-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, TFayroX+Wn+8VeMXGsFiz0dPDoBoKBoHvEP6hqkalw5xErwvgAeN40KuHubqxFaQ d5NrT9hRs/z1sEtTHqZ67w== 0000913610-00-000013.txt : 20000516 0000913610-00-000013.hdr.sgml : 20000516 ACCESSION NUMBER: 0000913610-00-000013 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20000331 FILED AS OF DATE: 20000515 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SANGSTAT MEDICAL CORP CENTRAL INDEX KEY: 0000913610 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 943076069 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: SEC FILE NUMBER: 000-22890 FILM NUMBER: 634065 BUSINESS ADDRESS: STREET 1: 1505 ADAMS DR CITY: MENLO PARK STATE: CA ZIP: 94025 BUSINESS PHONE: 6503280300 MAIL ADDRESS: STREET 1: 1505 ADAMS DR CITY: MENLO PARK STATE: CA ZIP: 94025 10-Q 1 FOR PERIOD ENDED MARCH 31, 2000 10Q doc


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549



FORM 10-Q



[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2000

OR

[  ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ________to _________

Commission file number 0-22890

SANGSTAT MEDICAL CORPORATION
(Exact name of Registrant as specified in its charter)

 
Delaware
94-3076-069
  (State or Other Jurisdiction of Incorporation or Organization) 
(IRS Employer Identification Number)

6300 Dumbarton Circle
Fremont, California   94555

(Address of principal executive offices)

510-789-4300
(Registrant's telephone number, including area code)



    Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file reports), and (2) has been subject to such filing requirements for the past 90 days. YES [X] NO [  ]

    The number of shares outstanding of the registrant's common stock, par value $.001 per share, as of March 31, 2000, was 17,907,372.



SANGSTAT MEDICAL CORPORATION
FORM 10-Q
For the Quarterly Period Ended March 31, 2000
Table of Contents

PART I. FINANCIAL INFORMATION

ITEM 1. Financial Statements
Page
     
           Condensed Consolidated Balance Sheets
           March 31, 2000 and December 31, 1999
**
     
           Condensed Consolidated Statements of Operations
           Three Months Ended March 31, 2000 and 1999
**
     
           Condensed Consolidated Statements of Cash Flows
           Three months ended March 31, 2000 and 1999
**
     
           Notes to Condensed Consolidated Financial Statements
**
     
ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
**
     
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
**
     

PART II. OTHER INFORMATION

ITEM 1. Legal Proceedings
**
     
ITEM 2. Changes in Securities and Use of Proceeds
**
     
ITEM 3. Defaults Upon Senior Securities
**
     
ITEM 4. Submission of Matters to a Vote of Security Holders
**
     
ITEM 5. Other Information
**
     
ITEM 6. Exhibits and Reports on Form 8-K
**
     
SIGNATURES
**







PART I -- FINANCIAL INFORMATION

Item 1. Financial Statements








SANGSTAT MEDICAL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)

                                                        March 31,   December 31,
                                                          2000         1999
                                                      ------------ ------------
                                                                        (1)
ASSETS

CURRENT ASSETS:
  Cash and cash equivalents.......................... $    26,054  $    16,862
  Short-term investments ............................       8,033        9,657
  Accounts receivable (net of allowance for doubtful
    accounts of $1,721 in 2000 and $1,469 in 1999)...      12,562       12,782
  Other receivables..................................       1,348        2,906
  Inventories........................................      45,751       46,270
  Prepaid expenses...................................       2,567        2,306
                                                      ------------ ------------
    Total current assets.............................      96,315       90,783

PROPERTY AND EQUIPMENT -- net........................       6,097        5,574

INTANGIBLE ASSETS (net of accumulated amortization
  of $2,097 in 2000 and $1,749 in 1999)..............      12,186       12,534
OTHER ASSETS.........................................       8,695        8,406
                                                      ------------ ------------
    TOTAL............................................ $   123,293  $   117,297
                                                      ============ ============

LIABILITIES AND STOCKHOLDERS' EQUITY

CURRENT LIABILITIES:
  Accounts payable................................... $    12,260  $    11,851
  Accrued liabilities................................       6,833        5,511
  Capital lease obligations -- current portion.......         645          700
  Deferred revenue -- current portion................       2,326        4,426
  Notes payable -- current portion...................       6,145        4,304
                                                      ------------ ------------
    Total current liabilities........................      28,209       26,792
                                                      ------------ ------------

CAPITAL LEASE OBLIGATIONS............................         659          125
DEFERRED REVENUE.....................................       8,722        9,304
NOTES PAYABLE........................................      36,850       40,067

STOCKHOLDERS' EQUITY:
  Preferred stock, $.001 par value 5,000 shares
    authorized; none outstanding.....................          --        --
  Common stock. $.001 par value, 25,000 shares
    authorized; outstanding: 2000 - 17,907
    shares; 1999 - 17,354 shares.....................     191,612      174,990
  Accumulated deficit................................    (141,066)    (133,277)
  Accumulated other comprehensive loss...............      (1,693)        (704)
                                                      ------------ ------------
    Total stockholders' equity.......................      48,853       41,009
                                                      ------------ ------------
    TOTAL............................................ $   123,293  $   117,297
                                                      ============ ============

(1) Derived from the Company's audited consolidated financial statements.

See Notes to Condensed Consolidated Financial Statements.






SANGSTAT MEDICAL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands)
(unaudited)


                                          Three Months Ended
                                               March 31,
                                       -----------------------
                                           2000        1999
                                       ----------- -----------
REVENUES:
  Net product sales................... $   15,358  $   10,103
  Revenue from collaborative
    agreements........................        582         425
                                       ----------- -----------
     Total revenues...................     15,940      10,528
                                       ----------- -----------

COSTS AND OPERATING EXPENSES:
  Cost of sales and manufacturing
    expenses..........................      7,857       5,841
  Research and development............      3,978       4,232
  Selling, general and administrative.     11,164       9,970
  Amortization of intangible assets...        348         357
                                       ----------- -----------
     Total costs and operating
       expenses.......................     23,347      20,400
                                       ----------- -----------
     Loss from operations.............     (7,407)     (9,872)

INTEREST INCOME (EXPENSE) - NET.......       (321)         23
                                       ----------- -----------
LOSS BEFORE INCOME TAXES..............     (7,728)     (9,849)
INCOME TAXES..........................        (61)        126
                                       ----------- -----------
NET LOSS.............................. $   (7,789) $   (9,723)
                                       =========== ===========
Net loss per share - basic and
  diluted (Note 2).................... $    (0.44) $    (0.60)
                                       =========== ===========
Shares used in per share
  computations........................     17,635      16,308
                                       =========== ===========

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME


                                          Three Months Ended
                                               March 31,
                                       -----------------------
                                           2000        1999
                                       ----------- -----------
Net loss.............................. $   (7,789) $   (9,723)
Unrealized gains and (losses) on
  marketable securities classified
  as available for sale...............       (642)       (773)
Foreign currency translation
  adjustments.........................       (347)       (988)
                                       ----------- -----------
   Total comprehensive loss........... $   (8,778) $  (11,484)
                                       =========== ===========

See Notes to Condensed Consolidated Financial Statements.





SANGSTAT MEDICAL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)






                                                         Three Months Ended
                                                              March 31,
                                                     -----------------------
                                                         2000        1999
                                                     ----------- -----------
CASH FLOWS FROM OPERATING ACTIVITIES:
  Net loss.......................................... $   (7,789) $   (9,723)
  Adjustments to reconcile net loss to net
    cash used in operating activities:
    Depreciation and amortization...................        895       1,297
    Non-cash interest expense.......................        398          --
    Stock compensation expense......................         --          28
    Deferred income taxes...........................         94          --
    Changes in assets and liabilities:
      Accounts receivable...........................        220         171
      Other receivables.............................      1,558       1,725
      Inventories...................................        519      (6,188)
      Prepaid expenses..............................       (261)       (424)
      Accounts payable..............................        409         346
      Accrued liabilities...........................      1,228      (1,087)
      Deferred revenue..............................     (2,682)         --
                                                     ----------- -----------
     Net cash used in operating activities..........     (5,411)    (13,855)
                                                     ----------- -----------
CASH FLOWS FROM INVESTING ACTIVITIES:
  Purchases of property and equipment...............       (437)         34
  Maturities of short-term investments..............      1,893       2,385
  Purchase of short-term investments................       (913)     (1,375)
  Other assets......................................       (289)      2,408
                                                     ----------- -----------
      Net cash provided by
         investing activities.......................        254       3,452
                                                     ----------- -----------
CASH FLOWS FROM FINANCING ACTIVITIES:
  Sale of common stock..............................     16,622       1,226
  Sale of convertible note payable..................         --       9,550
  Note payable borrowings...........................        177          --
  Note payable repayments...........................     (1,951)       (187)
  Repayment of capital lease obligations............       (152)        (93)
                                                     ----------- -----------
      Net cash provided by financing activities.....     14,696      10,496
                                                     ----------- -----------

EFFECT OF EXCHANGE RATE CHANGES ON CASH.............       (347)       (987)
                                                     ----------- -----------
NET INCREASE (DECREASE) IN CASH AND CASH
  EQUIVALENTS.......................................      9,192        (894)
CASH AND CASH EQUIVALENTS, Beginning of period......     16,862      16,286
                                                     ----------- -----------
CASH AND CASH EQUIVALENTS, End of period............ $   26,054  $   15,392
                                                     =========== ===========

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
  Cash paid during the period for interest,
     net of interest capitalized.................... $      305  $      103
                                                     =========== ===========
NONCASH INVESTING AND FINANCING ACTIVITIES:
  Property acquired under capital leases............ $      661  $       --
                                                     =========== ===========

  Unrealized loss on investments.................... $     (642) $     (773)
                                                     =========== ===========

See Notes to Condensed Consolidated Financial Statements.






SANGSTAT MEDICAL CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1. Basis of Presentation

The condensed consolidated financial statements include the accounts of SangStat Medical Corporation and its wholly owned subsidiaries. Intercompany accounts and transactions have been eliminated.

The condensed consolidated financial statements presented are unaudited and in the opinion of management reflect all adjustments (consisting only of normal recurring adjustments) which the Company considers necessary for a fair presentation of the financial condition and results of operations as of and for the interim periods presented. The results for interim periods are not necessarily indicative of the results to be expected for the full year. These condensed consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements and notes thereto included in the Company's 1999 Annual Report on Form 10-K.

2. Loss Per Share

Basic EPS is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted EPS reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted into common stock. Common share equivalents including stock options and convertible notes payable, aggregating 1,757,194 shares and 849,567 shares as of March 31, 2000 and 1999, respectively, have been excluded from diluted EPS as their effect would be antidilutive.

The following is a reconciliation of the numerators and denominators of the basic and diluted net loss per share computations (amounts in thousands, except per share figures):


                                                        Three Months Ended
                                                             March 31,
                                                     -----------------------
                                                         2000        1999
                                                     ----------- -----------
Net loss (numerator):
 Net loss - basic and diluted....................... $   (7,789) $   (9,723)
                                                     =========== ===========
Shares (denominator):
 Weighted average common shares outstanding - basic
  and diluted.......................................     17,635      16,308
                                                     =========== ===========
Net loss per share, basic and diluted............... $    (0.44) $    (0.60)
                                                     =========== ===========

 

3. Comprehensive Income (Loss)

The following are the components of accumulated other comprehensive loss (in thousands):


                                                      March 31,  December 31,
                                                         2000        1999
                                                     ----------- -----------
                                                         2000        1999
                                                     ----------- -----------
Unrealized gain (loss) on investments .............. $      (35) $      609
Accumulated translation adjustments ................     (1,658)     (1,313)
                                                     ----------- -----------
    Total........................................... $   (1,693) $     (704)
                                                     =========== ===========

 

4. Inventories

Inventories, valued at the lower of cost (first-in, first-out) or market consist of (in thousands):


                                                      March 31,  December 31,
                                                         2000        1999
                                                     ----------- -----------
                                                         2000        1999
                                                     ----------- -----------
Raw materials....................................... $   27,430  $   26,710
Work-in-progress....................................      8,942       9,498
Finished goods......................................      9,379      10,062
                                                     ----------- -----------
    Total........................................... $   45,751  $   46,270
                                                     =========== ===========

5. Notes Payable

Notes payable consist of (in thousands):


                                                      March 31,  December 31,
                                                         2000        1999
                                                     ----------- -----------
                                                         2000        1999
                                                     ----------- -----------
Note payable to Aventis............................. $   16,750  $   18,000
Discount on note payable to Aventis.................     (2,646)     (2,989)
Note payable to Abbott Laboratories.................     16,000      16,000
Convertible note....................................      9,713       9,609
Other debt..........................................      3,178       3,751
                                                     ----------- -----------
    Total...........................................     42,995      44,371
Less current portion................................     (6,145)     (4,304)
                                                     ----------- -----------
Long-term........................................... $   36,850  $   40,067
                                                     =========== ===========

 

6. Issuance of Common Stock

On February 15, 2000, the Company completed a private placement of 451,128 shares of common stock with an institutional investor. The stock was issued at $33.25, the closing price of the stock on February 14, 2000, for aggregate cash proceeds of $15,000,006.

 

7. Co-promotion, Distribution and Research Agreement

In May 1999, the Company and Abbott Laboratories ("Abbott") signed a multi-year co-promotion, distribution and research agreement for SangCya and cyclosporine capsules in the United States. The Company and Abbott will share marketing, promotional and development expenses as well as the profits from the co-promotion of these two products. The agreement ends December 31, 2004 unless both companies agree to extend it. Pursuant to this agreement, Abbott made an equity investment of $14 million during 1999 in exchange for approximately 894,000 shares of common stock, representing a premium to fair market value aggregating to $1.3 million. In addition, Abbott made a series of up-front and milestone payments totaling $15.8 million, including $1.9 million received in January 2000, and a long-term loan of $16 million to the Company received during 1999. Also, in January 2000, the Company made a milestone payment of $4.0 million to Abbott. All up-front and milestone payments received, net of milestone payments made, and the premium received on the sale of common stock to Abbott are recorded as deferred revenue and recognized ratably over the term of the agreement. Under the terms of the agreement, the Company may also receive an additional $5 million in milestone payments, contingent upon receiving regulatory approval for the cyclosporine capsule. In connection with the equity investment, Abbott and SangStat entered into a Right of First Refusal Agreement and a Registration Rights Agreement, and amended and restated their existing Supply Agreement.

 

8. Business Segment Data

The Company is organized and operates in two business segments: transplantation products and transplantation services. Transplantation products consist primarily of products for patient monitoring and therapeutic products for preventing and treating organ rejection. Transplantation services consist principally of mail order pharmaceutical and patient management services. The accounting policies of the segments are the same as those described in Note 1. The following information is presented in accordance with the requirements of SFAS No. 131, "Disclosures about Segments of an Enterprise and Related Information."

Business segment data consists of (in thousands):

 

                      Three
                     Months
                      ended    Transplantation   Transplantation
                    March 31,      Products          Services        Total
                    --------- ----------------- ----------------- ----------
Net revenues          2000    $         11,798  $          4,142  $  15,940
                      1999               7,475             3,053     10,528

Interest income       2000                (321)               --       (321)
  (expense) - net     1999                  23                --         23

Depreciation and      2000                 869                26        895
 amortization         1999               1,232                65      1,297

Income taxes          2000                 (61)               --        (61)
                      1999                 126                --        126

Segment loss          2000              (7,094)             (695)    (7,789)
                      1999              (9,211)             (512)    (9,723)

Segment assets        2000             118,283             5,010    123,293
                      1999             102,453             3,679    106,132

 

9. Recently Issued Accounting Standards

In June 1998, the Financial Accounting Standards Board issued SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities. This Statement requires companies to record derivatives on the balance sheet as assets or liabilities, measured at fair value. Gains or losses resulting from changes in the values of those derivatives would be accounted for depending on the use of the derivative and whether it qualifies for hedge accounting. SFAS 133 will be effective for the Company's fiscal year ending December 31, 2001. Management believes that this statement will not have a significant impact on the Company.

 

10. Litigation

Patent Litigation

US Patent Litigation

On February 11, 1999, Novartis Pharmaceuticals Corporation ("Novartis US") filed a lawsuit (case number 99-065) in Federal District Court for the District of Delaware against the Company alleging infringement of United States patent #5,389,382, a cyclosporine technology patented by Novartis A.G. (the "US Patent"). The Novartis A.G. patent does not cover Novartis' Neoral product but rather a separate delivery system not used in the Neoral formulation. Novartis US seeks the following relief: (i) a finding that SangStat willfully infringed the patent; (ii) to permanently enjoin SangStat from infringing the US Patent; (iii) treble damages; and (iv) reasonable attorneys' fees, costs and expenses.

On April 15, 1999, the Company filed its answer in this case and also filed a counterclaim against Novartis alleging that Novartis violated the anti-trust laws by engaging in a series of anti-competitive acts designed and intended to exclude the Company from the market. Novartis filed a motion to separate the anti-trust counterclaim and to stay discovery relating to that counterclaim. On March 30, 2000 the Court denied Novartis' motion, which means that both the patent and the anti-trust claims will be tried at the same time and the same jury will decide both claims. The trial date is October 23, 2000 and discovery is continuing.

UK Patent Litigation

On July 9, 1999, Novartis AG and Novartis Pharmaceuticals UK Limited ("Novartis UK") filed an action against IMTIX- SangStat (UK) Limited; SangStat UK, Limited, and SangStat Medical Corporation (collectively, the "UK Defendants") in the High Court of Justice, Chancery Division, Patents Court, London (HC-1999-02988) alleging infringement of United Kingdom Patent No 2 200 048 (the "UK Patent"), the counterpart to the US Patent. The lawsuit mirrors the US patent infringement lawsuit. Novartis AG and Novartis UK seek the following relief: (i) an injunction to restrain the UK Defendants from infringing the UK Patent; (ii) the delivery up or destruction of all material that would infringe such injunction; (iii) damages; (iv) a declaration that the UK Patent is valid, and has been infringed by the UK Defendants; and (v) costs. No trial date has been set at this time though the parties have agreed that the trial will not be scheduled before March 31, 2001.

Germany Patent Litigation

In January 2000, SangStat filed a Nullity Action in the German Federal Patents Court in Munich Germany seeking to invalidate German Patent 37 42 473, which is the German counter-part to the patent that Novartis is suing the Company on in the United States and the United Kingdom. If SangStat prevails in this nullity action, the patent would be invalidated, which would render any infringement action that Novartis might bring in Germany moot.

Regulatory Litigation

US Regulatory Litigation

Novartis US also sued the FDA on February 11, 1999 in the United States District Court for the District of Columbia (case number 1: 99CV-00323) alleging that the FDA did not follow its own regulations in approving SangCya Oral Solution in October 1998. The lawsuit alleges that because Neoral oral solution and SangCya Oral Solution are based on different formulation technologies, they should be classified as different dosage forms. Novartis asks that the court (i) allow Novartis to keep its microemulsion labeling; (ii) declare microemulsion to be a separate dosage form; and (iii) rescind the AB rating that was given to SangCya Oral Solution. Loss of the AB rating would prevent SangCya Oral Solution from being automatically substitutable for Neoral oral solution, which would impede the marketing of SangCya Oral Solution. SangStat does not believe that this lawsuit will impact the regulatory approval of Sang-2000 in the US.

In November 1999, Novartis filed a motion with the court requesting a preliminary injunction to block the FDA from enforcing its order requiring Novartis to change the labeling of its Neoral product line to make it consistent with the established name and descriptor for the product class: Cyclosporine Oral Solution, USP [MODIFIED]). At a hearing on December 7, 1999, the court rejected Novartis' motion for a preliminary injunction and ordered that the FDA may proceed to require Novartis to change its labeling. SangStat does not know if and when the FDA will require Novartis to change the Neoral labeling on the products, but recent advertising for Neoral has used the new labeling. FDA and SangStat have filed a motion for summary judgment but the court has not yet ruled on the motion.

UK Regulatory Litigation - SangCya Oral Solution

On October 18, 1999, Novartis UK was granted leave to seek judicial review of the decision by the Medicines Control Agency (the "MCA") to approve SangCya Oral Solution (Case No. HC-1969/99). On March 30, 2000, the High Court in London dismissed Novartis' application for judicial review, ruled that the MCA acted properly in granting the SangCya Oral Solution marketing authorization, ordered Novartis to pay MCA's costs incurred in defending the action, and refused Novartis' request to appeal the decision. The High Court ordered that Novartis did not have to pay SangStat its costs. Novartis has requested permission from the Court of Appeals to appeal the High Court's decision. If such request is granted, then a hearing will take place before the Court of Appeals in late 2000 or early 2001. The Court of Appeals could uphold the High Court's ruling, reverse the High Court's ruling, or refer the case to the European Court of Justice.

UK Regulatory Litigation - Sang-2000 (SangCya Capsules)

In November 1999, Novartis filed a request for judicial review of the refusal by MCA to state that it would not reference Neoral data in approving any cyclosporine capsule application. An agreement was reached between the parties in which Novartis agreed to stay the judicial review until the earlier of (i) the decision on the judicial review of SangCya Oral Solution or (ii) MCA's approval of a marketing authorization for Sang-2000, and in return, SangStat agreed that SangStat would not launch or commence mutual recognition procedures in relation to the Sang-2000 marketing authorization (including a request to MCA to prepare an assessment report) for a period of 28 days commencing on the day on which SangStat notifies Novartis' solicitors of capsule approval. The parties have agreed to continue the stay until the appeal of the High Court decision with respect to the judicial review of SangCya Oral Solution.

SangStat assumes that Novartis will seek a judicial review hearing with respect to our Sang-2000 marketing authorization within this 28-day period to rescind it or to obtain a preliminary injunction to prevent sale of Sang-2000 until final resolution of the matter. SangStat believes that if Novartis seeks a judicial review, it will be stayed until final resolution of the judicial review of the SangCya Oral Solution marketing authorization. If Novartis does not seek permission to appeal the High Court's decision on SangCya Oral Solution or if Novartis seeks such permission and it is not granted, then there has been a final resolution of the judicial review of the SangCya Oral Solution marketing authorization. In such event, the judicial review with respect to the granting of the Sang-2000 marketing authorization will progress.

Novartis has also indicated that it will seek an injunction to prevent Sang-2000 from being sold in the United Kingdom until final resolution of the judicial review relating to Sang-2000. Because the High Court ruled in favor of the MCA with respect to the SangCya Oral Solution marketing authorization, the Company believes that it is unlikely that a court would grant Novartis a preliminary injunction with respect to the Sang-2000 marketing authorization because Novartis would not, based on the facts known to date, be able to demonstrate a substantial likelihood of success on the merits of its claim. If the Court of Appeals agrees to hear Novartis' appeal and subsequently rules in Novartis' favor, Novartis may be more likely to obtain an injunction with respect to Sang-2000.

Italian Litigation

On May 5, 2000, Novartis Farma S.p.A. ("Novartis Italy") served IMTIX SangStat s.r.l., our Italian subsidiary, and IMTIX SangStat Ltd. with a summons to the Milan Tribunal. Novartis Italy alleges that by requesting mutual recognition from the Italian Health Authorities of the SangCya Oral Solution dossier approved by the MCA, SangStat implicitly requested that the Italian Health Authorities review the Neoral dossier. Novartis alleges that this request is an act of unfair competition in that (i) the Neoral data has ten year exclusivity and (ii) the data is secret and by requesting the MRP, SangStat is responsible for the Health Authorities act of unfair competition following use of the Neoral dossier in reviewing the SangCya dossier. The summons acknowledges that the UK High Court did not invalidate the SangCya marketing authorization. It does not acknowledge that the High Court indicated that the MCA could review the Neoral data. SangStat does not know whether or not Novartis Italy has also filed suit against the Italian Health Authorities. Novartis Italy has requested that the initial appearance of the parties before the Milan Tribunal occur November 20, 2000. SangStat does not have marketing approval for SangCya Oral Solution in Italy. Novartis Italy is seeking damages and an injunction to prevent the sale by SangStat of SangCya Oral Solution, or any other product for which SangStat may obtain approval based upon a reference to the Neoral dossier.

SangStat believes that these lawsuits are without merit and that SangStat will prevail in these matters. Although SangStat is optimistic that these disputes will ultimately be resolved favorably to SangStat, the course of litigation is inherently uncertain and there can be no assurance of a favorable outcome. Novartis' requested relief, if granted, could have a significant negative economic impact on SangStat. As a result of the Novartis patent suits and the UK judicial review, SangStat could be enjoined from selling SangCya Oral Solution for a significant period of time or ultimately be prevented from selling SangCya Oral Solution in the United States, the United Kingdom or any country in which SangStat attempts to launch SangCya Oral Solution. Should this happen, SangStat does not believe that it would be able to obtain a license from Novartis on acceptable terms for either jurisdiction because SangStat believes cyclosporine is an important product for Novartis and that Novartis would not want to diminish its profits from this product by licensing it to SangStat on acceptable terms. Failure to obtain any such required license could prevent SangStat from selling SangCya Oral Solution entirely in the United States, the United Kingdom, or any country in which SangStat attempts to launch SangCya Oral Solution, which would harm SangStat's future revenues. With respect to the FDA lawsuit, SangStat would retain its approval but lose its AB rating. If SangCya Oral Solution was no longer AB-rated to Neoral, pharmacists could not automatically substitute SangCya Oral Solution for Neoral and this would harm revenues. The litigation, whether or not resolved favorably to the Company, is likely to be expensive, lengthy and time consuming, will divert management's attention and could have a material adverse effect on the Company's business, financial condition, cash flows and results of operations.

 

11. Subsequent Event

On April 21, 2000 the Company signed an agreement with FINOVA Capital Corporation to provide a line of credit of up to $30 million. The agreement lasts for three years and may be renewed annually thereafter if both parties agree. The line of credit consists of two elements: a $15 million line of credit bearing interest at the prime rate and secured by a matching compensating cash balance, and a $15 million line of credit bearing interest at the prime rate plus 1.5% and based on eligible domestic accounts receivable and inventory, as defined in the agreement. Under the terms of the agreement, the Company is required to maintain a loan balance of at least $5 million. As security for the line of credit, the Company has granted Finova a first priority security interest in certain of its tangible and intangible assets and has pledged the stock of its two French subsidiaries, Imtix- SangStat SAS and SangStat Atlantique SA. In addition, the Company is required to meet certain financial covenants.

 

ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

This Management's Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with our Condensed Consolidated Financial Statements and Notes thereto included elsewhere in this Quarterly Report on Form 10-Q, as well as the Management's Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the fiscal year ended December 31, 1999. Except for the historical information contained herein, the discussion in this Quarterly Report on Form 10-Q contains certain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. The cautionary statements made in this Quarterly Report on Form 10-Q should be read as being applicable to all related forward-looking statements wherever they appear in this Quarterly Report on Form 10-Q. Our actual results could differ materially from those discussed here. Factors that could cause or contribute to such differences include those discussed in "Risk Factors," as well as those discussed elsewhere herein. In particular, we have included forward-looking statements regarding the following: (i) our strategy; (ii) the anticipated timing of our regulatory filings; (iii) other product development efforts that we intend to undertake; (iv) the growth of our product sales and markets; (v) the results of our litigation with Novartis; (vi) our future revenue and expenses, including our expectations regarding liquidity; and (vii) changes in our internal systems.

Results of Operations - Three Months Ended March 31, 2000 and 1999

SangStat, The Transplant Company®, is a global bio-pharmaceutical company applying a disease management approach to improving the outcome of organ, bone marrow, and stem cell transplantation. Since 1988, we have built a family of products and services to address the pre-transplant, acute care and chronic phases of transplant in the worldwide market. Our business is currently organized into two segments: Transplantation Products and Transplantation Services. The Transplantation Products segment consists of six marketed products, two principal product candidates and additional product candidates in various stages of research and development. We plan to capitalize on our products and product pipeline by developing relationships with key providers and managed care organizations to better integrate the management of transplant recipients' care to improve the outcomes and lower the costs of transplants. The Transplantation Services segment consists of the Transplant Pharmacy®, which provides mail order distribution of drugs and transplant patient management services, and TransplantRx.com™, the first online pharmacy dedicated to organ transplantation. During the first quarter of fiscal 2000, we continued to market and sell our two lead products, prepared for the launch of a cyclosporine capsule product, conducted clinical studies on these and other products and continued the development of The Transplant Pharmacy.

Total revenues. Total revenues consist of net sales of transplantation products and transplantation services. Total revenues were $15,940,000 for the three months ended March 31, 2000, an increase of $5,412,000 or 51% over total revenues of $10,528,000 for the three months ended March 31, 1999.

Net sales of transplantation products for the three months ended March 31, 2000 were $11,798,000, an increase of $4,323,000 or 58% over net sales of $7,475,000 for the three months ended March 31, 1999. The increase was due primarily to increased sales of Thymoglobulin and SangCya in the United States. Sales of transplantation products in Europe for the quarter ended March 31, 2000 were slightly lower than sales for the quarter ended March 31, 1999. Although sales measured in local currencies increased compared to the prior year quarter, the increase was more than offset by the effect of the fall in the value of European currencies versus the US dollar during the past year.

Net sales of transplantation services for the three months ended March 31, 2000 were $4,142,000, an increase of $1,089,000 or 36% over sales of $3,053,000 for the three months ended March 31, 1999. The increase in net sales was due primarily to an increase in the number of patients serviced by The Transplant Pharmacy. Net sales for all periods consisted entirely of drug sales to transplant patients.

Cost of sales and manufacturing. Total cost of sales and manufacturing expenses consist of cost of sales and manufacturing expenses of transplantation products and transplantation services. Total cost of sales were $7,857,000 for the three months ended March 31, 2000, an increase of $2,016,000 or 35% over total cost of sales of $5,841,000 for the three months ended March 31, 1999.

Cost of sales and manufacturing expenses for transplantation products were $4,288,000 for the three months ended March 31, 2000, an increase of $1,086,000 or 34% over cost of sales and manufacturing expenses of $3,202,000 for the three months ended March 31, 1999. The increase was primarily due to the increase in sales of transplantation products, especially Thymoglobulin.

Cost of sales for transplantation services for the three months ended March 31, 2000 were $3,569,000, an increase of $930,000 or 35% over cost of sales of $2,639,000 for the three months ended March 31, 1999. The increase in cost of sales was due primarily to the increase in sales of The Transplant Pharmacy. Cost of sales for all periods consisted entirely of the cost of drugs purchased from wholesalers and sold to transplant patients.

Research and development. Research and development expenses were $3,978,000 for the three months ended March 31, 2000, a decrease of $254,000 or 6% over research and development expenses of $4,232,000 for the three months ended March 31, 1999. Although spending declined slightly from the prior year quarter as clinical trials on SangCya and Thymoglobulin were completed, we started several new development programs, including pursuing label expansion of Thymoglobulin and pre-clinical work on RDP58, a product in development that inhibits synthesis of TNF-alpha.

Selling, general and administrative. Selling, general and administrative expenses for the three months ended March 31, 2000 were $11,164,000, an increase of $1,194,000 or 12% over selling, general and administrative expenses of $9,970,000 for the three months ended March 31, 1999. The increase in expenses is due primarily to higher legal expenses associated with the Novartis lawsuit. These expenses are expected to continue throughout fiscal 2000.

Interest income (expense) - net. Interest income (expense) - net for the three months ended March 31, 2000 was an expense of $321,000, net of interest capitalized of $50,000, compared to income of $23,000 for the three months ended March 31, 1999. The increase in expense in the first quarter of 2000 reflected additional interest on the notes payable to Aventis and Abbott Laboratories, and the convertible debt issued in March 1999.

Income taxes. For the three months ended March 31, 2000, we recorded a provision of $61,000 for European income taxes based upon taxable income of our European affiliates in the first quarter of 2000. For the three months ended March 31, 1999, we recorded a tax benefit of $126,000 based on losses of our European affiliates for the first quarter of fiscal 1999.

Net loss. Net loss consists of net loss of transplantation products and transplantation services. Net loss was $7,789,000 for the three months ended March 31, 2000, a decrease of $1,934,000 or 20% compared to net loss of $9,723,000 for the three months ended March 31, 1999.

Net loss for transplantation products for the three months ended March 31, 2000 was $7,094,000, a decrease of $2,117,000 or 23% compared to the net loss of $9,211,000 for the three months ended March 31, 1999. The decrease in net loss was due primarily to the increase in sales net of related cost of sales, partially offset by increases in selling, general and administrative expenses.

