exv10w1







    Exhibit 10.1



 


 




    LICENSE,
    DISTRIBUTION, MANUFACTURING AND SUPPLY AGREEMENT

    BY AND BETWEEN

    LUITPOLD PHARMACEUTICALS, INC., AMERICAN REGENT, INC.

    AND

    FRESENIUS USA MANUFACTURING, INC.

    June   , 2008



 












 







    LICENSE,
    DISTRIBUTION, MANUFACTURING AND SUPPLY AGREEMENT



 



    This LICENSE, DISTRIBUTION, MANUFACTURING AND SUPPLY AGREEMENT
    (this Agreement”) is made and entered into as of
    June   , 2008, by and between LUITPOLD
    PHARMACEUTICALS, INC., a corporation duly organized and
    existing under the applicable laws of the State of New York, and
    having a principal place of business in Shirley, New York
    (hereinafter referred to as “Luitpold”), AMERICAN
    REGENT, INC., a corporation duly organized and existing
    under the applicable laws of the State of New York, and having a
    principal place of business in Shirley, New York (hereinafter
    referred to as “AR”, and Luitpold and AR collectively
    referred to as “Luitpold/AR”), and FRESENIUS USA
    MANUFACTURING, INC., a corporation duly organized and
    existing under the applicable laws of the State of Delaware, and
    having a principal place of business in Waltham, Massachusetts
    (hereinafter referred to as “FUSA”). VIFOR
    (INTERNATIONAL), INC. (hereinafter referred to as
    “Vifor”) is also executing this Agreement to indicate
    its acknowledgement of and consent to the terms and provisions
    hereof, and to agree to those provision hereof that pertain to
    it. Luitpold/AR and FUSA are referred to herein individually as
    a “Party” and collectively as the “Parties.”



 




    RECITALS:



 



    WHEREAS, Luitpold/AR is party to a Master License Agreement with
    Vifor under which Luitpold/AR licenses from Vifor certain rights
    and Know-How (as hereinafter defined) relating to the Iron
    Products (as defined herein) and under which Vifor manufactures
    and supplies to Luitpold/AR the active pharmaceutical ingredient
    used in the manufacture of the Iron Products; and



 



    WHEREAS, Luitpold/AR licenses from Vifor the manufacturing,
    marketing and distribution rights to the Product sold under the
    Venofer®

    brand in various formulations, presentations and
    strengths; and



 



    WHEREAS, FUSA wishes to obtain from Luitpold/AR a sublicense and
    Vifor consents that Luitpold may grant a sublicense to FUSA for
    the exclusive right to manufacture (or arrange for the
    manufacture), package, label, use, distribute, market, promote,
    detail, advertise and sell the Iron Products for the Field in
    the Territory (as hereinafter defined), and to utilize the
    Trademarks (as hereinafter defined) to identify the Iron
    Products in connection with the manufacture, packaging,
    labeling, distribution, marketing, promotion, advertisement and
    sale thereof for the Field in the Territory as described herein,
    and Luitpold/AR and Vifor wish to grant such rights to FUSA on
    the terms and conditions set forth in this Agreement; and



 



    WHEREAS, FUSA wishes to contract with Luitpold/AR for
    Luitpold/AR to exclusively manufacture and supply the Iron
    Products to FUSA and Luitpold/AR agrees to manufacture and
    supply, FUSA’s requirements of finished dosage forms of the
    Iron Products, for distribution for the Field in the Territory
    for the Term (as hereinafter defined), and FUSA wishes to have
    Luitpold/AR purchase from Vifor on its behalf, and Vifor agrees
    to supply through Luitpold/AR on behalf of FUSA, FUSA’s
    requirements of the API (as hereinafter defined) for the Iron
    Products for incorporation into finished Product by Luitpold/AR
    for distribution for the Field in the Territory for the Term by
    FUSA; and



 



    WHEREAS, [*]



 



    NOW, THEREFORE, in consideration of the mutual covenants and
    agreements hereinafter set forth and other good and valuable
    consideration, the receipt and legal sufficiency of which are
    hereby mutually acknowledged, Luitpold/AR and FUSA hereby agree,
    and Vifor consents to such agreement, as follows:



 




    ARTICLE 1

    



 




    DEFINED TERMS
    



 



    1.01 Defined Terms.  The following terms,
    whether used in the singular or plural, shall have the meanings
    assigned to them below for purposes of this Agreement:



 



    “API” means, as applicable, the active
    pharmaceutical ingredient used in the manufacture of any of the
    Iron Products.













 






    “Adverse Event” shall mean any adverse event
    associated with the use of the Iron Products in humans, whether
    or not considered drug-related, including (i) an adverse
    event occurring in the course of the use of the Iron Products in
    professional practice; (ii) an adverse event occurring from
    an overdose, whether accidental or intentional, related to the
    Iron Products; (iii) an adverse event occurring from drug
    abuse related to the Iron Products; (iv) an adverse event
    occurring from withdrawal of the Iron Products; and (v) any
    failure of expected pharmacological action of an Iron Product,
    or such other definition as may from time to time be set forth
    in 21 CFR Part 314.80.



 



    “Affiliate” means, with respect to any Person,
    any other Person, that directly or indirectly controls, is
    controlled by, or is under common control with, such Person. For
    such purposes, control, controlled by and under common control
    with shall mean the possession of the power to direct or cause
    the direction of the management and policies of an entity,
    whether through the ownership of voting stock or partnership
    interest, by contract or otherwise. In the case of a
    corporation, the direct or indirect ownership of fifty percent
    (50%) or more, or the ownership percentage as required under
    local jurisdiction, of its outstanding voting shares or the
    ability otherwise to elect a majority of the board of directors
    or other managing authority of the entity shall in any event be
    deemed to confer control, it being understood that the direct or
    indirect ownership of a lesser percentage of such shares shall
    not necessarily preclude the existence of control.



 



    “Agreement” means this agreement, together with
    all appendices, exhibits and schedules hereto, as the same may
    be amended or supplemented in accordance with this Agreement.



 



    [*]



 



    [*]



 



    “Applicable Laws” means all laws (including the
    common law), ordinances, rules and regulations, written
    governmental interpretations thereof, guidance related thereto
    or the application thereof, applicable to this Agreement or the
    activities contemplated hereunder, including without limitation
    the FDA Act and applicable regulations, federal and state
    anti-kickback laws, privacy laws, consumer protection statutes,
    laws relating to sample accountability or Iron Products pedigree
    and any requirements under any Product Registrations applicable
    to the Iron Products for the Field in the Territory.



 



    “ASP” means average sales price as that term is
    defined in 42 U.S.C.
    § 1395w-3a,
    as such statute may be amended.



 



    “Business Day” means any day that is not a
    Saturday, Sunday or a United States federal holiday.



 



    “Calendar Quarter” means a period of three
    (3) consecutive calendar months commencing each
    January 1, April 1, July 1, and September 1 and
    ending each March 31, June 30, September 30 and
    December 31, as the case may be.



 



    [*]



 



    “cGMPs” means current Good Manufacturing
    Practices, as defined in under 21 U.S.C.
    section 351(a)(2)(B) and the FDA regulations promulgated
    thereunder, including without limitation, 21 C.F.R.
    Section 210 et seq., as amended and in effect from time to
    time.



 



    “Certificates of Analysis and Compliance” shall
    mean the certificate of analysis confirming the identity,
    strength, quality and purity of the Lot to which it pertains
    together with the certificate of compliance confirming that the
    same Lot was manufactured, tested, stored and supplied in
    compliance with cGMPs and Applicable Laws, each such certificate
    signed by an authorized signatory of Luitpold/AR.



 



    “Claim” means a FUSA Claim or a Luitpold/AR
    Claim, as applicable.



 



    “CMS” means the Centers for Medicare and
    Medicaid Services of the U.S. Department of Health and
    Human Services.



 



    [*]




    

    2








 






    “Commercially Reasonable Efforts” of a Party
    means those efforts consistent with the exercise of its prudent
    clinical, scientific and business judgment as applied to other
    commercialization efforts for products of similar clinical,
    scientific and commercial potential within the relevant product
    lines of such Party.



 



    “Confidential Information” has the meaning set
    forth in Section 10.01(a).



 



    “Confidentiality Agreement” has the meaning set
    forth in Section 10.01(b).



 



    “Contract Year” means each period of twelve
    consecutive months beginning on the Effective Date and each
    anniversary of the Effective Date during the term of this
    Agreement. A Contract Year may be designated by the calendar
    year in which it begins, e.g., “Contract Year 2008”
    will be the Contract Year beginning in 2008.



 



    “DDMAC” means the FDA’s Division of Drug
    Marketing, Advertising and Communications.



 



    “Discrepancy Reports” shall mean deviation
    reports pertaining to API or Iron Products generated by
    Luitpold/AR or Vifor that contain information relating to
    deviations that may require reporting to the FDA or a regulatory
    authority.



 



    “Drug Master File” or “DMF”
    shall mean a voluntary submission that may be used to provide
    confidential, detailed information about any of the Iron
    Products, API and facilities, processes, or articles used in the
    manufacturing, processing, packaging, and storing of the Iron
    Products or API.



 



    “Effective Date” means the first day of the
    month immediately following at least thirty (30) days after
    the date on which all conditions set forth in Section 13.01
    have been satisfied or waived in writing.



 



    [*]



 



    “Employees” has the meaning set forth in
    Section 3.10(a).



 



    “EOC” has the meaning set forth in
    Section 12.16.



 



    “Escrow Agent” has the meaning set forth in
    Section 6.11.



 



    “Escrow Agreement” has the meaning set forth in
    Section 6.11(h).



 



    “Escrow Materials” has the meaning set forth in
    Section 6.11(h).



 



    “Executive Oversight Committee” shall have the
    meaning set forth in Section 12.16.



 



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



 



    “FDA Act” shall mean the Federal Food Drug and
    Cosmetic Act, as amended, and as may be amended from time to
    time.



 



    “Federal and State Programs” has the meaning
    set forth in Section 3.07(c).



 



    “Field” means the provision of hemodialysis and
    peritoneal dialysis services to Stage V Hemodialysis
    Dependent — Chronic Kidney Disease (HDD-CKD) patients
    and Peritoneal Dialysis Dependent — Chronic Kidney
    Disease (PDD-CKD) patients in Independent Outpatient Dialysis
    Facilities.



 



    “FUSA Warehouse” means a warehouse of finished
    Iron Products to be maintained by FUSA, which shall be located
    initially at Charlotte, North Carolina.



 



    “FUSA Claim” has the meaning set forth in
    Section 8.01.



 



    “FUSA Party” has the meaning set forth in
    Section 8.01.



 



    “Governmental Authority” means any Federal,
    state, local or foreign governmental authority, agency or other
    body.



 



    “Independent Outpatient Dialysis Facilities”
    means facilities that are not hospital-based facilities and do
    not meet all of the criteria set forth in 42 C.F.R.
    § 413.174(c) (and any successor or amended
    regulations) as follows: (1) the facility is subject to the
    bylaws and operating decisions of a common governing board which




    

    3








 






    has final administrative responsibility, approves all personnel
    actions, appoints medical staff, and carries out similar
    management functions; (2) the facility’s director or
    administrator is under the supervision of the facilities’
    chief executive officer and reports through him or her to the
    governing body; and (3) the facility is financially
    integrated, as evidenced by the cost report, which reflects
    allocation of overhead to the facility through the required step
    down methodology.



 



    “Intellectual Property” means all intellectual
    property rights, including rights to inventions, US and foreign
    patents and patent applications, divisions, continuations,
    continuations in part, reissues or extensions thereof, Trade
    Secrets, Know-How and copyrights but excludes Trademarks, as
    listed on
    Exhibit 1.01-C,
    and which will be updated each September 30th and
    March 31st of each Annual Period.



 



    “Iron Products” means the Products and [*].



 



    “Know-How” means ideas, designs, concepts,
    compilations of information, methods, techniques, procedures and
    processes, inventions and discoveries, whether or not
    patentable, used or useful in the manufacture, packaging,
    labeling, use, promotion, distribution, or sale of the Iron
    Products.



 



    “Knowledge” of a Person other than a natural
    person means the actual knowledge of the officers of such Person
    having operating responsibility for the business of such Person.



 



    “Licensed Technology” means all Know-How, Trade
    Secrets, Intellectual Property, Trademarks, and Manufacturing
    Documentation used or useful in the manufacture, packaging,
    labeling, use, promotion, distribution, or sale of Iron Products
    in the Field.



 



    “Licensee” shall mean FUSA.



 



    “Lot” shall mean a single production run of any
    Iron Product.



 



    “Lot Documentation Package” shall mean all of
    the following related to a given Lot: (a) with respect to
    API, a Certificate of Analysis and Compliance, a summary list of
    Discrepancy Reports, and the actual Discrepancy Reports upon
    request by FUSA where required to release any Iron Product in
    the Territory and (b) with respect to Iron Products, a
    Certificate of Analysis and Compliance, batch production
    records, Discrepancy Reports and lot disposition form(s) signed
    by Luitpold/AR. In any event, Luitpold/AR shall provide FUSA all
    documentation required by the FDA or any Governmental Authority.
    If actual Discrepancy Reports are necessary for FUSA to comply
    with the requirements of the FDA or any Governmental Authority
    in the Territory and FUSA has submitted such request to
    Luitpold/AR, thereafter, the Lot Documentation Package shall
    include for each Lot the actual Discrepancy Reports (not merely
    the summaries thereof).



 



    “Luitpold/AR Claim” has the meaning set forth
    in Section 8.02.



 



    “Luitpold/AR Entities” means Luitpold/AR and
    those Luitpold/AR Affiliates that manufacture, distribute, sell,
    promote or market any Iron Products in the Territory.



 



    “Luitpold/AR Party” has the meaning set forth
    in Section 8.02.



 



    “Luitpold/AR Suppliers” has the meaning set
    forth in Section 6.11.



 



    “Manufacturing Documentation” means, with
    respect to any Iron Product, all Licensed Technology, any and
    all current validation reports, any current formulation’s
    manufacturing instructions, and current batch record templates,
    which are specific to or otherwise used in Secondary Manufacture
    of the finished form of the Iron Product. For avoidance of
    doubt, it is understood and agreed that the term
    “Manufacturing Documentation” shall only apply to such
    documents as are used in, or that relate to, the finished goods
    manufacturing process, and shall not in any case apply to the
    Primary Manufacturing process or to the synthesis of any of the
    API or Substance in the Iron Product.



