EXHIBIT
        10.38.2

       

      CONFIDENTIAL
        TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF 

      THIS
        DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY 

      FILED
        WITH THE COMMISSION.***

       

      MANUFACTURING
        AND SUPPLY AGREEMENT

       

      THIS
        MANUFACTURING AND SUPPLY AGREEMENT (this “Agreement”)
        dated
        as of September 8, 2005 (the “Effective
        Date”)
        is
        made and entered into by and between Inyx, Inc., a company organized and
        existing under the laws of Nevada (“Inyx”),
        and
        King Pharmaceuticals, Inc., a Tennessee corporation (“King”).
        Capitalized terms used in this Agreement shall have the meanings ascribed
        to
        them in Article 1 hereof or as otherwise set forth herein.

       

      RECITALS

       

      WHEREAS,
        Inyx is engaged in the manufacture in finished product form of the compounds
        cromolyn sodium and nedocromil sodium as sold in the United States and
        Canada;

       

      WHEREAS,
        King desires to have Inyx manufacture and supply it with Products (as defined
        herein) during the Term in accordance with this Agreement; 

       

      WHEREAS,
        Inyx agrees to manufacture and supply to King Products upon the terms and
        subject to the conditions provided herein; and

       

      WHEREAS,
        the parties have entered into that certain Collaboration Agreement, dated
        as of
        the date hereof (the “Collaboration
        Agreement”),
        for
        the purpose of pursuing a collaboration relating to the development, marketing
        and promotion of Products;

       

      NOW,
        THEREFORE, in consideration of the mutual covenants and agreements set forth
        in
        this Agreement, and for other good and valuable consideration, the receipt
        and
        sufficiency of which are hereby acknowledged, the parties hereto hereby agree
        as
        follows:

       

      ARTICLE
        1

       

      DEFINITIONS

       

      Unless
        otherwise specifically defined in this Agreement, each capitalized term used
        herein will have the meaning assigned to such term in the Collaboration
        Agreement. In addition, the following terms shall have the meanings set forth
        below. Unless the context indicates otherwise, the singular shall include
        the
        plural and the plural shall include the singular.

       

      
        
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            TREATMENT

           

        

        
           

          
            

          

        

        
           

        

      


      1.1    “Agreement”
        means
        this Manufacturing and Supply Agreement and all schedules and annexes attached
        hereto, and as the same may be amended or supplemented from time to time
        hereafter pursuant to the provisions hereof.

       

      1.2    “Bulk
        Form”
        means
        cromolyn sodium micronized stage 9 (the “Intal
        Bulk Form”)
        and
        nedocromil sodium dried stage 11 (the “Tilade
        Bulk Form”).
        

       

      1.3    “Business
        Day”
        means a
        day other than Saturday, Sunday or any day on which a commercial bank in
        New
        York is authorized to close. Any reference in this Agreement to “day” whether or
        not capitalized shall refer to a calendar day, not a Business Day.

       

      1.4    “cGMP”
        means
        current Good Manufacturing Practices (i) as promulgated under the Act at
        21 CFR
        (chapters 210 and 211), as the same may be amended or re-enacted from time
        to
        time and (ii) as required by Law in Canada, as applicable.

       

      1.5    “Collaboration
        Agreement”
        has the
        meaning set forth in the recitals.

       

      1.6    “Collaboration
        Documents”
        means
        collectively, this Agreement, the Technology Transfer Agreement, the
        Collaboration Agreement, the Marketing and Promotion Agreement, the Quality
        Agreement and the Development Agreement, as each such term is defined in
        the
        Collaboration Agreement.

       

      1.7    “Confidential
        Information”
        has the
        meaning set forth in Section 8.1(a).

       

      1.8    “Discretionary
        Manufacturing Changes”
        has the
        meaning set forth in Section 2.8(b).

       

      1.9    “Effective
        Date”
        has the
        meaning set forth in the recitals.

       

      1.10   “indemnitee”
        has the
        meaning set forth in Section 10.3.

       

      1.11   “indemnitor”
        has the
        meaning set forth in Section 10.3.

       

      1.12   “Initial
        Bulk Form”
        has the
        meaning set forth in Section 2.10(b).

       

      1.13    *
        * *
        .

       

      1.14    *
        *
        *.

       

      1.15    “Intal
        CFC Inhaler Product”
        means
        the cromolyn sodium inhaler pharmaceutical product in a chloro-fluoro-carbon
        (CFC) propellant driven inhaler and more particularly identified in NDA #18-887,
        and amendments thereto. 

       

      1.16    “Intal
        HFA Formulation Product”
        means
        the cromolyn sodium inhaler pharmaceutical product in a hydro-fluoro-alkane
        (HFA) propellant driven inhaler and more particularly described in NDA #20-957,
        and amendments thereto.

       

      1.17    “Intal
        Tech Transfer”
        has the
        meaning set forth in Section 2.10(b).

       

      
        
          CONFIDENTIAL
            TREATMENT

           

        

        
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      1.18    “Inyx”
        has the
        meaning set forth in the recitals.

       

      1.19    “King”
        has the
        meaning set forth in the recitals.

       

      1.20    “Laws”
        means
        all laws, statutes, rules, regulations, ordinances and other pronouncements
        having the effect of law of the United States, any foreign country,
        supra-national entity or any domestic or foreign state, province, county,
        city
        or other political subdivision of any Regulatory Authority.

       

      1.21    “Products”
        means
        the finished product forms of Intal CFC Inhaler Product, Intal HFA Formulation
        Product, and Tilade CFC Inhaler Product, and will include any Approved New
        Product, but will not include an Excluded New Product, and “Product”
        shall
        mean any of the foregoing individually as the context may require. 

       

      1.22    “Raw
        Materials”
        means
        all active pharmaceutical ingredients (including all Bulk Form), excipients,
        components, labeling and packaging materials and other materials required
        to
        manufacture a Product. 

       

      1.23    “Required
        Manufacturing Changes”
        has the
        meaning set forth in Section 2.8(a).

       

      1.24    “Specifications”
        means,
        with respect to each Product, the written specifications for each such Product
        as set forth in applicable NDAs.

       

      1.25    “Term”
        has the
        meaning set forth in Section 4.1.

       

      1.26    “Tilade
        CFC Inhaler Product”
        means
        the nedocromil sodium pharmaceutical product in a chloro-fluoro-carbon (CFC)
        propellant driven inhaler and more particularly identified in NDA #19-660,
        and
        any amendments thereto.

       

      1.27    “Tilade
        Tech Transfer”
        has the
        meaning set forth in Section 2.10(b).

       

      ARTICLE
        2

       

      MANUFACTURE,
        PURCHASE AND SALE OF PRODUCT

       

      2.1    Supply.

       

      (a)    Pursuant
        to the terms and conditions of this Agreement, during the Term Inyx agrees
        to
        manufacture, package and test for King, at Inyx’s Manati, Puerto Rico facility,
        Product for purchase and sale by King in the Territory. Inyx shall maintain
        sufficient supplies of Raw Materials and other required resources to perform
        the
        services required under this Agreement. 

       

      (b)    Inyx
        shall manufacture all Products delivered hereunder in (a) accordance with
        the
        Specifications, this Agreement and the Quality Agreement and (b) material
        compliance with Laws applicable to the manufacturing of Product to be marketed
        and sold in the Territory.

       

      
        
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            TREATMENT

           

        

        
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      2.2    Forecasts.
        

       

      (a)    Not
        later
        than thirty (30) days after receiving FDA approval for manufacturing, packaging
        and testing to be performed by Inyx and by July 1 of each calendar year for
        the
        Term, King shall furnish Inyx with a long range monthly forecast of the
        quantities of each Product that King intends to order for the shorter of
        (i) the
        remaining Term or (ii) three (3) years. Such forecasts shall represent the
        most
        current estimates for planning purposes, but shall not be purchase commitments.
        

