Amphastar Pharmaceuticals, Inc. (Form: 10-Q, Received: 11/13/2014 16:20:34)

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Except as set forth below there were no material changes from the risk factors previously disclosed in the Company’s IPO prospectus filed June 25, 2014 and our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2014, as filed with the SEC on August 13, 2014.

Risks Relating to Our Business and Industry

Our enoxaparin product represents a significant portion of our net revenues. If the sales volume or pricing of this product continues to decline, or if we are unable to satisfy market demand for this product, it could have a material adverse effect on our business, financial position and results of operations.

Sales from our enoxaparin product, which is our largest selling product, represented 64% and 54% of our total net revenues for the year ended December 31, 2013 and the three months ended September 30, 2014, respectively. We are currently experiencing declining revenue from enoxaparin and some of our other existing products and anticipate that we may operate at a loss in the near term while continuing to invest in developing new products. If the sales volume or pricing of enoxaparin continues to decline, or if we are unable to satisfy market demand for this product, our business, financial position and results of operations could be materially and adversely affected, and the market value of our common stock could decline. For example, due to intense pricing competition in the pharmaceutical industry, we have experienced significant declines in the per unit pricing and gross margins attributable to our enoxaparin product since its commercial launch, even during periods where we have increased market share and net revenues. This product could be rendered obsolete or economically impractical by numerous factors, many of which are beyond our control, including:

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decreasing average sales prices;

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development by others of new pharmaceutical products that are more effective than ours;

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entrance of new competitors into our markets;

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loss of key relationships with suppliers, group purchasing organizations or end-user customers;

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manufacturing or supply interruptions;

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changes in the prescribing practices of physicians;

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changes in third-party reimbursement practices;

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product liability claims; and

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product recalls or safety alerts.

Any factor adversely affecting the sale of enoxaparin may cause our revenues to decline, and we may not be able to achieve and maintain profitability.

Although we reported net income for fiscal 2012 and fiscal 2013, we have incurred losses in the first, second, and third quarters of 2014.

We recorded net losses of $1.6 million, $1.2 million, and $5.4 million for the three months ended March 31, 2014, June 30, 2014, and September 30, 2014, respectively, compared with net income of $2.4 million and $7.8 million for the three months ended March 31, 2013 and June 30, 2013, and a net loss of $0.2 million for the three months ended September 30, 2013, respectively. The losses resulted principally from a decrease in profit sharing revenues under our profit sharing agreement with Actavis, Inc., or Actavis, under which Actavis markets and distributes our enoxaparin product to the retail market in the U.S. We may continue to incur operating and net losses and negative cash flow from operations. Our business may generate operating losses to the extent Actavis reports decreased profit levels on their determined sales volumes and product pricing for enoxaparin, if we are unable to maintain and expand our relationships with group purchasing organizations or if we do not successfully commercialize our product candidates and generate sufficient revenues to support our level of operating expenses. Because of the numerous risks and uncertainties associated with our profit sharing agreement, our commercialization efforts and future product development, we are unable to predict whether we will be able to achieve and maintain profitability .

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Sales of our products may be adversely affected by the continuing consolidation of our customer base.

A significant proportion of our sales are made to relatively few U.S. wholesalers and group purchasing organizations. These customers are continuing to undergo significant consolidation. Sales to three of these customers for the year ended December 31, 2013 and the three months ended September 30, 2014, respectively, accounted for approximately 54% and 46% of our total net revenues, respectively. Such consolidation has provided and may continue to provide them with additional purchasing leverage, and consequently may increase the pricing pressures that we face. Additionally, the emergence of large buying groups representing independent retail pharmacies, and the prevalence and influence of managed care organizations and similar institutions, enable those groups to extract price discounts on our products.

Moreover, we are exposed to a concentration of credit risk as a result of this concentration among our customers. If one or more of our major customers experienced financial difficulties, the effect on us would be substantial. This could have a material adverse effect on our business, financial condition and results of operations.

Our net sales and quarterly growth comparisons may also be affected by fluctuations in the buying patterns of retail chains, major distributors and other trade buyers, whether resulting from seasonality, pricing, wholesaler buying decisions or other factors. In addition, because a significant portion of our U.S. revenues is derived from relatively few customers, any financial difficulties experienced by a single customer, or any delay in receiving payments from a single customer, could have a material adverse effect on our business, financial condition and results of operations.

Significant balances of intangible assets, including goodwill, are subject to impairment testing and may result in impairment charges, which may materially and adversely affect our results of operations and financial condition.

A significant amount of our total assets is related to goodwill and intangible assets. As of September 30, 2014 the value of our goodwill and intangible assets net of accumulated amortization was $43.2 million. Goodwill and other intangible assets are tested for impairment annually when events occur or circumstances change that could potentially reduce the fair value of the reporting unit or intangible asset. Impairment testing compares the fair value of the reporting unit or intangible asset to its carrying amount. For example, for the year ended December 31, 2012 we had an impairment charge of $2.1 million primarily related to equipment for a production project that was suspended. Any future goodwill or other intangible asset impairment, if any, would be recorded in operating income and could have a material adverse effect on our results of operations and financial condition.

Risks Relating to Regulatory Matters

Some of our products are marketed without FDA approval and may be subject to enforcement actions by the FDA.

A number of our prescription products are marketed without FDA approval. These products, like many other unapproved prescription drugs on the market, contain active ingredients that were first marketed prior to the enactment of the FFDCA. The FDA has assessed these products in a program known as the “Prescription Drug Wrap-Up” and has stated that these drugs cannot be lawfully marketed unless they comply with certain “grandfather” exceptions to the definition of “new drug” in the FFDCA. These exceptions have been strictly construed by FDA and by the courts, and the FDA has stated that it is unlikely that any of the unapproved prescription drugs on the market, including certain of our drugs, qualify for the exceptions. At any time, the FDA may require that some or all of our unapproved prescription drugs be approved and may direct that we recall these products and/or cease marketing the products until they are approved. The FDA may also take enforcement actions based on our marketing of these unapproved products, including but not limited to the issuance of an untitled letter or a warning letter, and a judicial action seeking injunction, product seizure and civil or criminal penalties. While the FDA has not undertaken any such enforcement actions against our unapproved drugs, the enforcement posture could change at any time and our ability to market such drugs would terminate with little or no notice. Moreover, our competitors may market FDA approved prescription products that compete against our unapproved prescription products. Such competitors have brought, and in the future may bring, claims against us alleging unfair competition or related claims.

As a result of our meetings with the FDA in 2009, we decided to discontinue all of our products that were subject to the Prescription Drug Wrap-Up program, with the exception of epinephrine in vial form. These products were all produced at our subsidiary, IMS. During the third quarter of 2010, the FDA requested that IMS reintroduce several of the withdrawn products to cope with a drug shortage, while IMS prepared and filed applications for approval of the products. Between August and October, 2010, IMS reintroduced atropine, calcium chloride, morphine, dextrose, epinephrine, lidocaine and sodium bicarbonate injections, and continues to market these products without FDA approval. For the year ended December 31, 2013 and the three months ended September 30, 2014, we recorded net revenues of $29.6 million and $8.3 million, respectively, from these products. IMS has received approval for one ANDA, filed three ANDAs and is preparing two additional ANDAs and one NDA with respect to these products for submission under an expedited review process by the FDA. We may not obtain approval for any of these products.

Risks Related to Ownership of Our Common Stock

Jack Y. Zhang and Mary Z. Luo, each of whom serves as a director and an executive officer, own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.

As of November 10, 2014, Jack Y. Zhang and Mary Z. Luo, each of whom serves as one of our directors and executive officers, and their affiliates beneficially own approximately 23.4% of our outstanding common stock, including shares of common stock subject to options exercisable within 60 days of November 10, 2014. Our directors, executive officers and each of our stockholders who own greater than 5% of our outstanding common stock and their affiliates, in the aggregate, own approximately 26.2% of the outstanding, including shares of our common stock, based on the number of shares outstanding and shares of our common stock subject to options exercisable within 60 days of November 10, 2014. As a result, these stockholders, if acting together, will be able to influence or control matters requiring approval by our stockholders, including the election of directors and the approval of mergers, acquisitions or other extraordinary transactions. They may also have interests that differ from yours and may vote in a way with which you disagree and which may be adverse to your interests. This concentration of ownership may have the effect of delaying, preventing or deterring a change of control of our company, could deprive our stockholders of an opportunity to receive a premium for their common stock as part of a sale of our company and might ultimately affect the market price of our common stock.

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[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Exhibit 10.1

28903 North Avenue Paine, Valencia, California 91355 USA

61 South Paramus Road, Paramus, New Jersey 07652 USA

One Casper Street, Danbury, Connecticut 06810 USA

www.mannkindcorp.com

Supply Agreement

This Supply Agreement (the “ Agreement ”) is made as of the 31st day of July, 2014 (the “ Effective Date ”) by and between MannKind Corporation, a Delaware corporation (“ MannKind ”), with its principal office and place of business at 28903 North Avenue Paine, Valencia, CA 91355, U.S.A., and Amphastar France Pharmaceuticals S.A.S., a French corporation (“ AFP ”), with its principal office and place of business at Usine Saint-Charles, 60590 Eragny-Sur-Epte, France (each of MannKind and AFP, a “ Party ” and together, the “Parties” ).

