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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): February 4, 2002
SANGSTAT MEDICAL CORPORATION
|
|
|
|
6300 Dumbarton Circle
Fremont, California 94555
510-789-4300
Not Applicable
Item 5. Other Events.
On February 4, 2002, SangStat Medical Corporation (the "Company") entered into a Purchase Agreement with the underwriters named therein for the public offering and sale of 4,500,000 shares of the Company's Common Stock. An additional 675,000 shares of Common Stock are subject to an over-allotment option granted to the underwriters. The Common Stock will be offered pursuant to a Prospectus Supplement, dated February 4, 2002, and the accompanying Prospectus, dated December 27, 2001, which together form a part of a Registration Statement on Form S-3 (Commission File No. 333-76028) previously filed with the Securities and Exchange Commission on December 28, 2001.
For additional information concerning these securities, refer to the exhibits attached to this Current Report on Form 8-K.
Item 7. Exhibits.
(a) Not applicable
(b) Not applicable
(c) Exhibits
1.1 |
Purchase Agreement, dated February 4, 2002, by and among SangStat Medical Corporation, Merrill Lynch & Co., Merrill Lynch, Pierce, Fenner & Smith Incorporated, J.P. Morgan Securities Inc., Thomas Weisel Partners LLC and Wells Fargo Securities, LLC. |
5.1 |
Opinion of Skadden, Arps, Slate, Meagher & Flom LLP. |
23.1 |
Consent of Skadden, Arps, Slate, Meagher & Flom LLP (included as part of Exhibit 5.1). |
SIGNATURE
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, thereto duly authorized.
Date: February 5, 2002
SANGSTAT MEDICAL CORPORATION |
By: | /s/ Stephen G. Dance |
| |
Stephen G. Dance | |
Senior Vice President, Finance |
EXHIBIT INDEX
Exhibit No.
|
Description |
1.1 |
Purchase Agreement, dated February 4, 2002, by and among SangStat Medical Corporation, Merrill Lynch & Co., Merrill Lynch, Pierce, Fenner & Smith Incorporated, J.P. Morgan Securities Inc., Thomas Weisel Partners LLC and Wells Fargo Securities, LLC. |
5.1 |
Opinion of Skadden, Arps, Slate, Meagher & Flom LLP. |
23.1 |
Consent of Skadden, Arps, Slate, Meagher & Flom LLP (included as part of Exhibit 5.1). |
SANGSTAT MEDICAL CORPORATION
(a Delaware corporation)
4,500,000 Shares of Common Stock
PURCHASE AGREEMENT
Dated: February 4, 2002
SANGSTAT MEDICAL CORPORATION
(a Delaware corporation)
4,500,000 Shares of Common Stock
(Par Value $0.001 Per Share)
PURCHASE AGREEMENT
February 4, 2002
MERRILL LYNCH & CO.
Merrill Lynch, Pierce, Fenner & Smith
Incorporated
J.P. Morgan Securities Inc.
Thomas Weisel Partners LLC
Wells Fargo Securities, LLC
c/o Merrill Lynch & Co.
Merrill Lynch, Pierce, Fenner & Smith
Incorporated
North Tower
World Financial Center
New York, New York 10281-1209
Ladies and Gentlemen:
SangStat Medical Corporation, a Delaware corporation (the "Company"), confirms its agreement with Merrill Lynch & Co., Merrill Lynch, Pierce, Fenner & Smith Incorporated ("Merrill Lynch") and each of the other Underwriters named in Schedule A hereto (collectively, the "Underwriters", which term shall also include any underwriter substituted as hereinafter provided in Section 10 hereof), with respect to the issue and sale by the Company and the purchase by the Underwriters, acting severally and not jointly, of the respective numbers of shares of Common Stock, par value $0.001 per share, of the Company ("Common Stock") set forth in said Schedule A, and with respect to the grant by the Company to the Underwriters, acting severally and not jointly, of the option described in Section 2(b) hereof to purchase all or any part of 675,000 additional shares of Common Stock to cover over-allotments, if any. The aforesaid 4,500,000 shares of Common Stock (the "Initial Securities") to be purchased by the Underwriters and all or any part of the 675,000 shares of Common Stock subject to the option described in Section 2(b) hereof (the "Option Securities") are hereinafter called, collectively, the "Securities".
The Company understands that the Underwriters propose to make a public offering of the Securities as soon as the Underwriters deem advisable after this Agreement has been executed and delivered.
The Company has filed with the Securities and Exchange Commission (the "Commission") a registration statement on Form S-3 (No. 333-76028) covering the registration of, among other things, the Securities under the Securities Act of 1933, as amended (the "1933 Act"), including the related preliminary prospectus or prospectuses. Promptly after execution and delivery of this Agreement, the Company will either prepare and file a prospectus supplement and, if required by Rule 424(b) (as defined below), a prospectus in accordance with the provisions of Rule 415 ("Rule 415") of the rules and regulations of the Commission under the 1933 Act (the "1933 Act Regulations") and paragraph (b) of Rule 424 ("Rule 424(b)") of the 1933 Act Regulations. Each prospectus, together with any related prospectus supplement, relating to the Securities used before such registration statement became effective, and each prospectus, together with the related prospectus supplement, or that was captioned "Subject to Completion" that was used after such effectiveness and prior to the execution and delivery of this Agreement, is herein called, together with the documents incorporated by reference therein pursuant to Item 12 of Form S-3 under the 1933 Act, a "preliminary prospectus." Such registration statement, as amended and including the exhibits thereto, schedules, if any, and the documents incorporated by reference therein pursuant to Item 12 of Form S-3 under the 1933 Act, at the time that it became effective is herein called the "Registration Statement." Any registration statement filed pursuant to Rule 462(b) of the 1933 Act Regulations is herein referred to as the "Rule 462(b) Registration Statement," and after such filing the term "Registration Statement" shall include the Rule 462(b) Registration Statement. The prospectus, dated December 27, 2001, and the final prospectus supplement relating to the offering of the Securities, including the documents incorporated by reference therein pursuant to Item 12 of Form S-3 under the 1933 Act, in the form first furnished to the Underwriters for use in connection with the offering of the Securities are herein called, collectively, the "Prospectus." For purposes of this Agreement, all references to the Registration Statement, any preliminary prospectus, the Prospectus or any amendment or supplement to any of the foregoing shall be deemed to include any copy filed with the Commission pursuant to its Electronic Data Gathering, Analysis and Retrieval system ("EDGAR").
