Exhibit 10.5

Note: Redacted portions have been marked with (***). The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

EXECUTION COPY

MANUFACTURING AGREEMENT

BETWEEN

NEW ABRAXIS, INC.

(TO BE RENAMED ABRAXIS BIOSCIENCE, INC.)

AND

APP PHARMACEUTICALS, LLC

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Note: Redacted portions have been marked with (***). The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

MANUFACTURING AGREEMENT

THIS MANUFACTURING AGREEMENT (this “Agreement”) is made by and between New
Abraxis, Inc., to be renamed Abraxis BioScience, Inc., a Delaware corporation
(“NEW ALPHA”), and APP Pharmaceuticals, LLC, a Delaware limited liability
company (“GENERICO”), as of this 13 day of November, 2007 (the “Effective
Date”).

RECITALS

A. NEW ALPHA or one or more its subsidiaries has developed and owns the rights
to the Product and the Pipeline Products (both as defined below).

B. GENERICO has the capabilities, facilities and equipment designed for and
capable of performing the Generico Manufacturing (as defined below) with respect
to the Product and the Pipeline Products, and GENERICO desires to perform such
Generico Manufacturing upon the terms and conditions contained herein.

AGREEMENT

NOW, THEREFORE, in consideration of the above Recitals, the mutual covenants and
agreements contained herein, and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties hereto
hereby agree as follows:

1. Definitions. For purposes of this Agreement, in addition to other defined
terms set forth in this Agreement, the terms set forth below will have the
following meanings:

1.1 “Action” means any actual or threatened claim, suit, demand, arbitration,
hearing, inquiry, proceeding, complaint, charge or investigation by or before
any court, Regulatory Authority or arbitrator.

1.2 “Affiliate” means, with respect to any Person, any entity controlling,
controlled by or under the common control of such Person. Such entity will be
considered an Affiliate only for the time during which such control exists. For
the purpose of this Agreement, “control” (together with its correlative meanings
“controlled by” or “under common control with”) means having, directly or
indirectly, the power to direct or cause the direction of management and
policies of such entity. For purposes of this Agreement, none of Gholdco or any
of its subsidiaries, including GENERICO, shall be considered an affiliate of NEW
ALPHA or any of its subsidiaries, and none of NEW ALPHA or any of its
subsidiaries shall be considered an affiliate of Gholdco or any of its
subsidiaries, including GENERICO.

1.3 “Alternative Compensation Amount” has the meaning set forth in
Section 2.8(B).

1.4 “Annual Forecasts” means, for 2008, the annual forecasts of the aggregate
units of Product and Pipeline Products to be supplied by GENERICO from each
Facility that are attached as Part A of Schedule 1.4 hereto, and for subsequent
years, the annual forecasts of the aggregate units of Product and Pipeline
Products from each Facility provided by NEW ALPHA to GENERICO at

 

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least thirty (30) days prior to January 1 of that year; provided, however, that
the forecasts provided by NEW ALPHA with respect to each year subsequent to 2008
shall not, without the approval of GENERICO (which approval shall not be
unreasonably be withheld or delayed), provide for the supply of Product and
Pipeline Products from any Facility that is more than (***) of the aggregate
units to be supplied from that Facility reflected in the estimates for 2009,
2010, 2011 and 2012 as set forth in Part B of Schedule 1.4. The 2009, 2010, 2011
and 2012 estimates shall not become “Annual Forecasts” for purposes hereof until
provided by NEW ALPHA under the terms of this Agreement.

1.5 “Breach” has the meaning set forth in Section 10.2.

1.6 “cGMP(s)” means current good manufacturing practices established under the
FDCA and the regulations promulgated thereunder; and other comparable laws and
regulations of any competent Regulatory Authorities applicable to manufacturing
activities or the Facility for the Product and Pipeline Products, all as amended
from time to time.

1.7 “Chemical Ingredients” means, with respect to the Product or any Pipeline
Product, the active pharmaceutical ingredient(s) and human albumin in the
Product or Pipeline Product, as applicable.

1.8 “Chemical Solution” means end product obtained after New Alpha Manufacturing
(other than the New Alpha Review and Release) is complete with respect to the
Product or any Pipeline Product.

1.9 “Chemical Testing” means in-process testing of the chemical properties of
the Product or any Pipeline Product during the process of manufacturing Product
or any Pipeline Product.

1.10 “Claim Notice” has the meaning set forth in Section 12.3.

1.11 “Competitor” means (***).

1.12 “Components” means all containers, closures, packaging components, labels
and labeling necessary for the manufacture of the Product or any Pipeline
Product as finished goods.

1.13 “Damages” means any and all losses, liabilities, obligations, costs,
expenses, damages or judgments of any kind or nature whatsoever (including
reasonable attorneys’, accountants’ and experts’ fees, disbursements of counsel
and other costs and expenses).

1.14 “EMEA” means the European Medicines Evaluation Agency or any successor
agency.

1.15 “Effective Date” means the date written in the preamble of this Agreement,
as set forth above.

1.16 “Estimated Generico Manufacturing Plan” means NEW ALPHA’s estimate of the
units of the Product with respect to which NEW ALPHA will place Purchase Orders
during each month of each rolling 12-month period during the Term, which
estimate will be delivered by NEW ALPHA to GENERICO on a monthly basis;
provided, however, that in no event will a given monthly

 

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estimate vary by more than (***) from the monthly estimate issued in respect of
the immediately preceding month. The Estimated Generico Manufacturing Plan shall
include, with respect to the Product, NEW ALPHA’s estimated requirements for
commercial sale, clinical supply, validation, stability or other uses thereof,
and for Generico Manufacturing at each Facility, during each month of the
applicable rolling 12-month basis.

1.17 “Facility” means (i) the Melrose Park Facility and (ii) the Grand Island
Facility.

1.18 “FDA” means the United States Food and Drug Administration or any other
successor agency of the United States Federal Government.

1.19 “FDA Modernization Plan” has the meaning set forth in Section 14.1(A).

1.20 “FDCA” means the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
Section 301 et. seq.), as amended from time to time.

1.21 “Force Majeure” has the meaning set forth in Section 15.4(A).

1.22 “GENERICO Indemnified Parties” has the meaning set forth in Section 12.2.

1.23 “Generico Manufacture,” “Generico Manufactured” and “Generico
Manufacturing” means the acquisition, sampling, testing and release of
Components, the acquisition and sampling of Materials and testing of Materials
supplied by GENERICO such as water for injection (“WFI”) and nitrogen, the
sampling of Chemical Ingredients and the manufacturing, lyophilization,
packaging, labeling, filling, holding, Microbiologic Testing of the Product and
Pipeline Products as more fully set forth on Exhibit A. For the avoidance of
doubt, Generico Manufacturing does not include New Alpha Manufacturing.

1.24 “Generico Products” means all of the existing products being manufactured
by GENERICO from time to time, including any variations of such products in
formulation, dosage, delivery system, or the like (but, for the avoidance of
doubt, in no event will the Generico Products include any product incorporating
“nab” technology).

1.25 “Gholdco” means Abraxis BioScience, Inc. (formerly known as Generico
Holdings, Inc. and to be renamed APP Pharmaceuticals, Inc.), a Delaware
corporation and the parent company of GENERICO.

1.26 “Grand Island Facility” means GENERICO’s manufacturing facility(s) whether
owned or leased located at 3159 Staley Road, Grand Island, New York.

1.27 “Grand Island Lease” has the meaning set forth in Section 10.1.

1.28 “HPFB” means the Health Products and Food Branch of Health Canada or any
successor agency of the Canadian government.

1.29 “IHI” means the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use or any successor
thereto.

 

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Securities and Exchange Commission.

 

1.30 “Indemnifiable Claim” has the meaning set forth in Section 12.3.

1.31 “Indemnified Party” has the meaning set forth in Section 12.3.

1.32 “Indemnifying Party” has the meaning set forth in Section 12.3.

1.33 “Legal Requirement” means any federal, state or local law, ordinance,
regulation, permit, order, writ, judgment, injunction, decree or award, or any
rule, regulation or published guidelines or any statement having the effect of
law, promulgated by any Regulatory Authority, including cGMPs.

1.34 “Management Fee” has the meaning set forth in Section 13.

1.35 “Materials” means, with respect to the Product or any Pipeline Product, all
inactive raw materials and excipients, excluding human albumin, used in the
formulation of the Product or any Pipeline Product necessary for their
manufacture as finished goods.

1.36 “Melrose Park EU Plan” has the meaning set forth in Section 14.2(A).

1.37 “Melrose Park Facility” means GENERICO’s manufacturing facility(s) whether
owned or leased located at 2020 Ruby Street, Melrose Park, Illinois.

1.38 “Melrose Park Lease” has the meaning set forth in Section 10.1.

1.39 “MHLW” means Japan’s ministry of Health, Labor and Welfare (also known as
“Korosho”) or any successor agency of the government of Japan.

1.40 “MOHFW” means India’s ministry of Health & Family Welfare or any successor
agency.

1.41 “Microbiologic Testing” means the microbiologic testing of the Product or
any Pipeline Product, as applicable, at the beginning of Generico Manufacturing
and at the completion of Generico Manufacturing.

1.42 “New Alpha Manufacture,” “New Alpha Manufactured” and “New Alpha
Manufacturing” means the acquisition, testing and release of Chemical
Ingredients, the testing and release of Materials (other than Materials supplied
by GENERICO such as WFI and nitrogen) and subsequent formulating, compounding
and Chemical Testing of the Product or any Pipeline Products as more fully set
forth on Exhibit A, and the New Alpha Review and Release.

1.43 “New Alpha Review and Release” means the supervision and signoff
contemplated by Section 2.9 of this Agreement and the written release of the
Product or any Pipeline Product, as applicable, following the completion of the
Generico Manufacturing with respect thereto.

1.44 “Parties” means GENERICO and NEW ALPHA (“Party” meaning one of the
Parties).

 

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Securities and Exchange Commission.

 

1.45 “Person” means any natural person, corporation, partnership, limited
partnership, limited liability company, proprietorship, other business
organization, trust, union, association or Regulatory Authority.

1.46 “Pipeline Products” means (A) ABI-008, ABI-009, ABI-010 and ABI-011 and
(B) other products as identified by NEW ALPHA that GENERICO is reasonably
capable of performing Generico Manufacturing at one or both of the Facilities,
and (***) and G-CSF (granulocyte-colony stimulating factor). Each of the
Pipeline Products in clauses (A) and (B) shall either (x) involve substantially
the same Generico Manufacturing steps, time and resources as the Product or
(y) shall (i) not require any material addition, upgrade or modification to any
GENERICO Facility (except where such addition, upgrade or modification would not
otherwise have one of the effects described in clauses (ii) and (iii) below, and
NEW ALPHA agrees to reimburse GENERICO in accordance with the last sentence of
this Section 1.46 in respect thereof), (ii) not require any reallocation or
diversion in any material respect of employees, space or other resources of
GENERICO and (iii) not otherwise impair or disrupt in any material respect the
ability of GENERICO to conduct its business or perform its obligations under
this Agreement. NEW ALPHA shall reimburse GENERICO for all incremental costs
reasonably incurred by GENERICO and paid to third parties (with the approval of
NEW ALPHA not to be unreasonably withheld) as a result of GENERICO manufacturing
any Pipeline Products described in clauses (A) and (B).

