<PAGE> 1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K/A
AMENDMENT NO. 1
(MARK ONE)
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
FOR THE FISCAL YEAR ENDED JUNE 30, 1999.
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 0-28272
AVIGEN, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
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DELAWARE 13-3647113
(STATE OR OTHER JURISDICTION OF (I.R.S. EMPLOYER
INCORPORATION OR ORGANIZATION) IDENTIFICATION NO.)
</TABLE>
1201 HARBOR BAY PARKWAY, SUITE 1000
ALAMEDA, CALIFORNIA 94502
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES AND ZIP CODE)
(510) 748-7150
(REGISTRANT'S TELEPHONE NUMBER,
INCLUDING AREA CODE)
SECURITIES REGISTERED PURSUANT TO SECTION 12(B) OF THE ACT:
TITLE OF EACH CLASS NAME OF EACH EXCHANGE ON WHICH REGISTERED
NONE
SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT:
COMMON STOCK, $.001 PAR VALUE
(TITLE OF CLASS)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Sections 13 of 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 such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes [X] No [ ]
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405
of Regulation S-K is not contained herein, and will not be contained, to the
best of registrant's knowledge, in any amendments to this Form 10-K/A. [X]
The aggregate market value of the voting stock held by nonaffiliates of the
registrant as of September 21, 1999, was approximately $119,784,849 based upon
the closing sale price of the registrant's Common Stock as reported on the
Nasdaq National Market System on such date. The number of outstanding shares of
the Registrant's Common Stock as of September 21, 1999 was 9,778,355.
<PAGE> 2
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K
(a) The following documents are filed as part of this Annual Report on
Form 10-K/A:
(1) Financial Statements:
Report of Ernst & Young LLP, Independent Auditors Balance Sheets
Statements of Operations Statements of Stockholders' Equity
Statements of Cash Flows Notes to Financial Statements
(2) Financial Statements schedules have been omitted from this report
because the information is provided in the Financial Statements
or is not applicable.
(3) Exhibits
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<CAPTION>
EXHIBIT
NUMBER EXHIBITS
- ------- --------
<S> <C>
1.1(1) Amended and Restated Certificate of Incorporation
3.2(1) Restated Bylaws of the Registrant
4.1(1) Specimen Common Stock Certificate
10.2(1, 2) 1993 Stock Option Plan
10.3(9) 1996 Equity Incentive Plan
10.4(1, 2) Form of Incentive Stock Option Grant
10.5(1, 2) Form of Nonstatutory Stock Option Grant
10.6(1, 2) 1996 Non-Employee Director Stock Option Plan
10.7(9) 1997 Employee Stock Purchase Plan
10.8(1) Form of Indemnification Agreement between the Registrant and
its directors and executive officers
10.9(1) Form of Common Stock Warrant
10.10(1) Form of Series A Preferred Stock Warrant
10.11(1) Form of Series B Preferred Stock Warrant
10.12(1) Form of Series C Preferred Stock Warrant
10.13(1) Form of Series D Preferred Stock Warrant
10.19(1) Form of Bridge Warrant
10.20(1) License Agreement between the Registrant and Research
Corporation Technologies, Inc., dated May 15, 1992, as
amended as of March 21, 1996 and April 26, 1996
10.21(1) License Agreement between the Registrant and The Johns
Hopkins University, dated November 23, 1993, as amended as
of March 21, 1996
10.22(1) License Agreement between the Registrant and The University
of Manitoba, dated February 2, 1994
10.23(1) Form of Underwriters' Warrant
10.24(1) Lease Agreement between the Registrant and Redding
Management, Inc., dated September 15, 1992, as amended June
30, 1995
10.25(1) Registration Rights Agreement between the Registrant and
certain stockholders named therein, dated November 1992
10.27(1, 2) Employment Agreement dated August 10, 1992, between the
Company and John Monahan.
10.29(8) Employment Agreement dated August 14, 1996, between the
Company and Thomas J. Paulson.
10.30(8) Employment Agreement dated October 23,1996, between the
Company and Robert M. Mauer.
10.32(8) Revolving line of credit signed November 22, 1996 with Wells
Fargo Bank
10.33(8) Equipment lease dated May 22, 1997 with Transamerica
Business Credit Corporation
10.34(3) Common Stock and Warrant Purchase Agreement by and among
Avigen and certain Purchasers listed on the Schedule of
Purchasers attached thereto.
10.35(4) Amendment to Common Stock and Warrant Purchase Agreement by
and among Avigen and certain Purchasers thereunder dated as
of September 25, 1998.
10.36(4) Management Transition Plan
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<TABLE>
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10.36.1(5) Form of Common Stock and Warrant Purchase Agreement, dated
October 30, 1998.
10.37(6) Form of Common Stock and Warrant Purchase Agreement Date
February 15, 1999.
10.38(7)(9) Factor IX patent and know-how exclusive license agreement
between the Children's Hospital of Philadelphia and Avigen,
dated May 20, 1999.
10.39(7) License Agreement between the Registrant and the University
of Florida Research Foundation, Inc., dated November 13,
1992, and its First Amendment, dated March 25, 1996
23.1(9) Consent of Ernst & Young LLP, Independent Auditors
24.1 Power of Attorney (Reference to the signature page herein)
27.1(9) Financial Data Schedule
</TABLE>
(1) Filed as an exhibit to the Registrant's Registration Statement on Form S-1
(No. 333-3220) and incorporated herein by reference.
