Document:

EXHIBIT 10.36

 

SUPPLY & PACKAGING AGREEMENT

 

This Supply
& Packaging Agreement (“Agreement”) is made and entered into as of
the 19th day of March, 2004 by and between Reliant Pharmaceuticals,
LLC, a limited liability company organized under the laws of Delaware
(being referred to herein as the “Company”) and Novartis
Consumer Health, Inc., a corporation organized under the laws of
Delaware (“Manufacturer”).

 

WITNESSETH:

 

WHEREAS, the
Company desires to engage the Manufacturer to manufacture and/or supply the
Products and the Packaged Tablets in the Territory to the Company on the terms
and conditions set forth herein; and

 

WHEREAS, the
Manufacturer wishes to manufacture and/or supply the Products and the Packaged
Tablets to the Company on the terms and conditions set forth herein.

 

NOW, THEREFORE,
in consideration of the premises and mutual covenants contained herein and for
other good and valuable consideration, the receipt and adequacy of which are
hereby acknowledged, the Parties agree as follows:

 

ARTICLE I

DEFINITIONS

 

1.1 Definitions.

 

As used in
this Agreement, the following terms shall have the meanings ascribed to them
below:

 

(a) “Act”
shall mean collectively the Federal Food, Drug, and Cosmetic Act of 1938,
including any amendments thereto, and all regulations, rules, guidelines and
procedures promulgated thereunder, and the Federal Controlled Substances Act,
including all amendments thereto, and all regulations rules, guidelines and
procedures promulgated thereunder.

 

(b) “Affiliate”
means, with respect to any Person, any other Person directly or indirectly
controlling or controlled by, or under direct or indirect common control with,
such Person. For purposes of this definition, a Person shall be deemed to
control another Person if it owns or controls more than fifty percent (5 0%) of
the voting equity of the other Person (or other comparable ownership if the
Person is not a corporation).

 

(c) “Agreement”
shall have the meaning set forth in the introductory paragraph.

 

(d) “API”
shall mean Isradipine.

 

 

(e) “API
Specifications” has the meaning set forth in NDA, as amended or supplemented in
accordance with this Agreement.

 

(f) “Adverse
Reactions” means any adverse event associated with the use of a drug in humans,
whether or not considered drug related, including the following:  an adverse event occurring in the course of
the use of a drug product in professional practice; an adverse event occurring
from drug overdose, whether accidental or intentional; an adverse event
occurring from drug abuse; an adverse event occurring from drug withdrawal; and
any failure of pharmacological action.

 

(g) “cGMP”
shall mean the quality systems and current good manufacturing practices set
forth in 21 C.F.R. (Parts 210 and 211) and all applicable directives, Regulatory
Requirements (as defined below) and FDA (as defined below) rules, regulations,
guides, guidance, each as amended from time to time and in effect during the
Term of this Agreement.

 

(h) “cGMP
Requirements” means the requirements of cGMP.

 

(k) “Contract
Year” means the the twelve (12) month period coinciding with the calendar year.
Notwithstanding the foregoing, for purposes of this Agreement, the first
Contract Year of this Agreement shall mean the period from the Effective date
to December 31, 2004. Thereafter each Contract Year shall be from January 1
through December 31 of each calendar year during the Term of this Agreement.

 

(1) “Drug
Layer Granulation” shall mean a granulate including API meeting the Product
Specifications.

 

(m) “Effective
Date” or “Commencement Date” means the date set forth in the preamble of this
Agreement.

 

(n) “FDA”
means the United States Food and Drug Administration or any successor thereof.

 

(o) “Forms”
has the meaning set forth in Section 13.5 of this Agreement.

 

(p) “Governmental
Authority” means any nation or government, any state, regional, local or to her
political subdivision thereof, any supernational organization of sovereign
states and any entity, department, commission, bureau, agency, authority,
board, court, official or officer, domestic or foreign, exercising judicial,
regulatory or administrative, functions of or pertaining to government.

 

(q) “Granulations”
shall mean collectively the Drug Layer Granulations and Osmotic Layer
Granulations.

 

(r) “Including”
or “includes” means “including, without limitation,” or “includes, without limitation.

 

(s) “IP” has
the meaning set forth in Section 12.2 of this Agreement.

 

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(t) “Law”
means each provision of any currently existing federal, State, local or foreign
law, statute, ordinance, code, rule, regulation (including without limitation,
the Act and cGMP’s), promulgated or issued by any Governmental Authority, as
well as any binding judgments, decrees, injunctions or agreements entered into
by any Governmental Authority.

 

(u) “Manufacturing”
or “Manufacture” shall mean the activities associated with producing the
Product including, but not limited to, Materials acquisition, manufacturing,
Packaging, testing and labeling of finished dosage form of the Product.

 

(v) “Manufacturer”
has the meaning set forth in the preamble of this Agreement.

 

(w) “Manufacturing
Fee” means the fee paid to the Manufacturer for the Products pursuant to
Section 6.1 of this Agreement.

 

(x) “Materials”
means all ingredients, packaging supplies, printed materials and all other
components used to Manufacture the Products excluding API.

 

(y) “NDA”
means the New Drug Application 20-336 as amended and supplemented for the
Product and as approved by the FDA to market the Product and any materials,
documents or information referred to or relied upon therein.

 

(z) “Osmotic
Layer Granulation” shall mean a granulate without API meeting the Product
Specifications.

 

(aa) “Packaged
Tablets” means Tablets as packaged in accordance with the Packaging
Specifications.

 

(bb) “Packaging”
or “Package” means packaging of Tablets.

 

(cc) “Packaging
Fee” means the fee paid to the Manufacturer for Packaging pursuant to Section
6.1 of this Agreement.

 

(dd) “Packaging
Specifications” means the requirements and standards for the Packaging of
Tablets as set forth in the NDA, as amended or supplemented in accordance with
this Agreement.

 

(ee) “Party”
means each of the Manufacturer and the Company.

 

(ff) “Product”
or “Products” means the Granulations meeting the Product Specifications.

 

(gg) “Product
Manufacturing Technology” means all trade secrets in the possession or under
the control of the Manufacturer, including research and development, formulae,
test procedures, manufacturing procedures, Product formulations or other
technical or proprietary information and knowledge, whether or not patentable,
that are necessary for, and used by the Manufacturer solely and specifically in
the manufacture of

 

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the Products
in the Territory (excluding, in any event, any plant, tangible property or
equipment).

 

(hh) “Product
Specifications” shall mean those product, process and Manufacturing
specifications used by Manufacturer in the Manufacture of Products in
compliance with all applicable Regulatory Requirements, including Product
formula and materials required for the Manufacture of the Products that are to
be manufactured, purchased and supplied under this Agreement, as such are in
effect as of the Effective Date as set forth in the NDA, which Product
Specifications may be amended from time to time by the mutual written agreement
of the Parties.

 

(ii) “Recall”
has the meaning set forth in Section 7.4(c) of this Agreement.

 

(jj) “Regulatory
Authority” shall mean any foreign, federal, state or local,  regulatory agency, department, bureau or other
governmental entity, including, without limitation, the FDA and the U.S. Drug
Enforcement Administration, which is responsible for issuing approvals,
licenses, registrations (including but not limited to, the NDA), permits or
authorizations necessary for, or otherwise governs, the Manufacture, handling,
use, storage, import, transport, distribution or sale of Products in the
Territory.

 

(kk) “Regulatory
Requirements” shall mean all applicable approvals, licenses, registrations
(including but not limited to, the NDA), cGMPs, and authorizations and all
other requirements of each applicable Regulatory Authority in relation to the
Products, including, but not limited to, each of the foregoing which is
necessary for, or otherwise governs, the Manufacture, handling, use, storage,
import, transport, distribution or sale of Products

 

(11) “Rolling
Monthly Forecast” has the meaning set forth in Section 3.1 of this Agreement.

 

(mm) “Tablets”
means fully manufactured tablets of Product as delivered to Manufacturer by the
Company or a third party specified by the Company to be packaged by
Manufacturer in accordance with this Agreement.

 

(nn) “Tablet
Specifications” means the specifications for the Tablets as set forth in the
NDA in effect at any relevant time during this Agreement.

 

(oo) “Term”
has the meaning set forth in Section 8.1 of this Agreement.

 

(pp) “Territory”
means United States of America its territories and possessions including Puerto
Rico.