 



    [*]



 



    “Material Adverse Effect” when used in
    connection with a Party means any change, event, violation,
    inaccuracy, circumstance or effect that is materially adverse to
    the business, assets (including intangible assets),
    capitalization, financial condition or results of operations of
    such entity and its parent (if applicable) or




    

    4








 






    subsidiaries taken as a whole; provided, however, that
    “Material Adverse Affect” shall not include changes,
    events, violations, inaccuracies, circumstances and effects that
    are caused by conditions affecting the United States
    economy as a whole.



 



    “NDA” means the Luitpold/AR New Drug
    Application
    21-135
    related to Iron Sucrose Injection, U.S.P., [*] requesting
    permission to place a drug on the market in accordance with
    21 CFR Part 314, and all amendments or supplements
    filed pursuant to the requirements of the FDA, including all
    documents, data and other information concerning such Iron
    Product which are necessary for FDA approval to market such Iron
    Product in the Territory.



 



    “NDC” means each of Luitpold’s/AR and
    FUSA’s National Drug Code. For Luitpold/AR this means NDC
    0517-2310
    and
    0517-2340
    and for FUSA this means
    49230-534
    and
    49230-103,
    plus any NDC codes added during the Term of the Agreement.



 



    [*]



 



    “New Law” has the meaning set forth in
    Section 5.01(a)(iv).



 



    [*]



 



    [*]



 



    “NOV” means notice of violation.



 



    “Party” and “Parties” have the
    meaning set forth in the introductory paragraph; provided, that
    for purposes of Articles 9, 10, Section 7.05(a) and
    Section 13.01(c) and to the extent Vifor makes an express
    representation, warranty or covenant herein, Vifor shall also be
    a Party and one of the Parties.



 



    “Person” means any natural person, corporation,
    firm, business trust, joint venture, association, organization,
    company, partnership, limited liability company, or other
    business entity, or any government or any agency or political
    subdivision thereof (including but not limited to FDA).



 



    “Primary Manufacture” or “Primary
    Manufacturing” means the process used in the manufacture of
    the API or Substance (including, but not limited to the
    synthesis thereof), the result of which will be used in
    Secondary Manufacturing of a pharmaceutical product, including
    without limitation the Products.



 



    “Products” means the pharmaceutical product
    covered by NDA
    21-135 in
    all dosage forms, formulations, line extensions and package
    configurations and comprising iron sucrose as an active
    ingredient marketed by Luitpold/AR or its Affiliate in the
    Territory under the trademark
    Venofer®

    and any improvements to such formulations or dosages (that do
    not require the application for a new Product Approval), as may
    hereafter be distributed by or licensed to Luitpold/AR or its
    Affiliates in the Field within the Territory during the Term.



 



    “Product Approval” shall mean an NDA for an
    Iron Product.



 



    “Product Packaging Materials” means all
    packaging materials used in the Secondary Manufacture of, and
    shipment of, the Iron Products, as in effect on the date hereof,
    including primary and secondary containers, closures, tertiary
    packaging materials, labels and leaflets, all as revised from
    time to time in accordance with the terms and conditions of this
    Agreement.



 



    “Product Registration” means the approvals or
    registrations (other than the FUSA NDC) for any of the Iron
    Products which have been, or may hereafter be, received by
    Luitpold/AR or Vifor in the Territory, including without
    limitation the Drug Master File (DMF) and NDA for the Iron
    Product.



 



    [*]



 



    “Product Specifications” shall mean all
    specifications for an Iron Product set forth in the Product
    Registration for the Iron Product.



 



    [*]



 



    “Recall” has the meaning set forth in
    Section 6.05.




    

    5








 






    [*]



 



    “Renewal Option” has the meaning set forth in
    Section 11.01.



 



    [*]



 



    [*]



 



    “Secondary Manufacture” or “Secondary
    Manufacturing” means the manufacturing and packaging
    process used in formulating the API and all excipients into a
    final dosage form of a pharmaceutical product.



 



    “Serious Adverse Event” means an Adverse Event
    occurring at any dose that results in any of the following
    outcomes: death, a life-threatening Adverse Event, inpatient
    hospitalization or prolongation of existing hospitalization, a
    persistent or significant disability/incapacity, or a congenital
    anomaly/birth defect. Important medical events that may not
    result in death, be life-threatening, or require hospitalization
    may be considered a Serious Adverse Event when, based upon
    appropriate medical judgment, they may jeopardize the patient or
    subject and may require medical or surgical intervention to
    prevent one of the outcomes listed in this definition.



 



    “Substance” shall mean API or any
    intermediaries thereof, which shall be identified by a CAS
    Registry Number, RN number or complete chemical description.



 



    “Term” means the period during which this
    Agreement is in full force and effect pursuant to
    Section 11.01.



 



    “Territory” means the United States of America
    and its territories and possessions.



 



    “Third Party” means any Person other than a
    Party, an Affiliate of a Party, Vifor or an Affiliate of Vifor.



 



    [*]



 



    “Trade Secrets” means business or technical
    information related to the manufacture, packaging, labeling,
    use, promotion, distribution, or sale of the Iron Products
    including, but not limited to, formulas or methods of
    manufacturing and production and Know-How that is not generally
    known to Third Parties and that derives actual or potential
    commercial value from not being generally know to Third Parties.



 



    “Transfer” has the meaning set forth in
    Section 2.07(a).



 



    [*]



 



    [*]



 



    1.02 Terms Generally.  All references
    herein to Articles, Sections, paragraphs, clauses, Exhibits and
    Schedules shall be deemed references to Articles, Sections,
    paragraphs, clauses Exhibits and Schedules to this
    Agreement unless the context shall otherwise require.



 




    ARTICLE 2

    



 




    LICENSE AND
    APPOINTMENT OF DISTRIBUTOR; RIGHTS AND LIMITATIONS;

    





    RIGHTS OF
    FIRST REFUSAL FOR THE PRODUCTS
    



 



    2.01 Products License and Appointment.  



 



    (a) Subject to the terms of this Agreement, Luitpold/AR
    hereby grants to FUSA, and Vifor consents to such grant, an
    exclusive right and license (exclusive even as to Luitpold/AR,
    Vifor and their respective Affiliates), limited to the Field, to
    use the Licensed Technology to make, have made, manufacture,
    have manufactured, package, label, use, promote, distribute,
    offer for sale and sell the Product within the Territory during
    the Term; [*]. Except to the extent otherwise provided in this
    Agreement, the rights granted to FUSA pursuant to this
    Section 2.01 may not be sublicensed without the prior
    written approval of Luitpold/AR. In addition, subject to the
    terms and conditions of this Agreement, Luitpold/AR hereby
    appoints FUSA as Luitpold/AR’s exclusive distributor
    (exclusive even as to Luitpold/AR and Vifor and their respective
    Affiliates) of the Product for the Field within the




    

    6








 






    Territory, and, in connection therewith, grants to FUSA the
    exclusive right (exclusive even as to Luitpold/AR and Vifor and
    their respective Affiliates) to market, promote, advertise, sell
    and distribute the Products for the Field within the Territory.
    The appointment made in the preceding sentence shall commence as
    of the Effective Date and continue throughout the Term, and
    shall not survive past the termination or expiration of the Term
    except as provided in Section 11.06. Luitpold/AR and its
    Affiliates shall not engage in any sale or distribution (except
    to the extent provided in Section 2.01(b) below) of the
    Products for the Field within the Territory during the Term;
    FUSA shall not engage in any sale or distribution of the
    Products outside the Field or the Territory during the Term.
    FUSA shall not knowingly sell to any of its Affiliates or any
    Third Party outside the Territory Products for resale inside the
    Territory. If Luitpold/AR becomes aware of any sale of Iron
    Products by FUSA or its Affiliates outside the Field or the
    Territory, or if FUSA becomes aware of any sale of Iron Products
    by Luitpold/AR in the Field in the Territory, the Party becoming
    aware of such sale shall bring the circumstances of such sale to
    the attention of the EOC for resolution.



 



    (b) Luitpold/AR shall retain the right to ship Products
    through its distribution channels in the Territory, as long as
    such shipment is solely in connection with providing Products to
    a Third Party for sale outside the Field or Territory or to FUSA
    for the Field within the Territory. Luitpold/AR will work with
    FUSA to transition all wholesalers contracts servicing the Field
    to FUSA, including AMD, Metro and AmeriSourceBergen.



 



    (c) [*]



 



    (d) In order to ensure a smooth transition to FUSA of
    Luitpold/AR’s customer’s for the Products in the Field
    within the Territory, FUSA and Luitpold/AR shall send a letter
    to all Luitpold/AR customers informing such customers that FUSA
    is the exclusive manufacturer and distributor of the Products in
    the Field within the Territory from and after the Effective
    Date. The form of such letter is attached hereto as
    Exhibit 2.01(d-1).
    Upon termination or expiration of this Agreement, FUSA and
    Luitpold/AR shall send a letter to all FUSA customers informing
    such customers that Luitpold/AR is the exclusive manufacturer
    and distributor of the Iron Products in the Field within the
    Territory from and after the termination/expiration date. The
    form of such letter shall be similar in substance to that
    attached hereto as
    Exhibit 2.01(d-2).



 



    2.02 [*]



 



    (a) [*]



 



    (b) [*]



 



    (c) [*]



 



    (d) [*]



 



    (e) [*]



 



    (f) [*]



 



    (g) [*]



 



    (h) [*]



 



    (i) [*]



 



    (j) [*]



 



    2.03 Territorial Limitation.  FUSA agrees
    that it shall conduct its sale and distribution of the Iron
    Products solely in the Field within the Territory. FUSA shall
    not sell, market, promote, advertise or distribute the Iron
    Products outside the Field or Territory. FUSA shall not
    knowingly sell the Iron Products, directly or indirectly, to any
    Third Party in the Territory for resale outside the Territory or
    outside the Field. Luitpold/AR shall use Commercially Reasonable
    Efforts to ensure that its Affiliates, agents or representatives
    shall not sell the Iron Products, directly or indirectly, to
    Third Parties in the Field within the Territory. [*]



 



    2.04 Restriction on
    Sub-Distributors.  Without the prior written
    consent of Luitpold/AR (which consent shall not be unreasonably
    withheld, delayed or conditioned), FUSA shall not grant to any
    Third Party any rights to market, promote, advertise, sell or
    distribute the Iron Products, and shall not enter into any
    agreement or




    

    7








 






    arrangement with respect to co-promoting the Iron Products. The
    foregoing notwithstanding, FUSA may employ the services of a
    Third Party in (a) the detailing of the Iron Products to
    healthcare professionals in the Field within the Territory, so
    long as any sales representative deployed by such Third Party
    for FUSA for such purpose shall at such time not detail products
    that are competitive with the Iron Products, (b) the
    receiving, warehousing, and shipping of the Iron Products for
    FUSA, or (c) the acceptance of orders, generation of
    invoices and collection and management of receivables with
    respect to FUSA’s sales of the Iron Products.



 



    2.05 Compliance with Product Registration Resale in Same
    Packaging.  FUSA shall not at any time do, and
    neither shall Luitpold/AR do or permit its agents or
    representatives to do, any act in violation of the Product
    Registration for any of the Iron Products in the Field within
    the Territory. In the event that any filings are required to be
    made with or approvals required to be obtained from applicable
    regulatory authorities in order to sell the Iron Products to
    FUSA or for FUSA to initiate distribution, marketing,
    advertisement, sale or promotion of the Iron Products in the
    Field within the Territory, the Parties shall cooperate fully to
    ensure that such filings and approvals are obtained or made as
    expeditiously as reasonably practicable. FUSA shall not alter in
    any manner any of the Iron Products or its packaging as
    manufactured for it by Luitpold/AR hereunder and shall sell the
    Iron Products without alteration in the form manufactured for it
    by Luitpold/AR. FUSA shall be responsible for all costs and
    expenses relating to same if for use in the Field.



 



    2.06 No Ownership Rights Conveyed on Effective
    Date.  Except for FUSA’s right to use the
    Trademarks and Manufacturing Documentation pursuant to
    Section 3.03 hereof, [*], no other right or license under
    any Trademark, the Manufacturing Documentation or under any
    patent rights or know-how owned or controlled by Luitpold/AR or
    any of its Affiliates to make or have made the Iron Products is
    granted under this Agreement to FUSA.



 



    2.07 [*]



 



    (a) [*]



 



    (b) [*]



 



    (c) [*]



 



    (d) [*]



 



    (e) [*]



 



    2.08 [*]



 




    ARTICLE 3

    



 




    FUSA
    RESPONSIBILITIES
    



 



    3.01 Distributor Diligence.  In
    fulfillment of its obligations under this Agreement, during the
    Term, FUSA shall:



 



    (i) provide, at its expense, a traceability system for the
    Iron Products reasonably comparable to customary industry
    practices and as required by Applicable Laws;



 



    (ii) use Commercially Reasonable Efforts to ensure that all
    sales force personnel promote the Iron Products in a manner that
    is consistent with each Iron Product’s applicable Product
    Registration and labeling and that is permitted by Applicable
    Laws in the Field. If FUSA becomes aware of any such activity in
    contravention of the immediately foregoing standards, FUSA shall
    take prompt affirmative action to ensure that such activity
    shall cease, and take additional remedial action to advise its
    sales personnel concerning the activities described in this
    subsection;



 



    (iii) use Commercially Reasonable Efforts not to take any
    action constituting a violation of Applicable Laws or breach of
    this Agreement and that would have a Material Adverse Effect on:



 



    (a) the commercialization of the Iron Products for the
    Field in the Territory; or




    

    8








 






    (b) the then existing business of Luitpold/AR, its
    Affiliates and licensees with respect to Iron Products outside
    of the Territory and Field;



 



    (iv) obtain, as soon as reasonably practicable following
    the Effective Date, and no later than six (6) months
    following the Effective Date, at FUSA’s sole and exclusive
    expense, any and all requisite NDC’s in FUSA’s name
    for the Product and, [*] except as otherwise provided in this
    Agreement, obtain any and all governmental approvals as are
    required for FUSA to fulfill its obligations hereunder.
    Luitpold/AR shall cause the NDC number obtained by FUSA to
    appear on all Iron Products (other than Products consisting of
    current inventory of finished goods on the Effective Date)
    manufactured by Luitpold/AR for FUSA;



 



    (v) maintain the availability of the current package
    inserts with respect to the Iron Products on any website
    maintained by FUSA or its Affiliates for the distribution,
    marketing, promotion, detailing, advertising or sale of the Iron
    Products and at such other locations where FUSA or any such
    Affiliates make information regarding the Iron Products
    available; and



 



    (vi) use Commercially Reasonable Efforts to sell, market,
    detail, promote, advertise and distribute the Iron Products in a
    manner that will not have a Material Adverse Effect on the Iron
    Products.