Net loss for transplantation services for the three months ended March 31, 2000 was $695,000, an increase of $183,000 or 36% compared to the net loss of $512,000 for the three months ended March 31, 1999. The increase in net loss was due primarily to an increase in selling, general and administrative expenses, partially offset by the increase in sales net of related cost of sales of The Transplant Pharmacy.

Liquidity and Capital Resources

During the first three months of 2000 and 1999, the net cash used in operating activities was approximately $5,411,000 and $13,855,000, respectively. The decrease in net cash used in operating activities in the first three months of fiscal 2000 was due substantially to more stable inventory levels and an increase in accrued liabilities, partially offset by net milestone payments to Abbott under the cyclosporine co-promotion agreement. As of March 31, 2000, the Company had cash, cash equivalents and short-term investments of $34,087,000 and total assets of $123,293,000.

Net cash provided by investing activities for the three months ended March 31, 2000 was $254,000 as compared to $3,452,000 for the comparable quarter in 1999. The amount in 2000 is primarily the result of the maturity of short-term investments, partially offset by purchases of property and equipment and other assets. In 1999, cash was provided by maturing short-term investments and a reduction in other assets.

Net cash provided by financing activities for the three months ended March 31, 2000 was $14,696,000 as compared to net cash provided of $10,496,000 for the same period in 1999. In February 2000, the Company completed a private placement of 451,128 shares of common stock with an institutional investor. The stock was issued at $33.25, the closing price of the stock on February 14, 2000, for aggregate proceeds of $15,000,006. The Company intends to use the proceeds to fund future working capital requirements. In March 1999, net cash provided by financing activities came primarily from the issuance of a $10 million convertible note due March 30, 2004.

In May 1999, the Company and Abbott Laboratories ("Abbott") signed a multi-year co-promotion, distribution and research agreement for SangCya and cyclosporine capsules in the United States. The Company and Abbott will share marketing, promotional and development expenses as well as the profits from the co-promotion of these two products. The agreement ends December 31, 2004 unless both companies agree to extend it. Pursuant to this agreement, Abbott made an equity investment of $14 million during 1999 in exchange for approximately 894,000 shares of common stock, representing a premium to fair market value aggregating to $1.3 million. In addition, Abbott made a series of up-front and milestone payments totaling $15.8 million, including $1.9 million received in January 2000, and a long-term loan of $16 million to the Company received during 1999. Also, in January 2000, the Company made a milestone payment of $4.0 million to Abbott. All up-front and milestone payments received, net of milestone payments made, and the premium received on the sale of common stock to Abbott are recorded as deferred revenue and recognized ratably over the term of the agreement. Under the terms of the agreement, the Company may also receive an additional $5 million in milestone payments, contingent upon receiving regulatory approval for the cyclosporine capsule. In connection with the equity investment, Abbott and SangStat entered into a Right of First Refusal Agreement and a Registration Rights Agreement, and amended and restated their existing Supply Agreement.

In April 2000, the Company signed an agreement with FINOVA Capital Corporation to provide a line of credit of up to $30 million. The agreement is for three years and may be renewed annually thereafter if both parties agree. The line of credit consists of two elements: a $15 million line of credit bearing interest at the prime rate and secured by a matching compensating cash balance, and a $15 million line of credit bearing interest at the prime rate plus 1.5% and based on eligible domestic accounts receivable and inventory. As additional security for the line of credit, the Company has granted FINOVA a first priority security interest in certain of its tangible and intangible assets and has pledged the stock of its two French subsidiaries, Imtix-SangStat SAS and SangStat Atlantique SA.

In the opinion of management, the Company has sufficient funds to continue operations for at least the next twelve months.

Euro-Currency

The Single European Currency (Euro) was introduced on January 1, 1999 with complete transition to this new currency required by January 2002. The Company is currently assessing the issues raised by the introduction of the Euro. The Company has made and expects to continue to make changes to its internal systems in preparation for the transition to the Euro. The Company further expects that use of the Euro may affect the Company's foreign exchange activities and may result in increased fluctuations in foreign currency results. Any delays in the Company's ability to be Euro-compliant could have an adverse impact on the Company's results of operations or financial position.

 

Risk Factors

We have a history of operating losses and our future profitability is uncertain. We were incorporated in 1988 and have experienced significant operating losses since that date. As of March 31, 2000, our accumulated deficit was $141,066,000. Our operating expenses have increased from approximately $31.0 million to $60.9 million to $89.9 million over the three year period ended December 31, 1999 and were 23.3 million for the three months ended March 31, 2000. Total revenues increased from approximately $4.5 million to $19.7 million to $58.2 million over the three year period ended December 31, 1999 and were $15.9 million for the three months ended March 31, 2000. Losses from operations increased from approximately $26.5 million to $41.3 million and decreased to $31.7 million over the three year period ended December 31, 1999. Losses from operations for the three months ended March 31, 2000 were $7.4 million. We cannot guarantee that we will ever achieve significant revenues from product sales or that we will achieve profitable operations. To date, our product revenues have been primarily derived from sales of Thymoglobulin, Lymphoglobuline, and SangCya Oral Solution.

We may elect to raise additional funds within the next 12 months. Within the next twelve months, we may elect to raise additional funds through financings and collaborative research and development arrangements with corporate partners. We may not be able to raise funds on favorable terms, if at all, and our discussions with potential collaborative partners may not result in any agreements. If adequate funds are not available, we may be required to delay, scale back or eliminate one or more of our development programs or obtain funds through arrangements with collaborative partners or others that may require us to relinquish rights to certain technologies, product candidates or products that we would not otherwise relinquish. To raise funds, we may also be required to sell shares of our common stock, which may be at prices below the price at which you may have purchased shares. Such sales would also constitute a dilution of your percent ownership of SangStat.

Our future growth depends on sales of key products. We expect to derive most of our future revenues from sales of the cyclosporine capsule, Thymoglobulin and SangCya Oral Solution. We have limited experience selling our products. Our sales of SangCya Oral Solution and Thymoglobulin began in 1998 and 1999, respectively. We have not yet begun selling our cyclosporine capsules. We will be marketing cyclosporine capsules in the United States under a co-promotion agreement with Abbott Laboratories. We cannot guarantee that Abbott will effectively perform under the agreement, and their failure to do so may delay regulatory approval and product launch. We also will not be the first generic cyclosporine capsule approved; Eon's generic cyclosporine capsule was approved in February 2000, but to the best of our knowledge, Eon has not yet launched its product.

Any factor adversely affecting the regulatory approval or sale of these key products, individually or collectively, would harm our business and results of operations. Sales of these key products could be adversely affected by the following:

    • competitive changes
    • regulatory matters
    • manufacturing or supply interruptions
    • number of contracts with managed care providers and group purchasing organization
    • factors affecting production
    • marketing or pricing actions
    • changes in the prescribing practices of transplant physicians
    • reimbursement practices of third party payers
    • product liability claims.

In particular, with respect to SangCya Oral Solution and cyclosporine capsules, sales may be affected by the following:

    • perceptions of both patients and physicians regarding use of a generic version of a critical, life-saving therapeutic
    • the availability and acceptance of the CycloTech device to be used in connection with SangCya Oral Solution
    • other generic competitors such as Eon
    • intense competitive pressure from Novartis as well as the Novartis litigation.

Failure of sales to meet forecasts may also cause excessive inventory build- up, which, if not sold prior to lot expiration, may be required to be taken as a charge against earnings.

Our litigation with Novartis may be resolved adversely and will be a drain on time and resources. We are involved in significant litigation with Novartis regarding our SangCya Oral Solution. See "Part II, Item 1 - Legal Proceedings." The course of litigation is inherently uncertain and we may not achieve a favorable outcome. As a result of the Novartis suits, we could be enjoined from selling SangCya Oral Solution for a significant period of time or ultimately be prevented from selling SangCya Oral Solution in the United States, the United Kingdom or any country in which we attempt to launch SangCya Oral Solution. Should this happen, we do not believe we would be able to obtain a license from Novartis on acceptable terms in any country because we believe cyclosporine is an important product for Novartis and that Novartis would not want to diminish its profits from this product by licensing it to us on acceptable terms. Failure to obtain any such required license could prevent us from selling SangCya Oral Solution entirely in the United States, the United Kingdom, or any country in which we attempt to launch SangCya Oral Solution, which would harm our future revenues. The litigation, whether or not resolved favorably to us, is likely to be expensive, lengthy and time consuming, and divert management's attention.

A slower product launch has created excess perishable inventories. Due to the inherent uncertainty of the timing of the SangCya Oral Solution approval and the concern over having insufficient inventory for the launch of SangCya Oral Solution, we manufactured large quantities of SangCya Oral Solution well in advance of the approval date. In the third and fourth quarters of 1999, we have written off $1.9 million. While demand for SangCya Oral Solution is growing, we may not sell this entire inventory prior to lot expiration. In addition, we also have significant amounts of bulk cyclosporine active ingredient, which we are not using for manufacturing finished product in the amount anticipated. We could write off portions of both our finished product and bulk active ingredient inventory in the future, which could significantly reduce the gross margin reported for that future period.

If we do not develop and market new products, our business will be harmed. To achieve profitable operations, we must successfully develop, obtain regulatory approval for, manufacture, introduce and market products and product candidates. We cannot guarantee that we will successfully do this. Our product candidates will require extensive development and testing, as well as regulatory approval prior to commercialization. Cost overruns could occur due to the following:

    • unanticipated regulatory delays or demands
    • unexpected adverse side effects
    • insufficient therapeutic efficacy.

These events would prevent or substantially slow down the development effort and ultimately would harm our business. Furthermore, there can be no assurance that any product candidate under development will be safe, effective or capable of being manufactured in commercial quantities at an economical cost, or that any product will not infringe the proprietary rights of others or will achieve market acceptance.

We may not be able to manufacture or obtain sufficient quantities of SangCya, Sang- 2000, or Thymoglobulin. We have contracted for commercial scale production of cyclosporine bulk material, the active ingredient of cyclosporine, for SangCya Oral Solution and Sang-2000, from Gensia Sicor and Abbott Laboratories. Gensia is a qualified supplier of cyclosporine bulk material in the SangCya Oral Solution and Sang-2000 regulatory applications. We have applied to qualify Abbott as an alternative cyclosporine raw material supplier, but this supplemental application has not yet been approved outside of the US. We have also contracted with Lilly for the manufacture of SangCya Oral Solution and Sang-2000. We cannot control these suppliers, and they may fail to timely deliver adequate supplies of a sufficiently high quality product, and any such failure may delay product launch, impair our ability to deliver our products on a timely basis, or otherwise impair our competitive position, which would harm our business and results of operations.

Thymoglobulin is also difficult to manufacture and there can be no assurance that we will be able to manufacture commercial quantities at an economical cost. We acquired the IMTIX division of Aventis in 1998, including certain manufacturing capabilities with respect to Thymoglobulin. From time to time prior to the acquisition, certain batches of Thymoglobulin did not meet manufacturing specifications, resulting in a shortage of Thymoglobulin for commercial sale. Since the acquisition, all batches of Thymoglobulin have met manufacturing specifications; however even after the acquisition, we still rely on Aventis for certain important manufacturing services, including quality assurance, quality control, and lyophilization. We cannot guarantee that Aventis will continue to effectively and continuously provide us these critical manufacturing services. We cannot guarantee we will not experience manufacturing difficulties with respect to Thymoglobulin in the future which may impair our ability to deliver products on a timely basis, or otherwise impair our competitive position, which would harm our business.

We rely on third parties for manufacturing. We generally rely on third parties to manufacture compounds (other than Thymoglobulin and Lymphoglobuline) and devices for commercial sales and clinical trials. We cannot guarantee manufacturers will meet FDA standards governing GMP or other regulatory guidelines, that any Biologics License Applications, or BLA, required for manufacturing will be filed, reviewed and approved, or that any third-party manufacturer will pass a pre-approval inspection. We cannot guarantee we will be able to enter into additional commercial scale manufacturing contracts or that any other third-party arrangements can be established on a timely or commercially reasonable basis, or at all. We will depend on all such third parties to perform their obligations effectively and on a timely basis. We cannot guarantee that such parties will perform, and any failures by third parties may delay clinical development or submission of products for regulatory approval, or otherwise impair our competitive position, which could harm our business. In addition, the manufacturing of drug candidates involves a number of technical steps and requires meeting stringent quality control specifications imposed by regulatory authorities and by us. Additionally, such products can only be manufactured in facilities approved by the applicable regulatory authorities. Because of these and other factors, we may not be able to replace our manufacturing capacity quickly or efficiently in the event that our manufacturers are unable to manufacture their products at one or more of their facilities. For certain of our potential products, we will need to develop our production technologies further for use on a larger scale in order to conduct human clinical trials and produce such products for commercial scale at an acceptable cost.

Failure of the market to adopt our products will harm our business. Whether or not our products receive regulatory approvals, the market may not accept our products. We cannot guarantee patients, physicians, pharmacists, or third-party payers will accept our products. Accordingly, we cannot guarantee our products and product candidates will obtain significant market share. Factors that may affect the willingness of patients, physicians, pharmacists and third-party payers to convert to SangStat products, if approved, include price, perception of bioequivalence, perceived clinical benefits and risks, ease of use, other product features and brand loyalty. In addition, other factors may limit the market acceptance of products we develop, including the timing of regulatory approval and market entry relative to competitive products, the availability of alternative therapies, the price of our products relative to alternative therapies, the availability of third-party reimbursement and the extent of our or third party distributor's or agents' marketing efforts. In particular, with respect to SangCya Oral Solution and cyclosporine capsules we cannot guarantee we will be successful in taking significant market share away from Novartis, even if product approval is granted.

Fluctuations in quarterly and annual operating results may adversely affect our stock price. Our quarterly and annual operating results may fluctuate due to a variety of factors. We therefore believe that quarter-to-quarter comparisons of our operating results may not be a good indication of our future performance, and you should not rely on them to predict our future performance or the future performance of our stock. Our operating losses have been substantial each year since inception. We also expect losses to continue in the near future as a result of a number of factors, including:

    • the uncertainty in the timing and the amount of revenue we earn upon product sales
    • our achievement of research and development milestones
    • our funding obligations under collaborative research agreements
    • expenses we incur for product development, clinical trials and marketing and sales activities.

Our operating results may also fluctuate significantly as a result of other factors, including:

    • the introduction of new products by our competition
    • regulatory actions
    • market acceptance of our products
    • adoption of new technologies
    • manufacturing capabilities
    • cost of litigation
    • third-party reimbursement policies.

Fluctuations in our operating results have affected our stock price in the past and are likely to continue to do so in the future. In particular, the realization of any of the risks described in this registration statement could have a significant and adverse impact on the market price for our stock.

Our stock price as well as the stock prices for competitors in our industry have historically been volatile. The market prices for securities of pharmaceutical and biotechnology companies, including ours, are highly volatile. The stock market has from time to time experienced significant price and volume fluctuations that may be unrelated to the operating performance of particular companies. The market price for our common stock may fluctuate as a result of factors such as:

    • announcements of new therapeutic products by us or our competitors
    • announcements regarding collaborative agreements
    • governmental regulations
    • clinical trial results
    • developments in patent or other proprietary rights
    • public concern as to the safety of drugs developed by us or others
    • comments made by securities analysts
    • general market conditions.

Our future success depends on our ability to successfully manage growth. We continue to expand our operations, which places a strain upon our management, systems and resources. Our ability to compete effectively and to manage future growth, if any, will require us to continue to, on a timely basis, improve our financial and management controls, reporting systems and procedures and expand, train and manage an increasing number of employees. Our failure to do so would harm our results of operations.

Failure to protect our intellectual property would adversely affect our business. Our success depends in part on our ability to obtain and enforce patent protection for our products and to preserve our trade secrets. We hold patents and pending patent applications in the United States and abroad. Some of our patents involve specific claims and thus do not provide broad coverage. There can be no assurance that our patent applications or any claims of these patent applications will be allowed, or found to be valid or enforceable, that any patents or any claims of these patents will provide us with competitive advantages for our products or that such issued patents and any patents issued under pending patent applications will not be successfully challenged or circumvented by our competitors. We have not conducted extensive patent and prior art searches with respect to our product candidates and technologies, and we cannot guarantee that third-party patents or patent applications do not exist or could not be filed in the United States, Europe or other countries which would have an adverse effect on our ability to market our products. We cannot guarantee claims in our patent applications would be allowed, or found to be valid or enforceable, or that any of our products would not infringe on others' patents or proprietary rights in the United States or abroad. We also have patent licenses from third parties whose patents and patent applications are subject to the same risk as ours are.

We cannot guarantee we will be able to manufacture, or that we have manufactured, formulated or commercialized SangCya Oral Solution and capsules without infringing patent or other proprietary rights of Novartis or other third parties. We have been sued by Novartis for patent infringement. See "Part II, Item 1 - Legal Proceedings."

Patent applications in the United States are maintained in secrecy until patents issue. Since publication of discoveries in the scientific or patent literature tends to lag behind actual discoveries by several months, we cannot be certain that we were the first to discover compositions covered by our pending patent applications or the first to file patent applications on such compositions. Our pending patent applications may not result in issued patents and any of our issued patents may not afford protection against a competitor.

We also rely on trade secrets and proprietary know-how that we seek to protect, in part, by confidentiality agreements with our employees and consultants. We cannot guarantee these agreements will not be breached, that we would have adequate remedies for any such breach or that our trade secrets will not otherwise become known or independently developed by competitors.

We have registered or applied for trademark registration of the names of all of our marketed products and plan to register the names of our products under development once a name has been selected for the product candidate. We have registered or applied for trademark registration of the names of most of our products under development or commercialized for research and development use. However, these trademark registrations may not be granted to us or may be challenged by competitors.

We face substantial competition. The drugs we develop compete with existing and new drugs being created by pharmaceutical, biopharmaceutical, biotechnology and diagnostics companies and universities. Many of these entities have significantly greater research and development capabilities, as well as substantial marketing, manufacturing, financial and managerial resources and represent significant competition. The principal factors upon which our products compete are product utility, therapeutic benefits, ease of use, effectiveness, marketing, distribution and price. With respect to Thymoglobulin, SangCya Oral Solution and cyclosporine capsules, we will be competing against large companies that have significantly greater financial resources and established marketing and distribution channels for competing products. For example, Novartis currently controls virtually 100% of the worldwide cyclosporine markets and has significantly greater resources than we do. We cannot guarantee we will be able to compete successfully against Novartis. To date, we have a limited number of contracts with managed care providers and group purchasing organizations. Our future sales will be dependent on our ability to enter into contracts with these entities. The drug industry is characterized by intense price competition and we expect we will face this and other forms of competition. We cannot guarantee that developments by others will not render our products or technologies obsolete or noncompetitive, or that we will be able to keep pace with technological developments. Many of our competitors have developed or are in the process of developing technologies that are, or in the future may be, the basis for products that compete with our own. Some of these products may have an entirely different approach or means of accomplishing the desired therapeutic effect than our products and may be more effective and less costly. In addition, many of these competitors have significantly greater experience than we do in undertaking preclinical testing and human clinical trials of pharmaceutical products and obtaining regulatory approvals of such products. Accordingly, our competitors may succeed in commercializing products more rapidly than we can. For example, we believe that the degree of market penetration of a cyclosporine capsule is dependent in part on whether we are the first company to market a bioequivalent formulation of cyclosporine. We believe that other companies may be developing cyclosporine formulations that may be marketed as generic equivalents. Were these competitors to develop their products more rapidly and complete the regulatory process sooner, that would harm our business.

Other treatments for the problems associated with transplantation that our products seek to address are currently available and under development. To the extent these therapeutics or monitoring products address the problems associated with transplantation on which we have focused, they may represent significant competition.

The Transplant Pharmacy may not become a viable distributor. Establishing The Transplant Pharmacy as a viable distributor of pharmaceutical products and services entails a number of risks, including our ability to enter into agreements with transplant centers to utilize The Transplant Pharmacy's services, compliance with state regulations regarding pharmacy licensing and compliance with federal and state laws regulating payments for referrals for health care services. On November 11, 1998, the Office of the Inspector General, or OIG, of the Department of Health & Human Services issued an Advisory Opinion which stated that the placement by a pharmacy of a licensed pharmacist at a hospital transplant center might constitute prohibited remuneration under the anti-kickback statute section of the Social Security Act. This Advisory Opinion was not addressed at us, and the Advisory Opinion only applies to the party to whom it was addressed. We believe the Advisory Opinion does not apply to an operation like The Transplant Pharmacy and our operation does not make prohibited remuneration. We cannot guarantee that the OIG will agree with this analysis, in which case we may modify The Transplant Pharmacy so that it would no longer include an on-site pharmacist at transplant centers. We cannot guarantee that we will be successful in establishing The Transplant Pharmacy as a viable distributor of pharmaceutical products and services.

If our products do not receive regulatory approvals, or if we do not otherwise comply with government regulations, our business would be harmed. Our research, preclinical development, clinical trials, manufacturing, marketing and distribution of our products in the United States and other countries are subject to extensive regulation by numerous governmental authorities including, but not limited to, the FDA. In order to obtain regulatory approval of a drug product, we must demonstrate to the satisfaction of the applicable regulatory agency, among other things, that such product is safe and effective for its intended uses and that the manufacturing facilities are in compliance with GMP requirements. We must also demonstrate the approvability of a BLA for our biological products. The approval of our generic product candidates is dependent on demonstrating bioequivalence with reference products in addition to assurance of compliance with GMP regulations.

The process of obtaining FDA and other required regulatory approvals is lengthy and will require the expenditure of substantial resources, and we cannot guarantee that we will be able to obtain the necessary approvals. Moreover, if and when such approval is obtained, the marketing, distribution and manufacture of our products would remain subject to extensive regulatory requirements administered by the FDA and other regulatory bodies. Failure to comply with applicable regulatory requirements can result in, among other things, warning letters, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, refusal of the government to grant pre-market clearance or pre-market approval, withdrawal of approvals and criminal prosecution of SangStat and our employees.

Our therapeutic products are subject to foreign regulatory requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement, which vary from country to country. The process of obtaining foreign regulatory approvals can be lengthy and require the expenditure of substantial resources, and we cannot guarantee we will be able to obtain the necessary approvals or the approvals for the proposed indications.

We depend on collaborative relationships. We have a number of strategic relationships for the development and distribution of our products. In particular, we have entered into a multi-year co-promotion, distribution and research agreement for SangCya Oral Solution and cyclosporine capsules in the U.S. with Abbott. We are dependent upon Abbott for certain regulatory, manufacturing, marketing, and sales activities under the agreement. Abbott may not perform satisfactorily and any such failure may delay regulatory approval, product launch, impair our ability to deliver products on a timely basis, or otherwise impair our competitive position, which would harm our business. We may enter into additional collaborative relationships with corporate and other partners to develop and commercialize certain of our potential products. We cannot assure you that we will be able to negotiate acceptable collaborative arrangements in the future, that such collaborations will be available to us on acceptable terms or that any such relationships, if established, will be scientifically or commercially successful.

We depend upon key personnel. Our ability to develop our business depends in part upon our attracting and retaining qualified management and scientific personnel. As the number of qualified personnel is limited, competition for such personnel is intense. We cannot assure you that we will be able to continue to attract or retain such people. The loss of our key personnel or the failure to recruit additional key personnel could significantly impede attainment of our objectives and harm our financial condition and results of operations. Our planned activities will require the addition of new personnel, including management, and the development of additional expertise by existing management personnel, in areas such as research, product development, preclinical testing, clinical trial management, regulatory affairs, finance, manufacturing, pharmacy affairs and marketing and sales. The inability to acquire such services or to develop such expertise could harm our business.

Pharmaceutical pricing and reimbursement is uncertain. Our ability to commercialize our products may depend in part on the extent to which reimbursement for the cost of such products and related treatment will be available from government health administration authorities, private health coverage insurers and other organizations. The pricing, availability of distribution channels and reimbursement status of newly approved healthcare products is highly uncertain and we cannot assure you that adequate third-party coverage will be available for us to maintain price levels sufficient for realization of an appropriate return on our investment in product development. In certain foreign markets, pricing or profitability of healthcare products is subject to government control. In the United States, there have been, and we expect that there will continue to be, a number of federal and state proposals to implement similar governmental control. In addition, an increasing emphasis on managed care in the United States has and will continue to increase the pressure on pharmaceutical pricing. While we cannot predict whether any such legislative or regulatory proposals will be adopted or the effect such proposals or managed care efforts may have on our business, the announcement of such proposals or efforts could harm our ability to raise capital, and the adoption of such proposals or efforts could harm our results of operations. Further, to the extent that such proposals or efforts harm other pharmaceutical companies that are our prospective corporate partners, our ability to establish corporate collaborations may be adversely affected. In addition, third-party payers are increasingly challenging the prices charged for medical products and services. We cannot guarantee that our products and product candidates, if approved, will be considered cost effective or that reimbursement to the consumer will be available or will be sufficient to allow us to sell our products on a competitive basis.

Our business exposes us to the risk of product liability claims for which we may not be adequately insured. We face an inherent business risk of exposure to product liability claims in the event that the use of our products results in adverse effects during research, clinical development or commercial use. We cannot guarantee we will avoid significant product liability exposure. Our product liability insurance coverage is currently limited to $10,000,000, which may not be adequate to cover potential liability exposures. Moreover, we cannot assure you adequate insurance coverage will be available at acceptable cost, if at all, or that a product liability claim would not harm our results of operations.

We deal with hazardous materials. In connection with our research and development activities and operations, we are subject to federal, state and local laws, rules, regulations and policies governing the use, generation, manufacture, storage, air emission, effluent discharge, handling and disposal of certain materials, biological specimens and wastes. We cannot assure you that we will not incur significant costs to comply with environmental and health and safety regulations. Our research and development involves the controlled use of hazardous materials, including but not limited to certain hazardous chemicals and infectious biological specimens. Although we believe that our safety procedures for handling and disposing of such materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be eliminated. In the event of such an accident, we could be held liable for any damages that result and any such liability could exceed our ability to pay.

Our charter documents, stockholder rights plan and Delaware law may serve to deter a takeover. Certain provisions of our Certificate of Incorporation and our recently amended Bylaws could delay or make more difficult a merger, tender offer or proxy contest, which could adversely affect the market price of our common stock. Our board of directors has the authority to issue up to 5,000,000 shares of preferred stock and to determine the price, rights preferences, privileges and restrictions, including voting rights, of those shares without any further vote or action by the stockholders. The rights of the holders of common stock will be subject to, and may be adversely affected by, the rights of the holders of any preferred stock that may be issued in the future. The issuance of preferred stock could have the effect of making it more difficult for a third party to acquire a majority of our outstanding voting stock. Further, we have adopted a stockholder rights plan. The plan allows for the issuance of a dividend to stockholders of rights to acquire our shares or, under certain circumstances, an acquiring corporation, at less than half their fair market value. The plan could have the effect of delaying, deferring or preventing a change in control. In addition, we are subject to the antitakeover provisions of Section 203 of the Delaware General Corporation Law, which will prohibit us from engaging in a "business combination" with an "interested stockholder" for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. The application of Section 203 also could have the effect of delaying or preventing a change of control.

ITEM 3. Quantitative And Qualitative Disclosures About Market Risk

Reference is made to part II, Item 7A, Quantitative and Qualitative Disclosures About Market Risk, in our Annual Report on Form 10-K for the year ended December 31, 1999.

PART II. OTHER INFORMATION

 

ITEM 1. Legal Proceedings

Patent Litigation

US Patent Litigation

On February 11, 1999, Novartis Pharmaceuticals Corporation ("Novartis US") filed a lawsuit (case number 99-065) in Federal District Court for the District of Delaware against the Company alleging infringement of United States patent #5,389,382, a cyclosporine technology patented by Novartis A.G. (the "US Patent"). The Novartis A.G. patent does not cover Novartis' Neoral product but rather a separate delivery system not used in the Neoral formulation. Novartis US seeks the following relief: (i) a finding that SangStat willfully infringed the patent; (ii) to permanently enjoin Sangstat from infringing the US Patent; (iii) treble damages; and (iv) reasonable attorneys' fees, costs and expenses.

On April 15, 1999, the Company filed its answer in this case and also filed a counterclaim against Novartis alleging that Novartis violated the anti-trust laws by engaging in a series of anti-competitive acts designed and intended to exclude the Company from the market. Novartis filed a motion to separate the anti-trust counterclaim and to stay discovery relating to that counterclaim. On March 30, 2000 the Court denied Novartis' motion, which means that both the patent and the anti-trust claims will be tried at the same time and the same jury will decide both claims. The trial date is October 23, 2000 and discovery is continuing.

UK Patent Litigation

On July 9, 1999, Novartis AG and Novartis Pharmaceuticals UK Limited ("Novartis UK") filed an action against IMTIX- SangStat (UK) Limited; SangStat UK, Limited, and SangStat Medical Corporation (collectively, the "UK Defendants") in the High Court of Justice, Chancery Division, Patents Court, London (HC-1999-02988) alleging infringement of United Kingdom Patent No 2 200 048 (the "UK Patent"), the counterpart to the US Patent. The lawsuit mirrors the US patent infringement lawsuit. Novartis AG and Novartis UK seek the following relief: (i) an injunction to restrain the UK Defendants from infringing the UK Patent; (ii) the delivery up or destruction of all material that would infringe such injunction; (iii) damages; (iv) a declaration that the UK Patent is valid, and has been infringed by the UK Defendants; and (v) costs. No trial date has been set at this time though the parties have agreed that the trial will not be scheduled before March 31, 2001.

Germany Patent Litigation

In January 2000, SangStat filed a Nullity Action in the German Federal Patents Court in Munich Germany seeking to invalidate German Patent 37 42 473, which is the German counterpart to the patent that Novartis is suing us on in the United States and the United Kingdom. If SangStat prevails in this nullity action, the patent would be invalidated, which would render any infringement action that Novartis might bring in Germany moot.

Regulatory Litigation

US Regulatory Litigation

Novartis US also sued the FDA on February 11, 1999 in the United States District Court for the District of Columbia (case number 1: 99CV-00323) alleging that the FDA did not follow its own regulations in approving SangCya Oral Solution in October 1998. The lawsuit alleges that because Neoral oral solution and SangCya Oral Solution are based on different formulation technologies, they should be classified as different dosage forms. Novartis asks that the court (i) allow Novartis to keep its microemulsion labeling; (ii) declare microemulsion to be a separate dosage form; and (iii) rescind the AB rating that was given to SangCya Oral Solution. Loss of the AB rating would prevent SangCya Oral Solution from being automatically substitutable for Neoral oral solution, which would impede the marketing of SangCya Oral Solution. SangStat does not believe that this lawsuit will impact the regulatory approval of Sang-2000 in the US.

In November 1999, Novartis filed a motion with the court requesting a preliminary injunction to block the FDA from enforcing its order requiring Novartis to change the labeling of its Neoral product line to make it consistent with the established name and descriptor for the product class: Cyclosporine Oral Solution, USP [MODIFIED]). At a hearing on December 7, 1999, the court rejected Novartis' motion for a preliminary injunction and ordered that the FDA may proceed to require Novartis to change its labeling. SangStat does not know if and when the FDA will require Novartis to change the Neoral labeling on the products, but recent advertising for Neoral has used the new labeling. FDA and SangStat have filed a motion for summary judgment but the court has not yet ruled on the motion.

UK Regulatory Litigation - SangCya Oral Solution

On October 18, 1999, Novartis UK was granted leave to seek judicial review of the decision by the Medicines Control Agency (the "MCA") to approve SangCya Oral Solution (Case No. HC-1969/99). On March 30, 2000, the High Court in London dismissed Novartis' application for judicial review, ruled that the MCA acted properly in granting the SangCya Oral Solution marketing authorization, ordered Novartis to pay MCA's costs incurred in defending the action, and refused Novartis' request to appeal the decision. The High Court ordered that Novartis did not have to pay SangStat its costs. Novartis has requested permission from the Court of Appeals to appeal the High Court's decision. If such request is granted, then a hearing will take place before the Court of Appeals in late 2000 or early 2001. The Court of Appeals could uphold the High Court's ruling, reverse the High Court's ruling, or refer the case to the European Court of Justice.