 

ARTICLE II

MANUFACTURE AND SALE OF PRODUCTS

 

2.1 Engagement. During the Term of
this Agreement and subject to the terms and conditions set forth herein,
Manufacturer shall Manufacture and Package, sell and deliver Products and
Packaged Tablets to Company, and the Company and its Affiliates shall purchase

 

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and take
delivery of Products and Packaged Tablets from Manufacturer. The Company shall
purchase all of its requirements for Products exclusively from Manufacturer,
subject to certain exceptions set forth herein. Manufacturer shall Manufacture,
Package and deliver Products and Packaged Tablets hereunder in material
accordance with the (i) Product Specifications; (ii) Packaging Specifications;
(iii) cGMP; (iv) the Act; and (v) all other applicable Regulatory Requirements.
During the Term and provided that Manufacturer is not in default of its
obligations hereunder, Company shall purchase all of its requirements for the
Products and Packaged Tablets exclusively from the Manufacturer, and
Manufacturer shall use commercially reasonable efforts to meet the Company’s
orders made in accordance with this Agreement. Notwithstanding the foregoing,
in the event that at any time during the Term (i) Manufacturer advises the
Company in writing that Manufacturer is unable to Manufacture, Package and/or
deliver in whole or in part, any order made by the Company in accordance with
the terms of this Agreement or (ii) the parties mutually agree based on the
Company’s forecasts made in good faith that Manufacturer cannot Manufacture,
Package and/or deliver all of the Company’s requirements for Products and or
Packaged Tablets in a timely manner as determined by Company subject to the
terms hereof, the Company shall have the right to purchase from a qualified
third party (the “Alternative Supplier”) such amount of Products or Packaged
Tablets, as the case may be (and only such amount), as Manufacturer was unable
to Manufacture, Package or deliver. In addition, in the event Manufacturer
fails (x) [***] in any calendar quarter or (y) [***] in any Contract Year to
either (i) deliver Products, at least [***]% of which meet the Product
Specifications, (ii) deliver Products within five (5) days of the agreed upon
delivery date as set forth in the Firm Order, (iii) deliver Packaged Tablets,
at least [***]% of which meet the Packaging Specifications or (iv) deliver
Packaged Tablets within five (5) days of the agreed upon delivery date as set
forth in a Firm Order, the Company shall have the immediate right to purchase
its requirements for Products and/or Packaged Tablets from the Alternative
Supplier until such a time as Manufacturer can demonstrate in good faith that
the cause for such failures has been cured and that Manufacturer is capable of
Manufacturing, Packaging and delivering Products and/or Packaged Tablets
meeting the Product Specifications or Packaging Specifications, as the case may
be, in accordance with the terms of this Agreement and subject to the approval
of applicable regulatory agencies if necessary. Following Manufacturer’s
demonstration of its ability to resume Manufacture and/or Packaging, Company
shall have the right to honor any non-cancellable commitments to the Alternate
Supplier including but not limited to taking delivery of all outstanding firm
orders for Products and/or Packaged Tablets for a period of ninety (90) days
after the date in which Manufacturer is able to resume Manufacture and/or
Packaging pursuant to this Section 2.1. The Manufacturer shall thereafter
resume the Manufacture, Packaging and delivery and the Company shall purchase
Product and/or Packaged Tablets from the Manufacturer in accordance with the
terms of this Agreement. Failure of Manufacturer to deliver Products meeting
the Product Specifications or Packaged Tablets meeting the Packaging
Specifications in accordance with the Company’s orders made consistent with
this Agreement shall not constitute a material breach by Manufacturer or give
the Company a right to terminate this Agreement but shall give Company the
right as set forth above to utilize the services of the Alternative Supplier to
perform the Manufacturing and Packaging services described herein; provided however, that failure by Manufacturer to comply
with its

 

[***]:  Certain information on this page has been
omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.

 

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“commercially
reasonable efforts” diligence requirement set forth above in this Section 2.1
shall constitute a breach of this Agreement and shall give rise to a right of
termination by the Company, subject to the cure provisions set forth Section
8.2(b) hereof. Subject to the terms set forth herein, the Manufacturer shall be
responsible for the purchase, at its own expense and for its own account, of
all raw materials used by Manufacturer to Manufacture the Products or perform
the Packaging, except that the Company shall be solely responsible for the cost
and delivery to Manufacturer of API meeting the API Specifications.

 

2.2 Manufacturing of Products. Subject
to Article 3 of this Agreement, the Manufacturer shall deliver the Products to
the Company or such other third party as may be directed by the Company to be
further manufactured into Tablets which the Company will thereafter cause to be
delivered to the Manufacturer for Packaging in accordance with the Packaging
Specifications. In accordance with Section 5.1 of this Agreement, Manufacturer
shall perform all necessary testing of the Products prior to their release. Upon
release by Manufacturer of Product meeting the Product Specifications as
evidenced by the Certificate of Analysis and Certificate of Conformance delivered
to Company, nothing shall excuse the Company of its obligation to accept
Products or its payment obligation, except in such instances where there is a
bona fide dispute as to whether the Products met the Product Specifications at
the time of their release, in which case such dispute will be resolved in
accordance with Section 5.4 hereof.

 

2.3 Packaging. In accordance with
Section 5.1 herein, Manufacturer shall perform the Packaging of Tablets in
accordance with the Packaging Specifications. In the event that the Packaging
is not performed in accordance with the Packaging Specifications, the
Manufacturer shall, at the Company’s request, re-perform the Packaging at the
Manufacturer’s cost. Except as required by the NDA and other Regulatory
Requirements, Manufacturer shall not be under obligation to inspect or
otherwise test Tablets delivered to the Manufacturer for Packaging. In the
event Manufacturer performs any such bulk Tablet release testing, the price
therefore shall be set in good faith by Manufacturer and paid by the Company as
invoiced. In the event any delivery or portion thereof of Packaged Tablets
fails to meet any established specifications as a result of the failure of the
Tablets to meet the Tablet Specifications at the time of delivery to Manufacturer,
the Manufacturer shall be under no obligation to reperform the Packaging as
provided above in this Section 2.3.

 

2.4 Labeling. The Company shall
specify all labeling to be used on each Packaged Tablet, including any changes
or modifications to such labels; provided that the Company shall ensure that
all such labeling complies with applicable Law and the Packaging Specifications.
Each Packaged Tablet and all labeling and packaging used in connection
therewith shall include the trademark associated with such product, in the
manner and to the extent specified in the Packaging Specifications. The
Manufacturer agrees to use the specified labeling (and only such labeling) on
the Packaged Tablets, and not to use such labeling on any other product. Any
change or modification to any label shall be implemented by the Manufacturer
(i) as soon as possible if required by Law, or (ii) within a reasonable
timeframe to be agreed upon by the Parties, following the Manufacturer’s
receipt of notification of such label changes; provided such changes or
modifications meet Regulatory Requirements. The Company shall reimburse the
Manufacturer for documented costs incurred in connection with any change made
in accordance with this Section 2.4, including the costs of obsolescence of
goods-in-

 

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process,
packaging materials and supplies, and finished goods not suitable for marketing
in the Territory, provided, that the Company shall
not be liable for any goods-in-process, packaging materials and supplies, and
finished goods in excess of those quantities necessary for Manufacturer to meet
the Company’s requirements, as set forth in the Rolling Monthly Forecast, for
the first three complete calendar months following the date of such change. The
Company shall own all IP on and related to such labeling of products. Notwithstanding
the foregoing, to the extent that Manufacturer shall purchase certain packaging
materials and supplies having extended lead times in order to satisfy its obligations
under the terms of this Agreement, the Company shall purchase at cost plus
fifteen (15%) percent (without additional mark up) all of such materials and
supplies owned by Manufacturer at the time of any change made that are made
obsolete as a result of such change.

 

2.5 Scope of Agreement. This Agreement
is intended to cover certain Manufacturing and Packaging services with respect
to Packaged Tablets. The Company has heretofore advised the Manufacturer of its
intention to have finished Tablets manufactured in part by a qualified third
party. The Company shall contract directly with such third party as it may
select to perform such manufacturing services (the “Tablet Manufacturer”), it
being expressly agreed that this Agreement shall not inure to the benefit of
such third party. This Agreement shall not apply or have any effect with
respect to orders placed for Product or Packaged Tablets pursuant to the supply
arrangement between the Company and Novartis Pharmaceuticals Corporation.

 

2.6 Qualification of Secondary Source.
The parties agree that at any time during the Term or following termination or
expiration of this Agreement, Company at its sole cost and expense may qualify
a source other than Manufacturer to Manufacture Products or perform Packaging
services. Manufacture agrees to cooperate with Company in the qualification of
the secondary source and assist in the obtaining of any necessary approvals at
the Company’s cost plus $200 per man hour for time spent by Manufacturer’s
employees, contractors or representatives in assisting Company in the
qualification of such secondary source.

 

ARTICLE III

FORECASTS ORDERS AND SHIPMENT

 

3.1 Forecasting. In order to assist
the planning of production runs for the Products and Packaged Tablets, the
Company shall, within thirty (30) days of the Commencement Date and at least
thirty (30) days in advance of the commencement of each calendar month during
the Term of this Agreement, provide the Manufacturer with its good faith
forecast for each month of the 18 months immediately following of the
quantities of each of the Products and Packaged Tablets that the Company
estimates it will be ordering during such months (“Rolling Monthly Forecast”). The
Company shall forecast in amounts comprising full batch quantities, as such
quantities are set forth on Schedule 3.1. The Manufacturer shall be entitled to
order sufficient quantities of long lead time components to meet the Company’s
forecasts.

 

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3.2 Orders.

