Miscellany

Co-Promotion Agreement

This Co-Promotion Agreement is entered as of May 7, 1999 (the "Effective Date") by and between Abbott Laboratories Inc. ("Abbott"), an Illinois corporation, with a place of business at 100 Abbott Park Road, Abbott Park, Illinois 60064-6400, and SangStat Medical Corporation ("SangStat") a Delaware corporation, with a place of business at 1505 Adams Drive, Menlo Park, California 94025.

Whereas, Abbott and SangStat are each developing a generic capsule formulation of cyclosporine which capsule is intended to be AB-rated equivalent to Neoral (as defined below);

Whereas, SangStat is currently marketing an oral solution cyclosporine product known as SangCya (Cyclosporine Oral Solution, USP [Modified]) that is AB-rated equivalent to Neoral;

Whereas, by combining SangStat's strengths in the transplant market, its portfolio of transplant-related products already on the market, and its technology in the field of at-home testing devices with Abbott's strengths in managed care and its technology in the field of assay development; Abbott and SangStat will create a stronger competitor to Novartis (as defined below), the market leader, than would otherwise prevail in the absence of this Agreement thereby enhancing competition;

Whereas, Abbott wishes SangStat to co-promote and sell Abbott's generic capsule formulation of cyclosporine under the terms and conditions set forth herein; and

Whereas, SangStat wishes Abbott to co-promote SangStat's generic capsule formulation of cyclosporine, along with SangCya and CycloTech (as defined below), under the terms and conditions set forth herein.

Now, therefore, in consideration of the foregoing, of the mutual covenants and undertakings contained herein, and of other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties intending to be legally bound hereby agree as follows:

1. Definitions
   
   
   
   1. "Abbott Detailing Commitment" has the meaning set forth in Section 3.2.3.
      
   2. "Acquiror" has the meaning set forth in Section 14.4.
      
   3. "Adverse Ruling" has the meaning set forth in Section 14.2.2.
      
   4. "Affiliate" means an entity controlling, controlled by, or under common control with a party to this Agreement. For purposes of this definition, "control" or any correlative form thereof, means the ownership of more than fifty percent of the voting stock of such entity, or if such entity is not a corporation, the ability to control the day-to-day operations and business of such entity.
      
   5. "ANDA" means an Abbreviated New Drug Application as such is defined by the FDA.
      
   6. "Base Rate" has the meaning set forth in Section 6.4.
      
   7. "Capsule Product" means a Party's, or any of its Affiliate's, generic capsule or tablet dosage form for which such Party either intends to seek, is seeking or has received Regulatory Approval and is an AB-rated product equivalent to Neoral or Sandimmune. The current expected Capsule Products are more particularly described in Exhibit A hereto.
      
   8. "Commercially Reasonable Efforts" means, with respect to each Party, efforts which are consistent with those utilized by such Party for its own internally-developed or in-licensed pharmaceutical products of similar market potential, at a similar stage of its product life, taking into account the existence of other competitive products in the market place or under development, the proprietary position of the product, the profitability of the product and other relevant factors.
      
   9. "Commission" means any commission due Abbott on SangCya, Sang-2000 or CycloTech.
      
   10. "Co-Promotion Committee" has the meaning set forth in Section 5.1.2.
       
   11. "Co-Promotion Plan" means, for any period, a written plan developed by SangStat and Abbott for such period that has been approved by the Executive Steering Committee and that sets forth the key elements of the sales and marketing strategy for the Products, including, without limitation, plans for promotional materials, clinical trials and studies, trade show participation, and advertising, which may include the elements set forth on Exhibit B.
       
   12. "CycloStat System" means the combination of the Abbott TDx assay and SangStat's CycloStat device.
       
   13. "CycloTech" means the dispensing device used in conjunction with SangCya, and which received 510(k) approval from the FDA on August 18, 1998, and which is more particularly described in Exhibit A.
       
   14. "CycloTech Commission Rate" has the meaning set forth in Section 6.5.3.
       
   15. "DDMAC" means the FDA's Division of Drug Marketing, Advertising and Communications.
       
   16. "Detailing" means the act of promoting a Product in the Territory through Physician Details and Sales Calls.
       
   17. "Detail Year" means, with respect to the Products, the calendar year. The first Detail Year shall commence on the earlier of Abbott's Launch Date for SangCya or ninety (90) days after the Effective Date and end December 31, 1999.
       
   18. "Development Committee" has the meaning set forth in Section 5.2.
       
   19. "Development Costs" means, with respect to a Product, the costs and expenses incurred by a Party in connection with designing and conducting (including, but not limited to, data monitoring, data collection, data analysis, physicians' and center fees, investigator meetings, external consultants and clinical research organizations) Phase IV clinical trials for such Product which have been approved by the Executive Steering Committee. Development Costs shall include the cost of all Product used in such clinical trials (calculated as the Manufacturing Cost for such Product), and reasonable internal costs directly relating to designing or conducting such clinical trials. The initial budget for Development Costs is set forth in Section 7.2.4. Development Costs do not include any overhead or other costs unless they are attributable to designing or conducting such clinical trials.
       
       
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