(2) Management Contract or Compensation Plan.
(3) Incorporated by reference from such document filed with the SEC as an
exhibit to the Company's Annual Report on Form 10-K for the year ended June
30, 1998, as filed with the SEC.
(4) Incorporated by reference from such document filed with the SEC as an
exhibit to the Company's Quarterly Report on Form 10-Q for the quarter year
ended September 30, 1998, as filed with the SEC.
(5) Incorporated by reference from such document filed with the SEC as an
exhibit to the Company's Quarterly Report on Form 10-Q for the quarter year
ended December 31, 1998.
(6) Incorporated by reference from such document filed with the SEC as an
exhibit to the Company's Quarterly Report on Form 10-Q for the quarter year
ended March 31, 1999, as filed with the SEC.
(7) Confidential treatment has been requested for a portion of this exhibit.
(8) Incorporated by reference from such document filed with the SEC as an
exhibit to the Company's Annual Report on Form 10-K for the year ended June
30, 1997, as filed with the SEC.
(9) Incorporated by reference from such document filed with the SEC as an
exhibit to the Company's Annual Report on Form 10-K for the year ended June
30, 1999, as filed with the SEC.
(b) The Company filed a report on Form 8-K dated May 12, 1999 reporting
under Item 5 the closing of a private placement.
<PAGE> 4
SIGNATURES
Pursuant to the requirements of Section 13 of 15(d) 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 on the 10th day of
February, 2000.
AVIGEN, INC.
By: /s/ JOHN MONAHAN
---------------------------
John Monahan, Ph.D.
President, Chief Executive Officer
and Director
<PAGE> 5
EXHIBIT INDEX
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SEQUENTIALLY
EXHIBIT NUMBERED
NUMBER DESCRIPTION OF DOCUMENT PAGE
- ------- ----------------------- ------------
<S> <C> <C>
1.1(1) Amended and Restated Certificate of Incorporation
3.2(1) Restated Bylaws of the Registrant
4.1(1) Specimen Common Stock Certificate
10.2(1, 2) 1993 Stock Option Plan
10.3(9) 1996 Equity Incentive Plan
10.4(1, 2) Form of Incentive Stock Option Grant
10.5(1, 2) Form of Nonstatutory Stock Option Grant
10.6(1, 2) 1996 Non-Employee Director Stock Option Plan
10.7(9) 1997 Employee Stock Purchase Plan
10.8(1) Form of Indemnification Agreement between the Registrant and
its directors and executive officers
10.9(1) Form of Common Stock Warrant
10.10(1) Form of Series A Preferred Stock Warrant
10.11(1) Form of Series B Preferred Stock Warrant
10.12(1) Form of Series C Preferred Stock Warrant
10.13(1) Form of Series D Preferred Stock Warrant
10.19(1) Form of Bridge Warrant
10.20(1) License Agreement between the Registrant and Research
Corporation Technologies, Inc., dated May 15, 1992, as
amended as of March 21, 1996 and April 26, 1996
10.21(1) License Agreement between the Registrant and The Johns
Hopkins University, dated November 23, 1993, as amended as
of March 21, 1996
10.22(1) License Agreement between the Registrant and The University
of Manitoba, dated February 2, 1994
10.23(1) Form of Underwriters' Warrant
10.24(1) Lease Agreement between the Registrant and Redding
Management, Inc., dated September 15, 1992, as amended June
30, 1995
10.25(1) Registration Rights Agreement between the Registrant and
certain stockholders named therein, dated November 1992
10.27(1, 2) Employment Agreement dated August 10, 1992, between the
Company and John Monahan.
10.29(8) Employment Agreement dated August 14, 1996, between the
Company and Thomas J. Paulson.
10.30(8) Employment Agreement dated October 23,1996, between the
Company and Robert M. Mauer.
10.32(8) Revolving line of credit signed November 22, 1996 with Wells
Fargo Bank
10.33(8) Equipment lease dated May 22, 1997 with Transamerica
Business Credit Corporation
10.34(3) Common Stock and Warrant Purchase Agreement by and among
Avigen and certain Purchasers listed on the Schedule of
Purchasers attached thereto.
10.35(4) Amendment to Common Stock and Warrant Purchase Agreement by
and among Avigen and certain Purchasers thereunder dated as
of September 25, 1998.
10.36(4) Management Transition Plan
10.36.1(5) Form of Common Stock and Warrant Purchase Agreement, dated
October 30, 1998.
10.37(6) Form of Common Stock and Warrant Purchase Agreement Date
February 15, 1999.
10.38(7)(9) Factor IX patent and know-how exclusive license agreement
between the Children's Hospital of Philadelphia and Avigen,
dated May 20, 1999.