 

(a) The Company
shall place orders for Products and Packaged Tablets in writing no less than
ninety (90) days in advance of the Company’s requested delivery dates, and the
Company shall deliver to Manufacturer sufficient quantities of API for such
requested delivery meeting the API Specifications no less than 45 days prior to
any such requested delivery date. Orders for Products and for Packaged Tablets
shall not be combined into a single purchase order. Each order shall
specifically refer to this Agreement and shall specify the quantity and
description of each Product or Packaged Tablet ordered and the requested
delivery date (which delivery dates shall not exceed two (2) times per month
unless otherwise agreed to by the parties and shall not be on Saturday, Sunday
or holiday). The minimum size of any order placed by the Company shall be a
full batch in accordance with Schedule 3.1, except with the advance approval of
the Manufacturer. The order forms shall be delivered to such location as the
Manufacturer designates in writing to the Company from time to time. The date
an order shall be deemed placed (the “Order Date”) shall be the earlier
of (a) the date that the Manufacturer receives the order form containing said
order, or (b) the date of receipt of the telexed or telecopied order. Each such
order shall be a firm order (“Firm Order”) for which the Manufacturer is
obligated to Manufacture Product and/or Package Tablets and the Company is
obligated to take delivery. The parties agree to negotiate in good faith any
changes proposed by Company to a Firm Order. Company shall be responsible for
all costs associated with any changes to a Firm Order requested by Company and
agreed to by Manufacturer. To the extent any conflict may exist between the
terms of any purchase order and this Agreement, the terms of this Agreement
will control.

 

(b) During any
month during the Term, the Manufacturer shall not be required to supply more
than one hundred twenty percent (120%) of the forecasted quantity of any
Product or Packaged Tablet set forth in the most recent Rolling Monthly
Forecast provided by the Company pursuant to Section 3.2(a) hereof for any
monthly order. Provided that Manufacturer has the capacity and is not in
default of its obligations hereunder, the Company shall purchase at least
eighty percent (80%) (the “Monthly Purchase Requirement”) of the forecasted
quantity of Products or Packaged Tablets set forth in the most recent Rolling
Monthly Forecast provided by the Company pursuant to Section 3.2(a) for the
applicable month. In the event Company fails to purchase the Monthly Purchase
Requirement in any given month, it shall not be a default hereunder provided
that Company (i) purchases at least fifty (50%) percent of such Monthly
Purchase Requirement of Products and Packaged Tablets every month and (ii)
purchases a cumulative quantity of Products and Packaged Tablets of at least
eighty (80%) per cent of the Rolling Monthly Forecast for the applicable month
and subsequent two (2) months.

 

(c) Within
fifteen days of the Effective Date, Company shall submit to Manufacturer the
initial Firm Order from the Commencement Date until June 30, 2004.

 

3.3 Delivery.

 

(a) The
Manufacturer shall Manufacture and supply the Products and Packaged Tablets in
response to Firm Orders placed by the Company, within 95% to 105% of the
quantities ordered in each Firm Order in accordance with the terms of this
Agreement, and the Company shall accept delivery of same. Delivery dates as set
forth in any Firm

 

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Order or
confirmation thereof shall be deemed to be estimated only but shall become
binding upon acceptance of the Firm Order by Manufacturer, provided that the
Company has delivered to Manufacturer API in accordance with Section 3.2(a)
hereof. The Manufacturer shall not be required to fill orders during any
calendar quarter that exceed the Firm Orders placed by the Company prior to the
commencement of such calendar quarter but shall make commercially reasonable
efforts to do so. Each shipment of Products and Packaged Tablets shall be
accompanied by a Certificate of Compliance (“COC”), in a form reasonably
acceptable to both Parties which hereafter shall be attached hereto as Exhibit
3.3 and other documents as defined in the Quality Agreement between the Parties.
Manufacturer shall be under no obligation to warehouse any Products, Tablets or
Packaged Tablets after their release by Manufacturer, or any API, except for
API to be used in the manufacture of Products within the following 90 days.

 

(b) All Products
and Packaged Tablets shipped under this Agreement shall be shipped FCA
Manufacturer’s shipping dock. The Company shall pay all freight, insurance
charges, taxes, import and export duties, inspection fees and other charges
applicable to the sale and transport of Products and Packaged Tablets purchased
by the Company. Title and risk of loss and damages to Products purchased by the
Company shall pass to the Company upon delivery to the carrier. In the event of
damage or loss to the Products after delivery to the carrier, the Company shall
be responsible to file claims with the carrier. The Manufacturer shall
cooperate with the Company in the filing of such claims.

 

ARTICLE IV

REPRESENTATIONS AND WARRANTIES

 

4.1 Representations, Warranties and
Covenants of Manufacturer. The Manufacturer hereby represents, warrants and
covenants to the Company:

 

(a) Products.
Provided that the API delivered by the Company to Manufacturer meets all of the
API Specifications, all Products and Packaged Tablets delivered pursuant to the
terms hereof by the Manufacturer (or any subcontractor thereof) to the Company
during the Term will at delivery be in compliance with the Product
Specifications and the Packaging Specifications respectively, cGMP, Regulatory
Requirements and any other applicable Law and, at the time of delivery of the
Products and the Packaged Tablets respectively, and the Products and the
Packaged Tablets will be free from defects in materials and workmanship and
shall not be adulterated or misbranded within the meaning of the Act. Manufacturer
shall not willfully or intentionally disrupt or cause the disruption of the
supply of Product or Packaged Tablets to Company.

 

(b) Authorization.
This Agreement has been duly executed and delivered by the Manufacturer and constitutes
valid and binding obligations of the Manufacturer, enforceable against the
Manufacturer in accordance with its terms, except as enforceability may be
limited by bankruptcy, fraudulent conveyance, insolvency, reorganization,
moratorium and other Laws relating to creditors’ rights generally and by
general equitable principles. The execution, delivery and performance of this
Agreement

 

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have been duly
authorized by all necessary corporate action on the part of the Manufacturer.

 

(c) Absence
of Conflicts. The execution, delivery and performance of this Agreement by
the Manufacturer does not conflict with or constitute a default under any
agreement, instrument or understanding, oral or written to which it is a party
or by which it may be bound, does not conflict with any provision of any
organizational document of the Manufacturer and does not conflict with or
violate any applicable Law.

 

(d) Organization
and Standing. The Manufacturer is a corporation, duly organized, validly
existing and in good standing under the Laws of the State of Delaware.

 

(e) Power
and Authority. The Manufacturer has corporate power and authority to
execute, deliver and perform this Agreement and to consummate the transactions
contemplated hereby.

 

(f) EXCEPT AS
EXPRESSLY STATED TN THIS AGREEMENT, THE MANUFACTURER MAKES NO EXPRESS OR
IMPLIED WARRANTY AS TO THE MERCHANTABILITY OF THE PRODUCTS, OR AS TO THEIR
FITNESS FOR A PARTICULAR PURPOSE AND DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR
IMPLIED.

 

4.2 Representations, Warranties and
Covenants of the Company. The Company hereby represents, warrants and
covenants to the Manufacturer:

 

(a) Authorization.
This Agreement has been duly executed and delivered by the Company and
constitutes valid and binding obligations of the Company, enforceable against
the Company in accordance with its terms except as enforceability may be
limited by bankruptcy, fraudulent conveyance, insolvency, reorganization,
moratorium and other Laws relating to or affecting creditors’ rights generally
and by general equitable principles. The execution, delivery and performance of
this Agreement has been duly authorized by all necessary action on the part of
the Company, its officers and directors.

 

(b) Absence
of Conflicts. The execution, delivery and performance of this Agreement by
the Company does not conflict with or constitute a default under any agreement,
instrument or understanding, oral or written to which it is a party or by which
it may be bound, does not conflict with any provision of any organizational
document of the Company and does not conflict with or violate any applicable
Law.

 

(c) Organization
and Standing. The Company is a limited liability company, duly organized,
validly existing and in good standing under the Laws of Delaware.

 

(d) Power
and Authority. The Company has full corporate power and authority to
execute, deliver and perform this Agreement and to consummate the transactions
contemplated hereby.

 

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(e) Compliance
with Law. The Company covenants that the sale and distribution of the
Products and the Packaged Tablets will be conducted in accordance with all
applicable Law, including without limitation, as permitted in the NDA.

 

ARTICLE V

QUALITY ASSURANCE

 

5.1 Manufacturer’s Covenants. The
Manufacturer hereby covenants during the Term it shall:

 

(a)
manufacture, test and release the Products in conformity with the Product
Specifications and all material applicable Law;

 

(b) perform
the Packaging in conformity with the NDA, the Packaging Specifications and all
material applicable Law;

 

(c) maintain
during the Term and for a period thereafter consistent with Manufacturer’s
policies and standard cGMP requirements all records as are necessary and appropriate
to demonstrate compliance with the Act, applicable cGMP requirements and any
other quality control standards of any Regulatory Authority in the Territory;
and

 

(d) grant the
Company the right, on reasonable advance notice and during normal business
hours during the Term of this Agreement no more than twice per year, to inspect
and audit the facilities and operations of the Manufacturer directly related to
the Manufacture and supply of the Products and the Packaging in order to
confirm compliance with the covenants contained in this Agreement; provided, however, the Manufacturer reserves the right to
refuse access to any facilities where there is a risk to health or safety or to
the security or quality of the Products, the Tablets, or any other products of
the Manufacturer or its contractors.