1.47 “Product” means ABRAXANE®, a cremapahor-free pacilitaxel formulation, and
any modifications thereto made by NEW ALPHA, subject to Section 2.2(G), and
provided that, as modified, the product remains an injectible formulation of
paclitaxel.

1.48 “Product Liability Costs” has the meaning set forth in Section 9.6.

1.49 “Product Liability Claim” means any Action by a third party and any appeal
from any Action asserted by a third party with respect to the Product or any
Pipeline Product alleging product liability, product defect, design,
manufacturing, packaging or labeling defect, failure to warn, or any similar
action relating to the formulation, manufacture, use or safety of the Product or
any Pipeline Product, as applicable.

1.50 “Projected Cycle Time” means, for any year, (i) with respect to NEW ALPHA,
the projected lyophilizer cycle time required by NEW ALPHA for that year based
on the most recent Annual Forecast determined without giving effect to the
permitted (***) increase in the definition of Annual Forecast or the (***)
increase permitted in Section 2.6 (i.e., not more than estimated in Schedule
1.4), and (ii) with respect to GENERICO, the projected lyophilizer cycle time
required by GENERICO for that year based on the production forecasts for that
year attached as part of Schedule 1.4 hereof.

1.51 “Proprietary Information” means all information relating to the Product or
any Pipeline Product, as applicable, concerning the properties, composition or
structure of the Product or any Pipeline Product, as applicable, the New Alpha
Manufacturing of the Product or any Pipeline Product, as applicable, or the
machines used to New Alpha Manufacture the Product or any Pipeline Product, as
applicable, the development, marketing or other commercialization of the Product
or any Pipeline Product, as applicable, (including, without limitation,
reagents, computer programs, algorithms, analytical methodology, suppliers of
ingredients and

 

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Securities and Exchange Commission.

 

equipment, names and expertise of employees and consultants, know-how, formulas,
processes, ideas, inventions, whether patentable or not, schematics and other
technical, business, financial, customer and product development plans,
forecasts, strategies and information relating to the Product and the Pipeline
Products), whether previously, currently or subsequently disclosed to the other
Party. Technology, innovations, improvements and modifications relating to the
Product or any Pipeline Product or made by or for NEW ALPHA or any of its
subsidiaries will be considered Proprietary Information of NEW ALPHA.

1.52 “Proprietary Rights” means any and all patent rights, copyrights, mask
work, trade secret rights and all other intellectual and industrial property
rights.

1.53 “Proration Percentage” means, for any year, with respect to a Party, a
fraction expressed as a percentage, the numerator of which is such Party’s
Projected Cycle Time for such year and the denominator of which is the aggregate
Projected Cycle Time of both Parties for such year.

1.54 “Proration Period” has the meaning set forth in Section 2.7(A).

1.55 “Purchase Order” means written orders for a quantity of the Product or a
number of batches of any Pipeline Product issued by NEW ALPHA and placed with
GENERICO. Each Purchase Order shall separately identify whether the Product or
Pipeline Products subject to such Purchase Order are for commercial sale,
clinical supply, validation, stability or other uses, and shall indicate the
Facility at which the Generico Manufacturing shall occur, if applicable, and the
Territory in which such quantities will be sold or used for clinical testing;
provided, however, that such Purchase Order shall be in accordance with the
applicable Estimated Generico Manufacturing Plan as set forth in Section 2.6.

1.56 “Reasonable Efforts” means a reasonable sustained, continued and active
application of diligent efforts, resources and urgency consistent with the
manner in which such efforts were provided by New Abraxis, LLC (and its
predecessor Abraxis BioScience, Inc.) and their subsidiaries prior to the
Effective Date (but not including any historical preference or priority given to
the Product as compared with GENERICO’s pharmaceutical products), and no less
than the efforts, urgency and resources commonly used by GENERICO in
manufacturing for its own business.

1.57 “Recall” has the meaning set forth in Section 8.1.

1.58 “Regulatory Approval” means (i) with respect to GENERICO, any and all
actions required by a Regulatory Authority for the manufacture of the Product in
the Territory, and (ii) with respect to NEW ALPHA, the filing and procurement of
any registration, permit and approval required by applicable Regulatory
Authorities for the importation, marketing, sale, distribution and use of the
Product in the Territory.

1.59 “Regulatory Authority” means (i) the FDA, (ii) with respect to the Grand
Island Facility, the FDA and the EMEA, and (iii) subject to Section 2.2(C), the
TGA, the MHLW, the MOHFW, the IHI and any other national, multinational,
federal, state, provincial or local regulatory agency, department, bureau or
other governmental entity in the Territory that has regulatory authority over
the Product or any Pipeline Product.

 

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1.60 “Rejected Product” means batches of Product or Pipeline Product which are
either (i) lost in production (or are not in compliance with the applicable
Specifications, cGMPs, the FDCA and any other applicable Legal Requirements) as
a result of the Generico Manufacturing or New Alpha Manufacturing or a failure
or deficiency of the Generico Manufacturing or New Alpha Manufacturing, or
(ii) determined by final decision of NEW ALPHA’s or GENERICO’s quality group not
to be suitable for final release.

1.61 “Specifications” means the description and attributes, Chemical
Ingredients, Components and Materials for the Product or any Pipeline Product,
along with manufacturing procedures for such Product. Specifications exclude NEW
ALPHA Proprietary Information. The Specifications include without limitation:

(A) sampling requirements (including lab and microbiological);

(B) intermediate specifications;

(C) processing aids;

(D) finished Product release criteria;

(E) stability specifications;

(F) Microbiologic Testing methods; and

(G) packaging, labels and labeling.

1.62 “Supply Deficit Period” has the meaning set forth in Section 2.8(A).

1.63 “Technology” means any and all ideas, techniques, inventions, methods,
data, information, formulae, processes, trade secrets, analytical methodology,
intellectual property, know-how, and test results, whether patentable or not,
and whether or not reduced to practice, including Proprietary Rights, owned,
controlled or otherwise in possession of or used by NEW ALPHA as of the
Effective Date, or during the Term and necessary or useful to make, have made,
develop, have developed, use, import, market, offer for sale or sell the Product
or any Pipeline Product.

1.64 “Term” has the meaning set forth in Section 10.1.

1.65 “TGA” means the Therapeutic Goods Administration, Department of Health and
Ageing, Australia.

1.66 “Territory” means (***).

 

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1.67 “Warehouse Services Agreement” means the Warehouse Services Agreement,
dated as of the Effective Date, between New Abraxis, LLC and Generico, as it may
be amended from time to time.

2. Generico Manufacturing and Other Services.

2.1 Subject to the terms, conditions and provisions of this Agreement, GENERICO
hereby covenants and agrees that during the Term it will perform the Generico
Manufacturing with respect to the Product and the Pipeline Products as requested
by NEW ALPHA in accordance with the terms hereof. GENERICO will perform the
Generico Manufacturing with respect to the Product and the Pipeline Products
solely and exclusively for NEW ALPHA and its designees.

2.2 GENERICO will, in good faith, use Reasonable Efforts to:

(A) obtain and maintain such approvals and licenses as may be required by any
Regulatory Authority or Legal Requirement for the manufacturing at the
Facilities of the Product or any Pipeline Product for commercial sale or
clinical development in the United States and its territories and possessions;
without limiting the foregoing, GENERICO shall use Reasonable Efforts to obtain
as promptly as practicable such approvals and licenses as may be required by any
Regulatory Authority or Legal Requirement for the manufacturing of the Product
for commercial sale in the United States on Line 6 of the Grand Island Facility;
provided, however, that nothing in this sub-clause (A) shall be interpreted to
require GENERICO to obtain any Regulatory Approvals for which NEW ALPHA is
responsible pursuant to Section 2.3;

(B) obtain and maintain such approvals and licenses as may be required by any
Regulatory Authority or Legal Requirement for the manufacturing at the Grand
Island Facility of the Product or any Pipeline Product for commercial sale or
clinical development in the territories of the European Union; provided,
however, that nothing in this sub-clause (B) shall be interpreted to require
GENERICO to obtain any Regulatory Approvals for which NEW ALPHA is responsible
pursuant to Section 2.3;

(C) obtain and maintain such approvals and licenses as may be required by any
Regulatory Authority or Legal Requirement for the manufacturing at the Grand
Island Facility or Melrose Park Facility of the Product or any Pipeline Product
for commercial sale or clinical development in other jurisdictions as shall be
reasonably requested by NEW ALPHA; provided, however, that nothing in this
Section 2.2(C) shall require GENERICO to obtain any such approvals or licenses
in any jurisdiction unless both (a) doing so would not require (i) any material
addition, upgrade or modification to any Facility (except where such addition,
upgrade or modification would not otherwise have one of the effects described in
clauses (ii) and (iii) below, and NEW ALPHA agrees to reimburse GENERICO in
accordance with clause (b) below in respect thereof), (ii) would not require any
reallocation or diversion in any material respect of employees, space or other
resources of GENERICO and (iii) would not otherwise impair or disrupt in any
material respect the ability of GENERICO to conduct its business or perform its
obligations under this Agreement, and (b) NEW ALPHA agrees to reimburse GENERICO
for all incremental costs reasonably incurred by GENERICO and paid to third
parties (with the approval of NEW ALPHA not to be unreasonably withheld) as a
result of obtaining any such approvals or licenses; and provided further that
nothing in this sub-clause (C) shall be interpreted to require GENERICO to
obtain any Regulatory Approvals for which NEW ALPHA is responsible pursuant to
Section 2.3;

 

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(D) maintain such facilities, resources and personnel, and such industry
expertise, as may be required for it to manufacture such units or batches of the
Product and any Pipeline Product as may be required hereunder and GENERICO will
inform NEW ALPHA of any planned modifications of GENERICO’s facilities,
equipment and processes, prior to implementation, that could result in the need
for any additional Regulatory Approvals with respect to the Product or any
Pipeline Product (such notice to be in writing and with sufficient time to
obtain any necessary Regulatory Approvals), and GENERICO and NEW ALPHA will
reasonably agree on the manner and timing of such modifications;

(E) perform the Generico Manufacturing in compliance with the terms and
conditions of this Agreement, the Specifications, cGMPs, the FDCA and any and
all other applicable Legal Requirements, and promptly provide NEW ALPHA with
copies of any correspondence, including inspection reports, from Regulatory
Authorities concerning GENERICO’s operation of the Facilities which could have
any bearing in a material respect upon this Agreement together with any
responses thereto;

