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Item 1.	BUSINESS.

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•	harmful micro-organisms;

•	cells containing foreign proteins known as antigens; and

•	potential disease-causing combinations of antigens and antibodies known as immune complexes.

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•	our products and investigational compounds do not infringe the patents;

•	the patents are not valid or enforceable; or

•	we have identified and are testing various alternatives that should not infringe the patents and which should permit continued development and commercialization of our products and investigational compounds.

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The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully soliciting, offering, receiving, or paying any remuneration, directly or indirectly, in cash or in kind, to induce or reward purchasing, ordering or arranging for or recommending the purchase or order of any item or service for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid. Liability may be established without a person or entity having actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it. In addition, PPACA amended the Social Security Act to provide that the government may assert that a claim including items or services resulting from a violation of the federal anti-kickback statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. A conviction for violation of the Anti-kickback Statute requires mandatory exclusion from participation in federal health care programs.

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The federal civil False Claims Act (“FCA”) prohibits, among other things, knowingly presenting, or causing to be presented claims for payment of government funds that are false or fraudulent, or knowingly making, using or causing to be made or used a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government. This statute permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. Government enforcement

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The federal False Statements Statute prohibits knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry, in connection with the delivery of or payment for healthcare benefits, items, or services.

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The federal Civil Monetary Penalties Law, which authorizes the imposition of substantial civil monetary penalties against an entity, such as a pharmaceutical manufacturer, that engages in activities including, among others (1) knowingly presenting, or causing to be presented, a claim for services not provided as claimed or that is otherwise false or fraudulent in any way; (2) arranging for or contracting with an individual or entity that is excluded from participation in federal health care programs to provide items or services reimbursable by a federal health care program; (3) violations of the federal Anti-Kickback Statute; or (4) failing to report and return a known overpayment.

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Analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental payers, including private insurers. Some of these state laws may be broader in scope than their federal analogues, such as state false claims laws that apply where a claim is submitted to any third-party payer, regardless of whether the payer is a private health insurer or a government healthcare program, state laws that prohibit certain marketing-related activities including the provision of gifts, meals or other items to certain health care providers, and state laws that require pharmaceutical companies to implement compliance programs or codes of conduct governing their sales and marketing activities.

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•	substantially greater financial and other resources;

•	larger research and development staffs;

•	lower labor costs; and/or

•	more extensive marketing and manufacturing organizations.

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Item 1A.	Risk Factors.

•	receipt of marketing approvals for Soliris for the treatment of PNH and aHUS in new territories, and the maintenance of marketing approvals in the United States, the European Union, Japan and other territories;

•	our ability to obtain sufficient coverage or reimbursement by government or third-party payers and our ability to maintain coverage or reimbursement at anticipated levels;

•	establishment and maintenance of commercial manufacturing capabilities ourselves or through third-party manufacturers;

•	the number of patients with PNH and aHUS, and the number of those patients who are diagnosed with PNH and aHUS and identified to us;

•	the number of patients with PNH and aHUS that may be treated with Soliris;

•	successful continuation of commercial sales in the United States, Japan and in European countries where we are already selling Soliris for the treatment of PNH and aHUS, and successful launch in countries where we have not yet obtained, or only recently obtained, marketing approval or commenced sales;

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•	acceptance of Soliris and maintenance of safety and efficacy in the medical community; and

•	our ability to develop, register and commercialize Soliris for indications other than PNH and aHUS.

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•	a product recall;

•	a product withdrawal;

•	significant administrative and judicial sanctions, including, warning letters or untitled letters;

•	significant fines and other civil penalties;

•	suspension, variation or withdrawal of a previously granted approval for Soliris;

•	interruption of production;

•	operating restrictions, such as a shutdown of production facilities or production lines, or new manufacturing requirements;

•	suspension of ongoing clinical trials;

•	delays in approving or refusal to approve our products including pending BLAs or BLA supplements for Soliris or asfotase alfa, or a facility that manufactures our products;

•	seizing or detaining product;

•	requiring us or our partners to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance;

•	injunctions; and/or

•	criminal prosecution.

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•	delay or failure in obtaining institutional review board (IRB), approval or the approval of other reviewing entities to conduct a clinical trial at each site;

•	delay or failure in reaching agreement on acceptable terms with prospective contract research organizations(CROs), and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

•	withdrawal of clinical trial sites from our clinical trials as a result of changing standards of care or the ineligibility of a site to participate in our clinical trials;

•	clinical sites and investigators deviating from trial protocol, failing to conduct the trial in accordance with regulatory requirements, or dropping out of a trial;

•	slow patient enrollment, including, for example, due to the rarity of the disease being studied;

•	delay or failure in having patients complete a trial or return for post-treatment follow-up;

•	long treatment time required to demonstrate effectiveness;

•	lack of sufficient supplies of the product candidate;

•	disruption of operations at the clinical trial sites;

•	adverse medical events or side effects in treated patients, and the threat of legal claims and litigation alleging injuries;

•	failure of patients taking the placebo to continue to participate in our clinical trials;

•	insufficient clinical trial data to support effectiveness of the product candidates;

•	lack of effectiveness or safety of the product candidate being tested;

•	lack of sufficient funds;

•	inability to meet required specifications or to manufacture sufficient quantities of the product candidate for development or commercialization activities in a timely and cost-efficient manner;

•	decisions by regulatory authorities, the IRB, ethics committee, or us, or recommendation by a data safety monitoring board, to suspend or terminate clinical trials at any time for safety issues or for any other reason;

•	failure to obtain the necessary regulatory approvals for the product candidate or the approvals for the facilities in which such product candidate is manufactured; and

•	decisions by competent authorities, IRBs or ethics committees to demand variations in protocols or conduct of clinical trials.

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•	failure of our product candidates to meet a regulatory agency's requirements for safety, efficacy and quality;

•	disagreement over interpretation of data from preclinical studies or clinical trials;

•	restricted distribution or limitation on the indicated uses for which a product may be marketed;

•	unforeseen safety issues or side effects and potential requirements to establish REMS or post-marketing obligations;

•	disapproval of the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and

•	governmental or regulatory delays and changes in regulatory requirements and guidelines.

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•	Soliris and our product candidates do not infringe the patents;

•	the patents are not valid; or

•	we have identified and tested or are testing various modifications that we believe should not infringe the patents and which should permit commercialization of our product candidates.

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•	substantial cash expenditures;

•	potentially dilutive issuance of equity securities;

•	incurrence of debt and contingent liabilities, some of which may be difficult or impossible to identify at the time of acquisition;

•	difficulties in assimilating the operations of the acquired companies;

•	diverting our management's attention away from other business concerns;

•	risks of entering markets in which we have limited or no direct experience;

•	the potential loss of our key employees or key employees of the acquired companies; and

•	failure of any acquired businesses or products or in-licensed products to achieve the scientific, medical, commercial or other results anticipated.

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•	fluctuations in currency exchange rates;

•	political or economic determinations that adversely impact pricing or reimbursement policies;

•	economic problems or political instability that disrupt health care payment systems;

•	difficulties or inability to obtain financing in markets;

•	unexpected changes in tariffs, trade barriers and regulatory requirements;

•	difficulties enforcing contractual and intellectual property rights;

•	changes in laws, regulations or enforcement practices with respect to our business, including without limitation laws relating to reimbursement, competition, pricing and sales and marketing of our products;

•	trade restrictions and restrictions on direct investments by foreign entities;

•	compliance with tax, employment and labor laws;

•	costs and difficulties in recruiting and retaining qualified managers and employees to manage and operate the business in local jurisdictions;

•	costs and difficulties in managing and monitoring international operations; and

•	longer payment cycles.

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Item 1B.	UNRESOLVED STAFF COMMENTS.

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Item 2.	PROPERTIES.

Item 3.	LEGAL PROCEEDINGS.

Item 4.	MINE SAFETY DISCLOSURES.

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Item 5.	MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.

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(1)	Reflects number of shares of common stock to be issued upon exercise of outstanding options under all our equity compensation plans, including our Amended and Restated 2004 Incentive Plan. All 12,043 shares of common stock remaining available for future issuance are available under the Amended and Restated 2004 Incentive Plan.

(2)	Does not include 1,808 restricted shares outstanding that were issued under the Amended and Restated 2004 Incentive Plan.

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Item 6.	SELECTED FINANCIAL DATA.

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Item 7.	MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. (amounts in thousands, except percentages and per share data)

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•	Revenue recognition;

•	Contingent liabilities;

•	Inventories;

•	Share-based compensation;

•	Valuation of goodwill, acquired intangible assets and in-process research and development (IPR&D);

•	Valuation of contingent consideration; and

•	Income taxes.

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•	estimated future cash flows from product sales resulting from completed products and in-process projects; and

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•	timing and probability of success of meeting commercial milestones, such as estimated future sales levels of a specific compound; and

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•	Increase of $39,154 in external clinical development expenses related primarily to an expansion of studies for eculizumab and asfotase alfa (see table below).

•	Increase of $95,425 in licensing agreement costs primarily due to the upfront payment of $100,000 on the option agreement entered into with Moderna Therapeutics, Inc. in the first quarter of 2014.

•	Increase of $7,857 in discovery research expenses primarily related to increases in external research expenses associated with our Moderna agreement and other external research expenses.

•	Increase of $46,635 in R&D payroll and benefit expense related primarily to the continued global expansion of staff supporting our increasing number of clinical and development programs.