 

(e) it will
enter into all necessary compliance agreements designated by the Company and
required by Law, including but not limited to agreements to cover adverse
incident reporting;

 

5.2 The Company’s Covenants. The
Company hereby covenants during the Term that:

 

(a) all API
delivered to Manufacturer shall be in compliance with the API Specifications at
the time of delivery to Manufacturer and shall include a COA from the supplier
thereof;

 

(b) all
Tablets shall have been tested by the Company and/or Tablet Manufacturer and
shall be in compliance with the Tablet Specifications at the time of delivery
to Manufacturer;

 

(c) it will
hold, store, handle, ship, deliver, distribute and/or sell the Packaged Tablets
in accordance with the Act, applicable cGMP requirements and material
applicable Laws;

 

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(d) it will
enter into all necessary compliance agreements designated by the Manufacturer
and required by Law, including but not limited to agreements to cover adverse
incident reporting; and

 

(e) except as
provided in this Agreement, upon delivery of the Products to the Company or its
third party designee, and except for time in which Tablets are at the
Manufacturer’s facility being Packaged, the Company shall be solely responsible
for compliance with all quality control testing and other testing requirements
set forth in this Agreement and all applicable Laws with respect to such
Products, Tablets and Packaged Tablets.

 

5.3 Non-Conforming Products. (a) By
Manufacturer. Notwithstanding any other provisions of this Agreement, the
Company agrees, if so requested after being advised of the basis on which
Manufacturer has requested return of the Products to return to the Manufacturer,
at the Manufacturer’s expense, any Products that are, or are claimed to be,
damaged or defective, or otherwise to dispose of such Products as the
Manufacturer may direct. Upon such return, Manufacturer shall Manufacture at no
cost to Company such quantity of Products alleged by Manufacturer to be damaged
or defective and subject to Section 13.1 hereof reimburse Company for the loss
or damage to the API arising from Manufacturer’s negligence, which negligence
shall be limited to (i) mishandling or improper storage of the API, excipients,
packaging materials, Granulations or containers in which any of the foregoing are
stored or transported; (ii) mishandling, improper operation of or failure
to maintain equipment; (iii) failure to follow batch records, standard
operating procedures, Company’s written instructions or (iv) such other conduct
determined to be negligent by a court of competent jurisdiction.

 

(b) By
Company. Company shall have a period of thirty (30) days (forty-five (45)
days if an outside testing laboratory is used) after the date of its receipt of
a shipment of Products to inspect and accept or reject such shipment for non
conformance with the Product Specifications or due to deviation from cGMPs,
Regulatory Requirements or any material applicable Law in the Manufacture of
the Product. If Company rejects such delivery of Product, it shall promptly
notify Manufacturer and the Parties shall thereafter in good faith attempt to
determine whether the Products did or did not conform to the Product
Specifications and shall reasonably cooperate with each other for such purpose
(including but not limited to providing the other party with reasonable access
to all documents, filings and other materials in such Party’s possession or
reasonably accessible to such Party and the Company’s provision to Manufacturer
of samples of such delivery for testing). If either Company or Manufacturer
determines that such shipment did not conform to the Product Specifications,
either party may, if such party determines it to be relevant, submit samples to
an independent laboratory of nationally recognized standing for testing and
acceptable to both Parties. If such independent laboratory determines that the
shipment conformed in all respects to the Product Specifications, Company shall
bear all expenses of shipping and testing such shipment samples and shall be
obligated to accept and pay for such shipment of Product. If such independent
laboratory confirms that such shipment did not meet the Product Specifications
in all respects, Seller shall, subject to the limitations of Section 13.1
relating to API, replace at no cost to Company, that portion of the Product
shipment that does not conform to the Product Specifications,

 

11

 

and shall bear
all expenses of shipping and testing the shipment samples, including any costs
incurred by Buyer in returning such Product to Seller or its nominee.

 

(c) During the
Term, to the extent necessary to comply with applicable Laws or as approved in
writing by the Company, the Company shall reimburse Manufacturer for the actual
cost of validation and qualification, including analytic method testing of
Manufacturer’s facility to the extent such costs relate to the services being
provided by Manufacturer hereunder.

 

5.4 Rejection of Delivered Packaged
Tablets. Within 30 days of receipt of any Packaged Tablet (forty-five (45)
days if an outside laboratory is used), the Company shall perform such
samplings and tests using validated test methods described in the applicable
NDA, or equivalent filing, for the packaging of Packaged Tablets, to determine
whether the Packaged Tablets meet the Packaging Specifications. It is
understood and agreed that the Company will not perform sampling and testing
until it has validated its-test methods. Any Product not refused within 30 days
shall be deemed accepted. If the Company wishes to refuse acceptance, the
Company shall, within such 30-day period, inform the Manufacturer of its
refusal to accept the lot(s) and the reason therefore. In the event that the
Company refuses or revokes acceptance, the Manufacturer, upon confirmation of
the reasons for refusal of the Product, shall re-perform the Packaging. If the
Manufacturer and the Company do not agree on the refusal or rejection of
Packaged Tablets for reason of failure to meet the Packaging Specifications,
then either party may refer the matter for final analysis to a specialized
laboratory of national reputation acceptable to both parties for the purpose of
determining the results. Any determination by such laboratory shall be final
and binding upon the parties hereto and shall be paid for by the Party whose
determination was not in accordance with the finding of such specialized
laboratory.

 

5.5 Sample Retention. Manufacturer on
behalf of both Company and Manufacturer shall retain representative samples and
associated documentation from each lot of finished Product and Packaged Tablets
for period required by applicable Regulatory Requirements and applicable Law.

 

ARTICLE VI

PRICE AND PAYMENTS

 

6.1 Manufacturing Fee. The prices for
the supply of each Product (the “Manufacturing Fee”) and Packaged Tablets (the “Packaging
Fee”) shall be equal to the prices set forth in Schedule 6.1; provided, however, the price for the Products and Packaged
Tablets set forth in Schedule 6.1 shall be modified at the commencement of each
Contract Year after the initial Contract Year as set forth in Section 6.2.

 

6.2 Fee Adjustment. Commencing on
January 1, 2005 and, on each anniversary of the Effective Date thereafter, the
price for both Products and Packaged Tablets for each Contract Year shall be
increased to reflect all demonstrated increases in the cost to the Manufacturer
of manufacturing the Products and the Packaging of Tablets. Notwithstanding

 

12

 

anything
hereinto the contrary, the annual price increase for both Products and Packaged
Tablets shall not exceed [***]%.

 

6.3 Invoices. Upon (i) delivery of
each shipment of Products in accordance with Section 3.3 of this Agreement to
the Tablet Manufacturer and (ii) delivery of Packaged Product to Company, the
Manufacturer shall promptly invoice the Company for such delivery. The
Manufacturer shall send all invoices to a single Company address.

 

6.4 Manner of Payment.

 

(a) The
Company shall make all payments for Products and Packaged Product sold
hereunder pursuant to this Article VI by check or by wire transfer in United
States currency, without any offset or deduction of any nature whatsoever,
within thirty (30) days after the date of the invoice (which shall not precede
delivery) provided that this obligation shall not apply to any Products or
Packaged Products that are rejected pursuant to Section 5.4 hereof until
Company’s receipt of conforming replacement product in accordance with the
terms of such section. All payments shall be made to such account as the
Manufacturer shall have specified in writing to the Company with written
confirmation of payment sent by facsimile to such address as the Manufacturer shall
have specified in writing to the Company. If the Company fails to pay any
invoiced amount when due, a service charge will be imposed by the Manufacturer
equal to the lesser of one and one-half percent (11⁄2%) or the highest rate
permitted by Law of the outstanding amount for each month or portion thereof
that such amount is overdue.

 

(b) Each
shipment of Products to the Company shall constitute a separate sale,
obligating the Company to pay therefor, whether said shipment be in whole or only
partial fulfillment of any order or confirmation issued in connection therewith.

 

(c) The
Company agrees not to make any deductions of any kind from any payments
becoming due to the Manufacturer unless the Company shall have received written
authorization from the Manufacturer authorizing such deduction.

 

6.5 Taxes. The Company shall bear
solely the cost of any taxes, levies, duties or fees of any kind, nature or
description whatsoever applicable to the sale and transportation of any
Products sold by the Manufacturer to the Company, and the Company shall
forthwith pay to the Manufacturer all such sums upon demand. The Company shall
provide to the Manufacturer any applicable sales, use or resale tax exemption
certificates prior to shipment of any Products.

 

ARTICLE VII

REGULATORY MATTERS; RECORDS

 

7.1 Inspections. The Manufacturer
shall be responsible at its sole expense for handling and responding to any FDA
or other Governmental Entity inspections with respect to its Manufacture of the
Products or Packaging of the Packaged Tablets during the Term of this

 

[***]:  Certain information on this page has been
omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.