       

      (b)    In
        addition to the non-binding, long range forecasts provided in
        Section 2.2(a), not later than thirty (30) days after receiving FDA
        approval for manufacturing, packaging and testing to be performed by Inyx,
        and
        at least six (6) months prior to the first day of each calendar month
        thereafter, King shall furnish Inyx with a short range non-binding rolling
        forecast of the quantities of each Product that King intends to order by
        month
        during the eighteen month (18) month period commencing with that calendar
        month
        or such shorter period as remains in the Term. For example, a forecast submitted
        by King on January 1, 2006 would cover the period from July 1, 2006 through
        December 31, 2007. 

       

      (c)    Inyx
        will
        use commercially reasonable efforts to fill orders in excess of the firm
        purchase orders. 

       

      2.3    Firm
        Orders.

       

      (a)    King
        shall place purchase orders with Inyx for Products. All purchase orders must
        be
        received by Inyx at least six (6) months prior to the delivery date specified
        in
        each respective order. Each purchase order shall specify the delivery schedule
        within the month, and Inyx shall deliver against each such purchase order
        in
        accordance with Section 2.5. King shall be obligated to purchase all such
        Products ordered and delivered by the delivery date specified in King’s purchase
        order, provided that such Products meet the Specifications. Unless otherwise
        specified in writing by Inyx, all orders placed by King with Inyx hereunder
        shall be addressed as follows:

       

      Inyx,
        Inc.

       

      604
        San
        Jose Road

      Cotto
        Norte Industrial Park

      Manati,
        PR 00674

       

      or
        

       

      P.O.
        Box
        345

      Manati,
        PR 00674

      Facsimile:
        (787) 854-5715

      Telephone:
        (787) 884-7904

      Attn:
        Dolores Fernandez


      
        
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            TREATMENT

           

        

        
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      (b)    Inyx
        shall accept each purchase order submitted in accordance with this Section
        2.3.
        Inyx shall be obligated to manufacture and deliver the specified quantity
        of
        each Product in accordance with the delivery schedule set forth in such purchase
        order. In addition, at all times during the Term, Inyx shall maintain at
        its
        facility one month of inventory of each Product calculated as the average
        monthly unit sales for the prior six (6)-month period. If at any time during
        the
        term of this Agreement, the manufacturer believes it will be unable to supply,
        on a timely basis, King with the full quantity of Product forecasted to be
        or
        actually ordered by King, Inyx shall promptly notify King.

       

      (c)    Any
        purchase orders, purchase order releases, confirmations, acceptances, advices
        and similar documents submitted by either party in conducting the activities
        contemplated under this Agreement are for administration purposes only and
        shall
        not add to or modify the terms of this Agreement. To the extent of any conflict
        or inconsistency between this Agreement and any such document, the terms
        and
        conditions of this Agreement shall control as to a particular order unless
        otherwise agreed to in writing by the parties.

       

      2.4    Changes
        in Orders.
        Inyx
        shall exercise its commercially reasonable efforts to comply with proposed
        amendments to purchase orders that King may request after sending a purchase
        order to Inyx.

       

      2.5    Delivery.
        

       

      (a)    Inyx
        agrees to meet the delivery dates and order quantities indicated in King’s
        binding and accepted firm orders for all Products. Any shipment delivered
        that
        is within plus or minus *** of the quantity ordered will be considered as
        meeting such order quantity and any shipment ready to be shipped on a date
        within plus or minus five (+/-5) Business Days of the delivery date specified
        on
        the relevant firm order will be considered as delivered on time.

       

      (b)    Inyx
        shall ship Product on a carrier or carriers specified by King. Product shall
        be
        shipped under the designated procedures provided by King for transportation
        of
        Product. Title and risk of loss as to any Product purchased by King shall
        pass
        to King upon the earlier of (i) a common carrier accepting possession or
        control
        of such Product and (ii) the passage of such Product from the loading dock
        of
        Inyx’s facility to any employee, agent or contractor of King or such common
        carrier. The costs of all freight, insurance, handling, fees, taxes and other
        costs associated with the shipment of Product, as well as all export licenses,
        import licenses and customs formalities for the import and export of goods
        should be considered Collaboration Costs and ***.

       

      2.6    Rejected
        Goods/Shortages.

       

      (a)    King
        shall notify Inyx in writing of (i) any claim relating to Product that fails
        to
        meet the Specifications or (ii) any shortage in quantity of any shipment
        of
        Product as soon as reasonably practical, but not later than forty-five (45)
        days
        of receipt of such Product. If the parties agree that such Product is defective
        (and such defect is not related to the handling, storage and use by any Third
        Party) or that there is a shortage, Inyx shall replace the defective Product
        or
        use its commercially reasonable efforts to make up the shortage, as applicable,
        at the next practical delivery date, at no additional cost to King. King
        shall
        make arrangements with Inyx for the return or disposal of any rejected Product;
        the costs of such return or disposal shall be paid by Inyx. In the event
        that
        only a limited supply of Product is available to replace or supply such
        rejection or shortage, then Inyx shall ship to King such quantities of Product
        as are available, and King will be promptly reimbursed or credited against
        future orders, at King’s option, for amounts paid for the remaining quantity of
        rejected Product.

       

      
        
          CONFIDENTIAL
            TREATMENT

           

        

        
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      (b)    If
        Inyx
        disagrees with King’s claim that such Product fails to meet the applicable
        Specifications, Inyx and King representatives shall attempt to resolve such
        dispute. If the representatives cannot resolve such dispute, a sample of
        such
        Product shall be submitted by Inyx and King to a mutually agreed-to qualified
        laboratory for testing against the Specifications, and the test results obtained
        by such laboratory shall be final and controlling. The fees and expenses
        of such
        laboratory testing shall be borne entirely by the party whose Product analysis
        was in error. In the event the test results indicate that the Product in
        question does not conform to the Specifications, Inyx shall replace such
        Product
        at no additional cost to King as soon as reasonably possible after receipt
        of
        such results; provided,
        however,
        Inyx
        shall have no liability to King if such Product fails to meet the
        Specifications, if the Product: (i) has been tampered with or otherwise altered
        other than by Inyx; (ii) has been subject to misuse, negligence or accident
        other than by Inyx; or (iii) has been stored, handled or used by others in
        a
        manner contrary to applicable regulatory requirements. In the event that
        only a
        limited supply of Product is available to replace or supply such rejection
        or
        shortage, then Inyx shall ship to King such quantities of the applicable
        Product
        as are available, and King will be promptly reimbursed or credited against
        future orders, at King’s option, for amounts paid for the remaining quantity of
        rejected Product.

       

      2.7    Capacity.

       

      (a)    In
        the
        event that Inyx, upon receiving a forecast under Section 2.2(b) or a purchase
        order under Section 2.3, is, or anticipates that it will be, unable to meet
        such
        forecast or purchase order, either in whole or in part, due to any reason,
        Inyx
        shall give written notice of such inability to King within ten (10) Business
        Days of receipt of such forecast or firm order. If such inability is partial,
        Inyx shall fulfill firm orders with such quantities of Product as are available.
        Inyx shall use its commercially reasonable efforts to ensure that firm orders
        are supplied in full on a timely basis.

       

      (b)    Inyx
        and
        King shall meet within thirty (30) days of such written notice pursuant to
        Section 2.7(a) to consider alternative arrangements for meeting King’s
        requirements for Product, including obtaining King’s unfulfilled requirements
        from a Third Party. Any alternative arrangements entered into pursuant to
        this
        Section 2.7(b) shall act in no way as a waiver of any other rights or remedies
        which King or Inyx may have under this Agreement or otherwise; provided,
        however,
        King
        shall have no obligation to pay for orders of Product that Inyx is unable
        to
        provide.

       

      (c)    In
        the
        event that Inyx’s inability to meet firm orders or forecasts is due to a
        shortage of production capacity at Inyx’s facility, in addition to the
        requirements of Sections 2.7(a) and 2.7(b) above, Inyx shall promptly
        notify King of such shortage of production capacity, and, if possible, the
        date
        such shortage of production capacity is expected to end. Inyx shall give
        priority to King’s firm orders, and satisfy and fulfill deliveries of Product
        ordered pursuant to King’s firm orders prior to utilizing such production
        capacity to produce products for any other Person, including Inyx and its
        Affiliates.