•	Increases of $3,285 and $3,930 in R&D operating and occupancy and depreciation and amortization expenses. respectively, related primarily to the continued expansion of global supply chain facilities and support services.

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Increase in salary, benefits and other labor expenses of $95,857. The increase was a result of increased headcount related to commercial development activities, including increases in payroll and benefits costs of $49,023 related to our global commercial staff to support global expansion. This increase was also due to increases in payroll and benefits of $46,835 within our general and administrative functions to support our infrastructure growth as a global commercial entity.

•	Increase in external selling, general and administrative expenses of $44,632. This increase was primarily due to an increase in marketing costs to support the continued growth in global sales of Soliris, as well as an increase in other administrative costs to support our infrastructure growth.

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•	Increase of $25,570 in external clinical development expenses related primarily to an expansion of studies of eculizumab, asfotase alfa and cPMP programs (see table below).

•	Increase of $5,804 in external product development expenses related primarily to costs associated with the preparation of regulatory filings for asfotase alfa and an increase in manufacturing costs related to our other product development programs, offset by a decrease in costs associated with the production of asfotase alfa for clinical studies.

•	Increase of $11,775 in discovery research expenses primarily related to the upfront payment of $14,500 on the license agreements entered into in 2013.

•	Increase of $48,425 in R&D payroll and benefit expense related primarily to global expansion of staff supporting our increasing number of clinical and development programs.

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Increase in salary, benefits and other labor expenses of $69,828. The increase was a result of increased headcount related to commercial development activities, including increases in payroll and benefits costs of $51,700 related to our global commercial staff to support global expansion. This increase was also due to increases in payroll and benefits of $18,100 within our general and administrative functions to support our infrastructure growth as a global commercial entity.

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Increase in external selling, general and administrative expenses of $35,214. This increase was primarily due to an increase in legal costs associated with the Novartis litigation, an increase in consulting fees related to our global supply chain expansion in Ireland, an increase in marketing costs to support the continued growth in global sales, as well as an increase in general administrative expenses due to infrastructure growth.

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•	Our reported net income was $656,912 and $252,895 for the years ended December 31, 2014 and 2013, respectively. During the first quarter of 2014, we recorded expense of $100,000 for an upfront payment related to an option agreement we entered into with Moderna Therapeutics, Inc.

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Non-cash items included depreciation and amortization, impairment of intangible assets, change in fair value of contingent consideration, share-based compensation expense, premium amortization of available-for-sale securities, and deferred taxes, and were increases to reconcile net income to net cash flows from operating activities of $76,869 and $240,529 for the years ended December 31, 2014 and 2013, respectively.

•	Non-cash items also included $251,136 and $105,714 of windfall tax benefits for the years ended December 31, 2014 and 2013, respectively. The amount of the windfall tax benefit was significantly higher during the year ended December 31, 2014 due to an increased stock price and increased level of stock option exercises.

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•	Net cash inflows due to changes in operating assets and liabilities was $157,430 and $109,639 for the years ended December 31, 2014 and 2013, respectively. The $157,430 change in operating assets and liabilities primarily relates to:

•	Increase in accounts receivable of $28,137 due primarily to increasing revenue.

•	Increase of $66,812 in inventory related to increased production of inventory to support commercial growth and the capitalization of $22,005 of inventory produced for commercial sale for products awaiting regulatory approval.

•	Increase of $18,392 in prepaid expenses and other assets related to an increase in prepaid manufacturing costs.

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Increase of $264,572 in accounts payable, accrued expenses and other liabilities primarily related to an increase in trade accounts payable, accrued manufacturing, accruals for purchases of property, plant and equipment, clinical costs, accrued compensation and a change in accrued income taxes. These increases were offset by a decrease in accruals for rebates of approximately $87,800 resulting from the agreement with the French government for reimbursement of prior year shipments and a decrease in accruals for royalties of approximately $20,100 resulting from the settlement agreement we entered into with a third party related to the calculation of royalties under a pre-existing license agreement.

•	Purchases of available-for-sale marketable securities of $664,228 and $1,048,429 for the year ended December 31, 2014 and 2013, respectively, offset by proceeds from the maturity or sale of available-for-sale marketable securities of $619,447 and $60,917 during the same periods.

•	Purchase of $37,500 of preferred equity of Moderna LLC during the year ended December 31, 2014.

•	Additions to property, plant and equipment of $136,650 and $29,329 for the years ended December 31, 2014 and 2013, respectively.

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Item 7A.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

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Item 8.	FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.

Item 9.	CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.

Item 9A.	CONTROLS AND PROCEDURES.

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Item 9A(T).	CONTROLS AND PROCEDURES.

Item 9B.	OTHER INFORMATION.

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Item 10.	DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.

Item 11.	EXECUTIVE COMPENSATION.

Item 12.	SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.

Item 13.	CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.

Item 14.	PRINCIPAL ACCOUNTING FEES AND SERVICES.

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Item 15.	EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.

Item 15(a)

(1)	Financial Statements

(2)	Financial Statement Schedules

(3)	Exhibits:

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(1)	Incorporated by reference to our Report on Form 8-K, filed on February 3, 2011.

(2)	Incorporated by reference to our Report on Form 8-K, filed on January 4, 2012.

(3)	Incorporated by reference to our Report on Form 8-K, filed on February 7, 2012.

(4)	Incorporated by reference to our Registration Statement on Form S-3 (Reg. No. 333-128085), filed on September 2, 2005.

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(5)	Incorporated by reference to our Annual Report on Form 10-K for the fiscal year ended December 31, 2011.

(6)	Incorporated by reference to our Report on Form 10-Q, filed on October 25, 2013.

(7)	Incorporated by reference to our Registration Statement on Form S-1 (Reg. No. 333-00202).

(8)	Incorporated by reference to our Registration Statement on Form 8-A (Reg. No. 000-27756), filed on February 21, 1997.

(9)	Incorporated by reference to Amendment No. 1 to our Registration Statement on Form 8-A (Reg. No. 000-27756), filed on October 6, 2000.

(10)	Incorporated by reference to Amendment No. 2 to our Registration Statement on Form 8-A (Reg. No. 000-27756), filed on February 12, 2002.

(11)	Incorporated by reference to Amendment No. 3 to our Registration Statement on Form 8-A (Reg. No. 000-27756), filed on November 17, 2004.

(12)	Incorporated by reference to our Annual Report on Form 10-K for the year ended December 31, 2006.

(13)	Incorporated by reference to our Report on Form 8-K filed on February 16, 2006.

(14)	Incorporated by reference to our Annual Report on Form 10-K for the fiscal year ended December 31, 2009.

(15)	Incorporated by reference to our Report on Form 8-K, filed on September 17, 2010.

+	Confidential treatment was granted for portions of such exhibit.

*	Confidential treatment requested under 17 C.F.R. §§200.80(b)(4) and 24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions have been filed separately with the SEC pursuant to the confidential treatment request.

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1.	Business Overview and Summary of Significant Accounting Policies

•	Revenue recognition;

•	Contingent liabilities;

•	Inventories;

•	Research and development expenses;

•	Share-based compensation;

•	Valuation of goodwill, acquired intangible assets and in-process research and development (IPR&D);

•	Valuation of contingent consideration; and

•	Income taxes.

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•	Building and improvements—five to thirty years

•	Machinery and laboratory equipment—three to ten years

•	Computer hardware and software—three to five years

•	Furniture and office equipment—three years

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2.	Acquisitions

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3.	Property, Plant and Equipment, Net

4.	Intangible Assets and Goodwill

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5.	Marketable Securities

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6.	Derivative Instruments and Hedging Activities

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7.	Accrued Expenses

8.	Debt

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9.	Commitments and Contingencies

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10.	Income Taxes

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11.	Share-based Compensation

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12.	Stockholders' Equity

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13.	Other Comprehensive Income and Accumulated Other Comprehensive Income

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14.	Fair Value Measurement

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15.	Employee Benefit Plans

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16.	Restructuring

17.	Segment Information

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(2)	Long-lived assets consist of property, plant and equipment.

18.	Subsequent Events

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19.	Quarterly Financial Information (unaudited)

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1.1	"Acquisition Cost" means the actual invoiced price paid by Lonza to any Third Party for acquiring any raw materials, packaging components and intermediates used exclusively in

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1.2

“Affiliate” means any corporation, partnership, limited liability company or other entity, which directly or indirectly controls, is controlled by or is under common control with the relevant Party to this Agreement, and "control" and its correlates means the ownership of more than fifty percent (50%) of the issued voting shares, or the legal power to direct or cause the direction of the general management and policies, of the Party in question.

1.3	“Alexion” means Alexion and, solely in respect of Section 21.7 and Exhibit B, Alexion Inc.

1.4

"Alexion Confidential Information" means all technical and other information known to, controlled or owned by Alexion or its Affiliates at any time during the Term, and not known to and at the free disposal of Lonza prior to its disclosure by Alexion or its Affiliates to Lonza and not in the public domain, including, without limitation, Alexion Materials, Alexion LSP, Alexion Tests and the Cell Line.

1.5	“Alexion Process” means that part of the Process which consists of know-how and improvements invented by or specifically for Alexion or any of its Affiliates.

1.6	“Alexion Materials” means Alexion New Material and Alexion Original Material.

1.7

“Alexion New Material” means all information, documents and materials relating to the Product that will be generated by Lonza, any Approved Subcontractor and/or Alexion under this Agreement, including without limitation, manufacturing and quality control instructions or requirements under any quality control agreements between the parties (including the QA Agreement), and specifications necessary to manufacture, label, package, store, handle, stability test, quality control test and release the Product, all in accordance with this Agreement, including without limitation the Product and partially-Processed Product. Alexion New Material does not include any Lonza Confidential Information.