10.39(7) License Agreement between the Registrant and the University
of Florida Research Foundation, Inc., dated November 13,
1992, and its First Amendment, dated March 25, 1996
</TABLE>
<PAGE> 6
<TABLE>
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SEQUENTIALLY
EXHIBIT NUMBERED
NUMBER DESCRIPTION OF DOCUMENT PAGE
- ------- ----------------------- ------------
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23.1(9) Consent of Ernst & Young LLP, Independent Auditors
24.1 Power of Attorney (Reference to the signature page herein)
27.1(9) Financial Data Schedule
</TABLE>
(1) Filed as an exhibit to the Registrant's Registration Statement on Form S-1
(No. 333-3220) and incorporated herein by reference.
(2) Management Contract or Compensation Plan.
(3) Incorporated by reference from such document filed with the SEC as an
exhibit to the Company's Annual Report on Form 10-K for the year ended June
30, 1998, as filed with the SEC.
(4) Incorporated by reference from such document filed with the SEC as an
exhibit to the Company's Quarterly Report on Form 10-Q for the quarter year
ended September 30, 1998, as filed with the SEC.
(5) Incorporated by reference from such document filed with the SEC as an
exhibit to the Company's Quarterly Report on Form 10-Q for the quarter year
ended December 31, 1998.
(6) Incorporated by reference from such document filed with the SEC as an
exhibit to the Company's Quarterly Report on Form 10-Q for the quarter year
ended March 31, 1999, as filed with the SEC.
(7) Confidential treatment has been requested for a portion of this exhibit.
(8) Incorporated by reference from such document filed with the SEC as an
exhibit to the Company's Annual Report on Form 10-K for the year ended June
30, 1997, as filed with the SEC.
(9) Incorporated by reference from such document filed with the SEC as an
exhibit to the Company's Annual Report on Form 10-K for the year ended June
30, 1999, as filed with the SEC.
(b) The Company filed a report on Form 8-K dated May 12, 1999 reporting
under Item 5 the closing of a private placement.
<PAGE> 1
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
EXHIBIT 10.39
NON-EXCLUSIVE
PATENT LICENSE AGREEMENT
TABLE OF CONTENTS
PREAMBLE
ARTICLES:
I DEFINITIONS
II GRANT
III DUE DILIGENCE
IV ROYALTIES
V REPORTS AND RECORDS
VI PATENT PROSECUTION
VII INFRINGEMENT
VIII PRODUCT LIABILITY
IX EXPORT CONTROLS
X NON-USE OF NAMES
XI ASSIGNMENT
XII TERMINATION
XIII PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
XIV MISCELLANEOUS PROVISIONS
THIS AGREEMENT is made and entered into this 13th day of November, 1992,
(the Effective Date) by and between THE UNIVERSITY OF FLORIDA RESEARCH
FOUNDATION, INC., a not-for-profit corporation duly organized and existing under
the laws of the State of Florida and having its principal office at 1 Progress
Boulevard, Alachua, Florida 32615, U.S.A. (hereinafter referred to as UFRFI),
and Avigen, Inc., a corporation duly organized under the laws of Delaware and
having its principal office at 19 Tarabrook Drive, Alameda, California 94563
(hereinafter referred to as LICENSEE).
WITNESSETH
WHEREAS, UFRFI is the owner of certain "Patent Rights" by assignment from
the University of Florida (hereinafter referred to as University) relating to
UFRFI Case No. UF#0431, U.S. Patent No. 5,139,941, Issued 08/18/92 "AAV
Transduction Vectors" invented by Drs. Nicholas Muzyczka, Kenneth I. Berns,
Richard J. Samulski & Paul L. Hermonat and has the right to grant licenses under
said Patent Rights, subject only to a royalty-free, non-exclusive license
heretofore granted to the United States Government;
WHEREAS, UFRFI desires to have the Patent Rights developed and utilized to
the fullest extent so that the benefits can be enjoyed by the general public and
is willing to grant a non-exclusive license thereunder;
1.
<PAGE> 2
WHEREAS, LICENSEE shall commit itself to a thorough, vigorous and diligent
program of exploiting the Patent Rights commercially so that public utilization
and royalty income to UFRFI shall result therefrom; and
WHEREAS, LICENSEE desires to obtain a non-exclusive license under the
Patent Rights upon the terms and conditions hereinafter set forth.
NOW, THEREFORE, in consideration of the premises and the mutual covenants
contained herein the parties hereto agree as follows:
ARTICLE 1
DEFINITIONS
For the purposes of this Agreement, the following words and phrases shall have
the following meanings:
1.1 "LICENSEE" shall mean the following:
(a) a related company of LICENSEE, the voting stock of which is
directly or indirectly at least fifty percent (50%) owned or controlled by
LICENSEE;
(b) an organization which directly or indirectly controls more than
fifty percent (50%) of the voting stock of LICENSEE;
(c) an organization, the majority ownership of which is directly or
indirectly common to the ownership of LICENSEE.
1.2 "PATENT RIGHTS" shall mean all of the following UFRFI intellectual
property:
(a) the United States patents and/or patent applications listed in
Appendix A;
(b) United States patents issued from the applications listed in
Appendix A and from divisionals and continuations of these applications;
(c) any reissues of United States patents described in (a) or (b)
above.
