Preview | OEM Agreement |

This OEM Agreement, (Agreement) is made and entered into as of September 22, 2004 (Effective Date), by and between Akorn-Strides, LLC, a Delaware limited liability company having a principal place of business at 2500 Millbrook Drive, Buffalo Grove, Illinois 60089-4694, United States of America (A-S), and Strides Arcolab Limited, a company organized under the laws of India having a principal place of business at Strides House, Bilekahalli, Bannerghatta Road, Bangalore 560 076, India (Strides), (each a Party and collectively the Parties).

A. A-S is a new entity formed by Strides and Akorn, Inc., a Louisiana corporation (Akorn), to engage in the development and marketing of generic drug products;

B. A-S desires to have Strides assist it in the preparation of ANDAs for the sale of certain Products by A-S and to manufacture such Products for sale to A-S exclusively in the Exclusive Market (as those terms are defined below), and Strides desires to assist A-S in the preparation of ANDAs for the sale of certain Products by A-S and to manufacture such Products for sale to A-S exclusively in the United States, pursuant to the terms and conditions of this Agreement.

NOW, THEREFORE, in consideration of the mutual promises, covenants and obligations contained herein, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

1.1 Act. The term Act means the United States Federal Food, Drug, and Cosmetic Act.

1.2 Affiliate. The term Affiliate means with respect to any Party, any party controlling, controlled by or under common control with any such Party. For purposes hereof, control and its derivatives means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a Party, whether through the ownership of voting securities or voting interests, by contract or otherwise.

1.4 ANDA. The term ANDA means an abbreviated new drug application filed with the FDA to provide for the review and ultimate approval of a generic drug product.

1.5 ANDA Materials. The term ANDA Materials means ANDAs prepared pursuant to ARTICLE 2 below, and all content thereof, and supporting documentation and official correspondence related thereto.

1.6 ANDA Product. The term ANDA Product means a generic drug active pharmaceutical ingredient in finished dosage form, (injectable, lyophilized, powder fill, soft gel capsule or tablet), approved by the FDA for sale in the United States pursuant to an ANDA, but excluding specifically Patent Challenging Products.

1.7 ANDA Schedule. The term ANDA Schedule has the meaning ascribed to it in Section 2.1, as may be amended by mutual agreement of the Parties from time to time.

1.8 Antidumping Laws. The term Antidumping Laws means the United States antidumping laws set forth in Title VII of the Tariff Act of 1930, as amended (19 U.S.C. 1673 et seq.).

1.9 Approved Facility. The term Approved Facility means the Strides facility that is approved in writing by A-S for the manufacturing of Products under this Agreement.

1.10 A-S Indemnitees. The term A-S Indemnitees has the meaning ascribed to it in Section 8.1.1.

1.11 A-S Materials. The term A-S Materials means any Property (i) owned or possessed by A-S as of the Effective Date; (ii) later made, acquired or developed by A-S during the term of this Agreement; or (iii) that are derived from materials provided by A-S to Strides, including, but not limited to, any of the above A-S Materials, A-S Confidential Information and any other materials provided to Strides in connection with this Agreement.

1.12 Certificate of Analysis. The term Certificate of Analysis means a certificate of analysis conforming in content and method with the requirements of the Act.

1.13 cGMP. The term cGMP means current Good Manufacturing Practices as established by the FDA as the same may be amended from time to time.

1.14 Components. The term Components means raw materials, such as media and columns, approved in advance by A-S for use in manufacturing of Products by Strides.

1.15 Confidential Information. The term Confidential Information means all confidential information of a Party relating to any designs, know-how, inventions, technical data, ideas, uses, processes, methods, formulae, research and development activities, work in process, or any scientific, engineering, manufacturing, marketing, business or financial information relating to the disclosing Party, its present or future products, sales, suppliers, customers, employees, investors or business, whether in oral, written, graphic or electronic form disclosed by the Parties prior to or during this Agreement (which is marked confidential or acknowledged as being confidential prior to disclosure). If the Confidential Information is disclosed orally or visually, it shall be identified as such at the time of disclosure and confirmed in writing by the disclosing party within thirty (30) days of disclosure. Confidential Information shall also include any other information in oral, written, graphic or electronic form which, given the circumstances surrounding such disclosure, would be considered confidential. This Agreement shall be deemed Confidential Information.

1.16 Cost of Production. The term Cost of Production means the cost of producing a Product, which is the sum of (i) material, fabrication, and other processing costs; (ii) selling, general, and administrative expenses; and (iii) the cost of containers and other packing expenses.

1.17 Derived. The term Derived or derived means obtained, developed, created, synthesized, designed, derived or resulting from, based upon or otherwise generated (whether directly or indirectly, or in whole or in part).

1.18 Epidemic Failure. The term Epidemic Failure means Product deficiencies resulting from defects in material, workmanship and/or manufacturing process that are in excess of one percent (1%) of the total number of Products shipped during any rolling six (6) month period.

1.19 Exclusive Market. The term Exclusive Market means the sale of Products to United States hospitals, medical clinics, physician groups and other wholesale drug markets in the United States.

1.20 FDA. The term FDA means the United States Food and Drug Administration.

1.21 Forecast. The term Forecast is defined in Section 4.2.1.

1.22 Grandfathered Product. The term Grandfathered Product refers to a generic drug active pharmaceutical ingredient in finished dosage form, (injectable, lyophilized, powder fill, soft gel capsule or tablet), (i) that has not had any changes in formulation, dosage form, potency, route of administration, indication or intended patient population since 1938 and that thereby does not qualify as a new drug under Section 321 of the Act; or (ii) that has not had any changes in formulation, dosage form, potency, route of administration, indication or intended patient population since 1962, and that, prior to 1962, was (X) used or sold commercially in the United States, (Y) not a new drug as defined by the Act at that time, and (Z) not covered by an effective application.

1.23 Insignia. The term Insignia means trademarks, trade names, logos, symbols, badges, labels, decorative designs, packaging designs or similar trade dress.

1.24 Intellectual Property Rights. The term Intellectual Property Rights means all United States and worldwide trademarks, service marks, trade dress, logos, copyrights, rights of authorship, inventions, patents, rights of inventorship, moral rights, rights of publicity and privacy, trade secrets, rights under unfair competition and unfair trade practices laws, and all other intellectual and industrial property rights related thereto.

1.25 Letter of Credit. The term Letter of Credit means an irrevocable letter of credit in the amount of One Million Two Hundred Fifty Thousand United States Dollars (US $1,250,000), issued by Strides Indian bank, acceptable to A-S acting reasonably, and confirmed by a United States Bank selected by A-S, as more fully set forth in Section 3.8.

1.26 Net Price. The term Net Price means the price for Products as calculated pursuant to Section 4.3.