deemed to be in breach hereof on
account of any delay in delivery or other performance caused in whole or in part
by, or

 

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otherwise materially related to, the occurrence of any contingency beyond P&G’s
or OSGP’s control, including but not limited to: war or hostility; failure or
delay on land, water or air transportation; act of any government or agency,
subdivision or branch thereof; judicial action; strikes or other labor disputes;
accident, fire, explosion, flood, epidemic, storm or other acts of God; shortage
of fuel or power, delay or failure to perform by any supplier; or, in general,
any other contingency whatsoever (whether similar or dissimilar to those set
forth herein) where P&G or OSGP has exercised ordinary care in the prevention
thereof.

29.2 Effects of Force Majeure: In the event of any contingency as described
hereunder, P&G or OSGP shall give immediate notice thereof to the other party.
P&G or OSGP shall render the delayed performance in the manner as practicable as
possible after such event of force majeure has ceased or otherwise abated
sufficiently in order to permit it to do so without incurring any material
additional expense that it would not have had in the absence of such event of
force majeure.

30 GOVERNING LAW AND LANGUAGE: This Agreement shall be governed by and
interpreted for any and all purposes in accordance with the laws of Ohio and
Ohio Courts shall have jurisdiction of any disputes hereunder. The parties agree
that the United Nations Convention on International Sale of Goods will have no
force or effect on transactions relating to this Agreement. The parties
understand the English language and are fully aware of all terms and conditions
contained herein. If any translation of this Agreement is made into any language
other than English, the English language version will continue to govern.

31 HEADINGS AND REFERENCES: All section headings contained in this Agreement are
for convenience of reference only and shall not affect the meaning or
interpretation of this Agreement.

32 AGREEMENT PRECEDENCE: Supplemental and/or transitional services agreements
may be executed as appropriate, including but not limited to information
technology, supply of P&G’s external customers, other joint support by the
parties, product stability testing, other quality assurance support, product
development activity, and facilities maintenance. In the event of any conflict
between this Agreement and any purchase order form, service level execution
agreements or other agreements which may be entered into by the parties and/or
their affiliates governing the same matters sat forth herein, this Agreement
will take precedence and its terms shall govern, unless such subsequent
agreement specifically refers to this Agreement and indicates that such
subsequent agreement will take precedence over this Agreement.

33 MUTUAL SUPPORT: During the Term of this Agreement one party may desire the
support of resources of the other party to conduct work not expressly covered by
this Agreement but needed to further the aims of both parties under this
Agreement. Both parties desire to cooperate in a reasonable manner to the extent
possible to provide requested support at a reasonable cost. Such requests for
support shall normally be made at least 30 days in advance of the date needed.
The party providing the requested support shall invoice the other party for any
agreed charges and expenses on a no less than weekly basis. Such invoices shall
be paid within 10 days. Neither party nor their

 

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Affiliates have liability under this Agreement due to damage or loss of any type
suffered as a result of performance or non-performance of the support requested
and provided by one party to the other. Details of support resource request
agreements shall be documented in letters of agreement.

34 NOTICES: All notices required or permitted pursuant to this Agreement will be
in writing and will be deemed to be properly given when actually received by the
person entitled to receive the notice at the address stated below, or at such
other address as a party may provide by notice to the other:

 

P&G:      

Mailing

     

Delivery

Procter & Gamble Pharmaceuticals, SARL

47 Route de Saint-Georges

1213 Petit-Lancy 1, Switzerland

Attention: Alasdair McGregor

     

Procter & Gamble Pharmaceuticals, SARL

47 Route de Saint-Georges

1213 Petit-Lancy 1, Switzerland

Attention: Alasdair McGregor

OSGP:      

Mailing:

     

Outsourcing Services Group

50 Tice Boulevard

Woodcliff Lake, NJ 07677

Attention: Perry M. Morgan

   and   

OSG Norwich Pharm. Inc.

6826 State Highway 12

Norwich, NY 13815

Attention: Chris Calhoun, President

Paul, Hastings, Janofsky & Walker LLP

695 Town Center Drive, 17th Floor

Costa Mesa, CA 92626

Attention: Peter Tennyson, Esq.

     

P&G and OSGP have caused their respective duly authorized representatives to
execute this Agreement, acting as agent(s) as set forth herein.

 

For:   Procter & Gamble Pharmaceuticals, SARL     For:   OSG Norwich
Pharmaceuticals, Inc.  

(P&G)

     

(OSGP)

By  

/s/ Alasdair D McGregor

    By  

/s/ Christopher R. Calhoun

 

(Signature)

     

(Signature)

Alasdair D McGregor

   

Christopher R. Calhoun

(Name Typed)

   

(Name Typed)

As:  

Purchasing Group Manager

    As:  

President

 

(Title)

     

(Title)

Date  

30/1/2006

    Date   January 24, 2006

 

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SCHEDULES:

A. Example Certificate Of Analysis (COA)

 

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Schedule B — Example Certificate Of Analysis

LOGO [g146537exgpg020.jpg]

GMP Statement/Batch Certificate

 

Product:    Calcium Carbonate 1250mg Tablets, Coated, BULK Manufacturing Date:
   Retest Date:   

Calcium Starch Granulation

Batch Number:

   Material Number:   

Core Tablets

Batch Number:

   Material Number:    Making Instruction & Version Number:    Special Event   
¨No     ¨Yes   (attach documentation) Rework1 or Reprocessing2:    ¨No    
¨Yes   (attach documentation)

Coated Tablets

Batch Number:

   Material Number:    Making Instruction & Version Number:    Average Gross
Weight:    Quantity:    Special Event    ¨No     ¨Yes   (attach documentation)
Rework or Reprocessing:    ¨No     ¨Yes   (attach documentation)

Attachments (Testing):    ¨   

Certificate of Analysis

Retest data, Laboratory or Out-of-       Specification Investigations:   
¨No     ¨Yes   (attach documentation)

Additional Notes / Attachments:

 

 

 

 

 

1

Reworking – Subjecting an in-process drug, bulk process intermediate or final
product of a single batch/lot an alternate manufacturing process due to a
failure to meet predetermined specifications. Reworking is an unexpected
occurrence and is not pre-approved as part of the marketing authorization.

2

Reprocessing – Subjecting all or part of a batch or lot of an in-process drug,
bulk process intermediate or bulk drug of a single batch/lot to a previous step
in the validated manufacturing process due to failure to meet predetermined
specifications. Reprocessing procedures are foreseen as occasionally necessary
and are validated and pre-approved by the quality control department or is part
of the marketing authorization.

 

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Hereby we certify according to Commission Directive 2001/83/EEC, Art. 51, that
this batch has been produced and tested in accordance with the European Guide to
Good Manufacturing Practises for Medicinal Products, Commission Directive
2003/94/EEC, or comparable accepted Good Manufacturing Practises guidelines
(PIC, WHO).

The product was stored under the approved storage conditions. Intermediate
material was used within its approved retest period unless otherwise noted
above.

 

 

   

 

OSG Quality Assurance     Date

 

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