UK Regulatory Litigation - Sang-2000 (SangCya Capsules)

In November 1999, Novartis filed a request for judicial review of the refusal by MCA to state that it would not reference Neoral data in approving any cyclosporine capsule application. An agreement was reached between the parties in which Novartis agreed to stay the judicial review until the earlier of (i) the decision on the judicial review of SangCya Oral Solution or (ii) MCA's approval of a marketing authorization for Sang-2000, and in return, SangStat agreed that SangStat would not launch or commence mutual recognition procedures in relation to the Sang-2000 marketing authorization (including a request to MCA to prepare an assessment report) for a period of 28 days commencing on the day on which SangStat notifies Novartis' solicitors of capsule approval. The parties have agreed to continue the stay until the appeal of the High Court decision with respect to the judicial review of SangCya Oral Solution.

SangStat assumes that Novartis will seek a judicial review hearing with respect to our Sang-2000 marketing authorization within this 28-day period to rescind it or to obtain a preliminary injunction to prevent sale of Sang-2000 until final resolution of the matter. SangStat believes that if Novartis seeks a judicial review, it will be stayed until final resolution of the judicial review of the SangCya Oral Solution marketing authorization. If Novartis does not seek permission to appeal the High Court's decision on SangCya Oral Solution or if Novartis seeks such permission and it is not granted, then there has been a final resolution of the judicial review of the SangCya Oral Solution marketing authorization. In such event, the judicial review with respect to the granting of the Sang-2000 marketing authorization will progress.

Novartis has also indicated that it will seek an injunction to prevent Sang-2000 from being sold in the United Kingdom until final resolution of the judicial review relating to Sang-2000. Because the High Court ruled in favor of the MCA with respect to the SangCya Oral Solution marketing authorization, the Company believes that it is unlikely that a court would grant Novartis a preliminary injunction with respect to the Sang-2000 marketing authorization because Novartis would not, based on the facts known to date, be able to demonstrate a substantial likelihood of success on the merits of its claim. If the Court of Appeals agrees to hear Novartis' appeal and subsequently rules in Novartis' favor, Novartis may be more likely to obtain an injunction with respect to Sang-2000.

Italian Litigation

On May 5, 2000, Novartis Farma S.p.A. ("Novartis Italy") served IMTIX SangStat s.r.l., our Italian subsidiary, and IMTIX SangStat Ltd. with a summons to the Milan Tribunal. Novartis Italy alleges that by requesting mutual recognition from the Italian Health Authorities of the SangCya Oral Solution dossier approved by the MCA, SangStat implicitly requested that the Italian Health Authorities review the Neoral dossier. Novartis alleges that this request is an act of unfair competition in that (i) the Neoral data has ten year exclusivity and (ii) the data is secret and by requesting the MRP, SangStat is responsible for the Health Authorities act of unfair competition following use of the Neoral dossier in reviewing the SangCya dossier. The summons acknowledges that the UK High Court did not invalidate the SangCya marketing authorization. It does not acknowledge that the High Court indicated that the MCA could review the Neoral data. SangStat does not know whether or not Novartis Italy has also filed suit against the Italian Health Authorities. Novartis Italy has requested that the initial appearance of the parties before the Milan Tribunal occur November 20, 2000. SangStat does not have marketing approval for SangCya Oral Solution in Italy. Novartis Italy is seeking damages and an injunction to prevent the sale by SangStat of SangCya Oral Solution, or any other product for which SangStat may obtain approval based upon a reference to the Neoral dossier.

SangStat believes that these lawsuits are without merit and that the SangStat will prevail in these matters. Although SangStat is optimistic that these disputes will ultimately be resolved favorably to SangStat, the course of litigation is inherently uncertain and there can be no assurance of a favorable outcome. Novartis' requested relief, if granted, could have a significant negative economic impact on SangStat. As a result of the Novartis patent suits and the UK judicial review, SangStat could be enjoined from selling SangCya Oral Solution for a significant period of time or ultimately be prevented from selling SangCya Oral Solution in the United States, the United Kingdom or any country in which SangStat attempts to launch SangCya Oral Solution. Should this happen, SangStat does not believe that it would be able to obtain a license from Novartis on acceptable terms for either jurisdiction because SangStat believes cyclosporine is an important product for Novartis and that Novartis would not want to diminish its profits from this product by licensing it to SangStat on acceptable terms. Failure to obtain any such required license could prevent SangStat from selling SangCya Oral Solution entirely in the United States, the United Kingdom, or any country in which SangStat attempts to launch SangCya Oral Solution, which would harm SangStat's future revenues. With respect to the FDA lawsuit, SangStat would retain its approval but lose its AB rating. If SangCya Oral Solution was no longer AB-rated to Neoral, pharmacists could not automatically substitute SangCya Oral Solution for Neoral and this would harm revenues. The litigation, whether or not resolved favorably to the Company, is likely to be expensive, lengthy and time consuming, will divert management's attention and could have a material adverse effect on the Company's business, financial condition, cash flows and results of operations.

ITEM 2. Changes In Securities And Use Of Proceeds

(c) On February 15, 2000 we sold 451,128 shares of our common stock to BioPharma Equities Holdings NV at a price of $33.25 per share. The aggregate offering price was $15,000,006 and was paid in cash. This sale was made pursuant to the exemption from registration set forth in Section 4(2) of the Securities Act of 1933, as amended (the "Securities Act"), as this sale was to one private party, and the purchaser represented their intention to acquire these shares for their own account and not with a view to any distribution thereof to the public. The certificate evidencing these shares bears a legend stating that the shares are not to be offered, sold or transferred other than pursuant to an effective registration statement under the Securities Act or an exemption from its registration requirements. This transaction did not involve an underwriter, underwriter's discount or commissions.

ITEM 3. Defaults Upon Senior Securities

None

ITEM 4. Submission Of Matters To A Vote Of Security Holders

None

ITEM 5. Other Information

None

ITEM 6. Exhibits and Reports on Form 8-K

(a) EXHIBITS - The following exhibits are attached hereto and filed herewith:

Exhibit Number
Description of Document
  3.5 Second Amended and Restated Bylaws
  10.33 Loan and Security Agreement between us and Finova Capital Corporation dated as of April 21, 2000
  27.1 Financial Data Schedule

(b) We filed a Current Report on Form 8-K on February 28, 2000.








SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused This report to be signed on its behalf by the undersigned thereunto duly authorized.

  SangStat Medical Corporation
  (Registrant)

Dated: May 15, 2000

  By:  /s/ STEPHEN G. DANCE
 
  Stephen G. Dance
  Senior Vice President,Finance
  (Principal Financial Officer)








EX-3.5 2 BYLAWS BYLAWS

Exhibit 3.5

Second Amended and Restated Bylaws

of

SangStat Medical Corporation

 

 

Second Amended and Restated Bylaws

of

SangStat Medical Corporation

    1. Stockholders.
      1. Place of Meetings. All meetings of stockholders shall be held at such place within or without the State of Delaware as may be designated from time to time by the Board of Directors or the President and Chief Executive Officer or, if not so designated, at the registered office of the corporation.
      2. Annual Meeting. The annual meeting of stockholders for the election of directors and for the transaction of such other business as may properly be brought before the meeting shall be held on a date to be fixed by the Board of Directors or the President and Chief Executive Officer at the time and place to be fixed by the Board of Directors or the President and stated in the notice of the meeting. If no annual meeting is held in accordance with the foregoing provisions, the Board of Directors shall cause the meeting to be held as soon thereafter as convenient.
      3. Special Meetings. Subject to any provision to the contrary in the Certificate of Incorporation, special meetings of stockholders may be called at any time by the Board of Directors, the Chairman of the Board or the President and Chief Executive Officer. Any such request shall state the purposes of the proposed meeting. Business transacted at any special meeting of stockholders shall be confined to the purpose or purposes stated in the notice of meeting. As soon as reasonably practicable after receipt of such a request, written notice of such meeting complying with Section 1.4 below shall be given.
      4. Notice of Meetings. Written notice of each annual meeting of stockholders shall be given not less than ten (10) nor more than sixty (60) days before the date on which the meeting is to be held. Written notice of each special meeting of stockholders shall be given not less than sixty (60) days before the date on which the meeting is to be held. The notice required by this Section 1.4 shall be given to each stockholder entitled to vote at such annual or special meeting, except as otherwise provided herein or as required by law (meaning here and hereafter, as required from time to time by the Delaware General Corporation Law or the Certificate of Incorporation). The notices of all meetings shall state the place, date and hour of the meeting. The notice of a special meeting shall state, in addition, the purpose or purposes for which the meeting is called. If mailed, notice is given when deposited in the United States mail, postage prepaid, directed to the stockholder at his address as it appears on the records of the corporation.
      5. Voting List. The officer who has charge of the stock ledger of the corporation shall prepare, at least ten (10) days before each meeting of stockholders, a complete list of the stockholders entitled to vote at the meeting, arranged in alphabetical order, and showing the address of each stockholder and the number of shares registered in the name of each stockholder. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting, during ordinary business hours, for a period of at least ten (10) days prior to the meeting, at a place within the city where the meeting is to be held, which place shall be specified in the notice of the meeting, or if not so specified, at the place where the meeting is to be held. The list shall also be produced and kept at the time and place of the meeting during the whole time of the meeting, and may be inspected by any stockholder who is present. This list shall presumptively determine the identity of the stockholders entitled to vote at the meeting and the number of shares held by each of them.
      6. Quorum. Except as otherwise provided by law or these bylaws, the holders of a majority of the shares of the capital stock of the corporation entitled to vote at the meeting, present in person or represented by proxy, shall constitute a quorum for the transaction of business. If a quorum shall fail to attend any meeting, the chairman of the meeting or the holders of a majority of the shares of stock entitled to vote who are present, in person or by proxy, may adjourn the meeting to another place, date or time.
      7. If a notice of any adjourned special meeting of stockholders is sent to all stockholders entitled to vote thereat, stating that it will be held with those present constituting a quorum, then except as otherwise required by law, those present at such adjourned meeting shall constitute a quorum, and all matters shall be determined by a majority of the votes cast at such meeting.

      8. Adjournments. Any meeting of stockholders may be adjourned to any other time and to any other place at which a meeting of stockholders may be held under these bylaws by the holders of a majority of the shares of stock present or represented at the meeting and entitled to vote, although less than a quorum, or, if no stockholder is present, by any officer entitled to preside at or to act as Secretary of such meeting. When a meeting is adjourned to another place, date or time, written notice need not be given of the adjourned meeting if the place, date and time thereof are announced at the meeting at which the adjournment is taken; provided, however, that if the date of any adjourned meeting is more than thirty (30) days after the date for which the meeting was originally noticed, or if a new record date is fixed for the adjourned meeting, written notice of the place, date, and time of the adjourned meeting shall be given in conformity herewith. At the adjourned meeting, the corporation may transact any business which might have been transacted at the original meeting.
      9. Voting and Proxies. Each stockholder shall have one vote for each share of stock entitled to vote held of record by such stockholder and a proportionate vote for each fractional share so held, unless otherwise provided by law. Each stockholder of record entitled to vote at a meeting of stockholders, may vote in person or may authorize any other person or persons to vote or act for him by written proxy executed by the stockholder or his authorized agent or by a transmission permitted by law and delivered to the Secretary of the corporation. No stockholder may authorize more than one proxy for his shares. Any copy, facsimile telecommunication or other reliable reproduction of the writing or transmission created pursuant to this Section may be substituted or used in lieu of the original writing or transmission for any and all purposes for which the original writing or transmission could be used, provided that such copy, facsimile transmission or other reproduction shall be a complete reproduction of the entire original writing or transmission.
      10. Action at Meeting. When a quorum is present at any meeting, any election shall be determined by a plurality of the votes cast by the stockholders entitled to vote at the election, and all other matters shall be determined by a majority of the votes cast affirmatively or negatively on the matter (or if there are two or more classes of stock entitled to vote as separate classes, then in the case of each such class, a majority of each such class present or represented and voting affirmatively or negatively on the matter) shall decide such matter, except when a different vote is required by express provision of law, the Certificate of Incorporation or these bylaws.
      11. All voting, including on the election of directors, but excepting where otherwise required by law, may be by a voice vote; provided, however, that upon demand therefor by a stockholder entitled to vote or his or her proxy, a stock vote shall be taken. Every stock vote shall be taken by ballots, each of which shall state the name of the stockholder or proxy voting and such other information as may be required under the procedure established for the meeting. Every vote taken by ballots shall be counted by an inspector or inspectors appointed by the chairman of the meeting. The corporation may, and to the extent required by law, shall, in advance of any meeting of stockholders, appoint one or more inspectors to act at the meeting and make a written report thereof. The corporation may designate one or more persons as an alternate inspector to replace any inspector who fails to act. If no inspector or alternate is able to act at a meeting of stockholders, the person presiding at the meeting may, and to the extent required by law, shall, appoint one or more inspectors to act at the meeting. Each inspector, before entering upon the discharge of his duties, shall take and sign an oath faithfully to execute the duties of inspector with strict impartiality and according to the best of his or her ability.

      12. Notice of Stockholder Business. At an annual meeting of the stockholders, only such business shall be conducted as shall have been properly brought before the meeting. To be properly brought before an annual meeting, business must be (i) specified in the notice of meeting (or any supplement thereto) given by or at the direction of the Board of Directors, (ii) properly brought before the meeting by or at the direction of the Board of Directors, or (iii) properly brought before an annual meeting by a stockholder. For business to be properly brought before an annual meeting by a stockholder, the stockholder must have given timely notice thereof in writing to the Secretary of the Corporation. To be timely, a stockholder proposal to be presented at an annual meeting shall be received at the Corporation's principal executive offices not less than 120 calendar days in advance of the date that the Corporation's (or the Corporation's predecessor's) proxy statement was released to stockholders in connection with the previous year's annual meeting of stockholders, except that if no annual meeting was held in the previous year or the date of the annual meeting has been advanced by more than 30 calendar days from the date contemplated at the time of the previous year's proxy statement, notice by the stockholders to be timely must be received not later than the close of business on the tenth day following the day on which the date of the annual meeting is publicly announced.
      13. A stockholder's notice to the Secretary of the Corporation shall set forth as to each matter the stockholder proposes to bring before the annual meeting (i) a brief description of the business desired to be brought before the annual meeting, (ii) the name and address, as they appear on the Corporation's books, of the stockholder proposing such business, (iii) the class and number of shares of the Corporation which are beneficially owned by the stockholder, and (iv) any material interest of the stockholder in such business.

      14. Conduct of Business. At every meeting of the stockholders, the Chairman of the Board, if there is such an officer, or if not, the person appointed by the Board of Directors, shall act as Chairman. The Secretary of the corporation or a person designated by the Chairman of the meeting shall act as Secretary of the meeting. Unless otherwise approved by the Chairman of the meeting, attendance at the stockholders' meeting is restricted to stockholders of record, persons authorized in accordance with Section 1.8 of these bylaws to act by proxy, and officers of the corporation.
      15. The Chairman of the meeting shall call the meeting to order, establish the agenda, and conduct the business of the meeting in accordance therewith or, at the Chairman's discretion, it may be conducted otherwise in accordance with the wishes of the stockholders in attendance. The date and time of the opening and closing of the polls for each matter upon which the stockholders will vote at the meeting shall be announced at the meeting.

        The Chairman shall also conduct the meeting in an orderly manner, rule on the precedence of, and procedure on, motions and other procedural matters, and exercise discretion with respect to such procedural matters with fairness and good faith toward all those entitled to take part. The Chairman may impose reasonable limits on the amount of time taken up at the meeting on discussion in general or on remarks by any one stockholder. Should any person in attendance become unruly or obstruct the meeting proceedings, the Chairman shall have the power to have such person removed from participation. Notwithstanding anything in these bylaws to the contrary, no business shall be conducted at a meeting except in accordance with the procedures set forth in this Section 1.11 and Section 1.10 above. The Chairman of a meeting shall, if the facts warrant, determine and declare to the meeting that any proposed item of business was not brought before the meeting in accordance with the provisions of this Section 1.11 and Section 1.10, and if he should so determine, he shall so declare to the meeting and any such business not properly brought before the meeting shall not be transacted.

      16. No Stockholder Action Without Meeting. Any action required or permitted to be taken by the stockholders of the Corporation must be effected at a duly called annual or special meeting of stockholders of the Corporation and may not be effected by any consent in writing by such stockholders.
    2. Board of Directors.
      1. General Powers. The business and affairs of the corporation shall be managed by or under the direction of a Board of Directors, who may exercise all of the powers of the corporation except as otherwise provided by law or the Certificate of Incorporation. In the event of a vacancy in the Board of Directors, the remaining directors, except as otherwise provided by law, may exercise the powers of the full Board until the vacancy is filled.
      2. Number and Term of Office. The number of directors shall initially be seven (7) and, thereafter, shall be fixed from time to time exclusively by the Board of Directors pursuant to a resolution adopted by a majority of the total number of authorized directors (whether or not there exist any vacancies in previously authorized directorships at the time any such resolution is presented to the Board for adoption). All directors shall hold office until the expiration of the term for which elected and until their respective successors are elected, except in the case of the death, resignation or removal of any director.
      3. Vacancies and Newly Created Directorships. Subject to the rights of the holders of any series of Preferred Stock then outstanding, newly created directorships resulting from any increase in the authorized number of directors or any vacancies in the Board of Directors resulting from death, resignation, retirement, disqualification or other cause (including removal from office by a vote of the stockholders) may be filled only by a majority vote of the directors then in office, though less than a quorum, and directors so chosen shall hold office for a term expiring at the next annual meeting of stockholders at which the term of office of the class to which they have been elected expires. No decrease in the number of directors constituting the Board of Directors shall shorten the term of any incumbent director.
      4. Resignation. Any director may resign by delivering his written resignation to the corporation at its principal office or to the President or Secretary. Such resignation shall be effective upon receipt unless it is specified to be effective at some other time or upon the happening of some other event.
      5. Regular Meetings. Regular meetings of the Board of Directors may be held without notice at such time and place, either within or without the State of Delaware, as shall be determined from time to time by the Board of Directors; provided that any director who is absent when such a determination is made shall be given notice of the determination. A regular meeting of the Board of Directors may be held without notice immediately after and at the same place as the annual meeting of stockholders.
      6. Special Meetings. Special meetings of the Board of Directors may be held at any time and place, within or without the State of Delaware, designated in a call by the Chairman of the Board, the President and Chief Executive Officer, two or more directors, or by one director in the event that there is only a single director in office.
      7. Notice of Special Meetings. Notice of any special meeting of directors shall be given to each director by the Secretary or by the officer or one of the directors calling the meeting. Notice shall be duly given to each director (i) by giving notice to such director in person or by telephone or electronic voice message system at least 24 hours in advance of the meeting, (ii) by sending a telegram, telecopy or telex, or delivering written notice by hand, to his last known business or home address at least 24 hours in advance of the meeting, or (iii) by mailing written notice to his last known business or home address at least three (3) day in advance of the meeting. A notice or waiver of notice of a meeting of the Board of Directors need not specify the purposes of the meeting. Unless otherwise indicated in the notice thereof, any and all business may be transacted at a special meeting.
      8. Participation in Meetings by Telephone Conference Calls. Directors or any members of any committee designated by the directors may participate in a meeting of the Board of Directors or such committee by means of conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other, and participation by such means shall constitute presence in person at such meeting.
      9. Quorum. A majority of the total number of authorized directors shall constitute a quorum at any meeting of the Board of Directors. In the event one or more of the directors shall be disqualified to vote at any meeting, then the required quorum shall be reduced by one for each such director so disqualified; provided, however, that in no case shall less than one-third (1/3) of the number so fixed constitute a quorum. In the absence of a quorum at any such meeting, a majority of the directors present may adjourn the meeting from time to time without further notice other than announcement at the meeting, until a quorum shall be present. Interested directors may be counted in determining the presence of a quorum at a meeting of the Board of Directors or at a meeting of a committee which authorizes a particular contract or transaction.
      10. Action at Meeting. At any meeting of the Board of Directors at which a quorum is present, the vote of a majority of those present shall be sufficient to take any action, unless a different vote is specified by law, the Certificate of Incorporation or these bylaws.
      11. Action by Consent. Any action required or permitted to be taken at any meeting of the Board of Directors or of any committee of the Board of Directors may be taken without a meeting, if all members of the Board or committee, as the case may be, consent to the action in writing. Any such written consents shall be filed with the minutes of proceedings of the Board or committee.
      12. Removal. Subject to the rights of the holders of any series of Preferred Stock then outstanding, any directors, or the entire Board of Directors, may be removed from office at any time, but only for cause and only by the affirmative vote of the holders of at least a majority of the voting power of all of the outstanding shares of capital stock entitled to vote generally in the election of directors, voting together as a single class.
      13. Committees. The Board of Directors may designate one or more committees, each committee to consist of one or more of the directors of the corporation, with such lawfully delegated powers and duties as it therefor confers, to serve at the pleasure of the Board. The Board may designate one or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee. In the absence or disqualification of a member of a committee, the member or members of the committee present at any meeting and not disqualified from voting, whether or not he or they constitute a quorum, may unanimously appoint another member of the Board of Directors to act at the meeting in the place of any such absent or disqualified member. Any such committee, to the extent provided in the resolution of the Board of Directors and subject to the provisions of the General Corporation Law of the State of Delaware, shall have and may exercise all the powers and authority of the Board of Directors in the management of the business and affairs of the corporation and may authorize the seal of the corporation to be affixed to all papers which may require it. Each such committee shall keep minutes and make such reports as the Board of Directors may from time to time request. Except as the Board of Directors may otherwise determine, any committee may make rules for the conduct of its business, but unless otherwise provided by such rules, its business shall be conducted as nearly as possible in the same manner as is provided in these bylaws for the Board of Directors.
      14. Compensation of Directors. Directors may be paid such compensation for their services and such reimbursement for expenses of attendance at meetings as the Board of Directors may from time to the determine. No such payment shall preclude any director from serving the corporation or any of its parent or subsidiary corporations in any other capacity and receiving compensation for such service.
      15. Nomination of Director Candidates. Subject to the rights of holders of any class or series of Preferred Stock then outstanding, nominations for the election of Directors may be made by the Board of Directors or a proxy committee appointed by the Board of Directors or by any stockholder entitled to vote in the election of Directors generally. However, any stockholder entitled to vote in the election of Directors generally may nominate one or more persons for election as Directors at a meeting only if timely notice of such stockholder's intent to make such nomination or nominations has been given in writing to the Secretary of the Corporation. To be timely, a stockholder nomination for a director to be elected at an annual meeting shall be received at the Corporation's principal executive offices not less than 120 calendar days in advance of the date that the Corporation's (or the Corporation's predecessor's) proxy statement was released to stockholders in connection with the previous year's annual meeting of stockholders, except that if no annual meeting was held in the previous year or the date of the annual meeting has been changed by more than 30 calendar days from the date contemplated at the time of the previous year's proxy statement, or in the event of a nomination for director to be elected at a special meeting, notice by the stockholders to be timely must be received not later than the close of business on the tenth day following the day on which such notice of the date of the special meeting was mailed or such public disclosure was made. Each such notice shall set forth: (a) the name and address of the stockholder who intends to make the nomination and of the person or persons to be nominated; (b) a representation that the stockholder is a holder of record of stock of the Corporation entitled to vote for the election of directors on the date of such notice and intends to appear in person or by proxy at the meeting to nominate the person or persons specified in the notice; (c) a description of all arrangements or understandings between the stockholder and each nominee and any other person or persons (naming such person or persons) pursuant to which the nomination or nominations are to be made by the stockholder; (d) such other information regarding each nominee proposed by such stockholder as would be required to be included in a proxy statement filed pursuant to the proxy rules of the Securities and Exchange Commission, had the nominee been nominated, or intended to be nominated, by the Board of Directors; and (e) the consent of each nominee to serve as a director of the Corporation if so elected.

      In the event that a person is validly designated as a nominee in accordance with this Section 2.15 and shall thereafter become unable or unwilling to stand for election to the Board of Directors, the Board of Directors or the stockholder who proposed such nominee, as the case may be, may designate a substitute nominee upon delivery, not fewer than five days prior to the date of the meeting for the election of such nominee, of a written notice to the Secretary setting forth such information regarding such substitute nominee as would have been required to be delivered to the Secretary pursuant to this Section 2.15 had such substitute nominee been initially proposed as a nominee. Such notice shall include a signed consent to serve as a director of the Corporation, if elected, of each such substitute nominee.

      If the chairman of the meeting for the election of Directors determines that a nomination of any candidate for election as a Director at such meeting was not made in accordance with the applicable provisions of this Section 2.15, such nomination shall be void; provided, however, that nothing in this Section 2.15 shall be deemed to limit any voting rights upon the occurrence of dividend arrearages provided to holders of Preferred Stock pursuant to the Preferred Stock designation for any series of Preferred Stock.

    3. Officers.
      1. Enumeration. The officers of the corporation shall consist of a President and Chief Executive Officer, a Secretary, a Chief Financial Officer and such other officers with such other titles as the Board of Directors shall determine, including, at the discretion of the Board of Directors, a Chairman of the Board, and one or more Vice Presidents and Assistant Secretaries. The Board of Directors may appoint such other officers as it may deem appropriate.
      2. Election. Officers shall be elected annually by the Board of Directors at its first meeting following the annual meeting of stockholders. Officers may be appointed by the Board of Directors at any other meeting.
      3. Qualification. No officer need be a stockholder. Any two or more offices may be held by the same person.
      4. Tenure. Except as otherwise provided by law, by the Certificate of Incorporation or by these bylaws, each officer shall hold office until his successor is elected and qualified, unless a different term is specified in the vote appointing him, or until his earlier death, resignation or removal.
      5. Resignation and Removal. Any officer may resign by delivering his written resignation to the corporation at its principal office or to the President or Secretary. Such resignation shall be effective upon receipt unless it is specified to be effective at some other time or upon the happening of some other event. Any officer may be removed at any time, with or without cause, by the Board of Directors.
      6. Chairman of the Board. The Board of Directors may appoint a Chairman of the Board. If the Board of Directors appoints a Chairman of the Board, he shall perform such duties and possess such powers as are assigned to him by the Board of Directors. Unless otherwise provided by the Board of Directors, he shall preside at all meetings of the stockholders, and, if he is a director, at all meetings of the Board of Directors.
      7. President. The President shall, subject to the direction of the Board of Directors, have responsibility for the general management and control of the business and affairs of the Corporation and shall perform all duties and have all powers which are commonly incident to the office of chief executive or which are delegated to him or her by the Board of Directors. The President shall be the Chief Executive Officer of the corporation. The President shall perform such other duties and shall have such other powers as the Board of Directors may from time to time prescribe. He or she shall have power to sign stock certificates, contracts and other instruments of the Corporation which are authorized and shall have general supervision and direction of all of the other officers, employees and agents of the Corporation, other than the Chairman of the Board.
      8. Vice Presidents. Any Vice President shall perform such duties and possess such powers as the Board of Directors or the President may from time to time prescribe. In the event of the absence, inability or refusal to act of the President, the Vice President (or if there shall be more than one, the Vice Presidents in the order determined by the Board of Directors) shall perform the duties of the President and when so performing shall have at the powers of and be subject to all the restrictions upon the President. The Board of Directors may assign to any Vice President the title of Executive Vice President, Senior Vice President or any other title selected by the Board of Directors.
      9. Secretary and Assistant Secretaries. The Secretary shall perform such duties and shall have such powers as the Board of Directors or the President may from time to time prescribe. In addition, the Secretary shall perform such duties and have such powers as are incident to the office of the Secretary, including, without limitation, the duty and power to give notices of all meetings of stockholders and special meetings of the Board of Directors, to keep a record of the proceedings of all meetings of stockholders and the Board of Directors, to maintain a stock ledger and prepare lists of stockholders and their addresses as required, to be custodian of corporate records and the corporate seal and to affix and attest to the same on documents.
      10. Any Assistant Secretary shall perform such duties and possess such powers as the Board of Directors, the President or the Secretary may from time to time prescribe. In the event of the absence, inability or refusal to act of the Secretary, the Assistant Secretary (or if there shall be more than one, the Assistant Secretaries in the order determined by the Board of Directors) shall perform the duties and exercise the powers of the Secretary.

        In the absence of the Secretary or any Assistant Secretary at any meeting of stockholders or directors, the person presiding at the meeting shall designate a temporary secretary to keep a record of the meeting.

      11. Chief Financial Officer. Unless otherwise designated by the Board of Directors, the Chief Financial Officer shall be the Treasurer. The Chief Financial Officer shall perform such duties and shall have such powers as may from time to time be assigned to him by the Board of Directors or the President. In addition, the Chief Financial Officer shall perform such duties and have such powers as are incident to the office of chief financial officer, including without limitation, the duty and power to keep and be responsible for all funds and securities of the corporation, to maintain the financial records of the Corporation, to deposit funds of the corporation in depositories as authorized, to disburse such funds as authorized, to make proper accounts of such funds, and to render as required by the Board of Directors accounts of all such transactions and of the financial condition of the corporation.
      12. Salaries. Officers of the corporation shall be entitled to such salaries, compensation or reimbursement as shall be fixed or allowed from time to time by the Board of Directors.
      13. Delegation of Authority. The Board of Directors may from time to time delegate the powers or duties of any officer to any other officers or agents, notwithstanding any provision hereof.
    4. Capital Stock.
      1. Issuance of Stock. Unless otherwise voted by the stockholders and subject to the provisions of the Certificate of Incorporation, the whole or any part of any unissued balance of the authorized capital stock of the corporation or the whole or any part of any unissued balance of the authorized capital stock of the corporation held in its treasury may be issued, sold, transferred or otherwise disposed of by vote of the Board of Directors in such manner, for such consideration and on such terms as the Board of Directors may determine.
      2. Certificates of Stock. Every holder of stock of the corporation shall be entitled to have a certificate, in such form as may be prescribed by law and by the Board of Directors, certifying the number and class of shares owned by him in the corporation. Each such certificate shall be signed by, or in the name of the corporation by, the Chairman or Vice-Chairman, if any, of the Board of Directors, or the President or a Vice President, and the Chief Financial Officer, or the Secretary or an Assistant Secretary of the corporation. Any or all of the signatures on the certificate may be a facsimile.
      3. Each certificate for shares of stock which are subject to any restriction on transfer pursuant to the Certificate of Incorporation, the bylaws, applicable securities laws or any agreement among any number of shareholders or among such holders and the corporation shall have conspicuously noted on the face or back of the certificate either the full text of the restriction or a statement of the existence of such restriction.

      4. Transfers. Except as otherwise established by rules and regulations adopted by the Board of Directors, and subject to applicable law, shares of stock may be transferred on the books of the corporation by the surrender to the corporation or its transfer agent of the certificate representing such shares properly endorsed or accompanied by a written assignment or power of attorney properly executed, and with such proof of authority or authenticity of signature as the corporation or its transfer agent may reasonably require. Except as may be otherwise required by law, by the Certificate of Incorporation or by the bylaws, the corporation shall be entitled to treat the record holder of stock as shown on its books as the owner of such stock for all purposes, including the payment of dividends and the right to vote with respect to such stock, regardless of any transfer, pledge or other disposition of such stock until the shares have been transferred on the books of the corporation in accordance with the requirements of these bylaws.
      5. Lost, Stolen or Destroyed Certificates. The corporation may issue a new certificate of stock in place of any previously saved certificate alleged to have been lost, stolen, or destroyed, upon such terms and conditions as the Board of Directors may prescribe, including the presentation of reasonable evidence of such loss, theft or destruction and the giving of such indemnity as the Board of Directors may require for the protection of the corporation or any transfer agent or registrar.
      6. Record Date. The Board of Directors may fix in advance a date as a record date for the determination of the stockholders entitled to notice of or to vote at any meeting of stockholders or to express consent (or dissent) to corporate action in writing without a meeting, or entitled to receive payment of any dividend or other distribution or allotment of any rights in respect of any change, concession or exchange of stock, or for the purpose of any other lawful action. Such record date shall not be more than sixty (60) nor less than ten (10) days before the date of such meeting, nor more than sixty (60) days prior to any other action to which such record date relates.

      If no record date is fixed, the record date for determining stockholders entitled to notice of or to vote at a meeting of stockholders shall be at the close of business on the day before the day on which notice is given, or, if notice is waived, at the close of business on the day before the day on which the meeting is held. The record date for determining stockholders entitled to express consent to corporate action in writing without a meeting when no prior action by the Board of Directors is necessary, shall be the day on which the first written consent is expressed. The record date for determining stockholders for any other purpose shall be at the close of business on the day on which the Board of Directors adopts the resolution relating to such purpose.

      A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting; provided, however, that the Board of Directors may fix a new record date for the adjourned meeting.