 



    (vii) Exclusively purchase API from Luitpold/AR (who will
    exclusively purchase it from Vifor) and have Iron Products
    exclusively manufactured by Luitpold/AR, [*].



 



    3.02 Promotional Materials and
    Activities.  



 



    (a) Subject to the provisions of Section 3.02(b)
    below, FUSA shall be solely responsible, at its sole expense and
    under its sole control, subject to review by Luitpold/AR, for
    conducting all promotional activities and for designing,
    preparing and distributing all materials, advertisements and
    activities used in the promotion, advertising and marketing of
    Iron Products for the Field within the Territory. FUSA shall
    ensure that all materials, advertisements and promotional
    activities comply with, and FUSA shall be solely responsible and
    liable for any failure of such materials and activities to
    comply with, the applicable labeling and Product Registration
    for any of the Iron Products and with Applicable Laws and
    regulations, unless, Luitpold/AR shall not have conducted any
    prior review or approval of such materials or activities or such
    materials or activities may have been previously used or
    conducted by Luitpold/AR. FUSA shall be solely responsible for
    fulfilling regulatory requirements pertaining to its promotional
    materials and activities, including, without limitation, sole
    responsibility for submitting to FDA all promotional and
    advertising materials prepared by or for FUSA at the time of
    initial dissemination, by way of a
    Form FDA-2253,
    consistent with 21 C.F.R. Part 314.81. To this effect,
    Luitpold/AR shall, upon the Effective Date, or as soon
    thereafter as is reasonably practicable, place a letter on file
    with DDMAC with respect to the Products advising DDMAC that FUSA
    shall be the sole marketer and promoter of the Products for the
    Field in the Territory and requesting that DDMAC address
    regulatory inquiries and concerns regarding FUSA’s
    promotional activities to FUSA as well as Luitpold/AR. FUSA
    shall promptly, but in no event less than ten (10) Business
    Days after FUSA’s receipt thereof, provide a copy to
    Luitpold/AR of any correspondence from a Governmental Authority
    with respect to any of the Iron Products, including, but not
    limited to, the FDA, reflecting any purported legal or
    regulatory violations or legal or regulatory action being
    considered or taken by such Governmental Authority, including
    without limitation, copies of FDA NOV’s and Warning
    Letters. FUSA shall provide Luitpold/AR with a written request
    for approval of any promotional materials or advertising and
    Luitpold/AR shall review and approve the same. In the event that
    FUSA receives no objection within ten (10) Business Days
    after a written request for approval, the promotional materials
    or advertising shall be deemed to have been reviewed and
    approved by Luitpold/AR. FUSA will incorporate any reasonable
    changes requested by Luitpold/AR in its review of materials and
    Luitpold/AR will provide its reasons for any required changes.
    FUSA will provide Luitpold/AR in writing with its reasons for
    not incorporating any changes requested by Luitpold/AR. FUSA
    shall absorb and be solely responsible for any and all lost
    profits, lost revenues, damages, losses, expenses and costs
    incurred by FUSA and its Affiliates pursuant to the terms of
    this Agreement arising from the failure of any promotional
    materials or advertising used, or activities conducted by, FUSA
    to comply with the applicable labeling, the Product
    Registrations
    and/or with
    Applicable Laws.



 



    (b) If FUSA (or Luitpold/AR) shall receive a Warning Letter
    from FDA which relates to manufacturing, marketing, promotion,
    advertisement, sale or distribution of Iron Products after the
    Effective Date, or FUSA (or




    

    9








 






    Luitpold/AR) shall receive an NOV from the FDA which relate to
    manufacturing, marketing, promotion, advertisement, sale or
    distribution of Iron Products after the Effective Date, either
    FUSA or Luitpold/AR shall have the right to call, and the other
    Party shall participate/or attend at its own expense, a meeting
    of the Parties (which shall include, but not be limited to
    senior level operational, manufacturing, regulatory affairs,
    marketing and sales management of each Party) to be held in
    Boston, Massachusetts and New York, New York, on an alternate
    basis. The purpose of such meeting shall be to discuss the
    actions or missions, promotional pieces or practices which led
    to the issuance of the Warning Letter or the NOV’s, as the
    case may be, and to discuss, if appropriate, appropriate
    corrective or remedial measures to the Party’s promotional
    review process.



 



    (c) Luitpold/AR acknowledges that it is actively promoting
    the Product for the Field in the Territory and has provided FUSA
    with copies of any advertising, promotional or training
    materials in its possession and used by Luitpold/AR relating to
    the Product, and shall permit FUSA, subject to compliance by
    FUSA with Applicable Laws, to update, adapt and use such
    materials for the Field in the Territory in developing new
    promotional materials (subject to any copyrights of Third
    Parties in such materials). Luitpold/AR reserves and retains
    title and all rights, including copyright rights, in and to all
    written, visual and electronic works and other materials
    (including without limitation training materials, promotion
    materials, brochures and other detail literature) provided by it
    to FUSA under this Agreement. Subject to the foregoing, FUSA is
    granted the nonexclusive right under this Section to use, copy,
    modify, and distribute such materials only for the purposes of
    this Agreement and in furtherance of the rights granted to FUSA
    hereunder, for the Term for any of the Iron Products to which
    such works and materials relate. FUSA shall ensure that all
    copyright notices and this permission notice appear on all
    copies of the written materials provided by Luitpold/AR and all
    adaptations and derivative works thereof. Any and all new
    promotional material developed by FUSA, including that which
    adapts or utilizes materials supplied to FUSA by Luitpold/AR,
    shall be filed with FDA at the time of initial dissemination via
    Form FDA-2253.
    Luitpold/AR represents and warrants to FUSA that any promotional
    or training materials or advertising used or activities provided
    by it to FUSA hereunder complies with the applicable labeling,
    the applicable Product Registrations, Applicable Laws,
    and/or any
    comments, guidance or direction given by FDA or DDMAC in the
    Pre-Launch Process, including without limitation, the FDA’s
    Guidance on Industry-Supported Educational and Scientific
    Activities and the OIG Guidance.



 



    (d) FUSA shall have strategic responsibility and sole
    authority and responsibility, at its sole expense, for
    conducting independent and non-independent symposia, speaker
    training and engagement programs, advisory board meetings and
    other consulting arrangements, scientific exhibits and other
    types of scientific exchange, and other such events or programs
    as FUSA, in its sole discretion, deems to be appropriate with
    respect to marketed and approved Iron Products for the Field
    within the Territory; provided, however, that any and all such
    events and programs must comply in all respects with Applicable
    Laws and relevant FDA policies, including without limitation,
    the FDA’s Guidance on Industry-Supported Educational and
    Scientific Activities and the OIG Guidance.



 



    3.03 Use of Trademarks; Trade
    Dress.  During the Term of this Agreement, and
    subject to the terms and conditions of this Agreement:



 



    (a) FUSA shall have the right to use the Trademarks, on an
    exclusive royalty-free basis (other than the payments required
    hereunder), to manufacture (or have manufactured), promote,
    market, sell and distribute the Iron Products for the Field
    within the Territory. Except as otherwise agreed to by
    Luitpold/AR, FUSA shall not identify the Iron Products by any
    designation other than the Trademarks for the Products. With
    respect to all Iron Products which bear FUSA’s NDC codes as
    provided herein, FUSA shall be identified as the distributor of
    such Products and as having the Iron Products manufactured for
    FUSA on the Iron Products’ label as the same may be
    required and specified under Applicable Law, or if Applicable
    Law does not specify how the licensee or distributor shall be
    indicated on an Iron Product’s label, then as determined
    (including without limitation as to size and placement) jointly
    by FUSA and Luitpold/AR. The use of the Trademarks by FUSA shall
    be expressly subject to subparagraph (c) below. FUSA
    acknowledges that Venofer is a registered trademark of Vifor and
    is licensed to Luitpold/AR, and is subject to the sublicense
    granted herein, including all marking requirements.



 



    (b) FUSA undertakes to use the Trademarks only in respect
    of the Iron Products purchased from Luitpold/AR [*] and only for
    the Field within the Territory.




    

    10








 






    (c) Whenever FUSA uses the Trademarks in advertising or in
    any other manner in connection with the Iron Products, FUSA
    shall clearly indicate that the Trademarks are owned or licensed
    to FUSA by Vifor and Luitpold/AR. When using the Trademarks
    under this Agreement, FUSA shall comply with all Applicable Laws
    pertaining to the Trademarks in force at any time in the
    Territory. During the Term of this Agreement, FUSA shall provide
    Luitpold/AR with copies of such foregoing material once each
    Calendar Quarter, as requested by Luitpold/AR for approval of
    the use of the Trademarks by FUSA. FUSA shall promptly take any
    and all actions directed by Luitpold/AR with respect to
    FUSA’s use of the Trademarks that are reasonably designed
    to ensure compliance with the provisions of this
    Section 3.03.



 



    3.04 Trademark Infringement by Third
    Parties.  If either Party becomes aware that a
    Third Party is infringing any Trademark used in connection with
    the Iron Products, such Party shall give written notice to the
    other Party describing in detail the nature of such
    infringement. If Vifor
    and/or
    Luitpold/AR elect not to pursue such infringement, FUSA shall
    have the right, but not the obligation, to enforce any such
    Trademarks against such Third Party infringer to the extent
    deemed necessary or appropriate by FUSA or its Affiliates, in
    their reasonable discretion, and to settle or compromise any
    such possible infringement by taking such action as FUSA or its
    Affiliates may determine; provided, however, that FUSA shall not
    settle any such potential infringement in a manner that has a
    Material Adverse Effect on the rights granted by Luitpold/AR to
    FUSA hereunder, except with Luitpold/AR’s and Vifor’s
    prior written consent (which consent shall not be unreasonably
    withheld). Luitpold/AR shall provide FUSA all reasonable
    assistance (including, without limitation, making documents and
    records available for review and copying, and making persons
    within its control available for pertinent testimony), at
    FUSA’s expense, in such enforcement.



 



    3.05 Rebates.  FUSA shall calculate,
    process, administer and be financially responsible for all
    commercial rebates and for rebates required on government claims
    pursuant to any government rebate programs with respect to all
    Iron Products sold for the Field in the Territory and labeled
    with FUSA’s NDC. Luitpold/AR shall calculate, process,
    administer and be financially responsible for all commercial
    rebates and for rebates required on government claims pursuant
    to any government rebate programs with respect to all Iron
    Products sold outside of the Field or the Territory and labeled
    with Luitpold/AR’s NDC.



 



    3.06 Medicare/Medicaid Information.  With
    respect to any of the Iron Products sold in the Territory by a
    Party after the Effective Date which bears such Party’s (or
    any of its Affiliates) NDC number, such Party shall be solely
    responsible for complying with its Medicare and Medicaid price
    reporting obligations, including but not limited to reporting
    the following information:) (a) on a monthly and quarterly
    basis, the “average manufacturer price” (as defined
    under the Social Security Act, 42 U.S.C.
    1396r-9-8(K)(1),
    and implementing regulations) for each of such Products,
    identified by NDC number and (b) on a quarterly basis,
    (i) the “best price” (as defined under the Social
    Security Act, 42 U.S.C.
    1396r-8(c)(1)C),
    and implementing regulations), (ii) the aggregate dollar
    amount of customary prompt payment discounts (as defined in
    42 C.F.R. 447.510(a)(3)), (iii) the aggregate dollar
    amount of nominally price sales amount (as defined in
    42 C.F.R. 447.504(a)(4)), and (iv) the “average
    sales price” (as defined under the Social Security Act,
    42 U.S.C.
    1395w-3a and
    implementing regulations) for each of such Products, identified
    by NDC number.



 



    3.07 Other Federal and State Government Pricing
    Programs.  



 



    (a) With respect to any of the Iron Products sold in the
    Territory by a Party after the Effective Date which bears such
    Party’s (or any of its Affiliates) NDC number, such Party
    shall be solely responsible for complying with its obligations
    (a) under 42 U.S.C. 256(b) (Public Health Service Act
    340B) to sell each of such Products, identified by NDC number,
    at discounted prices to eligible covered entities and
    (b) under 38 U.S.C. 8126 to place each of such
    Products, identified by NDC number, on the Federal Supply
    Schedule and to report “non-federal average manufacturers
    price” and “federal ceiling price” for each of
    such Products to the National Acquisition Center.



 



    (b) With respect to any of the Iron Products sold in the
    Territory by a Party after the Effective Date which bears such
    Party’s (or any of its Affiliates) NDC number, such Party
    shall be solely responsible for negotiating, implementing, and
    paying rebates under any voluntary supplemental rebate
    agreements with state Medicaid programs or supplemental rebate
    agreements with other state pharmaceutical assistance programs




    

    11








 






    (c) Promptly after the Effective Date, the Parties shall
    jointly notify (i) applicable Medicare and Medicaid groups
    at the Centers for Medicare and Medicaid Services, (ii) the
    Office of Pharmacy Affairs at the Health Resources and Services
    Administration, (iii) the United States Department of
    Defense, (iv) the Veteran’s Affairs National
    Acquisition Center, and (v) any State supplement rebate
    programs in which Luitpold/AR currently participates or in which
    FUSA intends to participate (the foregoing being hereinafter
    collectively referred to as the “Federal and State
    Programs”) of FUSA’s rights with respect to the Iron
    Products for the Field in the Territory, and that FUSA intends
    to and shall establish its own contractual relationships with
    the Federal and State Programs as soon as commercially
    reasonable.



 



    3.08 Shipping and Distribution
    Obligations.  



 



    (a) [*]



 



    (b) [*]



 



    Luitpold/AR will transfer to the FUSA Warehouse Iron Products
    according to FUSA’s purchase orders, FUSA’s requested
    delivery dates and other instructions from FUSA. The title and
    risk shall transfer to FUSA upon shipment to the FUSA Warehouse.
    The expenses of shipment, including freight insurance, shall be
    borne as provided in
    Exhibit 1.01-A.
    The Parties agree and confirm that no Iron Products will be
    shipped, sold, distributed or released prior to receipt of a
    Certificate of Analysis and Compliance for said Iron Products as
    required under Section 6.02.



 



    (c) Commencing on the Effective Date and thereafter, FUSA
    shall: (i) invoice and bill the purchasers of the Iron
    Products for the Field in the Territory from FUSA;
    (ii) confirm all orders placed with FUSA in accordance with
    FUSA’s customary practices; and (iii) collect the
    receivables resulting from FUSA’s sales of Iron Products
    for the Field in the Territory.



