<PAGE> 1
AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON FEBRUARY 13, 1996
REGISTRATION NO. 333-19125
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
------------------
PRE-EFFECTIVE
AMENDMENT NO. 1
TO
FORM S-4
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
------------------
VAXCEL, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
<TABLE>
<S> <C> <C>
DELAWARE 2830 58-2027283
(STATE OR OTHER JURISDICTION OF (PRIMARY STANDARD INDUSTRIAL (I.R.S. EMPLOYER
INCORPORATION OR ORGANIZATION) CLASSIFICATION CODE NUMBER) IDENTIFICATION NO.)
</TABLE>
154 TECHNOLOGY PARKWAY
NORCROSS, GEORGIA 30092
(770) 453-0195
(ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING AREA CODE, OF
REGISTRANT'S PRINCIPAL EXECUTIVE OFFICES)
PAUL J. WILSON III
PRESIDENT AND CHIEF EXECUTIVE OFFICER
VAXCEL, INC.
154 TECHNOLOGY PARKWAY
NORCROSS, GEORGIA 30092
(770) 453-0195
(NAME, ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING AREA CODE,
OF AGENT FOR SERVICE)
------------------
with copies to:
<TABLE>
<S> <C> <C>
GEORGE M. MAXWELL, JR. MARTYN D. GREENACRE DEBRA J. POUL
ALSTON & BIRD CHAIRMAN AND CHIEF EXECUTIVE OFFICER MORGAN, LEWIS & BOCKIUS LLP
ONE ATLANTIC CENTER ZYNAXIS, INC. 2000 ONE LOGAN SQUARE
1201 WEST PEACHTREE 371 PHOENIXVILLE PIKE PHILADELPHIA, PENNSYLVANIA 19103-6993
STREET MALVERN, PENNSYLVANIA 19355 (215) 963-5280
ATLANTA, GEORGIA (610) 889-2202
30309-3424
(404) 881-7570
</TABLE>
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE OF SECURITIES TO THE PUBLIC:
As soon as practicable after the merger (the "Merger") described in this
Registration Statement becomes effective.
If the securities being registered on this form are being offered in
connection with the formation of a holding company and there is compliance with
General Instruction G, check the following box. [ ]
------------------
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE TIME UNTIL THE REGISTRANT SHALL
FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF
THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SECTION 8(a), SHALL
DETERMINE.
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
<PAGE> 2
This amendment to Part II of Vaxcel, Inc.'s Registration Statement on Form
S-4, Registration Statement No. 333-19125 (the "Registration Statement") is
being filed in connection with the filing of Exhibit 10.4 to the Registration
Statement and a request for the confidentiality of certain portions thereof.
<PAGE> 3
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 20. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
ARTICLE VI OF THE CERTIFICATE OF INCORPORATION OF THE REGISTRANT PROVIDES:
SECTION 6.1. RIGHT TO INDEMNIFICATION. Each person who was or is made a
party or is threatened to be made a party to or is otherwise involved in any
threatened, pending or completed action, suit or proceeding, whether civil,
criminal, administrative, arbitrative or investigative, and whether formal or
informal (hereinafter a "proceeding"), by reason of the fact:
(a) that he or she, or a person of whom he or she is the legal
representative, is or was a director or Board-elected officer of the
Corporation, or
(b) that he or she, being at the time a director or Board-elected
officer of the Corporation, is or was serving at the request of the
Corporation as a director, trustee, officer, employee or agent of another
corporation or of a partnership, limited liability company, joint venture,
trust or other enterprise, including service with respect to an employee
benefit plan (collectively, "another enterprise" or "other enterprise"),
whether either in case (a) or in case (b) the basis of such proceeding is
alleged action or inaction (x) in an official capacity as a director or officer
of the Corporation, or as a director, trustee, officer, employee or agent of
such other enterprise, or (y) in any other capacity related to the Corporation
or such other enterprise while so serving as a director, trustee, officer,
employee or agent, shall be indemnified and held harmless by the Corporation to
the fullest extent permitted by Section 145 of the Delaware General Corporation
Law (or any successor provision or provisions) as the same exists or may
hereafter be amended (but, in the case of any such amendment, with respect to
alleged action or inaction occurring prior to such amendment, only to the extent
that such amendment permits the Corporation to provide broader indemnification
rights than permitted prior thereto), against all expense, liability and loss
(including without limitation attorneys' fees and expenses, judgments, fines,
ERISA excise taxes or penalties and amounts paid in settlement) actually and
reasonably incurred by such person in connection therewith. The persons
indemnified by this Article VI are hereinafter referred to as "indemnitees."