1.8	“Alexion Original Material” means all information, documents and materials that will be or have been provided by Alexion to Lonza under this Agreement, including without limitation, Confidential Information.

1.9	“Alexion Patent Rights” means all Patent Rights that are controlled by Alexion and are necessary or useful in the performance of the Services by Lonza as contemplated hereby. The Alexion Patent Rights are listed on Exhibit C and attached hereto.

1.10	"Alexion Tests" means the tests to be carried out on the Product following receipt by Alexion, as specified in the relevant PSA, as modified from time to time by written agreement between the Parties.

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1.11	“Approved Subcontractors” means any Affiliate of Lonza and/or other Third Party subcontracted by Lonza after prior written approval of Alexion to perform part of its obligations hereunder, all as listed in the QA Agreement.

1.12	“ARIMF” means Alexion Rhode Island Manufacturing Facility.

1.13	“Background Intellectual Property” means any Intellectual Property either (i) owned or controlled by a Party prior to the Effective Date or (ii) developed or acquired by a Party independently from the performance of this Agreement.

1.14	"Batch" means the quantity of bulk form of the Product produced from a single operation of the Process, at the [*]L or [*]L scale, as the context requires, and refers to an Engineering Batch, a Process Validation Batch, and/or a Commercial Batch, as the context requires.

1.15	“BLA” means a Biologics License Application and amendments thereto for a Product filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. §600 et seq., for FDA approval of a Product, and “sBLA” means a supplemental BLA.

1.16

"cGMP" means the regulatory requirements for current good manufacturing practices promulgated by the FDA under the FD&C Act, 21 C.F.R. §§ 210, 211 and 600 et seq. and under the PHS Act, 21 C.F.R. §§ 600-610 and specified by the EU/PIC guidelines, as such regulatory requirements may be amended from time to time, and the corresponding or similar national laws, rules and regulations of those jurisdictions in which the Product is manufactured. As used herein, the “FD&C Act” means the United States Federal Food, Drug and Cosmetic Act, as the same may be amended from time to time.

1.17	“Campaign” means any series of Batches for a Product at a particular Facility.

1.18	"Cell Line" means a proprietary Alexion cell line that expresses the Product.

1.19	“Certificate of Analysis” means, as further specified in the applicable Quality Agreement, with respect to each Batch subject thereto, a document prepared by Lonza certifying that the final bulk product has met all Specifications.

1.20	“Certificate of Compliance” means, as further specified in the applicable Quality Agreement, with respect to each Batch subject thereto, a document prepared by Lonza that incorporates the Certificate of Analysis and which also certifies that the final bulk product was manufactured according to cGMP.

1.21	“Commence” or "Commencement" means, with respect to the commencement of a Batch, the removal of the first ampoule of the Cell Line from the relevant cell bank stocks with the intent that such cells shall be used in accordance with this Agreement.

1.22	"Commercial Batch" means a Batch produced for the purposes of commercial use by Alexion.

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1.23	“Components” means for example Raw Materials, [*].

1.24	"Confidential Information" means Alexion Confidential Information and/or Lonza Confidential Information, as the context requires.

1.25	“Critical Components” means Components that are critical for the Services as defined in the Quality Agreement.

1.26	“Critical Decision” means a decision on any matter that will or would be reasonably likely to have a material impact on an operational, financial, quality and/or compliance basis, on a Product and/or any of the Services.

1.27	“Delivery” has the meaning set forth in Section 5.4.1.

1.28	“EMA” means the European Medicines Agency, or any successor agency thereto.

1.29	"Engineering Batch" means a Batch used for process demonstration and confirmation of some or all of the Process steps, and is described in Section 4.6.1 hereof.

1.30	“Executive Steering Committee” or “ESC” is defined in Section 3.2.1.

1.31	"Facility" means, as applicable, Lonza's commercial manufacturing facilities located at:

1.32	"FDA" means the United States Food and Drug Administration, or any successor agency thereto.

1.33	“FD&C Act” is defined in Section 1.16.

1.34	“Force Majeure Event” is defined in Section 20.1.

1.35	“Forecast” is defined in Section 5.2.1(a).

1.36

“Intellectual Property” means (i) inventions (whether or not patentable), patents, ideas, discoveries, trade secrets, copyrights, trademarks, trade names and domain names, rights in compositions of matter, rights in processes, rights in formulations, rights in articles of manufacture, rights in designs, rights in computer software, database rights, rights in confidential information (including know-how) and any other intellectual property rights,

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1.37

“Knowledge” An individual shall be deemed to have “Knowledge” of a particular fact or other matter if: (i) such individual is actually aware of such fact or other matter or (ii) (except when Knowledge is stated to be “actual Knowledge”) a prudent individual could be expected to discover or otherwise become aware of such fact or other matter in the course of conducting a reasonably comprehensive investigation concerning the truth or existence of such fact or other matter. Each of Lonza and Alexion shall be deemed to have “Knowledge” of a particular fact or other matter if any of their respective directors, officers or employees with the authority to establish policy for the company has actual knowledge of such fact or other matter after due and diligent inquiry.

1.38	“License Agreement” has the meaning ascribed to it by Exhibit B.

1.39	“Liabilities” is defined in Section 15.1.1.

1.40	“Lonza”, except where otherwise indicated, means:

1.41	"Lonza Confidential Information" means all technical and other information known to, owned or controlled by Lonza or its Affiliates from time to time, and not known to and at the free disposal of Alexion prior to its disclosure by Lonza or its Affiliates to Alexion and not in the public domain, including, without limitation, the Lonza Media Formulations and the Lonza Process.

1.42	“Lonza Media Formulations” means Lonza's proprietary formulations of cell growth medium and cell growth supplements used in the Process.

1.43	“Lonza Process” means that part of the Process which was originally invented by or for Lonza, plus any generic improvements or know-how which were invented by or for Lonza. Notwithstanding the foregoing, the Lonza Process specifically excludes any Alexion Process.

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1.44	"Materials of Environmental Concern" means any hazardous substance as is identified by any Regulatory Authority.

1.45	“Minimum Order” is defined in Section 5.2.2.

1.46	“Net Sales” means all monies received by or on behalf of Alexion or its Affiliates in respect of the worldwide sale of Product (eculizumab) less the following items to the extent that they are paid or allowed and included in the invoice price for the Product (eculizumab):

•	normal discounts actually granted;

•	credits granted for Product (eculizumab) or other goods returned or not accepted by customers;

•	packaging, transportation and prepaid insurance charges on shipments or deliveries to customers;

•	Customs duties, surcharges and other governmental charges;

•	taxes actually incurred by Alexion or its Affiliates (for example, VAT) in connection with the sale or delivery of Product (eculizumab) or other goods to customers; and

•	rebates or charge backs actually paid or credited.

1.47	"Non-Conforming Batch" means a Batch that fails to conform to the Specifications as set forth in Section 9.1 hereof.

1.48	“Out of Freeze Date” means the date of removal of the vial of cells from frozen storage for the production of a Batch.

1.49	"Party" or "Parties" means Alexion and/or Lonza, as the context requires.

1.50	“PAI” has the meaning set forth in Section 10.2.

1.51	“PIP” has the meaning set forth in Section 10.2.

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1.52	"PHS Act" means the Public Health Service Act, Biological Products, as amended.

1.53	“Post-Release Deviation” means a deviation raised by either Alexion or Lonza post-release of the Certificate of Compliance by Lonza regardless of when Alexion or Lonza become aware of or are informed of such deviation.

1.54	“Process” and “Processing” means any and all operations, including packaging for shipment, carried out for the manufacture of the Product under this Agreement, as summarily described under each PSA and in the applicable Quality Agreement and the applicable TTA, as such process may be changed from time to time in accordance with this Agreement.

1.55	“Process Validation” means those activities necessary to validate the Process at the relevant Facility, including a process validation master plan, a process specification cleaning validation, and a process performance qualification study.

1.56	“Process Validation Batches" means Batches that are produced to confirm reproducibility of the Process and are required to complete consistency studies, all to the extent necessary to support an approvable supplemental regulatory filing as determined by the applicable Regulatory Authorities.

1.57	"Product" means such proprietary biopharmaceutical product of Alexion or an Affiliate of Alexion as is set forth in an applicable PSA as a Product under this Agreement, and includes Product (eculizumab) and Product (Asfotase alfa) as well as any other product set forth in a PSA or a TTA.

1.58	“PSA” or “Product Specific Appendix” is defined in Section 2.3.

1.59	“Purchase Order” has the meaning set forth in Section 5.2.4.

1.60	"Quality Agreement" or “QA Agreement” means each Quality Agreement to be entered into, with respect to a Product, by and between the Parties no later than sixty (60) days after the execution of the PSA or such other date set forth in the applicable PSA for such Product, as the same may be amended from time to time by mutual written agreement of the Parties.

1.61	“Quality Assurance” or “QA” means the sum total of the organised quality assurance arrangements made with the purpose of ensuring that a Product meets the Specifications and shall specifically include all activities as set forth in the QA Agreement.

1.62	“Raw Materials” means ingredients, additives, disposables including filters and bags, and reagents, which are purchased or used by Lonza in the performance of the Services.