1.3 A "LICENSED PRODUCT" shall mean any product or part thereof which:
(a) is covered in whole or in part by an issued, unexpired claim or a
pending claim contained in the Patent Rights in the country in which any
Licensed Products are made, used or sold;
(b) is manufactured by using a process which is covered in whole or in
part by an issued, unexpired claim or a pending claim contained in the Patent
Rights in the country in which any Licensed Process is used or in which such
product or part thereof is used or sold;
(c) is derived from Patent Rights or know-how, and related to or
described in Patent Rights;
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[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
2.
<PAGE> 3
(d) is sold, manufactured or used in any country under this Agreement.
1.4 A "LICENSED PROCESS" shall mean:
(a) any process which is covered in whole or in part by an issued,
unexpired claim or a pending claim contained in the Patent Rights;
(b) is derived from Patent Rights or know-how, and related to or
described in Patent Rights;
(c) is sold, manufactured or used in any country under this Agreement.
1.5 "NET SALES" shall mean LICENSEE's and its Co-Developer's (as that term
is defined in Section 2.5) billings for Licensed Products and Licensed Processes
produced hereunder less the sum of the following:
(a) discounts allowed in amounts customary in the trade,
(b) sales taxes, tariff duties, and/or use taxes which are directly
imposed and are with reference to particular sales;
(c) outbound transportation prepaid or allowed; and
(d) amounts allowed or credited on returns.
No deductions shall be made for commissions paid to individuals whether they be
with independent sales agencies or regularly employed by LICENSEE and on its
payroll, or for cost of collections. Licensed Products shall be considered
"sold" when billed out or invoiced.
1.6 "TERRITORY" shall mean the United States.
1.7 "FIELDS OF USE" shall mean:
(a) Human [*] disorders, [*]. This field includes human [*] diseases
that arise due to the absence, over-expression or altered expression of proteins
normally [*]. This primary site and location of these proteins is [*].
Specifically included are human [*] and human disorders of the [*]. Specifically
excluded are human [*].
(b) Human [*] diseases. This field includes all forms of human [*].
This field also includes all forms of human [*].
(c) Human [*]. This field includes the [*].
(d) All human [*]. This Field includes: [*].
Specifically excluded from this Agreement are the following fields of use:
therapeutic and prophylactic applications for the human [*] diseases (including
[*]), diseases of [*], and all other human uses not specifically set out in (a)-
(d) above.
ARTICLE 2
GRANT
2.1 UFRFI hereby grants to LICENSEE the non-exclusive right and license to
make, have made, use, lease and sell the Licensed Products, and to practice the
Licensed Processes in
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[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
3.
<PAGE> 4
the Territory for the Fields of Use to the end of the term for which the Patent
Rights are granted unless sooner terminated according to the terms hereof.
2.2 LICENSEE agrees that Licensed Products shall be manufactured
substantially in the United States.
2.3 UFRFI reserves the right to practice under the Patent Rights and know-
how for its own purposes.
2.4 UFRFI reserves the right to grant other licenses under the Patent
Rights.
2.5 No rights are granted hereby allowing LICENSEE to grant sublicenses
under the Patent Rights. Notwithstanding the foregoing, in the event that
LICENSEE enters into an agreement with another business entity (hereinafter Co-
Developer) to jointly develop Licensed Products and/or Licensed Processes, then
LICENSEE may grant a limited sublicense to such Co-Developer for the sole
purpose of jointly developing Licensed Products and/or Licensed Processes. For
each of the 4 four (4) separate Fields of Use, LICENSEE may only have one
Co-Developer and may only grant one limited sublicense to said Co-Developer.
LICENSEE shall notify UFRFI in writing of the initiation of the license
negotiations for said limited sublicense with a potential Co-Developer.
2.6 LICENSEE hereby agrees that any limited sublicensing agreement it may
grant to a Co-Developer pursuant to Section 2.5 which shall relate to the
rights, privileges and license granted hereunder shall contain a statement
setting forth the date upon which LICENSEE's non-exclusive rights, privileges
and license hereunder shall terminate.
2.7 LICENSEE agrees that any limited sublicense granted by it pursuant to
Section 2.5 shall provide that the obligations to UFRFI of this Agreement shall
be binding upon the Co-Developer as if it were a party to this Agreement.
LICENSEE further agrees to attach copies of this Agreement to the limited
sublicense agreement.
2.8 LICENSEE agrees to forward to UFRFI a copy of the limited sublicense
agreement within thirty (30) days of the execution of the limited sublicense
agreement and further agrees to forward to UFRFI annually a copy of such reports
received by LICENSEE from its Co-Developer during the preceding twelve (12)
month period under the limited sublicense as shall be pertinent to a royalty
accounting under said limited sublicense agreement.
2.9 LICENSEE shall not receive from the Co-Developer anything of value in
lieu of cash payments in consideration for any limited sublicense under this
Agreement, without the express prior written permission of UFRFI.
2.10 The license granted hereunder shall not be construed to confer any
rights upon LICENSEE by implication, estoppel or otherwise as to any technology
not specifically set forth herein.
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[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
4.
<PAGE> 5
2.11 The Patent Rights covered by this Agreement are subject to the rights
and limitations of U.S. Code, Title 35, Chapter 38, and implementing regulations
thereof, and the grant under this Article II is subject to such rights and
limitations.