    5. General Provisions.
      1. Fiscal Year. The fiscal year of the corporation shall end on the 31st day of December.
      2. Corporate Seal. The corporate seal shall be in such form as shall be approved by the Board of Directors.
      3. Waiver of Notice. Whenever any notice whatsoever is required to be given by law, by the Certificate of Incorporation or by these bylaws, a waiver of such notice either in writing signed by the person entitled to such notice or such person's duly authorized attorney, or by telecopy, telegraph, cable or any other available method, whether before, at or after the time stated in such waiver, or the appearance of such person or persons at such meeting in person or by proxy, shall be deemed equivalent to such notice.
      4. Actions with Respect to Securities of Other Corporations. Except as the Board of Directors may otherwise designate, the President or any officer of the corporation authorized by the President shall have the power to vote and otherwise act on behalf of the corporation, in person or proxy, and may waive notice of, and act as, or appoint any person or persons to act as, proxy or attorney-in-fact to this corporation (with or without power of substitution) at any meeting of stockholders or shareholders (or with respect to any action of stockholders) of any other corporation or organization, the securities of which may be held by this corporation and otherwise to exercise any and all rights and powers which this corporation may possess by reason of this corporation's ownership of securities in such other corporation or other organization.
      5. Evidence of Authority. A certificate by the Secretary, or an Assistant Secretary, or a temporary Secretary, as to any action taken by the stockholders, directors, a committee or any officer or representative of the corporation shall as to all persons who rely on the certificate in good faith be conclusive evidence of such action.
      6. Certificate of Incorporation. All references in these bylaws to the Certificate of Incorporation shall be deemed to refer to the Certificate of Incorporation of the corporation, as amended and in effect from time to time.
      7. Severability. Any determination that any provision of these bylaws is for any reason inapplicable, illegal or ineffective shall not affect or invalidate any other provision of these bylaws.
      8. Pronouns. All pronouns used in these bylaws shall be deemed to refer to the masculine, feminine or neuter, singular or plural, as the identity of the person or persons may require.
      9. Notices. Except as otherwise specifically provided herein or required by law, all notices required to be given to any stockholder, director, officer, employee or agent shall be in writing and may in every instance be effectively given by hand delivery to the recipient thereof, by depositing such notice in the mails, postage paid, or by sending such notice by prepaid telegram, mailgram, telecopy or commercial courier service. Any such notice shall be addressed to such stockholder, director, officer, employee or agent at his or her last known address as the same appears on the books of the Corporation. The time when such notice shall be deemed to be given shall be the time such notice is received by such stockholder, director, officer, employee or agent, or by any person accepting such notice on behalf of such person, if hand delivered, or the time such notice is dispatched, if delivered through the mails or be telegram or mailgram.
      10. Reliance Upon Books, Reports and Records. Each director, each member of any committee designated by the Board of Directors, and each officer of the Corporation shall, in the performance of his duties, be fully protected in relying in good faith upon the books of account or other records of the Corporation, including reports made to the Corporation by any of its officers, by an independent certified public accountant, or by an appraiser selected with reasonable care.
      11. Time Periods. In applying any provision of these bylaws which require that an act be done or not done a specified number of days prior to an event or that an act be done during a period of a specified number of days prior to an event, calendar days shall be used, the day of the doing of the act shall be excluded, and the day of the event shall be included.
      12. Facsimile Signatures. In addition to the provisions for use of facsimile signatures elsewhere specifically authorized in these bylaws, facsimile signatures of any officer or officers of the Corporation may be used whenever and as authorized by the Board of Directors or a committee thereof.
    6. Amendments.
      1. By the Board of Directors. Except as is otherwise set forth in these bylaws or the Certificate of Incorporation, these bylaws may be altered, amended or repealed or new bylaws may be adopted by the affirmative vote of a majority of the directors present at any regular or special meeting of the Board of Directors at which a quorum is present. Notwithstanding the foregoing, amendment of Section 2.2 of these bylaws by the vote of the Board of Directors shall require a resolution adopted by the affirmative vote of not less than sixty-six and two-thirds percent (66- 2/3%) of the directors.
      2. By the Stockholders. Except as otherwise set forth in these bylaws, these bylaws may be altered, amended or repealed or new bylaws may be adopted by the affirmative vote of the holders of at sixty-six and two-thirds percent (66-2/3%) of the shares of the capital stock of the corporation issued and outstanding and entitled to vote at any annual meeting of stockholders, or at any special meeting of stockholders, provided notice of such alteration, amendment, repeal or adoption of new bylaws shall have been stated in the notice of such special meeting.
    7. Indemnification of Directors and Officers.
      1. Right to Indemnification. Each person who was or is made a party or is threatened to be made a party to or is involved in any action, suit or proceeding, whether civil, criminal, administrative or investigative ("proceeding"), by reason of the fact that he or she or a person of whom he or she is the legal representative, is or was a director or officer of the Corporation or is or was serving at the request of the Corporation as a director or officer of another corporation, or of a Partnership, joint venture, trust or other enterprise, including service with respect to employee benefit plans, whether the basis of such proceeding is alleged action in an official capacity as a director, officer or employee or in any other capacity while serving as a director, officer or employee, shall be indemnified and held harmless by the Corporation to the fullest extent authorized by Delaware Law, as the same exists or may hereafter be amended (but, in the case of any such amendment, only to the extent that such amendment permits the Corporation to provide broader indemnification rights than said Law permitted the Corporation to provide prior to such amendment) against all expenses, liability and loss reasonably incurred or suffered by such person in connection therewith and such indemnification shall continue as to a person who has ceased to be a director, officer or employee and shall inure to the benefit of his or her heirs, executors and administrators; provided, however, that, except as provided in Section 7.2 of this Article 7, the Corporation shall indemnify any such person seeking indemnity in connection with an action, suit or proceeding (or part thereof) initiated by such person only if (a) such indemnification is expressly required to be made by law, (b) the action, suit or proceeding (or part thereof) was authorized by the Board of Directors of the Corporation, (c) such indemnification is provided by the Corporation, in its sole discretion, pursuant to the powers vested in the Corporation under the Delaware General Corporation Law, or (d) the action, suit or proceeding (or part thereof) is brought to establish or enforce a right to indemnification under an indemnity agreement or any other statute or law or otherwise as required under Section 145 of the Delaware General Corporation Law. Such right shall be a contract right and shall include the right to be paid by the Corporation expenses incurred in defending any such proceeding in advance of its final disposition; provided, however, that, unless the Delaware General Corporation Law then so prohibits, the payment of such expenses incurred by a director or officer of the Corporation in his or her capacity as a director or officer (and not in any other capacity in which service was or is tendered by such person while a director or officer, including, without limitation, service to an employee benefit plan) in advance of the final disposition of such proceeding, shall be made only upon delivery to the Corporation of an undertaking, by or on behalf of such director or officer, to repay all amounts so advanced if it should be determined ultimately that such director or officer is not entitled to be indemnified under this Section or otherwise.
      2. Right of Claimant to Bring Suit. If a claim under Section 7.1 is not paid in full by the Corporation within ninety (90) days after a written claim has been received by the Corporation, the claimant may at any time thereafter bring suit against the Corporation to recover the unpaid amount of the claim and, if such suit is not frivolous or brought in bad faith, the claimant shall be entitled to be paid also the expense of prosecuting such claim. It shall be a defense to any such action (other then an action brought to enforce a claim for expenses incurred in defending any proceeding in advance of its final disposition where the required undertaking, if any, has been tendered to this Corporation) that the claimant has not met the standards of conduct which make it permissible under the Delaware General Corporation Law for the Corporation to indemnify the claimant for the amount claimed. Neither the failure of the Corporation (including its Board of Directors, independent legal counsel, or its stockholders) to have made a determination prior to the commencement of such action that indemnification of the claimant is proper in the circumstances because he or she has met the applicable standard of conduct set forth in the Delaware General Corporation Law, nor an actual determination by the Corporation (including its Board of Directors, independent legal counsel, or its stockholders) that the claimant has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that claimant has not met the applicable standard of conduct.
      3. Indemnification of Employees and Agents. The Corporation may, to the extent authorized from time to time by the Board of Directors, grant rights to indemnification, and to the advancement of related expenses, to any employee or agent of the Corporation to the fullest extent of the provisions of this Article with respect to the indemnification of and advancement of expenses to directors and officers of the Corporation.
      4. Non-Exclusivity of Rights. The rights conferred on any person in Sections 7.1 and 7.2 shall not be exclusive of any other right which such persons may have or hereafter acquire under any statute, provision of the Certificate of Incorporation, bylaw, agreement, vote of stockholders or disinterested directors or otherwise.
      5. Indemnification Contracts. The Board of Directors is authorized to enter into a contract with any director, officer, employee or agent of the Corporation, or any person serving at the request of the Corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, including employee benefit plans, providing for indemnification rights equivalent to or, if the Board of Directors so determines, greater than, those provided for in this Article 7.
      6. Insurance. The Corporation shall maintain insurance to the extent reasonably available, at its expense, to protect itself and any such director, officer, employee or agent of the Corporation or another corporation, partnership, joint venture, trust or other enterprise against any such expense, liability or loss, whether or not the Corporation would have the power to indemnify such person against such expense, liability or loss under the Delaware General Corporation Law.
      7. Effect of Amendment. Any amendment, repeal or modification of any provision of this Article 7 by the stockholders and the directors of the Corporation shall not adversely affect any right or protection of a director or officer of the Corporation existing at the time of such amendment, repeal or modification.

1. Stockholders 1

1.1 Place of Meetings 1

1.2 Annual Meeting 1

1.3 Special Meetings 1

1.4 Notice of Meetings 1

1.5 Voting List 1

1.6 Quorum 2

1.7 Adjournments 2

1.8 Voting and Proxies 2

1.9 Action at Meeting 3

1.10 Notice of Stockholder Business 3

1.11 Conduct of Business 4

1.12 No Stockholder Action Without Meeting 4

2. Board of Directors 4

2.1 General Powers 4

2.2 Number and Term of Office 4

2.3 Vacancies and Newly Created Directorships 5

2.4 Resignation 5

2.5 Regular Meetings 5

2.6 Special Meetings 5

2.7 Notice of Special Meetings 5

2.8 Participation in Meetings by Telephone Conference Calls 5

2.9 Quorum 6

2.10 Action at Meeting 6

2.11 Action by Consent 6

2.12 Removal 6

2.13 Committees 6

2.14 Compensation of Directors 7

2.15 Nomination of Director Candidates 7

3. Officers 8

3.1 Enumeration 8

3.2 Election 8

3.3 Qualification 8

3.4 Tenure 8

3.5 Resignation and Removal 8

3.6 Chairman of the Board 8

3.7 President 8

3.8 Vice Presidents 9

3.9 Secretary and Assistant Secretaries 9

3.10 Chief Financial Officer 9

3.11 Salaries 9

3.12 Delegation of Authority 10

4. Capital Stock 10

4.1 Issuance of Stock 10

4.2 Certificates of Stock 10

4.3 Transfers 10

4.4 Lost, Stolen or Destroyed Certificates 10

4.5 Record Date 11

5. General Provisions 11

5.1 Fiscal Year 11

5.2 Corporate Seal 11

5.3 Waiver of Notice 11

5.4 Actions with Respect to Securities of Other Corporations 11

5.5 Evidence of Authority 12

5.6 Certificate of Incorporation 12

5.7 Severability 12

5.8 Pronouns 12

5.9 Notices 12

5.10 Reliance Upon Books, Reports and Records 12

5.11 Time Periods 12

5.12 Facsimile Signatures 12

6. Amendments 13

6.1 By the Board of Directors 13

6.2 By the Stockholders 13

7. Indemnification of Directors and Officers 13

7.1 Right to Indemnification 13

7.2 Right of Claimant to Bring Suit 14

7.3 Indemnification of Employees and Agents 14

7.4 Non-Exclusivity of Rights 14

7.5 Indemnification Contracts 14

7.6 Insurance 14

7.7 Effect of Amendment 15








EX-10.34 3 LOAN DOCUMENT LOAN

Exhibit 10.34

 

 

LOAN AND SECURITY AGREEMENT

SANGSTAT MEDICAL CORPORATION

Borrower

6300 Dumbarton Circle
Fremont, California 94555

Address

94-3076069

Borrower Fed ID Tax No.

 

$30,000,000

Credit Limit

April 21, 2000

Date

 

 

CORPORATE FINANCE

 

table of contents

Page

1. DEFINITIONS. *

1.1 Defined Terms *

1.2 Other Terms. *

2. LOANS; INTEREST RATE AND OTHER CHARGES. *

2.1 Total Facility *

2.2 Loans *

2.3 Overlines; Overadvances *

2.4 [Intentionally Omitted] *

2.5 Loan Account *

2.6 Interest; Fees *

2.7 Default Interest Rate *

2.8 Examination Fee *

2.9 Excess Interest. *

2.10 Principal Payments; Proceeds of Collateral. *

2.11 Application of Collateral *

2.12 Application of Payments *

3. SECURITY. *

3.1 Security Interest in the Collateral *

3.2 Perfection and Protection of Security Interest *

3.3 Preservation of Collateral *

3.4 Insurance *

3.5 Collateral Reporting; Inventory. *

3.6 Receivables. *

3.7 Equipment *

3.8 Other Liens; No Disposition of Collateral *

3.9 Collateral Security *

3.10 Special Intellectual Property Provisions *

4. CONDITIONS OF CLOSING. *

4.1 Initial Advance *

4.2 Subsequent Advances *

5. REPRESENTATIONS AND WARRANTIES. *

5.1 Due Organization *

5.2 Other Names *

5.3 Due Authorization *

5.4 Binding Obligation *

5.5 Intangible Property *

5.6 Capital *

5.7 Material Litigation *

5.8 Title; Security Interests of FINOVA *

5.9 Restrictive Agreements; Labor Contracts *

5.10 Laws *

5.11 Consents *

5.12 Defaults *

5.13 Financial Condition *

5.14 ERISA *

5.15 Taxes *

5.16 Locations; Federal Tax ID No. *

5.17 Business Relationships *

5.18 Year 2000 Representations and Warranties *

5.19 Performance and Other Bonds *

5.20 Reaffirmations *

6. COVENANTS. *

6.1 Affirmative Covenants *

6.1.1 Taxes *

6.1.2 Notice of Litigation *

6.1.3 ERISA *

6.1.4 Change in Location *

6.1.5 Entity Existence *

6.1.6 Labor Disputes *

6.1.7 Violations of Law *

6.1.8 Defaults *

6.1.9 Capital Expenditures *

6.1.10 Books and Records *

6.1.11 Leases; Warehouse Agreements *

6.1.12 Additional Documents *

6.1.13 Financial Covenants *

6.1.14 Year 2000 Covenants *

6.1.15 Intangible Property *

6.1.16 Bank Accounts *

6.1.17 Minimum Loan Balances. *

6.2 Negative Covenants *

6.2.1 Mergers and Acquisitions *

6.2.2 Loans and Investments *

6.2.3 Dividends *

6.2.4 Adverse Transactions *

6.2.5 Indebtedness of Others *

6.2.6 Repurchase *

6.2.7 Name *

6.2.8 Prepayment *

6.2.9 Capital Expenditure *

6.2.10 Compensation *

6.2.11 Indebtedness *

6.2.12 Affiliate Transactions *

6.2.13 Nature of Business *

6.2.14 FINOVA's Name *

6.2.15 Margin Security *

6.2.16 Real Property *

6.2.17 Liens *

6.2.18 Change in Fiscal Year; Auditors *

6.2.19 Subordinated Documents in Certain Material Agreements *

6.2.20 Pharmacy Operation *

6.2.21 Self-Service Storage Facility. *

7. DEFAULT AND REMEDIES. *

7.1 Events of Default *

7.2 Remedies *

7.3 Standards for Determining Commercial Reasonableness *

8. EXPENSES AND INDEMNITIES *

8.1 Expenses *

8.2 Environmental Matters. *

9. MISCELLANEOUS. *

9.1 Examination of Records; Financial Reporting. *

9.2 Term; Termination. *

9.3 Recourse to Security; Certain Waivers *

9.4 No Waiver by FINOVA *

9.5 Binding on Successor and Assigns *

9.6 Severability *

9.7 Amendments; Assignments *

9.8 Integration *

9.9 Survival *

9.10 Evidence of Obligations *

9.11 Loan Requests *

9.12 Notices *

9.13 Brokerage Fees *

9.14 Disclosure *

9.15 Publicity *

9.16 Captions *

9.17 Injunctive Relief *

9.18 Counterparts; Facsimile Execution *

9.19 Construction *

9.20 Time of Essence *

9.21 Limitation of Actions *

9.22 Liability *

9.23 Notice of Breach by FINOVA *

9.24 Application of Insurance Proceeds *

9.25 Power of Attorney *

9.26 Governing Law; Waivers *

9.27 Mutual Waiver of Right to Jury Trial *

9.28 Lien Termination *

Exhibits

Exhibit A - Reporting Requirements

Exhibit 4.1 - Closing Agenda

Exhibit 5.5 - Intellectual Property

Exhibit 5.7 - Litigation

Exhibit 5.16 - Borrower Locations

Exhibit 6.1.16 - Bank Accounts

Exhibit 6.2.5 - Existing Guaranties

Exhibit 6.2.11 - Indebtedness

Exhibit 6.2.17 - Permitted Encumbrances

LOAN AND SECURITY AGREEMENT

THIS LOAN AND SECURITY AGREEMENT (collectively with the Schedule to Loan Agreement (the "Schedule") attached hereto, the "Agreement") dated the date set forth on the cover page, is entered into by and between the borrower named on the cover page (jointly and severally, the "Borrower"), whose address is set forth on the cover page and FINOVA Capital Corporation ("FINOVA"), whose address is 355 South Grand Avenue, Los Angeles, California 90071.

  1. DEFINITIONS.
    1. Defined Terms
    2. . As used in this Agreement, the following terms have the definitions set forth below:

      "Abbott" means Abbott Laboratories Inc., an Illinois corporation.

      "Additional Sums" has the meaning set forth in Section 2.9(a) hereof.

      "Affiliate" means any Person controlling, controlled by or under common control with any other Person. For purposes of this definition, "control" means the possession, directly or indirectly, of the power to direct or cause direction of the management and policies of any Person, whether through ownership of common or preferred stock or other equity interests, by contract or otherwise. Without limiting the generality of the foregoing, each of the following shall be an Affiliate with respect to Borrower and/or any Subsidiary of Borrower: any officer or director of Borrower or any Subsidiary of Borrower, any Material Shareholder (as defined below), member or Subsidiary of Borrower, and any other Person with whom or which Borrower has common Material Shareholders, officers or directors. As used herein, "Material Shareholder" shall mean any Person owning or controlling, directly or indirectly, in excess of 10% of the equity interests of Borrower or any Subsidiary of Borrower.

      "Agreement" has the meaning set forth in the preamble.

      "Applicable Usury Law" has the meaning set forth in Section 2.9(b) hereof.

      "Blocked Account(s)" means deposit accounts established for the benefit of, and under the exclusive dominion and control of FINOVA pursuant to an arrangement with such bank or financial institution as may be selected by Borrower and be acceptable to FINOVA.

      "Business Day" means any day on which commercial banks in both Los Angeles, California and Phoenix, Arizona are open for business.

      "Capital Expenditures" means all expenditures made and liabilities incurred in accordance with GAAP for the acquisition of any fixed asset or improvement, replacement, substitution or addition thereto which has a useful life of more than one year and including, without limitation, those arising in connection with Capital Leases.

      "Capital Lease" means any lease of property by Borrower that, in accordance with GAAP, should be capitalized for financial reporting purposes and reflected as a liability on the balance sheet of Borrower.

      "Cash Collateral" means cash and Cash Equivalents pledged to and under the exclusive dominion and control of FINOVA pursuant to the terms of the Control Agreement.

      "Cash Equivalents" means (a) marketable direct obligations issued by, or unconditionally guaranteed by, the United States government or issued by any agency thereof and backed by the full faith and credit of the United States, in each case maturing within thirty (30) days from the date of acquisition; (b) certificates of deposit, time deposits, eurodollar time deposits or overnight bank deposits having maturities of thirty (30) days or less from the date of acquisition issued by any commercial bank organized under the laws of the United States of America or any state thereof having combined capital and surplus of not less than $500,000,000; (c) repurchase obligations of any commercial bank satisfying the requirements of clause (b) of this definition, having a term of not more than thirty (30) days with respect to securities issued or fully guaranteed or insured by the United States government; (d) shares of money market mutual or similar funds which invest exclusively in assets satisfying the requirements of clauses (a) through (c) of this definition; or (e) commercial paper of an issuer rated at least A-1 by Standard and Poor's Ratings Services or P-1 by Moody's Investors Service, Inc., or carrying an equivalent rating by a nationally recognized rating agency, if both of the two named rating agencies cease publishing ratings of commercial paper issuers generally, and maturing within thirty (30) days from the date of acquisition.

      "Change of Control" means any of the following: (a) any person or group of persons (within the meaning of the Securities Exchange Act of 1934, as amended) shall have acquired beneficial ownership (within the meaning of Rule 13d-3 promulgated by the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended) of 51% or more of the issued and outstanding shares of capital Stock of Borrower having the right to vote for the election of directors of Borrower under ordinary circumstances; (b) during any period of twelve consecutive calendar months, individuals who at the beginning of such period constituted the board of directors of Borrower (together with any new directors whose election by the board of directors of Borrower or whose nomination for election by the stockholders of Borrower was approved by a vote of at least two-thirds of the directors then still in office who either were directors at the beginning of such period or whose elections or nomination for election was previously so approved) cease for any reason other than death or disability to constitute a majority of the directors then in office, or (c) except as provided in Section 6.2.20 hereof, Borrower shall cease to own and control at least ninety-five percent (95%) of the economic and voting rights associated with all of the outstanding capital Stock of any of its Subsidiaries.

      "Closing Date" means the date of the initial advance made by FINOVA pursuant to this Agreement.

      "Closing Fee" has the meaning set forth in the Schedule.

      "Code" means the Uniform Commercial Code as adopted and in effect in the State of Arizona from time to time.

      "Collateral" has the meaning set forth in Section 3.1 hereof.

      "Collateral Monitoring Fee" has the meaning set forth in the Schedule.

      "Compliance Certificate" has the meaning set forth in Section 9.1(b) hereof.

      "Control Agreement" means that certain Control Agreement among Borrower, FINOVA and Wells Fargo Bank, N.A. dated as or about the date hereof, as amended from time to time, pursuant to which Borrower shall, from time to time, deposit and maintain Cash Collateral pledged to and under the exclusive dominion and control of FINOVA to permit Borrower to receive Revolving B Credit Loans pursuant to Section 2.2.

      "Co-Promotion Agreement" means that certain Co-Promotion Agreement dated May 7, 1999 between Abbott and Borrower.

      "DDN" means DDN/Obergfel, LLC, a Wisconsin limited liability company.

      "DDN Distribution Agreement" means that certain Distribution Agreement dated as of January 19, 2000 between DDN and Borrower.

      "DDN Receivables" has the meaning set forth in Section 2.10(b).

      "Deposit Accounts" has the meaning set forth in Section 9105 of the Code.

      "Dilution" means with respect to Trade Receivables as a class, based on the experience of the immediately prior twelve (12) months, the result of dividing the dollar amount of (a) non-cash Receivables reductions, such as bad debt write-downs, discounts outside of the ordinary course of business, advertising outside of the ordinary course of business, returns, promotions, credits, or other dilution with respect to the Receivables by (b) Borrower's gross sales with respect to all Receivables (excluding extraordinary items) plus the dollar amount of clause (a).

      "Dilution Reserve" means a Loan Reserve established by FINOVA in an amount equal to the product of (x) the amount by which Dilution in respect of Borrower's Trade Receivables exceeds five percent (5%) (expressed as a percentage with one decimal place), based upon a twelve (12) month rolling average, or such other period as the Borrower and FINOVA shall agree, with such amount to be calculated based upon the results of each audit examination by FINOVA, multiplied by (y) the aggregate of Borrower's Eligible Trade Receivables then outstanding (based upon Borrower's monthly Collateral reports); which amount shall reduce the amount of Revolving A Credit Loans which would otherwise be available to Borrower under the formula set forth in Section 2.2 of the Schedule to this Agreement.

      "Dominion Account(s)" means depository accounts in the name of FINOVA at a bank or financial institution maintained by FINOVA for the receipt of collateral proceeds and payments.

      "Earnings Before Interest, Taxes, Depreciation and Amortization" for any fiscal period of Borrower means the net income of Borrower for such fiscal period, plus interest expense, depreciation and amortization and provision for income taxes for such fiscal period, and minus non-recurring miscellaneous income and expenses, all calculated in accordance with GAAP.

      "Eli Lilly" means Eli Lilly and Company, an Indiana corporation.

      "Eligible Inventory" means Inventory which FINOVA, in its Permitted Discretion, deems Eligible Inventory, based on such considerations as FINOVA may from time to time deem appropriate. Without limiting the generality of the foregoing, no Inventory shall be Eligible Inventory unless, in FINOVA's Permitted Discretion, such Inventory (i) consists of raw materials and finished goods, in good, new and salable condition which have at least six months of usable shelf life prior to the expiration date for use for manufacturing Borrower's products or sale for ultimate consumer use, (ii) is not obsolete, unmerchantable, slow moving, returned, damaged and/or defective, (iii) is not comprised of work in process, packaging materials or supplies; (iv) meets all standards imposed by any Governmental Authority; (v) conforms in all respects to the warranties and representations set forth herein; (vi) is at all times subject to FINOVA's duly perfected, first priority security interest; and (v) is situated at a location for which Borrower has delivered to FINOVA an executed landlord, bailee or related agreement, in form and substance acceptable to FINOVA. Notwithstanding the foregoing or anything to the contrary in this Agreement, in no event shall (I) Inventory situated at any Pharmacy Operation location or any location operated by Abbott or any of its Subsidiaries be Eligible Inventory; (II) any finished goods Inventory consisting of pharmaceutical products which have not yet received Regulatory Approval (provided that upon receipt of such Regulatory Approval, such Inventory will no longer be excluded under this clause II); or (III) Inventory consisting of any SangCya product be Eligible Inventory unless FINOVA shall have received an agreement with Abbott deemed acceptable to FINOVA in its sole discretion which provides FINOVA and its agents and/or assignees with a royalty free license and right to sell and/or dispose of all SangCya product and related inventory without payment to or restriction by Abbott or its assignees.

      "Eligible Receivable(s)" means collectively, the Eligible Trade Receivables and individually, any Eligible Trade Receivable.

      "Eligible Trade Receivables" means Trade Receivables arising in the ordinary course of Borrower's business from the sale of goods or rendition of services, which FINOVA, in its Permitted Discretion, shall deem eligible based on such considerations as FINOVA may from time to time deem appropriate. Without limiting the foregoing, a Trade Receivable shall not be deemed to be an Eligible Receivable if (i) the account debtor has failed to pay the Trade Receivable within a period of ninety (90) days after invoice date, to the extent of any amount remaining unpaid after such period; (ii) the account debtor has failed to pay more than 25% of all outstanding Trade Receivables owed by it to Borrower within ninety (90) days after invoice date; (iii) the account debtor is an Affiliate of Borrower; (iv) the goods relating thereto are placed on consignment, guaranteed sale, "bill and hold," "COD" or other terms pursuant to which payment by the account debtor may be conditional; (v) the account debtor is not located in the United States or Ontario, Canada, unless the Trade Receivable is supported by a letter of credit or other form of guaranty or security, in each case in form and substance satisfactory to FINOVA; (vi) the account debtor is the United States or any department, agency or instrumentality thereof or any State, city or municipality of the United States, except to the extent that the requirements of Section 6.1.12 have been satisfied; provided, that notwithstanding the foregoing, no Trade Receivable owed to Borrower by the Veterans Administration will be deemed ineligible for failure to comply with the provisions of Section 6.1.12 hereof for a period of sixty (60) days from the Closing Date, it being understood and agreed that after such sixty (60) day period, all such Veterans Administration Trade Receivables shall become ineligible unless and until Borrower shall have so complied with the provisions of Section 6.1.12 hereof with respect to such Veterans Administration Trade Receivables; (vii) Borrower is or may become liable to the account debtor for goods sold or services rendered by the account debtor to Borrower; (viii) the account debtor's total obligations to Borrower exceed 15% of all Eligible Trade Receivables, to the extent of such excess; provided however, that with respect to each of McKessonHBOC, Bindley Western Industries, Inc. and Cardinal Health, Inc., such account debtor's total obligations to Borrower exceed 45% (or such higher percentage as FINOVA in its sole discretion shall determine) of all Eligible Trade Receivables, to the extent of such excess and that with respect to each of Bergen Brunswig Corporation and Amerisource Corporation, such account debtor's total obligations to Borrower exceed 25% (or such higher percentage as FINOVA in its sole discretion shall determine) of all Eligible Trade Receivables, to the extent of such excess; (ix) the account debtor disputes liability or makes any claim with respect thereto (up to the amount of such liability or claim), or is subject to any insolvency or bankruptcy proceeding, or becomes insolvent, fails or goes out of a material portion of its business; (x) the amount thereof consists of late charges or finance charges; (xi) the amount thereof consists of a credit balance more than ninety (90) days past due; (xii) the face amount thereof exceeds $250,000, unless accompanied by evidence of shipment of the goods relating thereto satisfactory to FINOVA in its Permitted Discretion; (xiii) the invoice constitutes a progress billing on a project not yet completed, except that the final billing at such time as the matter has been completed and delivered to the customer may be deemed an Eligible Trade Receivable; (xiv) the amount thereof is not yet represented by an invoice or bill issued in the name of the applicable account debtor; (xv) the amount thereof is denominated in or payable with any currency other than U.S. Dollars; (xvi) such Trade Receivable is not at all times subject to FINOVA's duly perfected first priority security interest; or (xvii) the account debtor is Abbott or any of its Subsidiaries.

      "Equipment" means all of Borrower's present and hereafter acquired machinery, molds, machine tools, motors, furniture, equipment, furnishings, fixtures, trade fixtures, motor vehicles, tools, parts, dyes, jigs, goods and other tangible personal property (other than Inventory) of every kind and description used in Borrower's operations or owned by Borrower and any interest in any of the foregoing, and all attachments, accessories, accessions, replacements, substitutions, additions or improvements to any of the foregoing, wherever located.

      "ERISA" means the Employee Retirement Income Security Act of 1974, as amended, and the regulations thereunder.

      "ERISA Affiliate" means each trade or business (whether or not incorporated and whether or not foreign) which is or may hereafter become a member of a group of which Borrower is a member and which is treated as a single employer under ERISA Section 4001(b)(1), or IRC Section 414.

      "Event of Default" means any of the events set forth in Section 7.1 of this Agreement.

      "Examination Fee" has the meaning set forth in the Schedule.

      "Excess Availability" means, as of the date of determination thereof, the amount by which the average daily total principal balance of the Revolving Credit Loans which Borrower would have been permitted to have outstanding over the prior 30 days (and as of the proposed date of any subject payment), based on the formulas and reserves set forth in the Schedule, exceeds the sum of the Revolving Credit Loans then actually outstanding, such excess then being reduced by an amount necessary to provide for the payment of all accounts payable of Borrower which are more than 30 days past due date and all book overdrafts.

      "FDA" means the U.S. Food and Drug Administration and any successor thereto.

      "FINOVA Affiliate" has the meaning set forth in Section 9.22 hereof.

      "Holding Account" means an account established in the name of Borrower at a bank or financial institution acceptable to FINOVA with respect to which FINOVA, Borrower and such bank or financial institution shall have entered into a depository account agreement or similar control agreement which shall provide FINOVA a security interest in such account and all amounts on deposit therein and, following the occurrence of any Event of Default, permit FINOVA to assume exclusive dominion and control over such account.

      "GAAP" means generally accepted accounting principles in the United States of America as in effect from time to time as set forth in the opinions and pronouncements of the Accounting Principles Board and the American Institute of Certified Public Accountants and the statements and pronouncements of the Financial Accounting Standards Boards which are applicable to the circumstances as of the date of determination consistently applied, except that, for the financial covenants set forth in this Agreement, GAAP shall be determined on the basis of such principles in effect on the date hereof and consistent with those used in the preparation of the audited financial statements delivered to FINOVA prior to the date hereof.