 



    (d) [*]



 



    3.09 Pricing.  From and after the
    Effective Date, FUSA shall have the sole authority to determine
    the prices of Iron Products sold by it during the Term and to
    establish its own pricing policy for the Iron Products for the
    Field within the Territory, including price increases or
    decreases and the timing thereof as determined by FUSA.



 



    3.10 Sales Force and Support.  



 



    (a) FUSA shall be solely responsible for the costs and
    expenses of establishing and maintaining its sales force and
    marketing functions for the Iron Products for the Field in the
    Territory, and for conducting its other activities under this
    Agreement, and, subject to the foregoing, shall have the sole
    authority to control its sales force and direct the activities
    of its sales force. [*]



 



    (b) Within forty-five (45) days after the execution of
    this Agreement, Luitpold/AR shall provide all members of
    FUSA’s sales force (including management and
    representatives) personnel, a one-time Product-related training
    program conducted by Luitpold/AR. Luitpold/AR will be
    responsible for the costs and expenses of its personnel related
    to such training. In connection with Luitpold/AR’s
    Product-related training program, Luitpold/AR shall, to the
    extent available and in Luitpold/AR’s possession provide
    FUSA with one copy of any training materials previously used in
    training sales representatives in the Territory on the Product.
    FUSA shall have the sole responsibility for preparing additional
    and new materials for the Iron Product for sales training
    purposes as needed. Ongoing training of FUSA’s sales
    representatives and other personnel shall be the responsibility
    of FUSA at its cost and expense. The contents of any future
    additional training provided by FUSA that relates to the Iron
    Products shall be developed and coordinated by FUSA, and FUSA
    shall be solely responsible for training its sales force
    (including management and sales representatives) personnel, if
    any, with regard to Applicable Laws and directing such sales
    force and sales force personnel to be compliant with Applicable
    Laws.



 



    (c) Luitpold/AR shall use Commercially Reasonable Efforts
    to maintain its relationships with major customers for the Iron
    Products until such customers have been transitioned to FUSA,
    and during the first two (2) Contract Years, Luitpold/AR
    shall at FUSA’s request provide commercially reasonable
    support and cooperation to FUSA’s efforts to maintain the
    relationships with such major customers for the supply of Iron
    Products.




    

    12








 






    3.11 FUSA shall provide Luitpold/AR with a monthly report
    for each Iron Product on sales quantities, stock levels of each
    Iron Product, and if applicable of each Substance and marketing
    activities, which shall be in a format shown in
    Exhibit 3.11 attached hereto. FUSA shall provide
    Luitpold/AR on an annual basis every January a copy of
    FUSA’s report concerning the development of the market and
    the competitive activity in the Field in the Territory, together
    with any other reasonable information Luitpold/AR may be
    interested in for the better management and development of the
    Product [*].



 




    ARTICLE 4

    



 




    LUITPOLD/AR
    RESPONSIBILITIES
    



 



    4.01 Supply of Iron Products and API.  



 



    (a) Luitpold/AR shall manufacture exclusively on behalf of
    FUSA, pursuant to Articles 5 and 6 hereof and subject to
    the other terms and conditions as set forth in this Agreement,
    FUSA’s requirements of Iron Products for marketing, sale
    and distribution by FUSA for the Field in the Territory during
    the Term. Luitpold/AR’s obligation to manufacture Iron
    Products for FUSA under this Agreement shall terminate at such
    time as (i) [*], (ii) [*], (iii) [*].



 



    (b) [*]



 



    4.02 Retention of Product Registrations.  



 



    (a) During the Term, Luitpold/AR shall have sole
    responsibility for maintaining, and shall maintain, the Product
    Registrations in the Territory at its expense, including without
    limitation filing NDA Annual Reports and paying all product fees
    and establishment fees associated with the Product Registrations
    in the Territory; [*]. Luitpold/AR shall keep FUSA informed on a
    timely basis as to any developments that would have a Material
    Adverse Effect on a Product Registration. FUSA shall cooperate
    with Luitpold/AR with respect to obtaining and maintaining the
    Product Registrations, and shall execute, acknowledge and
    deliver such further instruments at Luitpold/AR’s request
    and expense, and use Commercially Reasonable Efforts to do all
    such other acts, as promptly as possible, which may be necessary
    or appropriate to obtain and maintain the Product Registrations
    in the Territory. FUSA shall, on a timely basis, provide to
    Luitpold/AR all information that FUSA has from time to time
    during the Term for each of the Iron Products that is reasonably
    necessary and relevant to Luitpold/AR’s obligations
    hereunder to fulfill such Iron Product Registration maintenance
    requirements. [*], FUSA and Luitpold/AR shall have joint
    decision-making authority in every case on whether and how to
    supplement, amend or otherwise alter the Product Registrations
    and any other issues in connection with such Product
    Registrations (including, but not limited to, decisions, subject
    to Section 6.07, to recall any Iron Product) and on whether
    and how to communicate with the FDA and other applicable
    governmental agencies or authorities in connection with such
    Product Registrations related to the Iron Products within the
    Field for the Territory.



 



    (b) During the Term, FUSA and Luitpold/AR shall each make
    its facilities available at reasonable times during business
    hours for inspection by representatives of Governmental
    Authorities. FUSA and Luitpold/AR each shall notify the other
    within twenty-four (24) hours (or, if such twenty-four
    (24) hour period ends on a day that is not a Business Day,
    then prior to noon on the next following Business Day) of
    receipt, and provide a copy thereof, of any notice of any FDA or
    other Governmental Authority inspection, investigation or other
    inquiry, or other material governmental notice or communication,
    relating to the manufacture, sale, marketing, promotion,
    distribution, or use of Iron Products in the Field within the
    Territory. FUSA and Luitpold/AR shall cooperate with each other
    during any such inspection, investigation or other inquiry. FUSA
    and Luitpold/AR shall discuss any response to observations or
    notifications received in connection with any such inspection,
    investigation or other inquiry and each shall give the other an
    opportunity to comment upon any proposed response before it is
    made and in particular Luitpold/AR shall notify FUSA of any
    issues specific to the manufacture of Iron Products that
    (A) could reasonably be expected to have a Material Adverse
    Effect on FUSA’s ability to market, sell or distribute Iron
    Products in the Field in the Territory, and (B) have
    regulatory implications that could reasonably be expected to
    have a Material Adverse Effect on FUSA’s ability to
    distribute Iron Products in the Field within the Territory. FUSA
    and Luitpold/AR will provide each other with copies of all
    correspondence received by it from, or filed by it with, any
    federal, state or local regulatory authority to the extent
    pertaining to each of the Iron Products or its, manufacturing,
    labeling, packaging, distribution, promotion, advertisement,
    marketing or sale in the Field within the Territory. In
    addition, Luitpold/AR will provide FUSA copies of all material
    correspondence received by Luitpold/AR from, or filed by
    Luitpold/AR




    

    13








 






    with, any federal, state or local regulatory authority to the
    extent such correspondence or filing could reasonably have an
    affect on FUSA’s ability to perform its obligations under
    this Agreement. [*]



 



    (c) During the Term, Luitpold/AR shall order from time to
    time, at FUSA’s request, Product Packaging Materials in
    sufficient quantities to permit the packaging of Iron Products
    ordered by FUSA from time to time hereunder. Luitpold/AR shall
    not be liable for any Product Packaging Material to the extent
    that such Product Packaging Material contains the
    specifications, instructions, directions
    and/or
    warnings, and all such packaging labels, package inserts and
    other packaging materials, relating to the Product
    Specifications, instructions, directions
    and/or
    warnings (or any changes or additions thereto) shall be the sole
    responsibility and under the sole authority of FUSA subject to
    the provisions of Section 3.02. Luitpold/AR shall not at
    any time do, and neither shall Luitpold/AR permit its agents or
    representatives to do, any act in violation of the Product
    Registration for the Iron Products in the Field within the
    Territory. In the event that in Luitpold/AR’s reasonable
    opinion any other or further filings are required to be made
    with or approvals required to be obtained from applicable
    regulatory authorities in order to change or supplement the
    package inserts and labeling, Luitpold/AR shall promptly advise
    FUSA in writing of any changes or supplements and shall have the
    responsibility for and authority to effect such filings and the
    sole right and discretion on how to effect such changes at
    Luitpold/AR’s expense. [*], the Parties acknowledge and
    agree that all Iron Products sold after the Effective Date in
    the Field within the Territory will be sold under a FUSA label,
    and, as soon as reasonably practicable following the Effective
    Date, all Iron Products in the Field within the Territory will
    be identified as FUSA products with such Iron Products
    identified as being manufactured for and distributed by FUSA
    pursuant to the licenses granted from Vifor and Luitpold/AR
    pursuant to this Agreement. In the event FUSA requests a change
    in labeling that would make any of the Product Packaging
    Materials obsolete, Luitpold/AR will, at FUSA’s option,
    either continue to use the obsolete materials until depleted or
    be reimbursed by FUSA for the cost of the obsolete materials.



 



    4.03 Prosecution and Maintenance of Trademarks and
    Patents.  



 



    (a) During the Term, FUSA shall be permitted to register
    and maintain, or cause to be registered and maintained, at its
    cost and expense, the FUSA Trademarks for the Field within
    Territory.



 



    (b) Notwithstanding any other provision of this Agreement
    to the contrary, Vifor and Luitpold/AR shall, at their sole cost
    and expense, prosecute, maintain, enforce, defend and not
    abandon any Licensed Technology owned, controlled or licensed to
    or from Vifor and Luitpold/AR covering the manufacture of Iron
    Products. Neither Vifor nor Luitpold/AR shall abandon any
    Licensed Technology owned, controlled or licensed to or from
    Vifor or Luitpold/AR with respect to the Iron Products in the
    Territory without giving sixty (60) days prior written
    notice to FUSA and permitting FUSA at its sole and exclusive
    expense to take reasonable and customary actions to maintain or
    preserve such Licensed Technology.



 



    (c) During the Term, Luitpold/AR shall at its sole cost and
    expense, maintain and enforce any contract entered into by
    Luitpold/AR covering the license, supply or access to or of any
    Licensed Technology, API, compounds, intermediates,
    biomaterials, packaging components, containers and other
    materials used in the manufacture of any Iron Product.



 




    ARTICLE 5

    



 




    MANUFACTURE
    OF IRON PRODUCTS
    



 



    5.01 Manufacture of Iron Products.  



 



    (a) Manufacture of Products.  During the
    Term and subject to the terms and conditions of this Agreement,
    Luitpold/AR agrees to manufacture and deliver to FUSA, and FUSA
    agrees to order and receive from Luitpold/AR Iron Products, in
    dosage form and packaged in the manner described in
    Exhibit 5.01(a) hereto, [*]. Iron Products manufactured by
    Luitpold/AR for FUSA shall use API purchased by Luitpold/AR from
    Vifor on behalf of FUSA. Vifor shall deliver such API to
    Luitpold/AR on behalf of FUSA and Vifor shall be responsible for
    all costs of freight and insurance to ship said API to
    Luitpold/AR. Iron Products delivered by Luitpold/AR under this
    Agreement shall have a remaining shelf life of no less than the
    expiration dating of the applicable Iron Product minus three
    (3) months as of the delivery date to FUSA, unless
    otherwise agreed to by the Parties.




    

    14








 





 



    Notwithstanding anything to the contrary in this Agreement,
    FUSA’s obligation to pay [*] shall be subject to adjustment
    or termination as follows:



 



    (i) [*]. Should the Parties fail to reach agreement with
    respect to such adjustment, FUSA shall be entitled to terminate
    this Agreement upon the delivery of written notice to
    Luitpold/AR in accordance with Section 12.03 hereof.



 



    (ii) [*]. Should the Parties fail to reach agreement with
    respect to such adjustment, FUSA shall be entitled to terminate
    this Agreement upon the delivery of written notice to
    Luitpold/AR in accordance with Section 12.03 hereof if the
    recall results from an issue related to the fundamental safety
    of the Iron Product and/or if the FDA requests or orders that
    marketing of the Iron Product cease.



 



    (iii) [*]



 



    (iv) [*]



 



    (v) [*]



 



    (vi) [*]



 



    (b) [*]



 



    (c) [*]



 



    5.02 Purchase Order Terms.  From and after
    the Transition Period, each Purchase Order shall be for a full
    Lot or multiples thereof of Iron Products and specify the date
    the Lot(s) should be deliverable; provided, that not more often
    than once per Contract Year, FUSA may order Iron Products in
    less than a full Lot or multiple thereof.



 



    5.03 Title and Risk of Loss.  Luitpold/AR
    shall maintain all FUSA Iron Products in Luitpold/AR’s
    warehouse in compliance with all Applicable Laws, including FDA
    regulations. Title to and risk of loss with respect to Iron
    Products shall pass from Luitpold/AR to FUSA upon shipment of
    the Product to FUSA at the FUSA Warehouse. [*]



 



    5.04 Acceptance and Rejection.  If any
    Iron Products supplied to FUSA by or on behalf of Luitpold/AR
    fail to conform to the applicable Product Specifications based
    on an inspection by FUSA of such Iron Product and packaging and
    shipping materials and components, including results of the
    applicable quality review and approval, including review of the
    batch record, Lot Documentation Package and other manufacturing
    documentation, then FUSA shall have the right to reject such
    non-conforming Iron Products. FUSA shall give written notice to
    Luitpold/AR of its rejection hereunder within twenty
    (20) days following FUSA’s receipt of the same or as
    soon thereafter as is reasonably practicable, specifying the
    grounds for such rejection. Such rejection notice shall be
    accompanied by a report (including a product sample from the
    batch analyzed) of the analysis of the allegedly non-conforming
    Iron Products that shall have been made using methods generally
    approved within the industry. Luitpold/AR shall replace any such
    rejected Iron Products with conforming Iron Products as soon as
    practicable after receipt of notice of rejection thereof, and in
    any event will do so within forty-five (45) days after
    receipt of notice of rejection thereof at no cost to FUSA.



 



    Luitpold/AR shall also make arrangements with FUSA for the
    return or destruction, at FUSA’s option, of any Iron
    Products rejected by FUSA. All such return shipping charges or
    costs of destruction shall be paid by Luitpold/AR. In the event
    that FUSA has paid for such rejected Iron Products, and such
    Iron Products have not been satisfactorily replaced, Luitpold/AR
    shall promptly refund or, at FUSA’s option, [*] or dispute
    such claim and, if necessary, initiate a dispute resolution in
    accordance with the following paragraph.