1.63	“Regulatory Authority” means any governmental authority in Switzerland, Singapore, US, EMEA, and/or any other country competent to grant Registrations for the Processing and/or marketing of pharmaceutical products and/or the Product and/or finished product comprised of the Product. For the avoidance of doubt, in the event that the regulations of

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1.64	[*].

1.65	“Services” means the services to be provided by Lonza which are the subject of this Agreement, including the services under each PSA and the provision of personnel and operation of relevant plant and equipment at the Facilities.

1.66	“SHE” means safety, security, health and environmental protection.

1.67	"Specifications" means the specifications for the relevant Product, as agreed by the Parties and set forth in the Quality Agreement, as may be modified from time to time by the written agreement of the Parties.

1.1	“Tech Transfer Agreement” or “TTA” is defined in Section 4.5.

2.1

Entire Agreement. This Agreement (including all Exhibits, the Quality Agreements, purchase orders, PSAs and TTAs) constitutes the entire understanding between the Parties with respect to the subject matter hereof and supersedes all prior agreements, negotiations, understandings, representations, statements and writings relating thereto, including but not limited to the Large-Scale Product Supply Agreement (Singapore) dated 19th October 2011, the Exclusive Manufacturing and Supply Agreement dated 23 December 2010 and the Manufacturing Services Agreement dated 5th November 2009, which three agreements were assigned to Alexion with an effective date of 1st January 2014. Except as otherwise expressly provided, this Section 2.1 will not affect any rights and obligations which, from the context thereof, are intended to survive termination or expiration of such prior agreements, nor shall it prejudice any other remedies that the Parties may have under such agreements. In addition, the License Agreement shall continue in force in accordance with its terms as modified by Exhibit B hereto,

2.2	Integration. To the extent any terms set forth in a PSA, TTA, Purchase Order and/or any Quality Agreement conflict with the terms set forth in this Agreement, the terms within this Agreement shall control unless otherwise expressly agreed by the Parties in writing in such PSA, TTA, Quality Agreement and/or Purchase Order.

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2.3	Product Specific Appendix/PSA. In conjunction with entering into this Agreement, the Parties may agree certain activities, the description of which shall be contained in an individual product specific appendix to this Agreement (the “PSA”, a form of which is attached hereto as Exhibit A), executed by a duly authorized officer of each Party.

2.4

Quality Agreements. In conjunction with entering into this Agreement, the Parties shall negotiate in good faith, execute and deliver a Quality Agreement for each Facility at which Lonza carries out Services under this Agreement that governs the responsibilities related to quality systems and quality requirements for Product at such Facility, including quality control, testing and release thereof. The parties shall negotiate and execute a Quality Agreement for each Facility (or revise as appropriate an existing Quality Agreement) within sixty (60) days of execution of the PSA relating to such Facility. Each Quality Agreement (including any revised existing Quality Agreement) is incorporated herein by reference and shall be subject to this Agreement.

2.5	TTA. In conjunction with entering into this Agreement, with respect to each Product to be manufactured under a specific PSA under this Agreement (with the exception of the manufacture of Product (eculizumab) in [*] and Product (Asfotase alfa) in [*]), the Parties

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3.1

Committees and Teams Generally. Each Party will be responsible for its internal decision making process and for informing the other Party of decisions made materially or adversely affecting the manufacturing and/or supply of the Product in a regular and timely manner. Without limiting the foregoing, the Parties will establish a Governance Structure comprised of an Executive Steering Committee, a Joint Steering Committee and Joint Project Teams to oversee the performance of this Agreement.

3.2	Executive Steering Committee.

3.2.3	Composition. The Executive Steering Committee shall be comprised of the following representatives from each Party:

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(a)	The Chief Global Operations Officer of Alexion and the Chief Operating Officer of Lonza

(b)	SVP, Global Manufacturing Operations of Alexion and the Senior Vice-President, Global Operations of Lonza

(c)	CMO, Business Management of Alexion and the Global Head of Sales for Lonza.

(d)	The Head of Quality of both parties; and

(e)	Additional representatives as identified and agreed by the ESC.

3.3	Joint Steering Committee

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3.4	Joint Project Team

(a)	Execution and completion of project activities and deliverables

(b)	Oversight of commercial manufacturing campaigns including all pre-campaign preparation and post-campaign activities.

(c)	Resolution of all operational issues that may arise from time to time associated with the manufacture of Product.

(d)	Escalation of unresolved issues to the JSC

3.4.3	Composition. Each JPT shall be headed up by a Lonza Project Manager and an Alexion CMO Business Manager as appointed by the Parties. The JPT shall be composed of appropriate Technical, Quality and/or Operational representatives from the Parties as is necessary to execute the responsibilities of the JPT.

3.5	Meetings.

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(a)

The JSC may make Critical Decisions only if a quorum exists, which means the meeting is attended by, for Alexion, representatives from External Quality Assurance, Technical Operations and CMO, Business Management at Director level or above, and for Lonza, the relevant Facility Site Head or regional Vice President of Operations, a relevant Facility or global Quality Assurance representative at Associate Director level or above, and either the Contract Manager or Sales representative, or in each case a delegate from each such function pursuant to Section 3.5.4.

(b)	If the JSC is unable, despite the good faith efforts of all members, to resolve a disputed issue that is within the purview of the JSC, the disputed issue shall be referred immediately by the JSC to the ESC. If the dispute cannot be resolved by the ESC, the matter will be handled in accordance with Article 19 hereof.

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(a)	Where a JPT is unable, despite good faith efforts of all members, to resolve a disputed issue that is within the purview of the JPT, the disputed issue shall be referred by agreement of the JPT, to the JSC for resolution.

(b)	The JPT may not make a Critical Decision, which shall be escalated to the JSC for decision.

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4.1	Supply of Alexion Materials. Pursuant to the agreements identified in Section 2.1, Lonza has possession of, or Alexion shall supply, sufficient Alexion Materials, including sufficient purified reference standard for the Product and sufficient ampoules of the Cell Line from an appropriate cell bank for Lonza to provide the Services.

4.2	Rights in Alexion Confidential Information, Alexion Patent Rights and Alexion Materials, Rights to the Processes and Biosimilar Restriction.

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4.3

Lonza Obligations Regarding Alexion Materials. At all times, Lonza shall use reasonable best efforts to keep the Alexion Materials secure and safe from loss, damage, theft, misuse and unauthorized access in such manner as Lonza stores its own materials of similar nature; not part with possession of the Alexion Materials or the Product save for the purpose of tests at the Testing Laboratories or as directed by Alexion; and cause all Testing Laboratories to be subject to confidentiality and non-use obligations no less onerous than those confidentiality and non-use obligations imposed on Lonza under this Agreement.

4.4

No Other License. Without prejudice to Lonza's right to receive payment hereunder or to Lonza's own proprietary rights in the Lonza Process, the Lonza Information and the Lonza Patent Rights, Lonza agrees that, except as expressly provided in Section 4.2 above, Lonza shall not by virtue of this Agreement acquire any right, license or title in, or to, the Alexion Patent Rights, the Alexion Confidential Information, the Alexion Materials or the Product.

4.5

TTA. By no later than sixty (60) days after the execution of a PSA, which PSA covers the manufacture of a Product (with the exception of the manufacture of Product (eculizumab) in [*] and Product (Asfotase alfa) in [*],), the Parties shall jointly develop and enter into a technology transfer agreement, which shall set forth the specific responsibilities of the Parties in connection with the modification of the applicable Facility and implementation of the Process at such Facility (each a “TTA”). Each TTA may be amended from time to time by mutual agreement of Lonza and Alexion. Each TTA will also incorporate by reference more detailed functional plans as needed.

4.6	Initial Batches.

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4.7	Raw Materials.

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5.1	Commitment to Manufacture; Purchase. Subject to the terms and conditions set forth in this Agreement, during the Term, Alexion shall retain Lonza, in accordance with the individual PSAs executed by the Parties, as a non-exclusive manufacturer of the Product (eculizumab), and as a non-exclusive manufacturer of Product (Asfotase alfa).

5.2	Production and Supply.

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(c)	Capacity Notice. Lonza shall make good faith efforts to notify Alexion at such time as Lonza receives firm orders that would prevent Lonza having the capacity to fulfill one or more Batches set forth in the [*] of any Forecast.

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•	[*] for one or two products in no more than [*]), and

•	[*].

•

In each of the foregoing cases, Lonza can supply from any of its Facilities provided that the total price for the Batches, including the fee for Raw Materials, supplied from the alternative Facility(ies) shall not be greater than if they had been supplied from the original Facility(ies) (by way of example, if the change is from the original Facility supplying on [*]L scale to an alternative Facility supplying on a [*]L scale, the total price for [*]supplied from the alternative Facility shall be no greater than the (i) the total price of [*] supplied from the original Facility plus (ii) the fee for the Raw Materials from the original Facility).

•	Any movement of a Product to a Facility that is not at such time under a PSA requires the prior written agreement of both Parties to a new PSA for such Facility and the Parties shall work together in good faith to agree such PSA.

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5.3

Cancellation Fee. The Minimum Order cannot be canceled either by Alexion or Lonza. Any demand above the Minimum Order for which Purchase Orders have been agreed by the Parties in accordance with Section 5.2.4 are binding on both Parties and cannot be cancelled by Alexion or Lonza. Any Minimum Order or demand above the Minimum Order that is binding that Alexion requests to be cancelled will be subject to payment of a cancellation charge equal to [*] of the Batch price and [*] of any handling fee for Raw Materials in accordance with section 4.7 above. If Lonza is able to resell the cancelled Batch

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5.4	Provision of Batches.