      "General Intangibles" means all general intangibles of Borrower, whether now owned or hereafter created or acquired by Borrower, including, without limitation, all choses in action, causes of action, corporate or other business records, Deposit Accounts, inventions, designs, drawings, blueprints, Trademarks, Copyrights, Licenses and Patents, names, trade secrets, goodwill, copyrights, registrations, licenses, franchises, customer lists, security and other deposits, rights in all litigation presently or hereafter pending for any cause or claim (whether in contract, tort or otherwise), and all judgments now or hereafter arising therefrom, all claims of Borrower against FINOVA, rights to purchase or sell real or personal property, rights as a licensor or licensee of any kind, royalties, telephone numbers, proprietary information, purchase orders, and all insurance policies and claims (including without limitation credit, liability, property and other insurance), tax refunds and claims, computer programs, discs, tapes and tape files, claims under guaranties, security interests or other security held by or granted to Borrower to secure payment of any of the Receivables by an account debtor, all contractual rights, all rights under Provider Agreements, all rights to indemnification and all other intangible property of every kind and nature (other than Receivables).

      "Governmental Authority" means any nation or government, governmental agency or instrumentality, state or other political subdivision thereof and any entity exercising executive, legislative, judicial, regulatory or administrative functions of or pertaining to government; including, without limitation, HCFA and state Medicaid administrative agencies.

      "Governmental Receivables" shall mean Receivables where the Payor is the United States of America, a state, or any agency or instrumentality thereof which is obligated to make any payments with respect to Medicare, Medicaid, or other Receivables representing amounts owing under any other program established by federal or state law which requires that payments for healthcare services or goods rendered to individuals be made to the providers of such services (including CHAMPUS as set forth in Title 10 U.S.C. Section 1071 et. seq., and the program set forth in Title 38 U.S.C. Section 1713).

      "Indebtedness" means all of Borrower's present and future obligations, liabilities, debts, claims and indebtedness, contingent, fixed or otherwise, however evidenced, created, incurred, acquired, owing or arising, whether under written or oral agreement, operation of law or otherwise, and includes, without limiting the foregoing (i) the Obligations, (ii) obligations and liabilities of any Person secured by a lien, claim, encumbrance or security interest upon property owned by Borrower, even though Borrower has not assumed or become liable therefor, (iii) obligations and liabilities created or arising under any lease (including Capital Leases) or conditional sales contract or other title retention agreement with respect to property used or acquired by Borrower, even though the rights and remedies of the lessor, seller or lender are limited to repossession, (iv) all unfunded pension fund obligations and liabilities and (v) deferred tax liabilities.

      "Indebtedness for Borrowed Money" means without duplication, all Indebtedness: (i) in respect of borrowed money (including, without limitation, pursuant to the Loan Documents or any Capital Leases), (ii) evidenced by a note, debenture, or other like written obligation to pay money (including, without limitation, all interest on the Obligations), (iii) for the deferred purchase price of property (other than trade payables arising in the ordinary course of business), or (iv) in respect of obligations under conditional sales or other title retention agreements; and all guaranties of any or all of the foregoing.

      "Initial Term" has the meaning set forth on the Schedule.

      "Insurer" means any Person which in the ordinary course of its business or activities agrees to pay for healthcare goods and services received by individuals, including, without limitation, a commercial insurance company, a non-profit insurance company (such as a Blue Cross/Blue Shield entity), an employer or union which self-insures for employee or member health insurance, a prepaid healthcare organization, a preferred provider organization, group purchasing organization and a health maintenance organization. "Insurer" includes, without limitation, insurance companies issuing health, personal injury, worker's compensation or other types of insurance, corporations, hospitals and third party intermediaries but does not include any individual guarantors or employee benefit plans.

      "Inventory" means all of Borrower's now owned and hereafter acquired goods, merchandise or other personal property, wherever located, to be furnished under any contract of service or held for sale or lease, all raw materials, work in process, finished goods and materials and supplies of any kind, nature or description which are or might be used or consumed in Borrower's business or used in connection with the manufacture, packing, shipping, advertising, selling or finishing of such goods, merchandise or other personal property, and all documents of title or other documents representing them.

      "Inventory Loans" has the meaning set forth in the Schedule.

      "IRC" means the Internal Revenue Code of 1986, as amended, and the regulations thereunder.

      "Lien" means any mortgage, pledge, assignment, lien, charge, encumbrance or security interest of any kind, or the interest of a vendor or lessor under any conditional sale agreement, Capitalized Lease or title retention agreement.

      "Liquidity" means, as of the date of determination thereof, the amount by which the sum of (A) the average daily total principal balance of the Revolving Credit Loans which Borrower would have been permitted to have outstanding over the prior thirty (30) days (and as of the proposed date of any subject payment), based on the formulas and reserves set forth in this Agreement, and (B) all Unencumbered Cash of Borrower, exceeds the sum of the Revolving Credit Loans then actually outstanding, such excess then being reduced by an amount necessary to provide for the payment of all accounts payable of Borrower which are more than thirty (30) days past due date and all book overdrafts.

      "Loan Documents" means, collectively, this Agreement, any note or notes executed by Borrower and payable to FINOVA, and any other present or future agreement entered into in connection with this Agreement, together with all alterations, amendments, changes, extensions, modifications, refinancings, refundings, renewals, replacements, restatements, or supplements, of or to any of the foregoing.

      "Loan Party" means Borrower and each other Affiliate of Borrower party (other than FINOVA) to any Loan Document.

      "Loan Reserves" means, as of any date of determination, such amounts as FINOVA may from time to time establish and revise in its Permitted Discretion reducing the amount of Revolving Credit Loans which would otherwise be available to Borrower under the lending formula(s) provided in the Schedule: (a) to reflect events, conditions, contingencies or risks which, as determined by FINOVA in good faith, do or may materially affect either (i) the Collateral or any other property which is security for the Obligations or its value, (ii) the assets, business or prospects of Borrower or any Loan Party or (iii) the security interests and other rights of FINOVA in the Collateral (including the enforceability, perfection and priority thereof) or (b) to reflect FINOVA's good faith belief that any collateral report or financial information furnished by or on behalf of Borrower or any Loan Party to FINOVA is or may have been materially incomplete, inaccurate or misleading in any material respect or (c) in respect of any state of facts which FINOVA determines in good faith constitutes an Event of Default or may, with notice or passage of time or both, constitute an Event of Default. Without in any way limiting the foregoing, the Loan Reserves shall include, without limitation, the Dilution Reserve and the Special Reserve.

      "Loan Year" means each twelve month period commencing on the Closing Date.

      "Loans" has the meaning set forth in Section 2.2 hereof.

      "Lock Box" has the meaning set forth in Section 2.10(b) hereof.

      "Lock Box Agreement" means an agreement between FINOVA and a financial institution acceptable to FINOVA governing a lockbox (and any related depository account) titled in the name of Borrower which shall provide FINOVA with a security interest in and exclusive domain and control over such lockbox (and/or any related depository account) and all cash and other items received or deposited therein. The terms of such Lock Box Agreement shall provide, inter alia, that until the occurrence of an Event of Default, FINOVA shall direct that all cash proceeds from such lockbox (and/or any related depository account) to be transferred to a Holding Account; provided that FINOVA, in its sole discretion, may, without notice, change such direction at any time after the occurrence of an Event of Default.

      "Material Judgement" shall mean any final judgment rendered against Borrower or any of its Subsidiaries which has not been bonded or stayed pending appeal and which (i) requires the payment of more than $250,000 by Borrower or its Subsidiaries (after deducting therefrom all amounts for which, in the reasonable opinion of FINOVA, applicable insurance coverage is then payable) and is not satisfied in full within thirty (30) days after entry, (ii) materially adversely affects the priority or value of FINOVA's liens on the Collateral, (iii) awards equitable relief enjoining or materially restricting Borrower's ability to acquire, produce and/or distribute any of its products, or (iv) results in a material and adverse affect on Borrower's and its Subsidiaries business, assets, operations, prospects or condition (financial or otherwise), taken as a whole.

      "Maximum Interest Rate" has the meaning set forth in Section 2.9(b) hereof.

      "Minimum Interest Charge" has the meaning set forth in the Schedule.

      "Minimum Liquidity Amount" shall mean for any date of determination an amount equal to 120% of the amount of Liquidity of Borrower required for compliance with the Liquidity covenant set forth in Section 6.1.13 of the Schedule to this Agreement.

      "Multiemployer Plan" means a "multiemployer plan" as defined in ERISA Sections 3(37) or 4001(a)(3) or IRC Section 414(f) which covers employees of Borrower or any ERISA Affiliate.

      "Obligations" means all present and future loans, advances, debts, liabilities, obligations, covenants, duties and indebtedness at any time owing by Borrower to FINOVA, whether evidenced by this Agreement, any note or other instrument or document, whether arising from an extension of credit, opening of a letter of credit, banker's acceptance, loan, guaranty, indemnification or otherwise, whether direct or indirect (including, without limitation, those acquired by assignment and any participation by FINOVA in Borrower's debts owing to others), absolute or contingent, due or to become due, including, without limitation, all interest, charges, expenses, fees, attorney's fees, expert witness fees, Examination Fee, Collateral Monitoring Fee, Closing Fee, Termination Fee and any other fees or sums chargeable to Borrower hereunder or under any other agreement with FINOVA.

      "Overadvance" has the meaning set forth in Section 2.3.

      "Overline" has the meaning set forth in Section 2.3.

      "Payor" shall mean any Insurer, any Governmental Authority and any other Person that is responsible for payment for all or any portion of a Receivable.

      "PBGC" means the Pension Benefit Guarantee Corporation.

      "Permitted Discretion" means FINOVA's judgment exercised in good faith based upon its consideration of any factor which FINOVA believes in good faith: (i) will or could materially adversely affect the value of any Collateral, the enforceability or priority of FINOVA's liens thereon or the amount which FINOVA would be likely to receive (after giving consideration to delays in payment and costs of enforcement) in the liquidation of such Collateral; (ii) suggests that any collateral report or financial information delivered to FINOVA by any Person on behalf of the Borrower is incomplete, inaccurate or misleading in any material respect; (iii) materially increases the likelihood of a bankruptcy, reorganization or other insolvency proceeding involving the Borrower, any Loan Party or any of the Collateral, or (iv) creates or reasonably could be expected to create an Event of Default. In exercising such judgment, FINOVA may consider such factors already included in or tested by the definition of Eligible Receivables or Eligible Inventory, as well as any of the following: (i) the financial and business climate of the Borrower's industry and general macroeconomic conditions, (ii) changes in collection history and dilution with respect to the Receivables, (iii) changes in demand for, and pricing of, Inventory, (iv) changes in any concentration of risk with respect to Receivables and/or Inventory, and (v) any other factors that change the credit risk of lending to the Borrower on the security of the Receivables and Inventory. The burden of establishing lack of good faith hereunder shall be on the Borrower.

      "Permitted Encumbrance" means (i) Liens existing as of the Closing Date set forth on Exhibit 6.2.17 hereto; (ii) Liens created after the date hereof by conditional sale or other title retention agreements (including Capital Leases) or in connection with purchase money Indebtedness with respect to Equipment acquired by any Borrower in the ordinary course of business in which the vendor of such Equipment finances at least 75% of the invoiced cost of such Equipment and involving the incurrence of an aggregate amount of purchase money Indebtedness and Capital Lease Obligations of not more than $250,000 outstanding at any one time for all such Liens (provided that such Liens attach only to the assets subject to such purchase money debt and such Indebtedness is incurred within sixty (60) days following such purchase and does not exceed 100% of the purchase price of the subject assets); and (iii) any other Liens or encumbrances which are expressly permitted by Section 3.10(a) hereof or which may be permitted by FINOVA in writing from time to time.

      "Permitted Liens" means any of the following Liens: (i) Liens in the Collateral granted to FINOVA; (ii) Liens for taxes or assessments and similar charges, which either are (a) not delinquent or (b) being contested diligently and in good faith by appropriate proceedings, and as to which Borrower has set aside reserves on its books in accordance with GAAP; (iii) statutory Liens, such as mechanic's, materialman's, warehouseman's, carrier's or other like Liens, incurred in good faith in the ordinary course of business, provided that the underlying obligations relating to such Liens are paid in the ordinary course of business, or are being contested diligently and in good faith by appropriate proceedings and as to which Borrower has set aside reserves on its books in accordance with GAAP, or the payment of which obligations are otherwise secured in a manner satisfactory to FINOVA; (iv) zoning ordinances, easements, licenses, reservations, provisions, covenants, conditions, waivers or restrictions on the use of property and other title exceptions, in each case, that are acceptable to FINOVA; (v) Liens to secure payment of insurance premiums (a) to be paid in accordance with applicable laws in the ordinary course of business relating to payment of worker's compensation, or (b) that are required for the participation in any fund in connection with worker's compensation, unemployment insurance, old-age pensions or other social security programs; and (vi) Permitted Encumbrances.

      "Person" means any individual, sole proprietorship, partnership, joint venture, trust, unincorporated organization, association, corporation, limited liability company, government, or any agency or political division thereof, or any other entity.

      "Pharmacy Operation" means Borrower's "Transplant Pharmacy" operation which provides retail and mail-order distribution of pharmaceutical and related products and services and shall include the "PRA Stat" and "Crea Stat" product lines.

      "Pharmacy Subsidiary" has the meaning set forth in Section 6.2.20(i) hereof.

      "Plan" means any plan described in ERISA Section 3(2) maintained for employees of Borrower or any ERISA Affiliate, other than a Multiemployer Plan.

      "Pledgors" has the meaning set forth in Section 4.1(cc) hereof.

      "Prepared Financials" means the balance sheets of Borrower as of December 31, 1998, and as of each subsequent date on which audited balance sheets are delivered to FINOVA from time to time hereunder, and the related statements of operations, changes in stockholders' equity and changes in cash flow for the periods ended on such dates.

      "Prime Rate" has the meaning set forth in the Schedule.

      "Prohibited Transaction" means any transaction described in ERISA Section 406 which is not exempt by reason of ERISA Section 408, and any transaction described in IRC Section 4975(c) which is not exempt by reason of IRC Section 4062(e).

      "Provider Agreements" means all agreements, certifications, reimbursement contracts, and other contracts and agreements required for or relating to the sale, distribution and/or provision of Borrower's products and/or services, whether now existing or hereafter issued to Borrower by, and/or entered into by Borrower with any Person.

      "Receivable Loans" has the meaning set forth on the Schedule.

      "Receivables" or "Receivable" means all of Borrower's now owned and hereafter acquired accounts (whether or not earned by performance), proceeds of any letters of credit naming Borrower as beneficiary, contract rights, chattel paper, instruments, documents and all other forms of obligations at any time owing to Borrower, all guaranties and other security therefor, whether secured or unsecured, all merchandise returned to or repossessed by Borrower, and all rights of stoppage in transit and all other rights or remedies of an unpaid vendor, lienor or secured party. Receivables includes all accounts and general intangibles, all rights, remedies, guaranties, security interests and liens, all records (other than medical records, unless patient consents with respect thereto have been received) and other property evidencing any and all proceeds which relating to or are associated with such Receivables subject to the confidentiality rights under applicable law.

      "Regulated Inventory" shall have the meaning set forth in Section 7.3 hereof.

      "Regulatory Approval" means the FDA approval of the Abbreviated New Drug Application required by the FDA to commercially market a pharmaceutical product in the United States.

      "Renewal Term" has the meaning set forth on the Schedule.

      "Reportable Event" means a reportable event described in ERISA Section 4043 or the regulations thereunder for which notice to the PBGC is not waived under the applicable regulations, a withdrawal from a plan described in ERISA Section 4063, or a cessation of operations described in ERISA Section 4062(e).

      "Retained Rights" means, with respect to any Governmental Receivable (except to the extent the obligor thereon may be required, pursuant to a court-ordered assignment which is valid, binding and enforceable under applicable Medicare and Medicaid laws, rules and regulations to make payments directly to a Person other than Borrower as the provider of the services giving rise thereto), the rights of Borrower to collect and receive direct payment from the Governmental Authority obligated in respect of such Governmental Receivable and, as applicable, to enforce the claim giving rise thereto against any federal Governmental Authority; provided, however, that even in the absence of such a court-ordered assignment, the "Retained Rights" shall not include the right of Borrower to retain the collections on any Government Receivable once payment thereon has been made to Borrower as the provider of the services giving rise thereto or to a lock-box or account under Borrower's dominion and control.

      "Revolving A Credit Loans" has the meaning set forth in the Schedule.

      "Revolving A Credit Limit" has the meaning set forth in the Schedule.

      "Revolving A Interest Rate" has the meaning set forth in the Schedule.

      "Revolving B Credit Loans" has the meaning set forth in the Schedule.

      "Revolving B Credit Limit" has the meaning set forth in the Schedule.

      "Revolving B Interest Rate" has the meaning set forth in the Schedule.

      "Revolving Credit Loans" shall mean collectively, the Revolving A Credit Loans and the Revolving B Credit Loans and, individually, any Revolving A Credit Loan or any Revolving B Credit Loans.

      "Rx Receivable" means a Receivable generated by Borrower pursuant to its Pharmacy Operation.

      "Schedule" has the meaning set forth in the preamble.

      "Self-Service Storage Facility" means the self-service storage facility operated by Door to Door Storage, Inc. in Union City, California where certain of the Collateral is stored.

      "Special Reserve" means (i) $5,000,000 at all times prior to the date on which Gengraf receives approval by the Federated Drug Administration ("FDA") for distribution in the United States (or, if earlier, the date on which Sang 2000 receives such FDA approval), (ii) $1,000,000 during the period from and after the date Gengraf receives FDA approval for distribution in the United States (or, if earlier, the date on which Sang 2000 receives such FDA approval), until FINOVA receives Borrower's financial statements evidencing that Borrower's Annualized EBITDA tested on a quarterly basis equals or exceeds $3,500,000 (such date, the "End Date") and (iii) zero ($0) from and after the End Date.

      "Start Date" has the meaning set forth in the Schedule.

      "Stock" shall mean all shares, options, warrants, general or limited partnership interests or other equivalents (regardless of how designated) of or in a corporation, partnership or equivalent entity whether voting or nonvoting, including common stock, preferred stock or any other "equity security" (as such term is defined in Rule 3a11-1 of the General Rules and Regulations promulgated by the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended).

      "Stock Pledge Agreements" has the meaning set forth in Section 4.1(cc) hereof.

      "Subordinated Debt" means unsecured liabilities of Borrower (including, without limitation, unsecured debt securities convertible into shares of common equity of Borrower), (a) the repayment of which is subordinated to the payment and performance of the Obligations, pursuant to a subordination arrangement acceptable to FINOVA, (b) having no principal amortization or sinking fund requirements; (b) having an expiry date not earlier than five (5) years from the date of issuance thereof; and (d) having terms and conditions which provide (x) the holders thereof only a default upon acceleration of the Obligations (but not upon the occurrence of a mere Event of Default) and (y) financial covenants which, if similar to those set forth in this Agreement, shall be set a levels at least 15% less restrictive than the levels set forth in this Agreement (it being understood that the foregoing restriction will not apply to the other financial covenants proposed in such Subordinated Debt which are not substantially similar to the financial covenants set forth in this Agreement).

      "Subsidiary" shall mean, with respect to any Person, (a) any corporation of which an aggregate of more than fifty percent (50%) of the outstanding Stock having ordinary voting power to elect a majority of the board of directors of such corporation (irrespective of whether, at the time, Stock of any other class or classes of such corporation shall have or might have voting power by reason of the happening of any contingency) is at the time, directly or indirectly, owned legally or beneficially by such Person and/or one or more Subsidiaries of such Person, or with respect to which any such Person has the right to vote or designate the vote of fifty percent (50%) or more of such Stock whether by proxy, agreement, operation of law or otherwise, and (b) any partnership or limited liability company in which such Person and/or one or more Subsidiaries of such Person shall have an interest (whether in the form of voting or participation in profits or capital contribution) of more than fifty percent (50%) or of which any such Person is a general partner or may exercise the powers of a general partner.

      "Termination Fee" has the meaning set forth in Section 9.2(d) hereof.

      "Total Facility" has the meaning set forth in Section 2.1 hereof.

      "Trade Receivable" means any Receivable not constituting a Rx Receivable or a Governmental Receivable.

      "Trademarks, Copyrights, Licenses and Patents" means, as to Borrower or any of its Subsidiaries, all of such Person's right, title and interest in and to, whether now owned or hereafter acquired: (i) trademarks, trademark registrations, trade names, trade name registrations, and trademark or trade name applications, including without limitation such as are listed on the Schedule or any of the other Loan Documents, as the same may be amended from time to time, and (a) renewals thereof, (b) all income, royalties, damages and payments now and hereafter due and/or payable with respect thereto, including without limitation, payments under all licenses entered into in connection therewith and damages and payments for past or future infringements thereof, (c) the right to sue for past, present and future infringements thereof, (d) all rights corresponding thereto throughout the world, and (e) the goodwill of the business operated by such Person connected with and symbolized by any trademarks or trade names; (ii) copyrights, copyright registrations and copyright applications, including without limitation such as are listed on the Schedule attached hereto and made a part hereof, as the same may be amended from time to time, and (a) renewals thereof, (b) all income, royalties, damages and payments now and hereafter due and/or payable with respect thereto, including without limitation, damages and payments for past or future infringements thereof, (c) the right to sue for past, present and future infringements thereof, and (d) all rights corresponding thereto throughout the world; (iii) license agreements, including without limitation such as are listed on the Schedule attached hereto and made a part hereof, and the right to prepare for sale, sell and advertise for sale any inventory now or hereafter owned by such Person and now or hereafter covered by such licenses; and (iv) patents and patent applications, registered or pending, including without limitation such as are listed on the Schedule or any of the other Loan Documents, as the same may be amended from time to time, and (a) all reissues, divisions, continuations, renewals, extensions and continuations-in-part thereof, (b) all income, royalties, shop rights, damages and payments with respect thereto, including without limitation, payments under all licenses entered into in connection therewith and damages and payments for past or future infringements thereof, (c) the right to sue for past, present and future infringements thereof, and (d) all rights corresponding thereto throughout the world.

      "Trigger Event(s)" means the occurrence of any Event of Default or any event with the passage of time or the giving of notice or both would constitute an Event of Default.

      "Unused Line Fee" has the meaning set forth in the Schedule.

      "Unencumbered Cash" shall mean cash or Cash Equivalents of Borrower which are not subject to any Lien in favor of any Person or restricted in use in any way.

    3. Other Terms.

    All accounting terms used in this Agreement, unless otherwise indicated, shall have the meanings given to such terms in accordance with GAAP. All other terms contained in this Agreement, unless otherwise indicated, shall have the meanings provided by the Code, to the extent such terms are defined therein.

  2. LOANS; INTEREST RATE AND OTHER CHARGES.
    1. Total Facility
    2. . Upon the terms and conditions set forth herein, FINOVA shall, upon Borrower's request, make advances to Borrower from time to time in an aggregate outstanding principal amount not to exceed the Total Facility amount (the "Total Facility") set forth on the Schedule hereto, subject to deduction for Loan Reserves as FINOVA deems proper from time to time in its Permitted Discretion, and less amounts FINOVA may be obligated to pay in the future on behalf of Borrower; provided, however, in no event shall any Revolving A Credit Loans be available to Borrower unless (i) Borrower shall have at all times Revolving B Credit Loans outstanding in a principal amount of not less than Seven Million Five Hundred Thousand Dollars ($7,500,000), and (ii) Borrower shall have satisfied the conditions set forth in Section 1 of "Additional Provisions" in the Schedule. The Schedule is an integral part of this Agreement and all references to "herein", "herewith" and words of similar import shall for all purposes be deemed to include the Schedule.

    3. Loans
    4. . Advances under the Total Facility ("Loans" and individually, a "Loan") shall be comprised of the amounts shown on the Schedule.

    5. Overlines; Overadvances
    6. . If at any time or for any reason the outstanding amount of advances extended or issued pursuant hereto exceeds any of the dollar limitations ("Overline") or percentage limitations ("Overadvance") in the Schedule, then Borrower shall, upon FINOVA's demand, immediately pay to FINOVA, in cash, the full amount of such Overline or Overadvance which, at FINOVA's option, may be applied to reduce the outstanding principal balance of the Loans or any other Obligations. Without limiting Borrower's obligation to repay to FINOVA on demand the amount of any Overline or Overadvance, Borrower agrees to pay FINOVA interest on the outstanding principal amount of any Overline or Overadvance, on demand, at the rate set forth on the Schedule and applicable to the Revolving Credit Loans.

    7. [Intentionally Omitted]
    8. Loan Account
    9. . All advances made hereunder shall be added to and deemed part of the Obligations when made. FINOVA may from time to time charge all Obligations of Borrower to Borrower's loan account with FINOVA.

    10. Interest; Fees
    11. . Borrower shall pay FINOVA interest on the daily outstanding balance of the Obligations at the per annum rate set forth on the Schedule. Borrower shall also pay FINOVA the fees set forth on the Schedule.

    12. Default Interest Rate
    13. . Upon the occurrence and during the continuation of an Event of Default, Borrower shall pay FINOVA interest on the daily outstanding balance of the Obligations at a rate per annum which is four percent (4%) in excess of the rate which would otherwise be applicable thereto pursuant to the Schedule.

    14. Examination Fee
    15. . Borrower agrees to pay to FINOVA the Examination Fee in the amount set forth on the Schedule in connection with each audit or examination of Borrower performed by FINOVA prior to or after the date hereof. Without limiting the generality of the foregoing, Borrower shall pay to FINOVA an initial Examination Fee in an amount equal to the amount set forth on the Schedule. Such initial Examination Fee shall be deemed fully earned at the time of payment and due and payable upon the closing of this transaction, and shall be deducted from any good faith deposit paid by Borrower to FINOVA prior to the date of this Agreement.

    16. Excess Interest.
        1. The contracted for rate of interest of the loan contemplated hereby, without limitation, shall consist of the following: (i) the interest rate set forth on the Schedule, calculated and applied to the principal balance of the Obligations in accordance with the provisions of this Agreement; (ii) interest after an Event of Default, calculated and applied to the amount of the Obligations in accordance with the provisions hereof; and (iii) all Additional Sums (as herein defined), if any. Borrower agrees to pay an effective contracted for rate of interest which is the sum of the above-referenced elements. The Examination Fee, attorneys fees, expert witness fees, Collateral Monitoring Fees, Closing Fees, Termination Fees, other fees, charges, goods, things in action or any other sums or things of value paid or payable by Borrower, whether pursuant to this Agreement or any other documents or instruments in any way pertaining to this lending transaction, or otherwise with respect to this lending transaction, that under any applicable law may be deemed to be interest with respect to this lending transaction, for the purpose of any applicable law that may limit the maximum amount of interest to be charged with respect to this lending transaction (collectively, the "Additional Sums"), shall be payable by Borrower as, and shall be deemed to be, additional interest and for such purposes only, the agreed upon and "contracted for rate of interest" of this lending transaction shall be deemed to be increased by the rate of interest resulting from the inclusion of the Additional Sums.
        2. It is the intent of the parties to comply with the usury laws of the State of Arizona (the "Applicable Usury Law"). Accordingly, it is agreed that notwithstanding any provisions to the contrary in this Agreement, or in any of the documents securing payment hereof or otherwise relating hereto, in no event shall this Agreement or such documents require the payment or permit the collection of interest in excess of the maximum contract rate permitted by the Applicable Usury Law (the "Maximum Interest Rate"). In the event (a) any such excess of interest otherwise would be contracted for, charged or received from Borrower or otherwise in connection with the loan evidenced hereby, or (b) the maturity of the Obligations is accelerated in whole or in part, or (c) all or part of the Obligations shall be prepaid, so that under any of such circumstances the amount of interest contracted for, shared or received in connection with the loan evidenced hereby, would exceed the Maximum Interest Rate, then in any such event (1) the provisions of this paragraph shall govern and control, (2) neither Borrower nor any other Person now or hereafter liable for the payment of the Obligations shall be obligated to pay the amount of such interest to the extent that it is in excess of the Maximum Interest Rate, (3) any such excess which may have been collected shall be either applied as a credit against the then unpaid principal amount of the Obligations or refunded to Borrower, at FINOVA's option, and (4) the effective rate of interest shall be automatically reduced to the Maximum Interest Rate. It is further agreed, without limiting the generality of the foregoing, that to the extent permitted by the Applicable Usury Law; (x) all calculations of interest which are made for the purpose of determining whether such rate would exceed the Maximum Interest Rate shall be made by amortizing, prorating, allocating and spreading during the period of the full stated term of the loan evidenced hereby, all interest at any time contracted for, charged or received from Borrower or otherwise in connection with such loan; and (y) in the event that the effective rate of interest on the loan should at any time exceed the Maximum Interest Rate, such excess interest that would otherwise have been collected had there been no ceiling imposed by the Applicable Usury Law shall be paid to FINOVA from time to time, if and when the effective interest rate on the loan otherwise falls below the Maximum Interest Rate, to the extent that interest paid to the date of calculation does not exceed the Maximum Interest Rate, until the entire amount of interest which would otherwise have been collected had there been no ceiling imposed by the Applicable Usury Law has been paid in full. Borrower further agrees that should the Maximum Interest Rate be increased at any time hereafter because of a change in the Applicable Usury Law, then to the extent not prohibited by the Applicable Usury Law, such increases shall apply to all indebtedness evidenced hereby regardless of when incurred; but, again to the extent not prohibited by the Applicable Usury Law, should the Maximum Interest Rate be decreased because of a change in the Applicable Usury Law, such decreases shall not apply to the indebtedness evidenced hereby regardless of when incurred.

    17. Principal Payments; Proceeds of Collateral.
        1. Principal Payments. Except where evidenced by notes or other instruments issued or made by Borrower to FINOVA specifically containing payment provisions which are in conflict with this Section 2.10 (in which event the conflicting provisions of said notes or other instruments shall govern and control), that portion of the Obligations consisting of principal payable on account of Loans shall be payable by Borrower to FINOVA immediately upon the earliest of (i) the receipt by FINOVA or Borrower of any proceeds of any of the Collateral, to the extent of said proceeds, (ii) the occurrence of an Event of Default in consequence of which FINOVA elects to accelerate the maturity and payment of such loans, or (iii) any termination of this Agreement pursuant to Section 9.2 hereof; provided, however, that any Overadvance or Overline shall be payable on demand pursuant to the provisions of Section 2.3 hereof.
        2. Collections. Until FINOVA notifies Borrower to the contrary and except with respect to the DDN Receivables (as defined below), Borrower may make collection of all Receivables for FINOVA by directing all account debtors, Payors and other third parties to remit all payments owing to Borrower to lockboxes subject to a Lock Box Agreement in favor of FINOVA (a "Lockbox") and/or a Holding Account. With respect to Receivables arising through sales of goods fulfilled by DDN (or any replacement thereto reasonably acceptable to FINOVA) under the DDN Distribution Agreement (or any replacement thereto reasonably acceptable to FINOVA) as to which DDN (or any such replacement thereof) is obligated to bill and collect as Borrower's agent (the "DDN Receivables"), if any, Borrower shall cause DDN (or any such replacement thereof) to remit all payments received from all account debtors directly to a Lockbox and/or to a Holding Account. In the event Borrower shall nevertheless directly receive any payments or other financial proceeds of any Collateral (other than for Governmental Receivables), Borrower shall receive all payments in trust for FINOVA and immediately deliver all payments to FINOVA in their original form as set forth below, duly endorsed in blank or cause the same to be deposited into a Holding Account and/or a Dominion Account or Blocked Account. FINOVA or its designee may, at any time, notify account debtors (other than Payors of Governmental Receivables) that the Receivables have been assigned to FINOVA and of FINOVA's security interest therein, and may collect the Receivables (other than any Governmental Receivable, unless pursuant to a valid court order) directly and charge the collection costs and expenses to Borrower's loan account. Borrower agrees that, in computing the charges under this Agreement, all items of payment shall be deemed applied by FINOVA on account of the Obligations two (2) Business Days after receipt by FINOVA of good funds which have been finally credited to FINOVA's account, whether such funds are received directly from Borrower or from the Blocked Account bank or the Dominion Account bank, pursuant to Section 2.10(c) hereof, and this provision shall apply regardless of the amount of the Obligations outstanding or whether any Obligations are outstanding; provided, that if any such good funds are received after 12:00 p.m. noon (Los Angeles time) on any Business Day or at any time on any day not constituting a Business Day, such funds shall be deemed received on the immediately following Business Day. FINOVA is not, however, required to credit Borrower's account for the amount of any item of payment which is unsatisfactory to FINOVA in its Permitted Discretion and FINOVA may charge Borrower's loan account for the amount of any item of payment which is returned to FINOVA unpaid.
        3. Establishment of a Blocked Account or Dominion Account. Unless Borrower shall be otherwise directed by FINOVA in writing and except with respect to Governmental Receivables, Borrower shall cause all proceeds of Collateral to be deposited into one or more Holding Accounts from which Borrower shall each Business Day, cause such amounts on deposit therein to be remitted to a Blocked Account or Dominion Account for the benefit of FINOVA, which amounts, unless otherwise provided herein, shall be applied in payment of the Obligations as provided for herein; provided that if the outstanding balance of Obligations (other than the principal balance of Revolving B Credit Loans) shall be less than $100,000 and no Event of Default shall have occurred and be outstanding, Borrower need not remit such funds to FINOVA and may instead transfer such funds to any other account of Borrower. Except with respect to Governmental Receivables, all funds deposited in a Blocked Account or Dominion Account shall immediately become the sole property of FINOVA and Borrower shall obtain the agreement by such bank to waive any offset rights against the funds so deposited. FINOVA assumes no responsibility for any Blocked Account or Dominion Account arrangement, including without limitation, any claim of accord and satisfaction or release with respect to deposits accepted by any bank thereunder. Alternatively, FINOVA may establish one or more Dominion Accounts and Borrower shall, as and when required herein, deposit all proceeds of Receivables and all cash proceeds of any sale of any other Collateral, or cause same to be deposited, in kind, in such Dominion Accounts of FINOVA in lieu of depositing same to Blocked Accounts, and all such funds shall be applied by FINOVA to the Obligations as provided herein.
        4. Governmental Receivables. It is the intent of the parties to comply with the laws and regulations of the United States under (i) 42 U.S.C. 1395u(b)(6) in connection with Medicare, (ii) 42 U.S.C. 1396a(a)(32) in connection with Medicaid, and (iii) 32 CFR 199.1 et. seq. in connection with CHAMPUS, and any other provisions affecting Governmental Receivables. Accordingly, it is agreed that, notwithstanding any provisions to the contrary in this Agreement or in any of the Loan Documents, in no event shall this Agreement or the Loan Documents require any pledge, action or other conduct to the extent they are violative of the aforementioned laws and regulations.
        5. Payments Without Deductions. Borrower shall pay principal, interest, and all other amounts payable hereunder, or under any other Loan Document, without any deduction whatsoever, including, but not limited to, any deduction for any setoff or counterclaim.
        6. Collection Days Upon Repayment. In the event Borrower repays the Obligations in full at any time hereafter, such payment in full shall be credited (conditioned upon final collection) to Borrower's loan account two (2) Business Days after FINOVA's receipt thereof.
        7. Monthly Accountings. FINOVA shall provide Borrower monthly with an account of advances, charges, expenses and payments made pursuant to this Agreement. Such account shall be deemed correct, accurate and binding on Borrower and an account stated (except for reverses and reapplications of payments made and corrections of errors discovered by FINOVA), unless Borrower notifies FINOVA in writing to the contrary within thirty (30) days after each account is rendered, describing the nature of any alleged errors or omissions.