 



    In the event of a conflict regarding whether Iron Products are
    non-conforming, which Luitpold/AR and FUSA are unable to
    resolve, a sample of such Iron Products, together with mutually
    agreed upon questions, shall be submitted by FUSA and
    Luitpold/AR to an independent laboratory reasonably acceptable
    to both Parties for testing against the applicable specification
    and the test results obtained by such laboratory shall be final
    and binding upon the Parties. The fees and expenses for such
    laboratory testing, and all additional shipping and
    transportation costs incurred as a result of the dispute, shall
    be borne entirely by the Party against whom such
    laboratory’s findings are made. In the event that the test
    results indicate that the Iron Products in question do not
    conform to the applicable




    

    15








 






    specifications, without limiting FUSA’s remedies hereunder,
    Luitpold/AR shall replace such Iron Products with conforming
    Iron Products in accordance with this Section 5.04, and
    that shall be FUSA’s sole remedy.



 



    [*]



 



    5.05 [*]



 



    5.06 Right of Offset.  The Parties agree
    that in the event that any obligation on the part of Luitpold/AR
    to FUSA under the terms of this Agreement is not fulfilled by
    Luitpold/AR when such obligation is due, then in such event and
    as long as such obligation remains unfulfilled, FUSA shall be
    entitled to offset any unpaid amounts which may otherwise be due
    to Luitpold/AR from FUSA and Luitpold/AR shall be entitled to
    offset any unpaid amounts which may otherwise be due to Vifor
    from Luitpold/AR proportionally. [*]



 



    5.07 [*]



 




    ARTICLE 6

    



 




    MANUFACTURE
    OF IRON PRODUCTS; CERTAIN REGULATORY MATTERS; COMMUNICATION
    



 



    6.01 Manufacture of Iron
    Products.  (a) Luitpold/AR shall manufacture
    for and deliver to FUSA Iron Products that (i) were made
    from API that conforms to applicable API Specifications,
    (ii) were prepared and handled in compliance with
    applicable cGMPs, Applicable Laws, Licensed Technology, the
    Manufacturing Documentation, master batch record and any other
    procedures or documents agreed upon by the Parties, in writing,
    (iii) conform with applicable Product Specifications and
    Product Registrations, (iv) are not adulterated or
    misbranded within the meaning of the U.S. Food, Drug and
    Cosmetic Act or similar provisions of any Applicable Laws,
    (v) are packaged and shipped in accordance with the
    applicable Packaging Specifications, and (vi) include a Lot
    Documentation Package. The API Specifications, Product
    Specifications and Packaging Specifications for Products are as
    set forth on the attached Exhibit 6.01, and as may be
    amended from time to time based on changes in the U.S.P.,
    regulatory approvals or changes to improve quality. Luitpold/AR
    covenants and agrees to use its Commercially Reasonable Efforts
    to supply FUSA’s forecasted requirements of Iron Products.
    At such time as the Parties [*], Luitpold/AR’s obligation
    to supply Iron Products under this Section 6.01 shall
    terminate. [*], Luitpold/AR shall ensure that, and Vifor agrees
    that, it shall supply a sufficient quantity of the API as is
    necessary to carry out Luitpold/AR’s obligations hereunder
    to enable Luitpold/AR [*] to manufacture the Iron Products
    ordered for FUSA. Vifor will ship to Luitpold/AR [*], the API
    once released by Vifor.



 



    6.02 Certificate of Analysis and
    Compliance.  Luitpold/AR shall conduct quality
    assurance tests on the Iron Products prior to shipment to in
    accordance with FDA requirements, shall furnish upon FUSA’s
    request and at FUSA’s cost samples to FUSA, and shall
    maintain appropriate documentation of each Lot included in the
    shipment in accordance with all applicable U.S. laws and
    regulations, including without limitation, the Lot Documentation
    Package. In addition, Luitpold/AR shall furnish FUSA along with
    the first shipment of Products [*], material safety data sheets
    containing the relevant safety and health information, and such
    other information as FUSA shall reasonably request in connection
    therewith.



 



    6.03 Safety Data Exchange.  Each of
    Luitpold/AR and FUSA agree to notify each other concerning
    possible Serious Adverse Events, possible Adverse Events that
    are not Serious Adverse Events and possible pregnancy exposures
    related to the Iron Products within the respective time periods,
    and in accordance with the procedures set forth on
    Exhibit 6.03.



 



    6.04 [Reserved.]  



 



    6.05 Product Recall.  If either Vifor,
    Luitpold/AR or FUSA obtains information that any of the Iron
    Products or any portion thereof is alleged or proven not to
    conform with the labeling or the Product Registration for such
    Iron Products for the Field within the Territory, it shall
    notify the other Party immediately and both Parties shall
    cooperate fully regarding the investigation and disposition of
    any such matter. Vifor, Luitpold/AR and FUSA shall each maintain
    such traceability records as are sufficient and as may be
    necessary to permit a recall or field correction of any Iron
    Products. In the event (a) any applicable federal or state
    regulatory authority in the Territory should issue a request,
    directive or order that any of the Iron Products be recalled, or
    (b) a court of competent




    

    16








 






    jurisdiction orders such a recall, or (c) FUSA or
    Luitpold/AR determines that any of the Iron Products already in
    interstate commerce in the Field within the Territory present a
    risk of injury or gross deception or is otherwise defective,
    misbranded
    and/or
    adulterated and that recall of such Iron Products is appropriate
    (any such event described in (a), (b) or (c), a
    “Recall”), each Party shall give telephonic notice (to
    be confirmed in writing) to the other within twenty-four
    (24) hours after becoming aware of an event described in
    (a) or (b), or after making the determination described in
    (c). Each Party shall have sole responsibility for determining
    all corrective action to be taken with respect to its NDC
    labeled Iron Product and to implement the Recall, but shall
    confer with the other Party and keep such other Party informed
    on a regular basis of its progress in planning and implementing
    the Recall. The Parties will use Commercially Reasonable Efforts
    to cooperate with and assist each other in connection therewith
    as may be requested. Each Party shall be responsible for all its
    expenses of effecting any such Recall (including any
    out-of-pocket expenses incurred by the other Party in connection
    with such cooperation), except to the extent such Recall is
    attributable to any negligence on the part of the other Party or
    any breach by a Party of its obligations under this Agreement,
    in which event the Party at fault or in breach will reimburse
    the other Party for its reasonable costs and expenses incurred
    that are so attributable to such negligence or breach. In the
    event of a Vifor or Luitpold/AR negligence or breach, Vifor
    and/or
    Luitpold/AR shall provide to FUSA replacement API or Iron
    Products (as applicable) for any recalled Iron Products at
    Luitpold/AR’s sole expense, except to the extent that such
    Recall is attributable to any negligence on the part of FUSA or
    any breach by FUSA of its obligations under this Agreement or
    any other agreement then in force and effect between the Parties.



 



    6.06 Product Complaints.  



 



    (a) FUSA and Luitpold/AR each shall maintain complaint
    files for Iron Products in accordance with cGMP’s. FUSA and
    Luitpold/AR each shall record any complaints received with
    respect to the Iron Products substantially in the format
    attached hereto as Exhibit 6.06. The Parties agree that
    they shall provide responses to each complainant within thirty
    (30) days of each complaint.



 



    (b) Luitpold/AR shall promptly provide to FUSA written
    notice (using the form specified in Section 6.06(a) above)
    of any complaints (and will provide copies of any written
    complaints) received by Luitpold/AR with respect to any Iron
    Product. FUSA shall promptly provide to Luitpold/AR written
    notice (substantially in the format specified in
    Section 6.06(a) above) of any complaints (and will provide
    copies of any written complaints) received by FUSA with respect
    to any Product. FUSA shall have responsibility for responding to
    all complaints, and for promptly providing Luitpold/AR with a
    copy of any responses to complaints, relating to Iron Products
    labeled with FUSA’s NDC, including but not limited to
    complaints from competitors regarding promotional activities by
    FUSA. Luitpold/AR shall have responsibility for responding to
    all complaints, and for promptly providing FUSA with a copy of
    any responses to complaints, relating to Iron Products labeled
    with Luitpold/AR’s NDC, including but not limited to
    complaints from competitors regarding promotional activities by
    Luitpold/AR. The Parties agree to cooperate with each other to
    provide any information the other Party, in good faith, deems
    necessary to respond to such complaints.



 



    6.07 Additional Covenants of FUSA.  FUSA
    shall (a) not give any Third Party purchaser of the
    Products any guarantee or warranty on behalf of Luitpold/AR,
    (b) follow up and investigate customer and tampering
    complaints related to Iron Products labeled with FUSA’s
    NDC, and keep Luitpold/AR informed, as appropriate, as to the
    nature, status and resolution of such complaints, and
    (c) upon delivery by Luitpold/AR to FUSA of any Iron
    Product, handle, use and store the Iron Products in compliance
    with cGMP’s and Applicable Laws.



 



    6.08 Compliance with Applicable
    Law.  Luitpold/AR represents and warrants that all
    Lot Documentation Packages and other documentation maintained by
    it under this Agreement will be prepared fully in accordance
    with all Applicable Laws and in a good scientific manner, and
    will otherwise be accurate and complete in all material
    respects. Each Party shall use Commercially Reasonable Efforts
    to maintain in full force and effect all necessary licenses,
    permits and other authorizations required by Applicable Law to
    carry out its duties and obligations under this Agreement. Each
    Party shall comply with all Applicable Laws, provided, that FUSA
    shall be solely responsible for compliance with those Applicable
    Laws pertaining to the marketing, promotion, advertisement, sale
    and distribution of the Iron Products in the Field within the
    Territory and labeled with FUSA’s NDC, including, without
    limitation, those Applicable Laws that apply to documentation
    and records retention pertaining to the distribution and use of
    Iron Products within the Territory, and Luitpold/AR shall be
    solely responsible for compliance with those




    

    17








 






    Applicable Laws pertaining to the manufacturing and supply of
    the Iron Products (including, without limitation, those
    Applicable Laws that apply to documentation and records
    retention pertaining to the manufacture of Iron Products within
    the Territory). Without limiting the generality of the
    foregoing, FUSA shall not promote the Iron Products for any
    indications not contained in the Product Registration or in any
    manner in conflict with the approved labeling and all Applicable
    Laws. FUSA shall store and distribute the Iron Products and
    trade forms in compliance with all Applicable Laws. Each Party
    will cooperate with the other to provide such letters,
    documentation and other information on a timely basis as the
    other Party may reasonably require to fulfill its reporting and
    other obligations under Applicable Laws to applicable
    Governmental Authorities. Except for such amounts as are
    expressly required to be paid by a Party to the other under this
    Agreement, each Party shall be solely responsible for any costs
    incurred by it to comply with its obligations under Applicable
    Laws.



 



    6.09 Reasonable Cooperation.  Luitpold/AR
    and FUSA each hereby agrees to use Commercially Reasonable
    Efforts to take, or cause to be taken, all actions and to do, or
    cause to be done, all things necessary or proper to make
    effective the transactions contemplated by this Agreement,
    including such actions as may be reasonably necessary to obtain
    approvals and consents of Governmental Authorities (including,
    without limitation, all NDA notifications to the FDA identifying
    FUSA as a distributor of the Iron Products in the Field for the
    Territory).



 



    6.10 Compliance Audits.  From time to time
    as FUSA may elect during the Term (but no more than twice during
    the first Annual Period of the term of this Agreement and not
    more than once during each Annual Period thereafter), during
    normal business hours and upon reasonable advance notice from
    FUSA (but not less than ten (10) Business Days’
    notice), Luitpold/AR shall permit duly authorized
    representatives of FUSA to review and inspect, on the premises
    of Luitpold/AR each manufacturing facility for Iron Products and
    on the premises of Luitpold/AR where such records and inventory
    are kept, inventory of Iron Products, Manufacturing
    Documentation and Luitpold/AR’s quality control records
    relating to the manufacture and storage of Iron Products to
    ensure compliance with cGMP’s, quality control standards
    and the packaging and labeling for Iron Products; and with
    applicable terms of this Agreement pertaining to the use of the
    Trademarks. From time to time as Luitpold/AR may elect during
    the Term (but no more than twice during the first Annual Period
    of the term of this Agreement and not more than once during each
    Annual Period thereafter), during normal business hours and upon
    reasonable advance notice from Luitpold/AR (but not less than
    ten (10) Business Days’ notice), FUSA shall permit
    duly authorized representatives of Luitpold/AR to review and
    inspect, on the premises of the FUSA Warehouse facility for Iron
    Products and on the premises of FUSA where such records and
    inventory are kept, inventory of the Products, to ensure
    compliance with cGMP’s, quality control standards and the
    packaging and labeling for Iron Products; and with applicable
    terms of this Agreement pertaining to the use of the Trademarks.



 



    6.11 [*]



 



    (a) [*]



 



    (b) [*]



 



    (i) [*]



 



    (ii) [*]



 



    (iii) [*]



 



    (iv) [*]



 



    (v) [*]



 



    (vi) [*]



 



    (vii) [*]



 



    (viii) [*]



 



    (ix) [*]



 



    (c) [*]



 



    (d) [*]




    

    18








 






    (e) [*]



 



    (f) [*]



 



    (g) [*]



 



    (h) [*]



 



    (i) [*]



 



    (j) [*]



 



    (k) [*]



 




    ARTICLE 7

    



 




    REPRESENTATIONS,
    WARRANTIES AND COVENANTS
    



 



    7.01 Representations and Warranties of Both
    Parties.  Each Party hereby represents and
    warrants to the other Party that, as of the Effective Date:



 



    (a) Good Standing.  Such Party is duly
    organized, validly existing and in good standing under the
    Applicable Laws of the state of its incorporation, is duly
    qualified to transact the business in which it is engaged in
    each jurisdiction where failure to be so qualified would have a
    Material Adverse Effect upon its business as currently
    conducted, and has full corporate power and authority to enter
    into this Agreement and to carry out the provisions of this
    Agreement.



 



    (b) Power and Authority.  Such Party has
    the requisite power and authority and the legal right to enter
    into this Agreement, and to perform its obligations hereunder,
    and has taken all necessary corporate action on its part to
    authorize the execution and delivery of the Agreement and the
    performance of its obligations hereunder. All persons who have
    executed this Agreement on behalf of such Party, or who will
    execute on behalf of such Party any agreement or instrument
    contemplated hereby, have been duly authorized to do so by all
    necessary corporate action.



 



    (c) Binding Obligation.  This Agreement
    has been duly executed and delivered on its behalf and (assuming
    the due execution and delivery hereof by the other Party) each
    such agreement is a legal and valid obligation binding upon it
    and is enforceable in accordance with its terms, except that:



 



    (i) such enforcement may be subject to bankruptcy,
    insolvency, reorganization, moratorium or other similar
    Applicable Laws now or hereafter in effect relating to creditors
    rights generally, and



 



    (ii) such enforcement may be limited by equitable
    principles and Applicable Law.