(F) implement, as soon as reasonably possible, any change or modification to the
manufacture or Specifications of the Product or any Pipeline Product that are
required or recommended by any Regulatory Authority or required by cGMPs or
Legal Requirements; provided, however, that NEW ALPHA shall reimburse GENERICO
for the reasonable out-of-pocket expenses incurred by GENERICO (with the
approval of NEW ALPHA not to be unreasonably withheld) as a result of such
change or modification to the extent that such change would not be necessary but
for the manufacturing of the Product or the Pipeline Products;

(G) implement, as soon as reasonably possible, any change or modification to the
manufacture or Specifications of the Product or any Pipeline Product that are
requested by NEW ALPHA; provided, however, that nothing in this Section 2.2(G)
shall require GENERICO to implement any such change or modification unless both
(a) doing so would not require (i) any material addition, upgrade or
modification to any Facility (except where such addition, upgrade, or
modification would not otherwise have one of the effects described in clauses
(ii) and (iii) below, and NEW ALPHA agrees to reimburse GENERICO in accordance
with clause (b) below in respect thereof), (ii) would not require any
reallocation or diversion in any material respect of employees, space or other
resources of GENERICO and (iii) would not otherwise impair or disrupt in any
material respect the ability of GENERICO to conduct its business or perform its
obligations under this Agreement, and (b) NEW ALPHA agrees to reimburse GENERICO
for all incremental costs reasonably incurred by GENERICO and paid to third
parties (with the consent of NEW ALPHA not to be unreasonably withheld) as a
result of any such change or modification;

(H) keep true, accurate and complete books, records, reports and accounts in
connection with or relative to the Product and each Pipeline Product, and the
Generico Manufacturing of the Product and the Pipeline Products, as well as any
other books and records as may be required from time to time by Legal
Requirements;

 

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(I) maintain batch records sufficient to trace the history of each batch, and
representative samples from each batch of Product and Pipeline Product
manufactured hereunder, for record keeping, stability testing and other
regulatory purposes in accordance with the Specifications and Legal
Requirements;

(J) during the process of Generico Manufacturing, allow NEW ALPHA to undertake
any Chemical Testing and other quality control measures reasonably requested by
NEW ALPHA in order to comply with the Specifications and requirements of any
Regulatory Authority; and

(K) maintain each Facility in good working order and within cGMPs (e.g.,
qualification, calibration, maintenance, validation), including critical systems
(e.g., WFI, HVAC, clean steam, compressed gasses, etc.); and

(L) maintain all manufacturing equipment (other than dedicated nanotechnology
equipment) in good working order and within cGMPs (e.g., qualification,
calibration, maintenance, validation).

2.3 NEW ALPHA or its licensees or designees will be solely responsible for
obtaining and maintaining compliance with any Regulatory Approvals relating to
the importation, marketing, sale, clinical testing, distribution and use of the
Product or any Pipeline Product.

2.4 NEW ALPHA, or any designee of NEW ALPHA, will have the right at any time
upon prior reasonable notice and during regular business hours to inspect and
examine the parts of the Facilities used in connection with and relative to the
Product and the Pipeline Products and the Generico Manufacturing. Any such
inspection or examination shall be scheduled at such time and conducted in such
manner as to minimize disruption to GENERICO’s normal operations.

2.5 NEW ALPHA will have the right, upon prior reasonable notice and during
regular business hours, to audit and inspect any and all documents and records
related to (A) GENERICO’s manufacture and supply of the Product and the Pipeline
Products and (B) GENERICO’s performance under this Agreement, including
GENERICO’s costs or expenses for which it is entitled to reimbursement
hereunder. GENERICO will also permit representatives of any Regulatory
Authority, including, but not limited to, the FDA or its agents, to visit and
inspect any and all facilities used in the Generico Manufacturing of the Product
and the Pipeline Products. This right of NEW ALPHA and the Regulatory
Authorities includes access to audit any and all documents and records relating
to GENERICO’s performance under this Agreement.

2.6 On or promptly after the Effective Date and, thereafter, by the end of the
first week of each month of the Term, NEW ALPHA will send to GENERICO an
Estimated Generico Manufacturing Plan. The Parties acknowledge and agree that
the Estimated Generico Manufacturing Plan is an estimate only and is not binding
upon NEW ALPHA, except that the estimate for the next three

 

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months shall be binding. GENERICO shall supply the quantity of the Product and
Pipeline Products reflected in Purchase Orders provided by NEW ALPHA from a
particular Facility for a given month to the extent that such Purchase Orders
are for no more than (***) of the aggregate number of units of the Product from
such Facility for such month reflected in the Estimated Generico Manufacturing
Plan submitted at least ninety (90) days before the calendar month in which such
Purchase Order is submitted. GENERICO shall not be obligated to supply the
quantity of the Product or any Pipeline Product earlier than seventy five
(75) days following the placement of the Purchase Order for the Product or any
Pipeline Product. For the initial 90 days of this Agreement, GENERICO will
supply the quantity of Product or Pipeline Product in accordance with orders
placed by New Abraxis, LLC (or its predecessor Abraxis Bioscience, Inc.), which
will, in accordance with the next sentence, be consistent with the Annual
Forecast for 2008. GENERICO shall supply quantities of the Product and any
Pipeline Product during any month of the Term in calendar year 2007 or 2008 in
accordance with orders placed by New Abraxis, LLC (or its predecessors Abraxis
Bioscience, Inc.) or Purchase Orders placed by NEW ALPHA as applicable;
provided, that GENERICO shall not be obligated to supply units of Product and
Pipeline Products from any Facility during any such month in excess of (***) of
the aggregate units of Product from such Facility reflected in the Annual
Forecast for 2008. GENERICO shall not be obligated to supply in any year from a
Facility a quantity of units of the Product and Pipeline Products that exceeds
by more than (***) the quantity of the Product indicated for such Facility in
the Annual Forecast for such year. GENERICO shall, subject to Section 2.2 and
this Section 2.6, use Reasonable Efforts to have the Generico Manufacturing with
respect to quantities of the Product and Pipeline Products subject to a Purchase
Order (or order referred to in the prior sentences) performed at the Facility
specified in the applicable Purchase Order (or order referred to in the prior
sentences) and otherwise in compliance with applicable Legal Requirements for
the commercial sale or clinical testing of the Product or Pipeline Products in
the Territory specified in the applicable Purchase Order; provided, however,
that if the Facility specified in the applicable Purchase Order is the only
Facility qualified to manufacture the Product or any Pipeline Product pursuant
to applicable Legal Requirements and the rules of any applicable Regulatory
Authority, then the Generico Manufacturing with respect thereto must be
performed at the Facility specified in the Purchase Order. Until the Estimated
Generico Manufacturing Plan is binding pursuant to this section, NEW ALPHA may
substitute Product for any Pipeline Product (or Pipeline Product for Product)
that is reflected on NEW ALPHA’s Annual Forecast or Estimated Generico
Manufacturing Plan, subject to all of the limitations in this Agreement.

2.7 In the event of any capacity constraints at any Facility or if GENERICO
reasonably anticipates that there will be capacity constraints at any Facility:

(A) GENERICO shall promptly notify NEW ALPHA in writing of any potential or
actual capacity constraints, and GENERICO and NEW ALPHA shall promptly meet to
discuss how to address such capacity constraints (the period during which such
capacity constraints are reasonably anticipated to prevent satisfaction of all
Purchase Orders for which GENERICO would otherwise be required to make delivery
during such period, the “Proration Period”). At such meeting, GENERICO shall
notify NEW ALPHA whether such capacity constraints will prevent GENERICO from
satisfying Purchase Orders expected to be placed by NEW ALPHA pursuant to the
current Estimated Generico Manufacturing Plan.

 

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(B) In connection with manufacturing of the Product for delivery during the
Proration Period, the lyophilizers and filling lines approved for manufacturing
the Product located at the Facilities shall be allocated equitably between the
Parties according to the Proration Percentage.

(C) GENERICO shall not in any event be responsible for any failure to
manufacture Product due to capacity constraints so long as it complies with this
Section 2.7 and uses Reasonable Efforts to eliminate, cure or overcome such
capacity constraints and end the Proration Period as soon as reasonably
practicable.

(D) If at any time the resources available for manufacturing under this
Agreement (other than with respect to lyophilizer and filing line capacity) are
less than the aggregate demand of both Parties, the resources that are available
shall be allocated equitably between the Parties.

2.8 Notwithstanding Section 2.7, if during the Term of this Agreement:

(A) If as a result of capacity constraints and the application of the Proration
Percentage in accordance with Section 2.7, GENERICO is not required, in
accordance with Section 2.7, to deliver sufficient units of the Product to
fulfill the production forecasts set forth in the Estimated Generico
Manufacturing Plan during any Proration Period (such Proration Period, the
“Supply Deficit Period”), NEW ALPHA may, at its sole option, elect to require
GENERICO to manufacture and deliver additional units of the Product in an amount
necessary to fulfill the production forecasts for such Supply Deficit Period.

(B) If NEW ALPHA so elects to have GENERICO manufacture and deliver additional
Product during a Supply Deficit Period pursuant to Section 2.8(A), GENERICO
shall be entitled to receive the following remuneration: After the end of each
90 day period during the Supply Deficit Period and at the end of the Supply
Deficit Period, the Parties shall determine in good faith the amount of net
profits attributable to the sale of Generico Products (determined in accordance
with generally acceptable accepted accounting principles as consistently applied
by GENERICO) that GENERICO would have realized (but did not realize) with
respect to such 90-day or other period during the Supply Deficit Period had NEW
ALPHA not exercised its option under Section 2.8(A), based on net profits
attributable to the Generico Products realized by GENERICO during the most
recent full fiscal quarter ending prior to the Supply Deficit Period, plus any
penalties incurred by GENERICO under GENERICO’s customer contracts as a result
of NEW ALPHA’s exercise of its option under Section 2.8(A) less (***) of the
total amount charged to NEW ALPHA for the additional units of the Product
manufactured during such Supply Deficit Period to fulfill the production
forecasts. Within sixty (60) days after the mutual determination of such amount
(the “Alternative Compensation Amount”), NEW ALPHA shall pay to GENERICO an
amount equal to such Alternative Compensation Amount. GENERICO shall use
commercially reasonable efforts to maximize profits attributable to Generico
Products in any Supply Deficit Period and to minimize the Alternative
Compensation Amount, including, without limitation, by using production capacity
available to GENERICO to manufacture higher margin products and seeking to
purchase Generico Products equal to the amount of any shortfall from third-party
suppliers.

 

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2.9 NEW ALPHA will provide, at its own cost, NEW ALPHA employees and personnel
to supervise and approve in writing, each stage of the manufacturing process
related to the manufacture of the Product and the Pipeline Products.