ARTICLE 3
DUE DILIGENCE
3.1 LICENSEE shall use its best efforts to bring one or more Licensed
Products or Licensed Processes to market through a thorough, vigorous and
diligent program for exploitation of the Patent Rights to attain maximum
commercialization of Licensed Products or Licensed Processes.
3.2 In addition, LICENSEE shall adhere to the following milestones:
(a) LICENSEE shall deliver to UFRFI on or before the first anniversary
of the Effective Date a business plan showing the amount of money, number and
kind of personnel and time budgeted and planned for each phase of development of
the Licensed Products and Licensed Processes and shall provide similar reports
to UFRFI on an annual basis on or before the ninetieth (90th) day following the
close of LICENSEE's fiscal year.
(b) LICENSEE shall initiate large animal studies using AAV vectors for
gene therapy within one (1) year of signing this Agreement.
(c) LICENSEE shall initiate human clinical studies utilizing AAV
vectors for gene therapy within four (4) years of signing this Agreement.
3.3 LICENSEE's failure to perform in accordance with Paragraphs 3.1 and 3.2
above shall be grounds for UFRFI to terminate this Agreement pursuant to
Paragraph 12.3 hereof.
ARTICLE 4
ROYALTIES
4.1 For the rights, privileges and license granted hereunder, LICENSEE
shall pay royalties to UFRFI in the manner hereinafter provided to the end of
the term of the Patent Rights or until this Agreement shall be terminated as
hereinafter provided:
(a) License Issue Fee of Seventy-five thousand Dollars ($75,000),
which said License Issue Fee shall be paid in two (2) installments:
(i) Thirty-seven thousand five hundred ($37,500) within sixty
(60) days after execution by both parties of this Agreement, and
(ii) Thirty-seven thousand five hundred ($37,500) within ninety
(90) days after execution by both parties of this Agreement.
If LICENSEE fails to pay the two installments of the License Issue Fee
within the time frame stipulated in this Paragraph 4.1(a) then this Agreement
shall immediately terminate.
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[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
5.
<PAGE> 6
(b) LICENSEE shall issue to UFRFI 80,000 shares of Class A Common
stock of LICENSEE immediately upon delivery and execution by both parties of a
Stock Acquisition Agreement to be attached hereto as Exhibit I. Said Stock
Acquisition Agreement shall be provided to UFRFI for UFRFI's execution and
signature by December 4, 1992 and shall contain all appropriate terms customary
for a stock acquisition agreement, including, but not limited to a dilution
clause giving parity to all owners of the Class A Common stock. The 80,000
shares of LICENSEE's stock to be issued to UFRFI, together with any additional
shares of stock of LICENSEE hereafter issued to UFRFI (collectively the
"Shares"), shall be delivered to UFRFI immediately upon issuance. Should
LICENSEE fall to provide to UFRFI said Stock Acquisition Agreement, or to issue
or deliver to UFRFI the Shares, then at the election of UFRFI this Agreement
shall terminate immediately.
(i) LICENSEE represents and warrants that as of the date of this
Agreement, LICENSEE has the following classes and numbers of securities
outstanding:
7,600,000 shares of Class A Common Stock par value $.001, 400,000 shares of
Class B Common Stock par value $.001 convertible into 400,000 shares of Class A
Common Stock par value $.001.
LICENSEE further represents end warrants that the 400,000 outstanding
shares of Class B Common Stock are convertible into 400,000 shares of Class A
Common Stock. LICENSEE further represents and warrants to UFRFI that upon the
date of issuance of the Shares, it will be authorized to issue the Shares as
fully paid and non-assessable equity participations in LICENSEE.
(ii) Upon the acquisition by UFRFI of the Shares, UFRFI shall not
be responsible for any debts, liabilities or responsibilities of LICENSEE.
(iii) Upon acquisition of the Shares, UFRFI shall have all of the
rights currently afforded to the holders of LICENSEE's Class A Common stock, as
outlined in the Certificate of Incorporation in the form to be attached hereto
as Exhibit II by December 4, 1992.
(iv) If LICENSEE fails to issue any of the Shares, then at the
election of UFRFI this Agreement shall immediately terminate and LICENSEE shall
comply with the termination provisions set forth in Section 12.7 herein.
(c) For each Licensed Product Regulatory Milestone Payments, as
follows:
(i) Twenty-five thousand Dollars ($25,000) upon completion of
Phase 1 clinical trials, "Phase 1" as defined by 21 Code of Federal Regulations,
Chapter 1;
(ii) Twenty-five thousand Dollars ($25,000) upon completion of
Phase 2 clinical trials, "Phase 2" as defined by 21 Code of Federal Regulations,
Chapter 1;
(iii) Twenty-five thousand Dollars ($25,000) upon completion of
Phase 3 clinical trials, "Phase 3" as defined by 21 Code of Federal Regulations,
Chapter 1; and
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[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
6.
<PAGE> 7
(iv) One-hundred thousand $100,000) upon issuance of a New Drug
Application ("NDA") or Product License Application ("PLA").
Payments (i), (ii) (iii) and (iv) shall be made for each Licensed Product,
with the exception that LICENSEE will not have to make payments (i), (ii) and
(iii) for the second Licensed Product to be developed by LICENSEE within any one
Field of Use.
(d) Running Royalty in an amount equal to [ * ] of the Net Sales of
the Licensed Products or Licensed Processes used, leased or sold by or for
LICENSEE or its Co-Developer.
