CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE ------------------------------------------------------------------------------ BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION"

 

                                                                 EXHIBIT 10.37.1

 

 

 "CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE

 ------------------------------------------------------------------------------

       BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION"

       -----------------------------------------------------------------

 

  DATE            18   MARCH   2005

 

PARTIES

 

(1)   INYX PHARMA LIMITED a company incorporated in England and Wales whose

      registered number is 4573515 and with registered office at 6 Seymour

      Court, Manor Park, Runcorn, Cheshire, WA7 1SY ("INYX"); and

 

(2)   GENERICS [UK] LIMITED a company incorporated in England and Wales whose

      registered number is 1558756 and with registered office at Station Close,

      Potters Bar, Hertfordshire, EN6 1TL ("GUK").

 

INTRODUCTION

 

(A)   GUK intends to obtain Registrations for the Product in the Territory to

      enable it to manufacture, package, market, distribute and sell the Product

      in the Territory. GUK wishes to appoint INYX as its non-exclusive

      manufacturer of the Product.

 

(B)   INYX is willing to assist GUK in obtaining Registrations and to

      manufacture for and exclusively supply GUK with the Product and GUK is

      willing to purchase the Product on the terms and subject to the conditions

      of this Agreement.

 

OPERATIVE PROVISIONS

 

1     Interpretation

 

1.1   In this Agreement (including the Introduction and the Schedules), the

      following words and expressions shall, unless the context otherwise

      requires, have the meanings set out opposite them below:

 

      Affiliate         in respect of INYX, shall mean any company which at the

                        relevant time is the ultimate holding company of that

                        party or a subsidiary (whether direct or indirect) of

                        that party's ultimate holding company; a company is a

                        "subsidiary" of another company, its "holding company",

                        if that other company (a) holds a majority of the voting

                        rights in it or (b) is a member of it and has the right

                        to appoint or remove a majority of its board of

                        directors, or (c) is a member of it and controls alone,

                        pursuant to an agreement with other shareholders or

                        members, a majority of the voting rights in it, or if it

                        is a subsidiary of a company which is itself a

                        subsidiary of that other company;

 

 

<PAGE>

 

                        in respect of GUK, shall mean the companies set out in

                        Schedule 1;

 

      Control           means the ability to direct the affairs of another

                        whether by the ownership of greater than fifty per cent

                        (50%) of the issued share capital of that other or by

                        the ability to appoint and maintain a majority of the

                        executive management board of that other or by contract

                        or otherwise;

 

      Delivery Address  GUK's premises at Unit 2 Summit Centre, Summit

                        Road, Cranborne Industrial Estate, Potters Bar, Herts

                        EN6 3QW and/or such other premises as GUK may direct;

 

      Device            the devices to be supplied by the Supplier, being (as

                        the case may be) a pressured metered dose inhaler and a

                        breath operated metered dose inhaler;

 

      Effective         the date of this Agreement first above written;

        Date

 

      Facility          INYX's facility at Astmoor Industrial Site, Runcorn or

                        such other facility approved by GUK and used in

                        connection with the manufacture of the Product;

 

      Intellectual      means any and all rights and interests, vested or

        Property        arising out of any patent (including any supplementary

        Rights          patent certificates), copyright, design rights (whether

                        registered or unregistered), trade mark (whether

                        registered or unregistered), trade secrets, industrial

                        property rights, rights in data, goodwill or

                        confidential information whether arising by common law

                        or by statute, any applications for the same, any

                        extensions or divisions of the same and/or the right to

                        apply for registration in respect of the same anywhere

                        in the world;

 

      MHRA              the Medicines and Healthcare Products Regulatory Agency

                        of the United Kingdom;

 

      Mutual            the European mutual recognition procedure in relation to

        Recognition     Registrations;

 

      Product           Salbutamol Hydrofluoroalkane (HFA) sold in standard

                        pressurised and/or breath operated metered dose

                        inhalation aerosols

 

                        And

 

                        containing those compounds listed in Schedule 2 in

                        finished pack form and any improvements thereto

                        [manufactured and / or sold under GUK's or its

                        Affiliates' Registration and such other products as the

                        parties may agree from time to time in writing];

 

 

                                       2

<PAGE>

 

      Quarter           any period of three months (or such shorter period as

                        may be applicable at the commencement or at end of the

                        Term) ending on the last day of March, June, September

                        or December (or, in the case of the last Quarter, ending

                        on the last day of the Term) as the case may be and

                        "Quarterly" shall be construed accordingly;

 

      Registration      the authorisation necessary to allow GUK (or its

                        Affiliates) to manufacture, package, market, distribute

                        and sell the Product in the Territory in accordance with

                        this Agreement;

 

      Specifications    the specifications for the formulation of the Product in

                        accordance with any Registrations and any other

                        specifications agreed by the parties in writing and

                        listed in Schedule 2;

 

      Technical         a technical agreement as required under EC law and cGMP

        Agreement       to be agreed between the parties as part of the

                        arrangement for ordering initial launch stocks of packed

                        Product (Schedule 5);

 

      Term              the term of this Agreement as set out in clause 10.1;

 

      Territory         all countries of the world;

 

      Year              each period of twelve months during the Term ending on

                        31 December provided that the first Year shall be the

                        period commencing on the Effective Date and ending on

                        the immediately subsequent 31 December and the last Year

                        shall be the period ending on the last day of the Term

                        and commencing on the immediately preceding I January.