 

13

 

Agreement. The
Manufacturer shall provide to the Company with prompt notice (not to exceed two
(2) business days) of any FDA or other Regulatory Authority inspections of the
facility and notify Company of any material observations made during such
inspection. Manufacturer shall provide to the Company any information
reasonably requested by the Company and all information requested by any
Regulatory Authority concerning any governmental inspection related to the
Products or Packaged Tablets. To the extent the Manufacturer requires the
assistance of the Company in order to fulfill its obligations pursuant to this
Section 7.1, the Company agrees to fully cooperate and assist the Manufacturer
at the Manufacturer’s expense. Notwithstanding any provision herein to the
contrary, Manufacturer shall provide Company with the opportunity to comment to
Manufacturer on any filings, notices or other correspondence with any
regulatory Authority that relates to or reasonable could affect the Manufacture,
Packaging or supply of Products or Packaged Tablets hereunder.

 

7.2 Reporting. Except as to
responsibilities which Manufacturer may not as a matter of law transfer, during
the Term of this Agreement, the Company will be responsible for any reporting
of matters regarding the Manufacture, Packaging and supply of the Products
and/or Packaged Tablets to the FDA or other Regulatory Authority, as the case
may be, in accordance with applicable Law, provided that Manufacturer provides
Company all information in its possession or control required to prepare any
such reports. Manufacturer shall promptly furnish copies of such reports to the
Company. The Manufacturer shall also advise the Company of any occurrences or
information that arises out of the manufacturing activities of the Manufacturer
or its contractors that have or could reasonably be expected to have adverse
regulatory compliance or reporting consequences concerning the Products and/or
Packaged Tablets.

 

7.3 Permits, Licenses and Approvals. During
the Term of this Agreement, the Manufacturer shall have primary responsibility
to and shall maintain all regulatory and governmental permits, licenses and
approvals that are necessary for the Manufacture, Packaging and shipment of the
Products and/or Packaged Tablets to the Company; provided,
however, that the Parties understand and agree that the Company owns
the NDA and, as a result, the Company will be responsible for any and all
NDA-related filings required pursuant to this Section 7.3. Each Party agrees
that, to the extent required to fulfill their respective obligations under this
Section 7.3, each Party will reasonably cooperate and assist the other party at
the requesting Party’s expense.

 

7.4 Complaints; Recalls; Market
Withdrawals; Adverse Reactions.

 

(a) Complaints.
Product complaint reports concerning the Manufacture or supply of Products or
Packaged Tablets received by the recipient will be faxed within two (2)
Business Days after receipt to the other party to:

 

Novartis Consumer Health, Inc.

200 Kimball Drive 

Parsippany, New Jersey 

Attn: Director of Quality Assurance 

Fax: 973-503-8413 

 

14

 

Reliant Pharmaceuticals, LLC 

110 Allen Road 

Liberty Corner, New Jersey 07938 

Attn: Quality Assurance Department 

Fax: 908-542-9405 

 

The Parties shall cooperate with each other to investigate all
complaints associated with the Products or Packaged Tablets and complete a
written report reasonably satisfactory to both parties.

 

(b) Recalls.
In the event that either party shall be required to initiate a Recall (as
defined herein) with respect to any Product or Packaged Tablet provided under
this Agreement, the party shall promptly notify the other party in writing. Except
where one party is required by Law to do so, Company shall have the sole and
exclusive right to initiate the Recall and shall provide Manufacturer with
written notice thereof. In the event of such a recall, the provisions of
Section 7.4(c) shall be applicable.

 

(c) Cost of
Recall. In the event that any Product, Tablet or Packaged Tablet
Manufactured or Packaged hereunder is quarantined or recalled, or is subject to
field alert, product withdrawal or stop-sale action, whether voluntary or by
governmental action (collectively, a “Recall”), it is agreed and
understood that any expenses, including reasonable fees of any experts or
attorneys that may be utilized by either party, government fines or penalties,
related to such recall, quarantine or stop-sale, shall be borne by the Company
unless it is determined that the sole cause necessitating such a Recall is that
either (i) the Products at issue are non-compliant with the Product
Specifications at the time that such Products are released by Manufacturer,
except to the extent that such non-compliance should reasonably have been
detected in connection with the bulk tablet release testing, or (ii) the
Packaged Tablets at issue are non- compliant with the Packaging Specifications
at the time that such Packaged Tablets are released by Manufacturer and such
non-compliance is not due to the negligence or intentional malfeasance of any
party other than the Manufacturer, in which case Manufacturer shall be liable
for up to the limits set forth in Section 13.1 hereof.

 

7.5 Adverse Reactions. The Company and
the Manufacturer shall observe the procedures and notification requirements
with respect to Adverse Reactions described in Schedule 7.5 attached hereto.

 

7.6 Insurance. At all times during the
Term of this Agreement, both the Company and Manufacturer shall each maintain,
or self-insure for, product liability insurance and recall insurance written on
a claims-made basis in an amount of not less than $5,000,000 annual aggregate.

 

7.7 Quality Agreement. Within at least
thirty (30) days following the Effective Date of this Agreement, the Parties
shall mutually agree upon a Quality Agreement which will appropriately address
regulatory, operational and quality responsibilities (the “Quality Agreement”).
The Quality Agreement will include a key contact list for each party.

 

15

 

ARTICLE VIII

TERM AND TERMINATION

 

8.1 Term. This Agreement shall
commence as of the Commencement Date and shall expire on the fifth (5th)
Anniversary of the Commencement Date (the “Initial Term”). Thereafter, the
Agreement shall automatically renew for up to three (3) successive one (1) year
renewal terms (each one year term after the Initial term a “Renewal Term”) (the
Initial Term and all Renewal Terms collectively, the “Term”) unless either Party
gives the other twelve (12) months prior written notice of its intention not to
renew.

 

8.2 Termination. Subject to the
Manufacturer’s obligations under Section 8.4 below, either Party shall have the
right to terminate this Agreement with immediate effect upon written notice to
the other upon the occurrence of either of the following:

 

(a) the other
Party files a petition in bankruptcy, or enters into an agreement with its
creditors, or applies for or consents to the appointment of a receiver or
trustee, or makes an assignment for the benefit of creditors, or becomes
subject to involuntary proceedings under any bankruptcy or insolvency Law; or

 

(b) the other
Party fails to cure any noncompliance with any of the terms and conditions
hereof within sixty (60) days prior written notice delivered to the non-
compliant Party by the other Party.

 

8.3 Effect of Termination. If this
Agreement is terminated pursuant to Section 8.2:

 

(a)
Termination of this Agreement shall not affect any obligations of either party
incurred prior to its termination including without limitation, each party’s
obligation with respect to any Firm Orders that have been submitted.

 

(b) If the
Company shall default in the payment of any indebtedness to the Manufacturer
when and as the same shall become due and payable, and if such default shall
continue for a period of ten (10) days after written notice of such default
shall have been given to the Company, then all of the liabilities and
obligations of the Company to the Manufacturer, whether then due or not, shall
become immediately due and payable.

 

(c) The
termination of this Agreement shall not release the Company from the obligation
to pay any sum that may be owing to the Manufacturer (whether then or
thereafter due to the Manufacturer) or operate to discharge any liability or
obligation that had been incurred by either party prior to any such termination.

 

(d) During the
period between the giving of any notice of termination pursuant to this Article
VIII and the effective date of the termination as set forth in such notice, all
Products shall be delivered to the Company solely on a C.O.D. basis.

 

16

 

8.4 Termination or Expiration of Agreement
Validation and Qualification Costs.

 

(a) Upon the
termination or expiration of this Agreement, the Manufacturer shall transfer,
or shall cause to be transferred at the Company’s sole expense, all remaining
API, Products, Packaged Tablets and raw materials (including artwork and film
pertaining to the labeling of boxes, cartons and prescribing information)
relating to the Products then owned or held by the Manufacturer and acquired in
reasonable quantities during the Term of this Agreement to fulfill the
Manufacturer’s obligations hereunder. Such raw materials shall be invoiced to
the Company at cost, plus 15%, and such Products and Packaged Tablets shall be
invoiced at the then-current price.

 

(b) It is
understood and agreed that the Company shall be responsible for all
Manufacturing of the Products and Packaging of Tablets after the earlier of the
termination or expiration of this Agreement or in connection with the use of an
Alternate Supplier. In addition, it is understood and agreed that the Company
shall be responsible, at its sole expense, for the validation and
qualification, including analytic method testing, of any manufacturing facility
to be used by the Company during or after the term of this Agreement. For
purposes of this Section 8.4(b), “manufacturing” shall mean the
manufacture of Products, including mix, fill and finish, and the manufacture of
active bulk components and Packaging of Tablets. Manufacturer shall cooperate
and assist Company in the transfer of Manufacturing to a third party during the
Term or following termination or expiration of this Agreement at the Company’s
cost plus $200 per man hour for time spent by Manufacturer’s employees,
contractors or representatives; provided however,
the Company shall not be invoiced for the first 125 man hours if the Company terminates
this Agreement in accordance with Section 8.2(b).