All references in this Agreement to financial statements and schedules and other information which is "contained," "included" or "stated" in the Registration Statement, any preliminary prospectus or the Prospectus (or other references of like import) shall be deemed to mean and include all such financial statements and schedules and other information which is incorporated by reference in the Registration Statement, any preliminary prospectus or the Prospectus, as the case may be; and all references in this Agreement to amendments or supplements to the Registration Statement, any preliminary prospectus or the Prospectus shall be deemed to mean and include the filing of any document under the Securities Exchange Act of 1934 (the "1934 Act") which is incorporated by reference in the Registration Statement, such preliminary prospectus or the Prospectus, as the case may be.
The Company represents and warrants to each Underwriter as of the date hereof, as of the Closing Time referred to in Section 2(c) hereof, and as of each Date of Delivery (if any) referred to in Section 2(b) hereof, and agrees with each Underwriter, as follows:
At the respective times the Registration Statement, any Rule 462(b) Registration Statement and any post-effective amendments thereto became effective and at the Closing Time (and, if any Option Securities are purchased, at the Date of Delivery), the Registration Statement, the Rule 462(b) Registration Statement and any amendments and supplements thereto complied and will comply in all material respects with the requirements of the 1933 Act and the 1933 Act Regulations and did not and will not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading. Neither the Prospectus nor any amendments or supplements thereto, at the time the Prospectus or any such amendment or supplement was issued and at the Closing Time (and, if any Option Securities are purchased, at the Date of Delivery), included or will include an untrue statement of a material fact or omitted or will omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The representations and warranties in this subsection shall not apply to statements in or omissions from the Registration Statement or Prospectus made in reliance upon and in conformity with information furnished to the Company in writing by any Underwriter through Merrill Lynch expressly for use in the Registration Statement or Prospectus.
Each preliminary prospectus and the prospectus filed as part of the Registration Statement as originally filed or as part of any amendment thereto, or filed pursuant to Rule 424 under the 1933 Act, complied when so filed in all material respects with the 1933 Act Regulations and each preliminary prospectus and the Prospectus delivered to the Underwriters for use in connection with this offering was identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T.
Any certificate signed by any officer of the Company or any of its subsidiaries delivered to the Underwriters or to counsel for the Underwriters shall be deemed a representation and warranty by the Company to each Underwriter as to the matters covered thereby.
In addition, in the event that any or all of the Option Securities are purchased by the Underwriters, payment of the purchase price for, and delivery of certificates for, such Option Securities shall be made at the above-mentioned offices, or at such other place as shall be agreed upon by the Underwriters and the Company, on each Date of Delivery as specified in the notice from the Underwriters to the Company.
Payment shall be made to the Company by wire transfer of immediately available funds to a bank account designated by the Company, against delivery for the respective accounts of the Underwriters of certificates for the Securities to be purchased by them. Merrill Lynch, individually and not as representative of the Underwriters, may (but shall not be obligated to) make payment of the purchase price for the Initial Securities or the Option Securities, if any, to be purchased by any Underwriter whose funds have not been received by the Closing Time or the relevant Date of Delivery, as the case may be, but such payment shall not relieve such Underwriter from its obligations hereunder.
provided, however, that this indemnity agreement shall not apply to any loss, liability, claim, damage or expense to the extent arising out of any untrue statement or omission or alleged untrue statement or omission made in reliance upon and in conformity with written information furnished to the Company by any Underwriter through Merrill Lynch expressly for use in the Registration Statement (or any amendment thereto), or any preliminary prospectus or the Prospectus (or any amendment or supplement thereto).
The relative benefits received by the Company on the one hand and the Underwriters on the other hand in connection with the offering of the Securities pursuant to this Agreement shall be deemed to be in the same respective proportions as the total net proceeds from the offering of the Securities pursuant to this Agreement (before deducting expenses) received by the Company and the total underwriting discount received by the Underwriters, in each case as set forth on the cover of the Prospectus, bear to the aggregate initial public offering price of the Securities as set forth on such cover.
The relative fault of the Company on the one hand and the Underwriters on the other hand shall be determined by reference to, among other things, whether any such untrue or alleged untrue statement of a material fact or omission or alleged omission to state a material fact relates to information supplied by the Company or by the Underwriters and the parties' relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission.
The Company and the Underwriters agree that it would not be just and equitable if contribution pursuant to this Section 7 were determined by pro rata allocation (even if the Underwriters were treated as one entity for such purpose) or by any other method of allocation which does not take account of the equitable considerations referred to above in this Section 7. The aggregate amount of losses, liabilities, claims, damages and expenses incurred by an indemnified party and referred to above in this Section 7 shall be deemed to include any legal or other expenses reasonably incurred by such indemnified party in investigating, preparing or defending against any litigation, or any investigation or proceeding by any governmental agency or body, commenced or threatened, or any claim whatsoever based upon any such untrue or alleged untrue statement or omission or alleged omission.
Notwithstanding the provisions of this Section 7, no Underwriter shall be required to contribute any amount in excess of the amount by which the total price at which the Securities underwritten by it and distributed to the public were offered to the public exceeds the amount of any damages which such Underwriter has otherwise been required to pay by reason of any such untrue or alleged untrue statement or omission or alleged omission.
No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the 1933 Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation.
For purposes of this Section 7, each person, if any, who controls an Underwriter within the meaning of Section 15 of the 1933 Act or Section 20 of the 1934 Act shall have the same rights to contribution as such Underwriter, and each director of the Company, each officer of the Company who signed the Registration Statement, and each person, if any, who controls the Company within the meaning of Section 15 of the 1933 Act or Section 20 of the 1934 Act shall have the same rights to contribution as the Company. The Underwriters' respective obligations to contribute pursuant to this Section 7 are several in proportion to the number of Initial Securities set forth opposite their respective names in Schedule A hereto and not joint.