 



    7.02 Representations and Warranties of
    Luitpold/AR.  Luitpold/AR hereby represents and
    warrants to FUSA that, as of the Effective Date:



 



    (a) No Violation of Instruments or
    Contracts.  The execution and the delivery of this
    Agreement and the consummation of the transactions contemplated
    hereby will not:



 



    (i) violate the Certificate of Incorporation or By-Laws of
    any of the Luitpold/AR Entities;



 



    (ii) [*] or, to the Knowledge of Luitpold/AR, any material
    instrument, agreement, mortgage, judgment, order, award, or
    decree specifically relating to the manufacturing, distribution
    or sale of Iron Products to which any Luitpold/AR Entity is a
    party or by which it is bound and which would have a Material
    Adverse Effect upon the manufacture, distribution or sale of
    Iron Products as currently conducted by such Luitpold/AR Entity
    (it being understood that certain contracts pertaining to the
    sale of Products to Third Parties may require the consent of
    such Third Party for assignment of same to FUSA and that Vifor
    shall have consented to this Agreement);



 



    (iii) to the Knowledge of Luitpold/AR, require the
    affirmative approval, consent, authorization or other order or
    action of any court, Governmental Authority or regulatory body
    or of any creditor of any of




    

    19








 






    the Luitpold/AR Entities, except for any
    Hart-Scott-Rodino
    filing required in connection with the Transfer.



 



    (b) Compliance with Applicable Law.  Each
    Luitpold/AR Entity is, in compliance with all requirements of
    Applicable Law within the Territory, except to the extent that
    any noncompliance, individually or in the aggregate, would not
    have a Material Adverse Effect on the conduct of the
    manufacture, distribution or sale of the Iron Products as
    currently conducted by such Luitpold/AR entity or the
    transactions contemplated by this Agreement, including the
    marketing, promotion, advertising, sale and distribution of the
    Iron Products in the Field within the Territory by FUSA pursuant
    to this Agreement, and would not have a Material Adverse Effect
    on Luitpold/AR’s ability to perform its obligations under
    this Agreement. Each Luitpold/AR entity represents and warrants
    that it has not, and covenants that it will not, pay anything of
    value to any government employee in connection with this
    Agreement.



 



    (c) Litigation and Claims.  There is no
    litigation, arbitration, claim, governmental or other
    proceeding, or, to the Knowledge of Luitpold/AR, governmental
    investigation pending or threatened in writing within the
    Territory relating to the Iron Products (it being understood
    that this sentence shall not constitute, and shall not be deemed
    to constitute, a representation or warranty with respect to the
    Trademarks), which, if adversely determined, would have a
    Material Adverse Effect.



 



    (d) [*]



 



    (e) Regulatory Filings.  Luitpold/AR has
    provided FUSA with access to a complete copy of each of the
    Product Registrations, including all material amendments and
    supplements thereto, relating to the Product in the Territory.
    Luitpold/AR is the lawful holder of all rights under each of the
    Product Registrations. Luitpold/AR has complied in all material
    respects with all Applicable Laws and regulations in connection
    with the preparation and submission to the FDA of each of the
    Product Registrations, and each of the Product Registrations has
    been approved by the FDA.



 



    (f) Licensed Technology.  



 



    (i) Luitpold/AR has a valid fully paid up assignable
    license, the term of which license (including renewals the
    exercise of which is entirely within the control of Luitpold/AR)
    extends [*] after the Effective Date, and to the Knowledge of
    Luitpold/AR, Vifor owns all, Licensed Technology and
    Intellectual Property relating to the Iron Products;



 



    (ii) Luitpold/AR’s license to the Licensed Technology
    in the Territory is in full force and effect, has been duly
    maintained, has not been cancelled, expired or abandoned as of
    the Effective Date and has a term (including renewals the
    exercise of which is entirely within the control of Luitpold/AR)
    extending for at least twenty (20) years after the
    Effective Date;



 



    (iii) Luitpold/AR and Vifor has not and will not pursue any
    actions in derogation of such rights or inconsistent with the
    rights conferred by this Agreement;



 



    (iv) Luitpold/AR and Vifor are unaware, as of the Effective
    Date, of any challenges to or violation of such rights by a
    Third Party; and



 



    (v) to the Knowledge of Luitpold/AR, none of the Licensed
    Technology infringes upon any Intellectual Property or trademark
    of any other Third Party in the Territory. There is no action,
    suit or proceeding pending or, to the Knowledge of Luitpold/AR
    or Vifor that has been threatened in writing by any Third Party
    in the Territory against Luitpold/AR, or an Affiliate of
    Luitpold/AR, Vifor or an affiliate of Vifor, as the case may be,
    which, if adversely determined, would have a Material Adverse
    Effect upon the ability of Luitpold/AR, or an Affiliate of
    Luitpold/AR, Vifor or an Affiliate of Vifor as the case may be,
    to use the Licensed Technology in connection with the
    manufacture, marketing, distribution or sale of the Iron
    Products in the Territory as currently conducted by Luitpold/AR,
    or a Luitpold/AR Affiliate, Vifor or an Affiliate of Vifor or to
    fulfill their respective obligations pursuant to the terms of
    this Agreement.




    

    20








 






    (g) Manufacturing
    Documentation.  Luitpold/AR holds a valid existing
    license to use, and Vifor or its Affiliates is the owner of, the
    Manufacturing Documentation.



 



    (h) Luitpold/AR is not debarred or suspended under the FDA
    Act and has not been charged with a violation of any laws or
    regulations relating to the regulation of any drug product under
    the FDA Act or any similar law or regulation in force in the
    Territory.



 



    7.03 Representations and Warranties of
    Vifor.  Vifor hereby represents and warrants to
    FUSA that, as of the Effective Date:



 



    (a) Vifor owns all of the Licensed Technology, Intellectual
    Property and Manufacturing Documentation relating to the Iron
    Products for use in the Field in the Territory, and to the
    Knowledge of Vifor, as of the Effective Date, there has been no
    challenge to Vifor’s ownership or infringement thereof by a
    Third Party;



 



    (b) Luitpold/AR’s license to the Licensed Technology
    in the Territory is in full force and effect, has been duly
    maintained, has not been cancelled, expired or abandoned as of
    the Effective Date and has a term (including renewals the
    exercise of which is entirely within the control of Luitpold/AR)
    extending for at least twenty (20) years after the
    Effective Date; and



 



    (c) to the Knowledge of Vifor, none of the Licensed
    Technology infringes upon any Intellectual Property or trademark
    of any Third Party in the Territory, and there is no action,
    suit or proceeding pending or, to the Knowledge of Vifor that
    has been threatened in writing by any Third Party in the
    Territory, which, if adversely determined, would have a Material
    Adverse Effect upon the ability of Vifor or any of its
    Affiliates, licensees or sublicensees to use the Licensed
    Technology in connection with the manufacture, marketing,
    distribution or sale of Iron Products in the Territory or upon
    the ability of Vifor to fulfill its obligations under this
    Agreement.



 



    7.04 Luitpold/AR Covenants.  



 



    (a) All Iron Products delivered by Luitpold/AR to FUSA
    pursuant to this Agreement shall be free and clear of all liens,
    security interest or other encumbrances at the time of delivery.



 



    (b) The Iron Products shipped by Luitpold/AR to FUSA shall,
    at the time of shipment have been formulated, manufactured,
    packaged, and stored by Luitpold/AR in conformity with cGMP and
    conform with applicable specifications and shall not be
    adulterated or misbranded within the meaning of the FDA Act and
    shall not be articles that may not be introduced into interstate
    commerce under Section 404 or 505 of the FDA Act.



 



    (c) [*]



 



    (d) Luitpold/AR will maintain throughout the Term all
    permits, licenses, registrations, and other forms of
    governmental authorizations and approvals required to be
    obtained and maintained by Luitpold/AR in order for Luitpold/AR
    to execute and deliver this Agreement and to perform its
    obligations hereunder in accordance with all applicable laws and
    shall otherwise perform its obligations hereunder in a manner
    which complies in all material respects with applicable laws.



 



    (e) Luitpold/AR will not knowingly, after using reasonable
    efforts, use in any capacity the services of any Person debarred
    or suspended under the FDA Act.



 



    (f) Between the execution of this Agreement and the
    Effective Date, Luitpold/AR shall continue to manufacture,
    distribute and sell Products in the ordinary course of its
    business and shall not take any action to materially increase
    the quantity of Products in its distribution channels in the
    Field in the Territory or terminate or make any material change
    in its contractual or commercial arrangements with any of its
    distributors or customers of Products in the Field in the
    Territory.



 



    (g) Luitpold/AR will continue to use Commercially
    Reasonable Efforts to prosecute the citizen’s petitions
    previously filed by Luitpold/AR relating to Iron Products.



 



    7.05 Vifor Covenants.  



 



    (a) [*]. All API delivered by Vifor to Luitpold/AR on
    behalf of FUSA pursuant to this Agreement shall be free and
    clear of all liens, security interest or other encumbrances at
    the time of delivery. [*]




    

    21








 






    (b) The API shipped by Vifor to Luitpold/AR on behalf of
    FUSA shall, at the time of shipment have been formulated,
    manufactured, packaged, and stored by Vifor in conformity with
    cGMP and conform with applicable specifications and shall not be
    adulterated or misbranded within the meaning of the FDA Act and
    shall not be articles that may not be introduced into interstate
    commerce under Section 404 or 505 of the FDA Act.



 



    (c) Vifor will maintain throughout the Term all permits,
    licenses, registrations, and other forms of governmental
    authorizations and approvals required to be obtained and
    maintained by Vifor in order for Vifor to execute and deliver
    this Agreement and to perform its obligations hereunder in
    accordance with all applicable laws and shall otherwise perform
    its obligations hereunder in a manner which complies in all
    material respects with applicable laws.



 



    (d) Vifor will not knowingly, after using reasonable
    efforts, use in any capacity the services of any Person debarred
    or suspended under the FDA Act.



 



    (e) Vifor will not pursue any actions in derogation of the
    rights conferred by this Agreement.



 



    (f) Vifor will only supply API manufactured by it at its
    current facility in St. Gallen, Switzerland. Should Vifor wish
    to use another facility to manufacture the substance, it shall
    notify Luitpold/AR (or FUSA if appropriate) and Luitpold/AR and
    Vifor will cooperate to obtain approval of the FDA for the
    alternate site with Vifor to bear all expense of obtaining such
    approval. Vifor agrees it will not switch the manufacturing site
    prior to Luitpold/AR having obtained approval for such change
    and will not modify the DMF without notice to and approval by
    Luitpold/AR and if necessary FDA.



 



    (g) [*]



 



    7.06 FUSA Covenants.  



 



    (a) FUSA will not knowingly, after reasonable efforts, use
    in any capacity the services of a Person debarred or suspended
    by FDA.



 



    (b) FUSA will comply with all Applicable Laws in all
    activities related to the rights granted hereunder.



 



    (c) FUSA will not manufacture, cause to have contract
    manufactured or distribute any pharmaceutical products indicated
    for the prevention
    and/or
    treatment of iron deficiency anemia in the Field in the
    Territory other than Iron Products; provided, however, that
    nothing in this Agreement shall operate to restrict the products
    that FUSA or its Affiliates may include in any formulary for use
    by physicians or that FUSA or its Affiliates may purchase and
    dispense in the provision of services in the Field.



 



    7.07 [*]



 



    7.08 No Reliance by Third Parties.  The
    representations, warranties and covenants of a Party set forth
    in this Agreement are intended for the sole and exclusive
    benefit of the Parties hereto, and may not be relied upon by any
    Third Party.



 




    ARTICLE 8

    



 




    INDEMNIFICATION
    AND INSURANCE
    



 



    8.01 Luitpold/AR Indemnity.  Luitpold/AR
    shall defend, indemnify and hold FUSA, its Affiliates, and its
    and their respective shareholders, employees, agents, officers,
    and directors (each a “FUSA Party”) harmless from and
    against any and all losses, liabilities, damages, fees
    (including, until such time as Luitpold/AR has notified FUSA in
    writing that it will assume control of a given FUSA Claim (as
    defined below), reasonable attorneys fees and costs pertaining
    to such FUSA Claim), and expenses paid or payable by a FUSA
    Party and that result from or arise in connection with a claim,
    suit or other proceeding made or brought against any FUSA Party
    (a “FUSA Claim”) arising out of, in connections with,
    related to or based on:



 



    (a) the breach of any obligation, covenant, agreement,
    representation or warranty of Luitpold/AR contained in this
    Agreement;



 



    (b) the manufacturing, distribution, marketing,
    advertisement, promotion or sale of any of Iron Products by
    Luitpold/AR, its Affiliates or any Third Party, and any use of
    any of Iron Products (including without




    

    22








 






    limitation Claims based on or relating to product liability),
    prior to the Effective Date or following the termination or
    expiration of this Agreement;



 



    (c) any manufacture, distribution, marketing,
    advertisement, promotion or sale of Iron Products, by
    Luitpold/AR, any of its Affiliates or any Third Party with which
    Luitpold/AR has entered into an agreement to manufacture,
    distribute, market, advertise, promote or sell Iron Products,
    outside the Field within the Territory, outside the Territory or
    any use outside the Territory of any such Iron Products that
    were sold by Luitpold/AR, any of its Affiliates or any Third
    Party with which Luitpold/AR has entered into an agreement to
    manufacture, distribute, market, advertise, promote or sell Iron
    Products, outside the Field within the Territory or outside the
    Territory (including without limitation Claims based on or
    relating to product liability), whether sold by Luitpold/AR, its
    Affiliates or any Third Party with which Luitpold/AR has entered
    into an agreement to manufacture, distribute, market, advertise,
    promote or sell Iron Products, prior to, during or following the
    Effective Date;



 



    (d) infringement of a Third Party’s patent rights,
    trademarks or other intellectual property rights by reason of
    FUSA’s exercise of any of the rights granted by Luitpold/AR
    to FUSA in this Agreement, including the right to manufacture
    (or have manufactured), distribute, market, advertise, promote
    or sell Iron Products under this Agreement and the sale by FUSA
    of Iron Products under the Licensed Technology, all in
    accordance with the provisions of this Agreement;



 



    (e) the manufacture, labeling or packaging of Iron Products
    by Luitpold/AR, its Affiliates or any Third Party, and any use
    of Iron Products (including without limitation Claims based on
    or relating to product liability), whether prior to, during or
    after, the Effective Date; or



 



    (f) negligence or willful misconduct on the part of
    Luitpold/AR, its Affiliates or any Third Party in the
    performance of Luitpold/AR’s obligations under the terms of
    this Agreement; provided, however, that Luitpold/AR shall not be
    obligated to indemnify a FUSA Party for any loss, liability,
    damages, fees or expenses incurred by such FUSA Party to the
    extent attributable solely to a breach by FUSA of any
    obligation, covenant, agreement, representation or warranty of
    FUSA contained in this Agreement, or to any act or omission
    constituting recklessness, gross negligence or willful
    misconduct on the part of FUSA or a FUSA Party.