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5.5	Excess Capacity.

5.5.2

Price Adjustment. Alexion’s obligation to utilize or pay for such excess capacity will be waived to the extent that Lonza sells such excess capacity at a price, net of its reasonable personnel and associated costs in selling such excess capacity, that is equal to or greater than Alexon would have paid had it utilized such capacity. If Lonza is able to sell the excess capacity only at a price that will yield Lonza revenues, net of Lonza’s reasonable personnel and associated costs in selling such excess capacity, that are less than Alexion would have paid had it utilized such capacity, it will only agree to such terms with Alexion’s consent and Alexion shall then be responsible for reimbursing Lonza for such lost revenues (i.e., the difference from

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6.1	Collection and Shipment. Alexion and Lonza will work together in good faith to determine estimated collection dates for Product under this Agreement and Lonza shall make Product available for collection on an [*] basis the relevant Facility (as defined by Incoterms 2010).

6.2	Title: Without prejudice to Section 7, title to and responsibility for the Product shall pass to Alexion on the date of Delivery.

6.3

Packaging and Labeling. Unless otherwise agreed, Lonza will package and label Product in accordance with its standard operating procedures. Alexion will inform Lonza in writing in advance of any special packaging and labeling requirements for the Product. All additional costs and expenses incurred by Lonza in complying with such special requirements shall be charged to Alexion in addition to the Price.

6.4

Transportation and Insurance. Alexion agrees that it shall arrange collection of the Product within [*] days after the date of Delivery. Alexion shall be responsible for insuring each Batch (at Alexion’s own cost) from the date of Delivery; Lonza shall be responsible for the costs to insure each Batch prior to the date of Delivery. The insurance value shall be equal to the replacement value of the Product ([*]). Lonza specifically acknowledges its obligation to provide validated cold storage (at the storage temperatures applicable at the Effective Date) for Product (eculizumab) and Product (Asfotase alfa), at all times prior to Alexion’s pickup. At Alexion’s request, Lonza will (acting as an independent agent for Alexion) arrange for the transportation of Product to a facility designated by Alexion together with insurance for the then applicable Price for the number of Batches transported. All additional costs and expenses incurred by Lonza in arranging transportation and insurance shall be charged to Alexion in addition to the Price provided Lonza invoices Alexion for such costs and expenses within the calendar quarter following shipment of the Batch. Transportation of the Product, whether or not under any arrangements made by Lonza on behalf of Alexion, shall be made at the sole risk and expense of Alexion. In cases where Alexion has not requested Lonza to arrange for transportation of Product, Lonza will provide reasonable co-operation with Alexion’s transportation agents in coordinating the collection of Product from the Facility.

6.5	Quarantine of Product. With the agreement of both parties, Lonza will Deliver Product Batches in quarantine prior to delivery of the Certificate of Compliance. Such request shall be accompanied by Alexion’s written acknowledgement that the Batch has been Delivered

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6.6	Inspection of Product. Where Lonza has made arrangements for the transportation of Product under Section 6.4, Lonza shall use its reasonable endeavors to notify Alexion of shipment by facsimile or e-mail (return receipt requested) on the date of dispatch. Alexion shall diligently examine the Product as soon as practicable after receipt. Notice of all claims arising out of:

6.7

Tests. Promptly following Delivery of a Batch of Product, or any sample intended to be representative thereof, Alexion shall carry out the Alexion Tests. If the Alexion Tests show that the Product fails to meet the applicable Specifications, then Alexion shall give Lonza written notice thereof within [*] days from the date of Delivery of the Batch and shall, unless otherwise directed by Lonza, return the Batch for further testing. In the absence of such written notice, the Batch shall be deemed to have been accepted by Alexion as meeting Specifications. If Lonza agrees, or it is determined pursuant to Section 6.8, that the returned Batch fails to meet Specifications and, to the extent that such failure is not due (in whole or in part) to acts or omissions of Alexion or any third party after Delivery of such Batch, the Batch in question shall be regarded as not having been Delivered and shall constitute or contribute towards a Supply Deficiency and entitle Alexion to the rights set forth in Section 5.4 (including Supply Deficiency) as well as this section 6.7, including a refund for the Batch Price and, for Product (eculizumab), an adjustment in respect of [*] in the case of a lost cycle and/or lost Batch in accordance with the relevant PSA.

6.8	Disputes. If there is any dispute concerning whether a Batch meets the applicable Specifications and/or the reasons therefor, such dispute shall be referred for decision to

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7.1	Milestone Payments

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(d)	A fee in respect of Process Validation, estimated to be [*], payable as set out in the relevant PSA. Lonza shall obtain Alexion’s prior written consent before incurring any of these Process Validation costs.

7.2	Batch Pricing

7.2.2	Process Validation Batches in [*]. For each Process Validation Batch of Product (Asfotase alfa) and Product (eculizumab) manufactured in [*] in compliance with this Agreement, Alexion shall pay Lonza an amount equal to [*] per Batch.

7.2.3	Commercial Batches. For each Commercial Batch that is manufactured in compliance with this Agreement, Alexion shall pay Lonza the following amounts:

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7.3	Other Rights of Inspection

7.4	Invoicing for Batches: For amounts owed under or related to Section 7.2, an invoice for [*] of the applicable Batch price may be issued for each Batch in a Campaign, on or after

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7.4.1	Where an invoice has been issued by Lonza for a Batch of Product and the Batch is terminated or rejected prior to the invoice being paid, then Lonza will issue Alexion [*].

7.4.2	Where an invoice has been issued by Lonza for a Batch of Product and the Batch is terminated or rejected after the invoice has been paid, then Lonza will return the payment or payments made on such invoice(s) for the terminated/rejected Batch in full within [*] days of the termination or rejection date of the Batch.

7.5

Invoicing for Raw Materials [*]. In accordance with section 4.7.1, Lonza shall invoice Alexion for Raw Materials upon Delivery of the corresponding Batch, and for safety stock of Raw Materials, Lonza shall invoice Alexion upon expiry of such Raw Materials. For any [*] (including safety stock for these items) ordered by Lonza for use in the manufacture of a Product, upon receipt of the invoice from the vendor, Lonza shall forward such invoice promptly to Alexion. Alexion shall pay Lonza in accordance with the thirty (30) day period referred to in section 7.4 above.

7.6	Payments in Lieu of Royalty. In respect of Product (eculizumab) only, whether manufactured in the [*] Facility or the [*] Facility (or such other Facility as the Parties may agree), Alexion shall make certain payments in lieu of royalty in accordance with Exhibit B.

7.7	Payment Method. All payments due hereunder shall be made by wire transfer in immediately available funds to a ba1nk designated by the Party to receive payment under the applicable PSA. Past due amounts shall bear interest at two percent (2.0%) per annum over the base rate from time to time of Bank of America, interest to accrue on a day to day basis.

7.8	Taxes. Each Party shall comply with its applicable taxation guidelines regarding filing and reporting for tax purposes. Neither Party shall treat their relationship under this Agreement

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8.1	Process. Lonza shall not unreasonably refuse any written request from Alexion to make changes to the Process (for example, changes to the Process which are required by an applicable regulatory authority or applicable laws) but no change to the Process shall be made except by an agreement in writing signed by the authorized representatives of the Parties.

8.2	Specifications. Lonza shall not unreasonably refuse any written request from Alexion to make changes to the Specifications (for example, changes to the Specifications that are required by an applicable regulatory authority or applicable laws), but no change to the Specifications shall be made except by an agreement in writing signed by the authorized representatives of the Parties.

8.3	Adjustments resulting from Process and Specification Changes. Any changes to a Process (such as column re-packing) or to the Specifications shall be implemented on terms and conditions to be agreed, which may include, but not be limited to, additional development services (to be performed on terms to be agreed), and reasonable adjustments to the Batch price.

9.1

Non-Conforming Batch. Promptly following Delivery of a Batch of Product, or any sample intended to be representative thereof, Alexion shall carry out the Alexion Tests. If the Alexion Tests show that the Product fails to meet the applicable Specifications, then Alexion shall give Lonza written notice thereof within [*] days from the date of Delivery of the Batch and shall, unless otherwise directed by Lonza, return the Batch for further testing. In the absence of such written notice, the Batch shall be deemed to have been accepted by Alexion as meeting Specifications. If Lonza agrees, or it is determined pursuant to Section 6.8, that the returned Batch fails to meet Specifications and, to the extent that such failure is not due (in whole or in part) to acts or omissions of Alexion or any Third Party after Delivery of such Batch, the Batch in question shall be regarded as not having been Delivered and shall constitute or contribute towards a Supply Deficiency

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9.2

No Lonza Liability. If it is determined by agreement of the Parties (or in the absence of such agreement, by a mutually acceptable qualified independent Third Party whose fees shall be paid by the non-prevailing Party), or it is determined pursuant to Section 6.8 that either (i) such Batch is not a Non-Conforming Batch, or (ii) such Batch is a Non-Conforming Batch but the nonconformity was not caused by Lonza (or its agents or, as set forth in Section 9.4, suppliers), then in either such case Alexion shall pay to Lonza the price of such Batch and Lonza shall have no liability to Alexion with respect thereto.

9.3

Lonza Liability; Replacement of Product. If it is determined by agreement of the Parties (or in the absence of such agreement, by a mutually acceptable qualified independent Third Party whose fees shall be paid by the non-prevailing Party) that the nonconformity was caused by Lonza (or its agents or, as set forth in Section 9.4, suppliers), at Alexion's written request, Lonza shall, in accordance with section 5.4, replace such Non-Conforming Batch with conforming Product, at no additional cost to Alexion except for payment of the price of the replacement conforming Product, to the extent that Alexion has not previously paid the price therefor. In such case, the last sentence of Section 5.4.3(II) and 5.4.5 shall also apply.