(a) if the number of Defaulted Securities does not exceed 10% of the number of Securities to be purchased on such date, each of the non- defaulting Underwriters shall be obligated, severally and not jointly, to purchase the full amount thereof in the proportions that their respective underwriting obligations hereunder bear to the underwriting obligations of all non-defaulting Underwriters, or
(b) if the number of Defaulted Securities exceeds 10% of the number of Securities to be purchased on such date, this Agreement or, with respect to any Date of Delivery which occurs after the Closing Time, the obligation of the Underwriters to purchase and of the Company to sell the Option Securities to be purchased and sold on such Date of Delivery shall terminate without liability on the part of any non-defaulting Underwriter.
No action taken pursuant to this Section shall relieve any defaulting Underwriter from liability in respect of its default.
In the event of any such default which does not result in a termination of this Agreement or, in the case of a Date of Delivery which is after the Closing Time, which does not result in a termination of the obligation of the Underwriters to purchase and the Company to sell the relevant Option Securities, as the case may be, either the Underwriters or the Company shall have the right to postpone Closing Time or the relevant Date of Delivery, as the case may be, for a period not exceeding seven days in order to effect any required changes in the Registration Statement or Prospectus or in any other documents or arrangements. As used herein, the term "Underwriter" includes any person substituted for an Underwriter under this Section 10.
If the foregoing is in accordance with your understanding of our agreement, please sign and return to the Company a counterpart hereof, whereupon this instrument, along with all counterparts, will become a binding agreement between the Underwriters and the Company in accordance with its terms.
Very truly yours,
SANGSTAT MEDICAL CORPORATION
By__________________________________
Title:
CONFIRMED AND ACCEPTED,
as of the date first above written:
MERRILL LYNCH & CO.
MERRILL LYNCH, PIERCE, FENNER & SMITH
INCORPORATED
J.P. MORGAN SECURITIES INC.
Thomas Weisel Partners LLC
Wells Fargo Securities, LLC
By: MERRILL LYNCH, PIERCE, FENNER & SMITH
INCORPORATED
By __________________________________
Authorized Signatory
For themselves and as Underwriters of the other Underwriters named in Schedule A hereto.
SCHEDULE A
Name of Underwriter |
Number of |
|
|
Merrill Lynch, Pierce, Fenner & Smith Incorporated |
|
J.P. Morgan Securities Inc. |
1,710,000 |
Thomas Weisel Partners LLC . |
855,000 |
Wells Fargo Securities, LLC |
225,000 |
|
|
Total |
4,500,000 |
SCHEDULE B
SANGSTAT MEDICAL CORPORATION
4,500,000 Shares of Common Stock
(Par Value $0.001 Per Share)
1. The initial public offering price per share for the Securities, determined as provided in said Section 2, shall be $17.25.
2. The purchase price per share for the Securities to be paid by the several Underwriters shall be $16.26, being an amount equal to the initial public offering price set forth above less $0.99 per share; provided that the purchase price per share for any Option Securities purchased upon the exercise of the over-allotment option described in Section 2(b) shall be reduced by an amount per share equal to any dividends or distributions declared by the Company and payable on the Initial Securities but not payable on the Option Securities.
SCHEDULE C
List of persons
subject to lock-up
Steve Aselage
Jean-Jacques Bienaimé
Roland Buelow, Ph.D.
Stephen G. Dance
Fredric J. Feldman, Ph.D.
Robert C. Floc'h, Ph.D.
Ralph E. Levy
Richard D. Murdock
Andrew Perlman, M.D., Ph.D.
Nicholas J. Simon III
Raymond J. Tesi, M.D.
Vincent R. Worms
Schedule D
List of Company's
Subsidiaries
SangStat Atlantique S.A.S.
IMTIX - SangStat S.A.S.
SangStat Luxembourg S.a.r.l.
IMTIX - SangStat Netherlands BV
IMTIX - SangStat GmbH
IMTIX- SangStat (Switzerland) GmbH
SangStat Spain S.L.
IMTIX - SangStat Austria GmbH
IMTIX - SangStat Italy Srl
IMTIX - SangStat UK
SangStat Canada, Ltd.
SangStat U.K., Ltd.
SangStat Medical International Cayman
SangStat Netherlands BV
Chronimmune Pharmaceuticals, Inc.
Human Organ Sciences, Inc.
The Transplant Pharmacy, Inc.
XenoStat, Inc.
Exhibit A
FORM OF OPINION OF COMPANY'S COUNSEL
TO BE DELIVERED PURSUANT TO
SECTION 5(b)
We have been orally advised by the Commission that the Registration Statement was declared effective under the Securities Act at 5:00 p.m., on January 15, 2002, and we have been orally advised by the Commission that no stop order suspending the effectiveness of the Registration Statement has been issued and, to the best of our knowledge, no proceedings for that purpose have been instituted or are pending or threatened by the Commission.
1. The Company is validly existing as a corporation in good standing under the laws of the State of Delaware.
2. The Company has the corporate power and corporate authority to own, lease and operate its properties and to conduct its business as described in the Prospectus and to execute and deliver the Purchase Agreement and to consummate the transactions contemplated thereby.
3. The Company has the status set forth in Schedule A hereto set forth opposite the jurisdiction listed on Schedule A hereto.
4. The Company has an authorized capitalization as set forth in the Prospectus under the caption "Capitalization."
5. The Securities have been duly authorized by the Company and, when delivered to and paid for by the Underwriters in accordance with the terms of the Purchase Agreement against payment of the consideration set forth in the Purchase Agreement, will be validly issued, fully paid and nonassessable, and will be free and clear of any preemptive rights or any similar rights arising under the General Corporation Law of the State of Delaware, the Certificate of Incorporation, the Bylaws or, to our knowledge, any Applicable Contract, and no holder of the Securities is or will be subject to personal liability by reason of being such a holder.