2.10 In addition to Generico Manufacturing, during the Term, GENERICO will
provide NEW ALPHA the additional services listed on Schedule 2.10 in return by
payment of NEW ALPHA of the amounts set forth on such Schedule 2.10 following
receipt of an invoice from GENERICO. Invoices will be issued by GENERICO
promptly after each month-end during the Term of this Agreement, and payment
shall be made, net 30 days after receipt by NEW ALPHA of an invoice, so long as
the invoice complies with the terms and conditions of this Agreement.

3. New Alpha Manufacturing.

3.1 NEW ALPHA will perform the New Alpha Manufacturing and will procure Chemical
Ingredients and supply to GENERICO the Chemical Solution at an agreed schedule
in amounts and times sufficient in order for GENERICO to meet its obligations
under Section 2.

3.2 NEW ALPHA will for the New Alpha Manufacturing in good faith use Reasonable
Efforts to:

(A) have such resources and personnel, and such industry expertise, as may be
required for it to perform the New Alpha Manufacturing as required hereunder;

(B) perform the New Alpha Manufacturing in compliance with the terms and
conditions of this Agreement, the Specifications, cGMPs, the FDCA and any and
all other applicable Legal Requirements;

(C) keep true, accurate and complete books, records, reports and accounts in
connection with the New Alpha Manufacturing as well as any other books and
records as may be required from time to time by any applicable Legal
Requirement;

(D) maintain all nanotechnology specific equipment in good working order and
within cGMPs (e.g., qualification, calibration, maintenance, validation); and

(E) arrange for pickup and transportation of finished Product and Pipeline
Products; provided, that, during the period in which the Warehouse Services
Agreement is in effect, GENERICO will in good faith use Reasonable Efforts to
arrange for such pickup and transportation.

3.3 Following completion of Generico Manufacturing, NEW ALPHA will perform
Chemical Testing as required by applicable Legal Requirements. Section 6.1 shall
govern release of any Product or Pipeline Product.

3.4 GENERICO, or any designee of GENERICO, will have the right at any time upon
prior reasonable notice and during regular business hours to inspect and examine
NEW ALPHA’s portions of the Facilities used in connection with and relative to
the Product and the Pipeline Products and the New Alpha Manufacturing thereof.
Any such inspection and examination shall be scheduled at such time and
conducted in such manner as to minimize disruption to NEW ALPHA’s normal
operations.

 

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3.5 GENERICO will have the right, upon prior reasonable notice and during
regular business hours, to audit and inspect any and all documents and records
related to NEW ALPHA’s performance under this Agreement, including NEW ALPHA’s
costs and expenses for which it is entitled to reimbursement hereunder. NEW
ALPHA will also permit representatives of any Regulatory Authority, including,
but not limited to, the FDA or its agents, to visit and inspect NEW ALPHA’s
portions of the Facilities used in the New Alpha Manufacturing of the Product
and the Pipeline Products. This right of GENERICO and the Regulatory Authorities
includes access to audit any and all documents and records relating to NEW
ALPHA’s performance under this Agreement. Sections 3.4 and 3.5 shall not be
interpreted to require NEW ALPHA to provide or disclose any documents, records
or other information to the extent constituting Proprietary Information.

3.6 NEW ALPHA shall, at its option (as determined in its sole discretion),
perform New Alpha Manufacturing with respect to GENERICO’s products, pending
products and products under development as requested from time to time by
GENERICO. The scope, timing and cost for any such New Alpha Manufacturing shall
be as agreed between NEW ALPHA and GENERICO (in their sole discretion).

4. Price and Payment.

4.1 With the issuance by NEW ALPHA of a Purchase Order, NEW ALPHA shall
designate whether (and, as applicable, what portion of) the ordered Product
shall be used for commercial sale, clinical supply, validation, stability or
other uses, and each Purchase Order with respect to quantities of the Product
that will be commercially sold, shall indicate the Facility at which the
Generico Manufacturing shall occur and the Territory in which such quantities
will be sold. The price per unit of the Product, and the price per batch of any
Pipeline Product, to be charged by GENERICO with respect to each unit or batched
delivered by GENERICO shall be as set forth in Schedule 4.1. The price of the
Product and any Pipeline Product will not include delivery of the Product or
Pipeline Product to NEW ALPHA or any of its distributors. The risk of loss of
any Product will transfer FOB shipping point (i.e., GENERICO manufacturing
Facility).

4.2 GENERICO will issue an invoice to NEW ALPHA for each Purchase Order, based
upon and reflecting the applicable price. Invoices will be issued upon
(i) written release of the Product or Pipeline Product by NEW ALPHA and
(ii) delivery to NEW ALPHA’s common carrier for delivery. Payment shall be made,
net 30 days after receipt by NEW ALPHA of an invoice, so long as the invoice
complies with the terms and conditions of this Agreement. Notwithstanding the
foregoing, payment with respect to Product or Pipeline Products that are
Rejected Products shall be paid in accordance with Section 6.

 

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5. Regulatory Approval.

5.1 GENERICO will use Reasonable Efforts to cooperate with NEW ALPHA and its
licensees with respect to obtaining all Regulatory Approvals relating to the
Product and the Pipeline Products in any Territory, subject to Section 2.2(C).
Without limiting the foregoing, GENERICO will use Reasonable Efforts to provide
NEW ALPHA with such data monitoring support and data analysis support related to
manufacturing issues as NEW ALPHA may reasonably request. All data and
information relating to such support with respect to the Product or any Pipeline
Product will, if it relates solely to the Product or any Pipeline Product, be
the exclusive property of NEW ALPHA and may be used by NEW ALPHA, at no cost to
NEW ALPHA, in such manner as NEW ALPHA determines.

5.2 GENERICO will use Reasonable Efforts to assist NEW ALPHA in the preparation
and submission of a chemistry, manufacturing and controls (CMC) section and
plant master file or other regulatory documents to any Regulatory Authority as
reasonably requested by NEW ALPHA. Notwithstanding anything to the contrary in
this Section 5.2, all CMC information that relates solely to the Product or any
Pipeline Product will be owned exclusively by, and will be the exclusive
Proprietary Information of, NEW ALPHA and any CMC information not relating
solely to the Product or any Pipeline Product will, to the extent relating to
the Product or any Pipeline Product, be owned by NEW ALPHA and will be
Proprietary Information of NEW ALPHA and may be used by GENERICO, at no cost to
GENERICO, subject to Section 11 hereof, in connection with the requirements of
any Regulatory Authority.

5.3 NEW ALPHA will use Reasonable Efforts to cooperate with GENERICO with
respect to obtaining and maintaining all Regulatory Approvals relating to
manufacturing of the Product and the Pipeline Products for commercial sale or
clinical development in any Territory. Without limiting the foregoing, NEW ALPHA
will use Reasonable Efforts to provide GENERICO with such data monitoring
support and data analysis support related to the Generico Manufacturing of the
Product and the Pipeline Products as GENERICO may reasonably request; provided,
however, that nothing in this Section 5.3 shall be interpreted to require NEW
ALPHA to provide or disclose any documents, records or other information that
constitutes Proprietary Information. All data and information relating to such
support with respect to the Product and any Pipeline Product will, to the extent
it relates to the Product or any Pipeline Product, be the property of NEW ALPHA,
and will be the Proprietary Information of NEW ALPHA, and any CMC information
not relating solely to the Product or any Pipeline Product will, to the extent
relating to the Product or any Pipeline Product, be owned by NEW ALPHA, and will
be Proprietary Information of NEW ALPHA, and may be used by GENERICO, at no cost
to GENERICO, subject to Section 11 hereof, in connection with the requirements
of any Regulatory Authority.

6. Rejected Product.

6.1 NEW ALPHA will inspect pursuant to New Alpha Review and Release, and
GENERICO will inspect pursuant to Generico Manufacturing, each batch of Product
and Pipeline Product for compliance with the Specifications, cGMPs, the FDCA and
any and all other applicable Legal Requirements. If after inspection of Product
or Pipeline Product NEW ALPHA notifies GENERICO, or GENERICO notifies NEW ALPHA,
that any Product or Pipeline Product is non-compliant, as determined by such
Party’s testing and inspection of the Product or Pipeline Product, the Parties
will in good faith attempt to mutually determine whether the failure of the
Product or Pipeline Product, as applicable, to comply is a result of Generico
Manufacturing or New Alpha Manufacturing and the provisions of Section 6.2 will
apply; provided, however, that the provisions of Section 6.2 will not apply (and
thus GENERICO will

 

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have no responsibility or liability relating to any non-compliance) with respect
to any Pipeline Products in clause (A) or (B) of such definition unless, in any
quarter beginning with the first quarter ending after the Effective Date, (***)
of such Pipeline Products are non-compliant; provided further, that Pipeline
Products shall only be determined non-compliant if GENERICO fails to perform
Generico Manufacturing according to the Specifications for such Pipeline Product
provided by NEW ALPHA.

6.2 If the Parties are unable to mutually determine whether the failure of the
Product or Pipeline Products to comply is a result of Generico Manufacturing or
New Alpha Manufacturing within 60 days of the delivery of a rejection notice by
either Party, such dispute will be resolved by an independent, FDA-approved
testing organization or consultant of recognized repute within the U.S.
pharmaceutical industry, to be mutually designated by the Parties, the
designation of which will not be unreasonably withheld or delayed by either
Party. To the extent the Parties are unable to agree on a testing organization
or consultant, each Party will designate one such entity and those two entities
will agree on a mutually acceptable testing entity. The testing entity of the
Product shall determine the source of the non-compliance (i.e., Generico
Manufacturing or New Alpha Manufacturing). Both Parties will provide the testing
entity with such information as the testing entity reasonably requires in order
to make such determination; provided, however, that either Party may, to the
extent it deems necessary, withhold from the independent third party testing
entity any Proprietary Information. Any determination by the independent third
party testing entity will be final and binding upon the Parties. If the
independent third party testing entity states that it is unable to make a
determination as a result of NEW ALPHA’s or GENERICO’s, as applicable, decision
to not disclose Proprietary Information, the non-compliance of the applicable
Rejected Product will be deemed to have resulted from (A) New Alpha
Manufacturing in the event NEW ALPHA is the non-disclosing Party or (B) Generico
Manufacturing in the event GENERICO is the non-disclosing Party. If the
independent third party testing entity’s determination is inconclusive, then the
non-compliance of such Rejected Product will be deemed to have resulted 50% from
New Alpha Manufacturing and 50% from Generico Manufacturing. NEW ALPHA shall
have the final determination over the disposition of any Product or Pipeline
Product; provided, that no Product or Pipeline Product shall be released if
either Party has determined that such Product or Pipeline Product is
non-compliant. The Parties agree to handle the costs associated with Rejected
Product manufactured for NEW ALPHA as follows:

(A) To the extent that a Rejected Product is determined to be such as a result
of the Generico Manufacturing or a failure or deficiency of the Generico
Manufacturing, then GENERICO will replace the Rejected Product as promptly as
practicable (if requested by NEW ALPHA) and, subject to clause (B) below, no
payment shall be required to be made by NEW ALPHA in respect of such Rejected
Product and any payment that may have been made shall, at NEW ALPHA’s election,
be refunded by GENERICO within 30 days of such determination or credited to any
amounts then owing by NEW ALPHA to GENERICO hereunder; provided, however, that
GENERICO will not be obligated to replace and will not have any liability to NEW
ALPHA in respect of the Rejected Product, unless the batches of the Rejected
Product resulting from the Generico Manufacturing are more than (***) of the
total batches of Product (or (***) of the total batches for Pipeline Products)
manufactured for NEW ALPHA in any calendar year during the Term. To the extent
the batches of Rejected Product exceed such (***) or (***), as applicable,
GENERICO shall reimburse NEW ALPHA for the Chemical Ingredients and Materials
used in the New Alpha Manufacturing of such excess Rejected Product.