RECITALS

Whereas , MannKind has developed and obtained marketing approval for its product AFREZZA ® (“ MannKind Product ”); and

Whereas , AFP is in the business of manufacturing and supplying recombinant human insulin, an active pharmaceutical ingredient (“ API ”); and

Whereas , MannKind and AFP desire to enter into this Agreement to provide the terms and conditions upon which AFP shall manufacture for and supply to MannKind recombinant human insulin API, SIHR Insulin (“ Product ”).

Agreement

Now Therefore , in consideration for the representations, warranties and covenants set forth below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as set forth below.

1. Certain Definitions.

1.1 “Affiliate” means, with respect to any Party, another entity or person which directly or indirectly, is controlled by, or controls, or is under common control with such Party, where, for purposes of this definition, the term “control” means ownership, directly or indirectly, of more than 50% of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or more than 50% of the equity interests in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby a Party controls or has the right to control the Board of Directors or equivalent governing body of a corporation or other entity, or if such level of ownership or control is prohibited in any country, any entity owning or controlling at the maximum control or ownership right permitted in the country where such entity exists.

1.2 “Confidential Information” means any confidential or proprietary information of a Party disclosed to the other Party or generated in the course of this Agreement, including inventions, know-how, works of authorship, software, data, software tools, designs, schematics, plans or other information relating to any work in process, future development, engineering, manufacturing, marketing or business plan, or financial or personnel matters relating to either Party, its present or future products, sales, suppliers, customers, employees, investors or business.

1.3 “Current Good Manufacturing Practices” or “ cGMP ” means the methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug or API to assure that such drug or API meets the regulatory requirements of the FDA and as further defined in 21 C.F.R. Parts 210 and 211 and the guidance of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research and the European Commission Directive 2003/94/EC of October 8, 2003.

1.4 “Excluded Countries” means [***].

1.5 “FDA” means the United States Food and Drug Administration or any successor agency in the United States.

1.6 “Intellectual Property Rights” means any and all rights in and to discoveries, concepts, ideas, Technical Information, developments, specifications, methods, drawings, designs, flow charts, diagrams, models, formulae, procedures, processes, schematics, specifications, algorithms, apparatus, inventions, ideas, know-how, materials, techniques, methodologies, modifications, improvements, works of authorship and data (whether or not protectable under patent, copyright, trade secrecy or similar laws), including patents, copyrights, trade secrets, manufacturing documentation, and any other form of protection afforded by law to inventions, works of authorship, databases or technical information and applications and registrations with respect thereto.

1.7 “Non-conforming Product” means Product that does not conform to the Specifications, the Quality/Technical Agreement, or does not conform to cGMP, or is not free from defect, adulteration or contamination, or is not free and clear of all liens, claims and encumbrances upon delivery.

1.8 “Project Team” has the meaning set forth in § 2.2(a).

1.9 “ Purchase Commitment Quantities ” has the meaning set forth in § 6.1.

1.10 “Purchase Order” means a purchase order that is issued by MannKind and accepted by AFP for the purpose of obtaining the Product under this Agreement.

1.11 “Quality/Technical Agreement ” or “ QTA ” means a separate agreement, executed subsequent to this Agreement, between the Parties which shall be incorporated herein by reference, and which sets forth, among other things, the quality control and quality assurance terms for the Product. In case of a discrepancy between this Agreement and the Quality/Technical Agreement, as to quality and technical matters the terms of the Quality/Technical Agreement shall govern, otherwise the provisions of this Agreement shall prevail.

1.12 “ Quarter ” shall mean a period of three consecutive months during a calendar year beginning on and including January 1 st , April 1 st , July 1 st and October 1 st .

1.13 “ Specifications ” means the technical specifications for the Product, as further described in the QTA .

1.14 “Technical Information” means either Party’s pre-existing technical documentation and information relating to manufacture of the Product, or to human insulin for use in the manufacture of the MannKind Product.

1.15 “Territory” means all countries in the world except the Excluded Countries.

2. Performance Obligations

2.1 Supply .

(a) Performance. AFP shall manufacture and supply the Product in accordance with the Specifications, Quality/Technical Agreement, and all applicable laws of the United States and European Union. AFP shall perform its activities in accordance with professional standards and practices including, but not limited to cGMP. AFP shall provide cGMP facilities as well as resources for such services including, but not limited to testing, release, storage, and manufacture of the Product. MannKind shall provide AFP, upon request and only for use in accordance with the terms of this Agreement, with any and all Technical Information of MannKind that AFP reasonably determines it may need to manufacture and supply the Product. Any distribution or sales by MannKind of the Product or the MannKind Product made using the Product shall be limited to the Territory until such time, if ever, as the geographical restrictions on the distribution and sale of the Product are no longer applicable under any third party license agreement with AFP.

(b) Manufacturing Site; Subcontracting. AFP shall manufacture the Product only at its facility in Eragny-Sur-Epte, France and shall not manufacture Product at any other site, except with MannKind’s prior written consent, which it may withhold in its reasonable discretion. AFP shall not delegate or subcontract the performance of activities under this Agreement to third party subcontractors, except with MannKind’s prior written consent, which it may withhold in its reasonable discretion, provided that, if MannKind provides consent to allow AFP to delegate or subcontract the performance of any such activities to a third party, such consent shall be subject to the condition that AFP shall control the performance of such activities and remains fully responsible to MannKind for the performance of such activities and any material breach of this Agreement by such third party subcontractor, and require that such third party subcontractor agrees in writing to comply with confidentiality restrictions at least as stringent as those set forth in this Agreement.

2.2 Project Team.

(a) Formation; Composition. The Parties shall form a team (“ Project Team ”), which shall be responsible for oversight of the activities under this Agreement. Each Party shall appoint to the Project Team an equal number of team members that have the requisite skills in the disciplines necessary for performance of activities under this Agreement. Each Party may change its Project Team members at any time by written notice to the other.

(b) Meetings. The Project Team shall meet at such times and locations as are agreeable to a majority of the Project Team members, but no less than once per year. Project Team meetings may take place in person or through video or telephone communications. At the initial meeting of the Project Team, the Project Team shall establish operating procedures for its meetings and activities. At each meeting of the Project Team, the Parties shall provide an update on the status of the activities conducted under this Agreement. Other personnel of each Party may attend Project Team meetings. Each Party shall bear the expense of participation of its respective Project Team members and other personnel in Project Team meetings. Written minutes shall be kept of all Project Team meetings and shall include material decisions made at such meetings.

2.3 Regular Communication. Each Party shall be available to the other Party for a reasonable number of telephone and written consultations on a schedule to be determined by mutual arrangement between the Parties. Each Party shall respond to all telephone and written (e.g. letters, e-mail, fax) communications within five (5) business days.

2.4 Regulatory Matters . The Parties shall cooperate diligently and in good faith to obtain any and all necessary approvals and permits for the manufacture and supply of the Product. The Parties shall bear their respective costs and shall pay all costs, consistent with industry practice, associated with obtaining such approvals or permits for the Product. The Parties shall provide such technical assistance to each other as is commercially reasonable for this purpose. AFP will provide MannKind with such information and data regarding the manufacture of Product to the extent necessary for MannKind and its Affiliates and licensees to prepare and defend any inquiries from regulatory authorities to satisfy regulatory requirements with respect to the Product. Only in the event that AFP needs to obtain third party services in order to support MannKind, its Affiliates, and licensee(s) to obtain or maintain approvals or permits with respect to the Product, as it specifically relates to the MannKind Product, MannKind and AFP agree to negotiate in good faith such services and the costs therefore.

2.5 Regulatory Compliance . In performing its obligations hereunder AFP shall comply with all applicable U.S. and foreign federal, state, municipal, or local laws, rules, regulations, orders, decisions or permits of any relevant jurisdiction relating to matters including, but not limited to employment, safety, health, environmental standards and requirements, non-discrimination, equal employment opportunity, import/export and privacy protection. Such laws include, but are not limited to the U.S. Occupational Safety and Health Act, the U.S. Fair Labor Standards Act, and the U.S. Food and Drug Cosmetic Act and all applicable laws of France.

3. Sale and Purchase Terms

3.1 Purchase . Subject to contractual obligations of MannKind and subject to the other provisions of this Agreement, AFP shall sell to MannKind and its Affiliates, and MannKind and its Affiliates shall purchase from AFP, at least the quantities of Product described in § 6.1.