6. The Purchase Agreement has been duly authorized, executed and delivered by the Company.
7. The Registration Statement, at the time it became effective, and the Prospectus, as of its date, excluding the documents incorporated by reference therein, appeared on their face to be appropriately responsive in all material respects to the requirements of the Securities Act and the General Rules and Regulations under the Securities Act, except that in each case we do not express any opinion as to the financial statements and schedules and other financial data included or incorporated by reference therein or excluded therefrom, or the exhibits thereto, and, except to the extent expressly stated in paragraph 11, we do not assume any responsibility for the accuracy, completeness or fairness of the statements contained in the Registration Statement or the Prospectus.
8. Each of the Incorporated Documents, when it was filed, appeared on its face to be appropriately responsive in all material respects with the requirements of the Exchange Act and the applicable rules and regulations of the Commission thereunder, except that we do not express any opinion as to the financial statements and related notes and schedules and other financial data included or incorporated by reference therein or excluded therefrom or the exhibits thereto.
9. The form of certificate used to evidence the Common Stock complies in all material respects with the applicable requirements of the Certificate of Incorporation, the Bylaws, the General Corporation Law of the State of Delaware and the Nasdaq National Market.
10. To our knowledge, there are no legal or governmental proceedings pending to which the Company is a party or to which any property of the Company is subject that are required to be disclosed in the Prospectus pursuant to Regulation S-K of the General Rules and Regulations under the Securities Act that are not so disclosed.
11. Each of (i) the description of the Company's Common Stock contained under Item 4, "Description of Registrant's Securities to be Registered," in its registration statement on Form 8-B, filed with the Commission on December 4, 1995, except that we express no view with respect to the penultimate sentence thereof and, with respect to the last sentence thereof, we note the issuance by the Company of Preferred Stock Purchase Rights (the "Rights") in accordance with the provisions of that certain Rights Agreement, dated August 14, 1995, between the Company and The First National Bank of Boston, as amended pursuant to that certain First Amendment to Rights Agreement, dated October 8, 2001, between the Company, Fleet National Bank and Equiserve Trust Company, N.A., (ii) the description of the Rights contained under Item 1, "Description of Registrant's Securities to be Registered," in the Company's Registration Statement on Form 8-A, filed with the Commission on August 25, 1995, as amended by Amendment No. 1 to Form 8-A filed with the Commission on October 9, 2001, and (iii) the statements contained in the Registration Statement under Item 15, insofar as such statements purport to summarize certain provisions of the laws or documents referred to therein, fairly summarize such provisions in all material respects.
12. To our knowledge, there are no contracts or documents of a character required to be filed as exhibits to the Registration Statement which are not filed as required.
13. No Governmental Approval, which has not been obtained or taken and is not in full force and effect, is required to authorize, or is required in connection with, the execution or delivery of the Purchase Agreement by the Company or the consummation by the Company of the transactions contemplated thereby.
14. The execution and delivery by the Company of the Purchase Agreement and the consummation by the Company of the transactions contemplated thereby, including the issuance and sale of the Securities, and the use of the proceeds from the sale of the Securities as described in the Prospectus under the caption "Use of Proceeds" do not and will not, whether with or without giving notice or lapse of time or both, (i) conflict with the Certificate of Incorporation or Bylaws, (ii) constitute a violation of, or a breach or default under, the terms of any Applicable Contract or (iii) violate or conflict with, or result in any contravention of, any Applicable Law or any Applicable Order. We do not express any opinion, however, as to whether the execution, delivery or performance by the Company of the Purchase Agreement will constitute a violation of, or a default under, any covenant, restriction or provision with respect to financial ratios or tests or any aspect of the financial condition or results of operations of the Company or any of its subsidiaries.
15. The Company is not an "investment company" or an entity "controlled" by an "investment company," as such terms are defined in the Investment Company Act of 1940, as amended.
16. The Rights under the Company's Shareholder Rights Plan to which holders of the Securities will be entitled have been duly authorized by the Company and, when the Securities are delivered to and paid for by the Underwriters in accordance with the terms of the Purchase Agreement against payment of the consideration set forth in the Purchase Agreement, will be validly issued.
In addition, we have participated in conferences with officers and other representatives of the Company, representatives of the independent accountants of the Company and you and your counsel at which the contents of the Registration Statement and the Prospectus and related matters were discussed. We did not participate in the preparation of the Incorporated Documents but have, however, reviewed such documents and discussed the business and affairs of the Company with officers and other representatives of the Company. Although we are not passing upon, and do not assume any responsibility for, the accuracy, completeness or fairness of the statements contained in the Registration Statement or the Prospectus and have made no independent check or verification thereof (except to the limited extent referred to in paragraph 11 above), on the basis of the foregoing, no facts have come to our attention that have led us to believe that the Registration Statement, at the time it became effective, contained an untrue statement of a material fact or omitted to state any material fact required to be stated therein or necessary to make the statements therein not misleading or that the Prospectus, as of its date and as of the date hereof, contained or contains an untrue statement of a material fact or omitted or omits to state a material fact necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading, except that we express no opinion or belief with respect to the financial statements and schedules and other financial data included or incorporated by reference therein or excluded therefrom or the exhibits to the Registration Statement.
Exhibit B
FORM OPINION OF COMPANY'S U.S. REGULATORY
COUNSEL TO BE DELIVERED
PURSUANT TO SECTION 5(b)
We have examined statements in the Company's [Prospectus] under "Government Regulation," "Litigation--Novartis Regulatory Litigation--U.S. Regulatory Litigation," in the second to last and third to last sentences under "Litigation-Summary," in the first two sentences under "Risk Factors--We may not be able to manufacture or obtain sufficient quantities of our products, which could lead to product shortages and harm our business, under "Risk Factors-- Government Regulation imposes significant costs and restrictions on the development and commercialization of our products, and we may not obtain regulatory approvals for our products," and under "Risk Factors--If our preclinical and clinical testing of potential products is unsuccessful, our business will be harmed" (the "Regulatory Language"), insofar as such statements summarize applicable provisions of the United States federal statutes, rules and regulations administered by the United States Food and Drug Administration ("FDA") or summarize filings in the Novartis lawsuit against FDA (case number 1: 99CV-00323).