 

(c) To
facilitate the Company’s use of the Product Manufacturing Technology subsequent
to the termination or expiration of this Agreement, upon such termination,
expiration or earlier upon the reasonable request of the Company, the
Manufacturer agrees to provide, and use commercially reasonable efforts to
cause its contractors to provide, the Company with (i) reasonable access to the
facilities of the Manufacturer and its contractors and (ii) for a period of 60
days after such termination or expiration, reasonable access to the personnel
of the Manufacturer and its contractors, in any case limited to those
facilities or personnel directly responsible for the manufacturing of the
Products. The Company hereby agrees to reimburse the Manufacturer or its
contractors, as the case may be, for all out-of-pocket expenses incurred in
connection with personnel of the Manufacturer or its contractors assisting the
Company at any location other than such person’s regular place of work and to
pay the Manufacturer an amount equal to $200 per man hour for time spent by
Manufacturer’s employees, contractors or representatives.

 

(d)
Termination or expiration of this Agreement shall not relieve the Parties of
any obligation accruing prior to such termination. The rights and obligations
of the Parties under Sections 8.3, 8.4, 10.1, Article VI, Article XI and
Article XIII of this Agreement shall survive the expiration or termination of
this Agreement.

 

(e) Upon the
expiration or termination of this Agreement, the Manufacturer and the Company
shall promptly return all confidential information that it was provided by the
other Party pursuant to this Agreement.

 

17

 

8.5 Termination Rights Construction. For
the purposes of interpreting termination rights hereunder, the Manufacture of
Products on the one hand and the Packaging of Tablets on the other hand shall
be deemed to be separate services such that a right to terminate one such set
of services by either Party shall not create or result in a right to terminate
the other.

 

ARTICLE IX

FORCE MAJEURE

 

9.1 Force Majeure. Except as otherwise
expressly set forth in this Agreement, neither Party shall be deemed to have
defaulted under or breached this Agreement for failure or delay in fulfilling
or performing any term or provision of this Agreement (other than the payment
of money) when such failure or delay shall be caused (directly or indirectly)
by fire; flood; accident; explosion; equipment or machinery breakdown;
sabotage; strike or any labor disturbance; civil commotions; riots; invasions;
acts of terrorism; wars; acts, restraints, requisitions, regulations, or
directions of any Governmental Entity; compliance by the either party with any
request of any Governmental Entity; compliance by either party with any request
for material represented to be for purposes of (directly or indirectly)
producing articles for national defense or national defense facilities;
shortage of labor, fuel, power or raw materials; inability to obtain supplies;
failure of normal sources of supply; inability to obtain or delays of
transportation facilities; any act of God; or any cause (whether similar or
dissimilar to the foregoing) beyond the reasonable control of the other party. The
party claiming an event of force majeure shall promptly notify the other party
in writing and provide full particulars of the cause or event and also keep the
other party informed of any further developments. The party so affected shall
use commercially reasonable efforts to remove the cause of the non-performance
and resume performance hereunder. If by reason of such causes the Manufacturer’s
supply of any products shall be limited which requires an allocation to be made,
Manufacturer shall meet the needs of Company on a basis no less favorable than
pro rata on a volume basis to its own internal needs. If the period of
non-performance as result of a force majeure event exceeds an aggregate of
ninety (90) days within a six (6) month period, either party may terminate this
Agreement.

 

ARTICLE X

CONFIDENTIALITY

 

10.1 Nondisclosure and Nonuse Obligation.
Either party (the “Disclosing Party”) or its contractors may, from time to
time, give the other party (the “Recipient”) valuable information of a technical
or non-technical nature that is not generally known to the trade or public. Both
parties agree that they will not disclose to anyone in any manner whatsoever
(except as authorized in writing by the Disclosing Party) any such information,
including information relating in any way to the Products, processes, and
services of Disclosing Party or its contractors, which becomes known to the
Recipient during the period that this Agreement is in effect. The obligations
of this Article X shall not apply to information (i) that is known to the
Recipient as shown by written records prior to its disclosure by Disclosing
Party or its contractors; (ii) that becomes public information or is generally
available to the public other than by an unauthorized act or omission of Recipient;
or (iii) that is received by the Recipient from third parties who are in
rightful possession of such information and who are lawfully entitled to
disclose such information to the Recipient. Upon termination of this Agreement,
both parties

 

18

 

shall return
to the other all documents that include confidential information of the other
or its contractors, including all copies of such documents, and shall make no
further use of such information.

 

ARTICLE XI

INDEMNIFICATION

 

11.1 By Manufacturer. Except as may be
limited by Section 13.1 of this Agreement, from and after the Effective Date,
the Manufacturer shall indemnify, defend and hold harmless the Company and its
Affiliates and their respective officers, directors, employees, agents,
advisors and shareholders (“Company Indemnified Parties”) from and against any
and all suits, claims, judgments, losses, liabilities, costs or expenses
(including reasonable attorneys fees) and damages of any kind or character (“Losses”)
which any Company Indemnified party may suffer or incur either directly or
indirectly or in connection with any suits, claims, demands, actions, causes of
action, liabilities, proceedings, investigations, inquiries, injunctions or
regulatory actions by a third party to the extent such Losses arise from or
arising solely from a breach by the Manufacturer of any of its representations,
warranties, agreements, covenants or obligations contained in or made pursuant
to this Agreement.

 

11.2 By The Company. From and after
the Effective Date, the Company shall indemnify, defend and hold harmless the
Manufacturer and its Affiliates and their respective officers, directors,
employees, agents, advisors and shareholders (“Manufacturer Indemnified Parties”)
from and against any and all Losses which any Manufacturer Indemnified Party
may suffer or incur either directly or indirectly in connection with any suits,
claims, demands, actions, causes of action, liabilities, proceedings,
investigations, inquiries, injunctions or regulatory actions by a third party
to the extent such Losses by a third party arise from product liability claims
brought by third parties or a breach by the Company of any of its
representations, warranties, agreements, covenants or obligations contained in
or made pursuant to this Agreement, except where such Losses arise from the
negligence or willful misconduct of the Manufacturer or solely from a breach by
the Manufacturer of any of its representations, warranties, agreements, covenants
or obligations under this Agreement.

 

ARTICLE XII

INTELLECTUAL PROPERTY RIGHTS

 

12.1 License. The Company hereby
grants to the Manufacturer, and to each contractor which the Manufacturer may
cause to manufacture and supply Products or Packaged Tablets, (as provided in
Section 13.2A below) for the Term of this Agreement, a limited royalty-free,
nontransferable right and license under the Product Intellectual Property, such
license to be nonexclusive in the Territory to Manufacture, Package and supply the
Products and/or Packaged Tablets to and for the Company without limitation to
the purchase obligations of the Company and its Affiliates under Section 2.1
hereof.

 

12.2 Inventions. Each Party shall own
all right, title to and interest in any inventions, discoveries or innovations,
whether patentable or not, that such Party or its employees or agents may make
in performing such Party’s obligations hereunder (the “IP”).

 

19

 

ARTICLE XIII

MISCELLANEOUS

 

13.1 LIMITATION ON LIABILITY.

 

NOTWITHSTANDING ANYTHING TO THE CONTRARY
HEREIN, NONE OF THE MANUFACTURER, THE COMPANY OR THEIR RESPECTIVE AFFILIATES
SHALL BE LIABLE TO THE OTHER FOR PUNITIVE OR EXEMPLARY DAMAGES WHETHER IN
CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING
OUT OF OR RELATING TO THIS AGREEMENT. IN ADDITION, NONE OF THE MANUFACTURER,
THE COMPANY OR THEIR RESPECTIVE AFFILIATES SHALL BE LIABLE TO THE OTHER FOR
SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER IN CONTRACT,
WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF OR
RELATING TO THIS AGREEMENT; PROVIDED, HOWEVER, IN THE EVENT OF
FRAUD OR INTENTIONAL MALFEASANCE (WHICH SHALL NOT BE DEEMED TO INCLUDE BREACH
OF CONTRACT CLAIMS) THE INJURED PARTY SHALL BE ENTITLED TO COLLECT SPECIAL,
INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES IF AWARDED BY A COURT OF
COMPETENT JURISDICTION, BUT UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE LIABLE
TO THE OTHER FOR PUNITIVE OR EXEMPLARY DAMAGES. THE FOREGOING EXCLUSIONS ARE
NOT INTENDED TO, NOR SHALL, EXCLUDE ACTUAL OR COMPENSATORY DAMAGES. COMMENCING
AS OF THE EFFECTIVE DATE AND CONTINUING UNTIL THE FIRST ADJUSTMENT DESCRIBED IN
SECTION 13.2 HEREIN, MANUFACTURER’S LIABILITY TO THE COMPANY FOR THE REPLACEMENT
COST OF API PURSUANT TO THIS AGREEMENT, SHALL BE LIMITED TO $200,000 PER BATCH.
EXCEPT IN THE CASE OF FRAUD OR INTENTIONAL MALFEASANCE WHICH SHALL NOT BE
SUBJECT TO ANY LIMITATION OF LIABILITY EXCEPT AS EXPRESSLY PROVIDED ABOVE IN
THIS SECTION 13.1, MANUFACTURER’S AGGREGATE LIABILITY FOR ALL OTHER CLAIMS
HEREUNDER SHALL NOT EXCEED $5,000,000, EXCLUSIVE OF ANY LIABILITY FOR THE
REPLACEMENT COST OF API PURSUANT TO THE SENTENCE IMMEDIATELY PRECEDING.