3.2 Schedule for Delivery . Each year during the term of this Agreement, no later than December 1 st , MannKind shall provide to AFP a schedule for delivery of the following calendar year’s annual Product Purchase Commitment Quantities. Annual Product quantities must be requested with multiple delivery dates, and in all cases, the deliveries requested for the quantities shall be whole batch quantities (or multiples thereof, as applicable). Such requested deliveries shall not exceed quantity of [***] kg of Product per delivery. AFP shall be deemed to have satisfied its obligations with respect to quantity of Product if the actual quantity of Product supplied is within plus or minus [***] percent (+/- [***]%) of the quantity set forth in the applicable Purchase Order. No later than fifteen (15) calendar days prior to the end of each Quarter during the Term, MannKind shall provide AFP with the forecasted schedule of delivery of the Product for the next successive four (4) Quarters (or until the Term ends if shorter), on a rolling basis, the first two (2) Quarters of which shall be broken down on a month-by-month basis (the “ Forecast ”). Each Forecast shall be deemed to be an update of any Forecast previously provided by MannKind to AFP during the Term. The first two (2) Quarters of each Forecast shall be binding (the “ Firm Order Period ”) and simultaneously with submission of the Forecast, MannKind shall submit any Purchase Order(s) for the quantities of the Product to be delivered during the second (2nd) Quarter of such Forecast (i.e., the last Quarter of the Firm Order Period). AFP will deliver the designated quantities to MannKind on the dates specified. Time is of the essence for delivery dates and quantities. If AFP cannot meet the dates specified or proposes alternate delivery dates, it must notify MannKind in writing within fifteen (15) calendar days after receipt of MannKind’s most recent Forecast. In no event shall any delivery be later than one (1) month beyond MannKind’s requested delivery date as long as the delivery per quarter of the Purchase Commitment Quantities does not exceed [***] kilograms ([***] kg).

Notwithstanding the foregoing, for the Purchase Commitment Quantity to be delivered in the 4th Quarter of 2014 and the 1st Quarter of 2015, MannKind shall issue a Purchase Order no later than thirty calendar days after execution of this Agreement (“Initial Order”). The Purchase Commitment Quantity of the Initial Order shall not be less than [***] kg for the 4th Quarter of 2014, except that the Purchase Commitment Quantity actually delivered under the Initial Order for the 4th Quarter of 2014 shall be limited by the amount that AFP can deliver in the 4th Quarter of 2014. The Purchase Commitment Quantity of the Initial Order for the 1st Quarter of 2015 shall not be less than [***] kg. For avoidance of doubt, the Purchase Commitment Quantity of the Initial Order shall not be less than [***] kg in total. MannKind and AFP shall mutually agree on specific delivery dates under the Initial Order, and, in the event AFP is unable to deliver the Purchase Commitment Quantity recited in the Initial Order for the 4th Quarter of 2014, MannKind and AFP shall mutually agree upon an altered quantity allocation of Product as between the 4th Quarter of 2014 and the 1st Quarter of 2015, which shall not be less than [***] kg total in any event.

3.3 Purchase Orders . MannKind shall issue Purchase Orders to AFP based on the Forecast provided to AFP in accordance with the terms of § 3.2. All orders shall be evidenced by specific and separate Purchase Orders issued by MannKind to AFP pursuant to this § 3.3. Purchase Orders for Product may be submitted by MannKind to AFP in writing, or electronically pursuant to a mutually agreed upon process. All Purchase Orders shall contain: (a) the quantities ordered; (b) the purchase price for Product ordered in accordance with § 6; (c) delivery dates; and (d) delivery address as well as any other appropriate instructions. If MannKind issues any such Purchase Orders, AFP shall inform MannKind in writing of its acceptance or rejection thereof; provided that AFP may not reject any Purchase Order for quantities ordered in accordance with § 6.1 where the delivery dates are in accordance with the terms of § 3.2. Any deviation from an agreed upon scheduled delivery date for Product shall occur only upon written approval by the Parties. For the avoidance of doubt, this Agreement shall take precedence over the terms and conditions set forth in any Purchase Order; in other words, no additional, ambiguous or inconsistent terms in any Purchase Orders or Purchase Order acknowledgements shall have any legal effect.

3.4 Notice of Potential Product Delivery Delays . If AFP is unable to provide to MannKind the quantities of Product in accordance with the provisions of this Agreement, during any calendar year, then AFP shall inform MannKind in writing within ten (10) days of learning of such event. Such notice shall in no event be received by MannKind later than forty five (45) days prior to any delivery date, and AFP shall use commercially reasonable efforts to resolve the condition that caused such delay.

3.5 Additional Quantity. MannKind may submit a written request to AFP for quantities of Product in addition to the quantities set forth in § 6.1 of this Agreement. AFP will use commercially reasonable efforts to attempt to supply such additional quantities. AFP will respond in writing, within thirty (30) days, whether it can meet the additional quantities of Product. Upon agreement between AFP and MannKind of a specific quantity and delivery time, MannKind will submit a Purchase Order for such additional quantities of Product in accordance with the terms of § 3.3. The Parties shall negotiate in good faith the pricing for such additional quantities in no event shall the pricing be more than the amount as set forth in § 6.1.

4. Manufacture

4.1 Raw Materials. AFP shall be responsible for obtaining, and shall store at no cost to MannKind, any and all materials required for the manufacture of the Product, in reasonable quantities consistent with MannKind’s designated quantities and orders for the Product. AFP shall use and rotate all stock of materials on a first-in, first-out basis. AFP shall conduct on-site quality audits of its inclusion bodies supplier on a regular basis, but shall not be obligated to conduct more than one (1) such audit every calendar year. AFP represents and warrants that AFP has a long-term supply agreement with [***] for the sufficient supply of inclusion bodies to support AFP’s obligations with respect to the Purchase Commitment Quantities and Purchase Price (without resorting to § 6.1(b)) under this Agreement and covenants that during the term of this Agreement AFP shall not unreasonably terminate such agreement or amend such agreement in a manner that would adversely affect AFP’s ability to perform its obligations under this Agreement. If during the term of this Agreement AFP intends to qualify an appropriate alternate source of inclusion bodies to supplement or replace its supply from [***] then AFP must notify MannKind in writing and AFP agrees that such change shall not adversely affect AFP’s ability to perform its obligations under this Agreement. AFP has provided or will provide to MannKind and its potential licensee(s) the opportunity to review a true and correct copy of such agreement, at AFP’s location or Amphastar Pharmaceuticals, Inc.’s location, as in effect as of the Effective Date (as redacted to protect any proprietary information of AFP or [***]).

4.2 Manufacture of Product. AFP shall reserve sufficient production capacity and inventory of Product in order to be able to supply to MannKind pursuant to the terms of this Agreement. AFP shall manufacture Product in accordance with § 2.1, § 2.5, and United States and European Union regulations applicable to the transportation, storage, use, handling and disposal of hazardous materials. Each Party shall promptly notify the other of any new instructions or specifications with respect to the Product required under any applicable laws and shall confer with each other with respect to the best means to comply with such requirements. AFP represents and warrants to MannKind that it has, and shall maintain during the term of this Agreement, all government permits, including without limitation health, safety and environmental permits, necessary for the conduct of the actions and procedures that it undertakes pursuant to this Agreement.

4.3 Product Specifications; Testing. Product supplied hereunder shall conform to the Specifications and the warranty set forth in § 7.2. AFP or applicable qualified contract laboratories shall perform quality control testing and quality oversight on the Product to be delivered to MannKind or its designee hereunder.

4.4 Audits. Upon MannKind’s written request to AFP, which shall be not less than thirty (30) days in advance, MannKind, or its licensee(s) identified in such a written request, shall have the right to have its representatives visit AFP’s facility during normal business hours to review and inspect AFP’s manufacturing operations and quality systems related to the Product and to discuss any related issues with AFP’s manufacturing and management personnel. Such audits of AFP shall not exceed one (1) time per calendar year for MannKind and shall not exceed one (1) time per year for MannKind’s sole licensee. If MannKind adds additional licensee(s), only one (1) licensee is entitled to an audit per calendar year. For the avoidance of doubt, only two (2) audits total are allowed per calendar year. MannKind, or its licensee(s) will be entitled to perform additional audits, upon shorter notice, if Non-conforming Products are produced by AFP or complaints or other inquiries by regulatory authorities relating to the Products produced hereunder are received by either Party, or for any additional reasons where good cause is articulated in writing by MannKind.

4.5 Change in Manufacturing Process. AFP shall provide prior written notice to MannKind before AFP implements any change in the materials, suppliers, contract laboratories, equipment, processes, procedures, or test methods used to manufacture the Product, but only to the extent that such changes affect AFP’s United States Drug Master File of the Product or any other regulatory filing throughout the Territory. If MannKind does not notify AFP of an objection within ten (10) business days of receipt of AFP’s notice and, as far as AFP is aware having made due inquiry, such change would not require approval or notification of the applicable regulatory authorities with respect to the MannKind Product, then AFP may proceed with the change without the prior written approval of MannKind. If MannKind notifies AFP within such ten (10) business day period that such change would require approval or notification of the applicable regulatory authorities with respect to the MannKind Product, then AFP shall not make such change without the prior written consent of MannKind, which prior written consent shall not be unreasonably withheld. With respect to any changes that would not require approval or notification of the applicable regulatory authorities in connection with the MannKind Product, if MannKind notifies AFP of an objection to such change within such ten (10) business day period, the Parties will discuss the change in good faith for up to an additional ten (10) business days (or longer, if agreed by the Parties) in the interest of reaching a mutually agreeable resolution; provided, that if agreement is not reached on such change (and that change does not require notification or approval of the applicable regulatory authorities with respect to the MannKind Product) then AFP may proceed with such change following such discussions.