Based upon the foregoing, and subject to the qualifications and limitations set forth elsewhere in this letter, the statements contained in the Regulatory Language in the [Prospectus], insofar as such statements summarize applicable provisions of the United States federal statutes, rules and regulations administered by the FDA or summarize filings in the Novartis lawsuit against FDA (case number 1: 99CV- 00323), are correct in all material respects.
We have had no involvement in the preparation of the [Prospectus] or matters disclosed therein other than (1) our review of the filings in the Novartis lawsuit against FDA (case number 1: 99CV-00323) and (2) our review of the Regulatory Language of the [Prospectus]. Based upon the foregoing, and subject to the qualifications and limitations set forth elsewhere in this letter, nothing has come to our attention that would lead us to believe that the Regulatory Information, at the time the Registration Statement or any amendment thereto became effective, at the time the Prospectus was issued, at the time any amended or supplemented prospectus was issued or at the Closing Time, contained an untrue statement of material fact or omitted to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading."
The opinions stated above are limited to the matters set forth herein. No opinion may be inferred or implied beyond the matters expressly stated in this opinion letter, and the opinions stated above must be read in conjunction with the assumptions, limitations, exceptions and qualifications set forth in this opinion letter. We do not assume responsibility to advise you of changes that might be brought to our attention regarding the matters discussed herein after the date hereof.
The law covered by this opinion is limited to laws, rules and regulations administered by FDA, in each case as they exist on the date of this opinion. In rendering this opinion, we have relied on the information contained in the Annual Report including, without limitation, the Regulatory Language. We have not relied on any other statements, documents, or information.
This opinion is rendered solely for the benefit of the several Underwriters in connection with the issuance and sale of common stock of the Company described above. This opinion may not be used or relied upon by any other person or entity and may not be disclosed, quoted, filed with a governmental agency, or otherwise referred to or furnished to any other person without our express prior written consent.
Exhibit C
FORM OPINION OF COMPANY'S INTELLECTUAL PROPERTY
COUNSEL TO BE DELIVERED
PURSUANT TO SECTION 5(b)
February 8, 2002
Merrill Lynch & Co.
Merrill Lynch, Pierce, Fenner & Smith Inc.
J.P. Morgan Securities Inc.
Thomas Weisel Partners LLC
Wells Fargo Securities, LLC
c/o Merrill Lynch & Co.
Merrill Lynch, Pierce, Fenner & Smith Inc.
North Tower
World Financial Center
New York, New York 10281-1209
RE: SangStat Medical Corporation Intellectual Property
Ladies and Gentlemen:
We are outside Patent Counsel to SangStat Medical Corporation, a Delaware corporation (the "Company"), in connection with the entering into by the Company of that certain Purchase Agreement dated February 4, 2002. This opinion is being furnished pursuant to Section 5(b)(iii) of the Purchase Agreement.
For the purposes of rendering the opinions set forth below, we (1) have not done independent searches regarding the validity of Company patents, (2) are familiar with the Company's technology and (3) have reviewed or are otherwise familiar with the following (collectively the "Documents"):
A. the Prospectus dated December 27, 2001 and the Supplement thereto dated January 18, 2002 (collectively the "Prospectus");
B. the U.S. patents and pending patent applications which we have prosecuted or are prosecuting listed on Schedule A attached hereto (the "U.S. Patent Rights");
C. the non-U.S. patents and non-U.S. pending patent applications which we have prosecuted or are prosecuting listed on Schedule B attached hereto (the "Non-U.S. Patent Rights");
D. copies of assignments relevant to ownership of only those patents and patent applications to which the Company has rights and which we are prosecuting or have prosecuted, and patents issuing therefrom ("the Applications and Patents") as included in Schedules A & B; and
E. our internal files pertaining to the Company.
Whenever our opinions herein are qualified by the phrase "to the best of our knowledge," except as may be further qualified below, such language means that based upon the knowledge of the attorneys within our firm (i.e., not including matters as to which such attorneys could be deemed to have constructive knowledge and not including knowledge of attorneys or patent agents outside of Patent Counsel who, at any time, may have had responsibility for the Company matters, including responsibility for the prosecution of the Applications or Patents) after reviewing the Documents or based on being otherwise familiar with the Documents, and such review of or our familiarity with our files, including the prosecution file histories for the applications and patents being prosecuted by us, we believe that such opinions are factually correct.
Based upon, and subject to the foregoing, and upon a review of such matters of law as we have deemed appropriate, it is our opinion and judgment that:
(1) To the best of our knowledge, the information in the Prospectus Supplement under the headings:
a) "Risk Factors - Our litigation with Novartis may be resolved adversely and could consume our time and resources;"
b) "Risk Factors - Novartis's patent lawsuit against Abbott with respect to Gengraf may be resolved adversely;"
c) "Risk Factors - Failure to protect our intellectual property will harm our competitive position;"
d) "Business - Strategic Relationships;"
e) "Business - Patents and Proprietary Technology;" and
f) "Business - Litigation;"
to the extent that such information constitutes matters of law, summaries of legal matters, documents or proceedings, or legal conclusions, to the extent they relate to patent matters, has been reviewed by us and is correct in all material respects. Nothing has come to our attention that makes us believe that:
a) any statement in the above referenced materials contain any untrue statement of a material fact;
b) any statement in the above referenced materials omit a material fact required to be stated; or
c) any statement in the above referenced materials omit a material fact necessary to make the statements therein not misleading, in the light of the circumstances under which they were made.
(2) Attached as Schedule A hereto is a list of the Company's U.S. patents and pending U.S. patent applications (the "U.S. Patent Rights") which, to the best of our knowledge, are owned by the Company as indicated on Schedule A. To the best of our knowledge, where the Company is listed on Schedule A as the owner or co-owner of any U.S. Patent Right, either (a) an assignment from the inventor(s) to the Company has been recorded in the United States Patent and Trademark Office, or (b) the inventor(s) are under obligation of assignment to the Company, and an assignment will be recorded in the United States Patent and Trademark Office. To the best of our knowledge, there are no claims to any ownership interests or liens on any of the U.S. Patent Rights by any party other than the Company, with the exception of those U.S. Patent Rights which are co-owned by the Company and the University of North Carolina at Chapel Hill, as indicated on Schedule A.