 

13.2 Adjustment of Liability Limit. On
January 1 of each Contract Year after the first Contract Year, Company shall
have the option on written notice to Manufacturer to adjust the limit of
liability for API that Manufacturer assumes hereunder for such Contract Year,
it being the express understanding of the parties that the price that the
Company pays per batch for Product shall be increased or decreased, as the case
may be, such that the cost of Products per batch is equal to $[***](plus any
adjustments made pursuant to section 6.2 hereof), plus [***]([***]%) percent of
the adjusted per event liability limit.

 

13.3. Assignment. Neither party shall
assign or otherwise transfer this Agreement or any interest herein or any right
hereunder without the prior written consent of the

 

[***]:  Certain information on this page has been
omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.

 

20

 

other party
which consent shall not be unreasonably withheld, delayed or conditioned and
any such purported assignment, transfer, or attempt to assign or transfer any
interest or right hereunder without the prior written consent of the other
party shall be null, void and of no effect provided however that either party
may assign and delegate its rights and duties hereunder without obtaining such
consent (a) to any Affiliate of such party or (b) to any person or entity that
acquires substantially all of the business or assets of such party to which
this Agreement relates. For purposes of this Section 13.2, none of the
following shall constitute an assignment by Company: (a) conversion of Company
from a limited liability company to a corporation (whether such conversion is
effected by statutory conversion provisions, merger or otherwise), or (b) the
issuance of debt or equity securities by Company in connection with any
financing transaction.

 

13.4. Subcontractors. Manufacturer
shall not engage any third party to perform any of the Manufacturing,
Packaging, or other services required in the Manufacture or Packaging of the
Products or Packaged Tablets without the prior written consent of the Company,
which consent will not be unreasonably withheld, delayed or conditioned. Such
consent is not required if the third party contractor (i) is listed in the
Product’s approved NDA on file with the FDA, or (ii) performs any of the
services required in the manufacture of the Products, as of the Commencement
Date. In any instance where Manufacturer utilizes a third party to perform any
of the services hereunder, Manufacturer shall continue to be primarily liable
to Company hereunder.

 

13.5. Severability. If any provision
of this Agreement is held to be illegal, invalid or unenforceable by any Law or
public policy, the remaining provisions of this Agreement shall nevertheless
remain in full force and effect and shall not be affected by the illegal,
invalid or unenforceable provision or by its severance herefrom so long as the
economic or legal substance of the transactions contemplated hereby is not
affected in any manner materially adverse to any party. Upon such determination
that any term or other provision is invalid, illegal or unenforceable, the
parties shall negotiate in good faith to modify this Agreement so as to effect
the original intent of the parties as closely as possible in an acceptable
manner in order that the transactions contemplated hereby are consummated as
originally contemplated to the greatest extent possible.

 

13.6. Notices. All notices or other
communications which are required or permitted hereunder shall be in writing
and delivered personally, sent by telecopier (and promptly confirmed by
personal delivery, registered or certified mail or overnight courier), sent by
nationally-recognized overnight courier or sent by registered or certified
mail, postage prepaid, addressed as follows:

 

If to the Manufacturer, to:

 

Novartis Consumer Health, Inc.

200 Kimaball Drive

Parsippany, New Jersey 07054

Attention: Vice President of Supply and Logistics

 

21

 

with a copy (which shall not constitute notice) to:

 

General Counsel (same address)

 

If to the Company, to:

 

Reliant Pharmaceuticals, LLC

110 Allen Road

Liberty Corner, New Jersey 07938

Attn: President

 

with a copy (which shall not constitute notice) to:

 

General Counsel (same address)

 

or to such other address as the Party to whom notice is to be given may
have furnished to the other Party in writing in accordance herewith. Any such
communication shall be deemed to have been given when delivered. It is
understood and agreed that this Section 13.4 is not intended to govern the
ordinary course of business communications necessary between the Parties in
performing their duties, in due course, under the terms of this Agreement,
including the placement of orders and the delivery of forecasts.

 

13.7. Applicable Law. This Agreement
shall be governed by and construed in accordance with the Laws of the State of
New York, without giving effect to principles of conflict of Laws thereof.

 

13.8. Entire Agreement. This Agreement
and the attached Schedules and Exhibits, which are incorporated herein,
constitute the entire agreement between the Parties with respect to the subject
matter hereof and all prior agreements with respect hereto are superseded. Each
Party confirms that it is not relying on any representations, warranties,
covenants or understandings of any kind, nature or description whatsoever of
the other Party, except such as are as specifically set forth herein, except
that nothing herein shall be construed as intended to relieve or release the
Company from its obligation to make payment of monies or satisfy any other
obligations which the Company may owe to the Manufacturer. No amendment or
modifications hereof shall be binding upon the Parties unless set forth in a
writing specified to be an explicit amendment to this Agreement duly executed
by authorized representatives of both Parties. The parties recognize that,
during the Term of this Agreement, a purchase order, acknowledgement form or
similar routine document (collectively “Forms”) may be used to implement or
administer provisions of this Agreement. Therefore, the parties agree that the
terms of this Agreement shall prevail in the event of any conflict between this
Agreement and the printed provision of such Forms, or typed provisions of Forms
that add to, vary, modify or are at conflict with the provisions of this
Agreement with respect to the Products sold during the Term of this Agreement.

 

13.9 Headings. The headings used in
this Agreement are intended for convenience only and shall not be considered
part of the written understanding between the Parties and shall not affect the
construction of this Agreement.

 

13.10. Independent Contractors. The
relationship between the Manufacturer and the Company is solely that of buyer
and seller. It is expressly agreed that the Manufacturer, on

 

22

 

the one hand,
and the Company, on the other hand, shall be independent contractors and that
neither the relationship between the Parties nor this Agreement shall be
construed as creating a partnership, joint venture or agency. Neither the
Manufacturer, on the one hand, nor the Company, on the other hand, shall have
the authority to make any statements, representations or commitments of any
kind, or to take any action or to incur any liability or obligation which shall
be binding on the other, without the prior consent of the other Party to do so.
All persons employed by a Party shall be employees of such Party and not of the
other Party and all costs and obligations incurred by reason of any such
employment shall be for the account and expense of such Party.

 

13.11 Waiver. The waiver by either
Party of any right hereunder or the failure to perform or of a breach by the
other Party shall not be deemed a waiver of any other right hereunder or of any
other breach or failure by said other Party whether of a similar nature or
otherwise.

 

13.12 Counterparts. This Agreement may
be executed in two or more counterparts, each of which shall be deemed an
original, but all of which together shall constitute one and the same
instrument.

 

13.13. No Benefit to Third Parties. The
representations, warranties, covenants and agreements set forth in this
Agreement are for the sole benefit of the Parties and their successors and
permitted assigns, and nothing herein, express or implied, is intended to or
shall confer upon any person or entity any legal or equitable rights, benefits
or remedies.

 

13.14. New Supplier of API. The
Manufacturer shall use commercially reasonable efforts to assist the Company,
during the Term to (i) locate and qualify a new supplier of API that meets cGMP
Requirements, the API Specifications and applicable Law (“Compliant API”) for
the Products and (ii) provide such documents and take such other actions as are
necessary to allow the Company to list and obtain FDA approval for the new
supplier as an alternate supplier of API in the NDA. The Company shall have the
responsibility of locating and qualifying a new supplier of Compliant API for
use in manufacturing the Products, provided that whether or not the Company is
successful in doing so during the Term shall not be a basis for force majeure
to apply for the benefit of the Manufacturer during the Term, or excuse or
delay Manufacturer’s obligations to deliver Products pursuant to this Agreement.

 

[SIGNATURE PAGE FOLLOWS]

 

23

 

IN WITNESS WHEREOF, the Parties have caused
this Agreement to be executed by their duly authorized representatives as of
the date first above written.

 

	
  Reliant Pharmaceuticals, LLC

  	
  Novartis Consumer Health, Inc.

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  	
  Name:

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  	
  Title:

  	
   

  	
   

  
										

 

 

SCHEDULE 6.1

 

Manufacturing
Fees

 

	
  Item

  	
   

  	
  Cost Per
  Granulation

  
	
  Drug Granulation

  	
   

  	
  [***]

  
	
  Osmotic Granulation

  	
   

  	
  [***]

  

 

Packaging
Fees

Tablets Made From NCH Granulations

 

	
  Item No.

  	
   

  	
  Item Description

  	
   

  	
  Cost Per Unit

  
	
  923501 & 923601

  	
   

  	
  DynaCirc CR 5mg 7’s & DynaCirc CR 10mg 7’s

  	
   

  	
  $

  	
  [***]

  
	
  23515 & 23615

  	
   

  	
  DynaCirc CR 5 mg 30’s & DynaCirc CR 10 mg 30’s

  	
   

  	
  $

  	
  [***]

  
	
  23505 & 23605

  	
   

  	
  DynaCirc CR 5 mg 100’s & DynaCirc CR 10mg 100’s

  	
   

  	
  $

  	
  [***]

  

 

Tablets Made From Granulations Other Than NCH

 

	
  Item No.