 

1.2   In this Agreement:

 

      (a)   references to clauses, Schedules and the parties are to clauses of,

            and the Schedules and parties to, this Agreement;

 

      (b)   headings and captions are for ease of reference only and shall not

            affect the interpretation of this Agreement; and

 

      (c)   references to GUK's rights (including its right to acquire the

            Product) under this Agreement shall be construed to include its

            Affiliates; for the avoidance of doubt losses suffered by any

            Affiliates pursuant to breach by INYX shall be treated as losses

            suffered directly by GUK and recoverable accordingly.

 

 

                                       3

<PAGE>

 

2     Appointment

 

2.1   Subject to the remaining terms of this Agreement, GUK appoints INYX as its

      non-exclusive manufacturer of the Product in the Territory.

 

2.2   INYX agrees at all times to manufacture and supply Product (where Product

      is manufactured by INYX under GUK's Registrations) only for GUK

 

2.3   GUK shall be free to purchase Product from third parties (or manufacture

      such Product itself), provided that 52% of GUK's annual requirement for

      the Product is purchased from INyX.

 

3     Registration

 

3.1   GUK shall, at its cost, make applications for Registration in such

      countries within the Territory as it deems appropriate. It is acknowledged

      that GUK shall be entitled to take advantage of Mutual Recognition where

      appropriate.

 

3.2   To enable GUK to apply for Registrations as soon as possible after the

      Effective Date, INYX agrees to provide GUK in a timely manner, with all

      the assistance it reasonably requires from time to time to make the

      applications for Registrations and as GUK reasonably requires thereafter.

      In particular INYX shall, or shall procure that others, regularly monitor

      all supplies of Product (including Devices and components therefor and all

      ingredients (active and inactive) and compounds with which the Device is

      to be filled) and to ensure that these are supplied within Specifications

      set by GUK. INYX will operate only from manufacturing facilities approved

      (or to be approved prior to production) by an appropriate regulatory

      authority and by GUK.

 

3.3   All Registrations and Intellectual Property associated with registrations

      obtained by GUK shall remain the exclusive property of GUK. INYX shall

      have the right to use without limitations all improvements to the

      manufacturing process.

 

4     Manufacture and Supply

 

4.1   The Product shall be manufactured by INYX at the Facility.

 

4.2   The Product shall be manufactured by INYX in accordance with the

      Specifications and subject to current standards of good manufacturing

      practice as published from time to time by the relevant authorities in the

      Territory in relation to medicinal products.

 

4.3   GUK shall be entitled, at any time during the Term and without materially

      disrupting the business of INYX, to have access to the Facility during

      normal working hours and on reasonable prior written notice, in order to

      verify that INYX is adhering to its obligations under this Agreement. If

      GUK is not reasonably satisfied that INYX is complying with such

      obligations then (without prejudice to its other rights) it shall notify

      INYX in writing of any changes or modifications it reasonably requires

      which INYX shall implement as soon as practically possible.

 

4.4   The parties recognize that certain items of equipment (Schedule 4) used by

      INYX belong to GUK. GUK shall (where it elects to purchase Product from

      another, or manufacture or have manufactured, Product, and in any event,

      upon termination) be entitled to collect such equipment immediately and

      INYX shall co-operate fully with GUK in this regard. For so long as the

      equipment is used by INYX, INYX shall properly use and maintain the

      equipment, keep the equipment in good repair and condition and obtain

      insurance therefor (for the full replacement cost). All risk of loss or

      damage to the equipment shall be for INYX for so long as it is using the

      equipment.

 

 

                                       4

<PAGE>

 

5     Forecasts and Deliveries

 

5.1   INYX agrees to maintain levels of intermediate buffer stocks (filled,

      unlabelled cans) of the Product in such quantities as the parties may

      agree from time to time and INYX shall invoice GUK upon transfer to bulk

      stock at 70.0% of the price as agreed in terms of Clause 7.1 GUK shall

      provide INYX on a quarterly basis with non-binding Quarterly rolling

      forecasts of GUK's and its Affiliates (and third party distributors)

      likely requirements of Product for the subsequent 12 month period and to

      place firm orders for the Packed Product not less than two months before

      the desired delivery date.

 

5.2   Despatch shall be made by INYX such as to ensure that deliveries are made

      during GUK's normal business hours.

 

5.3   Risk in the Product shall pass to GUK on despatch to the Delivery Address

      and title shall pass on payment in full by GUK.

 

5.4   Each consignment of the Product ordered by GUK shall be delivered in full

      by the due date, subject to any changes agreed between the Parties in

      writing.

 

5.5   INYX will despatch the Product to GUK, ex-works Runcorn (as that term is

      defined Incoterms 1990 Edition), to the Delivery Address on or before the

      date stipulated in the relevant order.

 

5.6   Each delivery or consignment of the Product shall include a packing note

      quoting or attaching:

 

      (a)   the batch number and order number;

 

      (b)   product documentation should be defined!; and

 

      (c)   a certificate of analysis