4.6 Documentation. AFP shall keep complete, accurate and authentic accounts, notes, data and records of the work performed under this Agreement adequate to comply with all applicable laws. AFP shall maintain complete and adequate records pertaining to the methods and facilities used by it for the manufacture, testing and supply of the Product. Upon MannKind’s written request, AFP shall make these documents available for MannKind on-site review at AFP’s facility. MannKind acknowledges that all of AFP’s manufacturing records shall be protected under the confidentiality provisions of § 11.

4.7 Recall of Product. In the event that: (a) any regulatory authority issues a request, directive or order that the Product be recalled or retrieved; (b) a court of competent jurisdiction orders that the Product be recalled or retrieved; or (c) AFP determines that the Product should be recalled or retrieved, AFP shall promptly notify MannKind, in writing, of such event and shall conduct such activity and take appropriate corrective actions, at AFP’s expense.

5. Delivery and Acceptance

5.1 Time and Place of Delivery . AFP shall deliver the Product to MannKind DAT (“Delivered at Terminal,” as such term is defined in INCOTERMS 2010) to John F. Kennedy International Airport (“ JFK ”), or other designated terminal within the United States (“Alternate Designated Terminal”) at MannKind’s reasonable discretion upon reasonable written notice to AFP, to arrive on or before the scheduled date as set forth in the Purchase Orders. AFP shall ensure that the shipping, handling and storage conditions are sufficiently maintained so that there is no adverse impact to Product quality. Upon delivery to MannKind, AFP shall ensure Product will have a remaining expiry date of not less than four (4) years.

5.2 Risk of Loss. AFP shall bear the risk of loss for the Product through delivery to, and unloading at, JFK or Alternate Designated Terminal, at which time title to the Product and the risk of loss shall pass to MannKind.

5.3 Documents. Each shipment of the Product shall be accompanied by relevant certificates of analysis and a copy of the invoice. Each certificate of analysis shall certify with respect to each shipment and batch (identified by batch number) (a) the quantity of the shipment, and (b) that Product delivered conforms to Specifications, as well as any further information required by the relevant regulatory authorities that MannKind may have previously notified AFP is necessary. MannKind shall be under no obligation to accept any shipment of Product without an accompanying certificate of analysis.

5.4 Inspection, Acceptance and Rejection . MannKind shall have the right to inspect the Product as follows:

(a) Delivery Inspection. Upon delivery at MannKind’s designated facility, MannKind shall perform testing to determine whether the Product is acceptable to MannKind, conforms with the Specifications and cGMPs, is free from defect, adulteration and contamination and is free and clear of all liens, claims and encumbrances.

(b) Acceptance; Rejection. If, after performing such testing MannKind determines and informs AFP in writing that any Product delivered is a Non-conforming Product, MannKind shall so notify AFP in writing within forty-five (45) days from receipt of the shipment. In the event that AFP agrees that the Product is Non-conforming Product, MannKind may, at its option, return such Non-conforming Product to AFP or request replacement of the Non-conforming Product at AFP’s sole cost and at the earliest possible timeframe that is commercially reasonable. If MannKind exercises such return rights, MannKind shall return any such Non-conforming Product in accordance with AFP’s then current return procedures, and AFP shall replace such Non-conforming Product. If AFP does not replace such Non-conforming Product so as to remedy any reported non-conformity within forty-five (45) days after such non-conformity is reported to AFP, then MannKind may reject such Non-conforming Product by providing prompt written notice of such rejection to AFP. In the event of such rejection of any Non-conforming Product, AFP shall promptly credit or refund the net purchase price paid by MannKind. MannKind may charge AFP for all costs of shipment of Non-conforming Product and for the cover costs of the Product. If MannKind does not notify AFP that any Product is a Non-conforming Product during the forty-five (45) day period following delivery of such Product at MannKind’s designated facility, or does not reject any Non-conforming Product in accordance with the procedure described above, such Product shall be deemed to have been accepted by MannKind. Acceptance or deemed acceptance under this § 5.4 shall not limit AFP’s warranty obligations or MannKind’s warranty rights under § 7.2.

In the event of a discrepancy between MannKind and AFP as to whether the Product is Non-conforming Product or there otherwise exists a dispute between the Parties over the extent to which such non-conformity is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and analyses on samples of the Product that allegedly is Non-conforming. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules.

6. Pricing; Quantities; and Payment

6.1 Purchase Commitment and Purchase Price . MannKind shall purchase from AFP the minimum quantities of Product (the “ Purchase Commitment Quantities ”) at the purchase price per gram (the “ Purchase Price ”) in each calendar year as provided in the table set forth below. In the event that MannKind fails to meet the Purchase Commitment Quantities in any given calendar year, MannKind shall pay AFP for the difference in the amount of the Purchase Commitment Quantities and the actual amount purchased for the corresponding calendar year (such difference, the “ Purchase Commitment Difference ”). AFP shall issue an invoice and MannKind shall pay the Purchase Commitment Difference no later than thirty (30) days after the close of the corresponding calendar year.

Calendar Year	Purchase Commitment Quantities (kg)	Purchase Price (per gram)	Comment
2015	[***]	EUR [***]	Up to [***] kg to be delivered in the fourth quarter of 2014.
2016	[***]	EUR [***]
2017	[***]	EUR [***]
2018	[***]	EUR [***]
2019	[***]	EUR [***]

All amounts due under this § 6.1 shall be due and payable by MannKind to AFP in EUR in accordance with § 6.2. In calendar year 2016 and thereafter, the Purchase Price shall be subject to adjustment as follows:

(a) The Purchase Price will be subject to an obligatory annual adjustment on January 1 of each calendar year equal to the percentage change in the [***] (the “ Index ”), where the annual adjustment is calculated using the historical twelve (12) month percentage change of the Index, as of December 1 of the immediate prior year; provided, however, that if the percentage change (either increase or decrease, as applicable) of the Index equals or exceeds [***] percent (i.e., +/- [***]%), the Purchase Price adjustment shall not be obligatory, but instead the Parties shall attempt in good faith to negotiate an adjusted Purchase Price based on such change, which attempted negotiations shall be concluded no later than February 15 of that calendar year.

(b) In addition to any adjustment to the Purchase Price pursuant to §6.1(a), if for causes beyond AFP’s reasonable control (including market shortage, market embargo, etc.), AFP has incurred any price increase(s) in its aggregate material and service costs (such increased costs measured on a per gram basis of Product, the “ Cost Excess ”) which are in excess of [***] percent ([***]%) of the Purchase Price in a given calendar year, then the Purchase Price for the next calendar year shall be increased by the percentage increase of the Cost Excess as compared to the aggregate costs for such materials and services during the prior calendar year.

(c) If AFP delivers any Product Purchase Commitment Quantities, as defined in the Firm Order Period through a Purchase Order accepted by AFP, beyond sixty (60) days after the committed delivery date, then such quantities shall be subject to a [***] percent ([***]%) discount off the Purchase Price.

6.2 Payment . MannKind shall pay AFP for the Product within forty-five (45) days from shipment date of the Product. In the event the Product is detained due to Customs or FDA then MannKind shall notify AFP of such delay and the period for payment shall be extended for the period commensurate with such delay. AFP shall submit an invoice electronically to MannKind, Attention: Accounts Payable, valenciaap@mannkindcorp.com. If any portion of an invoice is disputed then MannKind shall pay the undisputed amount and the Parties shall use good faith efforts to reconcile the disputed amount as soon as practicable. AFP shall not suspend work or seek to terminate this Agreement or any Purchase Order solely on account of MannKind’s failure to pay any invoiced amount which is the subject of a good faith bona fide dispute, provided that MannKind pays all non-disputed amounts.

6.3 Reservation Fee . No later than five (5) days after the Effective Date, MannKind shall make payment to AFP in the amount of EUR 11,000,000, which will be considered as partial payment for the calendar year 2015 Purchase Commitment Quantities of [***] kilograms of Product. This reservation fee is non-refundable and deemed fully earned by, and to be the property of AFP in all events, including but not limited to the event that MannKind fails to purchase the calendar year 2015 Purchase Commitment Quantities, except for and excluding only the event of a material breach of AFP’s obligations under this Agreement that occurs prior to the delivery of the full amount of calendar year 2015 Purchase Commitment Quantities. Any invoice(s) for the calendar year 2015 designated quantities will be adjusted to reflect a credit for the reservation fee. For avoidance of doubt, this Reservation Fee will only be adjusted against the purchase of quantity that is delivered in calendar year 2015, and not calendar year 2014 or in any other calendar year.

6.4 Taxes. The Party receiving payments under this Agreement shall pay any and all taxes levied on account of such payment. If any taxes are required to be withheld by the paying Party, it shall (a) deduct such taxes from the remitting payment, (b) timely pay the taxes to the proper taxing authority, and (c) send proof of payment to the other Party and certify its receipt by the taxing authority within sixty (60) calendar days following such payment. AFP shall ensure that the proper harmonized code is used for Customs shipping documentation in accordance with 19 CFR 152.11.

7. Representations And Warranties; Covenants

7.1 General Representations and Warranties. Each Party represents and warrants:

(a) Corporate Power and Authorization. It is duly organized and validly existing under the laws of the state of its incorporation, and has full corporate power and authority to execute and deliver this Agreement and to perform all of its obligations hereunder; and

(b) Binding Agreement . This Agreement is a legal and valid obligation binding upon it and enforceable in accordance with its terms; and

(c) No Conflict. The execution, delivery and performance of this Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any law or regulation of any court, governmental body, or administrative or other agency having jurisdiction over it; and

(d) Resources. It has adequate resources, both financial and otherwise, to perform its duties hereunder.