       

      
        
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      (d)    Inyx
        shall notify King as soon as possible of the date upon which such shortage
        of
        production capacity will cease. Upon resumption of production of Products,
        King
        shall resume obtaining its requirements for Products from Inyx to the extent
        such resumption is consistent with any contractual arrangements entered into
        with Third Parties pursuant to Section 2.7(b). 

       

      2.8    Manufacturing
        Changes.

       

      (a)    For
        changes to the Specifications or manufacturing processes that are required
        by
        applicable Laws (collectively “Required
        Manufacturing Changes”),
        Inyx
        and King shall cooperate in making such changes timely.

       

      (b)    For
        changes to the Specifications or manufacturing process that are not Required
        Manufacturing Changes (collectively “Discretionary
        Manufacturing Changes”),
        Inyx
        and King must each agree to any Discretionary Manufacturing Changes and shall,
        to the extent commercially reasonable under the circumstances, cooperate
        in
        making such changes, and each agrees that it shall not unreasonably withhold
        its
        consent to such Discretionary Manufacturing Changes. Notwithstanding the
        foregoing, King’s standard change control procedures shall be utilized in
        reviewing such changes.

       

      (c)    Notwithstanding
        the foregoing, all internal and external costs, including, without limitation,
        obsolete raw materials, work-in-process, Product, packaging and labeling
        materials (i) associated with Required Manufacturing Changes shall be born
        ***,
        and (ii) all such costs associated with Discretionary Manufacturing Changes
        shall be borne by ***.

       

      2.9    Labeling
        and Packaging.
        King
        shall provide to Inyx master labeling specification documents and camera-ready
        proofs of labeling for, and other printed materials to be included as part
        of,
        each Product, and King warrants that all such labeling and printed material
        will
        comply in all respects with all applicable Laws and the registration for
        such
        Product.

       

      2.10   Raw
        Materials.

       

      (a)    Except
        with respect to the Initial Bulk Form, Inyx shall be solely responsible for
        obtaining all Raw Materials required for the manufacture of each
        Product.

       

      (b)    *
        * * .


       

      (c)    In
        the
        event that any Initial Bulk Form purchased by Inyx pursuant to this Section
        2.10
        does not meet the quality standards applicable to such Initial Bulk Form,
        King
        will reimburse Inyx an amount equal to *** Initial Bulk Form. If King disagrees
        with Inyx’s claim that such Initial Bulk Form fails to meet the applicable
        quality standards, Inyx and King representatives shall attempt to resolve
        such
        dispute. If the representatives cannot resolve such dispute, a sample of
        such
        Initial Bulk Form shall be submitted by Inyx and King to a mutually agreed-to
        qualified laboratory for testing, and the test results obtained by such
        laboratory shall be final and controlling. The fees and expenses of such
        laboratory testing shall be borne entirely by the party whose analysis was
        in
        error. 

       

      
        
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      (d)    Within
        ten (10) days of receipt of notice from King that the Initial Bulk Form is
        available for shipment to Inyx, Inyx will make all arrangements necessary,
        at
        its sole cost, to cause the Initial Bulk Form to be shipped to its manufacturing
        facility. Title and the risk of loss of the Initial Bulk Form shall pass
        to Inyx
        upon the receipt of the Initial Bulk Form by a common carrier designated
        by
        Inyx.

       

      (e)    After
        the
        Initial Bulk Form has been received by such common carrier, King will invoice
        Inyx for the amount of Initial Bulk Form being sold to Inyx. Payment shall
        be
        due within thirty (30) days of the date of such invoice. Interest on any
        part of
        the payment that is past due will be determined as described in Section 3.2.
        Neither Inyx’s payment for the Initial Bulk Form nor the costs of transportation
        or storage thereof will be Collaboration Costs.

       

      ARTICLE
        3

       

      PRICING
        AND PAYMENT

       

      3.1    *
        * *
.
        

       

      3.2    Payment
        / Terms.
        All
        payments required by this Agreement shall be made in United States Dollars
        by
        wire transfer to an account designated by Inyx. All invoices are to be paid
        in
        full within thirty (30) days from the date of invoice. Invoices should be
        submitted within thirty (30) days after the end of each calendar quarter
        during
        the Term. At the end of the year Inyx shall prepare a reconciliation statement
        for the expenses incurred related to the COGS during the calendar year. If
        such
        reconciliation statement shall show that either party reasonably incurred
        and
        paid expenses in excess of the amount payable by such party, and that the
        other
        party paid expenses below the amount payable by such party, then within thirty
        (30) days after such reconciliation statement is submitted to King, the
        underpaying party shall reimburse the overpaying party for the amount of
        such
        underpayment up to the amount payable by to such overpaying party. In the
        case
        of a good faith dispute regarding payment, King may in its discretion determine
        to pay such disputed amounts claimed by Inyx to be due, and, in the event
        amounts are finally determined not to be due by King, Inyx shall repay to
        King
        such excess amounts determined not to be due, and interest shall accrue on
        any
        such amount, at the lesser of (i) the prime rate as reported by the Wall
        Street
        Journal, New York Edition, or any reputable publication mutually agreed to
        by
        the parties plus an additional *** or (ii) the maximum rate permitted by
        Law,
        with such interest to begin accruing on a daily basis from the date such
        disputed payment was received by Inyx. 

       

      ARTICLE
        4

       

      TERM
        AND TERMINATION 

       

      4.1    Term;
        Supply of Product.
        The
        term of this Agreement (the “Term”)
        will
        commence upon the Effective Date and will continue, unless terminated earlier
        in
        accordance with the provisions of this Article 4, until the later of December
        31, 2015 and the last date on which any Approved New Product is sold.


       

      
        
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      4.2    Early
        Termination.
        Either
        King or Inyx may terminate this Agreement forthwith by notice in writing
        to the
        other party upon the occurrence of any of the following events:

       

      (a)    if
        such
        other party breaches in a material way any of the representations, warranties,
        covenants, or agreements set forth in this Agreement or otherwise materially
        defaults in the performance of any of its duties or obligations under this
        Agreement, which breach or default is not cured within sixty (60) days after
        written notice is given to the breaching party specifying the breach or
        default;

       

      (b)    if
        there
        are two or more similar or substantially similar material breaches of this
        Agreement by the breaching party within any 12 month period, which termination
        will be effective thirty (30) days following such written notice; provided,
        however, that any failure of a non-breaching party to exercise this termination
        right with respect to certain breaches will not be deemed a waiver of the
        ability of such non-breaching party to exercise this right upon any subsequent
        breach;

       

      (c)    if
        such
        other party is declared bankrupt or insolvent, if there is an assignment
        for the
        benefit of creditors, or if a receiver is appointed or proceedings commenced
        (and not dismissed within sixty (60) days), voluntarily or involuntarily,
        under
        any bankruptcy or similar law; or

       

      (d)    if
        either
        party provides at least three (3) years’ written notice to the other party.


       

      4.3    Termination
        by King.
        i)
        Subject
        to the terms of Section 4.3(b) below, King will have the right to terminate
        this
        Agreement immediately upon written notice to Inyx if there is a Change of
        Control of Inyx. 

       

      (b)    *
        * *
        .

       

      4.4    Consequences
        of Termination and Survival.
        Termination of this Agreement for whatever reason shall not affect the accrued
        rights and obligations of either Inyx or King arising under or out of this
        Agreement. The obligations under Article 6 (Product Recalls), Article 7
        (Warranties), Article 8 (Nondisclosure and Confidentiality), Article 9
        (Intellectual Property Rights), Article 10 (Indemnification and Insurance),
        or
        any other provision which expressly or by implication is intended to survive
        expiration or termination shall survive expiration or termination of this
        Agreement.

       

      4.5    Payments
        Upon Termination.
        

       

      (a)    The
        expiration or termination of this Agreement pursuant to this Article 4 will
        not
        release either party from any obligation to pay to the other party any amounts
        accrued under any of the Collaboration Documents in connection with activities
        completed, Collaboration Costs incurred, and revenue realized with respect
        to
        the period prior to the effective date of such expiration or termination.
        

