Manufacturing Agreement

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

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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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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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 ABRAXANEae , 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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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 ...