9.4	Batch Failures. If it is determined by agreement of the Parties (or in the absence of such agreement, by a mutually acceptable qualified independent Third Party whose fees shall be paid by the non-prevailing Party) that a Batch fails to meet Specifications due to:

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10.1

Regulatory Support and Audits. Lonza shall provide regulatory support to Alexion, including annual updates to any drug master files, biologics licenses and other manufacturing or marketing applications and approvals applicable to each Product held by Lonza or Alexion and the preparation for and hosting of inspections by the U.S. FDA (or other Regulatory Authorities) or Alexion (in the case of Alexion’s inspections, at mutually convenient times). Alexion shall be entitled to conduct, and the price has been calculated to include Lonza regulatory support for, one (1) audit per Product for each Facility (at such times set forth in the applicable Quality Agreement) by Alexion personnel of up to [*] days each prior to commencement of the Services at each Facility and, thereafter, one audit (at such time set forth in the applicable Quality Agreement) by Alexion personnel of up to [*] days each per Product at each Facility in any one twelve month period, as well as for cause/event audits.

10.2

Additional Support. In addition, Lonza shall allow, and the price has been further calculated to include: a) two representatives of Alexion or one of its Affiliates located at the each Facility (i.e., a person-in-plant, or, “PIP”) for a period of up to [*] months prior to Commencement of each Batch, to no longer than [*] past final release by Lonza for each Batch manufactured; b) Batch record audits of each Batch shall be permitted and copies of documentation can be provided upon request without additional cost to Alexion; and c) those costs incurred by Lonza in completion of any Pre-Approval Inspection (“PAI”) for the Product from [*].

10.3	Regulatory Submissions. Alexion shall advise Lonza of any regulatory submissions regarding the Product which may require responses from Lonza to questions from the Regulatory Authorities in a timely fashion, taking account of the amount of information Lonza is required to provide. Lonza specifically acknowledges and agrees that no

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10.4

Amendments. If Lonza is required to amend the way it manufactures or tests the Product as a result of a change in any statutory or regulatory requirement after the Effective Date, it shall use all reasonable efforts to comply with such requirement. In this event the Parties shall negotiate in good faith any appropriate revision to the Price to reflect additional costs incurred by Lonza and any appropriate revision to the time schedules for providing the Product. Lonza shall not be required or entitled to amend the Services in any way unless and until the Parties have reached such agreement.

10.5

Follow-Up Audits. If Alexion conducts an audit of a Facility pursuant to its rights under Section 10.1 and, as a result of default on the part of Lonza, Alexion has just cause to conduct further audits in order to satisfy itself as to the matters of default in question, Alexion shall be entitled, without additional payment to Lonza, to conduct [*] per Product per facility (at such times set forth in the applicable Quality Agreement) in order to satisfy itself of the matters in question unless Alexion determines during such additional audit that the default is continuing in which case Alexion may conduct an additional follow-up audit(s) until the default is resolved. Any further audits beyond this number shall be performed on reasonable terms and conditions and at a price to be agreed, based on Lonza's standard rates.

10.6	Assignment of Shared BLA. Within [*] days following termination or expiration of this Agreement, Lonza shall assign to Alexion or Alexion’s designee Lonza's interest in any shared regulatory filing or license that relates exclusively to the Product and shall provide written notice thereof to Alexion.

11.1

Assistance of Lonza. If Alexion recalls any Product (voluntarily or by order of a Regulatory Authority) or is required to respond to inquiries of any Regulatory Authority relating to the Services hereunder, Lonza agrees to provide reasonable assistance to Alexion at Alexion’s sole expense. Any assistance to be provided by Lonza in response to inquiries of Regulatory Authorities shall be provided on terms to be agreed at Lonza's standard rates for providing such assistance.

11.2

Reimbursement by Lonza. Subject to the limitations of Lonza's liability to Alexion set out in this Agreement, Lonza agrees to reimburse Alexion for [*] incurred by Alexion as a result of recall of a Product mandated by law or by an applicable regulatory body, but only to the extent Lonza's negligence or willful misconduct in performing the Services has caused such recall to be required and such recall could not have reasonably have been

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12.1

Responsibility for Quality Assurance and Quality Control. The Parties shall negotiate in good faith to enter into a Quality Agreement, with respect to each Facility, no later than [*] days after the execution of the first PSA (or such other date set forth in such PSA) for such Facility. Responsibility for Quality Assurance obligations and quality control of each Product shall be allocated between Alexion and Lonza as set forth in each Quality Agreement and in standard operating procedures agreed upon in writing by Alexion and Lonza from time to time.

13.1	Background IP. Except as expressly otherwise provided herein, neither Party will, as a result of this Agreement, acquire any right, title, or interest in any Background Intellectual Property of the other Party.

13.2

New Alexion IP. Subject to section 13.3, Alexion shall own all right, title, and interest in and to any and all Intellectual Property that Lonza and its Affiliates or other contractors or agents of Lonza develop, conceive, invent, first reduces to practice or makes, solely or jointly with Alexion or others, that (a) directly relates to the use of, (b) is solely a direct derivative of or (c) is an improvement to either (i) Alexion Confidential Information, (ii) and Alexion Background Intellectual Property or (iii) materials, processes or composition of matter that are owned or controlled by Alexion (collectively, the “New Alexion Intellectual Property”). For avoidance of doubt, “New Alexion Intellectual Property” shall include any material, processes, compositions of matter, articles of manufacture or other items that solely embody, or that are claimed or covered by, any of the foregoing Intellectual Property, but excluding any New General Application Intellectual Property.

13.3

New Lonza IP. Subject to the license granted in section 13.5, Lonza shall own all right, title and interest in Intellectual Property that Lonza and its Affiliates, the External Laboratories or other contractors or agents of Lonza, solely or jointly with Alexion, develops, conceives, invents, or first reduces to practice or makes in the course of performance of this Agreement that (i) is generally applicable to the development or manufacture of chemical or biological products or product components other than Intellectual Property that specifically relates to Products or (ii) is an improvement of, or direct derivative of, any Lonza Background Intellectual Property (“New General Application Intellectual Property”). For avoidance of doubt, “New General Application

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13.4

Assignment. Lonza hereby assigns to Alexion all of its right, title and interest in any New Alexion Intellectual Property. Lonza shall execute, and shall require its personnel as well as its Affiliates, or other contractors or agents and their personnel involved in the performance of this Agreement to execute, any documents reasonably required to confirm Alexion’s ownership of the New Alexion Intellectual Property, and any documents required to apply for, maintain and enforce any patent or other right in the New Alexion Intellectual Property.

13.5	Licence to Alexion. Subject to the terms and conditions set forth herein, Lonza hereby grants to Alexion a non-exclusive, world-wide, fully paid-up, irrevocable, transferable license, including the right to grant sublicenses, under the New General Application Intellectual Property, to make, use, sell, offer for sale and import Product manufactured under this Agreement.

13.6	Licence to Lonza. Alexion hereby grants Lonza the non-exclusive right to use the Alexion Confidential Information, Alexion Background Intellectual Property and New Alexion Intellectual Property during the Term solely for the purpose of fulfilling its obligations under this Agreement.

1.4	Alexion. Alexion represents warrants and covenants to Lonza that:

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1.5	Lonza. Lonza represents warrants and covenants to Alexion that:

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14.2.9	Lonza maintains has at all times and shall during the term of this Agreement shall maintain each Facility in accordance with cGMP requirements, including all cGMP certificates necessary and/or required, and all legal and regulatory requirements.

1.6

Limitation of Liability. Subject to the exceptions set forth in this Section 14.3 below, each Party’s liability under this Agreement shall not exceed the greater of (a) the total amount paid by Alexion to Lonza under this Agreement (and not just a single PSA) during the [*] preceding the date the allegedly liable Party received notice from the other Party alleging the liability and (b) [*]. Notwithstanding the foregoing, a Party’s liability for any of the following shall not be limited or capped:

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1.7

Disclaimer of Consequential Damages. EXCEPT FOR CLAIMS ARISING FROM THE MISUSE OR MISAPPROPRIATION OF THE OTHER PARTY'S CONFIDENTIAL INFORMATION OR INTELLECTUAL PROPERTY, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES ARISING FROM OR RELATED TO BREACH OF THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY CLAIMS FOR DAMAGES BASED UPON LOST PROFITS FOR SALES TO THIRD PARTIES. THE FOREGOING DISCLAIMER SHALL BE EFFECTIVE TO THE EXTENT PERMITTED BY APPLICABLE LAW.

2.6	Indemnification.

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2.7	Indemnification Procedures.

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2.8

Procedure for Product Liability Claims. Notwithstanding anything to the contrary in Section 15.2.2, in the event Alexion seeks indemnification from Lonza under Section 15.1.2(f), then the Parties, each at its own expense, shall cooperate in the defense and settlement of such claims, provided, however that in the event that it is determined that such product liability was not the result of an action of Lonza for which Lonza has indemnified Alexion pursuant to Section 15.1.2(f), then Alexion shall reimburse Lonza for all reasonable fees and expenses incurred by Lonza (including without limitation attorneys’ fees) in the defense and settlement of such claim and provided further in the event that it is determined that such product liability was the result of an action of Lonza for which Lonza has indemnified Alexion pursuant to Section 15.1.2(f) then Lonza shall reimburse Alexion for all reasonable fees and expenses (including without limitation attorneys’ fees) incurred by Alexion in the defense and settlement of such claim. Notwithstanding the foregoing, in the event that it is determined that such product liability was only partially the result of an action of Lonza for which Lonza has indemnified Alexion pursuant to Section 15.1.2(f), any payments and reasonable attorney fees incurred in connection with such claims are to be apportioned between the Parties in accordance with the degree of cause attributable to each Party.