    18. Application of Collateral
    19. . Upon the occurrence and continuation of an Event of Default FINOVA shall have the right to apply or reverse and re-apply any and all payments to any portion of the Obligations in such order and manner as FINOVA shall determine in its Permitted Discretion. To the extent that Borrower makes a payment or FINOVA receives any payment or proceeds of the Collateral for Borrower's benefit which is subsequently invalidated, declared to be fraudulent or preferential, set aside or required to be repaid to a trustee, debtor in possession, receiver or any other party under any bankruptcy law, common law or equitable cause, or otherwise, then, to such extent, the Obligations or part thereof intended to be satisfied shall be revived and continue as if such payment or proceeds had not been received by FINOVA, and FINOVA may adjust the balance of the Loan as FINOVA, in its Permitted Discretion, deems appropriate under the circumstances.

    20. Application of Payments

    . (a) Except as otherwise provided in Section 2.11 above or as provided in Section 2.12(b) below, the amount of all payments or amounts received by FINOVA with respect to the Loan shall be applied to the extent applicable under this Agreement: (i) first, to accrued interest through the date of such payment, including any Default Interest; (ii) then, to any late fees, overdue risk assessments, Examination Fee and expenses, collection fees and expenses and any other fees and expenses due to FINOVA hereunder; and (iii) last, the remaining balance, if any, to the unpaid principal balance of the Loan; provided however, while an Event of Default exists under this Agreement, or under any other Loan Document, each payment hereunder shall be (x) held as cash collateral to secure Obligations relating to any contingent obligations arising under the Loan Documents and/or (y) applied to amounts owed to FINOVA by Borrower as FINOVA in its Permitted Discretion may determine. In calculating interest and applying payments as set forth above: (a) interest shall be calculated and collected through the date a payment is actually applied by FINOVA under the terms of this Agreement; (b) interest on the outstanding balance shall be charged during any grace period permitted hereunder; (c) at the end of each month, all accrued and unpaid interest and other charges provided for hereunder shall be added to the principal balance of the Loan; and (d) to the extent that Borrower makes a payment or FINOVA receives any payment or proceeds of the Collateral for Borrower's benefit that is subsequently invalidated, set aside or required to be repaid to any other Person, then, to such extent, the Obligations intended to be satisfied shall be revived and continue as if such payment or proceeds had not been received by FINOVA and FINOVA may adjust the Loan balances as FINOVA, in its Permitted Discretion, deems appropriate under the circumstances.

    (b) At all times prior to the occurrence and continuation of a Trigger Event, Borrower may only fund payments of principal of the Revolving B Credit Loans by either directing FINOVA to liquidate and apply Cash Collateral already on deposit in the Control Account to payment of such Obligations and/or by funding an additional amount of immediately available funds to FINOVA with specific instructions to apply the same to such Obligations. Upon the occurrence and during the continuation of a Trigger Event, FINOVA may, in its sole discretion, at any time, liquidate all or any of the Cash Collateral on deposit in the Control Account and apply the same to payment of the Obligations owing in respect of the Revolving B Credit Loans; provided that if such Trigger Event is also an Event of Default, FINOVA shall be further entitled to apply all or any portion of the Cash Collateral on deposit in the Control Account to payment of any and all Obligations in such order as FINOVA may elect in its sole discretion.

  3. SECURITY.
    1. Security Interest in the Collateral
    2. . To secure the payment and performance of the Obligations when due, Borrower hereby grants to FINOVA a first priority security interest (subject only to Permitted Encumbrances) in all of Borrower's now owned or hereafter acquired or arising Inventory, Equipment, Receivables, life insurance policies and the proceeds thereof, Trademarks, Copyrights, Licenses and Patents, Investment Property (as defined in Section 9-115 of the Code), Provider Agreements and General Intangibles, including, without limitation, all of Borrower's Deposit Accounts, money, any and all property now or at any time hereafter in FINOVA's possession (including claims and credit balances), and all proceeds (including proceeds of any insurance policies, proceeds of proceeds and claims against third parties), all products and all books and records and computer data related to any of the foregoing (all of the foregoing, together with all other property in which FINOVA may be granted a lien or security interest, is referred to herein, collectively, as the "Collateral"); provided that in no event will any Receivables or other Collateral be deemed to include any of the Retained Rights.

    3. Perfection and Protection of Security Interest
    4. . Borrower shall, at its expense, take all actions requested by FINOVA at any time to perfect, maintain, protect and enforce FINOVA's first priority security interest and other rights in the Collateral and the priority thereof from time to time (subject only to Permitted Encumbrances), including, without limitation, (i) executing and filing financing or continuation statements and amendments thereof and executing and delivering such documents and titles in connection with motor vehicles as FINOVA shall require, all in form and substance satisfactory to FINOVA, (ii) maintaining a perpetual inventory and complete and accurate inventory stock records, (iii) delivering to FINOVA appropriate documents as required by FINOVA covering any portion of the Collateral is kept in a warehouse, delivering to FINOVA warehouse receipts covering such Collateral and for which warehouse receipts are issued, and transferring Inventory to warehouses designated by FINOVA, (iv) delivering to FINOVA all letters of credit on which Borrower is named beneficiary. FINOVA may file, without Borrower's signature, one or more financing statements disclosing FINOVA's security interest under this Agreement. Borrower agrees that a carbon, photographic, photostatic or other reproduction of this Agreement or of a financing statement is sufficient as a financing statement. If any Collateral is at any time in the possession or control of any warehouseman, bailee or any of Borrower's agents or processors, Borrower shall notify such Person of FINOVA's security interest in such Collateral and, upon FINOVA's request, instruct them to hold all such Collateral for FINOVA's account subject to FINOVA's instructions. From time to time, Borrower shall, upon FINOVA's request, execute and deliver confirmatory written instruments pledging the Collateral to FINOVA, but Borrower's failure to do so shall not affect or limit FINOVA's security interest or other rights in and to the Collateral. Until the Obligations have been fully satisfied and FINOVA's obligation to make further advances hereunder has terminated, FINOVA's security interest in the Collateral shall continue in full force and effect.

    5. Preservation of Collateral
    6. . FINOVA may, in its Permitted Discretion, at any time discharge any lien or encumbrance on the Collateral or bond the same, pay any insurance, maintain guards, pay any service bureau, obtain any record or take any other action to preserve the Collateral and charge the cost thereof to Borrower's loan account as an Obligation.

    7. Insurance
    8. . Borrower will maintain and deliver evidence to FINOVA of such insurance as is required by FINOVA, written by insurers, in amounts, and with lender's loss payee, additional insured, and other endorsements, satisfactory to FINOVA. All premiums with respect to such insurance shall be paid by Borrower as and when due. Accurate and certified copies of the policies shall be delivered by Borrower to FINOVA. If Borrower fails to comply with this Section, FINOVA may (but shall not be required to) procure such insurance and endorsements at Borrower's expense and charge the cost thereof to Borrower's loan account as an Obligation.

    9. Collateral Reporting; Inventory.
        1. Invoices. Borrower shall not re-date any invoice or sale from the original date thereof or make any claims for reimbursement or sales on extended terms beyond those customary in Borrower's industry, or otherwise extend or modify the term of any Receivable. If Borrower becomes aware of any matter adversely affecting any Receivable related to a particular invoice in dispute in excess of $25,000, including information affecting the credit of the account debtor thereon, Borrower shall promptly notify FINOVA in writing.
        2. Instruments. In the event any Receivable is or becomes evidenced by a promissory note, trade acceptance or any other instrument for the payment of money, Borrower shall immediately deliver such instrument to FINOVA appropriately endorsed to FINOVA and, regardless of the form of any presentment, demand, notice of dishonor, protest and notice of protest with respect thereto, Borrower shall remain liable thereon until such instrument is paid in full.
        3. Physical Inventory. Borrower shall conduct a physical count of the Inventory on an annual basis and promptly supply FINOVA with a copy of such accounts accompanied by a report of the value (calculated at the lower of cost or market value on a first in, first out basis) of the Inventory and such additional information with respect to the Inventory as FINOVA may request from time to time.
        4. Returns. For so long as no Event of Default has occurred and is continuing and subject to the provisions of Section 3.6(b), if any account debtor returns any Inventory to Borrower in the ordinary course of its business, Borrower shall promptly determine the reason for such return and promptly issue a credit memorandum to the account debtor (sending a copy to FINOVA) in the appropriate amount. In the event any attempted return occurs after the occurrence of any Event of Default, Borrower shall (i) hold the returned Inventory in trust for FINOVA, (ii) segregate all returned Inventory from all of Borrower's other property, (iii) conspicuously label the returned Inventory as FINOVA's property, and (iv) immediately notify FINOVA of the return of any Inventory, specifying the reason for such return, the location and condition of the returned Inventory, and on FINOVA's request deliver such returned Inventory to FINOVA.
        5. Borrower shall not consign any Inventory.

    10. Receivables.
        1. Eligibility. (i) Borrower represents and warrants that each Receivable covers and shall cover a bona fide sale or lease and delivery by it of goods or the rendition by it of services in the ordinary course of its business, and shall be for a liquidated amount and FINOVA's security interest shall not be subject to any offset, deduction, counterclaim, rights of return or cancellation, lien or other condition other than in the ordinary course of Borrower's business but solely to the extent arising in connection with regular, periodic reviews of Borrower's collection history or billing as undertaken from time to time by Governmental Authorities. If any representation or warranty herein is breached as to any Receivable or any Receivable ceases to be an Eligible Receivable for any reason other than payment thereof, then FINOVA may, in addition to its other rights hereunder, designate any and all Receivables owing by that account debtor as not Eligible Receivables; provided, that FINOVA shall in any such event retain its security interest in all Receivables, whether or not Eligible Receivables, until the Obligations have been fully satisfied and FINOVA's obligation to provide loans hereunder has terminated.
        2. (ii) FINOVA at any time in the exercise of its Permitted Discretion shall be entitled to (i) establish and increase or decrease reserves against Eligible Receivables and Eligible Inventory, (ii) reduce the advance rates in the Schedule or restore such advance rates to any level equal to or below the advance rates set forth in the Schedule or (iii) impose additional restrictions (or eliminate the same) to the standards of eligibility set forth in the definitions of "Eligible Receivables" and "Eligible Inventory". FINOVA may but shall not be required to rely on the schedules and/or reports delivered to FINOVA in connection herewith in determining the then eligibility of Receivables and Inventory. Reliance thereon by FINOVA from time to time shall not be deemed to limit the right of FINOVA to revise advance rates or standards of eligibility as provided above. In determining whether to reduce the lending formula, FINOVA may consider events, conditions, contingencies or risks which are also considered in determining Eligible Receivables or Eligible Inventory, or in establishing Loan Reserves. The burden of establishing lack of good faith hereunder shall be on the Borrower.

        3. Disputes. Borrower shall notify FINOVA promptly of all disputes or claims and settle or adjust such disputes or claims at no expense to FINOVA, but no discount, credit or allowance shall be granted to any account debtor and no returns of merchandise shall be accepted by Borrower without FINOVA's consent, except for discounts, credits and allowances made or given in the ordinary course of Borrower's business. FINOVA may, at any time after the occurrence of an Event of Default, settle or adjust disputes or claims directly with account debtors for amounts and upon terms which FINOVA considers advisable in its reasonable credit judgment and, in all cases, FINOVA shall credit Borrower's loan account with only the net amounts received by FINOVA in payment of any Receivables.

    11. Equipment
    12. . Borrower shall keep and maintain the Equipment in good operating condition and repair and make all necessary replacements thereto to maintain and preserve the value and operating efficiency thereof at all times consistent with Borrower's past practice, ordinary wear and tear excepted. Borrower shall not permit any item of Equipment to become a fixture (other than a trade fixture) to real estate or an accession to other property.

    13. Other Liens; No Disposition of Collateral
    14. . Borrower represents, warrants and covenants that except for FINOVA's security interest, Permitted Encumbrances, and such other liens, claims and encumbrances as may be permitted by FINOVA in its Permitted Discretion from time to time in writing, (a) all Collateral is and shall continue to be owned by it free and clear of all liens, claims and encumbrances whatsoever and (b) Borrower shall not, without FINOVA's prior written approval, sell, encumber or dispose of or permit the sale, encumbrance or disposal of any Collateral or all or any substantial part of any of its other assets (or any interest of Borrower therein), except for the sale of Inventory in the ordinary course of Borrower's business and the replacement of Equipment deemed by Borrower in good faith to be commercially obsolete to Borrower's business. In the event FINOVA gives any such prior written approval with respect to any such sale of Collateral, the same may be conditioned on the sale price being equal to, or greater than, an amount acceptable to FINOVA. The proceeds of any such sales of Collateral shall be remitted to FINOVA pursuant to this Agreement for application to the Obligations.

    15. Collateral Security
    16. . The Obligations shall constitute one loan secured by the Collateral. FINOVA may, in its Permitted Discretion, (i) exchange, enforce, waive or release any of the Collateral, (ii) apply Collateral and direct the order or manner of sale thereof as it may determine, and (iii) settle, compromise, collect or otherwise liquidate any Collateral in any manner without affecting its right to take any other action with respect to any other Collateral.

    17. Special Intellectual Property Provisions

    . (a) FINOVA acknowledges that Abbott holds a security interest in and to the marketing rights for SangCya in the United States (the "Abbott Senior Collateral") and a nonexclusive royalty free license in certain of Borrower's Trademarks, Copyrights, Licenses and Patents which relate to the SangCya product. FINOVA and Borrower each hereby acknowledge and agree that notwithstanding any of the other terms set forth in this Agreement or any of the other Loan Documents (including, without limitation, the Patent Security Agreement and the Trademark Security Agreement), Borrower and/or its Subsidiaries may hereafter grant to other Persons not constituting Affiliate of Borrower or its Subsidiaries, in bona fide arms-length transactions, a security interest in Borrower's or any Subsidiaries' Trademarks, Copyrights, Licenses and Patents (collectively, the "Intellectual Property") which shall constitute Permitted Encumbrance on such Intellectual Property and rank senior in priority to the security interest of FINOVA in such Intellectual Property, if and only if the following conditions precedent are met: (i) FINOVA shall receive ten (10) Business Days prior written notice of the proposed grant of any security interest in any Intellectual Property including the reasons for such grant, a description of the proposed terms of such grant and, if then available, a copy of the proposed agreements under which such grant is to be effectuated, (ii) no Event of Default or event which, with the passage of time or the giving of notice or both, would constitute an Event of Default shall have occurred and be continuing, and (iii) prior to or concurrent with the grant of such security interest, FINOVA and the Person to which such grant of security interests shall have entered into an intercreditor agreement on terms and conditions acceptable to FINOVA pursuant to which (I) FINOVA shall acknowledge the senior priority of such Person's security interest in and to such of the Intellectual Property in which such Person is intended to have been granted a senior lien (but shall not agree any terms subordinating Obligations or restricting or limiting FINOVA from enforcing any of its rights and remedies against Borrower and/or any other Loan Party and (II) such Person shall grant to FINOVA and its designees and/or assignees, a non-exclusive royalty free right and license to use such Intellectual Property at all times from and after the occurrence of an Event of Default and in each and every location which such Person may be entitled to use the same, to complete or arrange for the completion of processing any raw materials or work in process into finished goods, or sell, liquidate or dispose of any raw materials, work in process or finished goods which, in each case, constitute Collateral.

    (b) FINOVA and Borrower each hereby acknowledge and agree that notwithstanding any of the other terms set forth in this Agreement or any of the other Loan Documents (including, without limitation, the Patent Security Agreement and the Trademark Security Agreement), Borrower and/or its Subsidiaries may hereafter enter into agreements with Persons not constituting Affiliate of Borrower or its Subsidiaries, in bona fide arms-length transactions, to sell, assign, exchange, license, contribute in a joint venture or otherwise transfer all or any part of the Intellectual Property (other than solely a security interest therein) to such Persons (each an "IP Assignment" and collectively, the "IP Assignments"), if and only if the following conditions precedent are met (collectively, the "IP Release Conditions"): (i) FINOVA shall receive ten (10) Business Days prior written notice of the proposed IP Assignment including (a) a description of the proposed terms thereof, (b) a copy of the documents, if then available, under which such IP Assignment is to be effectuated and (c) a certificate of the President or other senior financial officer of Borrower certifying the nature of products and/or services of Borrower and/or its Subsidiaries which are derived from or dependent in any way upon the Intellectual Property which is the subject of such IP Assignment and computing and stating the impact which the omission of all related Inventory and Receivables from eligibility for advances hereunder will have on the availability of Revolving A Credit Loans after giving effect to such proposed IP Assignment, (ii) FINOVA shall be satisfied that after omitting all Inventory which is derived from or dependent in any way upon the Intellectual Property which is the subject of such IP Assignment and all Receivables arising from the sale of any such Inventory, Borrower shall have Excess Availability of not less than $1.00 and (iii) no Event of Default or event which, with the passage of time or the giving of notice or both, would constitute an Event of Default shall have occurred and be continuing. Provided that each of the IP Release Conditions have been met with respect to a proposed IP Assignment, FINOVA shall, promptly upon the request of Borrower, execute and deliver such releases as may be reasonably necessary to release FINOVA's security interest in and to the Intellectual Property which is the subject of such IP Assignment.

  4. CONDITIONS OF CLOSING.
    1. Initial Advance
    2. . The obligation of FINOVA to make the initial advance hereunder is subject to the fulfillment, to the satisfaction of FINOVA and its counsel, of each of the following conditions on or prior to the date set forth on the Schedule:

        1. Loan Documents. FINOVA shall have received each of the following Loan Documents: (i) the Agreement fully and properly executed by Borrower; (ii) promissory notes in such amounts and on such terms and conditions as FINOVA shall specify, executed by Borrower; (iii) such security agreements, intellectual property assignments, pledge agreements, mortgages and deeds of trust as FINOVA may require with respect to this Agreement, executed by each of the parties thereto and, if applicable, duly acknowledged for recording or filing in the appropriate governmental offices; (iv) such Blocked Account or Dominion Account agreements as it shall determine; and (v) such other documents, instruments and agreements in connection herewith as FINOVA shall require, executed, certified and/or acknowledged by such parties as FINOVA shall designate;
        2. Minimum Excess Availability. Borrower shall have Liquidity (without deducting from Excess Availability the Special Reserve) as of the Closing Date and not calculated on a thirty (30) day average under the Revolving Credit Loans of not less than $30,000,000, after giving effect to (i) the initial advance hereunder, (ii) any applicable Loan Reserves against borrowing availability under the Revolving Credit Loans, and (iii) payment in full of all of Borrower's accounts payable outstanding thirty (30) days or more from due date and all book overdrafts;
        3. [Intentionally Omitted];
        4. Charter Documents. FINOVA shall have received copies of Borrower's By-laws and Articles or Certificate of Incorporation or Operating Agreement and Certificate of Formation, as amended, modified, or supplemented to the Closing Date, certified by the Secretary of Borrower;
        5. Good Standing. FINOVA shall have received a certificate of corporate status with respect to Borrower, dated within a reasonable time prior to the Closing Date, by the Secretary of State of the state of incorporation of Borrower, which certificate shall indicate that Borrower is in good standing in such state;
        6. Foreign Qualification. FINOVA shall have received certificates of corporate status with respect to Borrower and each other Loan Party, each dated within a reasonable time prior to the Closing Date, issued by the Secretary of State of each jurisdiction in which such party's failure to be duly qualified or licensed would have a material adverse effect on its financial condition or assets, indicating that such party is in good standing;
        7. Authorizing Resolutions and Incumbency. FINOVA shall have received a certificate from the Secretary of Borrower and each Loan Party attesting to (i) the adoption of resolutions of such Loan Party's Board of Directors, and shareholders or members if necessary, authorizing the borrowing of money from FINOVA and execution and delivery of the Loan Documents to which such Loan Party is a party, and authorizing specific officers of Borrower to execute same, and (ii) the authenticity of original specimen signatures of such officers;
        8. Insurance. FINOVA shall have received the insurance certificates and certified copies of policies required by Section 3.4 hereof, in form and substance satisfactory to FINOVA and its counsel, together with an additional insured endorsement in favor of FINOVA with respect to all liability policies and a lender's loss payable endorsement in favor of FINOVA with respect to all casualty and business interruption policies, each in form and substance acceptable to FINOVA and its counsel;
        9. [Intentionally Omitted];
        10. Searches; Certificates of Title. FINOVA shall have received searches reflecting the filing of its financing statements and fixture filings in such jurisdictions as it shall determine, and shall have received certificates of title with respect to the Collateral which shall have been duly executed in a manner sufficient to perfect all of the security interests granted to FINOVA;
        11. Landlord, Bailee and Mortgagee Waivers. FINOVA shall have received landlord, bailee and/or mortgagee waivers from the lessors, bailees and/or mortgagees of Borrower's chief executive office, and, in the case of Collateral located at the Self-Service Storage Facility, (i) a copy of a fully executed and delivered letter from Borrower to Door to Door Storage, Inc. pursuant to which Borrower has designated FINOVA as an "Alternate Contact"; and (ii) a copy of a fully executed and delivered Request to Add an Authorized Agent form from Borrower to Door to Door Storage, Inc. pursuant to which Borrower has designated FINOVA as an "Authorized Agent";
        12. Fees. Borrower shall have paid all fees payable by it on the Closing Date pursuant to this Agreement;
        13. Opinion of Counsel. FINOVA shall have received an opinion of Borrower's counsel in form and substance satisfactory to FINOVA;
        14. Officer Certificate. FINOVA shall have received a certificate of the President and the Chief Financial Officer or similar official of Borrower, attesting to the accuracy of each of the representations and warranties of Borrower set forth in this Agreement and the fulfillment of all conditions precedent to the initial advance hereunder;
        15. Solvency Certificate. If requested, FINOVA shall have received a signed certificate of the Borrower's duly elected Chief Financial Officer concerning the solvency and financial condition of Borrower, on FINOVA's standard form;
        16. Lock Box, Dominion and Holding Accounts. The Lock Box, Dominion and Holding Accounts referred to in Section 2.10(c) hereof shall have been established with Silicon Valley Bank;
        17. [Intentionally Omitted].
        18. Environmental Certificate. FINOVA shall have received an Environmental Certificate from Borrower, in form and substance satisfactory to FINOVA in its discretion, with respect to all locations of Collateral;
        19. Search and References. FINOVA shall have received and approved the results of UCC, tax lien, litigation, judgment, and bankruptcy searches regarding Borrower and shall have received satisfactory customer, vendor and credit reference checks.
        20. Eli Lilly No Offset and Bailee Agreement. FINOVA shall have received a No Offset and Bailee Waiver Agreement executed by Eli Lilly and on terms and conditions satisfactory to FINOVA covering the Borrower's Inventory situated at Eli Lilly.
        21. Control Agreement. FINOVA shall have received a Control Agreement executed by Borrower and a financial institution acceptable and on terms and conditions satisfactory to FINOVA.
        22. DDN Agreement. FINOVA shall have received an agreement executed by DDN (and/or any party replacing DDN) and Borrower and pursuant to which, inter alia, DDN acknowledges FINOVA's lien rights in all collateral held or received by DDN, agrees to remit all proceeds of Receivables and sales of Collateral directly to the Holding Account or Dominion Account for the benefit of FINOVA and on terms and conditions satisfactory to FINOVA agrees to only take direction from FINOVA concerning the disposition of Collateral in its possession at all times after receiving written notice of an Event of Default.
        23. No Material Adverse Changes. Prior to the Closing Date, there shall have occurred no material adverse change in the financial condition of Borrower, or in the condition of the assets of Borrower and its Subsidiaries, from that shown on the financial statements for Borrower and its Subsidiaries dated September 30, 1999. At the closing, Borrower shall deliver to FINOVA an officer's certification confirming that Borrower is unaware of the existence of any such material adverse change in Borrower's or its Subsidiaries' financial condition as of the Closing Date.
        24. Projections. Borrower shall submit cash flow projections and pro forma balance sheet with adjusting entries (i) showing that the proposed financing will provide sufficient funds for the Borrower's projected working capital needs, and (ii) showing: (1) that the Borrower will have reasonably sufficient capital for the conduct of its business following the initial funding, and (2) that the Borrower will not incur debts beyond its ability to pay such debts as they mature.
        25. Material Agreements. FINOVA shall have received, reviewed and approved all material agreements to which Borrower shall be a party.
        26. Opinions. To the extent any Person other than Borrower shall be parties to the Loan Documents, FINOVA reserves the right to require satisfactory opinions of counsel for each such Person concerning the proper organization of such Person and the due authorization, execution, delivery, enforceability, validity and binding effect of the Loan Documents to which such Person is a party. Each such opinion of counsel shall confirm, to the satisfaction of FINOVA, that the opinion is being delivered to FINOVA at the instruction of the party represented by such counsel, that FINOVA is entitled to rely on such opinion and that for purposes of such reliance, FINOVA is deemed to be in privity with the opining counsel.
        27. Stock Pledge and Subsidiary Loan Documents. Borrower and/or its subsidiaries shall have executed and delivered a Stock Pledge Agreement of even date herewith ("Stock Pledge Agreement"), pledging in favor of FINOVA all of the issued and outstanding capital stock of Borrower's U.S. and French subsidiaries (including SangStat Atlantique) and SangStat Atlantique shall have executed and delivered a Stock Pledge Agreement pledging in favor of FINOVA not less than 100% of the issued and outstanding capital stock of IMTIX - SangStat S.A.S. FINOVA shall be in possession on the Closing Date of original stock certificates evidencing all shares of stock so pledged to FINOVA, and of undated stock Powers and Assignments Apart from Certificate, executed in blank by Borrower and SangStat Atlantique (the "Pledgors") with respect to all such shares together with such other agreements and instruments as may be necessary to create a first priority perfected pledge of such stock in favor of FINOVA. In addition, FINOVA shall have received such opinions of local French counsel regarding each of SangStat Atlantique and IMTIX - SangStat S.A.S. as FINOVA may reasonably request.
        28. Pending Litigation. FINOVA shall have received and found acceptable information and documents pertaining to all pending litigation to which Borrower is a party as of the Closing Date including, without limitation, all litigation with Novartis Pharmaceuticals.
        29. Schedule Conditions. Borrower shall have complied with all additional conditions precedent as set forth in the Schedule attached hereto.
        30. Other Matters. All other documents and legal matters in connection with the transactions contemplated by this Agreement shall have been delivered, executed and recorded and shall be in form and substance satisfactory to FINOVA and its counsel including, without limitation, each of the items listed on the Closing Checklist attached as Exhibit 4.1 hereto.

    3. Subsequent Advances

    . The obligation of FINOVA to make any advance (including the initial advance) shall be subject to the further conditions precedent that, on and as of the date of such advance: (a) the representations and warranties of Borrower set forth in this Agreement shall be accurate, before and after giving effect to such advance or issuance and to the application of any proceeds thereof; (b) no Event of Default and no event which, with notice or passage of time or both, would constitute an Event of Default has occurred and is continuing, or would result from such advance or issuance or from the application of any proceeds thereof; (c) no material adverse change has occurred in the Borrower's business, operations, financial condition, in the condition of the Collateral or other assets of Borrower or in the prospect of repayment of the Obligations; and (d) FINOVA shall have received such other approvals, opinions or documents as FINOVA shall reasonably request. In addition to the foregoing conditions set forth above in clauses (a), (b), (c) and (d) of this Section 4.2, FINOVA's obligation to make any advances of Revolving B Credit Loans shall be further subject to the condition that no Trigger Event shall have occurred and be continuing.