4.2 Royalty payments shall be paid in United States dollars in Gainesville,
Florida or at such other place as UFRFI may reasonably designate.
4.3 In the event that any taxes, withholding or otherwise, are levied by
any taxing authority in connection with accrual or payment of any royalties
payable by LICENSEE under this Agreement, and LICENSEE determines in good faith
that it must pay such taxes, LICENSEE shall have the right to pay such taxes to
the local tax authorities on behalf of UFRFI and payment of the net amount due
after reduction by the amount of such taxes, shall fully satisfy LICENSEE's
royalty obligations under this Agreement. LICENSEE shall provide UFRFI with
appropriate receipts or other documentation supporting such payment. LICENSEE
shall inform UFRFI in writing, within thirty (30) days of notification that
taxes will or have been levied by a taxing authority.
4.4 In the event that UFRFI shall enter into a license agreement with any
third party for any Field of Use licensed to LICENSEE on royalty terms more
favorable to the third party licensee, then:
(a) UFRFI shall promptly notify LICENSEE of any license so developed
and describe in the notice any royalty and other consideration to be provided by
third party licensee, and
(b) LICENSEE shall have thirty (30) days to notify UFRFI whether
LICENSEE desires to modify the royalty agreement to equal the royalty terms made
available to such third party licensee.
ARTICLE 5
REPORTS AND RECORDS
5.1 LICENSEE shall keep full, true and accurate books of account containing
all particulars that may be necessary for the purpose of showing the amounts
payable to UFRFI hereunder. Said books of account shall be kept at LICENSEE's
principal place of business or the principal place of business of the
appropriate division of LICENSEE to which this Agreement relates. Said books and
the supporting data shall be open at all reasonable times for five (5) years
following the end of the calendar year to which they pertain, to the inspection
of UFRFI or its agents for the purpose of verifying LICENSEE's royalty statement
or compliance in other respects with this Agreement.
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COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
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7.
<PAGE> 8
5.2 LICENSEE shall deliver to UFRFI true and accurate reports, giving such
particulars of the business conducted by LICENSEE and its Co-Developer during
the preceding three-month period under this Agreement as shall be pertinent to a
royalty accounting hereunder. These shall include at least the following;
(a) number of Licensed Products manufactured and sold.
(b) total billings for Licensed Products sold.
(c) accounting for all Licensed Processes used or sold.
(d) deductions applicable as provided in Paragraph 1.5.
(e) total royalty due.
(f) names and addresses of the Co-Developer of LICENSEE.
The reports required by this Section 5.2 shall be made within forty-five
(45) days after December 31 each year until the first NDA or PLA or similar
governmental regulatory marketing approval is obtained. Beginning with the
calendar quarter during which said first approval occurs LICENSEE shall, within
forty-five (45) days after March 31, June 30, September 30 and December 31, of
each year, deliver to UFRFI the reports required by this Section 5.2
5.3 With each such report submitted, LICENSEE shall pay to UFRFI the
royalties due and payable under this Agreement. If no royalties shall be due,
LICENSEE shall so report.
5.4 The license and royalty payments set forth in this Agreement shall, if
overdue, bear interest until payment at the monthly rate of one percent (1%).
The payment of such interest shall not foreclose UFRFI from exercising any other
rights it may have as a consequence of the lateness of any payment.
ARTICLE 6
PATENT PROSECUTION
6.1 UFRFI shall apply for, seek issuance of, and maintain during the term
of this Agreement the Patent Rights in the United States. The prosecution,
filing and maintenance of all Patent Rights patents and applications shall be
the primary responsibility of UFRFI; provided, however, LICENSEE shall assist
UFRFI in obtaining patent extension pursuant to U.S. Code, Title 35, Section
156.
6.2 Payment of all fees and costs relating to the filing, prosecution, and
maintenance of the Patent Rights shall be the responsibility of UFRFI.
ARTICLE 7
INFRINGEMENT
7.1 LICENSEE shall inform UFRFI promptly in writing of any alleged
infringement of the Patent Rights by a third party and of any available evidence
thereof.
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8.
<PAGE> 9
7.2 UFRFI shall, at its discretion, use diligence to cause infringement to
cease by the grant of a license or other remedy or use diligence in bringing an
infringement action against the third party. UFRFI reserves the right to
identify LICENSEE in such suit as having rights under Patent Rights. UFRFI shall
not name LICENSEE as a co-party in such suit without an express written request
from LICENSEE.
7.3 In a case in which UFRFI brings an infringement action against a third
party, this action shall be at no cost to LICENSEE unless LICENSEE joins the
suit as a co-party. LICENSEE is under no obligation to join any such suit and
UFRFI must approve, at its sole discretion, the addition of LICENSEE as a
co-party.
7.4 Nothing in this Agreement shall be construed as an agreement by UFRFI
to bring or prosecute actions or suits against third parties for infringement of
Patent Rights.