7.2 AFP Warranty . AFP represents and expressly warrants that the Product provided hereunder shall be in compliance with all applicable laws and regulations, free from defect, adulteration and contamination and free and clear of all liens, claims and encumbrances upon delivery. In addition to § 5.4 upon any breach of the warranty AFP shall at AFP’s sole expense promptly (and in no event longer than sixty (60) days) correct, at no cost to MannKind, and at MannKind’s request, any such breach by replacement of any Non-conforming Product and shall provide technical assistance to MannKind to address the Product non-conformity issues. Any replacement shall be considered a new Product for purposes of this § 7.2.

AFP represents and expressly warrants that the Product provided hereunder shall conform to the Specifications, shall be supplied in compliance with the QTA and instructions from MannKind, except where MannKind has failed to notify AFP of any Product that does not so conform pursuant to the terms of § 5.4(b); provided, however, that AFP shall remain liable for Product having latent defects that could not have been discovered by MannKind within the applicable period described in § 5.4(b) despite reasonable inspection by MannKind.

AFP represents and expressly warrants that it has and shall at all times throughout the term of this Agreement has, whether by right, title, interest, including by license or otherwise, the Intellectual Property Rights that are required to use, manufacture, market, offer to sell, sell, import and export the Product, and that this Agreement shall not infringe any third party patent rights.

7.3 Limitation of Liability. THE EXPRESS WARRANTIES AND REPRESENTATIONS SET FORTH IN SECTION 7.2, AND ANY OTHER AFP WRITTEN PROMISE OR STATEMENT EXPRESSLY REFERRED TO AS A WARRANTY, REPRESENTATION OR COVENANT IN THE AGREEMENT, ARE IN LIEU OF ALL OTHER WARRANTIES AND REPRESENTATIONS, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE WHICH ARE HEREBY DISCLAIMED AND EXCLUDED BY AFP, INCLUDING ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR USE, AND NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, INCLUDING PATENT RIGHTS.

7.4 Disclaimer of Consequential Damages. As used in this Section 7.4, the term “ AFP LIABILITY” MEANS LIABILITY OF AFP OF ANY KIND, WHETHER UNDER CONTRACT, WARRANTY, TORT (INCLUDING LIABILITY FOR NEGLIGENCE), STRICT LIABILITY, STATUTE, OR ANY OTHER LEGAL OR EQUITABLE THEORY OF LIABILITY, ARISING OUT OF, CONNECTED WITH, OR RELATING IN ANY MANNER TO THIS AGREEMENT. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW AND NOTWITHSTANDING THAT ANY REMEDY REFERRED TO, OR LIMITATION OF CUMULATIVE LIABILITY SET FORTH, WITH THE EXCEPTION OF ANY WILLFUL MISCONDUCT, IN NO EVENT WILL AFP LIABILITY INCLUDE, AND AFP SHALL NOT BE LIABLE FOR, ANY SPECIAL, INDIRECT, INCIDENTAL, OR CONSEQUENTIAL LOSSES OR DAMAGES (INCLUDING LOSS OF PROFIT OR REVENUES, INJURY TO GOODWILL, LOSS OF THE USE OF GOODS OR EQUIPMENT, DAMAGE TO ANY ASSOCIATED EQUIPMENT, COST OF CAPITAL, DOWNTIME COSTS, OR CLAIMS OF MANNKIND’S CUSTOMERS, AFFILIATES, LICENSEES, DISTRIBUTORS OR OTHER THIRD PARTIES FOR SUCH DAMAGES OR LOSSES) EVEN IF AFP WAS ADVISED OF THE POSSIBILITY OF SUCH POTENTIAL DAMAGE OR LOSS;

7.5 Cumulative Liability. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, AFP LIABILITY WILL BE LIMITED TO DAMAGES AND LOSSES NOT TO EXCEED IN THE AGGREGATE [***] EUROS (EU [***]) . IT IS UNDERSTOOD THAT THE FOREGOING MONETARY LIMITATION OF LIABILITY REPRESENTS AFP’S TOTAL AND CUMULATIVE LIABILITY FOR ALL AFP LIABILITY.

7.6 No Debarred or Disqualified Persons. AFP represents and warrants that it shall not employ, contract with, or retain any person directly or indirectly to perform any activities relating to the manufacture or supply of Product if such a person (a) is under investigation by the FDA for debarment or is presently debarred by the FDA pursuant to 21 U.S.C. § 335a or its successor provisions or by the applicable regulatory authority in any country or jurisdiction outside the United States under comparable regulations, or (b) has a disqualification hearing pending or has been disqualified by the FDA pursuant to 21 C.F.R. § 312.70 or its successor provisions or by the applicable regulatory authority in any other country or jurisdiction outside the United States under comparable regulations. In addition, AFP represents and warrants that it has not engaged in any conduct or activity which could lead to any of the above-mentioned disqualification or debarment actions. If, during the term of this Agreement, AFP or any person employed or retained by it to perform any activities relating to the manufacture or supply of Product (i) comes under investigation by the FDA or by the applicable regulatory authority in any country or jurisdiction outside the United States for a debarment action or disqualification, (ii) is debarred or disqualified, or (iii) engages in any conduct or activity that could lead to any of the above-mentioned disqualification or debarment actions, AFP shall immediately notify MannKind of same.

7.7 Covenants. Contemporaneous with the Effective Date, the Parties hereby agree to negotiate in good faith the execution of a Quality/Technical Agreement, incorporated hereby by reference, which sets forth, among other things, the quality control and quality assurance terms for the Product. Such Quality/Technical Agreement shall be mutually agreed to in writing prior to placement of any Purchase Order for the Product.

8. Indemnification

8.1 Mutual Indemnification. Each Party (the “ Indemnifying Party ”) shall indemnify and hold harmless the other Party and its Affiliates, and their respective directors, employees, consultants and agents (the “ Indemnified Parties ”) from and against any and all liabilities, losses, damages, costs, and other expenses (including attorneys’ and expert witnesses’ costs and fees) ( “Losses” ) incurred by the Indemnified Parties as a result of any claim, demand, action or proceeding by any third party (a “Claim” ) to the extent arising from or relating to any breach of any representation, warranty, covenant, or obligation of the Indemnifying Party under this Agreement or any intentional misconduct or gross negligence by the Indemnifying Party or any of its employees, agents, or subcontractors, except, in each case, to the extent such Losses result from the intentional misconduct or gross negligence of, any of the Indemnified Parties.

8.2 Indemnification Procedures. In the event of any Claim for which any Indemnified Party is or may be entitled to indemnification hereunder, the Indemnified Party may, at its option, require the Indemnifying Party to defend such Claim at the Indemnifying Party’s sole expense. Indemnifying Party may not settle any such Claim without the Indemnified Party’s express prior written consent.

8.3 Failure to Defend or Settle. If the Indemnifying Party fails or wrongfully refuses to defend or settle any Claims, then the Indemnified Party shall, upon written notice to the Indemnifying Party, have the right to defend or settle (and control the defense of) such Claims. In such case, the Indemnifying Party shall cooperate, at its own expense, with the Indemnified Party and its counsel in the defense and settlement of such Claims, and shall pay, as they become due, all costs, damages, and reasonable legal fees incurred therefore.

9. Insurance Protection. Each Party shall obtain and maintain during the term of this Agreement liability, comprehensive, and workers’ compensation insurance with a reputable insurance company to help protect against those insurable risks that such Party may incur in connection with the performance of its obligations under this Agreement. Each Party shall provide, upon request, to the other Party any such policies of such insurance, and the premium receipt(s) and insurance certificate(s) therefore.

10. Term; Termination

10.1 Term. This Agreement shall begin on the Effective Date and, unless terminated sooner as provided in § 10.2, expire on December 31, 2019. The Parties may renew this Agreement for additional, successive two (2) year terms upon twelve (12) months written notice, given prior to the end of the initial or any additional two (2) year term.

10.2 Termination Events

(a) For Cause . A Party shall have the right to terminate this Agreement for cause if the other Party materially breaches this Agreement and fails to cure such breach within sixty (60) days after receiving written notice that specifies the particulars of such breach.

(b) Force Majeure. A Party shall have a right to terminate this Agreement in accordance with § 12.14.

(c) Without Cause. MannKind shall have the right to terminate this Agreement without cause upon two (2) years’ prior written notice to AFP.

(d) Business Circumstances. A Party shall have the right to terminate this Agreement in the event of the other Party’s liquidation, bankruptcy or state of insolvency upon written notice to such other Party.

(e) Regulatory Decisions. MannKind may terminate this Agreement upon a thirty (30) day written notice to AFP if a controlling regulatory authority withdraws approval of the MannKind Product.