       

      
        
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      (b)    Inyx
        will
        fulfill its obligations hereunder with respect to any orders received from
        King
        and accepted by Inyx prior to any expiration or termination of this
        Agreement.

       

      (c)    Within
        thirty (30) days after the expiration or termination of this Agreement, each
        party will provide to the other a reasonably detailed statement of Collaboration
        Costs incurred by such party hereunder or under any of the other Collaboration
        Documents during the period of January 1 of the calendar year in which such
        expiration or termination occurs through the effective date of such expiration
        or termination; and (ii) any final reports with respect to revenue or net
        sales
        with respect to the Products during such period, as required by any of the
        other
        Collaboration Documents.

       

      (d)    Within
        thirty (30) days after receipt of such information, the AMC will determine
        the
        net amounts due and or payable by Inyx and King, and such amounts will be
        paid
        by the parties within thirty (30) days after such AMC
        determination.

       

      (e)    Inyx
        will
        deliver to King all Improvements and all documents, material, data, records,
        analyses, and information related thereto.

       

      4.6    Technical
        Assistance.
        Upon
        expiration or termination of this Agreement, upon the requests of King, Inyx
        shall provide King with the assistance of its employees and access to its
        other
        internal resources to provide King with a reasonable level of technical
        assistance and consultation with the transfer of the Products to, and the
        regulatory qualification of, a finished goods supplier of King’s
        election.

       

      ARTICLE
        5

       

      CERTIFICATES,
        ACCESS AND REGULATORY MATTERS

       

      5.1    Testing;
        Certificate of Analysis.
        Inyx
        shall perform, or cause to be performed the tests required to be performed
        by
        Inyx pursuant to the Quality Agreement on each lot of Product manufactured
        pursuant to this Agreement before delivery to King. Each test report shall
        set
        forth the items tested, Specifications and test results in a certificate
        of
        analysis, containing the types of information which shall have been approved,
        by
        mutual agreement of the parties, for each lot delivered. Inyx shall send,
        or
        cause to be sent, such certificates to King prior to delivery of each lot
        unless
        otherwise agreed. In addition, Inyx will supply King with reference standards
        for normal commercial testing at Inyx’s expense. All other reference standards
        requested by King shall be provided by Inyx to King at King’s
        expense.

       

      5.2    Notice
        of Failure to Meet Specifications.
        Upon
        Inyx’s discovery that any batch or lot of Product fails to conform to the
        applicable Specifications, Inyx will notify King within forty-eight hours
        of
        such failure to meet the applicable Specifications and of the nature thereof
        in
        detail, including, but not limited to, supplying King with all investigatory
        reports, data, and communications, out-of-specification reports and data
        and the
        results of all outside laboratory testing and conclusions, if any. Inyx shall
        investigate all such failures promptly, and at its expense, cooperate with
        King
        in determining the cause for the failure and a corrective action to prevent
        future failures.

       

      
        
          CONFIDENTIAL
            TREATMENT

           

        

        
          10

          
            

          

        

        
           

        

      


      5.3    Records.
        Inyx
        shall maintain all manufacturing, packaging, analytical and stability records,
        all records of shipment, and all validation data relating to the Product
        to the
        extent and for the time periods required by applicable Laws with respect
        to the
        Product.

       

      5.4    Regulatory
        Compliance.
        Inyx
        shall advise King promptly if an authorized agent of a Regulatory Authority
        visits its manufacturing facilities where the Product is being manufactured
        or
        quality tested. Inyx shall furnish to King all material information supplied
        to,
        or supplied by, any Regulatory Authority, including the Form 483 observations
        and responses, to the extent that such report relates to the Product, or
        the
        ability of Inyx to supply such Product, within forty-eight hours of their
        receipt of such information or delivery of such information, as the case
        may be.
        King shall have fifteen (15) days to review and provide comments to Inyx
        prior
        to Inyx responding to any Regulatory Authority. Should Inyx choose not to
        include or address King’s comments when responding to the Regulatory Authority,
        then Inyx shall provide King a reason as to why King’s comments were not
        included or addressed. Before Inyx responds to any Regulatory Authority,
        King
        shall have the right to review and approve such final response. 

       

      5.5    Changes.
        In
        addition to the requirements of Section 2.8, Inyx shall not change the critical
        specified raw materials, packaging materials, their source, analytical test
        procedures or critical manufacturing conditions or critical manufacturing
        equipment used in the manufacture of Product without the prior written consent
        of King, which consent shall not be unreasonably withheld.

       

      5.6    Access
        to Facilities.
        Upon
        the reasonable prior written request of King, King shall have the right to
        inspect those portions of the manufacturing, storage and testing facilities
        of
        Inyx where Product is being manufactured, stored or tested, as the case may
        be,
        during regular business hours, to ascertain compliance with cGMPs and the
        Specifications. If the FDA or other applicable Regulatory Authority asserts
        any
        notice to the effect that Inyx has failed to comply with any applicable Law
        in
        connection with the manufacture of Product, or if Inyx delivers Product that
        does not meet the applicable Specifications, then King shall have the right
        to
        inspect such portions of the manufacturing facilities of Inyx that relate
        to the
        manufacture and testing of such Product upon reasonable notice and during
        normal
        business hours. Notwithstanding the provisions of this Section 5.6, King
        shall
        have no obligation nor be deemed to have an obligation to inspect the facilities
        of Inyx.

       

      5.7    Product
        Inquiries and Complaints.
        Inyx
        will promptly submit to King all Product safety and efficacy inquiries, Product
        quality complaints and adverse drug event reports received by Inyx, together
        with all available evidence and other information relating thereto, in
        accordance with procedures to be agreed upon by the parties. Except as otherwise
        required by Law or governmental regulation, King, as the party holding the
        applicable NDA, will be responsible for investigating and responding to all
        such
        inquiries, complaints and adverse events regarding Product. It shall be the
        responsibility of King, as the party holding the applicable NDA, to comply
        with
        all applicable national, federal, state and local governmental reporting
        requirements regarding adverse drug events and Product quality
        matters.

       

      
        
          CONFIDENTIAL
            TREATMENT

           

        

        
          11

          
            

          

        

        
           

        

      


      5.8    Response
        to Complaints and/or Adverse Drug Events.

       

      (a)    Pursuant
        to a reported complaint and/or adverse drug event, if the nature of the reported
        complaint and/or adverse drug event requires testing during the period, Inyx
        will, upon King’s request and approval and at Inyx’s reasonable expense, perform
        analytical testing of corresponding retention samples and provide the results
        thereto to King as soon as reasonably practicable. King as the party holding
        the
        applicable NDA shall remain responsible for reporting to the FDA or any other
        Regulatory Authority. Such testing shall be performed using NDA approved
        testing
        procedures as set forth in the applicable NDA.

       

      (b)    If
        the
        parties disagree as to which party is responsible, Inyx and King representatives
        shall attempt to resolve such dispute. If the representatives cannot resolve
        such dispute, the retention samples shall be submitted by Inyx and King to
        a
        mutually agreed-to qualified laboratory for testing, and the test results
        obtained by such laboratory shall be final and controlling. The fees and
        expenses of such laboratory testing shall be borne entirely by the party
        whose
        analysis was in error.

       

      5.9    Additional
        Information.
        Each
        party shall provide to the other in a timely manner, but in no event less
        than
        sixty (60) days prior to the due date of such party’s annual report to the FDA
        or any other Regulatory Authority with respect to the Products, all information
        in written form which such party requests regarding the Products in order
        to
        comply with applicable Laws. 

       

      5.10   Quality
        Agreement.
        Each
        party shall perform the duties required of it pursuant to the Quality Agreement
        to be entered into by the parties. To the extent the Quality Agreement conflicts
        with this Agreement with respect to a quality issue, the Quality Agreement
        shall
        control.