 

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(B) To the extent that Rejected Product is determined to be such as a result of
the New Alpha Manufacturing or a failure or deficiency of the New Alpha
Manufacturing, then GENERICO shall invoice NEW ALPHA for the Product or Pipeline
Product within 30 days of such determination. Payment shall be made, net 30 days
after receipt by NEW ALPHA of an invoice, so long as the invoice complies with
the terms and conditions of this Agreement.

(C) In the event that the reason for the Rejected Product in part results from
the Generico Manufacturing or a failure or deficiency of the Generico
Manufacturing and in part from the New Alpha Manufacturing or a failure or
deficiency of the New Alpha Manufacturing, then the costs of the Product or
Pipeline Products, as applicable, shall be allocated in an equitable manner
between the Parties.

7. Adverse Experience Reporting. Each Party will promptly report to the other
Party any information of which it becomes aware concerning any adverse drug
experience in connection with the use of the Product, including the incidence
and the severity thereof. Each Party shall be responsible for reporting adverse
experiences in accordance with applicable Legal Requirements; provided, however,
that NEW ALPHA will bear all reasonable expenses incurred by GENERICO and NEW
ALPHA in connection therewith. NEW ALPHA will provide to GENERICO copies of any
reports submitted to the FDA and/or Regulatory Authority relating to any adverse
drug experiences that are reasonably significant. GENERICO shall be responsible
for receiving and documenting any complaint regarding the Product, as well as
forwarding the complaint information to the applicable Facility quality unit and
responding to the customer.

8. Recalls.

8.1 Each Party shall promptly notify the other if such Party believes that a
recall, withdrawal or field correction (each, a “Recall”) of the Product or any
Pipeline Product may be necessary or advisable.

8.2 NEW ALPHA shall be responsible for the Recall decision, notification of
Regulatory Authorities, the Recall strategy and generation of the final Recall
letter. During the period in which the Warehouse Services Agreement is in
effect, if any, GENERICO will be responsible for executing the Recall,
reconciling Product, preparing and submitting Recall status reports and
termination requests to applicable Regulatory Authorities with respect to Recall
of the Product and any Pipeline Product. Following termination of the Warehouse
Services Agreement, NEW ALPHA will be responsible for all Recall activities with
respect to Recall of the Product and any Pipeline Product that was not
previously shipped from the Premises (as defined in the Warehouse Services
Agreement) by GENERICO. In either case, NEW ALPHA shall (subject to Section 8.3)
bear all expenses incurred by GENERICO (with the consent of NEW ALPHA not to be
unreasonably withheld) and NEW ALPHA in connection with such Recall. Each of the
Parties will reasonably cooperate with the other Party in connection with any
Recall. Each Party will maintain complete and accurate Recall records relating
to the Product or any Pipeline Product for any periods that are required by any
Legal Requirements.

 

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8.3 In the event that it is determined that any Product or Pipeline Product is
recalled as a result of GENERICO’s gross negligence, bad faith, intentional
misconduct or intentional breach of this Agreement, then GENERICO shall bear all
of the costs and expenses of such Recall, including without limitation expenses
related to communications and meetings with all required Regulatory Authorities,
customer credits for recalled stock, the cost of notifying customers and costs
associated with shipment of recalled Product or Pipeline Product from customers
and shipment of an equal amount of replacement Product or Pipeline Product to
those customers, subject to Sections 12.2 and 12.8. In the event that any
Product or Pipeline Product is recalled other than as a result of GENERICO’s
gross negligence, bad faith, intentional misconduct or intentional breach of
this Agreement (or for which the liability would exceed the limitations set
forth in Section 12.9), then NEW ALPHA shall bear all of the costs and expenses
of such Recall, including without limitation expenses related to communications
and meetings with all required Regulatory Authorities, expenses of replacement
stock, the cost of notifying customers and costs associated with shipment of
recalled Product or Pipeline Product from customers and shipment of an equal
amount of replacement Product to those customers. In the event that the reason
for any Recall of Product hereunder is in part the responsibility of GENERICO as
described herein and in part the responsibility of NEW ALPHA as described
herein, then the expenses shall be allocated in an equitable manner between the
Parties.

8.4 If the Parties are unable to mutually agree on the source cause of the
Recall within 5 days of the event causing the Recall, such dispute will be
resolved in the same manner as set forth in Section 6.2. The fees and expenses
of the testing entity making the determination will be paid by the Party against
which the determination is made. NEW ALPHA shall have the final determination
over the disposition of any Recalled Product.

9. Product Liability.

9.1 For so long as NEW ALPHA is commercially marketing and selling the Product,
or conducting the New Alpha Manufacturing with respect to the Product or any
Pipeline Product, it shall maintain product liability insurance with respect to
the Product and the Pipeline Products, as applicable, with a reputable carrier,
in the amounts set forth in Exhibit B, naming GENERICO and its Affiliates as
additional insureds.

9.2 For so long as GENERICO is performing Generico Manufacturing with respect to
the Product or any Pipeline Product, it shall maintain product liability
insurance with respect to the Product and the Pipeline Products, with a
reputable carrier, in the amounts set forth in Exhibit C hereto, naming NEW
ALPHA and its Affiliates as additional insureds.

9.3 Each Party must notify the other Party as promptly as practicable if a
Product Liability Claim is commenced or threatened against any Party. Each Party
must cooperate with the other Party in connection with any Product Liability
Claim that is commenced or threatened against the other Party.

9.4 If a Product Liability Claim is asserted against both Parties, each Party
will have the right, at its own cost (subject to Section 9.6), to designate
counsel to defend itself in such Product Liability Claim. If a Product Liability
Claim is brought against one Party but not the other Party, the named Party will
(subject to Section 9.5) have absolute control of litigation, except that:

(A) the other Party may appoint counsel to participate in the defense of such
Product Liability Claim if the named Party reasonably determines that the
participation would not adversely affect the attorney-client privilege; and

 

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(B) if the litigation could reasonably be expected to have an adverse effect on
the development and commercialization of the Product or any Pipeline Product,
the named Party will consult with the other Party regarding the conduct of the
litigation if the named Party reasonably determines that the cooperation would
not adversely affect the attorney-client privilege.

9.5 Neither Party shall agree to a settlement of any Product Liability Claim
without the consent of the other Party, in that other Party’s absolute
discretion, if the settlement:

(A) admits any liability of the other Party or any of its Affiliates with
respect to such Product Liability Claim;

(B) does not release the other Party and its Affiliates from all liabilities and
obligations with respect to such Product Liability Claim; or

(C) imposes non-monetary damages or injunctive or other equitable relief against
the other Party or any of its Affiliates.

9.6 NEW ALPHA will be solely responsible for any Damages payable by NEW ALPHA or
GENERICO to third parties following final judgment or settlement of any Product
Liability Claim arising from use or sales of the Product (collectively, “Product
Liability Costs”), and must promptly pay or reimburse GENERICO if GENERICO pays
or incurs any Product Liability Costs, subject to the immediately following
sentence. GENERICO will be responsible for any Product Liability Costs to the
extent they arise from or as a result of the negligence, bad faith, intentional
misconduct or intentional breach of this Agreement by GENERICO, and must
promptly pay or reimburse NEW ALPHA if NEW ALPHA pays or incurs any Product
Liability Costs that arise from or relate to GENERICO’s gross negligence, bad
faith, intentional misconduct or intentional breach of this Agreement, subject
to Sections 12.2 and 12.8.

10. Term and Termination.

10.1 This Agreement will commence on the Effective Date and will continue
through December 31, 2011 (the “Term”). The Term shall be automatically extended
for an additional year until December 31, 2012 upon the occurrence of either (or
both) of (i) GENERICO’S exercise of its option to extend the term of that
certain Lease, dated as of the date hereof, between GENERICO and New Abraxis,
LLC for the Melrose Park Facility (the “Melrose Park Lease”), so that the
Melrose Park Lease expires on December 31, 2012 or (ii) New Abraxis, LLC’s
exercise of its option to extend the term of that certain Lease, dated as of the
date hereof, between GENERICO and New Abraxis, LLC for the Grand Island Facility
(the “Grand Island Lease”), so that the Grand Island Lease expires on
December 31, 2012.

10.2 The non-defaulting Party may terminate this Agreement if the other Party
commits a material breach or default (“Breach”) under this Agreement, which
Breach is not remedied within 60 days after the receipt of written notice of the
Breach by the non-defaulting Party (except as to the payment of money by NEW
ALPHA, for which the cure period will be 20 days) and which

 

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Breach is continuing at the time of termination. Notwithstanding the foregoing,
if the Breach is not curable in 60 days, and the breaching or defaulting Party
in good faith notifies the other Party in writing prior to the 60 days that it
is initiating cure of the Breach, and initiates cure of such Breach within 60
days and in good faith continues to attempt to cure the Breach, then this
Agreement shall not be terminated pursuant to this Section 10.2. The right of a
Party to terminate this Agreement provided in this Section 10.2 will not be
affected in any way by its waiver of, or failure to take such action with
respect to, any previous Breach.

10.3 This Agreement may be terminated immediately by either NEW ALPHA or
GENERICO if the other Party:

(A) does not pay its debts generally as they become due, or is unable to pay its
debts generally as they become due;

(B) has or has instituted against it any proceeding seeking to adjudicate it
bankrupt or insolvent, or seeking liquidation, winding up, reorganization,
arrangement, adjustment, protection, relief or composition of it or its debts
under any law relating to bankruptcy, insolvency or reorganization or relief of
debtors;

(C) makes a general assignment for the benefit of creditors;

(D) seeks the entry of an order for relief or the appointment of a receiver,
liquidator, sequestrator, trustee, custodian or similar official for it; or

(E) takes advantage of any other law or procedure for the protection of
creditors.

10.4 Termination is not the sole remedy under this Agreement, and whether or not
termination is effected, all other remedies remain available to each Party.

10.5 NEW ALPHA may terminate this Agreement for any reason at any time by giving
GENERICO not less than 3 months prior written notice.