10.3 Effects of Termination . Upon the expiration or earlier termination of this Agreement: (a) MannKind shall pay to AFP all amounts due to AFP under this Agreement, including any unpaid Purchase Commitment Difference within sixty (60) days of the effective date of such expiration or earlier termination; provided however, only in the event of a termination by MannKind pursuant to §10.2(c) or §10.2(e), MannKind shall pay to AFP within sixty (60) calendar days of the effective date of such expiration or earlier termination, the full payment for all remaining Purchase Commitment Quantities as provided in the table set forth in §6.1, as well as any unpaid Purchase Commitment Difference; and (b) each Party shall return to the other Party, upon the other Party’s request, all tangible items of the other Party in its possession or under its control evidencing the Confidential Information of the other Party, if applicable. The expiration or earlier termination of this Agreement shall not affect any rights or claims of a Party hereunder that accrued prior to the date of such expiration or earlier termination.

10.4 Survival. Sections (§): § 1, §2.4, §2.5, §3.1, §6.1, §4.4, §4.6, §4.7, §7, §8, §9, §10.3, §10.4, §11, §12 shall survive the expiration or termination of this Agreement.

11. Confidential Information

11.1 Confidentiality Obligations . Each Party shall at all times, and notwithstanding any termination or expiration of this Agreement, hold in confidence and not disclose to any third party Confidential Information of the other Party, except as approved in writing by the other Party to this Agreement, and shall use the Confidential Information for no purpose other than the purposes expressly permitted by this Agreement. For clarification, all MannKind Intellectual Property Rights, shall be Confidential Information of MannKind. For clarification, all AFP Intellectual Property Rights shall be the Confidential Information of AFP. Each Party shall only permit access to Confidential Information of the other Party to those of its and its Affiliates’ employees, consultants, agents, and attorneys and, in the case of MannKind, to its licensee of rights to the MannKind Product, in each case who have a need to know and are bound by confidentiality obligations at least as restrictive as those contained herein. The obligations in this § 11.1 shall terminate five years from the date of expiration or termination of this Agreement in accordance with § 10.

11.2 Exceptions to Confidentiality Obligations . A Party’s obligations under this Agreement with respect to any portion of the other Party’s Confidential Information shall terminate when the Party that is subject to such obligations can document in writing that such information: (a) entered the public domain through no fault of such Party; (b) was in such Party’s possession free of any obligation of confidence at the time it was communicated to such Party by the other Party; (c) was rightfully communicated to such Party free of any obligation of confidence subsequent to the time it was communicated to such Party by the other Party; or (d) was developed by employees or agents of such Party independently of and without reference to any information communicated to such Party by the other Party.

11.3 Authorized Disclosure . Notwithstanding anything to the contrary, a Party shall not be in violation of § 11.1 with regard to a disclosure of the other Party’s Confidential Information that is in response to a valid order by a court or other governmental body or necessary to comply with applicable law or governmental regulations, provided that if such Party is required to make any such disclosure of the other Party’s Confidential Information it shall to the extent practicable give reasonable advance notice to the other Party of such disclosure requirement in order to permit the other Party to seek confidential treatment of or to limit the Confidential Information required to be disclosed.

11.4 Previous Confidential Disclosure Agreements . As of the Effective Date, the terms of this § 11 shall supersede any prior confidential disclosure agreements between the Parties dealing with the subject of this Agreement. Any information disclosed under such prior agreements shall be deemed disclosed under this Agreement.

11.5 Publicity; Filing of Agreement. Each Party shall have the right to issue from time to time press releases that disclose the relationship of the Parties under this Agreement upon the agreement of the Parties, which agreement shall not be unreasonably withheld, delayed, or conditioned. Any press releases that are to be issued by either Party shall be in a form and substance as may be mutually agreed upon by the Parties. The Parties will coordinate in advance with each other in connection with the filing of this Agreement (including redaction of certain provisions of this Agreement) with the U.S. Securities and Exchange Commission (the “ SEC ”), the NASDAQ stock exchange or any other stock exchange or governmental agency on which securities issued by a Party or its Affiliate are traded, and each Party will use reasonable efforts to seek confidential treatment for the terms proposed to be redacted; provided, that each Party will ultimately retain control over what information to disclose to the SEC, the NASDAQ stock exchange or any other stock exchange or governmental agency, as the case may be, and provided further that the Parties will use their reasonable efforts to file redacted versions with any governing bodies which are consistent with redacted versions previously filed with any other governing bodies. Other than such obligation, neither Party (nor its Affiliates) will be obligated to consult with or obtain approval from the other Party with respect to any filings to the SEC, the NASDAQ stock exchange or any other stock exchange or governmental agency.

12. Miscellaneous

12.1 Assignment. Except as expressly provided hereunder, neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred by either Party without the prior written consent of the other Party (which consent shall not be unreasonably withheld); provided, however , that either Party may assign this Agreement and its rights and obligations hereunder without the other Party’s consent (a) in connection with the transfer or sale of all or substantially all of the business of such Party to which this Agreement relates to a third party, whether by merger, sale of stock, sale of assets or otherwise, including, for greater certainty, by MannKind to its licensee(s) of the MannKind Product in connection with the transfer of manufacturing responsibility for the MannKind Product to such licensee, or (b) to any Affiliate. Notwithstanding the foregoing, any such assignment to an Affiliate or licensee(s) shall not relieve the assigning Party of its responsibilities for performance of its obligations under this Agreement, and the assigning Party hereby guarantees the performance of this Agreement by such Affiliate or licensee(s). The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties. Any assignment not in accordance with this Agreement shall be void.

12.2 Ownership Rights. Each Party shall retain ownership and control of their respective works of authorship, inventions, know-how, information, data, and all Intellectual Property Rights therein that were in existence as of the Effective Date or are created thereafter, whether or not in the course of the performance of its obligations under this Agreement. The Parties hereby acknowledge that neither Party has, nor shall it acquire, any interest in any of the other party’s Intellectual Property Rights, unless otherwise expressly agreed to in writing.

12.3 Relationship of the Parties. It is expressly agreed that AFP and MannKind shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture or agency of any kind. Neither Party shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party.

12.4 Amendment. Unless otherwise provided herein, this Agreement may not be changed, waived, discharged, or terminated orally, but instead only by a written document that is signed by the duly authorized officers of both Parties.

12.5 Waiver. No failure or delay by either Party in exercising any right, power, or privilege under this Agreement shall operate as a waiver thereof, nor shall any single or partial waiver thereof include any other or further exercise thereof or the exercise of any other right, power, or privilege.

12.6 Severability. Whenever possible, each provision of the Agreement shall be interpreted in such manner as to be effective and valid under applicable law, but if any term or provision of this Agreement is held to be prohibited by or invalid under applicable law, such provision shall be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of the Agreement and this Agreement shall be interpreted and construed as if such provision had never been contained herein.

12.7 Notices. All notices and statements to be given (which shall be in writing) and all payments to be made hereunder shall be given or made at the respective addresses of the Parties as set forth above, unless notification of a change of address is given. All notices, payments and statements to be made hereunder shall be mailed by certified or registered mail, return receipt requested, or sent by overnight courier, or by facsimile or other electronic means. Any notice given pursuant to this Agreement by mail shall be considered effective three (3) business days after mailing. Any notice sent by overnight courier shall be considered effective one day after mailing. The date of transmission of any notice sent by electronic means shall be deemed to be the date the notice or statement is transmitted.

12.8 Construction. The section headings of this Agreement are inserted only for ease of reference only, and shall not be used to interpret, define, construe, or describe the scope or extent of any aspect of this Agreement. Unless otherwise expressly stated, when used in this Agreement the word “including” means “including but not limited to.” References to “days” shall mean calendar days unless reference to business days is made expressly. Each Party represents that it has had the opportunity to participate in the preparation of this Agreement and hence the Parties agree that the rule of construction that ambiguities be resolved against the drafting Party shall not apply to this Agreement.

12.9 No Third Party Beneficiaries. Unless expressly provided, no provisions of this Agreement are intended or shall be construed to confer upon or give to any person other than MannKind and AFP any rights, remedies, or other benefits under or by reason of this Agreement.

12.10 Dispute Resolution. If a dispute arises under this Agreement, the Parties shall use reasonable efforts to attempt to resolve such dispute, including escalation of discussions to the appropriate level of management, as provided in § 12.13, prior to exercising any remedies that may exist before commencing an action against the other Party. Notwithstanding the foregoing, either Party may at any time seek equitable relief under § 12.11 without first attempting to resolve a dispute under this § 12.10 provided, however, that such Party notifies the other Party promptly after it files any such action.

12.11 Equitable Relief. Each Party acknowledges and agrees that any breaches or violations of § 3 or § 11 may cause the non-breaching Party irreparable damage for which the award of monetary damages would be inadequate. Consequently, the non-breaching Party may seek to enjoin the breaching Party from any and all acts in violation of any such provisions, which remedy shall be cumulative and not exclusive, and a Party may seek the entry of an injunction enjoining any breach or threatened breach of such provisions, in addition to any other relief to which the non-breaching Party may be entitled at law or in equity.

12.12 Governing Law . This Agreement shall be governed by and interpreted under the laws the State of Delaware, without regard to its conflict or choice of law provisions. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.