       

      ARTICLE
        6

       

      PRODUCT
        RECALLS

       

      6.1    Product
        Recalls.
        In the
        event (i) any Regulatory Authority issues a request, directive or order that
        Product be recalled, (ii) a court of competent jurisdiction orders such a
        recall, or (iii) King as holder of the applicable NDA shall reasonably determine
        that Product should be recalled, withdrawn or a field correction issued,
        the
        parties shall take all appropriate corrective actions, and shall cooperate
        in
        the investigations surrounding the recall. In the event that King as applicable
        NDA holder determines that Product should be recalled, to the extent possible,
        King shall consult with Inyx prior to taking any corrective actions. In the
        event of any Product recall, withdrawal, or field correction resulting solely
        from Inyx’s negligence or any cause or event arising from the failure of Inyx to
        manufacture, test, store or handle Bulk Forms or Products in accordance with
        cGMP and the Specifications, (a) Inyx shall bear all reasonable costs associated
        with such recall, withdrawal, or field correction, which shall include the
        expenses of notification and destruction or return of the recalled Product
        and
        all other documented out-of-pocket costs incurred in connection with such
        recall, and (b) Inyx shall, subject to King’s election, either supply the
        Product, without charge to King, in an amount sufficient to replace the amount
        of the Product recalled, withdrawn or subject to field correction, or refund
        King, or give credit to King against outstanding receivables due from King
        against the purchase price for shipments of the Product to be delivered to
        King
        in the future, in amounts equal to *** for Products so recalled, withdrawn
        or
        subjected to field correction, plus reasonable transportation costs incurred
        by
        King with respect to such Product. All costs associated with any other type
        of
        Product recall, withdrawal, or field correction shall be deemed Collaboration
        Costs and will be ***.

       

      
        
          CONFIDENTIAL
            TREATMENT

           

        

        
          12

          
            

          

        

        
           

        

      


      6.2    Disputes.
        If
        there is any dispute concerning which party’s acts or omissions gave rise to
        such recall of Product, such dispute shall be referred for decision to an
        independent expert, acting as an expert and not as an arbitrator, to be
        appointed by agreement between King and Inyx. The decision of such independent
        expert shall be in writing and, except for manifest error on the face of
        the
        decision, shall be binding on both King and Inyx. The costs of such independent
        expert shall be borne by the party who is found to be responsible for the
        recall
        by the independent expert. After such determination, costs shall be paid
        by the
        responsible party in accordance with Section 6.1.

       

      ARTICLE
        7

       

      WARRANTIES

       

      7.1    Compliance
        with cGMP.
        Inyx
        warrants that all Product will be manufactured in conformity with
        cGMP.

       

      7.2    Conformity
        with Specifications.
        Inyx
        warrants that Product manufactured by Inyx and sold to King pursuant to this
        Agreement will meet the Specifications at the time of delivery to the common
        carrier for such Product in effect at the time of manufacture.

       

      7.3    Compliance
        with the Act.
        Inyx
        warrants that all Product delivered to King pursuant to this Agreement will,
        at
        the time of such delivery, not be adulterated within the meaning of the Act
        and
        will not be an article which may not, under the provisions of such Act, be
        introduced into interstate commerce.

       

      7.4    No
        Liens.
        Inyx
        warrants that all Product delivered to King pursuant to this Agreement will,
        at
        the time of such delivery, be free and clear of all liens, encumbrances,
        security interests and other encumbrances.

       

      7.5    Compliance
        with Applicable Laws.
        During
        the term of this Agreement, Inyx shall comply in all material respects with
        all
        Laws applicable to the conduct of its business in the performance of this
        Agreement.

       

      7.6    Raw
        Materials and Components.
        Inyx
        represents and warrants to King that it currently has access to sufficient
        supplies of Raw Materials and other required resources to perform the services
        required under this Agreement. 

       

      7.7    FDA
        Debarment.
        As of
        the Effective Date, neither Inyx nor any of its employees or agents, in their
        capacity as such, have been disqualified or debarred by the FDA, pursuant
        to 21
        U.S.C. §§ 335(a) or (b), or been charged with or convicted under United States
        law for conduct relating to the development or approval, or otherwise relating
        to the regulation of any Product under the Generic Drug Enforcement Act of
        1992,
        or any other relevant law, rule, or regulation or been disbarred, disqualified,
        or convicted under or for any equivalent or similar applicable foreign law,
        rule, or regulation. 

       

      
        
          CONFIDENTIAL
            TREATMENT

           

        

        
          13

          
            

          

        

        
           

        

      


      7.8    Exclusion
        of Other Warranties.
        EXCEPT
        WHERE OTHERWISE SET FORTH IN THIS AGREEMENT OR THE OTHER COLLABORATION
        DOCUMENTS, SECTIONS 7.1, 7.2, 7.3, 7.4, 7.5, 7.6 AND 7.7 ARE IN LIEU OF ALL
        CONDITIONS, WARRANTIES AND STATEMENTS IN RESPECT OF PRODUCT AND THE SERVICES
        PROVIDED HEREUNDER, WHETHER EXPRESSED OR IMPLIED BY STATUTE, CUSTOM OF THE
        TRADE
        OR OTHERWISE, INCLUDING BUT WITHOUT LIMITATION ANY SUCH CONDITION, WARRANTY
        OR
        STATEMENT RELATING TO THE DESCRIPTION OR QUALITY OF PRODUCT, ITS MERCHANTABILITY
        OR FITNESS FOR A PARTICULAR PURPOSE OR USE UNDER ANY CONDITIONS, AND ANY
        SUCH
        CONDITION, WARRANTY OR STATEMENT IS HEREBY EXCLUDED. 

       

      7.9    Limitation
        of Liability.
        IN NO
        EVENT SHALL INYX OR KING AND/OR THEIR RESPECTIVE AFFILIATES BE LIABLE UNDER
        OR
        WITH RESPECT TO THIS AGREEMENT FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL,
        SPECIAL OR PUNITIVE DAMAGES OF ANY KIND, INCLUDING BUT NOT LIMITED TO LOSS
        OF
        PROFITS OR DUE TO BREACH OF WARRANTY, TORT, BREACH OR REPUDIATION OF ANY
        TERM OR
        CONDITION OF THIS AGREEMENT.

       

      ARTICLE
        8

       

      NONDISCLOSURE
        AND CONFIDENTIALITY

       

      8.1    Nondisclosure
        Obligations.
        

       

      (a)    Each
        party acknowledges that it may receive confidential or proprietary information
        (the “Confidential
        Information”)
        of the
        other party in the performance of the Collaboration Documents, including
        information obtained or reviewed in connection with any audits or investigations
        performed pursuant to this Agreement. Each party will hold confidential and
        will
        not, directly or indirectly, disclose, publish, or use for the benefit of
        any
        Third Party or itself, except in carrying out its duties under the Collaboration
        Documents, any confidential or proprietary information of the other party
        or
        confidential or proprietary information jointly developed by the parties,
        without first having obtained the furnishing party’s written consent to such
        disclosure or use. “Confidential
        Information”
        will
        include know-how, scientific information, clinical data, efficacy and safety
        data, adverse event information, formulas, methods and processes,
        specifications, pricing information (including discounts, rebates, and other
        price adjustments), and other terms and conditions of sales, customer
        information, business plans, and all other intellectual property. The Patent
        Rights and Technology will be deemed the Confidential Information of King.
        The
        restrictions in this Article 8 will not apply to any information
        that:

       

      (i)    is
        or
        becomes part of the public domain other than by unauthorized acts of the
        receiving party or its Affiliates, sublicensees, Consultants, and contractors,
        as applicable;

       

      
        
          CONFIDENTIAL
            TREATMENT

           

        

        
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      (ii)    can
        be
        shown by written documentation to have been disclosed to the receiving party
        or
        its Affiliates or sublicensees by a Third Party who was not otherwise prohibited
        from transmitting the information to the receiving party by a contractual,
        legal, or fiduciary obligation of confidence to the disclosing
        party;

       

      (iii)    prior
        to
        disclosure under this Agreement, was already in the possession of the receiving
        party or its Affiliates or sublicensees, provided such information was not
        obtained directly or indirectly from the other party hereto pursuant to a
        confidentiality agreement;

       