ARTICLE 8
PRODUCT LIABILITY
8.1 LICENSEE shall at all times during the term of this Agreement and
thereafter, indemnify, defend and hold UFRFI and the University, their trustees,
officers, employees and affiliates, harmless against all claims and expenses,
including legal expenses and reasonable attorneys' fees, arising out of the
death of or injury to any person or persons or out of any damage to property and
against any other claim, proceeding, demand, expense and liability of any kind
whatsoever resulting from the production, manufacture, sale, use, lease,
consumption or advertisement of the Licensed Product(s) and/or Licensed
Process(es) or arising from any obligation of LICENSEE hereunder.
8.2 LICENSEE shall obtain and carry in full force and effect liability
insurance which shall protect LICENSEE and UFRFI in regard to events covered by
Paragraph 8.1 above.
8.3 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, UFRFI MAKES
NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR
A PARTICULAR PURPOSE, AND VALIDITY OF PATENT RIGHTS CLAIMS, ISSUED OR PENDING.
ARTICLE 9
EXPORT CONTROLS
LICENSEE hereby agrees that it shall not sell, transfer, export or reexport
any Licensed Products or Licensed Processes or related information in any form,
or any direct products of such information, except in compliance with all
applicable laws, including the export laws of any U.S. government agency and any
regulations thereunder, and will not sell, transfer, export or reexport any such
Licensed Products or Licensed Processes or information to any persons or any
entities with regard to which there exist grounds to suspect or believe that
they are violating such laws. LICENSEE shall be solely responsible for obtaining
all licenses, permits or authorizations required from the U.S. and any other
government for any such export or reexport. To the extent
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9.
<PAGE> 10
not inconsistent with this Agreement, UFRFI agrees to provide LICENSEE with such
assistance as it may reasonably request in obtaining such licenses, permits or
authorization.
ARTICLE 10
NON-USE OF NAMES
LICENSEE shall not use the names of the University of Florida or University
of Florida Research Foundation, Inc. nor of any of either institution's
employees, nor any adaptation thereof, in any advertising, promotional or sales
literature without prior written consent obtained from UFRFI in each case,
except that LICENSEE may state that it is licensed by UFRFI under one or more of
the patents and/or applications comprising the Patent Rights.
ARTICLE 11
ASSIGNMENT
This Agreement is not assignable except that LICENSEE may assign this
Agreement to a successor by merger or sale of all of LICENSEE's business related
to Licensed Processes and Licensed Products. The assignor shall remain liable
and responsible for the performance and observance of all duties and obligations
under this Agreement.
ARTICLE 12
TERMINATION
12.1 If LICENSEE shall cease to carry on its business, this Agreement shall
terminate upon notice by UFRFI.
12.2 This Agreement shall immediately terminate if LICENSEE fails to do any
of the following:
(a) make the payment stipulated by Section 4.1(a)(i) in the time frame
stipulated by Section 4.1(a)(i) ; or
(b) make the payment stipulated by Section 4.1(a)(ii) in the time
frame stipulated by Section 4.1(a)(ii) ; or
(c) provide LICENSEE's Certificate of Incorporation, an equitable
Stock Acquisition Agreement and issue and deliver the Shares in accordance with
Section 4.1 (b) in the time frame stipulated by Section 4.1(b).
UFRFI shall provide LICENSEE with written notification of the date of
termination under this Section 12.2.
12.3 Notwithstanding the immediate termination of the Agreement for
LICENSEE's failure to pay as set forth in Section 12.2 above, should LICENSEE
fail to pay UFRFI fees and royalties due and payable hereunder, UFRFI shall have
the right to terminate this Agreement on thirty (30) days' notice, unless
LICENSEE shall pay UFRFI within the thirty (30) day period, all such fees and
royalties and interest due and payable. Upon the expiration of the thirty (30)
days
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10.
<PAGE> 11
period, if LICENSEE shall not have paid all such fees and royalties and interest
due and payable, the rights, privileges and license granted hereunder shall
terminate.
12.4 Upon any material breach or default of this Agreement by LICENSEE,
other than those occurrences set out in Paragraphs 12.1, 12.2, and 12.3
hereinabove, which shall always take precedence in that order over any material
breach or default referred to in this Paragraph 12.4, UFRFI shall have the right
to terminate this Agreement and the rights, privileges and license granted
hereunder by ninety (90) days' notice to LICENSEE. Such termination shall become
effective unless LICENSEE shall have cured any such breach or default prior to
the expiration of the ninety (90) day period.
12.5 LICENSEE shall have the right to terminate this Agreement at any time
on three (3) months' written notice to UFRFI, and upon payment of all amounts
due UFRFI through the effective date of the termination.
12.6 UFRFI may terminate this Agreement upon the occurrence of the third
separate default by LICENSEE within any consecutive three (3) year period for
failure to pay royalties when due.
12.7 Upon termination of this Agreement for any reason, nothing herein
shall be construed to release either party from any obligation that matured
prior to the effective date of such termination. LICENSEE and any Co/Developer
thereof may, however, after the effective date of such termination, sell all
Licensed Products, and complete Licensed Products in the process of manufacture
at the time of such termination and sell the same, provided that LICENSEE shall
pay to UFRFI the royalties thereon as required by Article IV of this Agreement
and shall submit the reports required by Article V hereof on the sales of
Licensed Products.
12.8 In the event either party files for bankruptcy or a receiver is
appointed, this Agreement may immediately thereafter be terminated at the option
of the other party.