(3) Attached as Schedule B to such opinion is a list of the Company's non-U.S. patents and pending non-U.S. patent applications (the "Non-U.S. Patent Rights") which, to the best of our knowledge, are owned by the Company as indicated on Schedule B. To the best of our knowledge, where the Company is listed on Schedule B as the owner or co-owner of any Non-U.S. Patent Rights, the named inventors of the Non-U.S. Patent Rights have either (a) executed an assignment to the Company, or (b) are under an obligation to execute an assignment to the Company. To the best of our knowledge, there are no claims to any ownership interests or liens on any of the Non-U.S. Patent Rights by any party other than the Company, with the exception of those U.S. Patent Rights which are co-owned by the Company and the University of North Carolina at Chapel Hill, as indicated on Schedule B.
(4) Attached as Schedule C to such opinion is a list of the U.S. patents and pending patent applications which, to the best of our knowledge, the Company has licensed the rights to use (the "Licensed Patent Rights"). To the best of our knowledge, as of the date hereof, the Licensed Patent Rights cover fields of use related to the conduct of business in the manner described in the Prospectus. To the best of our knowledge, other than as set forth in the Prospectus, there are no claims by any third parties that the Company lacks adequate rights in any of the Licensed Patent Rights.
(5) We are unaware of any facts that would lead us to believe, with respect to the patents and patent applications set forth on Schedules A and B, that: (a) any of the patents are invalid or unenforceable, (b) any patent issued in respect of a patent application would be invalid or unenforceable, or (c) any material defects exist in respect of form in the preparation or filing of any of the patent applications prepared by such counsel.
(6) To the best of our knowledge, for each of the U.S. patents applications filed and prosecuted by us reflected in Schedule A, the Company has disclosed or intends to disclose to the United States Patent and Trademark Office all information now known and believed to be material to patentability under 37 C.F.R. 1.56.
(7) Other than the disclosures set forth in the Prospectus, to the best of our knowledge, the Company has not received any claim of infringement of any patents held by others, and to the best of our knowledge, there is no pending or threatened action, suit, proceeding or claim by others that the Company is infringing a patent.
(8) To the best of our knowledge, there are no pending or threatened legal or governmental proceedings relating to the U.S. and non-U.S. patents and pending patent applications reflected in Schedules A and B, other than proceedings before the United States Patent and Trademark Office (or any applicable foreign equivalent, as the case may be) that are carried out during the course of prosecution.
Very truly yours,
cc: Adrian Arima (w/encl.)
1072779
Exhibit D
FORM OF OPINION OF COMPANY'S U.K. REGULATORY COUNSEL
Our Ref: JMM/SANGS/007
Your Ref: AJK
8 February 2002
Merrill Lynch, Pierce, Fenner & Smith Incorporated
J.P. Morgan Securities Inc.
Thomas Weisel Partners LLC
Wells Fargo Securities, LLC
c/o Merrill Lynch, Pierce, Fenner & Smith Incorporated
North Tower
World Financial Center
New York, New York 10281-1209
Ladies and Gentlemen:
SANGSTAT UK REGULATORY LITIGATION - OPINION ON PROSPECTUS
I have considered the wording that relates to the UK regulatory litigation involving the cyclosporine oral solution product and capsule product (the "UK Regulatory Litigation") of SangStat Medical Corporation (the "Company") as contained in (i) the registration statement on Form S-3 (File No. 333-76028) of the Company, filed with the Securities and Exchange Commission (the "Commission") on December 28, 2001 (the "Registration Statement"), (ii) the preliminary prospectus supplement, dated January 18, 2002 (the "Preliminary Prospectus Supplement"), in the form filed by the Company with the Commission pursuant to Rule 424(b) of the General Rules and Regulations (the "Rules and Regulations") under the U.S. Securities Act of 1933, as amended (the "Securities Act"), and (iii) the final prospectus supplement, dated February _____ 2002 (the "Final Prospectus Supplement"), in the form filed by the Company with the Commission pursuant to Rule 424(b) of the Rules and Regulations. I understand, but have not independently established or verified, that the Registration Statement was declared effective under the Securities Act on January 15, 2002. The Registration Statement, the Preliminary Prospectus Supplement and the Final Prospectus Supplement are hereinafter collectively referred to as the "Documents." The wording that relates to the UK Regulatory Litigation as contained in the Documents is contained in the Annex to this letter, and is hereinafter referred to as the "Wording."
I am the partner in charge of the UK Regulatory Litigation (including the reference to the European Court of Justice) and can confirm that the Wording is correct in all material respects.
Nothing has come to my attention that would lead me to believe that the Wording, at the time the Registration Statement became effective, at the time the Preliminary Prospectus was issued, at the time the Final Prospectus Supplement was issued or at the date of this letter, contained an untrue statement of material fact or omitted to state a material fact required to be stated to make the Wording not misleading.
Yours faithfully
JANE MUTIMEAR
Exhibit E
FORM OF OPINION OF COMPANY'S FRENCH LITIGATION COUNSEL
Our Ref: EXG/SANGS/0007
Your Ref: AJK
8 February 2002
Merrill Lynch, Pierce, Fenner & Smith Incorporated
J.P. Morgan Securities Inc.
Thomas Weisel Partners LLC
Wells Fargo Securities, LLC
c/o Merrill Lynch, Pierce, Fenner & Smith Incorporated
North Tower
World Financial Center
New York, New York 10281-1209
Ladies and Gentlemen:
SANGSTAT FRENCH LITIGATION - OPINION ON PROSPECTUS
I have considered the wording that relates to the French litigation between Imtix Sangstat, on the one hand, and IFFA CREDO and Elevage Scientifique des Dombes, on the other hand (the "French Litigation") as contained in (i) the registration statement on Form S-3 (File No. 333-76028) of Sangstat Medical Corporation (the "Company"), filed with the Securities and Exchange Commission (the "Commission") on December 28, 2001 (the "Registration Statement"), (ii) the preliminary prospectus supplement, dated January 18, 2002 (the "Preliminary Prospectus Supplement"), in the form filed by the Company with the Commission pursuant to Rule 424(b) of the General Rules and Regulations (the "Rules and Regulations") under the U.S. Securities Act of 1933, as amended (the "Securities Act"), and (iii) the final prospectus supplement, dated February __, 2002 (the "Final Prospectus Supplement"), in the form filed by the Company with the Commission pursuant to Rule 424(b) of the Rules and Regulations.