      (iv)    can
        be
        shown by written documentation to have been independently developed by the
        receiving party or its Affiliates without breach of any of the provisions
        of
        this Agreement, including without reference to the Confidential Information
        of
        the disclosing party;

       

      (v)    is
        disclosed by the receiving party pursuant to oral questions, interrogatories,
        requests for information or documents, subpoena, or a civil investigative
        demand
        of a court or governmental agency; provided, however, that the receiving
        party
        notifies the other party promptly following receipt thereof so that the other
        may seek a protective order or other appropriate remedy to prevent or limit
        such
        disclosure; and provided further that the receiving party furnishes only
        that
        portion of the information that it is advised by counsel is legally required
        and
        imposes such obligations of secrecy as are possible in that regard;

       

      (vi)    is
        required or permitted to be disclosed by the receiving party under any
        statutory, regulatory, or similar legislative requirement or any rule of
        any
        stock exchange to which it or any Affiliate is subject; provided, however,
        that
        the other party will be allowed to review the proposed disclosure and the
        receiving party agrees to consider in good faith any proposed revisions thereof
        provided to the receiving party within two (2) business days of the other
        party’s receipt of the proposed disclosure, and the parties will seek
        confidential treatment for such disclosure as permitted by applicable law;
        or

       

      (vii)    is
        required by authorities to obtain Regulatory Approval.

       

      (b)    The
        receiving party agrees that it will disclose the Confidential Information
        only
        to its employees and Consultants who need to know such Confidential Information
        for such party to perform its obligations hereunder. The receiving party
        agrees
        (i) to inform all of its employees and Consultants who receive Confidential
        Information of the confidential nature thereof and to direct all such employees
        and Consultants to treat the Confidential Information confidentially in
        accordance with this Agreement; (ii) to be responsible for any breach of
        the
        Agreement by any of its employees and Consultants; and (iii) to make all
        reasonable, necessary, and appropriate efforts to safeguard the Confidential
        Information from disclosure other than as permitted hereby, which will include
        requiring all employees and Consultants who have access to Confidential
        Information of the disclosing party to execute written obligations to maintain
        the same in confidence and not to use such information except as expressly
        permitted under the Collaboration Documents. Each party agrees to enforce
        confidentiality obligations to which its employees and Consultants are
        obligated.

       

      
        
          CONFIDENTIAL
            TREATMENT

           

        

        
          15

          
            

          

        

        
           

        

      


      (c)    Upon
        the
        expiration or termination of this Agreement or upon request of the disclosing
        party, the receiving party will return to the disclosing party any and all
        Confidential Information of the disclosing party and any reproductions
        thereof.

       

      (d)    The
        obligations set forth in this Article 8 will survive the termination or
        expiration of this Agreement for a period of five (5) years (or, in the case
        of
        any Confidential Information identified as a trade secret by the disclosing
        party at the time of disclosure, for so long as such trade secret Confidential
        Information is susceptible of remaining a trade secret). 

       

      8.2    Terms
        of this Agreement.
        The
        parties agree not to disclose any terms or conditions of this Agreement to
        any
        Third Party without the prior consent of the other parties, except as required
        by applicable Laws.

       

      8.3    Injunctive
        Relief.
        The
        parties hereto understand and agree that remedies at Law may be inadequate
        to
        protect against any breach of any of the provisions of this Article 8 by
        either
        party or their employees, agents, officers or directors or any other person
        acting in concert with it or on its behalf. Accordingly, each party may be
        entitled to the granting of injunctive relief by a court of competent
        jurisdiction against any action that constitutes any such breach of this
        Article
        8.

       

      8.4    Production
        of Generics.
        During
        the Term, and for two (2) years following the termination or expiration of
        this
        Agreement, Inyx shall not, and shall not permit any of its Affiliates to,
        sell,
        produce, manufacture, market or distribute any generic product identical
        to the
        Product in the Territory. 

       

      ARTICLE
        9

       

      INTELLECTUAL
        PROPERTY RIGHTS

       

      9.1    Ownership
        of Tangible Materials.
        King
        shall retain ownership of all information, documents and materials which
        King
        provides to Inyx in connection with the performance of the services by Inyx
        hereunder, and King shall have the right to use, all reports, documents and
        other tangible materials which Inyx provides to King in the performance of
        such
        services. Any such Confidential Information, documents, and materials shall
        be
        subject to Article
        8.
        Furthermore, King will have sole and exclusive ownership of all right, title,
        and interest on a worldwide basis, with full rights to license or sublicense,
        subject to the licenses granted Inyx in the Collaboration Documents, in and
        to
        any and all

       

      (a)    the
        Products and New Products,

       

      (b)    Technology
        transferred to Inyx’s facilities pursuant to this Agreement,

       

      (c)    Technology
        and Patent Rights as they exist as of the Effective Date, and

       

      (d)    any
        Improvements to the Technology and associated Patent Rights, developed after
        the
        Effective Date during the Term, whether developed by King or Inyx or jointly
        by
        King and Inyx and any permitted Third Parties, including all rights to any
        Technology and Patent Rights related to Excluded New Products;

       

      
        
          CONFIDENTIAL
            TREATMENT

           

        

        
          16

          
            

          

        

        
           

        

      


      provided
        that such ownership of right, title, and interest does not extend to the
        Inyx
        Respiratory Products.

       

      9.2    Inventions
        Disclosure and Generally.
        Each
        Party will promptly provide the AMC with written notice concerning all
        Improvements that are conceived, made, or developed in the course of carrying
        out the Collaboration Program by employees or Consultants of either of them
        or
        their Affiliates, alone or jointly with employees or Consultants of the other
        Party or its Affiliates or permitted Third Parties. Such notice will be treated
        as the Confidential Information of King hereunder. 

       

      9.3    Assignment.
        Inyx
        agrees to, and hereby does, and will cause each of its employees, Consultants,
        Affiliates and permitted submanufacturers (collectively with Inyx, the
“Assignors”)
        to,
        transfer, assign, and convey exclusively to King, its successors and assigns,
        forever, the entire right, title, and interest in and to all Improvements
        developed by each such Assignor, alone or jointly with each other or King,
        including all intellectual property rights associated therewith. Inyx further
        agrees, and will cause the other Assignors, (i) to promptly provide King
        with
        written notice, in sufficient detail, of any Improvements such Assignor makes
        pursuant to the Collaboration Documents and (ii) to provide King with such
        additional information and to execute and deliver, and to cause the other
        Assignors to execute and deliver, any documents or take any other actions
        or
        otherwise cooperate with King as may reasonably be necessary, or as King
        may
        reasonably request, to document, enforce, protect, or otherwise perfect King’s
        rights in any Improvement, including filing any applicable patent
        applications.

       

      9.4    Employees.
        Inyx
        agrees to have each employee enter into a written agreement with Inyx that
        includes an assignment to Inyx, or directly to King with respect to
        Improvements, of all right, title and interest in and to all work product
        and
        all inventions arising during the course of his or her employment with Inyx
        in
        connection with such Improvements or the Collaboration Program, and all
        intellectual property rights attaching thereto. 

       

      ARTICLE
        10

       

      LIMITATION
        OF LIABILITY, INDEMNIFICATION AND INSURANCE

       

      10.1   Indemnification
        by King.
        Except
        as otherwise specifically provided, King and/or its Affiliates shall indemnify
        and hold harmless Inyx and its Affiliates against all claims, actions, costs,
        expenses, including court costs and legal fees on a full indemnity basis,
        or
        other liabilities (“Liabilities”)
        whatsoever in respect of:

       

      (a)    any
        negligence or willful misconduct by King and/or its Affiliates in relation
        to
        the use, marketing, manufacture, storage, distribution, handling or sale
        of
        Product;

       

      (b)    any
        labeling of any Product to the extent that such labeling has been supplied
        by or
        at the direction of King and/or its Affiliates and applied in accordance
        with
        instructions from King; and

       

      
        
          CONFIDENTIAL
            TREATMENT

           

        

        
          17

          
            

          

        

        
           

        

      


      (c)    any
        representation or warranty made by King and/or its Affiliates to its customers
        or users with respect to Product, other than representations or warranties
        contained in Sections 7.1, 7.2, 7.3, 7.4, 7.5, 7.6 or 7.7; 

       

      provided,
        however, that King will not be required to indemnify Inyx with respect to
        any
        such Liability hereunder to the extent the same is caused primarily by any
        breach of contract, negligent act or omission or intentional misconduct by
        Inyx
        or any or its Affiliates or is otherwise covered by Inyx’s indemnification
        obligation in Section 10.2.