  5. REPRESENTATIONS AND WARRANTIES.
  6. Borrower represents and warrants that:

    1. Due Organization
    2. . It is a corporation, duly organized, validly existing and in good standing under the laws of the State set forth on the Schedule, is qualified and authorized to do business and is in good standing in all states in which such qualification and good standing are necessary in order for it to conduct its business and own its property, and has all requisite power and authority to conduct its business as presently conducted, to own its property and to execute and deliver each of the Loan Documents to which it is a party and perform all of its Obligations thereunder, and has not taken any steps to wind-up, dissolve or otherwise liquidate its assets;

    3. Other Names
    4. . Borrower has not, during the preceding five (5) years, been known by or used any other corporate or fictitious name except as set forth on the Schedule, nor has Borrower been the surviving corporation of a merger or consolidation or acquired all or substantially all of the assets of any Person during such time;

    5. Due Authorization
    6. . The execution, delivery and performance by Borrower of the Loan Documents to which it is a party have been authorized by all necessary corporate action and do not and shall not constitute a violation of any applicable law or of Borrower's Articles or Certificate of Incorporation, By-Laws, or any other organizational or governing documents, as applicable, or any other document, agreement or instrument to which Borrower is a party or by which Borrower or its assets are bound;

    7. Binding Obligation
    8. . Each of the Loan Documents to which Borrower is a party is the legal, valid and binding obligation of Borrower enforceable against Borrower in accordance with its terms;

    9. Intangible Property
    10. . Borrower possesses adequate assets, licenses, patents, patent applications, copyrights, trademarks, trademark applications and trade names for the present and planned future conduct of its business without any known conflict with the rights of others (except as set forth on Exhibit 5.7 hereto), and each is valid and has been duly registered or filed with the appropriate Governmental Authorities; each of Borrower's U.S. licenses, patents, patent applications, copyrights, trademarks and trademark applications which have been registered or filed with any Governmental Authority (including the U.S. Patent and Trademark Office and the Library of Congress) are listed by name, date and filing number on the Schedule;

    11. Capital
    12. . Borrower has capital sufficient to conduct its business, is able to pay its debts as they mature, and owns property having a fair salable value greater than the amount required to pay all of its debts (including contingent debts);

    13. Material Litigation
    14. . Except as described on Exhibit 5.7 hereto, Borrower has no pending or overtly threatened litigation, actions or proceedings which would materially and adversely affect its business, assets, operations, prospects or condition, financial or otherwise, or the Collateral or any of FINOVA's interests therein;

    15. Title; Security Interests of FINOVA
    16. . Borrower has good, indefeasible and merchantable title to the Collateral and, upon the execution and delivery of the Loan Documents, the filing of UCC-1 Financing Statements, delivery of the certificate(s) evidencing any pledged securities, the filing of any collateral assignments or security agreements regarding Borrower, Trademarks, Copyrights, Licenses and/or Patents, if any, with the appropriate governmental offices and the recording of any mortgages or deeds of trust with respect to real property, in each case in the appropriate offices, this Agreement and such documents shall create valid and perfected first priority liens in the Collateral, subject only to Permitted Encumbrances;

    17. Restrictive Agreements; Labor Contracts
    18. . Borrower is not a party or subject to any contract or subject to any charge, corporate restriction, judgment, decree or order materially and adversely affecting its business, assets, operations, prospects or condition, financial or otherwise, or which restricts its right or ability to incur Indebtedness, and it is not party to any labor dispute. In addition, no labor contract is scheduled to expire during the Initial Term of this Agreement, except as disclosed to FINOVA in writing prior to the date hereof;

    19. Laws
    20. . Borrower is not in violation of any applicable statute, regulation, ordinance or any order of any court, tribunal or governmental agency, in any respect materially and adversely affecting the Collateral or its business, assets, operations, prospects or condition, financial or otherwise, including without limitation any violation of the Fair Labor Standards Act, and Borrower specifically represents and warrants that it is not producing goods in violation of Federal minimum wage requirements;

    21. Consents
    22. . Borrower has obtained or caused to be obtained or issued any required consent of a governmental agency or other Person in connection with the financing contemplated hereby;

    23. Defaults
    24. . Borrower is not in default with respect to any note, indenture, loan agreement, mortgage, lease, deed or other agreement to which it is a party or by which it or its assets are bound, nor has any event occurred which, with the giving of notice or the lapse of time, or both, would cause such a default;

    25. Financial Condition
    26. . The Prepared Financials fairly present Borrower's financial condition and results of operations and those of such other Persons described therein as of the date thereof in accordance with GAAP; there are no material omissions from the Prepared Financials or other facts or circumstances not reflected in the Prepared Financials; and there has been no material and adverse change in such financial condition or operations since the date of the initial Prepared Financials delivered to FINOVA hereunder;

    27. ERISA
    28. . The Borrower and any Plans are in compliance in all material respects with the provisions of ERISA and the qualification requirements of IRC Section 401(a). Borrower has received no notice indicating that it or any Plan does not so comply. No notice of intent to terminate a Plan has been filed under ERISA Section 4041, nor has any Plan been terminated under ERISA. The PBGC has not instituted proceedings to terminate, or appointed a trustee to administer, a Plan. No lien upon the assets of Borrower has arisen with respect to a Plan. No Prohibited Transaction or Reportable Event has occurred with respect to a Plan. Neither Borrower nor any ERISA Affiliate has incurred any withdrawal liability with respect to any Multiemployer Plan. Borrower and each ERISA Affiliate have made all contributions required to be made by them to any Plan or Multiemployer Plan when due. There is no accumulated funding deficiency in any Plan, whether or not waived;

    29. Taxes
    30. . Borrower has filed all tax returns and such other reports as it is required by law to file and has paid or made adequate provision for the payment on or prior to the date when due of all taxes, assessments and similar charges that are due and payable;

    31. Locations; Federal Tax ID No.
    32. Borrower's chief executive office and the offices and locations where it keeps the Collateral (except for Inventory in transit) are at the locations set forth on the Schedule, except to the extent that such locations may have been changed after notice to FINOVA in accordance with Section 6.1.4 hereof; Borrower's federal tax identification number is as shown on the Schedule;

    33. Business Relationships
    34. . There exists no actual or threatened termination, cancellation or limitation of, or any modification or change in, the business relationship between Borrower and any customer or any group of customers whose purchases individually or in the aggregate are material to the business of Borrower, or with any material supplier, and there exists no present condition or state of facts or circumstances which would materially and adversely affect Borrower or prevent Borrower from conducting such business after the consummation of the transactions contemplated by this Agreement in substantially the same manner in which it has heretofore been conducted;

    35. Year 2000 Representations and Warranties
    36. . Borrower has taken all action necessary to assure that there will be no material adverse change to Borrower's business by reason of the advent of the year 2000, including without limitation that all computer-based systems, embedded microchips and other processing capabilities effectively recognize and process dates after December 31, 1999; and

    37. Performance and Other Bonds
    38. . Borrower represents that there are no performance bonds or other bonds posted as of the Closing Date, and that it has no plans or intent to post any such bonds after the Closing Date.

    39. Reaffirmations

    . Each request for a loan made by Borrower pursuant to this Agreement shall constitute (i) an automatic representation and warranty by Borrower to FINOVA that there does not then exist any Event of Default and (ii) a reaffirmation as of the date of said request of all of the representations and warranties of Borrower contained in this Agreement and the other Loan Documents.

  7. COVENANTS.
    1. Affirmative Covenants
    2. . Borrower covenants that, so long as any Obligation remains outstanding and this Agreement is in effect, it shall:

      1. Taxes
      2. . File all tax returns and pay or make adequate provision for the payment of all taxes, assessments and other charges on or prior to the date when due;

      3. Notice of Litigation
      4. . Promptly notify FINOVA in writing of any litigation, suit or administrative proceeding which (x) asserts a claim for monetary damages in excess of $250,000 (whether or not covered by applicable insurance) or (y) assuming such litigation, suit or proceeding were adversely determined against Borrower, would constitute a Material Judgment;

      5. ERISA
      6. . Notify FINOVA in writing (i) promptly upon the occurrence of any Reportable Event with respect to a Plan, other than a termination, partial termination or merger of a Plan or a transfer of a Plan's assets and (ii) prior to any termination, partial termination or merger of a Plan or a transfer of a Plan's assets;

      7. Change in Location
      8. . Notify FINOVA in writing forty-five (45) days prior to any change in the location of Borrower's chief executive office or the location of any Collateral, or Borrower's opening or closing of any other place of business;

      9. Entity Existence
      10. . Maintain its corporate, limited liability company or partnership entity existence and its qualification to do business and good standing in all states necessary for the conduct of its business and the ownership of its property and maintain adequate assets, licenses, patents, copyrights, trademarks and trade names for the conduct of its business;

      11. Labor Disputes
      12. . Promptly notify FINOVA in writing of any labor dispute to which Borrower is or may become subject and the expiration of any labor contract to which Borrower is a party or bound;

      13. Violations of Law
      14. . Promptly notify FINOVA in writing of any violation of any law, statute, regulation or ordinance of any governmental entity, or of any agency thereof, applicable to Borrower which may materially and adversely affect the Collateral or Borrower's business, assets, prospects, operations or condition, financial or otherwise;

      15. Defaults
      16. . Notify FINOVA in writing within five (5) Business Days of Borrower's default under any note, indenture, loan agreement, mortgage, lease or other agreement to which Borrower is a party or by which Borrower is bound, or of any other default under any Indebtedness of Borrower for which the total amount of the obligation exceeds $100,000.

      17. Capital Expenditures
      18. . Promptly notify FINOVA in writing of the making of any Capital Expenditure materially affecting Borrower's business, assets, prospects, operations or condition, financial or otherwise, except to the extent permitted in the Schedule;

      19. Books and Records
      20. . Keep adequate records and books of account with respect to its business activities in which proper entries are made in accordance with GAAP, reflecting all of its financial transactions;

      21. Leases; Warehouse Agreements
      22. . Provide FINOVA with (i) copies of all agreements between Borrower and any landlord, warehouseman or bailee which owns any premises at which any Collateral may, from time to time, be located (whether for processing, storage or otherwise), and (ii) without limiting the landlord, bailee and/or mortgagee waivers to be provided pursuant to Section 4.1(k) hereof, additional landlord, bailee and/or mortgagee waivers in form acceptable to FINOVA with respect to all locations where any Collateral is hereafter located; provided however, that Borrower shall not be required to provide any landlord, bailee and/or mortgagee waivers for any location solely related to the Pharmacy Operation;

      23. Additional Documents
      24. . At FINOVA's request, promptly execute or cause to be executed and delivered to FINOVA any and all documents, instruments or agreements deemed necessary by FINOVA to facilitate the collection of the Obligations or the Collateral or otherwise to give effect to or carry out the terms or intent of this Agreement or any of the other Loan Documents. Without limiting the generality of the foregoing, and subject to the proviso at the end of subsection (vi) of the definition of "Eligible Trade Receivables" contained in this Agreement, if any of the Receivables (other than Receivables arising under Medicare or Medicaid) with a face value in excess of $1,000 arises out of a contract with the United States of America or any department, agency, subdivision or instrumentality thereof, Borrower shall promptly notify FINOVA of such fact in writing and shall execute any instruments and take any other action required or requested by FINOVA to comply with the provisions of the Federal Assignment of Claims Act;

      25. Financial Covenants
      26. . Comply with the financial covenants set forth on the Schedule;

      27. Year 2000 Covenants
      28. . Take all action necessary to assure that there will be no material adverse change to Borrower's business by reason of the advent of the year 2000, including without limitation that all computer-based systems, embedded microchips and other processing capabilities effectively recognize and process dates after December 31, 1999. At FINOVA's request, Borrower shall provide to FINOVA assurance reasonably acceptable to FINOVA that Borrower's computer-based systems, embedded microchips and other processing capabilities are year 2000 compatible;

      29. Intangible Property
      30. . Borrower will notify FINOVA if it creates, purchases or otherwise receives any Trademarks, Copyrights, Licenses or Patents after the Closing Date and Borrower shall execute all additional Documents FINOVA deems necessary, in its Permitted Discretion, to properly grant a security interest in such Trademarks, Copyrights, Licenses and Patents to FINOVA, subject to the terms of Section 3.10 hereof;

      31. Bank Accounts
      32. . Borrower shall notify FINOVA in writing prior to establishing any bank account not listed on Exhibit 6.1.16 to the Schedule, and if requested by FINOVA, shall deliver to FINOVA an Assignment of Bank Accounts Agreement in form and substance satisfactory to FINOVA, acknowledged by the bank at which such account is to be established; and

      33. Minimum Loan Balances. Borrower shall at all times during the term of this Agreement maintain a minimum outstanding principal balance of Five Million Dollars ($5,000,000) with respect to the Revolving Credit B Loan; provided, however, that no Event of Default shall occur as a result of Borrower's failure to comply with this Section 6.1.17. It is understood and agreed by the parties that FINOVA's sole remedy for Borrower's failure to comply with this Section 6.1.17 shall be Borrower's payment of the Minimum Interest Charge set forth in Section 2.6 of the Schedule.

    3. Negative Covenants
    4. . Without FINOVA's prior written consent, so long as any Obligation remains outstanding and this Agreement is in effect, Borrower shall not:

      1. Mergers and Acquisitions
      2. . Make any material change in its capital structure or in its business or operations which might adversely affect the repayment of the Obligations, or merge or consolidate with any other Person or acquire all or any substantial portion of the assets of any other Person;

      3. Loans and Investments
      4. . Make advances, loans or extensions of credit to, or invest in, any Person, except for loans or cash advances to employees which are permitted in the Schedule; provided however, that notwithstanding the foregoing, Borrower may make intercompany advances, loans or extensions of credit to its Subsidiaries so long as the following conditions are satisfied at the time of any such advance: (i) no Event of Default has occurred is continuing, and (ii) Borrower shall have Liquidity of at least the Minimum Liquidity Amount;

      5. Dividends
      6. . Declare or pay cash dividends upon any of its stock or, subject to the provisions of Section 6.2.20 hereof, distribute any of its property or redeem, retire, purchase or acquire directly or indirectly any of its stock; provided however, that notwithstanding the foregoing, Borrower may, upon termination of the employment of any employee, repurchase stock from such employee pursuant to employee benefit plans or other agreements of employment so long as the following conditions are satisfied at the time of any such repurchase: (i) no Event of Default has occurred and is continuing, (ii) Borrower shall have Liquidity of at least the Minimum Liquidity Amount, and (iii) such repurchase, together with the aggregate amount of all such repurchases in any Fiscal Year of Borrower, is not greater than $250,000;

      7. Adverse Transactions
      8. . Enter into any transaction which materially and adversely affects the Collateral or its ability to repay the Obligations in full as and when due;

      9. Indebtedness of Others
      10. . Guarantee or become directly or contingently liable for the Indebtedness of any Person, except by endorsement of instruments for deposit and except for the existing guarantees made by Borrower prior to the date hereof, if any, which are set forth in the Schedule;

      11. Repurchase
      12. . Make a sale to any customer on a bill-and-hold, guaranteed sale, sale and return, sale on approval, consignment, or any other repurchase or return basis;

      13. Name
      14. . Use any corporate or fictitious name other than its corporate name as set forth in its Articles or Certificate of Incorporation on the date hereof or as set forth on the Schedule;

      15. Prepayment
      16. . Prepay any Indebtedness other than trade payables and other than the Obligations;

      17. Capital Expenditure
      18. . Make or incur any Capital Expenditure if, after giving effect thereto, the aggregate amount of all Capital Expenditures by Borrower in any fiscal year would exceed the amount set forth on the Schedule;

      19. Compensation
      20. . Pay total compensation, including salaries, withdrawals, fees, bonuses, commissions, drawing accounts and other payments, whether directly or indirectly, in money or otherwise, during any fiscal year to all of Borrower's executives, officers and directors (or any relative thereof) in an amount in excess of the amount set forth on the Schedule;

      21. Indebtedness
      22. . Create, incur, assume or permit to exist any Indebtedness (including Indebtedness in connection with Capital Leases) in excess of the amount set forth on the Schedule, other than (i) the Obligations, (ii) trade payables and other contractual obligations to suppliers and customers incurred in the ordinary course of business, and (iii) other Indebtedness existing on the date of this Agreement and set forth on Exhibit 6.2.11 hereto (except Indebtedness paid on the date of this Agreement from proceeds of the initial advances hereunder), and (iv) Subordinated Debt;

      23. Affiliate Transactions
      24. . Except as set forth below and subject to the provisions of Section 6.2.20 hereof, sell, transfer, distribute or pay any money or property to any Affiliate, or invest in (by capital contribution or otherwise) or purchase or repurchase any stock or Indebtedness, or any property, of any Affiliate, or become liable on any guaranty of the indebtedness, dividends or other obligations of any Affiliate. Notwithstanding the foregoing, Borrower may pay compensation permitted by Section 6.2.10 to employees who are Affiliates and, if no Event of Default has occurred, Borrower may engage in transactions with Affiliates in the normal course of business, in amounts and upon terms which are fully disclosed to FINOVA and which are no less favorable to Borrower than would be obtainable in a comparable arm's length transaction with a Person who is not an Affiliate;

      25. Nature of Business
      26. . Enter into any new business or make any material change in any of Borrower's business objectives, purposes or operations;

      27. FINOVA's Name
      28. . Use the name of FINOVA in connection with any of Borrower's business or activities, except in connection with internal business matters or as required in dealings with governmental agencies and financial institutions or with trade creditors of Borrower, solely for credit reference purposes;

      29. Margin Security
      30. . Engage principally, or as one of its important activities, in the business of extending credit for the purpose of purchasing or carrying margin stock (within the meaning of Regulation U issued by the Board of Governors of the Federal Reserve System), nor permit proceeds of any Loan or other advance to be used to purchase or carry any margin stock or to extend credit to others for the purpose of purchasing or carrying any margin stock, or in any manner which might cause such Loan or other advance or the application of such proceeds to violate (or require any regulatory filing under) Regulation T, Regulation U, Regulation X or any other regulation of the Board of Governors of the Federal Reserve System, in each case as in effect on the date or dates of such Loan or other advance and such use of proceeds. Further, no proceeds of any Loan or other advance will be used to acquire any security of a class which is registered pursuant to Section 12 of the Securities Exchange Act of 1934;

      31. Real Property
      32. . Purchase or acquire any real property without FINOVA's prior written consent, a condition of which consent shall include delivery of appropriate environmental reports and analysis, in form and substance satisfactory to FINOVA and its counsel;

      33. Liens
      34. . Create, incur, assume or suffer to exist any Lien upon any of its property, whether now owned or hereafter acquired, except Permitted Liens;

      35. Change in Fiscal Year; Auditors
      36. . Change or permit any Subsidiary to change the commencement or ending date of its fiscal year or retain the independent public auditors for purposes of preparing the Borrower's audited financial statements which are different than those retained by Borrower and its Subsidiaries at the time of the Closing Date, in each case, without receiving the prior written consent of FINOVA; or

      37. Subordinated Documents in Certain Material Agreements
      38. . Permit the amendment or modification of (i) any of the documents or instruments evidencing the Subordinated Debt or (ii) the Co-Promotion Agreement unless the prior written consent of FINOVA has first been obtained.

      39. Pharmacy Operation
      40. . Notwithstanding anything to the contrary contained in this Agreement and subject to receiving the prior written consent of FINOVA (which shall not be unreasonably withheld or delayed so long as the requirements set forth below are met), Borrower may: (i)  cause assets relating solely to the Pharmacy Operation to be contributed to a Subsidiary (the "Pharmacy Subsidiary"), and promptly thereafter (subject to the existence of favorable market conditions, as reasonably determined by Borrower) conduct an initial public offering or other sale of equity interests in such Pharmacy Subsidiary and/or spin-off such Subsidiary as a dividend to existing shareholders of Borrower's Stock, or (ii)  cause assets relating solely to the Pharmacy Operation to be sold or assigned for fair market value in a bona fide arms-length transaction with a Person not constituting an Affiliate of Borrower,

        in each case, only if the following conditions are satisfied: (a) Borrower shall have provided FINOVA with not less than thirty (30) days prior written notice thereof, together with copies of the proposed documentation relating thereto, and FINOVA shall have determined in good faith that only assets relating exclusively to the Pharmacy Operation are the subject of the proposed transaction; and (b) no Event of Default shall then be outstanding or shall result from giving effect to such proposed transaction. In the event a Pharmacy Subsidiary is established in accordance with the terms set forth above and No Event of Default shall have occurred and remain continuing, Borrower shall have no obligation under this Agreement or any other Loan Document to pledge the Stock of such Pharmacy Subsidiary or cause such Pharmacy Subsidiary to grant a guarantee and/or a lien in favor of FINOVA to secure the Obligations. If an Event of Default shall have occurred and be continuing, and no initial public offering and/or spin-off shall have yet occurred with respect to the Transplant Subsidiary, Borrower shall, promptly upon FINOVA's written request, cause the Pharmacy Subsidiary to execute such guaranty and security agreements with respect to the Obligations as FINOVA may request and pledge all outstanding Stock of the Transplant Subsidiary owned by Borrower or any other Subsidiary of Borrower to FINOVA to secure the Obligations.

      41. Self-Service Storage Facility.

    Change or otherwise modify the designation of FINOVA as an "Authorized Agent" and a "Alternate Contact" in connection with the Self-Service Storage Facility; provided, however, that so long as no Event of Default shall have occurred or is continuing, FINOVA agrees that it shall not remove the Collateral located therein or terminate the account associated therewith.

  8. DEFAULT AND REMEDIES.
    1. Events of Default
    2. . Any one or more of the following events shall constitute an Event of Default under this Agreement:

        1. Borrower fails to pay when due and payable any portion of the Obligations at stated maturity, upon acceleration or otherwise;
        2. Borrower or any other Loan Party fails or neglects to perform, keep, or observe any Obligation including, but not limited to, any term, provision, condition, covenant or agreement contained in any Loan Document to which Borrower or such other Loan Party is a party;
        3. Any material adverse change occurs in Borrower's business, assets, operations, prospects or condition, financial or otherwise, as determined by FINOVA in its Permitted Discretion;
        4. The value or priority of FINOVA's security interest in the Collateral is materially impaired, as determined by FINOVA in its Permitted Discretion;
        5. Any portion of Borrower's assets in excess of $100,000 is seized, attached, subjected to a writ or distress warrant, is levied upon or comes into the possession of any judicial officer;
        6. Borrower shall generally not pay its debts as they become due or shall enter into any agreement (whether written or oral), or offer to enter into any agreement, with all or a significant number of its creditors regarding any moratorium or other indulgence with respect to its debts or the participation of such creditors or their representatives in the supervision, management or control of the business of Borrower;
        7. Any bankruptcy or other insolvency proceeding is commenced by Borrower, or any such proceeding is commenced against Borrower and remains undischarged or unstayed for forty- five (45) days;
        8. Any notice of lien, levy or assessment is filed of record with respect to any portion of Borrower's assets and Borrower fails to remove such lien, levy or assessment in excess of $250,000 within ten (10) Business Days of learning of same, provided however, that if FINOVA determines in its Permitted Discretion that such lien, levy or assessment cannot be removed within such time period and that Borrower has meritorious defenses to such action, then it will not be an Event of Default so long as Borrower, within the ten (10) Business Day time period, commences and thereafter diligently pursues its removal;
        9. Any Material Judgment is entered against Borrower or any Loan Party;
        10. Any default shall occur under (i) any material agreement between Borrower and any third party including, without limitation, any default which would result in a right by such third party to accelerate the maturity of any Indebtedness of Borrower to such third party, but only so long as such default is likely to result in damages of $250,000 or more, or (ii) any Subordinated Debt;
        11. Except as expressly set forth in Sections 5.18(a), (b) and (c) hereof with respect to certain types of violations of such sections, any representation or warranty made or deemed to be made by Borrower, any Affiliate or any other Loan Party in any Loan Document or any other statement, document or report made or delivered to FINOVA in connection therewith shall prove to have been misleading in any material respect;
        12. Any Loan Party breaches or violates, terminates or attempts to terminate any Loan Document delivered in connection herewith;
        13. Any of the following which could have a material adverse effect on the financial condition of Borrower; any Prohibited Transaction or Reportable Event shall occur with respect to a Plan; any lien upon the assets of Borrower in connection with any Plan shall arise; Borrower or any of its ERISA Affiliates shall fail to make full payment when due of all amounts which Borrower or any of its ERISA Affiliates may be required to pay to any Plan or any Multiemployer Plan as one or more contributions thereto; Borrower or any of its ERISA Affiliates creates or permits the creation of any accumulated funding deficiency in any Plan, whether or not waived; or
        14. The Co-Promotion Agreement shall have been terminated, revoked or cancelled for any reason; and
        15. Any Change of Control shall occur.

      NOTWITHSTANDING ANYTHING TO THE CONTRARY HEREIN, FINOVA RESERVES THE RIGHT TO CEASE MAKING ANY ADVANCES OR LOANS IF AN EVENT OF DEFAULT HAS OCCURRED AND IS CONTINUING.

    3. Remedies
    4. . Upon the occurrence of an Event of Default, FINOVA may, at its option and in addition to all of its other rights under the Loan Documents, cease making Loans, terminate this Agreement and/or declare all of the Obligations to be immediately payable in full. Borrower agrees that FINOVA shall also have all of its rights and remedies under applicable law, including, without limitation, the default rights and remedies of a secured party under the Code, and upon the occurrence of an Event of Default Borrower hereby consents to the appointment of a receiver by FINOVA in any action initiated by FINOVA pursuant to this Agreement and to the jurisdiction and venue set forth in Section 9.26 hereof, and Borrower waives notice and posting of a bond in connection therewith. Further, FINOVA may, at any time, take possession of the Collateral and keep it on Borrower's premises, at no cost to FINOVA, or remove any part of it to such other place(s) as FINOVA may desire, or Borrower shall, upon FINOVA's demand, at Borrower's sole cost, assemble the Collateral and make it available to FINOVA at a place reasonably convenient to FINOVA. FINOVA may sell and deliver any Collateral at public or private sales, for cash, upon credit or otherwise, at such prices and upon such terms as FINOVA deems advisable, at FINOVA's discretion, and may, if FINOVA deems it reasonable, postpone or adjourn any sale of the Collateral by an announcement at the time and place of sale or of such postponed or adjourned sale without giving a new notice of sale. Borrower agrees that FINOVA has no obligation to preserve rights to the Collateral or marshall any Collateral for the benefit of any Person. FINOVA is hereby granted a license or other right to use, without charge, Borrower's labels, patents, copyrights, name, trade secrets, trade names, trademarks and advertising matter, or any similar property, in completing production, advertising or selling any Collateral and Borrower's rights under all licenses and all franchise agreements shall inure to FINOVA's benefit. Any requirement of reasonable notice shall be met if such notice is mailed postage prepaid to Borrower at its address set forth in the heading to this Agreement at least five (5) days before sale or other disposition. The proceeds of sale shall be applied, first, to all attorneys fees and other expenses of sale, and second, to the Obligations in such order as FINOVA shall elect. FINOVA shall return any excess to Borrower and Borrower shall remain liable for any deficiency to the fullest extent permitted by law.

    5. Standards for Determining Commercial Reasonableness

    . Borrower and FINOVA agree that the following conduct by FINOVA with respect to any disposition of Collateral shall conclusively be deemed commercially reasonable (but other conduct by FINOVA, including, but not limited to, FINOVA's use of other or different times, places and manners of noticing and conducting any disposition of Collateral shall not be deemed unreasonable): Any public or private disposition: (i) as to which on no later than the fifth calendar day prior thereto written notice thereof is mailed or personally delivered to Borrower and, with respect to any public disposition, on no later than the fifth calendar day prior thereto notice thereof describing in general non-specific terms, the Collateral to be disposed of is published once in a newspaper of general circulation in the county where the sale is to be conducted (provided that no notice of any public or private disposition need be given to the Borrower or published if the Collateral is perishable or threatens to decline speedily in value or is of a type customarily sold on a recognized market); (ii) which is conducted at any place designated by FINOVA, with or without the Collateral being present; and (iii) which commences at any time between 8:00 a.m. and 5:00 p.m. Without limiting the generality of the foregoing, Borrower expressly agrees that, with respect to any disposition of accounts, instruments and general intangibles, it shall be commercially reasonable for FINOVA to direct any prospective purchaser thereof to ascertain directly from Borrower any and all information concerning the same, including, but not limited to, the terms of payment, aging and delinquency, if any, the financial condition of any obligor or account debtor thereon or guarantor thereof, and any collateral therefor. Without limiting any of the other provisions set forth herein or in any other Loan Document, Borrower acknowledges and agrees that upon the occurrence and during the continuation of any Trigger Event, FINOVA shall no longer have any obligation to fund any advances of Revolving B Credit Loans, may, without notice, liquidate and apply all or any portion of the Cash Collateral to payment of the Obligations owing in respect of Revolving B Credit Loans; provided that if such Trigger Event is also an Event of Default, FINOVA shall be further entitled to apply all or any portion of the Cash Collateral on deposit in the Control Account to payment of any and all Obligations in such order as FINOVA may elect in its sole discretion. Borrower acknowledges and agrees that FINOVA, in addition to all of its other rights and remedies under the Loan Documents or under applicable law, may, in its sole discretion, at anytime from and after the occurrence of an Event of Default, appoint a licensed collateral agent or assign a portion of its rights under the Loan Documents with respect to any Inventory subject to regulation under applicable state or federal law ("Regulated Inventory") to a licensed distributor for repossessing, foreclosing upon, selling or disposing of all or any portion of such Regulated Inventory. Given the fact that certain of the Inventory is Regulated Inventory, Borrower acknowledges that FINOVA and/or its designees or assignees may experience greater difficulty and higher expense in arranging for the realization of FINOVA's (or its assignee's) Lien rights with respect to such Regulated Inventory and/or the sale or other disposition of the same and agrees that all such additional costs and expenses incurred by FINOVA shall be subject to reimbursement under Section 8.1 of this Agreement.

  9. EXPENSES AND INDEMNITIES
    1. Expenses
    2. . Borrower covenants that, so long as any Obligation remains outstanding and this Agreement remains in effect, it shall promptly reimburse FINOVA for all costs, fees and expenses incurred by FINOVA in connection with the negotiation, preparation, execution, delivery, administration and enforcement of each of the Loan Documents, including, but not limited to, the attorneys' and paralegals' fees of in-house and outside counsel, expert witness fees, lien, title search and insurance fees, appraisal fees, all charges and expenses incurred in connection with any and all environmental reports and environmental remediation activities, and all other costs, expenses, taxes and filing or recording fees payable in connection with the transactions contemplated by this Agreement, including without limitation all such costs, fees and expenses as FINOVA shall incur or for which FINOVA shall become obligated in connection with (i) any inspection or verification of the Collateral, (ii) any proceeding relating to the Loan Documents or the Collateral, (iii) actions taken with respect to the Collateral and FINOVA's security interest therein, including, without limitation, the defense or prosecution of any action involving FINOVA and Borrower or any third party, (iv) enforcement of any of FINOVA's rights and remedies with respect to the Obligations or Collateral and (v) consultation with FINOVA's attorneys and participation in any workout, bankruptcy or other insolvency or other proceeding involving any Loan Party or any Affiliate, whether or not suit is filed or the issues are peculiar to federal bankruptcy or state insolvency laws. Borrower shall also pay all FINOVA charges in connection with bank wire transfers, forwarding of loan proceeds, deposits of checks and other items of payment, returned checks, establishment and maintenance of lockboxes and other Blocked Accounts, and all other bank and administrative matters, in accordance with FINOVA's schedule of bank and administrative fees and charges in effect from time to time.

    3. Environmental Matters.

    The Environmental Certificate dated on or about the date of this Agreement is incorporated herein for all purposes as if fully stated in this Agreement.

  10. MISCELLANEOUS.
    1. Examination of Records; Financial Reporting.
        1. Examinations
        2. . FINOVA shall at all reasonable times have full access to and the right to examine, audit, make abstracts and copies from and inspect Borrower's records, files, books of account and all other documents, instruments and agreements relating to the Collateral and the right to check, test and appraise the Collateral (consistent with the State and Federal laws regarding patient confidentiality); provided however, that if no Event of Default has occurred and is continuing, FINOVA shall give reasonable prior notice to Borrower of any such examination. Borrower shall deliver to FINOVA any instrument necessary for FINOVA to obtain records from any service bureau maintaining records for Borrower. All instruments and certificates prepared by Borrower showing the value of any of the Collateral shall be accompanied, upon FINOVA's request, by copies of related purchase orders and invoices and records relating to the applications of collections of Rx Receivables (including Misdirected Payments). FINOVA may, at any time upon the occurrence and during the continuation of an Event of Default, and after any cure period has expired, remove from Borrower's premises Borrower's books and records (or copies thereof) or require Borrower to deliver such books and records or copies to FINOVA. FINOVA may, without expense to FINOVA, use such of Borrower's personnel, supplies and premises as may be reasonably necessary for maintaining or enforcing FINOVA's security interest.

        3. Reporting Requirements

      . Borrower shall furnish FINOVA, upon request, such information and statements as FINOVA shall request from time to time regarding Borrower's business affairs, financial condition and the results of its operations. Without limiting the generality of the foregoing, Borrower shall provide FINOVA with the information set forth on Exhibit A attached hereto.

    2. Term; Termination.
        1. Term
        2. . The Initial Term of the Revolving Credit Loans facility and the obligation of FINOVA to make advances with respect thereto in accordance with this Agreement shall be as set forth on the Schedule, and if the parties hereto shall so agree in writing, the Revolving Credit Loans facility and this Agreement shall be renewed for one or more Renewal Term(s) as set forth in the Schedule, unless earlier terminated as provided herein.

        3. Prior Notice
        4. . Each party shall have the right to terminate this Agreement effective at the end of the Initial Term or at the end of any Renewal Term by giving the other party written notice not less than sixty (60) days prior to the effective date of such termination, by registered or certified mail.

        5. Payment in Full
        6. . Upon the effective date of termination, the Obligations shall become immediately due and payable in full in cash.

        7. Early Termination; Termination Fee

      . In addition to the procedure set forth in Section 9.2(b), Borrower may terminate this Agreement at any time but only upon sixty (60) days' prior written notice and prepayment of the Obligations. Upon any such early termination by Borrower or any termination of this Agreement by FINOVA upon the occurrence of an Event of Default, then, and in any such event, Borrower shall pay to FINOVA upon the effective date of such termination a fee (the "Termination Fee") in an amount equal to the amount shown on the Schedule.