12.13 Alternative Dispute Resolution . The Parties shall attempt by direct negotiation, between the Project Team, or pertinent members, in good faith to resolve promptly any dispute arising out of or relating to this Agreement. If the matter cannot be resolved in the normal course of business either Party shall give the other Party written notice of any such dispute not resolved at which time the dispute shall be referred to the senior management of the respective Parties who shall likewise attempt to resolve the dispute.

If the dispute has not been resolved by negotiation as detailed above, or if the Parties fail to meet, within twenty (20) business days from such notice, either party may submit the dispute to arbitration to the International Institute for Conflict Prevention & Resolution (“CPR”) for resolution in accordance with the CPR Arbitration Rules and Commentary. A single, impartial arbitrator mutually acceptable to the Parties shall conduct the arbitration. In the event the Parties cannot agree on an arbitrator within ten (10) business days after the end of the aforesaid twenty (20) business days, either Party may have an arbitrator appointed by the CPR.

The location of the arbitration shall be in New York, NY, USA, unless the Parties agree otherwise. As a condition of appointment of the arbitrator, said arbitrator shall agree to use her/his best efforts to conclude the proceeding within thirty (30) business days. Said arbitrator shall further have the authority to limit the volume of evidence and documents to be submitted by the Parties. Any court having jurisdiction thereof may enter judgment upon the award rendered by the arbitrator. This Section shall, however, not be construed to limit or to preclude either Party from bringing any action in any court of competent jurisdiction for injunctive or other provisional relief as necessary or appropriate.

12.14 Force Majeure . AFP shall not be liable to MannKind for any failure or delay in the performance of any of its obligations under this Agreement arising out of any event or circumstance beyond its reasonable control, including war, rebellion, terrorism, civil commotion, strikes, lock-outs or industrial or labor disputes; fire, explosion, earthquake, acts of God, flood, drought, or bad weather; or requisitioning or other act or order by any government or regulatory authority. If such failure or delay occurs, then AFP shall give MannKind notice of the circumstances causing such failure or delay, and AFP shall be excused from the performance of such of its obligations that it is thereby disabled from performing for so long as it is disabled and for sixty (60) calendar days thereafter; provided, however, that AFP commences and continues to take reasonable and diligent actions to cure such failure or delay. Notwithstanding the foregoing, if AFP is disabled from the performance of any material obligation under this Agreement for a period of ninety (90) calendar days or more, then MannKind shall have the right to terminate this Agreement upon written notice to AFP, in which event the provisions of § 10.3 shall apply.

12.15 Attorneys’ Fees. If any claim, action, or dispute arises between the parties with respect to any matter covered by this Agreement that leads to a proceeding before a court of competent jurisdiction to resolve such claim, the Prevailing Party in such proceeding shall be entitled to receive from the other Party its reasonable attorneys’ fees, expert witness fees, court costs and other out-of-pocket costs incurred in connection with such proceeding, in addition to any other relief that it may be awarded. For purposes of this Section, the term “Prevailing Party” means that Party in whose favor any monetary or equitable award is made or in whose favor any dispute is resolved, regardless of any settlement offers.

12.16 Entire Agreement . This Agreement includes all exhibits attached hereto and any Specifications that are executed by authorized representatives of the Parties, and constitutes the entire agreement by and between the Parties as to the subject matter hereof. This Agreement supersedes and replaces in its entirety all prior agreements, understandings, letters of intent, and memoranda of understanding by and between the Parties hereto, in either written or oral form. No amendment or modification of this Agreement shall be valid unless set forth in writing referencing this Agreement and executed by authorized representatives of both Parties.

12.17 English Language. This Agreement has been prepared in the English language and the English language shall control its interpretation. In addition, all notices required or permitted to be given hereunder, and all written, electronic, oral or other communications between the Parties regarding this Agreement, or delivered pursuant to the terms of this Agreement, shall be in the English language. Any proceedings related to dispute resolution including, but not limited to legal, equitable, or alternative dispute resolution, shall be conducted in the English language.

12.18 Counterparts; Electronic or Facsimile Signatures. This Agreement may be executed in any number of counterparts, each of which shall be an original, but all of which together shall constitute one instrument. This Agreement may be executed and delivered electronically or by facsimile and upon such delivery such electronic or facsimile signature will be deemed to have the same effect as if the original signature had been delivered to the other Party.

12.19 Reservation of Rights. Except for the rights expressly provided in this Agreement, no other rights are granted by either Party to the other Party. Notwithstanding anything to the contrary, no rights or licenses are granted under this Agreement by either Party to the other for the use of any trade names, trademarks, and service marks.

In Witness Whereof , the Parties hereto have this day caused this Agreement to be executed by their duly authorized officers.

Amphastar France Pharmaceuticals S.A.S.		MannKind Corporation


By:	/s/ Franck Vitali	By:	/s/ Matthew Pfeffer
Name:	Franck Vitali	Name:	Matthew Pfeffer
Title:	Plant Manager	Title:	CFO


Delaware		33-0702205
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)


		PAGE
Item 1. Financial Statements (unaudited):

	Condensed Consolidated Balance Sheets as of September 30, 2014 and December 31, 2013	1

	Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2014 and 2013	2

	Consolidated Statements of Comprehensive Income (Loss) for the Three and Nine Months Ended September 30, 2014 and 2013	3

	Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2014 and 2013	4

	Notes to Condensed Consolidated Financial Statements	5

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations		22

Item 3. Quantitative and Qualitative Disclosure about Market Risk		26

Item 4. Controls and Procedures		27

Part II. OTHER INFORMATION

Item 1. Legal Proceedings		27

Item 1A. Risk Factors		27

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds		29

Item 3. Default Upon Senior Securities		29

Item 4. Mine Safety Disclosures		29

Item 5. Other Information		29

Item 6. Exhibits		29

Signatures		30

	September 30, 2014			December 31, 2013
ASSETS		(unaudited)
Current Assets:
Cash and cash equivalents	$	72,881		$	53,587
Restricted cash and restricted short-term investments		1,495			1,325
Accounts receivable, net		26,604			24,585
Inventories, net		88,052			69,916
Income tax refund and deposits		5,139			2,429
Prepaid expenses and other assets		4,913			5,033
Deferred tax assets		16,096			16,096

Total current assets		215,180			172,971
Property, plant, and equipment, net		134,112			116,619
Goodwill and intangible assets, net		43,221			40,163
Other assets		2,502			2,877
Deferred tax assets		6,118			6,118

Total assets	$	401,133		$	338,748

LIABILITIES AND EQUITY
Current Liabilities:
Accounts payable	$	10,013		$	20,380
Accrued liabilities		10,446			7,628
Income taxes payable		2,791			2,847
Accrued payroll and related benefits		11,863			9,161
Current portion of product return accrual		2,498			2,639
Current portion of deferred revenue		14,596			643
Current portion of long-term debt and capital leases		10,078			22,104
Deferred tax liability		797			—
Total current liabilities		63,082			65,402

Long-term product return accrual		791			1,953
Long-term deferred revenue		2,143			2,625
Long-term debt and capital leases, net of current portion		41,271			10,069
Long-term deferred tax liabilities		10,726			7,154

Total liabilities		118,013			87,203
Commitments and Contingencies:
Stockholders’ equity:
Preferred stock: par value $.0001; authorized shares—20,000,000; none issued		—			—
Common stock; par value $.0001; authorized shares—300,000,000; issued and outstanding shares—44,645,437 and 38,765,940 at September 30, 2014 and December 31, 2013, respectively		4			4
Additional paid-in capital		219,288			177,732
Retained earnings		65,631			73,809
Accumulated other comprehensive loss		(1,803	)		—

Total stockholders’ equity		283,120			251,545

Total liabilities and stockholders’ equity	$	401,133		$	338,748

	Three Months Ended September 30,						Nine Months Ended September 30,
	2014			2013			2014			2013
Net revenues	$	59,711		$	59,318		$	154,584		$	174,805
Cost of revenue		47,920			39,038			115,288			107,478

Gross profit		11,791			20,280			39,296			67,327

Operating expenses:
Selling, distribution, and marketing		1,454			1,462			4,066			4,059
General and administrative		9,556			9,545			25,040			22,966
Research and development		8,585			9,041			20,788			25,736
Impairment of long-lived assets		13			6			361			6

Total operating expenses		19,608			20,054			50,255			52,767

Income (loss) from operations		(7,817	)		226			(10,959	)		14,560

Non-operating income (expense):
Interest income		94			49			154			145
Interest expense, net		(504	)		(195	)		(1,159	)		(737	)
Other income (expense), net		243			255			(367	)		477

Total non-operating income (expense), net		(167	)		109			(1,372	)		(115	)

Income (loss) before income taxes		(7,984	)		335			(12,331	)		14,445
Income tax expense (benefit)		(2,605	)		494			(4,153	)		4,412

Net income (loss)	$	(5,379	)	$	(159	)	$	(8,178	)	$	10,033

Net income (loss) per common share:
Basic	$	(0.12	)	$	0.00		$	(0.20	)	$	0.26

Diluted	$	(0.12	)	$	0.00		$	(0.20	)	$	0.26

Weighted-average shares used to compute net income (loss) per common share:
Basic		44,644			38,709			41,060			38,708