       

      10.2   Indemnification
        by Inyx.
        Except
        as otherwise specifically provided, Inyx shall indemnify and hold harmless
        King
        against all Liabilities whatsoever in respect of:

       

      (a)    Inyx’
        and/or its Affiliates’ failure to comply with the Specifications, cGMP, or
        applicable Laws; and

       

      (b)    any
        breach of a representation or warranty made by Inyx and/or its Affiliates
        in
        Article 7;

       

      (c)    any
        negligence or willful misconduct by Inyx and/or its Affiliates in the
        manufacture, testing, storage and handling of Product; 

       

      provided,
        however, that Inyx will not be required to indemnify King with respect to
        any
        such Liability hereunder to the extent the same is caused primarily by any
        breach of contract, negligent act or omission or intentional misconduct by
        King
        or any or its Affiliates or is otherwise covered by King’s indemnification
        obligation in Section 10.1.

       

      10.3   Procedures
        for Indemnification for Third-Party Claims.
        A party
        (the “indemnitee”)
        that
        intends to claim indemnification under this Article 10 will notify the other
        party (the “indemnitor”)
        within
        a reasonable time in writing of any action, claim, or liability in respect
        of
        which the indemnitee believes it is entitled to claim indemnification; provided
        that the failure to give timely notice to the indemnitor will not release
        the
        indemnitor from any liability to the indemnitee except to the extent the
        indemnitor is actually prejudiced thereby. The indemnitor will have the right,
        by notice to the indemnitee, to assume the defense of any such action or
        claim
        within the fifteen (15) day period after the indemnitor’s receipt of notice of
        any action or claim with counsel of the indemnitor’s choice and at the sole cost
        of the indemnitor. If the indemnitor does not so assume the defense of such
        Third Party claim, the indemnitee may assume such defense with counsel of
        its
        choice and at the sole cost of the indemnitor. If the indemnitor so assumes
        such
        defense, the indemnitee may participate therein through counsel of its choice,
        but at the sole cost of the indemnitee. The party not assuming the defense
        of
        any such claim will render all reasonable assistance to the party assuming
        such
        defense, and all reasonable out-of-pocket costs of such assistance will be
        for
        the account of the indemnitor. No such claim will be settled other than by
        the
        party defending the same, and then only with the consent of the other party,
        which will not be unreasonably withheld; provided that the indemnitee will
        have
        no obligation to consent to any settlement of any such action or claim that
        imposes on the indemnitee any liability or obligation that cannot be assumed
        and
        performed in full by the indemnitor, and the indemnitee will have no right
        to
        withhold its consent to any settlement of any such action or claim if the
        settlement involves only the payment of money by the indemnitor or its
        insurer.

       

      
        
          CONFIDENTIAL
            TREATMENT

           

        

        
          18

          
            

          

        

        
           

        

      


      10.4    Distribution/
        Product Liability Insurance.
        King
        and Inyx shall obtain and maintain in effect for the term of this Agreement,
        liability insurance or indemnity policies, in an amount not less than ***
        in the
        aggregate with an indemnity to principals clause with respect to products
        liability and distribution. Such policies shall be blanket policies and shall
        insure against liability on the part of each party and any of its Affiliates,
        as
        their interests may appear, due to injury, disability or death of any person
        or
        persons, or injury to property, arising from the distribution of Products.
        Upon
        the execution of this Agreement and thereafter on January 1 of each year
        during
        the Term, Inyx shall provide to King a certificate of insurance (i) summarizing
        the insurance coverage and (ii) identifying any exclusions. Each party shall
        promptly notify the other of any material adverse alterations to the terms
        of
        this policy or decreases in the amounts for which insurance is provided.
        Either
        party may satisfy its obligations hereunder through self-insurance to the
        same
        extent. 

       

      10.5    Product
        Liability Claims.
        As soon
        as it becomes aware, each party will give the other prompt written notice
        of any
        defect or alleged defect in a Product, any injury alleged to have occurred
        as a
        result of the use or application of the Product, and any circumstances that
        may
        give rise to litigation or recall of a Product or regulatory action that
        may
        affect the sale or manufacture of a Product, specifying, to the extent the
        party
        has such information, the time, place and circumstances thereof and the names
        and addresses of the persons involved. Each party will also furnish promptly
        to
        the other copies of all papers received in respect of any claim, action or
        suit
        arising out of such alleged defect, injury or regulatory action.

       

      ARTICLE
        11

       

      GENERAL
        PROVISIONS

       

      11.1    Notices.
        Except
        as otherwise specifically provided herein, any notice or other documents
        to be
        given under this Agreement will be in writing and will be deemed to have
        been
        duly given if sent by registered post, nationally recognized overnight courier,
        or confirmed facsimile transmission to a party (followed by hard copy by
        mail),
        or delivered in person to a party at the address or facsimile number set
        out
        below for such party or such other address as the party may from time to
        time
        designate by written notice to the other:

       

      If
        to
        King:


       

      King
        Pharmaceuticals, Inc.

      501
        Fifth
        Street

      Bristol,
        Tennessee 37620

      Attn:
        President

      Facsimile:
        (423) 989-8006


      
        
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      with
        a
        copy to:


       

      King
        Pharmaceuticals, Inc.

      501
        Fifth
        Street

      Bristol,
        Tennessee 37620

      Attn:
        Executive Vice President and General Counsel

      Facsimile:
        (423) 989-6282 

       

      and


       

      Jones
        Day

      222
        East
        41st Street

      New
        York,
        New York 10017

      Attn:
        John J. Hyland, Esq.

      Facsimile:
        (212) 755-7306


       

      If
        to
        Inyx:


       

      Inyx,
        Inc.

      825
        Third
        Avenue

      40th
        Floor

      New
        York,
        New York 10022

      Attn:
        Chairman and CEO

      Facsimile:
        (212) 838-0060

       

      with
        a
        copy to:


       

      Bennett
        Jones LLP

      10th
        Floor, 10035-105 Street

      Edmonton,
        Alberta

      Canada
        T5J 3T2

      Attn:
        Enzo J. Barichello, Q.C.

      Facsimile:
        (780) 421-7951

       

      Any
        such
        notice or other document will be deemed to have been received by the addressee
        three (3) business days following the date of dispatch of the notice or other
        document by post or, where the notice or other document is sent by overnight
        courier, by hand, or is given by facsimile, simultaneously with the transmission
        or delivery thereof.

       

      11.2    Entire
        Agreement.
        This
        Agreement with the Exhibits and Schedules attached hereto, together with
        the
        other Collaboration Documents, contains all of the terms agreed to by the
        Parties regarding the subject matter hereof and thereof and supersede any
        prior
        agreements, understandings, or arrangements between them, whether oral or
        in
        writing. This Agreement may not be amended, modified, altered, or supplemented
        except by means of a written agreement or other instrument executed by both
        of
        the parties hereto. No course of conduct or dealing between the parties will
        act
        as a modification or waiver of any provisions of this Agreement. Any other
        terms
        and conditions, including without limitation any terms and conditions contained
        in any purchase order or sales invoice issued pursuant to this Agreement,
        are
        hereby expressly excluded.

       

      
        
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      11.3    Equitable
        Relief.
        The
        parties understand and agree that, in view of the uniqueness of the Product
        and
        the long term supply of the Product contemplated hereunder, King shall be
        entitled to equitable relief in the event that Inyx breaches its obligations
        to
        supply the Product hereunder in addition to any other remedy to which King
        may
        be entitled by law.