10.6 Upon termination or expiration of this Agreement for whatever reason, the
Parties shall reasonably cooperate with each other to transfer to NEW ALPHA all
Chemical Ingredients, Materials, Components, finished goods inventory, retained
samples, stability samples and work in process in the possession, custody or
control of GENERICO (and NEW ALPHA shall reimburse GENERICO for its reasonable
expenses occurred in procuring and manufacturing such items) and GENERICO shall
use Reasonable Efforts to cooperate with NEW ALPHA with respect to technology
transfer matters for the Product and Pipeline Products.

11. Confidentiality.

11.1 Each Party recognizes that the other Party holds its Proprietary
Information as important. In particular, each Party recognizes that the other
Party’s Proprietary Information (and the confidential nature thereof) is
critical to the other Party’s business and that neither Party would enter into
this Agreement without assurance that such information and the value thereof
will be protected as provided in this Section 11 and elsewhere in this
Agreement.

 

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11.2 Each Party must, therefore:

(A) hold the other Party’s Proprietary Information in confidence and take
reasonable precautions to protect the Proprietary Information (including,
without limitation, no less than all precautions that it employs with respect to
its own confidential materials);

(B) except as required by law, regulation or legal process, not divulge (except
pursuant to a sublicense expressly authorized in this Agreement) the other
Party’s Proprietary Information or any information derived therefrom to any
third person; provided, however, that if a Party is required to make any such
disclosure of the other Party’s Proprietary Information, such Party shall give
reasonable advance notice to the other Party of such required disclosure and
will use reasonable efforts consistent with prudent business judgment to secure
confidential treatment of such Proprietary Information prior to its disclosure
(whether through protective orders or confidentiality agreements or otherwise);
and provided, further that if GENERICO is required to disclose NEW ALPHA’s
Proprietary Information that constitutes CMC information, GENERICO will provide
NEW ALPHA with prompt written notice so that NEW ALPHA may seek, at NEW ALPHA’s
expense, an appropriate protective order to avoid disclosure of such Proprietary
Information. If NEW ALPHA has attempted and failed to obtain a protective order
and GENERICO is, upon advice of its counsel, compelled to disclose Proprietary
Information related to CMC information to prevent liability for contempt or
other censure or penalty or other liability, GENERICO may disclose such portion
of the Proprietary Information that is required to be disclosed, In such case,
GENERICO will use Reasonable Efforts (at NEW ALPHA’s expense) so that
confidential treatment will be accorded to any Proprietary Information so
disclosed; and

(C) not make any use whatsoever at any time of the other Party’s Proprietary
Information except for purposes of and expressly authorized in this Agreement.

11.3 Any employee or contractor given access to any Proprietary Information must
have a legitimate “need to know” and must be bound in writing to maintain the
confidence of information to which it is given access.

11.4 Without granting any right or license, the disclosing Party agrees that the
foregoing restrictions will not apply with respect to information that the
receiving Party is able to demonstrate by competent evidence:

(A) is in or (through no improper action or inaction by the receiving Party or
any Affiliate of the receiving Party or their agents or employees) enters the
public domain (and is readily available without substantial effort);

(B) was rightfully disclosed to it by another Person without restriction; or

(C) was independently developed by it by Persons without access to such
information and without use of any of the disclosing Party’s Proprietary
Information.

 

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

 

11.5 Each Party’s obligations under this Section 11 will terminate five years
after the date of termination or expiration of this Agreement. The Parties
recognize and acknowledge that prior to the Effective Date of this Agreement,
each Party has received the other Party’s Proprietary Information and each
hereby agrees to protect the Proprietary Information to the same extent as set
forth in this Section 11.

11.6 Immediately upon termination or expiration of this Agreement, each Party
will turn over to the other Party all Proprietary Information of the other Party
and all documents or media containing any Proprietary Information and any and
all copies or extracts thereof.

11.7 Each Party acknowledges and agrees that due to the unique nature of
Proprietary Information, there may be no adequate remedy at law for any breach
of a Party’s obligations under this Section 11, that any breach may result in
irreparable harm to the disclosing Party, and therefore, that upon any breach or
any threat of breach, the disclosing Party will be entitled to appropriate
equitable relief (without the posting of any bond) in addition to whatever
remedies it might have at law in connection with any breach or enforcement of
the receiving Party’s obligations under this Agreement or the unauthorized use
or release of any Proprietary Information.

11.8 GENERICO hereby acknowledges that it and its Affiliates do not have, and
shall not acquire by virtue of this Agreement, any rights to or under any
goodwill, trademark, tradename, copyright, patent or other intellectual property
of NEW ALPHA or any of its Affiliates, nor in any of NEW ALPHA’s or its
Affiliates’ trademarks or trade names appearing on the label or packaging
materials of the Product or any of the Pipeline Products. GENERICO agrees to do
nothing by act or omission which would impair NEW ALPHA’s or its Affiliates’
rights, ownership and title in the aforementioned.

11.9 NEW ALPHA hereby acknowledges that it does not have, and shall not acquire
by virtue of this Agreement, any rights to or under any goodwill, trademark,
tradename, copyright, patent or other intellectual property of GENERICO, nor in
any of GENERICO’s trademarks or trade names appearing on the label or packaging
materials of the Product or any Pipeline Products. NEW ALPHA agrees to do
nothing by act or omission which would impair GENERICO’s or its Affiliates’
rights, ownership and title in the aforementioned.

11.10 If either Party becomes aware of any product or activity of any third
Party that involves or may involve infringement or other violation of any
Technology, that Party must promptly notify the other Party in writing of the
infringement or violation. NEW ALPHA may in its discretion take or not take
whatever action it believes is appropriate. GENERICO will fully cooperate with
NEW ALPHA with respect to bringing any action, including joining as a party to
the suit, if necessary, supplying essential documentary evidence and making
essential witnesses then in its employ available, in each case only to the
extent that such cooperation would not interfere with the operation of
GENERICO’s business and subject to the reimbursement of GENERICO for reasonable
out-of-pocket expenses incurred by it in connection with such cooperation.

 

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subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

 

12. Indemnification.

12.1 GENERICO agrees, subject to Sections 12.8 and 12.9, to indemnify, defend
and hold harmless NEW ALPHA and its Affiliates and their respective officers,
directors, employees and agents from any Damages incurred by or assessed against
them resulting from a third party claim caused by or alleged to be caused by:

(A) GENERICO’s gross negligence, bad faith, intentional misconduct or
intentional failure to perform any of its obligations under this Agreement; and

(B) any Product Liability Claim arising from the gross negligence or bad faith
of, or intentional misconduct or intentional breach of this Agreement by,
GENERICO or any GENERICO Affiliate.

12.2 NEW ALPHA agrees to indemnify, defend and hold harmless GENERICO, its
Affiliates, and their officers, directors, employees and agents (the “GENERICO
Indemnified Parties”) from any Damages incurred by or assessed against them
resulting from a third party claim caused by or alleged to be caused by:

(A) NEW ALPHA’s failure to perform any of its obligations under this Agreement;

(B) any Product Liability Claim arising from the (i) negligence, fraud or
intentional misconduct of NEW ALPHA or any NEW ALPHA Affiliates or (ii) the New
Alpha Manufacturing or any failure or deficiency in the New Alpha Manufacturing;

(C) any claim that the manufacture, use or sale of the Product or any Pipeline
Product infringes a patent or any other proprietary right of a third party;

(D) any Recall, Product Liability Claim or other third-party claim (i) not
arising from the gross negligence or bad faith of, or intentional misconduct or
intentional breach of this Agreement by, the GENERICO Indemnified Parties or
(ii) to the extent the liability of the GENERICO Indemnified Parties therefrom
would result in the GENERICO Indemnified Parties being subject to liability for
which GENERICO is not responsible under Section 12.9.

12.3 If any Party entitled to be indemnified pursuant to this Section 12 (an
“Indemnified Party”) receives notice of the assertion by any Person of any claim
or of the commencement by any such Person of any Action (any such claim or
Action being referred to herein as an “Indemnifiable Claim”) with respect to
which another Party hereto (an “Indemnifying Party”) is or may be obligated to
provide indemnification, the Indemnified Party must promptly notify the
Indemnifying Party in writing (the “Claim Notice”). The failure to provide such
notice will not relieve or otherwise affect the obligation of the Indemnifying
Party to provide indemnification hereunder, except to the extent that any
Damages directly resulted or were caused by such failure.

12.4 The Indemnifying Party will have 30 days after receipt of the Claim Notice
to undertake, conduct and control, through counsel of its own choosing and at
its expense, the settlement or defense of the claim, and the Indemnified Party
will cooperate with the Indemnifying Party in connection with the settlement or
defense, if:

(A) the Indemnifying Party permits the Indemnified Party to participate in the
settlement or defense through counsel chosen by the Indemnified Party (subject
to the consent of the Indemnifying Party, which consent shall not be
unreasonably withheld);

 

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(B) the fees and expenses of such counsel will not be borne by the Indemnifying
Party; and

(C) the Indemnifying Party does not settle any Indemnifiable Claim without the
Indemnified Party’s consent. So long as the Indemnifying Party is vigorously
contesting any Indemnifiable Claim in good faith, the Indemnified Party may not
pay or settle the claim without the Indemnifying Party’s consent, which consent
shall not be unreasonably withheld.

12.5 If the Indemnifying Party does not notify the Indemnified Party within 30
days after receipt of the Claim Notice that it elects to undertake the defense
of the Indemnifiable Claim described in the Claim Notice, the Indemnified Party
has the right to contest, settle or compromise the Indemnifiable Claim in the
exercise of its reasonable discretion. However, the Indemnified Party must
notify the Indemnifying Party of any compromise or settlement of any such
Indemnifiable Claim.

12.6 Notwithstanding anything in this Section 12 to the contrary, GENERICO is
not entitled to assume the defense for any Indemnifiable Claim (and will be
liable for the reasonable fees and expenses incurred by the Indemnified Party in
defending the claim) if the Indemnifiable Claim seeks an order, injunction or
other equitable relief (or other relief for other than money damages) against
NEW ALPHA or its Affiliates which NEW ALPHA determines, after conferring with
its counsel, cannot be separated from any related claim for money damages and
which, if successful, would adversely affect the commercialization of the
Product or any Pipeline Product. However, if an equitable relief portion of the
Indemnifiable Claim can be separated from that for money damages, GENERICO may
assume the defense of the portion relating to money damages.

12.7 In calculating any amount that any Indemnifying Party is required to pay an
Indemnified Party in respect of Damages provided under this Agreement, such
amount shall be (A) reduced to take into account any net tax benefit realized by
the Indemnified Party arising from the incurrence or payment by the Indemnified
Party of such Damages and (B) increased to take into account any net tax cost
incurred by the Indemnified Party as a result of the receipt or accrual of
payments hereunder (grossed-up for such increase), in each case determined by
treating the Indemnified Party as recognizing all other items of income, gain,
loss, deduction or credit before recognizing any item arising from such Damages
(provided that if the tax benefit or cost is realized in a tax period following
the period in which the indemnity payment is made, the tax benefit or cost
amount (as the case may be) shall be paid over when realized).