ARTICLE 13
PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
Any payment, notice or other communication pursuant to this Agreement shall
be sufficiently made or given on the date of mailing if sent to such party by
certified first class mail, postage prepaid, addressed to it at its address
below or as it shall designate by written notice given to the other party:
In the case of UFRFI:
President
University of Florida Research Foundation, Inc.
223 Grinter Hall
Gainesville, Florida 32611-2037
With a copy to:
Director
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11.
<PAGE> 12
Office of Patent, Copyright and Technology Licensing
186 Grinter Hall
Gainesville, Florida 32611-2037
All payments to:
Director
Office of Patent, Copyright and Technology Licensing
186 Grinter Hall
Gainesville, Florida 32611-2037
In the case of LICENSEE:
President
Avigen, Inc.
19 Tarabrook Drive
Alameda, California 94563
ARTICLE 14
MISCELLANEOUS PROVISIONS
14.1 This Agreement shall be construed, governed, interpreted and applied
in accordance with the laws of the State of Florida, U.S.A.
14.2 The parties hereto acknowledge that this Agreement sets forth the
entire agreement and understanding of the parties hereto as to the subject
matter hereof, and shall not be subject to any change or modification except by
the execution of a written instrument subscribed to by the parties hereto.
14.3 The provisions of this Agreement are severable, and in the event that
any provisions of this Agreement shall be determined to be invalid or
unenforceable under any controlling body of the law, such invalidity or
unenforceability shall not in any way affect the validity or enforceability of
the remaining provisions hereof.
14.4 LICENSEE agrees to mark the Licensed Products sold in the United
States with all applicable United States patent numbers.
14.5 The failure of either party to assert a right hereunder or to insist
upon compliance with any term or condition of this Agreement shall not
constitute a waiver of that right or excuse a similar subsequent failure to
perform any such term or condition by the other party.
IN WITNESS WHEREOF, the parties have hereunto set their hands and seals and duly
executed this Agreement the day and year set forth below.
UNIVERSITY OF FLORIDA RESEARCH FOUNDATION, INC.
By /s/ Donald Price
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12.
<PAGE> 13
Name Dr. Donald R. Price
Title President
Date November 19, 1992
AVIGEN, INC.
By /s/ Jeffrey Wolf
------------------------------------
Name Jeffrey Wolf
----------------------------------
Title Vice President
---------------------------------
Date 11/13/92
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13.
<PAGE> 14
APPENDIX A
UFRFI Case No. UF #0431
"AAV TRANSDUCTION VECTORS"
United States Patent No. 5139941
By DRS. NICHOLAS MUZYCZKA, KENNETH BERNS, RICHARD SAMULSKI and PAUL HERMONAT
Date Patent Issued 08/18/92
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COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
14.
<PAGE> 15
AMENDMENT TO LICENSE AGREEMENT
THIS AMENDMENT is effective as of the 25th day of March, 1996 ("Effective
Date") by and between AVIGEN, INC., a Delaware corporation (the "Company") and
The University of Florida Research Foundation, Inc., a non-profit Florida
corporation ("UFRFI")
W I T N E S S E T H
WHEREAS, the parties hereto have entered into a License Agreement, dated
November 13, 1992 (hereinafter the "License Agreement"); and
WHEREAS, the parties desire to waive and modify certain milestone
provisions under Article III.
NOW, THEREFORE, in consideration of the premises and mutual covenants herein
contained, and other good and valuable consideration, the receipt of which is
acknowledged by the parties, the parties hereby agree as follows:
1. Section 3.2 is hereby amended to read in its entirety as follows:
"3.2 In addition, LICENSEE shall adhere to the following milestones:
(a) LICENSEE shall deliver to UFRFI on or before the first anniversary of
the Effective Date a business plan showing the amount of money, number and kind
of personnel and time budgeted and planned for each phase of development of the
Licensed Products and Licensed Processes and shall provide similar reports to
UFRFI on an annual basis on or before the ninetieth (90th) day following the
close of LICENSEE's fiscal year.
(b) LICENSEE shall initiate large animal studies using AAV vectors for gene
therapy by no later than January 1, 1996.
(c) LICENSEE shall initiate human clinical studies utilizing AAV vectors
for gene therapy by no later than May 18, 1998.
2. Section 3.3 is hereby amended to read In its entirety as follows:
"3.3 LICENSEE's failure to perform in accordance with Sections 3.1 and 3.2 of
this Agreement shall be grounds for UFRFI to terminate this Agreement in
accordance with the provisions of Section 12.4 hereunder.
3. UFRFI hereby waives any default arising out the failure to achieve the
milestones set forth in Section 3.2(b) prior to the date of this Amendment to
License Agreement.
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15.
<PAGE> 16
IN WITNESS WHEREOF, the parties have each caused this Amendment to License
Agreement to be signed and delivered by their duly authorized representatives as
of the date first written above.
AVIGEN, INC.
By: /s/ John Monahan
-----------------------------------
Title: CEO
--------------------------------
THE UNIVERSITY OF FLORIDA RESEARCH FOUNDATION, INC.
BY: /s/ J. L. Heggestat
-----------------------------------
Title: Executive Director
--------------------------------
April 10, 1996
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AMENDED.
16.