  	
   

  	
  Item Description

  	
   

  	
  Cost Per Unit

  
	
  923501 & 923601

  	
   

  	
  DynaCirc CR 5m&7’s & DynaCirc CR 10mg 7’s

  	
   

  	
  $

  	
  [***]

  
	
  23515 & 23615

  	
   

  	
  DynaCirc CR 5 mg 30’s & DynaCirc CR 10 mg 30’s

  	
   

  	
  $

  	
  [***]

  
	
  23505 & 23605

  	
   

  	
  DynaCirc CR 5 mg 100’s & DynaCirc CR 10mg 100’s

  	
   

  	
  $

  	
  [***]

  

 

The prices for the supply of each Product (the “Manufacturing Fee”) and
Packaged Tablets (the “Packaging Fee”) shall be equal to the prices set forth
in Schedule 6.1 of the supply agreement; provided however,
the price for the Products and Packaged Tablets set forth in Schedule 6.1 shall
be modified at the commencement of each Contract Year after the initial
Contract Year as set forth in Section 6.2, Fee Adjustment, of the supply
agreement.

 

[***]:  Certain information on
this page has been omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.EXHIBIT 10.36(a)

 

February 23,
2006

 

Novartis
Consumer Heath, Inc.

200 Kimball
Drive

Parsippany, NJ
07054

Attn: Mr. Ivan
Marti

 

Dear Ivan:

 

This letter will confirm the agreement
between Novartis Consumer Health, Inc. (“Manufacturer”) and Reliant Pharmaceuticals,
Inc. (“Company’s concerning certain outstanding amounts for which payment is
due from Company to Manufacturer and such other matters as set forth herein. Capitalized
teams used but not otherwise defined have the meanings ascribed to them in the
Packaging and Supply Agreement between the parties dated March, 2004 (the “Agreement”).

 

The parties agree as follows:

 

1.                                       For
purchase orders accepted by Manufacturer and Product delivered to Company prior
to August 11, 2005, the Manufacturing Fee for each Drug Granulation containing
API manufactured by Novartis AG or its affiliates shall be $[***], consisting
of (a) a $[***] granulation service fee and (b) a Liability Fee of $[***] per
batch, which Liability Fee is in consideration of Manufacturer’s agreement
(except in cases of Manufacturer’s fraud or intentional malfeasance) to
contribute up to a limit of $200,000 per batch for replacement of lost or
damaged API in accordance with the Agreement. The Manufacturing Fee for all
Product delivered to Company on August 11, 2005 or thereafter containing API
manufactured by Novartis AG, if any, shall be $[***] ($0 Liability Fee). The
parties further agree that the Manufacturing Fee per batch for each Drug
Granulation containing API manufactured by Shasun and each Osmotic Granulation
delivered to Company at any time shall be $[***] ($0 Liability Fee). Manufacturer
shall have no liability (except in the cases of Manufacturer’s fraud or
intentional malfeasance) with respect to losses or damage to API with respect
to batches for which there is $0 Liability Fee in accordance with the Agreement.
As of February 10, 2006, the aggregate outstanding balance owed by Company to
Manufacturer is $[***]. Such amount reflects (i) $[***] in outstanding
Manufacturing Fees, (ii) $[***] in outstanding packaging fees and (iii) $[***]
in outstanding development fees. Attached as Exhibit A is a spreadsheet which
provides a detailed accounting

 

[***]: Certain information on this page has
been omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.

 

 

supporting the
above amounts. Payment in the amount of $[***], shall be made within ten (10)
days of the date of this letter.

 

2.                                       Notice
is hereby given to Manufacturer that pursuant to Section 13.2 of the Agreement
effective as of August 11, 2005, the Liability Fee set forth on Schedule 6.1 to
the Agreement for each Drug Granulation without regard to whether such Drug
Granulation contains Novartis manufactured API or Shasun manufactured API shall
be $0 and that the cost per batch of each Drug Granulation shall be $[***] for
Product delivered on or after August 11, 2005. For the avoidance of doubt,
except in the case of Manufacturer’s fraud or intentional malfeasance, Manufacturer
shall have no liability for any losses or damage to API in connection with (i)
any Product delivered on or after August 11, 2005 or (ii) Product containing
Shasun API delivered at any time.

 

3.                                       In
consideration of the agreements set forth herein, including without limitation
Manufacturer’s consent to accelerate the time in which the Company may reduce
the Liability Fee under the Agreement, and such other good and valuable
consideration, the receipt and legal sufficiency of which is hereby acknowledged,
Company waives and releases Manufacturer as of the date of this letter (i) from
any claims that any Product previously delivered to Company are non-conforming
pursuant to the Agreement, except to the extent of any latent defects in the
Product not detectable as of the date of this letter, (ii) from any claims
alleging untimely delivery or invoicing by Manufacturer for Product previously
delivered. and (iii) from any claims alleging breach by Manufacturer of any of
the terms of the Agreement between the parties as of the date of this letter,
except to the extent that such causes of action could not have been discovered
as of the date of this letter upon the exercise of reasonable diligence. Company
represents that as of the date of this letter, it is unaware of any claims of
untimely delivery or invoicing of any Product for which PQ’s are currently
outstanding. Except for amounts referenced herein or in Exhibit A hereto,
Manufacturer represents and warrants that as of the date of this letter after
reasonable diligence it is unaware of any claims of non-payment of any invoices
for product previously delivered and of any claims against Company of breach or
default under the Agreement.

 

If this letter accurately sets forth our
agreement, please have a copy of this letter executed by an authorized
representative of Manufacturer and return it to me. Thank you for your
continued courtesy and cooperation in this matter.

 

	
   

  	
  Very truly yours,

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  Michael J. Lerner

  
	
   

  	
  Vice President, Legal Affairs

  

 

[***]: Certain information on this page has
been omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.

 

2

 

Agreed and
accepted this 3rd day of February           ,
2006

 

 

	
   

  	
   

  
	
  By:

  	
  Ivan Marti

  
	
  Title:

  	
  V.P., Supply
  Chain

  
	
   

  	
   

  
	
  cc:

  	
  Andrew
  Haskell, Associate General Counsel

  
			

 

3

 

Dynacirc
Granulation Reconciliation

(9/16/05)

 

	
  Item

  Number

  	
   

  	
  Description

  	
   

  	
  Batch #

  	
   

  	
  Qty

  (kg)

  	
   

  	
  Sales Order #

  (Assignment)

  	
   

  	
  Invoice #

  	
   

  	
  Value

  	
   

  	
  Reliant

  PQ

  	
   

  	
  Billing

  Date

  	
   

  
	
  100000317

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000317

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000317

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000317

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000316

  	
  Dynacirc Osmotic Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000315

  	
  Dynacirc Osmotic Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82610

  	
  Dynacirc Shasun Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82600

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82600

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82600

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000318

  	
  Dynacirc Shasun Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000316

  	
  Dynacirc Osmotic Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000316

  	
  Dynacirc Osmotic Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000316

  	
  Dynacirc Osmotic Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82610

  	
  Dynacirc Shasun Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82600

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000317

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82500

  	
  Dynacirc Osmotic Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82500

  	
  Dynacirc Osmotic Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82500

  	
  Dynacirc Osmotic Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82500

  	
  Dynacirc Osmotic Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000318

  	
  Dynacirc Osmotic Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000317

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000317

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000317

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000318

  	
  Dynacirc Shasun Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000318

  	
  Dynacirc Shasun Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000318

  	
  Dynacirc Shasun Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000316

  	
  Dynacirc Osmotic Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000316

  	
  Dynacirc Osmotic Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000318

  	
  Dynacirc Shasun Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000318

  	
  Dynacirc Shasun Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  100000318

  	
  Dynacirc Shasun Drug Granulation

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82600

  	
  Dynacirc ESL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82600

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82500

  	
  Dynacirc Osmotic Granulation

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82600

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82600

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  

 

[***]: Certain information on this page has
been omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.

 

 

	
  82500

  	
  Dynacirc Osmotic Granulation

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82610

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  $

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  82600

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  82600

  	
  Dynacirc BSL Drug Granulation

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  82500

  	
  Dynacirc Osmotic Granulation

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

 

	
   

  	
   

  	
  Invoice
  price is wrong in SAP. The price should be $[***] per drug granulation and $[***] per osmotic granulation.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Potentially
  double invoice. Original invoice from Pharma (Invoice #13650) for $[***]. Not able to confirm payment. 

  
	
   

  	
   

  	
  Manual
  Invoice (not in SAP).

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Manual
  invoice (not in SAP).

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Manual
  Invoice (not in SAP). Original Invoice sent for $[***]. Follow up invoice credit for $[***]. This was a demo batch.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Granulation
  delivered but never invoiced.

  

 

[***]: Certain information on this page has
been omitted and filed separately with the Commission.  Confidential treatment has been requested
with respect to the omitted portions.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00128-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00128-of-00352.parquet"}]]