       

      11.4    Force
        Majeure.
        Neither
        party will be liable to the other party for any failure to perform as required
        by this Agreement if the failure to perform is due to circumstances reasonably
        beyond such party’s control including acts of God, civil disorders or
        commotions, acts of aggression, fire, explosions, floods, drought, war,
        sabotage, embargo, utility failures, material shortages, a national health
        emergency, or appropriations of property. A party whose performance is affected
        by a force majeure event will take prompt action using its reasonable best
        efforts to remedy the effects of the force majeure event. If, as a result
        of a
        force majeure event, a party is unable to fully perform its obligations
        hereunder for any consecutive period of one hundred eighty (180) days, the
        other
        party will have the right to terminate this Agreement, upon providing written
        notice to the nonperforming party, such termination to be effective thirty
        (30)
        days from the date of such notice. 

       

      11.5    Relationship
        of the Parties.
        The
        parties hereto are acting and performing as independent contractors, and
        nothing
        in this Agreement creates the relationship of partnership, joint venture,
        sales
        agency, or principal and agent. Neither party is the agent of the other,
        and
        neither party may hold itself out as such to any other party. All financial
        obligations associated with each party’s business will be the sole
        responsibility of such party.

       

      11.6    Publicity.
        Any
        press release, publicity or other form of public written disclosure related
        to
        this Agreement prepared by one party shall be submitted to the other party
        prior
        to release for approval, which approval shall not be unreasonably withheld
        by
        such other party.

       

      11.7    Use
        of
        Party’s Name.
        Except
        as expressly provided or contemplated hereunder and except as otherwise required
        by applicable law, no right is granted pursuant to this Agreement to either
        party to use in any manner the trademarks or name of the other party, or
        any
        other trade name, service mark, or trademark owned by or licensed to the
        other
        party in connection with the performance of the Agreement. Notwithstanding
        the
        above, either party shall be permitted to use the other party’s name and marks,
        as may be required under applicable law, in connection with securities or
        other
        public filings.

       

      11.8    Severability.
        In the
        event that any of the provisions or a portion of any provision of this Agreement
        is held to be invalid, illegal, or unenforceable by a court of competent
        jurisdiction or a governmental authority, such provision or portion of provision
        will be construed and enforced as if it had been narrowly drawn so as not
        to be
        invalid, illegal, or unenforceable, and the validity, legality, and
        enforceability of the enforceable portion of any such provision and the
        remaining provisions will not be adversely affected thereby.

       

      
        
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      11.9    Assignment.
        Inyx
        may not assign or otherwise transfer this Agreement or any interest herein
        or
        right hereunder without the prior written consent of King, and any such
        purported assignment, transfer, or attempt to assign or transfer any interest
        herein or right hereunder will be void and of no effect. King may freely
        assign
        and otherwise transfer this Agreement or any interest herein or right hereunder
        without Inyx’s consent. Subject to the foregoing, this Agreement will be binding
        upon and inure to the benefit of the parties hereto and their respective
        permitted successors and assigns. In addition, King may assign its rights
        under
        this Agreement as security to one or more financial institutions providing
        financing to King and may be assigned pursuant to the terms of the security
        agreement. 

       

      11.10   Governing
        Law.
        This
        Agreement will be construed under and in accordance with, and governed in
        all
        respects by, the laws of the State of New York, without regard to its conflicts
        of law principles.

       

      11.11   Consent
        to Jurisdiction.
        Each of
        the parties hereby submits to the exclusive general jurisdiction of the courts
        of the State of New York and the courts of the United States of America for
        the
        Eastern District of New York in any action or proceeding arising out of or
        relating to this Agreement and to the jurisdiction of the appellate courts
        to
        which appeals are required to be taken from any of the foregoing. Each of
        the
        parties waives any defense of inconvenient forum to the maintenance of any
        such
        action or proceeding. Any party may make service on any other party by sending
        or delivering a copy of the process to the party to be served at the address
        and
        in the manner provided for the giving of notices in Section
        11.1
        above.
        Nothing in this Section
        11.11,
        however, will affect the right of any party to serve legal process in any
        other
        manner permitted by law or equity.

       

      11.12   Headings.
        The
        headings contained in this Agreement are for reference purposes only and
        will
        not affect in any way the meaning or interpretation of this
        Agreement.

       

      11.13   Non-Waiver.
        The
        failure of either party to enforce or to exercise, at any time or for any
        period
        of time, any term of or any right arising pursuant to this Agreement does
        not
        constitute, and will not be construed as, a waiver of such term or right,
        and
        will in no way affect that party’s right later to enforce or exercise such term
        or right.

       

      11.14   Interpretation.
        The
        parties hereto acknowledge and agree that: (a) each party and its
        representatives have reviewed and negotiated the terms and provisions of
        this
        Agreement and have contributed to its revision; and (b) the terms and provisions
        of this Agreement will be construed fairly as to each party hereto and not
        in
        favor of or against either party regardless of which party was generally
        responsible for the preparation or drafting of this Agreement.

       

      11.15   Third
        Party Beneficiaries.
        This
        Agreement is not intended to confer upon any non-party rights or remedies
        hereunder, except as may be received or created as part of a valid
        assignment.

       

      11.16   Further
        Assurances.
        Each of
        Inyx and King agrees to duly execute and deliver, or cause to be duly executed
        and delivered, such further instruments and do and cause to be done such
        further
        acts and things, including the filing of such additional assignments,
        agreements, documents, and instruments, that may be necessary or as the other
        party hereto may at any time and from time to time reasonably request in
        connection with the Collaboration Documents or to carry out more effectively
        the
        provisions and purposes of, or to better assure and confirm unto such other
        party its rights and remedies under, the Collaboration Documents.

       

      
        
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      11.17    Certain
        Expenses and Commissions.
        Except
        as otherwise expressly set forth in this Agreement or the other Collaboration
        Documents, the parties hereto will each pay all their costs and expenses,
        including legal and accounting fees, incurred in connection with the
        preparation, negotiation, execution, and delivery of the Collaboration Documents
        and will indemnify and hold the other harmless from and against any and all
        other claims or liabilities for such costs and expenses incurred by reason
        of
        any action taken by any such party.

       

      11.18    Counterparts.
        This
        Agreement will become binding when any one or more counterparts hereof,
        individually or taken together, will bear the signatures of each of the parties
        hereto. This Agreement may be executed in any number of counterparts, each
        of
        which will be deemed an original as against the party whose signature appears
        thereon, but all of which taken together will constitute but one and the
        same
        instrument.

       

      [Signatures
        on Following Page]

      



      
        
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      IN
        WITNESS WHEREOF, the parties hereto have each caused this Agreement to be
        duly
        executed as of the Effective Date.

       

      
        	 	 	 
	 	INYX,
                INC.
	 
 	 
 	 
 
	 	By:  	/s/ Jack
                Kachkar
	 	
                
Jack
                Kachkar
	 	Chairman
                and CEO


      

       

      
        	 	 	 
	 	KING
                PHARMACEUTICALS, INC.
	 
 	 
 	 
 
	 	By:  	/s/ Brian
                Markison
	 	
                
Brian
                Markison
	 	President
                and CEO


      

       

       

      



      
        
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      SCHEDULE
        3.1

       

      INITIAL
        PRODUCT COSTS

       

      Intal
        8.1 gm; 112 dose

      ***/unit
        for Intal CFC Inhaler Product 

      *
        Intal
        HFA Formulation Product will cost approximately *** more due to increased
        component costs for such Product’s metered dose inhalers (“MDIs”). 

       

      Intal
        14.2 gm; 200 dose

      ***/unit
        for Intal CFC Inhaler Product 

      *
        Intal
        HFA Formulation Product will cost approximately *** more due to increased
        component costs for such Product’s MDIs.

       

      Tilade
        16.2 gm; 104 dose

      ***/unit
        for Tilade CFC Inhaler Product 

      *
        Tilade
        HFA version will cost approximately *** more due to increased component costs
        for such product’s MDIs. 

       

      The
        costs
        indicated above do not include the costs associated with the Initial Bulk
        Form,
        for which, as provided in Section 2.10, Inyx will be solely
        responsible.

       

      
        
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