    3. Recourse to Security; Certain Waivers
    4. . All Obligations shall be payable by Borrower as provided for herein and, in full, at the termination of this Agreement; recourse to security shall not be required at any time. Borrower waives presentment and protest of any instrument and notice thereof, notice of default and, to the extent permitted by applicable law, all other notices to which Borrower might otherwise be entitled.

    5. No Waiver by FINOVA
    6. . Neither FINOVA's failure to exercise any right, remedy or option under this Agreement, any supplement, the Loan Documents or other agreement between FINOVA and Borrower nor any delay by FINOVA in exercising the same shall operate as a waiver. An Event of Default shall exist or continue or be continuing until such Event of Default is waived in writing by FINOVA as herein provided. No waiver by FINOVA shall be effective unless in writing and then only to the extent stated. No waiver by FINOVA shall affect its right to require strict performance of this Agreement. FINOVA's rights and remedies shall be cumulative and not exclusive.

    7. Binding on Successor and Assigns
    8. . All terms, conditions, promises, covenants, provisions and warranties shall inure to the benefit of and bind FINOVA's and Borrower's respective representatives, successors and assigns.

    9. Severability
    10. . If any provision of this Agreement shall be prohibited or invalid under applicable law, it shall be ineffective only to such extent, without invalidating the remainder of this Agreement.

    11. Amendments; Assignments
    12. . This Agreement may not be modified, altered or amended, except by an agreement in writing signed by Borrower and FINOVA. Borrower may not sell, assign or transfer any interest in this Agreement or any other Loan Document, or any portion thereof, including, without limitation, any of Borrower's rights, title, interests, remedies, powers and duties hereunder or thereunder. Borrower hereby consents to FINOVA's participation, sale, assignment, transfer or other disposition, at any time or times hereafter, of this Agreement and any of the other Loan Documents, or of any portion hereof or thereof, including, without limitation, FINOVA's rights, title, interests, remedies, powers and duties hereunder or thereunder. In connection therewith, FINOVA may disclose all documents and information which FINOVA now or hereafter may have relating to Borrower or Borrower's business. To the extent that FINOVA assigns its rights and obligations hereunder to a third party, FINOVA shall thereafter be released from such assigned obligations to Borrower and such assignment shall effect a novation between Borrower and such third party.

    13. Integration
    14. . This Agreement, together with the Schedule (which is a part hereof) and the other Loan Documents, reflect the entire understanding of the parties with respect to the transactions contemplated hereby.

    15. Survival
    16. . All of the representations and warranties of Borrower contained in this Agreement shall survive the execution, delivery and acceptance of this Agreement by the parties. No termination of this Agreement or of any guaranty of the Obligations shall affect or impair the powers, obligations, duties, rights, representations, warranties or liabilities of the parties hereto and all shall survive such termination.

    17. Evidence of Obligations
    18. . Each Obligation may, in FINOVA's discretion, be evidenced by notes or other instruments issued or made by Borrower to FINOVA. If not so evidenced, such Obligation shall be evidenced solely by entries upon FINOVA's books and records.

    19. Loan Requests
    20. . Each oral or written request for a loan by any Person who purports to be any employee, officer or authorized agent of Borrower shall be made to FINOVA on or prior to 11:00 a.m., Los Angeles time, on the Business Day on which the proceeds thereof are requested to be paid to Borrower and shall be conclusively presumed to be made by a Person authorized by Borrower to do so and the crediting of a loan to Borrower's operating account shall conclusively establish Borrower's obligation to repay such loan. Unless and until Borrower otherwise directs FINOVA in writing, all loans shall be wired to Borrower's operating account set forth on the Schedule.

    21. Notices
    22. . Any written notice, consent or other communication provided for in this Agreement shall be delivered personally (effective upon delivery), via facsimile (effective upon confirmation of transmission), via overnight courier (effective the next Business Day after dispatch if instructed to deliver on next Business Day) or via U.S. Mail (effective 3 days after mailing, postage prepaid, first class) to each party at its address(es) and/or facsimile number(s) set forth below its signature, or to such other address as either party shall specify to the other in writing from time to time.

    23. Brokerage Fees
    24. . Borrower represents and warrants to FINOVA that, except for a fee to Reedland Capital in an amount not to exceed $450,000 and the grant of certain warrant rights for 50,000 shares of Borrower's common stock (for which the Borrower shall be solely liable), with respect to the financing transaction herein contemplated, no Person is entitled to any brokerage fee or other commission and Borrower agrees to indemnify and hold FINOVA harmless against any and all such claims.

    25. Disclosure
    26. . No representation or warranty made by Borrower in this Agreement, or in any financial statement, report, certificate or any other document furnished in connection herewith contains any untrue statement of a material fact or omits to state any material fact necessary to make the statements herein or therein not misleading. There is no fact known to Borrower or which reasonably should be known to Borrower which Borrower has not disclosed to FINOVA in writing with respect to the transactions contemplated by this Agreement which materially and adversely affects the business, assets, operations, prospects or condition (financial or otherwise), of Borrower.

    27. Publicity
    28. . Subject to the prior written approval of Borrower, such approval not to be unreasonably withheld or delayed, FINOVA is hereby authorized to issue appropriate press releases and to cause a tombstone to be published announcing the consummation of this transaction and the aggregate amount thereof.

    29. Captions
    30. . The Section titles contained in this Agreement are without substantive meaning and are not part of this Agreement.

    31. Injunctive Relief
    32. . Borrower recognizes that, in the event Borrower fails to perform, observe or discharge any of its Obligations under this Agreement, any remedy at law may prove to be inadequate relief to FINOVA. Therefore, FINOVA, if it so requests, shall be entitled to temporary and permanent injunctive relief in any such case without the necessity of proving actual damages.

    33. Counterparts; Facsimile Execution
    34. . This Agreement may be executed in one or more counterparts, each of which taken together shall constitute one and the same instrument, admissible into evidence. Delivery of an executed counterpart of this Agreement by telefacsimile shall be equally as effective as delivery of a manually executed counterpart of this Agreement. Any party delivering an executed counterpart of this Agreement by telefacsimile shall also deliver a manually executed counterpart of this Agreement, but the failure to deliver a manually executed counterpart shall not affect the validity, enforceability, and binding effect of this Agreement.

    35. Construction
    36. . The parties acknowledge that each party and its counsel have reviewed this Agreement and have participated jointly in the negotiations and drafting of this Agreement and hereby agree that the normal rule of construction to the effect that any ambiguities are to be resolved against the drafting party shall not be employed in the interpretation of this Agreement or any amendments or exhibits hereto.

    37. Time of Essence
    38. . Time is of the essence for the performance by Borrower of the Obligations set forth in this Agreement.

    39. Limitation of Actions
    40. . Borrower agrees that any claim or cause of action by Borrower against FINOVA, or any of FINOVA's directors, officers, employees, agents, accountants or attorneys, based upon, arising from, or relating to this Agreement, or any other present or future agreement, or any other transaction contemplated hereby or thereby or relating hereto or thereto, or any other matter, cause or thing whatsoever, whether or not relating hereto or thereto, occurred, done, omitted or suffered to be done by FINOVA, or by FINOVA's directors, officers, employees, agents, accountants or attorneys, whether sounding in contract or in tort or otherwise, shall be barred unless asserted by Borrower by the commencement of an action or proceeding in a court of competent jurisdiction by the filing of a complaint within one year after the first act, occurrence or omission upon which such claim or cause of action, or any part thereof, is based and service of a summons and complaint on an officer of FINOVA or any other Person authorized to accept service of process on behalf of FINOVA, within 30 days thereafter. Borrower agrees that such one-year period of time is a reasonable and sufficient time for Borrower to investigate and act upon any such claim or cause of action. The one-year period provided herein shall not be waived, tolled, or extended except by a specific written agreement of FINOVA. This provision shall survive any termination of this Loan Agreement or any other agreement.

    41. Liability
    42. . Neither FINOVA nor any FINOVA Affiliate shall be liable for any indirect, special, incidental or consequential damages in connection with any breach of contract, tort or other wrong relating to this Agreement or the Obligations or the establishment, administration or collection thereof (including without limitation damages for loss of profits, business interruption, or the like), whether such damages are foreseeable or unforeseeable, even if FINOVA has been advised of the possibility of such damages. Neither FINOVA, nor any FINOVA Affiliate shall be liable for any claims, demands, losses or damages, of any kind whatsoever, made, claimed, incurred or suffered by the Borrower through the ordinary negligence of FINOVA, or any FINOVA Affiliate. "FINOVA Affiliate" shall mean FINOVA's directors, officers, employees, agents, attorneys or any other Person or entity affiliated with or representing FINOVA.

    43. Notice of Breach by FINOVA
    44. . Borrower agrees to give FINOVA written notice of (i) any action or inaction by FINOVA or any attorney of FINOVA in connection with any Loan Documents that may be actionable against FINOVA or any attorney of FINOVA or (ii) any defense to the payment of the Obligations for any reason, including, but not limited to, commission of a tort or violation of any contractual duty or duty implied by law. Borrower agrees that unless such notice is fully given as promptly as possible (and in any event within thirty (30) days) after Borrower has knowledge, or with the exercise of reasonable diligence should have had knowledge, of any such action, inaction or defense, Borrower shall not assert, and Borrower shall be deemed to have waived, any claim or defense arising therefrom.

    45. Application of Insurance Proceeds
    46. . The net proceeds of any casualty insurance insuring the Collateral, after deducting all costs and expenses (including attorneys' fees) of collection, shall be applied, at FINOVA's option, either toward replacing or restoring the Collateral, in a manner and on terms satisfactory to FINOVA, or toward payment of the Obligations. Any proceeds applied to the payment of Obligations shall be applied as set forth herein. In no event shall such application relieve Borrower from payment in full of all installments of principal and interest which thereafter become due in the order of maturity thereof. Notwithstanding the foregoing to the contrary, absent an Event of Default, in the event that the total loss is less than $250,000, Borrower shall have the option of repairing or replacing the damages or destroyed Collateral with equivalent replacement Collateral.

    47. Power of Attorney
    48. . Borrower appoints FINOVA and its designees as Borrower's attorney, with the power to endorse Borrower's name on any checks, notes, acceptances, money orders or other forms of payment or security that come into FINOVA's possession; to sign Borrower's name on any invoice or bill of lading relating to any Receivable, on drafts against customers or Payors, on assignments of Receivables, on notices of assignment, financing statements and other public records, on verifications of accounts and on notices to customers or Payors or account debtors; to send requests for verification of Receivables to customers or account debtors; after the occurrence of any Event of Default, to notify the post office authorities to change the address for delivery of Borrower's mail to an address designated by FINOVA and to open and dispose of all mail addressed to Borrower; and to do all other things FINOVA deems necessary or desirable to carry out the terms of this Agreement. Borrower hereby ratifies and approves all acts of such attorney. Neither FINOVA nor any of its designees shall be liable for any acts or omissions nor for any error of judgment or mistake of fact or law while acting as Borrower's attorney. This power, being coupled with an interest, is irrevocable until the Obligations have been fully satisfied and FINOVA's obligation to provide loans hereunder shall have terminated

    49. Governing Law; Waivers
    50. . THIS AGREEMENT, INCLUDING WITHOUT LIMITATION ENFORCEMENT OF THE OBLIGATIONS, SHALL BE INTERPRETED IN ACCORDANCE WITH THE INTERNAL LAWS (AND NOT THE CONFLICT OF LAWS RULES) OF THE STATE OF ARIZONA GOVERNING CONTRACTS TO BE PERFORMED ENTIRELY WITHIN SUCH STATE. BORROWER HEREBY CONSENTS TO THE EXCLUSIVE JURISDICTION OF ANY STATE OR FEDERAL COURT LOCATED WITHIN THE COUNTY OF MARICOPA IN THE STATE OF ARIZONA OR, AT THE SOLE OPTION OF FINOVA, IN ANY OTHER COURT IN WHICH FINOVA SHALL INITIATE LEGAL OR EQUITABLE PROCEEDINGS AND WHICH HAS SUBJECT MATTER JURISDICTION OVER THE MATTER IN CONTROVERSY. BORROWER WAIVES ANY OBJECTION OF FORUM NON CONVENIENS AND VENUE. BORROWER FURTHER WAIVES PERSONAL SERVICE OF ANY AND ALL PROCESS UPON IT, AND CONSENTS THAT ALL SUCH SERVICE OF PROCESS BE MADE BY MESSENGER, CERTIFIED MAIL OR REGISTERED MAIL DIRECTED TO BORROWER AT THE ADDRESS SET FORTH BELOW ITS SIGNATURE HERETO AND SERVICE SO MADE SHALL BE DEEMED TO BE COMPLETED UPON THE EARLIER OF ACTUAL RECEIPT OR THREE (3) DAYS AFTER THE SAME SHALL HAVE BEEN POSTED TO BORROWER'S ADDRESS; BORROWER FURTHER WAIVES ANY RIGHT IT MAY OTHERWISE HAVE TO COLLATERALLY ATTACK ANY JUDGMENT ENTERED AGAINST IT.

    51. Mutual Waiver of Right to Jury Trial
    52. . FINOVA AND BORROWER EACH HEREBY WAIVES THE RIGHT TO TRIAL BY JURY IN ANY ACTION OR PROCEEDING BASED UPON, ARISING OUT OF, OR IN ANY WAY RELATING TO: (I) THIS AGREEMENT; (II) ANY OTHER PRESENT OR FUTURE INSTRUMENT OR AGREEMENT BETWEEN FINOVA AND BORROWER; OR (III) ANY CONDUCT, ACTS OR OMISSIONS OF FINOVA OR BORROWER OR ANY OF THEIR DIRECTORS, OFFICERS, EMPLOYEES, AGENTS, ATTORNEYS OR ANY OTHER PERSONS AFFILIATED WITH FINOVA OR BORROWER; IN EACH OF THE FOREGOING CASES, WHETHER SOUNDING IN CONTRACT OR TORT OR OTHERWISE.

    53. Lien Termination

. In recognition of FINOVA's right to have all of its attorneys' fees and other expenses incurred in connection with this Agreement secured by the Collateral, notwithstanding the payment in full of the Obligations, FINOVA shall not be required to execute or record any terminations or satisfactions of any of its liens on the Collateral unless and until Borrower has executed and delivered to FINOVA general releases of all claims, in form and substance satisfactory to FINOVA.

DO NOT TAKE OUT THIS CONTINUOUS SECTION BREAK - -

[SIGNATURE PAGE FOLLOWS]

 

Borrower:

SANGSTAT MEDICAL CORPORATION

Fed. Tax ID # 94-3076069

 

By: /s/ Steven G. Dance

Title: Senior Vice President, Finance

 

 

Borrower's address for notices:

6300 Dumbarton Circle
Fremont, CA 94555
Attn: Stephen Dance
acsimile: (510) 789-4203

FINOVA:

FINOVA CAPITAL CORPORATION

 

 

By /s/ Ronald S. Montgomery

Title: Vice President

 

FINOVA's address for notices:

FINOVA Capital Corporation
355 South Grand Avenue
Suite 2400
Los Angeles, CA 90071
Attn: Ronald Vanek & Portfolio Manager

Facsimile: (213) 625-2486

 

with a copy to:

FINOVA Capital Corporation
4800 North Scottsdale Road
Scottsdale, AZ 85251-7623
Attn: Joseph D'Amore
Facsimile: (480) 636-4937








Schedule to
Loan and Security Agreement

Borrower: SangStat Medical Corporation
Address: 6300 Dumbarton Circle
Fremont, CA 94555

Date: April  , 2000

This Schedule forms an integral part of the Loan and Security Agreement between the above Borrower and FINOVA Capital Corporation dated the above date, and all references herein and therein to "this Agreement" shall be deemed to refer to said Agreement and to this Schedule.

 

TOTAL FACILITY (SECTION 2.1):

$30,000,000

LOANS (SECTION 2.2):

Revolving A Credit Loans: A revolving line of credit available to the Borrower, so long as all applicable conditions precedent set forth in Section 4.2 of the Agreement, are met consisting of loans against Borrower's Eligible Receivables ("Receivable Loans") and against Borrower's Eligible Inventory ("Inventory Loans") (the Receivable Loans and the Inventory Loans shall be collectively referred to as the "Revolving A Credit Loans") in an aggregate outstanding principal amount not to exceed the lesser of (a) or (b) below:

(a) Fifteen Million Dollars ($15,000,000) (the "Revolving A Credit Limit"), less the Dilution Reserve, the Special Reserve and, without duplication, any other Loan Reserves, or

(b) the sum of

(i) an amount equal to 85% of the net amount of Eligible Trade Receivables; plus

(ii) an amount not to exceed the lesser of:

(A) the sum of (I) 25% of the value of Borrower's Eligible Inventory consisting of raw materials and (II) 35% of the value of Borrower's Eligible Inventory consisting of finished goods, in each case, calculated at the lower of cost or market value and determined on a first-in, first-out basis, or

(B) $7,000,000; less

(iii) the Dilution Reserve, the Special Reserve and, without duplication, any other Loan Reserves;

provided, however, in no event shall any Revolving A Credit Loans be available to Borrower unless (i) Borrower shall have at all times Revolving B Credit Loans outstanding in a principal amount of not less than Seven Million Five Hundred Thousand Dollars ($7,500,000), and (ii) the Dominion Account shall have been established at Silicon Valley Bank pursuant to an agreement satisfactory to FINOVA.

Revolving B Credit Loans: A revolving line of credit available to the Borrower, so long as all applicable conditions precedent set forth in Section 4.2 of the Agreement are met, consisting of loans against Cash Collateral (the "Revolving B Credit Loans") in an aggregate outstanding principal amount not to exceed the lesser of (a) or (b) below:

(a) Fifteen Million Dollars ($15,000,000) (the "Revolving B Credit Limit"), less any Loan Reserves (other than the Dilution Reserve or the Special Reserve and without duplication of any other Loan Reserve which has been already applied to reduce loan availability under the Revolving A Credit Loans), or

(b) an amount equal to 100% of Cash Collateral, less any Loan Reserves (other than the Dilution Reserve or the Special Reserve, and without duplication of any other Loan Reserve which has been already applied to reduce loan availability under the Revolving A Credit Loans);

provided, however, the minimum amount of each Revolving B Credit Loan (and the corresponding amount of Cash Collateral to be deposited into the Control Account to provide availability for such advance) shall not be less than $3,000,000.

 

INTEREST AND FEES (SECTION 2.6):

Revolving A Interest Rate. Borrower shall pay FINOVA interest on the daily outstanding balance of Borrower's Revolving A Credit Loans at a per annum rate of 1.50% in excess of the rate of interest announced publicly by Citibank, N.A., (or any successor thereto), from time to time as its "prime rate" (the "Prime Rate") which may not be such institution's lowest rate. The interest rate chargeable hereunder in respect of the Revolving A Credit Loans (herein, the "Revolving A Interest Rate") shall be increased or decreased, as the case may be, without notice or demand of any kind, upon the announcement of any change in the Prime Rate. Each change in the Prime Rate shall be effective hereunder on the first day following the announcement of such change.

Interest charges and all other fees and charges under this Agreement shall be computed on the basis of a year of 360 days and actual days elapsed and shall be payable to FINOVA in arrears on the first day of each month.

Revolving B Interest Rate. Borrower shall pay FINOVA interest on the daily outstanding balance of the Revolving B Credit Loans at a per annum rate equal to the Prime Rate. The interest rate chargeable hereunder in respect of the Revolving B Credit Loans (herein, the "Revolving B Interest Rate") shall be increased or decreased, as the case may be, without notice or demand of any kind, upon the announcement of any change in the Prime Rate. Each change in the Prime Rate shall be effective hereunder on the first day following the announcement of such change.

Minimum Interest Charge. With respect to each calendar month or portion thereof during the term of this Agreement (excluding the calendar month in which this Agreement is executed), Borrower shall pay FINOVA, on the first day of the next month, as a minimum charge, the amount by which the aggregate accrued interest on the Revolving A Credit Loans and the Revolving B Credit Loans for such month is less than the product of Five Million Dollars ($5,000,000) multiplied by the Revolving B Interest Rate (the "Minimum Interest Charge").

Collateral Monitoring Fee. At the closing of this transaction and on the first day of each calendar month thereafter, Borrower shall pay FINOVA a collateral monitoring fee of $750 ("Collateral Monitoring Fee"); provided however, that Borrower agrees and acknowledges that each Loan Year a full year's fee shall be deemed earned at the beginning of the respective Loan Year.

Closing Fee. At the closing of this transaction, Borrower shall pay to FINOVA a closing fee equal to $300,000 less the commitment fee of $150,000 previously received by FINOVA (the "Closing Fee"). Borrower acknowledges that the Closing Fee was fully earned by FINOVA on the Closing Date.

Unused Line Fee. With respect to each fiscal month, or portion thereof during the term of this Agreement, Borrower shall unconditionally pay to FINOVA a fee equal to 0.375% per annum of the difference between the Revolving A Credit Limit and the average daily outstanding balance of the Revolving A Credit Loans during such month, or portion thereof ("Unused Line Fee"), which fee shall be calculated and payable monthly, in arrears, and shall be due and payable, commencing on the first day of the Borrower's first month following the Closing Date and continuing on the first day of each month thereafter; provided however, if the Revolving A Credit Limit shall be reduced in accordance with the provisions of this Agreement to an amount less than that provided on the Closing Date, the Unused Line Fee shall be calculated with reference to such lesser amount.

Examination Fee. Borrower agrees to pay to FINOVA an examination fee in the amount of $600 per person per day in connection with each audit or examination of Borrower performed by FINOVA prior to or after the date hereof, plus all costs and expenses incurred in connection therewith (the "Examination Fee"). Such examination shall be performed no less frequently than on a quarterly basis. Without limiting the generality of the foregoing, Borrower shall pay to FINOVA an initial Examination Fee in an amount equal to $600 per person per day, plus all costs and expenses incurred in connection therewith. Such initial Examination Fee shall be deemed fully earned at the time of payment and due and payable upon the closing of this transaction, and shall be deducted from any good faith deposit paid by Borrower to FINOVA prior to the date of this Agreement.

 

BORROWER INFORMATION:

Borrower's State of Incorporation (Section 5.1): Delaware.

Borrower's copyrights, patents trademarks, and licenses (Section 5.5): See Exhibit 5.5 hereto.

Fictitious Names/Prior Corporate Names (Section 5.2):

Prior Corporate Names: None.

Fictitious Names: None.

Borrower Locations (Section 5.16) See Exhibit 5.16 hereto.

Borrower's Federal Tax Identification Number (Section 5.16): 94- 3076069

 

 

FINANCIAL COVENANTS (SECTION 6.1.13):

Borrower shall comply with all of the following covenants. Compliance shall be determined as of the end of each month, except as otherwise specifically provided below:

Tangible Net Worth

shall mean, with respect to Borrower at any date, the Net Worth (as defined below) of Borrower at such date, excluding, however, from the determination of the total assets of Borrower at such date, (a) all goodwill, capitalized organizational expenses, capitalized research and development expenses, trademarks, trade names, copyrights, patents, patent applications, licenses and rights in any thereof, and all other intangible items, (b) all unamortized debt discount and expense, (c) treasury Stock or the Stock of any Subsidiaries, and (d) any write-up in the book value of any asset resulting from a revaluation thereof. As used herein, "Net Worth" shall mean, with respect to Borrower as of any date of determination, the book value of the assets of Borrower, minus (a) reserves applicable thereto, and minus (b) all of such Borrower's liabilities (including accrued and deferred income taxes), all as determined in accordance with GAAP.

Minimum Tangible Net Worth

Maintain at all times during each period set forth below Tangible Net Worth equal to or greater than the amounts set forth below opposite such periods:

Period

Amount

Closing Date - 6/30/00

$24,800,000

7/01/00 - 9/30/00

$21,400,000

10/01/00 - 12/31/00

$18,000,000

1/01/01 - 3/31/01

$19,200,000

4/01/01 - 6/30/01

$20,000,000

7/01/01 - 9/30/01

$22,000,000

10/01/01 - 12/31/01

$25,000,000

All times thereafter

$27,200,000

Liquidity

Maintain at all times during each period set forth below Liquidity not less than the amounts set forth below opposite such periods:

Period

Amount

Closing Date - 6/30/00

$25,000,000

7/01/00 - 9/30/00

$20,000,000

10/01/00 - 12/31/00

$12,000,000

1/01/01 - 3/31/01

$8,000,000

4/01/01 - 6/30/01

$5,000,000

7/01/01 - 9/30/01

$5,000,000

10/01/01 - 12/31/01

$5,000,000

All times thereafter

$7,500,000

 

 

NEGATIVE COVENANTS (SECTION 6.2):

Employee Advances:

Borrower shall not make any loans or advances to employees except in the ordinary course of business and consistent with past practices of Borrower in an aggregate amount not exceeding at any time $1,600,000, and in no event shall Borrower make any new loans or advances to employees during the term of this Agreement in excess of $800,000.

Existing Guaranties:

See Exhibit 6.2.5.

Capital Expenditures:

Borrower shall not make or incur any Capital Expenditure if, after giving effect thereto, the aggregate amount of all Capital Expenditures by Borrower (i) in the fiscal year ended December 31, 2000 would exceed $3,500,000, and (ii) any fiscal year thereafter would exceed $2,500,000.

Compensation:

Borrower shall not pay total compensation, including salaries, withdrawals, fees, bonuses, commissions, drawing accounts and other payments, whether directly or indirectly, in money or otherwise, during any fiscal year to all of Borrower's executives, officers and directors (or any relative thereof) in an amount in excess of the amount authorized by the Compensation Committee of the Board of Directors of Borrower.

Indebtedness for Borrowed Money:

Borrower shall not create, incur, assume or permit to exist any Indebtedness for Borrowed Money in excess of $500,000 other than (i) the Obligations, and (ii) other Indebtedness existing on the date of this Agreement and reflected in Exhibit 6.2.11 attached hereto (other than Indebtedness paid on the date of this Agreement from proceeds of the initial advances hereunder) and (iii) Subordinated Debt.

 

TERM (SECTION 9.2):

The initial term of this Agreement shall be three (3) years from the date hereof (the "Initial Term") and if the parties hereto shall so agree in writing, shall be renewed for successive periods of one (1) year each (each, a "Renewal Term"), unless earlier terminated as provided in Section 7 or 9.2 above or elsewhere in this Agreement.

 

TERMINATION FEE (SECTION 9.2):

The Termination Fee applicable to the Revolving Credit Loans facility provided for in Section 9.2(d) shall be an amount equal to the following percentage of the Revolving Credit Limit:

(i) Two percent (2%), if such early termination occurs on or prior to the first anniversary of the Closing Date of this Agreement; and

(ii) One half of one percent (0.50%), if such early termination occurs after the first anniversary of the Closing Date of this Agreement but prior to the second anniversary of the Closing Date of this Agreement. No Termination Fee shall be applicable from and after the second anniversary of the Closing Date.

 

DISBURSEMENT (SECTION 9.11):

Unless and until Borrower otherwise directs FINOVA in writing, all loans shall be wired to Borrower's following operating account:

Silicon Valley Bank

3003 Tasman Drive

Santa Clara, CA 95054

ABA # 121140399

for credit to SangStat Medical Corporation

checking account number 273004970

 

ADDITIONAL PROVISIONS:

1. Qualified to do Business in Tennessee. Within thirty (30) days after the Closing Date, Borrower shall have taken all steps necessary to duly qualify to do business as a foreign corporation in Tennessee, and shall have provided FINOVA with a good standing certificate (or its equivalent) from the Secretary of State of the State of Tennessee evidencing the same.

2. French Legal Opinion. Within ten (10) days after the Closing Date, Borrower shall have taken all steps and delivered all documents necessary to cause DePardieu Brocas Maffei & Leygonie to issue their legal opinion in favor of FINOVA, including, without limitation:

(i) share transfer register evidencing the pledge of 100% of the outstanding voting stock of SangStat Atlantique to FINOVA;

(ii) share transfer register evidencing the pledge of 100% of the outstanding voting stock of IMTIX SangStat to FINOVA;

(iii) shareholders' resolutions of SangStat Atlantique approving the pledges;

(iv) evidence of the authority of the signatory of the pledge agreements to pledge the shares in SangStat Atlantique and IMTIX SangStat in favor of FINOVA;

(v) certified articles of association of SangStat Atlantique and certificate of incorporation of SangStat Atlantique; and

(vi) certified articles of association of IMTIX Atlantique and certificate of incorporation of IMTIX Atlantique.

 

Borrower:

SANGSTAT MEDICAL CORPORATION

 

By______________________________

Title____________________________

 

FINOVA:

FINOVA CAPITAL CORPORATION

By______________________________

Title_____________________________

 

EXHIBIT A - REPORTING REQUIREMENTS

INSTRUCTIONS TO SANGSTAT MEDICAL CORPORATION ("BORROWER") FOR THE HANDLING OF BORROWER'S ACCOUNT WITH FINOVA CAPITAL CORPORATION ("FINOVA")

1. On a weekly basis (and on each day on which Borrower shall make a request for an advance), FINOVA's standard form collateral and loan report, together with accounts receivable certifications and notice of assignment documents on a daily basis or as described in the Schedule, together with cash receipt and revenue reports.

2. Upon FINOVA's request, copies of sales journals, cash receipt journals, and deposit slips, copies of service invoices, customer statements and credit memoranda issued, remittance advices and reports, evidence of billing and copies of shipping and delivery documents.

3. Within five (5) days of the date due (or earlier if available) all cost reports (interim and annual) from all Governmental Authorities or other Persons, as applicable.

4. Within ten (10) days after the end of each month,

(a) monthly agings (aged from service date) and reconciliations of Receivables (with listings of concentrated accounts);

(b) monthly agings (aged from invoice date) of accounts payable, with outstanding and held check registers; and

(c) monthly perpetual inventory reports for the Inventory valued on a first in, first out basis at the lower of cost or market (in accordance with GAAP).

5. Within thirty (30) days after the end of each month, unaudited financial statements with respect to the prior month prepared on a basis consistent with such statements prepared in prior months and otherwise in accordance with GAAP other than lack of footnotes and year-end adjustments.

6. Within thirty (30) days after the end of each quarter, unaudited financial statement with respect to the prior quarter prepared on a basis consistent with such statements prepared in prior quarters and otherwise in accordance with GAAP other than lack of footnotes and year-end adjustments.

7. Audited annual consolidated and consolidating financial statements, prepared in accordance with GAAP applied on a basis consistent with the most recent Prepared Financials provided to FINOVA by Borrower, including balance sheets, income and cash flow statements, accompanied by the unqualified report thereon of independent certified public accountants acceptable to FINOVA, together with the management letter, in the form provided to the directors and shareholders of Borrower, as soon as available, and in any event, within ninety (90) days after the end of each of Borrower's fiscal years.

8. Within thirty (30) days prior to the end of each fiscal year of Borrower annual operating budgets (including income statement, balance sheets and cash flow statements, by month) for the upcoming fiscal year of Borrower.

9. Such certificates relating to any of the foregoing as FINOVA may request, including, without limitation, a monthly certificate from the president and the chief financial officer of Borrower ("Compliance Certificate") showing Borrower's compliance with each of the financial covenants set forth in this Agreement, and stating whether any Event of Default has occurred or event which, with giving of notice or the passage of time, or both, would constitute an Event of Default, and if so, the steps being taken to prevent or cure such Event of Default, and such other certificates relating to the reporting requirements set forth in this Exhibit or in Section 9.1 of the Loan and Security Agreement, as FINOVA shall reasonably request. All reports or financial statements submitted by Borrower shall be in reasonable detail and shall be certified by the principal financial officer of Borrower as being complete and correct in all material respects.

STATE OF )

) ss:

COUNTY OF )

BEFORE ME, a Notary Public, in and for said county and state, personally appeared the above-named SangStat Medical Corporation, a Delaware corporation, by ____________________________ its _______________________________, who acknowledged that he/she did sign the foregoing agreement and that the same is he/her free act and deed and the free act and deed of said corporation.

IN WITNESS WHEREOF, I have hereunto set my hand and official seal at ______________________, this _______ day of ____________, 2000.

 

______________________

Notary Public








EX-27.1 4 FINANCIAL DATA SCHEDULE
5 THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2000. 1,000 3-MOS DEC-31-2000 JAN-01-2000 MAR-31-2000 26,054 8,033 14,283 1,721 45,751 96,315 6,097 0 123,293 28,209 0 0 0 191,612 (142,759) 123,293 15,358 15,940 7,857 7,857 15,490 0 0 (7,728) 61 (7,789) 0 0 0 (7,789) (0.44) (0.44)
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