2.9

Abatement. Notwithstanding anything to the contrary in this Agreement, in the event that the use of the Lonza Process or the Lonza Media Formulations is held in a suit or proceeding to infringe any intellectual property rights of a third party (or to constitute the misappropriation of a trade secret of a third party), and the use of the Lonza Process and/or the Lonza Media Formulations is enjoined, or Lonza has an objective basis (confirmed by an opinion of its legal counsel) for believing that it is likely to be found to infringe or constitute a misappropriation, or is likely to be enjoined, then Lonza shall, at its sole cost

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2.10

Insurance. Lonza shall obtain and maintain insurance coverage of the types and in the amounts customary and consistent with the chemical industry standards. Without limiting the foregoing, Lonza shall obtain and maintain third party liability insurance and shall name Alexion and its Affiliates as named insureds on that policy. Alexion shall obtain and maintain insurance coverage which is customary and consistent with pharmaceutical industry standards, naming Lonza and its Affiliates as named insureds and providing that Lonza shall be notified at least thirty (30) days in advance of termination of such coverage.

2.11	Survival of Indemnification Obligations. The provisions of this Article 15 shall survive the termination or expiration of this Agreement.

3.6	Confidentiality Obligations.

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3.7	Exclusions. The obligations of confidentiality and nonuse applicable hereunder to Lonza with respect to Alexion Confidential Information and to Alexion with respect to Lonza Confidential Information shall not apply to any information which the recipient demonstrates:

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3.8	Notification of Mandatory Disclosure.

3.9	No Licenses; Maintenance of Confidentiality; Non-use Obligations.

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3.10	Survival of Confidentiality Obligations. The provisions of this Article 16 shall survive the termination or expiration of this Agreement.

3.11

Information Under Certain Prior Agreements. The Parties agree that all Confidential Information exchanged between the Parties or their Affiliates under previous confidentiality agreements still in effect shall be deemed Confidential Information under this Agreement (either Alexion Confidential Information or Lonza Confidential Information, as the context requires) and shall be subject to the terms of this Agreement.

4.8

Press Releases. No press release, publicity or other form of public written disclosure related to this Agreement, including the existence thereof, shall be permitted by either Party unless the other Party has indicated its consent to the form of the release in writing. This Section shall not apply to any disclosure as is deemed necessary, in the reasonable judgment of the responsible Party, to comply with regional, national, federal or state or local laws or regulations (including the rules and regulations of any national stock exchange on which such Party's securities are traded), or in connection with any proceedings under Section 19, provided, that each Party will take reasonable best efforts to have this Agreement and any reference to the provisions hereof filed under seal or otherwise kept confidential in any such proceeding.

4.9	Use of Names. Subject to the final sentence of Section 17.1, no Party shall use the name of the other Party in any advertising or promotional material, or otherwise, in connection with this Agreement or any related agreements, without the prior written consent of such other Party.

5.6	Term. Unless sooner terminated pursuant to the terms of this Agreement or extended by mutual agreement of the Parties, the term of this Agreement (the "Term") shall commence on the Effective Date and shall remain in effect until [*].

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5.7	Termination.

5.8	Consequences of Termination.

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(a)	Lonza shall cease and refrain from manufacturing and supplying Product for Alexion in accordance with Section 5.2.4;

(b)	Each Party shall deliver to the other Party all of the other Party’s Confidential Information;

(a)

Lonza shall deliver to Alexion all Alexion intellectual property transferred by Alexion to Lonza hereunder and all copies of all manufacturing records and information relating to the Process and/or Product that Lonza has maintained under this Agreement. Notwithstanding the foregoing, (i) Lonza may retain and continue to use copies of such data, records, information, and documentation to the extent strictly required to comply with all applicable material regional, national, state and local laws, ordinances and governmental rules or regulations, and (ii) Lonza legal department may retain one copy of the foregoing, in each case, subject to its continuing obligation of confidentiality under Article 16;

(b)	Lonza shall deliver to Alexion all remaining raw materials or destroy such raw material, as determined in Alexion’ sole discretion. Alexion shall purchase any remaining useable raw materials, including without limitation any safety stock, at their Acquisition Cost; and.

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(c)	all Alexion equipment will, at Alexion’s discretion and Alexion’s cost, either be (i) removed and returned to Alexion, (ii) removed and destroyed, or (iii) rendered inoperable.

6.9	Governing Law. The construction, validity, performance and enforcement of this Agreement shall be governed and enforced pursuant to the laws of Switzerland, without giving effect to the principles of conflicts of law thereof.

6.10

Dispute Resolution. Subject to Section 6.8, in the event of the failure on the part of any required representative of the Parties hereto or the Joint Steering Committee to resolve any matter required by this Agreement to be agreed, or in the event of any other dispute or claim arising between the Parties under this Agreement, the Parties shall attempt by good faith negotiations to resolve such dispute or claim between them by reference to the Executive Steering Committee, which shall negotiate in good faith during a period of not less than thirty (30) days to resolve such matter, dispute or claim. If the Executive Steering Committee is not able to resolve such matter, dispute or claim within such thirty (30) day period, the matter, dispute or claim shall be submitted to the Chief Executive Officers of Alexion Inc and Lonza Group AG (“CEOs”) for resolution. If the CEOs are unable to resolve such matter, dispute or claim within a further thirty (30) day period, the matter, dispute or claim shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one or more arbitrators appointed in accordance with the said Rules.

6.11	Injunctive Relief. Nothing in this Agreement shall be construed to limit either party’s right to seek immediate injunctive relief in the event of a breach hereof for which no monetary damages is calculable, including without limitation any provisions related to confidentiality and intellectual property.

6.12	No Waiver. No failure or delay on the part of either Lonza or Alexion to exercise or enforce any rights conferred on it by the Agreement shall be construed or operate as a waiver thereof nor shall any single or partial exercise of any right, power or privilege or

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6.13	Severability. The illegality or invalidity of any provision (or any part thereof) of this Agreement shall not affect the legality, validity or enforceability of the remainder of its provisions or the other parts of such provision, as the case may be.

7.9

Effect of Force Majeure Event. No Party shall be in breach of this Agreement if there is any failure of performance under this Agreement (except for payment of any amounts due under this Agreement) occasioned by any reason beyond the control and without the fault or negligence of the Party affected thereby, including an act of God, fire, act of government or state, war, civil commotion, insurrection, embargo, an infectious virus which cannot be detected by testing and which causes a shutdown for a substantial period of a large portion of a Facility due to contamination despite reasonable best efforts by Lonza to prevent such occurrence, prevention from or hindrance in obtaining energy or other utilities, a market shortage of raw materials or necessary components, but specifically excluding labor disputes or work stoppages of whatever nature (a "Force Majeure Event"). Nothing in this Section 20.1 shall, however, release such Party from using its Reasonable best efforts to avoid or remove all such causes. Upon cessation of such Force Majeure Event, the affected Party shall promptly resume performance under this Agreement.

7.10

Notice of Force Majeure; ESC. Each Party agrees to give the other Party prompt written notice of the occurrence of any Force Majeure Event, the nature thereof, and the extent to which the affected Party will be unable fully to perform its obligations under this Agreement. At the request of either Party, the ESC shall meet and discuss in good faith possible ways to correct or remedy the Force Majeure Event. Each Party further agrees to use Reasonable best efforts to correct the Force Majeure Event as quickly as practicable and to give the other Party prompt written notice when it is again fully able to perform such obligations.

7.11	Termination. Alexion may terminate this Agreement if Lonza is unable to perform pursuant to this Article 20 for a period of [*] months, and Lonza may terminate this Agreement if Alexion is unable to perform pursuant to this Article 20 for a period of [*] months.

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8.4	Additional Duties and Obligations of Lonza.

21.1.2	Records. Lonza shall maintain proper technical files and administrative and accounting records with respect to the Services in accordance with all applicable laws. All such original files and records, in whatever form, shall be retained by Lonza for a period not less than [*] years, or any longer periods as per applicable laws, from the date of termination of this Agreement.

21.1.3	Personnel. Without relieving or limiting Lonza’s obligations hereunder in any way whatsoever, all Services shall be performed by Lonza’s personnel or Lonza’s contractors who have the necessary technical skills, qualifications, experience and training to complete the Services.

8.5

Alexion Material. All Alexion Material (including, but not limited to, manufacturing formula, processing instructions, sampling and testing methods, etc.), whether or not patentable, shall be the sole and exclusive property of Alexion. All Alexion New Material shall be supplied to Alexion or its designee in accordance with the terms of this Agreement. Lonza shall not sell or otherwise dispose of any Alexion Materials, except as expressly authorized by Alexion.

8.6

Approved Subcontractors. Lonza shall not subcontract or delegate any portion of its obligations hereunder, except to an Approved Subcontractor, and provided that Lonza shall remain solely and fully liable for the performance of Approved Subcontractors. Lonza shall ensure that any Approved Subcontractor performs its obligations pursuant to the terms of this Agreement, including the Annexes. Lonza shall maintain copies of the documents held by or under the control of the Approved Subcontractors to be provided to Alexion, as required under this Agreement.