I understand, but have not independently established or verified, that the Registration Statement was declared effective under the Securities Act on January 15, 2002. The Registration Statement, the Preliminary Prospectus Supplement and the Final Prospectus Supplement are hereinafter collectively referred to as the "Documents."
The wording that relates to the French Litigation as contained in the Documents is contained in the Annex to this letter, and is hereinafter referred to as the "Wording."
I am the partner in charge of the here above mentioned French litigation and can confirm that the Wording is correct in all material respects.
Nothing has come to my attention that would lead me to believe that the Wording, at the time the Registration Statement became effective, at the time the Preliminary Prospectus was issued, at the time the Final Prospectus Supplement was issued or at the date of this letter, contained an untrue statement of material fact or omitted to state a material fact required to be stated to make the Wording not misleading.
Yours faithfully
Marion BARBIER
Exhibit F
FORM OF OPINION OF COMPANY'S SPECIAL FRENCH COUNSEL
[ROMAND & BONTEMS LETTERHEAD]
LYON, February 8, 2002
Merrill Lynch, Pierce, Fenner & Smith Incorporated
J.P. Morgan Securities Inc.
Thomas Weisel Partners LLC
Wells Fargo Securities, LLC
c/o Merrill Lynch, Pierce, Fenner & Smith Incorporated
North Tower
World Financial Center
New York, New York 10281-1209
Ladies and Gentlemen:
We have acted as special counsel on certain matters of French law to IMTIX-SangStat SAS, in connection with the purchase by you (the "Underwriters"), and the sale (a) by SangStat Medical Corporation, a Delaware corporation (the "Company") to the Underwriters of 4,000,000 shares of the Company's common stock (the "Firm Shares") and (b) up to an additional 600,000 shares of the Company's common stock (the "Option Shares") at the Underwriters' option, by the Company to cover over-allotments. The Firm Shares and the Option Shares are collectively referred to herein as the "Securities."
In rendering the opinions set forth herein, we have examined and relied on originals or copies of the following:
We have also examined originals or copies, certified or otherwise identified to our satisfaction, of such records of IMTIX-SangStat SAS and such agreements, certificates and receipts of public officials, certificates of officers or other representatives of IMTIX-SangStat SAS and others, and such other documents as we have deemed necessary or appropriate as a basis for the opinions set forth below.
In our examination, we have assumed the legal capacity of all natural persons, the genuineness of all signatures, the authenticity of all documents submitted to us as originals, the conformity to original documents of all documents submitted to us as certified or photostatic copies, and the authenticity of the originals of such copies. In making our examination of executed documents, we have assumed that the parties thereto had the power, corporate or other, to enter into and perform all obligations thereunder and have also assumed the due authorization by all requisite action, corporate or other, and the execution and delivery by such parties of such documents and the validity and binding effect thereof on such parties.
We express no opinion as to the laws of any jurisdiction other than the laws of France. Insofar as the opinions expressed herein relate to matters governed by laws other than the laws of France, we have assumed, but without having made any independent investigation, that such laws do not affect any of the opinions set forth herein. The opinions expressed herein are based on laws in effect on the date hereof, which laws are subject to change with possible retroactive effect.
"Material Adverse Effect" means a material adverse change in the condition, financial or otherwise, or in the earnings, business affairs or business prospects of the Company and its subsidiaries considered as one enterprise, whether or not arising in the ordinary course of business.
Based upon the foregoing and subject to the limitations, qualifications, exceptions and assumptions set forth herein, we are of the opinion that IMTIX-SangStat SAS has been duly incorporated and is validly existing as a corporation in good standing under the laws of France, has corporate power and authority to own, lease and operate its properties and to conduct its business as described in the Prospectus and is duly qualified as a foreign corporation to transact business and is in good standing in each jurisdiction in which such qualification is required, whether by reason of the ownership or leasing of property or the conduct of business, except where the failure so to qualify or to be in good standing would not result in a Material Adverse Effect; except as otherwise disclosed in the Registration Statement, all of the issued and outstanding capital stock of IMTIX-SangStat SAS has been duly authorized and validly issued, is fully paid and non-assessable and, to the best of our knowledge, is owned by the Company, directly or through subsidiaries, free and clear of any security interest, mortgage, pledge, lien, encumbrance, claim or equity; none of the outstanding shares of capital stock of IMTIX- SangStat SAS was issued in violation of the preemptive or similar rights of any securityholder of IMTIX-SangStat SAS.
This opinion is being furnished only to you in connection with the purchase by you, as representatives of the several underwriters, and the sale by the Company to the several underwriters of the Securities, and is solely for your benefit and is not to be used, circulated, quoted or otherwise referred to for any other purpose or relied upon by any other person for any other purpose without our prior written consent.
Yours faithfully,
Yves Romand
Exhibit G
FORM OF LOCK-UP
January __, 2002
MERRILL LYNCH & CO.
Merrill Lynch, Pierce, Fenner & Smith
Incorporated
as Representative of the several
Underwriters to be named in the
within-mentioned Purchase Agreement
c/o Merrill Lynch & Co.
Merrill Lynch, Pierce Fenner & Smith
Incorporated
North Tower
World Financial Center
New York, New York 10281-1209
Re: Proposed Public Offering by SangStat Medical Corporation
Dear Sirs:
The undersigned, a stockholder and an officer and/or director of SangStat Medical Corporation, a Delaware corporation (the "Company"), understands that Merrill Lynch & Co., Merrill Lynch, Pierce, Fenner & Smith Incorporated ("Merrill Lynch") proposes to enter into a Purchase Agreement (the "Purchase Agreement") with the Company providing for the public offering of shares (the "Securities") of the common stock, par value $0.001 per share (the "Common Stock"), of the Company. In recognition of the benefit that such an offering will confer upon the undersigned, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the undersigned agrees with each underwriter to be named in the Purchase Agreement that, during a period of ninety (90) days from the date of the Purchase Agreement, the undersigned will not, without the prior written consent of Merrill Lynch, directly or indirectly, (i) offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant for the sale of, or otherwise dispose of or transfer any shares of the Common Stock or any securities convertible into or exchangeable or exercisable for the Common Stock, whether now owned or hereafter acquired by the undersigned or with respect to which the undersigned has or hereafter acquires the power of disposition, or file any registration statement under the Securities Act of 1933, as amended, with the Securities and Exchange Commission with respect to any of the foregoing or (ii) enter into any swap or any other agreement or any transaction that transfers to another, in whole or in part, directly or indirectly, the economic consequences of ownership of the Common Stock, whether any such swap or transaction is to be settled by delivery of Common Stock or such other securities, in cash or otherwise.