Diluted		44,644			38,709			41,060			38,848

	Euros		U.S. Dollars
	(in thousands)
At Closing, April 2014	€	13,252	$	18,352
December 2014		4,899		6,214
December 2015		3,186		4,041
December 2016		3,186		4,041
December 2017		500		634
	€	25,023	$	33,282

	Fair Value
	Euros		U.S. Dollars
	(in thousands)
Inventory	€	15,565	$	21,554
Real property		4,800		6,647
Machinery & equipment		6,800		9,417
Intangibles		80		111
Goodwill		3,155		4,369
Total assets acquired	€	30,400	$	42,098

Accrued liabilities	€	2,425	$	3,358
Deferred tax liabilities		3,155		4,369
Total liabilities assumed		5,580		7,727

Total fair value of consideration transferred	€	24,820	$	34,371

	Nine Months Ended September 30,				Year Ended December 31,
	2014				2013
	(in thousands)
Beginning balance		$	18,104			$	11,898
Provision related to sales made in the current period			118,643				213,075
Credits issued to third parties			(124,449	)			(206,869	)
Ending balance		$	12,298			$	18,104

	Net Revenue						Net Revenue						Long-Lived Assets
	Three Months Ended September 30,						Nine Months Ended September 30,						September 30,			December 31,
	2014			2013			2014			2013			2014			2013
	(in thousands)
U.S.		$	53,729		$	59,318		$	148,500		$	174,805		$	98,744		$	99,398
China			—			—			—			—			21,011			17,221
France			5,982			—			6,084			—			14,357			—
Total		$	59,711		$	59,318		$	154,584		$	174,805		$	134,112		$	116,619

	% of Total Accounts Receivable						% of Net Revenue						% of Net Revenue
	September 30,			December 31,			Three Months Ended September 30,						Nine Months Ended September 30,
	2014			2013			2014			2013			2014			2013
Actavis, Inc.		31	%		44	%		35	%		32	%		33	%		34	%
AmerisourceBergen		10	%		11	%		14	%		15	%		15	%		15	%
Cardinal Health		10	%		7	%		13	%		13	%		14	%		14	%
McKesson		16	%		13	%		19	%		29	%		23	%		26	%

	Total		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
	(in thousands)
Cash equivalents:
Money market accounts	$	40,013	$	40,013	$	—	$	—
Restricted short-term investments:
Certificates of deposit		1,495		1,495		—		—

Fair value measurement as of September 30, 2014	$	41,508	$	41,508	$	—	$	—

Cash equivalents:
Money market accounts	$	41,183	$	41,183	$	—	$	—
Restricted short-term investments:
Certificates of deposit		1,325		1,325		—		—

Fair value measurement as of December 31, 2013	$	42,508	$	42,508	$	—	$	—

	Weighted-Average Life (Years)		Original Cost		Accumulated Amortization		Net Book Value
			(in thousands)
Definite-lived intangible assets
Product rights		12	$	27,134	$	20,451	$	6,683
Patents		10		293		71		222
Trademarks		11		19		13		6
Land-use rights		39		2,540		206		2,334
Other intangible assets		1		505		505		—
Subtotal		12		30,491		21,246		9,245
Indefinite-lived intangible assets
Trademark		*		29,225		—		29,225
Goodwill		*		4,649		—		4,649
AFP customers		*		102		—		102
Subtotal		*		33,976		—		33,976
As of September 30, 2014		*	$	64,467	$	21,246	$	43,221

	September 30, 2014			December 31, 2013
	(in thousands)
Raw materials and supplies	$	42,049		$	34,470
Work in process		23,558			14,698
Finished goods		23,430			26,501
Total inventory		89,037			75,669
Less reserve for excess and obsolete inventories		(985	)		(5,753	)
Total inventory, net	$	88,052		$	69,916

	Options			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value (1)
								(in thousands)
Outstanding as of December 31, 2013		10,771,755		$	15.39
Options granted		1,661,862			15.04
Options exercised		(65,000	)		10.79
Options cancelled		(60,198	)		12.11
Options expired		(796,988	)		18.86
Outstanding as of September 30, 2014		11,511,431		$	15.14		4.87	$	1,975
Exercisable as of September 30, 2014		5,732,361		$	17.27		3.60	$	806

	Options			Weighted-Average Grant Date Fair Value
Nonvested as of December 31, 2013		5,617,554		$	3.12
Options granted		1,661,862			4.02
Options vested		(1,440,148	)		3.00
Options forfeited		(60,198	)		4.35
Nonvested as of September 30, 2014		5,779,070			3.39

	Total DSUs Issued			Total Fair Market Value of DSUs Issued as Compensation (1)
				(in thousands)
DSUs outstanding at December 31, 2013		98,495
DSUs granted		449,544		$	6,389
DSUs forfeited		(994	)
Common stock delivered		(9,497	)
DSUs surrendered for taxes		(7,774	)
DSUs outstanding at September 30, 2014		529,774

	Three Months Ended September 30,						Change
	2014			2013			Dollars			%
	(in thousands)
Net revenues
Enoxaparin	$	32,040		$	36,189		$	(4,149	)		(11	%)
Insulin		5,982			—			5,982			100	%
Other products		21,689			23,129			( 1,440	)		(6	%)
Total net revenues		59,711			59,318			393			1	%
Cost of revenues		47,920			39,038			8,882			23	%
Gross profit	$	11,791		$	20,280		$	(8,489	)		(42	%)
as % of net revenues		20	%		34	%

	Nine Months Ended September 30,						Change
	2014			2013			Dollars			%
	(in thousands)
Net revenues
Enoxaparin	$	85,337		$	111,326		$	(25,989	)		(23	%)
Insulin		6,084			—			6,084			100	%
Other products		63,163			63,479			(316	)		0	%
Total net revenues		154,584			174,805			(20,221	)		(12	%)
Cost of revenues		115,288			107,478			7,810			7	%
Gross profit	$	39,296		$	67,327		$	(28,031	)		(42	%)
as % of net revenues		25	%		39	%

	Nine Months Ended September 30,
	2014
	(in thousands)
Statement of Cash Flow Data:
Net cash provided by (used in)
Operating activities		$	8,729
Investing activities			( 29,845	)
Financing activities			40,670
Effect of exchange rate changes on cash			(260	)
Net increase (decrease) in cash and cash equivalents		$	19,294

Period	Total Number of Shares Purchased		Average Price Paid per Share	Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs	Maximum Number of Shares that May Yet Be Purchased Under the Plans or Programs
July 1 – July 31, 2014	—		—	—	—
August 1 – August 31, 2014	—		—	—	—
September 1 – September 30, 2014	35,000	(1)	$11.81	—	—


		AMPHASTAR PHARMACEUTICALS, INC. (Registrant)

By:		/s/ JACK Y. ZHANG
		Jack Y. Zhang
		Chief Executive Officer (Principal Executive Officer)


		AMPHASTAR PHARMACEUTICALS, INC. (Registrant)

By:		/s/ WILLIAM J. PETERS
		William J. Peters
		Chief Financial Officer (Principal Financial and Accounting Officer)

Exhibit No.		Description


10.1†		Supply Agreement, dated July 31, 2014, between MannKind Corporation and Amphastar France Pharmaceuticals, S.A.S.

10.2		First Amendment to Supply Agreement, dated October 31, 2014, by and between MannKind Corporation, Amphastar France Pharmaceuticals, S.A.S., and Amphastar Pharmaceuticals, Inc.

31.1		Certification of Chief Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

31.2		Certification of Chief Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1#		Certification of Chief Executive Officer Pursuant to Rules 13a-14(b) and 15d-14(b) of the Securities Exchange Act of 1394 and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

32.2#		Certification of Chief Financial Officer Pursuant to Rules 13a-14(b) and 15d-14(b) of the Securities Exchange Act of 1394 and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101.INS		XBRL Instance Document.*

101.SCH		XBRL Taxonomy Extension Schema Document.*

101.CAL		XBRL Taxonomy Extension Calculation Linkbase Document.*

101.LAB		XBRL Taxonomy Extension Label Linkbase Document.*

101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document.*

101.DEF		XBRL Taxonomy Extension Definitions Linkbase Document.*

#	The information in Exhibits 32.1 and 32.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act (including this Report), unless the Registrant specifically incorporates the foregoing information into those documents by reference.

*	These interactive data files are being furnished as part of this Quarterly Report, and, in accordance with Rule 402 of Regulation S-T, shall not be deemed filed for purposes of Section 11 or 12 of the Securities Act of 1933, as amended, or Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability under those sections.

†	Confidential treatment requested as to portions of the exhibit. Confidential materials omitted and filed separately with the SEC.

	MannKind Corporation

	By: /s/ Kathleen M. Farley
	Name: Kathleen M. Farley
	Title: V.P. Strategic Operations


	Amphastar France Pharmaceuticals S.A.S.

	By: /s/ Franck Vitali
	Name: Franck Vitali
	Title: Plant Manager


	Amphastar Pharmaceuticals, Inc.

	By: /s/ Jason Shandell
	Name: Jason Shandell
	Title: President



By:		/ S /JACK Y. ZHANG
		Jack Y. Zhang
		Chief Executive Officer
		(Principal Executive Officer)



By:		/ S /WILLIAM J. PETERS
		William J. Peters
		Chief Financial Officer
		(Principal Financial and Accounting Officer)