8.7

Facility. Lonza will Process the Products exclusively at the Facilities specified in the applicable PSA for such Product. Transfer of the Processing of the Products to another facility or Facility requires the prior written approval of Alexion. If Lonza transfers or sells any rights in any Facility it shall ensure that all of Alexion’s rights as set forth in this Agreement shall continue to apply in full force and effect after any such transfer or sale.

8.8

Authorizations and Permits. Lonza warrants that it holds, and/or will cause its Approved Subcontractors to hold, all necessary authorizations and permits for any and all Processing under this Agreement from the competent authorities of the country or countries where such Processing takes place for the acquisition, manufacture, storage and handling of the Components and the Product. Lonza shall provide, and/or shall cause its Approved Subcontractors to provide copies of any such authorizations and permits to Alexion upon

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8.9	Technology Transfer. At any time during the course of this Agreement, Alexion can request that Lonza transfer the Process for any Product to a Third Party, and the Parties shall enter into a technology transfer agreement according to the terms in Exhibit D.

8.10

Assignment. Neither Party shall be entitled to assign this Agreement without the prior written consent of the other, which consent shall not be unreasonably withheld or delayed, except that both Parties shall be entitled without the prior written consent of the other to assign this Agreement (i) to an Affiliate, (ii) to any joint venture company of which that Party is the beneficial owner of more than fifty per cent (50%) of the issued voting share capital thereof or (iii) to any company to which that Party may transfer all or substantially all of its assets or capital stock relating to the activities contemplated under this Agreement, whether through purchase, merger, consolidation or otherwise (each of (i)-(iii) being a “Permitted Assignee”). In the event of transfer or assignment of this Agreement by Lonza to a Permitted Assignee, the obligations of Section 4.2.2 and 4.2.3, including all cross references thereto shall continue to be binding upon the Permitted Assignee and shall still be binding on Lonza for as long as such terms are binding on the assignee or transferee. Any purported assignment contrary to this Section 21.6 shall be null and void.

8.11

Guarantee of Performance. Lonza Group hereby guarantees the performance by Lonza of the Services and/or any other obligations on Lonza in this Agreement, and shall be responsible for Lonza’s actions and omissions as if they were the actions and omissions of Lonza Group. Alexion Inc hereby guarantees the performance by Alexion of the financial obligations on Alexion in this Agreement, and shall be responsible for Alexion’s actions and omissions relating to such financial obligations as if they were the actions and omissions of Alexion Inc.

8.12	Publicity. The text of any press release or other communication to be published by or in the media concerning the subject matter of this Agreement (not previously published pursuant to this Section 21.3) shall require the prior written approval of Lonza and Alexion, except to the extent required by law.

8.13	Independent Contractor. Each Party to this Agreement acts as an independent contractor and nothing in this Agreement shall be construed to create a relationship of partnership, principal and agent, or joint venture between the Parties.

8.14	Notices. Any notice or other communication to be given under this Agreement shall be delivered personally or sent by first class pre-paid registered or certified mail, return receipt requested, nationally recognized courier service or facsimile transmission addressed as follows:

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8.15	Headings. The headings in this Agreement are for convenience of reference only and shall not constitute part of this Agreement.

8.16	Counterparts. This Agreement may be executed in several counterparts, each of which is an original but all of which shall constitute one instrument.

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8.17	Binding Effect. This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns. Other than Indemnitees, no other person or entity shall have any rights or benefits under this Agreement.

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1.

Alexion shall keep true and accurate records and books of account containing all data necessary for the calculation of the PILR payable to Lonza (Switzerland). Such records and books of account shall be kept for no less than [*] years from the date of sales of the Product (eculizumab) to which they relate and shall, upon reasonable notice having been given by Lonza, be open at all reasonable times during business hours for inspection by Lonza or its duly authorized representative.

2.

Alexion shall prepare a statement in respect of each calendar quarter which shall show for the quarter in question details of the sales of Product (eculizumab), the weighted average exchange rates used to convert to US Dollars, and the PILR due and payable to Lonza (Switzerland) thereon. Alexion’s best estimate of such statement shall be submitted to Lonza within [*] days of the end of the calendar quarter to which it relates together with a remittance for the estimated

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a.

shall be made in US Dollars to Lonza (Switzerland). Amounts payable to Lonza (Switzerland) based on sales in currencies other than US Dollars shall be converted to US Dollars at the rate of exchange at the close of business on the date Alexion receives the amount from the Alexion customer. The rate of exchange shall be the value of US Dollars compared to the other currency as published by Thomson Reuters. The rate of exchange used reflects the prior day ending rate. Alexion may change the source of such rates not more than [*] every [*] by giving Lonza advance written notice and provided the new source is an internationally recognized provider of managed rates and the rates are consistent with those used for Alexion’s audited financial statements.

b.

are exclusive of any Value Added Tax or of any other applicable taxes, levies, imposts, duties and fees of whatever nature imposed by or under the authority of any government or public authority which shall be paid by Alexion, provided that an exception shall apply in the case of any withholding taxes, which Alexion is required by applicable law to deduct against PILR payments due under this Agreement. The parties agree to co-operate in all respects necessary to take advantage of the relevant double taxation agreements as may be available to reduce or eliminate any withholding tax at source.

c.	shall be made to the following account:

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1.	Alexion and, in its capacity as guarantor under Section 21.2 of the Agreement, Alexion Inc, undertake to pay the PILR directly to Lonza Swiss Licences.

2.	Lonza Swiss Licences shall be entitled to enforce the payments of the PILR.

3.	Lonza Swiss Licences shall be entitled to enforce the audit and the related rights under Exhibit 1 of the Agreement as they relate to the PILR.

4.	Lonza Swiss Licences shall become the direct beneficiary of any payments due under Section 19.2.1 of the Agreement.

5.	Lonza Swiss Licences has the right to compel performance from Alexion and Alexion Inc according to Art. 112 sec. 2 of the Swiss Code of Obligations.

6.	By signing this supplement Lonza Swiss Licences notifies Alexion and Alexion Inc of its intention to exercise the conferred rights according to Art. 112 sec. 3 of the Swiss Code of Obligations.

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7.

Payment by Alexion or, as guarantor, Alexion Inc, of any PILR (or of any payment under Section 19.2.1 of the Agreement) to Lonza Swiss Licences shall satisfy all payment obligations of Alexion and Alexion Inc under the Agreement with respect to such PILR (or payment under Section 19.2.1) and shall relieve Alexion and Alexion Inc of any obligation to pay Lonza Group and/or Lonza Biologics Tuas Pte Ltd any amount with respect to such PILR (or such payment under Section 19.2.1). Nothing contained in this Section 2.8 shall relieve Alexion or Alexion Inc of any obligation to Lonza Swiss Licences with respect to the payment of interest that accrues in respect of PILR payments that are not received by the applicable due date and which becomes payable in accordance with Exhibit 1 to the Agreement (under the heading “Late Payments”).

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•	Product ([*])

◦	Lonza shall provide up to [*] hours of support over a period of a maximum of [*], whichever is reached first, but Lonza shall use reasonable commercial endeavours to provide further support to Alexion if the transfer has not been completed by that point.

◦	Lonza would initiate support to begin tech transfer within [*] of the official request by Alexion of their intent to tech transfer

◦	Alexion shall pay USD [*] for [*] hours of Lonza support, plus all reasonable travel and accommodation expenses of Lonza

◦	Not to be carried out at same time as Soliris TT support to another supplier

◦	Tech transfer agreement to include a [*] to Alexion to use the Lonza Patent Rights and Lonza Information

◦	Tech transfer agreement to include right for Alexion to cross reference Lonza’s drug master files and other regulatory submissions

◦	No more than [*] in Lonza facility by Alexion (other CMO not to be onsite at any Lonza facility) or [*] to new CMO by Lonza, as reasonably agreed between the Parties

◦	Not to be carried out prior to completion of the Asfotase[*]TT and validation batches to [*]

•	Product ([*])

o	Up to a maximum of [*] hours of support over a period of a maximum [*], whichever is reached first, but Lonza shall use reasonable commercial endeavours to provide further support to Alexion if the transfer has not been completed by that point.

o	Lonza would initiate support to begin tech transfer within [*] of the official request by Alexion of their intent to tech transfer

o	Alexion shall pay USD [*] for [*] hours of Lonza support, plus all reasonable travel and accommodation expenses of Lonza

o	Not to be carried out prior to completion of the [*] TT and validation batches to Porriño

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o	Not to be carried out at same time as Asfotase alfa TT support to another supplier

o	No more than [*] in Lonza facility by Alexion (other CMO not to be onsite at any Lonza facility) or [*] to new CMO by Lonza, as reasonably agreed between the Parties

o	Tech transfer agreement to include a non-exclusive license to Alexion to use the Lonza Patent Rights and Lonza Information

o	Tech transfer agreement to include right for Alexion to cross reference Lonza’s drug master files and other regulatory submissions

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1	I have reviewed this Annual Report on Form 10-K for the year ended December 31, 2014 of Alexion Pharmaceuticals, Inc.;

2	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4	The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)	Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)	Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5	The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

1	I have reviewed this Annual Report on Form 10-K for the year ended December 31, 2014 of Alexion Pharmaceuticals, Inc.;

2	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4	The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)	Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)	Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5	The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

(1)	the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)	the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

(1)	the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)	the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.