12.8 NOTWITHSTANDING ANYTHING TO THE CONTRARY HEREIN, NEITHER PARTY WILL BE
LIABLE HEREUNDER FOR MONETARY DAMAGES UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER

 

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Securities and Exchange Commission.

 

LEGAL OR EQUITABLE THEORY FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL
DAMAGES, INCLUDING WITHOUT LIMITATION, LOSS OF PROFITS FROM THE USE OF (OR
INABILITY TO USE) THE TECHNOLOGY, THE DEVELOPMENT OR COMMERCIALIZATION OF THE
PRODUCT OR OTHERWISE IN CONNECTION WITH, OR ARISING OUT OF, THIS AGREEMENT,
OTHER THAN WITH RESPECT TO DAMAGES FOR GENERICO EXTRAORDINARY FAILURE (as
defined in Section 12.9)

12.9 Notwithstanding anything herein to the contrary, in no event will the
GENERICO Indemnified Parties have any liability to NEW ALPHA or any of its
Affiliates, or to any third party in connection with this Agreement, for
monetary Damages in excess of $100 million in the aggregate, except to the
extent that such Damages are the result of (A) one of GENERICO’s (or one of its
parent entity’s) executive officers, in bad faith, affirmatively instructing
employees of GENERICO to materially breach GENERICO’s obligation to manufacture
the Product or any Pipeline Product under this Agreement or (B) any intentional
failure by GENERICO, in bad faith, to cure any material breach of GENERICO’s
obligation to manufacture the Product or any Pipeline Product under this
Agreement (which is capable of being cured) following notice thereof in
accordance with Section 15.3 (if such breach is not cured within a reasonable
period of time following receipt of such notice of such breach) (any of the
occurrences set forth in sub clauses (A) and (B) of this Section 12.9, “GENERICO
Extraordinary Failure”).

13. Management Fee. NEW ALPHA will pay GENERICO a facility management fee (the
“Management Fee”) equal to $3,000,000 for each of the 2008, 2009 and 2010
calendar years, or a total of $9,000,000, such payment to be made within 30 days
following the end of the applicable calendar year. The Management Fee shall be
in addition to, and not in lieu of, any amounts otherwise payable under this
Agreement. In addition, the Management Fee shall be reduced to the extent
employees of GENERICO at the Melrose Park Facility are transferred to NEW ALPHA
as more fully described in Section 14.5 below.

14. Melrose Park and Grand Island Facilities.

14.1 FDA Compliance.

(A) Each of NEW ALPHA and GENERICO shall cooperate reasonably and in good faith
with the other Party to develop a mutually acceptable plan to modernize the
Melrose Park Facility as requested or required by the FDA or that, in both
Parties’ reasonable judgment, are necessary to maintain FDA Regulatory Approvals
(the “FDA Modernization Plan”). All costs and expenses contemplated by the FDA
Modernization Plan shall be borne by NEW ALPHA. The scope and timing of
implementation of, and expenditures under, the FDA Modernization Plan shall be
mutually determined in good faith between the Parties.

(B) GENERICO will, in good faith, execute the actions contemplated by the FDA
Modernization Plan, subject to NEW ALPHA’s review and approval. NEW ALPHA shall
reimburse GENERICO for all out-of pocket costs to third parties reasonably
incurred (with the approval of NEW ALPHA not to be unreasonably withheld) in
connection with GENERICO’s performance of such actions. In connection with such
actions, GENERICO will not in any event be obligated to incur incremental
shutdown time outside the ordinary course of its business, reduce in any
material respect production capacity available for producing Generico Products
(or, without the consent of NEW ALPHA, the Product or any Pipeline Product) or
otherwise impact or disrupt in any material respect GENERICO’s or NEW ALPHA’s
business.

 

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Securities and Exchange Commission.

 

14.2 EU Compliance.

(A) To the extent requested by NEW ALPHA, GENERICO shall cooperate reasonably
and in good faith in connection with NEW ALPHA’s preparation of a plan to obtain
necessary Regulatory Approvals from the EMEA with respect to the Melrose Park
Facility (the “Melrose Park EU Plan”). All costs and expenses contemplated by
the Melrose Park EU Plan shall be borne by NEW ALPHA (unless GENERICO initiates
plans to commercialize its products or product candidates in Europe, in which
case the Parties shall allocate the costs and expenses contemplated by the
Melrose Park EU Plan between them equitably in good faith). Subject to
Section 14.2(B) below, the scope and timing of implementation of, and
expenditures under, the Melrose Park EU Plan shall be in the sole discretion of
NEW ALPHA.

(B) During the term of the Melrose Park Lease, GENERICO will, in good faith,
complete the actions required under the Melrose Park EU Plan as soon as
reasonably practicable following the Effective Date. In connection with such
actions, GENERICO will not in any event be obligated to incur incremental
shutdown time outside the ordinary course of its business, reduce in any
material respect production capacity available for producing Generico Products
(or, without the consent of NEW ALPHA, the Product or any Pipeline Product) or
otherwise impact or disrupt in any material respect GENERICO’s or NEW ALPHA’s
business or the actions required by the FDA Modernization Plan. The Parties
acknowledge that the FDA Modernization Plan shall not in any event include any
incremental costs included in the Melrose Park EU Plan.

14.3 Decommissioned Equipment. GENERICO will not de-commission, modify, move or
fail to maintain any equipment or systems or revise approved regulatory
processes related to systems and equipment in the Melrose Park Facility that is
operational as of the Effective Date such that the equipment or system would
require re-validation in accordance with FDA regulatory requirements. For the
avoidance of doubt, in no event will GENERICO have any obligation to re-validate
any equipment or system that is decommissioned as of the Effective Date.

14.4 Melrose Park Equipment. GENERICO will maintain the equipment and systems in
the Melrose Park Facility in reasonably good working order.

14.5 Melrose Park Facility Conveyance/Transfer.

(A) Transfer of Employees at Melrose Park Facility. To the extent reasonably
requested by NEW ALPHA, GENERICO shall cooperate reasonably and in good faith
with NEW ALPHA with respect to the transfer of GENERICO’s employees at the
Melrose Park Facility to NEW ALPHA. If and to the extent NEW ALPHA hires any
such employees, the Management Fee shall be reduced on a dollar-for-dollar basis
based upon the total compensation (i.e., base salary, bonus, medical benefits,
equity incentives, etc.) paid to such employees.

 

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(B) Training. NEW ALPHA shall have the right to train and integrate all
appropriate personnel of GENERICO with respect to Nab technology. In connection
with such training, GENERICO will not in any event be obligated to incur
incremental shutdown time outside the ordinary course of its business, reduce in
any material respect production capacity available for producing Generico
Products (or, without the consent of NEW ALPHA, the Product or any Pipeline
Product) or otherwise impact or disrupt in any material respect GENERICO’s or
NEW ALPHA’s business.

 

  14.6 Contract Manufacturing and Alpha Manufacturing.

(A) To the extent of excess capacity at the Melrose Park Facility (in all cases
after satisfying 100% of NEW ALPHA’s and GENERICO’s actual demand for the
Product, Pipeline Products and Generico Products, as applicable, GENERICO will
undertake any contract manufacturing opportunities presented by NEW ALPHA
subject to the following:

(i) GENERICO will in no event be required to contract manufacture any products
that then compete with any of its products, pending products or products (it
being understood that the foregoing shall not apply with respect to Pipeline
Products);

(ii) GENERICO will have sole discretion to decide on key terms of contract
manufacturing (including but not limited to price, liability provisions,
duration, volume levels);

(iii) NEW ALPHA will bear all responsibility for sourcing all such contract
manufacturing opportunities;

(iv) GENERICO will receive the net proceeds from any contract manufacturing
performed by GENERICO; and

(v) GENERICO contract manufacturing shall not obligate NEW ALPHA to perform
contract manufacturing following the end of the Term, except with NEW ALPHA’s
prior written consent.

(B) Subject to Section 14.6(A)(i) above, GENERICO will, in good faith, consider
opportunities to provide access, at dedicated times, during which NEW ALPHA
employees may utilize the equipment in the Melrose Park Facility for contract
manufacturing (performed by NEW ALPHA employees, all costs of which are to be
borne by NEW ALPHA), in all cases subject to the following sentence. GENERICO
will not in any event be obligated to incur incremental shutdown time outside
the ordinary course of its business, reduce in any material respect production
capacity available for producing Generico Products (or, without the consent of
NEW ALPHA, the Product or any Pipeline Product) or otherwise impact or disrupt
in any material respect GENERICO’s or NEW ALPHA’s business or the actions
required by the FDA Modernization Plan. NEW ALPHA will receive any proceeds from
any contract manufacturing performed by NEW ALPHA.

 

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15. Miscellaneous Provisions.

15.1 Independent Contractors. NEW ALPHA and GENERICO are independent Parties,
and nothing contained herein will be construed to create a joint venture,
partnership or similar relationship. Neither Party is authorized to, nor will
it, make any statements, claims, representations, warranties or otherwise act in
any way so as to incur any liability whatsoever for which the other Party may
become directly, indirectly or contingently liable.

15.2 Assignment. The rights and obligations of the Parties under this Agreement
may not be assigned or transferred in any manner, including, without limitation,
by operation of law, sale of stock or sale of assets, without the prior written
approval, which shall not be unreasonably withheld, of the other Party (and any
attempt to do so will be void) except that rights to payment of money may be
assigned without such approval. Despite the foregoing, in no event will NEW
ALPHA be obligated to consent to an assignment of this Agreement to a
Competitor.

15.3 Notices. Any and all notices given pursuant to this Agreement shall be in
writing and shall be deemed duly given (a) on the date of delivery if delivered
personally, (b) upon confirmation of receipt if delivered by facsimile, (c) on
the first business day following the date of dispatch if delivered by a
recognized next-day courier service, or (d) on the date received if delivered by
registered or certified mail, return receipt requested, postage prepaid. All
notices hereunder shall be delivered as set forth below, or pursuant to such
other instructions as may be designated in writing by the Party to receive such
notice:

If to NEW ALPHA to:

Abraxis BioScience, Inc.

11755 Wilshire Boulevard

Suite 2000

Los Angeles, CA 90025

Fax: (310) 998-8553

Attention: Chief Executive Officer

with a copy to:

Abraxis BioScience, Inc.

11755 Wilshire Boulevard

Suite 2000

Los Angeles, CA 90025

Fax: (310) 998-8553

Attention: General Counsel

If to GENERICO to:

APP Pharmaceuticals, Inc.

1501 East Woodfield Road, Suite 300E

Schaumburg, Illinois 60173

Fax: (847) 413-2652

Attention: Chief Executive Officer

 

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with a copy to:

APP Pharmaceuticals, Inc.