 



    8.02 FUSA Indemnity.  FUSA shall defend,
    indemnify and hold Luitpold/AR, its Affiliates, and its and
    their respective employees, agents, officers, and directors
    (each a “Luitpold/AR Party”) harmless from and against
    any and all losses, liabilities, damages, fees (including, until
    such time as FUSA has notified Luitpold/AR in writing that it
    will assume control of a given Claim, reasonable attorneys fees
    and costs pertaining to such Claim), and expenses paid or
    payable by a Luitpold/AR Party (including without limitation
    payments that Luitpold/AR may be required to make to its
    licensors of any rights pertaining to any of the Iron Products
    and suppliers of any components of any Iron Product) that result
    from or arise in connection with a claim, suit or other
    proceeding made or brought against any Luitpold/AR Party (a
    “Luitpold/AR Claim”) based on:



 



    (a) the breach by FUSA of any obligation, covenant,
    agreement, representation or warranty of FUSA contained in this
    Agreement;



 



    (b) the distribution, marketing, advertisement, promotion
    or sale of Iron Products by FUSA and its Affiliates in the
    Territory after the Effective Date;



 



    (c) infringement of a Third Party’s trademarks, other
    than by reason of the use by FUSA of the Trademarks;



 



    (d) any failure of FUSA to comply with Applicable Laws in
    connection with the distribution, marketing, advertisement,
    promotion or sale of Iron Products, including but not limited to
    (i) any failure of promotional materials developed by FUSA
    to comply with applicable labeling and Product Registrations and
    Applicable Law, and (ii) the unlawful making by FUSA of any
    unsupportable or off-label claims with respect to Iron
    Products; or



 



    (e) negligence or willful misconduct on the part of FUSA,
    its Affiliates or any Third Party in the performance of
    FUSA’s obligations under of this Agreement; provided,
    however, that FUSA shall not be




    

    23








 






    obligated to indemnify a Luitpold/AR Party for any loss,
    liability, damages, fees or expenses incurred by such
    Luitpold/AR Party to the extent attributable to a breach by
    Luitpold/AR of any obligation, covenant, agreement,
    representation or warranty of Luitpold/AR contained in this
    Agreement, or to any act or omission constituting negligence,
    recklessness, gross negligence, or willful misconduct on the
    part of Luitpold/AR or a Luitpold/AR Party.



 



    (f) FUSA or its manufacturer’s noncompliance with
    instructions, including, but not limited to, expenses for
    manufacturing, repackaging, recalling or destroying defective
    Iron Product(s) and the out-of-pocket expenses incurred by
    Vifor/Luitpold/AR to determine such non-compliance and to assist
    FUSA in eliminating such non-compliance.



 



    8.03 Control of Proceedings.  Each
    indemnified Party shall:



 



    (a) give the indemnifying Party written notice of any Claim
    or potential Claim promptly after the indemnified Party receives
    notice of any such Claim or Potential Claim (provided that
    failure to give any such notice shall not alter or reduce the
    indemnification obligations of any Indemnifying Party except to
    the extent that such failure caused the Indemnified Parties to
    incur increased losses, liabilities, damages or fees);



 



    (b) allow the indemnifying Party to assume exclusive
    control of the defense and settlement (including all decisions
    relating to litigation, defense and appeal) of any such Claim
    (so long as it has confirmed its indemnification obligation
    responsibility to such indemnified Party under this
    Section 8.03 with respect to a given Claim); provided that
    the controlling Party may not settle such Claim in any manner
    that would require payment by the other Party, or would have a
    Material Adverse Effect on the rights granted to the other Party
    hereunder, or would materially conflict with the terms of this
    Agreement, without first obtaining the other Party’s prior
    written consent; and



 



    (c) reasonably cooperate with the indemnifying Party in its
    defense of the Claim (including, without limitation, making
    documents and records available for review and copying and
    making persons within its/his/her control available for
    pertinent testimony) at the indemnifying Party’s expense.
    If the indemnifying Party defends the claim, an indemnified
    Party may participate in, but not control, the defense of such
    Claim using attorneys of its/his/her choice and at its/his/her
    sole cost and expense. An indemnifying Party shall have no
    obligation or liability under this Article 8 as to any
    Claim for which settlement or compromise of such Claim or an
    offer of settlement or compromise of such Claim is made by an
    indemnified Party without the prior written consent of the
    indemnifying Party. If the indemnifying Party notifies the other
    in writing that it will not defend the other Party against a
    Claim asserted against the other Party, or if the indemnifying
    Party fails to defend or take other reasonable, timely action,
    in response to such Claim asserted against the other Party, the
    other Party shall have the right, but not the obligation, to
    defend or take other reasonable action to defend its interests
    in such proceedings, and shall have the right to litigate,
    settle or otherwise dispose of any such Claim.



 



    8.04 Insurance.  Each Party shall maintain
    at all times during the Term, and thereafter for three
    (3) years, or as long as such insurance is reasonably and
    commercially available, product liability insurance with
    coverage limits of not less than [*] with insurance carriers
    reasonably acceptable to the other Party. The minimum level of
    insurance set forth herein shall not be construed to create a
    limit on the Parties’ liability with respect to its
    indemnification obligations hereunder. Prior to the Effective
    Date (and upon renewal thereof), each Party shall furnish the
    other Party a certificate of insurance evidencing such coverage
    as of the Effective Date (and upon renewal thereof) and upon
    reasonable request by the other Party at any time hereafter.
    Each such certificate of insurance shall include a provision
    whereby the insurer providing such certificate shall endeavor to
    provide thirty (30) days’ written notice prior to any
    material coverage modification or cancellation by either the
    other Party or the insurer. The insurance provided by Luitpold
    hereunder will be endorsed to name FUSA and its Affiliates as
    additional insureds and to provide that such insurance will be
    primary and noncontributory to any other insurance available to
    FUSA and its Affiliates, and the certificates of insurance will
    evidence such endorsement. The insurance to be provided by a
    Party pursuant to this Section 8.04 may be provided by
    policies owned by the Party or a parent company of such Party.



 



    8.05 LIMITATION OF LIABILITY.  



 



    (a) EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS
    AGREEMENT, IN NO EVENT SHALL ANY OF FUSA, LUITPOLD/AR OR VIFOR
    BE LIABLE TO ANY OTHER PARTY HERETO FOR ANY




    

    24








 






    CONSEQUENTIAL, SPECIAL, INCIDENTAL OR INDIRECT DAMAGES
    (INCLUDING, WITHOUT LIMITATION, ANY DAMAGES ARISING FROM THE
    LOSS OF BUSINESS, DATA, PROFITS OR GOODWILL OR THE COST OF
    PROCUREMENT OF SUBSTITUTE GOODS, SERVICES OR TECHNOLOGY)
    INCURRED OR SUFFERED BY THE OTHER PARTY WITH RESPECT TO A
    PERSON’S PERFORMANCE OR FAILURE TO PERFORM UNDER THIS
    AGREEMENT, OR FOR ANY OTHER REASON, EVEN IF APPRISED OF THE
    LIKELIHOOD OF SUCH DAMAGES.



 



    (b) EXCEPT AS EXPRESSLY PROVIDED HEREIN, NONE OF FUSA,
    LUITPOLD/AR OR VIFOR MAKES ANY REPRESENTATIONS OR WARRANTIES OF
    ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED
    TO, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
    PURPOSE OR ANY OTHER MATTER WITH RESPECT TO ANY SUBSTANCE OR
    PRODUCT, WHETHER USED ALONE OR COMBINED WITH OTHER MATERIALS OR
    OTHERWISE.



 



    (c) Notwithstanding any such consent, Vifor and Luitpold/AR
    shall have no liability and no obligations with respect to any
    advertising and promotional activities produced by, or for any
    representations made or implied directly or indirectly by FUSA
    or any Person employed by or acting on behalf of FUSA in
    connection therewith.



 



    (d) The limitation of liability expressed in
    Section 8.05(c) above shall not affect or otherwise limit
    the obligation of each Party to indemnify other Parties (in
    accordance with the provisions of Section 8.01, 8.02 and
    8.03 as applicable) for claims which are brought by Third
    Parties.



 



    8.06 Survival.  The rights and obligations
    of the Parties under this Article 8 shall survive the
    termination or expiration of this Agreement.



 




    ARTICLE 9

    



 




    FORCE MAJEURE
    



 



    9.01 Force Majeure.  Any delays in
    performance by any Party under this Agreement, including with
    respect to the payment of obligations, shall not be considered
    breach of this Agreement if and to the extent caused by
    occurrences beyond the reasonable control of the Party affected,
    including but not limited to acts of God, embargoes,
    governmental restrictions, materials shortages or failure of any
    supplier (where such shortage or failure is attributable to an
    event of force majeure suffered by such supplier), fire, flood,
    explosion, earthquake, hurricanes, epidemic, blockage, terrorism
    or threat of terrorist attack, storms, tornadoes, riots, wars,
    civil disorder, failure of public utilities or common carriers,
    labor disturbances, rebellion or sabotage. The Party suffering
    such occurrence shall notify the other Party as soon as
    practicable of such inability and of the period for which such
    inability is expected to continue, and any time for performance
    hereunder shall be extended by the actual time of delay caused
    by the occurrence; provided, that the Party suffering such
    occurrence uses Commercially Reasonable Efforts to mitigate any
    damages incurred by the other Party.



 




    ARTICLE 10

    



 




    CONFIDENTIALITY
    



 



    10.01 [*]



 



    (a) [*]



 



    (b) [*]



 



    (c) [*]



 



    (d) [*]



 



    10.02 [*]



 



    10.03 [*]




    

    25








 







    ARTICLE 11

    



 




    TERM;
    TERMINATION
    



 



    11.01 Term.  This Agreement shall commence
    on the Effective Date and, unless earlier terminated, shall
    continue in full force and effect for a period expiring on the
    tenth anniversary thereof. In addition, FUSA shall have the
    option (the “Renewal Option”) of extending the term
    hereof for up to two (2) consecutive periods of five
    (5) additional years [*]. Each Renewal Option may be
    exercised by written notice delivered by FUSA no later than one
    hundred and eighty (180) days prior to the expiration of
    the then-current term. [*].



 



    11.02 Termination.  Prior to the
    expiration of the Term, this Agreement may be terminated:



 



    (a) immediately upon the mutual written consent of the
    Parties;



 



    (b) by a Party, upon ninety (90) days’ prior
    written notice if the other Party materially breaches or
    defaults in the performance of its obligations under this
    Agreement and fails to take reasonable measures to cure such
    breach within such ninety (90) days following receipt of
    written notice from a non-breaching Party specifying the breach
    to be cured; or



 



    (c) upon written notice by a Party if (i) the other
    Party shall have been dissolved, ceased active business
    operations or liquidated, unless such dissolution, cessation or
    liquidation results from reorganization, acquisition, merger or
    similar event, or (ii) bankruptcy or insolvency
    proceedings, including any proceeding under Title 11 of the
    U.S. Code, have been brought by or against the other Party
    and, in the event such a proceeding has been brought against the
    other Party, remains undismissed for a period of sixty
    (60) days, or an assignment has been made for the benefit
    of such Party’s creditors or a receiver of such
    Party’s assets has been appointed.



 



    11.03 Post-Termination.  Termination of
    this Agreement shall not affect any payment obligations or other
    liabilities, which have accrued as of the date of such
    termination.



 



    11.04 Insolvency or Bankruptcy.  In the
    event that (i) a Party shall commence any case, proceeding
    or other action (A) under any existing or future law of any
    jurisdiction, domestic or foreign, relating to bankruptcy,
    insolvency, reorganization or relief of debtors, seeking to have
    an order of relief entered with respect to it, or seeking to
    adjudicate it a bankrupt or insolvent, or seeking
    reorganization, arrangement, adjustment,
    winding-up,
    liquidation, dissolution, composition or other relief with
    respect to it or its debts, or (B) seeking appointment of a
    receiver, trustee, custodian, conservator or other similar
    official for it or for all or any substantial part of its
    assets, or the Party shall make a general assignment for the
    benefit of its creditors; or (ii) there shall be commenced
    against a Party any case, proceeding or other action of a nature
    referred to in clause (i) above that (A) results in
    the entry of an order for relief or any such adjudication or
    appointment or (B) remains undismissed, undischarged or
    unbonded for a period of sixty (60) days; or
    (iii) there shall be commenced against the Party any case,
    proceeding or other action seeking issuance of a warrant of
    attachment, execution, restraint or similar process against all
    or any substantial part of its assets that results in the entry
    of an order for any such relief that shall not have been
    vacated, discharged, or stayed or bonded pending appeal within
    sixty (60) days from the entry thereof; or (iv) the
    Party shall take any action in furtherance of, or indicating its
    consent to, approval of, or acquiescence in, any of the acts set
    forth in clauses (i), (ii), or (iii) above; or (v) the
    Party shall generally not, or shall be unable to, or shall admit
    in writing its inability to, pay its debts as they become due;
    then, in addition to any other remedies available to the other
    Party by Applicable Law or in equity, the other Party may
    terminate this Agreement by giving written notice to the other
    Party, which shall be effective immediately upon delivery of
    such notice.



 



    11.05 Other Termination.  At any time if
    the Luitpold/AR facility is shut down or the NDA for the Product
    is withdrawn or suspended, or marketing of the Product is
    terminated by Luitpold/AR due to safety reasons, then, in
    addition to any other remedies available to FUSA under
    Applicable Law, in equity or under this Agreement, FUSA may
    terminate this Agreement by giving written notice to
    Luitpold/AR, which shall be effective on such date as shall be
    designated in such notice.