Notwithstanding the foregoing, the undersigned may transfer shares of Common Stock, (i) as a bona fide gift or gifts, provided that the donee or donees thereof agree to be bound by the restrictions set forth herein, (ii) to any trust for the direct or indirect benefit of the undersigned or the immediate family of the undersigned, provided that the trustee of the trust agrees to be bound by the restrictions set forth herein or (iii) in transactions relating to shares of Common Stock acquired by the undersigned in open market transactions after the completion of the public offering of the Securities. For purposes of this Agreement, "immediate family" shall mean any relationship by blood, marriage or adoption, not more remote than first cousin. In addition, notwithstanding the foregoing, if the undersigned is a corporation, the corporation may transfer the Common Stock to any wholly-owned subsidiary of such corporation; provided, however, that in any such case, it shall be a condition to the transfer that the transferee execute an agreement stating that the transferee is receiving and holding such Common Stock subject to the provisions of this Agreement and there shall be no further transfer of such Common Stock except in accordance with this Agreement, and provided further that any such transfer shall not involve a disposition for value.
This Agreement shall lapse and become null and void if the public offering of the Securities shall not have been completed by February 28, 2002.
Very truly yours,
____________________________
(Print Shareholder Name)
Signature:____________________
By:____________________
Title, if applicable:
EXHIBIT 5.1
February 5, 2002
SangStat Medical Corporation
6300 Dumbarton Circle
Fremont, CA 94555
Re: SangStat Medical Corporation
Registration Statement on Form S-3
(File No. 333-76028)
Ladies and Gentlemen:
We have acted as special counsel to SangStat Medical Corporation, a Delaware corporation (the "Company"), in connection with the public offering by the Company of up to 5,175,000 shares (including 675,000 shares subject to an over-allotment option) (the "Shares") as set forth in the Registration Statement and the Prospectus (each as hereinafter defined) of the Company's Common Stock, par value $0.001 per share (the "Common Stock").
This opinion is being furnished in accordance with the requirements of Item 601(b)(5) of Regulation S-K under the Securities Act of 1933, as amended (the "Act").
In connection with this opinion, we have examined originals or copies, certified or otherwise identified to our satisfaction, of (i) the Registration Statement on Form S-3 (File No. 333-76028) as filed with the Securities and Exchange Commission (the "Commission") on December 28, 2001 under the Act (the "Registration Statement"); (ii) the final prospectus, comprised of the prospectus supplement relating to the Shares, dated February 4, 2002 (the "Prospectus"), in the form filed with the Commission pursuant to Rule 424(b) of the General Rules and Regulations under the Act, and the accompanying base prospectus, dated December 27, 2001; (iii) the documents filed by the Company pursuant to the Securities Exchange Act of 1934, as amended, and incorporated by reference into the Prospectus as of the date hereof (collectively, the "Incorporated Documents"); (iv) an executed copy of the Purchase Agreement, dated February 4, 2002 (the "Purchase Agreement"), entered into by and among the Company, as issuer, and, Merrill Lynch, Pierce, Fenner & Smith Incorporated, J.P. Morgan Securities Inc., Thomas Weisel Partners LLC and Wells Fargo Securities, LLC as underwriters (the "Underwriters"); (v) a specimen certificate representing the Common Stock; (vi) the Certificate of Incorporation, as amended, of the Company, as certified by the Secretary of State of the State of Delaware; (vii) the Second Amended and Restated Bylaws of the Company, as currently in effect; and (viii) certain resolutions of the Board of Directors of the Company and resolutions of the Pricing Committee thereof. We also have examined originals or copies, certified or otherwise identified to our satisfaction, of such records of the Company and such agreements, certificates of public officials, certificates of officers or other representatives of the Company and others, and such other documents, certificates and records as we have deemed necessary or appropriate as a basis for the opinions set forth herein.
In our examination, we have assumed the legal capacity of all natural persons, the genuineness of all signatures, the authenticity of all documents submitted to us as originals, the conformity to original documents of all documents submitted to us as certified, conformed or photostatic copies and the authenticity of the originals of such latter documents. In making our examination of executed documents, we have assumed that the parties thereto, other than the Company, its directors and officers, had the power, corporate or other, to enter into and perform all obligations thereunder and have also assumed the due authorization by all requisite action, corporate or other, and execution and delivery by such parties of such documents and the validity and binding effect thereof on such parties. As to any facts material to the opinions expressed herein which we have not independently established or verified, we have relied upon statements and representations of officers and other representatives of the Company and others.
We express no opinion as to the laws of any jurisdiction other than Delaware corporate law. The opinions expressed herein are based on laws in effect on the date hereof, which laws are subject to change with possible retroactive effect.
Based upon and subject to the foregoing, we are of the opinion that when the Shares have been delivered to and paid for by the Underwriters in accordance with the terms of the Purchase Agreement, the issuance and sale of the Shares will have been duly authorized, and the Shares will be validly issued, fully paid and nonassessable.
We hereby consent to the filing of this opinion with the Commission as an exhibit to the Registration Statement. We also consent to the reference to our firm under the caption "Validity of Securities" in the Registration Statement and under the caption "Legal Matters" in the Prospectus. In giving this consent, we do not thereby admit that we are included in the category of persons whose consent is required under Section 7 of the Act or the rules and regulations of the Commission.
Very truly yours,
/s/ SKADDEN, ARPS, SLATE, MEAGHER & FLOM LLP