1501 East Woodfield Road, Suite 300E

Schaumburg, Illinois 60173

Fax: (847) 413-2652

Attention: General Counsel

15.4 Force Majeure.

(A) The obligations of a Party hereunder will be suspended during the time and
to the extent that such Party is prevented from complying therewith due to any
event or circumstances beyond the reasonable control and without the fault or
negligence of the affected Party (which circumstance is hereinafter referred to
as “Force Majeure”), including but not limited to floods, fire, storms,
earthquakes, lockouts, explosion, hostilities, war (whether declared or
undeclared), acts of terrorism, civil disturbances, order or acts of any
government, whether de jure or de facto or any official purporting to act under
authority of any such government (other than as to Regulatory Approval),
illegality arising from domestic or foreign laws or regulations, insurrections,
quarantine or custom restrictions (other than due to the action or inaction of
the Party claiming a Force Majeure), acts of God or other similar events beyond
the reasonable control of, as the case may be, NEW ALPHA or GENERICO which
results in hindrance of the performance by the Party of its obligations
hereunder.

(B) As soon as possible after being affected by a Force Majeure circumstance,
the affected Party must furnish to the other Party all particulars of the Force
Majeure and the manner in which its performance is thereby prevented or delayed.
The Party whose obligations hereunder have been suspended will promptly and
diligently pursue appropriate action to enable it to lift the Force Majeure
situation, except that Party shall not be obligated to settle any strike,
lockout or other labor difficulty on terms contrary to its wishes.

15.5 Amendment and Waiver. This Agreement (including the Exhibits hereto) may be
amended, modified, superseded or cancelled, and any other of the terms or
conditions hereof may be modified, only by a written instrument executed by both
Parties or, in the case of a waiver, by the Party waiving compliance. Failure of
either Party at any time or times to require performance of any provision hereof
will in no manner affect the right of such Party at a later time to enforce the
same, and no waiver of any nature, whether by conduct or otherwise, in any one
or more instances, will be deemed to be or considered as a further or continuing
waiver of any provision of this Agreement.

15.6 Severability. If any one or more of the agreements, provisions or terms
contained herein are declared invalid, illegal or unenforceable in any respect,
the validity of the remaining agreements, provisions or terms contained will
shall in no way be affected, prejudiced or invalidated thereby.

 

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15.7 Entire Agreement. This Agreement, together with the Exhibits hereto and the
Specifications, contains the entire agreement between the Parties, and
supersedes any agreements between them with respect to the subject matter
hereof.

15.8 Section Headings; Recitals. The section headings contained in this
Agreement are for reference purposes only and will not affect in any way the
meaning or interpretation of this Agreement. The recitals are hereby
incorporated into this Agreement by reference.

15.9 Governing Law. This Agreement shall be governed by and construed and
enforced in accordance with the substantive law (without regard to conflicts of
law provisions) of the State of Delaware.

15.10 Consent to Jurisdiction. Each of GENERICO and NEW ALPHA irrevocably agrees
that any legal action or proceeding with respect to this Agreement, the
transactions contemplated hereby, any provision hereof, the breach, performance,
validity or invalidity hereof or for recognition and enforcement of any judgment
in respect hereof brought by another Party or its successors or permitted
assigns shall be brought and determined in any federal or state court located in
the State of Delaware, and each of GENERICO and NEW ALPHA hereby irrevocably
submits with regard to any such action or proceeding for themselves and in
respect to their property, generally and unconditionally, to the exclusive
jurisdiction of the aforesaid courts. Each of GENERICO and NEW ALPHA hereby
irrevocably waives, and agrees not to assert, by way of motion, as a defense,
counterclaim or otherwise, in any action or proceeding with respect to this
Agreement, the transactions contemplated hereby, any provision hereof or the
breach, performance, enforcement, validity or invalidity hereof, (A) any claim
that it is not personally subject to the jurisdiction of the above-named courts
for any reason other than the failure to lawfully serve process, (B) that it or
its property is exempt or immune from jurisdiction of any such court or from any
legal process commenced in such courts (whether through service of notice,
attachment prior to judgment, attachment in aid of execution of judgment,
execution of judgment or otherwise) and (C) to the fullest extent permitted by
applicable laws, that (i) the suit, action or proceeding in any such court is
brought in an inconvenient forum, (ii) the venue of such suit, action or
proceeding is improper and (iii) this Agreement, or the subject matter hereof,
may not be enforced in or by such courts.

15.11 No Strict Construction. The language used in this Agreement will be deemed
to be the language chosen by the Parties hereto to express their mutual intent,
and no rule of strict construction will apply to any term or condition of this
Agreement.

15.12 Survival. Except to the extent that any monies are owed and not yet paid
and for the provisions of Sections 1, 2.2(H), 2.2(I), 2.5, 3.2(C), 3.5, 5.1
(last sentence), 5.2 (last sentence), 5.3 (last sentence), 6, 8, 9, 10, 11, 12
and 15, none of the provisions herein shall survive termination or expiration of
this Agreement. Sections 2.2(H), 2.5, 3.2(C) and 3.5 shall survive until the
seventh anniversary of the termination or expiration of this Agreement.

15.13 Counterparts. This Agreement may be executed in separate counterparts,
each of which will be deemed to be an original, but which together will
constitute one and the same instrument. An executed signature page of this
Agreement delivered by facsimile transmission shall be effective as an original
executed signature page.

 

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15.14 Enforcement. The Parties agree that irreparable damage would occur in the
event that any of the provisions of this Agreement were not performed by the
Parties in accordance with their specific terms. It is accordingly agreed that
the Parties shall be entitled to specific performance of the terms hereof, this
being in addition to any other remedy to which a Party is entitled at law or in
equity.

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IN WITNESS WHEREOF, the Parties hereto have executed this Manufacturing
Agreement as of the date and year first written above.

 

NEW ABRAXIS, INC. By:   /s/ Patrick Soon-Shiong Name:   Patrick Soon-Shiong
Title:   CEO APP PHARMACEUTICALS, LLC By:   /s/ Patrick Soon-Shiong Name:  
Patrick Soon-Shiong Title:   CEO

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Securities and Exchange Commission.

 

EXHIBIT A

DESCRIPTION OF PRODUCT, OR PIPELINE PRODUCTS, PROCESSING

(***).

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Securities and Exchange Commission.

 

EXHIBIT B

NEW ALPHA INSURANCE

$25,000,000 per incident and in the aggregate

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Securities and Exchange Commission.

 

EXHIBIT C

GENERICO INSURANCE

$25,000,000 PER INCIDENT AND IN THE AGGREGATE

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Securities and Exchange Commission.

 

SCHEDULE 1.4

PART A

2008 ANNUAL FORECAST

Melrose Park

 

GENERICO Lyophilizer Cycles:

   (***)         

NEW ALPHA Lyophilizer Cycles:

   (***)         

Units (in millions)

           

GENERICO Lyophilizer-produced Units

   (***)         

NEW ALPHA Lyophilizer-produced Units

   (***)         

Grand Island

GENERICO Lyophilizer Cycles:

   (***)         

NEW ALPHA Lyophilizer Cycles:

   (***)         

Units (in millions)

           

GENERICO Lyophilizer-produced Units

   (***)         

NEW ALPHA Lyophilizer-produced Units

   (***)          PART B 2009, 2010, 2011 AND 2012 ESTIMATES Melrose Park     
2009    2010    2011    2012

GENERICO Lyophilizer Cycles:

   (***)    (***)    (***)    (***)

NEW ALPHA Lyophilizer Cycles:

   (***)    (***)    (***)    (***)

Units (in millions)

           

GENERICO Lyophilizer-produced Units

   (***)    (***)    (***)    (***)

NEW ALPHA Lyophilizer-produced Units

   (***)    (***)    (***)    (***)

--------------------------------------------------------------------------------

Note: Redacted portions have been marked with (***). The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

 

Grand Island

 

     2009    2010    2011    2012

GENERICO Lyophilizer Cycles:

   (***)    (***)    (***)    (***)

NEW ALPHA Lyophilizer Cycles:

   (***)    (***)    (***)    (***)

Units (in millions)

           

GENERICO Lyophilizer-produced Units

   (***)    (***)    (***)    (***)

NEW ALPHA Lyophilizer-produced Units

   (***)    (***)    (***)    (***)

--------------------------------------------------------------------------------

Note: Redacted portions have been marked with (***). The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

 

SCHEDULE 1.66

TERRITORIES

 

  •  

European Economic Area

 

  •  

(***)

 

  •  

Australia

 

  •  

Japan

 

  •  

China (including Hong Kong and Macau)

 

  •  

India

 

  •  

Republic of Korea

 

  •  

(***)

 

  •  

(***)

 

  •  

(***)

 

  •  

(***)

 

  •  

(***)

 

  •  

(***)

 

  •  

(***)

 

  •  

(***)

 

  •  

(***)

 

  •  

Gulf States (including Saudi Arabia, United Arab Emirates, Kuwait, Oman and
Dubai)

 

  •  

(***)

 

  •  

(***)

 

  •  

(***)

 

  •  

(***)

 

  •  

(***)

--------------------------------------------------------------------------------

Note: Redacted portions have been marked with (***). The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

 

SCHEDULE 2.10

OTHER SERVICES

 

Service

   Charges1     

Assumptions

Manufacturing-Related Information Technology Support

   (***)      (***)

Corporate QA, including;

 

•       establishment of quality systems and regulatory oversight;

 

•       review of suppliers to ensure quality systems requirements are met;

 

•       review of internal functions to ensure quality systems requirements are
met;

 

•       provide polices, SOPs & protocols support to all functions;

 

•       provide warehousing support to ensure materials have been received,
sampled and shipped according to requirements;

 

•       review of product development reports;

 

•       calibration, maintenance and preventive maintenance of analytical
equipment; and

   (***)      (***)

--------------------------------------------------------------------------------

1

Charges shall be increased each year by (***). Actual charges will be based upon
time and materials.

--------------------------------------------------------------------------------

Note: Redacted portions have been marked with (***). The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

 

Service

   Charges1     

Assumptions

•       QA, validation and change control of multi-site computer systems.

       

Corporate QC, including;

 

•       analytical testing of raw materials and components; and

 

•       validation of analytical equipment and software systems.

   (***)      (***)

CGMP and other plant-related training

   (***)      (***)

--------------------------------------------------------------------------------

Note: Redacted portions have been marked with (***). The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

 

SCHEDULE 4.1

UNIT COST FOR ABRAXANE2

 

1. (***) for units manufactured at 2020 Ruby Street, Melrose Park, Illinois.

 

2. (***) for units manufactured at 3159 Staley Road, Grand Island, New York.

BATCH COST FOR ANY PIPELINE PRODUCT

 

  •  

Actual cost for Generico Manufacturing, plus (***). The actual cost for Generico
Manufacturing of Pipeline Products shall be verified and approved by NEW ALPHA
prior to their production.

--------------------------------------------------------------------------------

2

Charges shall be increased each year by (***).