    

    26








 






    11.06 Effect of Termination or Expiration.



 



    (a) Upon any early termination of this Agreement by
    Luitpold/AR pursuant to 11.02(b) or (c), or upon expiration of
    this Agreement pursuant to Section 11.01, FUSA shall
    promptly:



 



    (i) return to Luitpold/AR all relevant records, materials
    or Confidential Information relating to the Iron Products in its
    (or any of its any Affiliate’s or contractors’)
    possession or control;



 



    (ii) cease all manufacturing, marketing, sale, promotion,
    advertising, and distribution of the Iron Products,



 



    (iii) discontinue use of the Trademarks, destroy all
    advertising or other printed materials bearing the Trademarks,
    and FUSA’s right to use the Trademarks for the Iron
    Products in the Field within the Territory shall terminate and
    cooperate with Luitpold/AR to transition the business in the
    Field back to Luitpold/AR;



 



    (iv) transfer and assign all right, title and interest in
    and to all Product Registrations, clinical trial certificates
    and other administrative files relating to the Iron Product(s)
    and Substance(s) to Luitpold/AR in a commercially reasonable
    time; and



 



    (v) immediately return to Luitpold/AR any stock of API, or
    Substance(s) that FUSA may have as of the termination date at
    FUSA’s expense.



 



    (b) Upon any early termination of this Agreement by the
    Parties pursuant Section 11.02(a), FUSA shall have the
    right to continue to market, sell and distribute all of its
    remaining inventory of Iron Products for three (3) months
    following such termination or expiration. [*].



 



    (c) During the three (3) month period prior to
    expiration of this Agreement pursuant to Section 11.01, the
    Parties shall cooperate to minimize the quantity of Iron
    Products labeled with FUSA’s NDC code that will be held by
    FUSA as of the date of termination. [*].



 



    (d) [*]



 




    ARTICLE 12

    



 




    GENERAL
    PROVISIONS
    



 



    12.01 Assignment.  Neither Party shall
    assign, subcontract or otherwise transfer this Agreement or any
    interest herein or right hereunder without the prior written
    consent of the other Parties hereto, and any such purported
    assignment, transfer or attempt to assign or transfer any
    interest herein or right hereunder shall be void and of no
    effect; except that each Party may assign its rights and
    obligations hereunder to an Affiliate. Neither Party may assign
    this Agreement and its rights and obligations hereunder in
    connection with a sale or transfer of all or substantially all
    of its business or a merger, consolidation or other change in
    control or other similar transaction without the prior written
    consent of the other Parties hereto. It is understood and
    agreed, however, that any permitted assignment of this Agreement
    in accordance with the terms hereof, shall be fully binding
    upon, and enforceable against, the permitted successors and
    assigns of the assignor without further action on the part of
    the Parties or its permitted successors or assigns.



 



    12.02 Non-Waiver.  Any failure on the part
    of a Party to enforce at any time or for any period of time any
    of the provisions of this Agreement shall not be deemed or
    construed to be a waiver of such provisions or of any right of
    such Party thereafter to enforce each and every such provision
    on any succeeding occasion or breach thereof.




    

    27








 






    12.03 Notices.  Unless otherwise
    explicitly set forth herein, any notice required or permitted to
    be given hereunder shall be in writing and shall be delivered
    personally by hand, sent by reputable overnight courier,
    signature required, or sent by facsimile with proof of
    successful transmission, in each case to the addresses of each
    Party and Vifor set forth below or to such other address or
    addresses as shall be designated by the recipient in writing in
    the same matter:



 



    If to FUSA:

    Fresenius USA Manufacturing, Inc.

    d/b/a Fresenius Medical Care North America

    920 Winter Street

    Waltham, Massachusetts 02451

    Attention: Law Department

    Telephone: 781-699-9000

    Facsimile: 781-699-9410



 



    With a copy to:

    Robinson, Bradshaw & Hinson, P.A.

    101 North Tryon Street, Suite 1900

    Charlotte, North Carolina 28246

    Attention: David J. Clark

    Telephone: 704-377-8390

    Facsimile: 704-373-3990

    E-Mail:
    dclark@rbh.com



 



    If to Luitpold/AR:

    Luitpold Pharmaceuticals, Inc.

    One Luitpold Drive

    P.O. Box 9001

    Shirley, New York 11967

    Attention: President and CEO

    Telephone: 631-924-4000

    Facsimile: 631-924-8650

    E-Mail:
    mjhelenek@luitpold.com



 



    with a copy to:

    Sheppard Mullin Richter & Hampton LLP

    1300 I Street, N.W.

    11th Floor East

    Washington, DC 20005

    Attention: Peter S. Reichertz

    Telephone: 202-772-5333

    Facsimile: 202-312-9426

    E-Mail:
    preichertz@sheppardmullin.com



 



    If to Vifor:

    Vifor International, Inc.

    Rechenstrasse 37,

    CH-9001

    St. Gallen, Switzerland

    Attention: Director

    Facsimile:
    011-41-58-851-8485

    E-mail:          



 



    Copies of any communication made in accordance with this
    Section 12.03 may be transmitted by
    e-mail, but
    e-mail
    transmission shall not alone be deemed effective delivery.




    

    28








 





 



    12.04 Amendments.  This Agreement may be
    waived, amended, supplemented or modified only by a written
    agreement executed by each of the Parties.



 



    12.05 Entirety of Agreement.  This
    Agreement, with the Exhibits and Schedules attached hereto, and
    the Services Agreement contain the entire understanding of the
    Parties with respect to the subject matter hereof and thereof
    and supersede all previous and contemporaneous verbal and
    written agreements, representations and warranties with respect
    to such subject matter. This Agreement shall not be strictly
    construed against either Party.



 



    12.06 Public Announcements.  The form and
    content of any public announcement to be made by a party
    regarding the subject matter of this Agreement, shall be subject
    to the prior written consent of the other parties (which consent
    may not be unreasonably withheld or delayed), except as may be
    required by Applicable Law (including, without limitation,
    disclosure requirements of the SEC, NASDAQ, or any other stock
    exchange) in which event the disclosing Person shall use
    Commercially Reasonable Efforts to give the other parties hereto
    reasonable advance notice and reasonable opportunity to review
    any such disclosure.



 



    12.07 Governing Law.  This Agreement shall
    be governed by and construed in accordance with the Applicable
    Laws of the State of Delaware, without regard to its conflicts
    of law principles.



 



    12.08 Relationship of the Parties.  In
    making and performing this Agreement, the Parties are acting,
    and intend to be treated, as independent entities and nothing
    contained in this Agreement shall be construed or implied to
    create an agency, partnership, joint venture, or employer and
    employee relationship between or among the Parties. Except as
    otherwise expressly provided herein, neither Party may make any
    representation, warranty or commitment, whether express or
    implied, on behalf of or incur any charges or expenses for or in
    the name of any other party hereto. No Party hereto shall be
    liable for the act of any other Party hereto unless such act is
    expressly authorized in writing by such Party.



 



    12.09 Counterparts.  This Agreement shall
    become binding when any one or more counterparts hereof,
    individually or taken together, shall bear the signatures of
    each of the Parties and Vifor. This Agreement may be executed in
    any number of counterparts, each of which shall be deemed an
    original as against the Person on whose behalf it was executed,
    but all of which taken together shall constitute but one and the
    same instrument.



 



    12.10 Severability.  If any part of this
    Agreement is declared invalid by any legally governing authority
    having jurisdiction over a Party or Vifor, then such declaration
    shall not affect the remainder of the Agreement and the parties
    hereto shall revise the invalidated part in a manner that will
    render such provision valid without impairing such parties’
    original intent.



 



    12.11 Cumulative Rights.  Except as herein
    expressly provided, the rights, powers and remedies hereunder
    shall be in addition to, and not in limitation of, all rights,
    powers and remedies provided at Applicable Law or in equity, or
    under any other agreement between the Parties, and all of such
    rights, powers and remedies shall be cumulative, and may be
    exercised successively or cumulatively.



 



    12.12 No Other Rights.  No rights or
    licenses in or to either Party’s or Vifor’s patent
    rights, Know-How, Trade Secrets, copyrights or trademarks shall
    be created or implied hereunder, except those licenses and
    rights that are expressly granted in this Agreement.



 



    12.13 Expenses.  Each party shall each
    bear its own direct and indirect expenses incurred in connection
    with the negotiation and preparation of this Agreement and,
    except as otherwise expressly set forth in this Agreement, the
    performance of the obligations contemplated hereby.



 



    12.14 Facsimile Execution.  This Agreement
    may be executed in facsimile counterparts each of which is
    hereby agreed to have the legal binding effect of an original
    signature. The Parties and Vifor hereto agree to forward the
    original signatures by overnight mail to the other Parties upon
    execution.



 



    12.15 License Survival During
    Bankruptcy.  All rights and licenses granted under
    or pursuant to this Agreement to the Licensed Technology are,
    and shall otherwise be deemed to be, for purposes of
    Paragraph 365(n) of the U.S. Bankruptcy Code, licenses
    of rights to “intellectual property” as defined under
    Paragraph 101(35A) of the U.S. Bankruptcy Code.
    Luitpold/AR and Vifor agree that FUSA, as a licensee of such
    rights under this Agreement, shall retain and may fully exercise
    all of its rights and elections under the U.S. Bankruptcy
    Code,




    

    29








 






    subject to performance by FUSA of its obligations under this
    Agreement. In the event Luitpold/AR elects to terminate this
    Agreement because of a Bankruptcy Event and FUSA elects to
    continue the licenses under this Agreement as contemplated by
    the preceding sentence, then FUSA shall be entitled, upon
    reasonable request to Luitpold/AR and Vifor, to have access, in
    confidence, to such Licensed Technology not already in
    FUSA’s possession as shall be reasonably necessary to make
    use of the license rights under this Agreement without
    participation by Luitpold/AR.



 



    12.16 [*]



 



    12.17 [*]



 



    12.18 Dispute Resolution.  In the event of
    a disagreement or decision-deadlock among the members of the EOC
    as to any material matter within the scope of this Agreement,
    and/or
    matters that a Party considers to be or potentially cause a
    breach of a material term hereunder, the EOC will diligently and
    in good faith seek to resolve the matter in dispute. If the EOC
    is unable to resolve the dispute, despite its good faith
    efforts, the dispute shall be referred to the Chief Executive
    Officer or Business Unit President of each Party. In the event
    that no mutual agreement is reached by the Chief Executive
    Officer or Business Unit President, neither Party shall incur
    any liability to the other Party solely as a result of failing
    to resolve a disagreement or decision-deadlock under this
    Section 12.18.



 




    ARTICLE 13

    



 




    CONDITIONS
    



 



    13.01 The respective obligations of each Party to effect
    the transactions contemplated hereby shall be subject to the
    fulfillment at or prior to the Effective Date of the following
    conditions:



 



    (a) All consents, authorizations, orders and approvals of,
    and filings and registrations with, any federal or state
    governmental commission, board, or other regulatory body that
    are required for the consummation by each party hereto of the
    transactions provided for herein shall have been obtained or
    made, and the applicable waiting period under the
    Hart-Scott-Rodino
    Act shall have expired or been terminated.



 



    (b) There shall not have occurred after the date hereof and
    prior to the Effective Date any material adverse change in the
    condition (financial or otherwise), business or prospects of
    Luitpold/AR taken as a whole.



 



    (c) [*]



 



    (d) approval of the transactions contemplated hereby by the
    respective Board of Directors, Management Boards and Supervisory
    Boards of the parties hereto.



 




    [End
    of text; signature page follows]




    

    30








 






    IN WITNESS WHEREOF, the parties hereto have duly executed this
    License, Distribution, Manufacturing and Supply Agreement as of
    the date first set forth above.



 



    LUITPOLD PHARMACEUTICALS, INC.



 


			
	 	    By: 
	
    /s/  Mary
    Jane Helenek









    Name:     Mary Jane Helenek



			
	 	    Title: 
	
    President & CEO




 



    AMERICAN REGENT, INC.



 


			
	 	    By: 
	
    /s/  Mary
    Jane Helenek









    Name:     Mary Jane Helenek



			
	 	    Title: 
	
    President & CEO




 



    FRESENIUS USA MANUFACTURING, INC



 


			
	 	    By: 
	
    /s/  Rice
    Powell









    Name:     



			
	 	    Title: 
	
    President




 



    VIFOR (INTERNATIONAL)
    INC.1




 


			
	 	    By: 
	
    /s/  A.
    Coombs









    Name:     G. Zampieri



			
	 	    Title: 
	
    CEO Vifor Pharma




 


			
	 	        
	
    /s/  G.
    Zampieri









    Name:     G. Zampieri



			
	 	    Title: 
	
    Head of Ind. Ops.



 

 


    1 Executing

    this Agreement to indicate its acknowledgement of and consent to
    the terms and provisions hereof, and to agree to be bound to
    those provision hereof that pertain to it.




    

    31








 







    SCHEDULES



 



    7.02(d) [*]



 




    EXHIBITS



 


	 	 	 	 	 
	
 
	
    1
	
    .01-A
	
 
	
    [*]

	
 
	
    1
	
    .01-C
	
 
	
    [*]

	
 
	
    1
	
    .01-D
	
 
	
    [*]

	
 
	
    1
	
    .01-E
	
 
	
    [*]

	
 
	
    1
	
    .01-F
	
 
	
    [*]

	
 
	
    2
	
    .01(c)
	
 
	
    [*]

	
 
	
    2
	
    .01(d-1)
	
 
	
    [*]

	
 
	
    2
	
    .01(d-2)
	
 
	
    [*]

	
 
	
    3
	
    .11
	
 
	
    [*]

	
 
	
    5
	
    .01(a)
	
 
	
    [*]

	
 
	
    6
	
    .01
	
 
	
    [*]

	
 
	
    6
	
    .03
	
 
	
    [*]

	
 
	
    6
	
    .06
	
 
	
    [*]

	
 
	
    6
	
    .08
	
 
	
    [*]

	
 
	
    6
	
    .11
	
 
	
    [*]

	
 
	
    7
	
    .05(a)
	
 
	
    [*]










    

    32








 







    EXHIBIT 1.01-A



 



    [*]



 



    [*]



 



    [*]



 



    [*]



 



    [*]




    

    33








 







    EXHIBIT 1.01-C



 



    [*]




    

    34








 







    EXHIBIT 1.01-D



 




    [*]
    




    

    35








 







    EXHIBIT 1.01-E



 




    [*]
    




    

    36








 







    EXHIBIT 1.01-F



 




    [*]
    




    

    37








 







    EXHIBIT 2.01(c)



 




    [*]
    




    

    38








 







    EXHIBIT 2.01(d)



 




    [*]
    




    

    39








 







    EXHIBIT 5.01



 




    [*]
    




    

    40








 







    EXHIBIT 6.08



 




    [*]
    




    

    41








 







    EXHIBIT 6.11



 




    [*]
    




    

    42








 







    EXHIBIT 7.05(a)



 




    [*]
    




    

    43