Such indemnification as to such alleged action or inaction shall continue as to
an indemnitee who has after such alleged action or inaction ceased to be a
director or officer of the Corporation, or director, trustee, officer, employee
or agent of such other enterprise; and shall inure to the benefit of the
indemnitee's heirs, executors and administrators. Notwithstanding the foregoing,
except as may be provided in the Bylaws or by the Board of Directors, the
Corporation shall not indemnify any such indemnitee in connection with a
proceeding (or portion thereof) initiated by such indemnitee (but this
prohibition shall not apply to a counterclaim, cross-claim or third-party claim
brought by the indemnitee in any proceeding) unless such proceeding (or portion
thereof) was authorized by the Board of Directors. The right to indemnification
conferred in this Article VI: (i) shall be a contract right; (ii) shall not be
affected adversely as to any indemnitee by any amendment of this Certificate of
Incorporation with respect to any alleged action or inaction occurring prior to
such amendment; and (iii) shall, subject to any requirements imposed by law and
the Bylaws, include the right to be paid by the Corporation the expenses
(including attorneys' fees) incurred in defending any such proceeding in advance
of its final disposition.
SECTION 6.2. RELATIONSHIP TO OTHER RIGHTS AND PROVISIONS CONCERNING
INDEMNIFICATION. The rights to indemnification and to the advancement of
expenses conferred in this Article VI shall not be exclusive of any other right
which any person may have or hereafter acquire under this Certificate of
Incorporation, any statute, bylaw, agreement, vote of shareholders or
disinterested directors or otherwise. The Bylaws may contain such other
provisions concerning indemnification, including provisions specifying
reasonable procedures relating to and conditions to the receipt by indemnitees
of indemnification, provided that such provisions are not inconsistent with the
provisions of this Article VI.
SECTION 6.3. OTHER OFFICERS, EMPLOYEES AND AGENTS. The Corporation may,
to the extent authorized from time to time by the Board of Directors, grant
rights to indemnification, and to the advancement of
II-1
<PAGE> 4
expenses, to any other officer, employee or agent of the Corporation (or any
person serving at the Corporation's request as a director, trustee, officer,
employee or agent of another enterprise) or to any person who is or was a
director, officer, employee or agent of any of the Corporation's affiliates,
predecessor or subsidiary corporations or of a constituent corporation absorbed
by the Corporation in a consolidation or merger or who is or was serving at the
request of such affiliate, predecessor or subsidiary corporation or of such
constituent corporation as a director, trustee, officer, employee or agent of
another enterprise, in each case as determined by the Board of Directors to the
fullest extent of the provisions of this Article VI in cases of the
indemnification and advancement of expenses of directors and Board-elected
officers of the Corporation, or to any lesser extent (or greater extent, if
permitted by law) determined by the Board of Directors. If so indemnified, such
persons shall be included in the term "indemnitee" or "indemnitees" as used in
this Article VI and in the Bylaws of the Corporation.
ARTICLE VII OF THE BYLAWS OF REGISTRANT PROVIDES:
SECTION 7.01. INDEMNIFICATION PROVISIONS IN CERTIFICATE OF
INCORPORATION. The provisions of this Article VII are intended to supplement
Article VI of the Certificate of Incorporation pursuant to Sections 6.2 and 6.3
thereof. To the extent that this Article VII contains any provisions
inconsistent with said Article VI, the provisions of the Certificate of
Incorporation shall govern. Terms defined in such Article VI shall have the same
meaning in this Article VII.
SECTION 7.02. INDEMNIFICATION OF OTHERS. The Corporation may indemnify
and advance expenses to its other officers, employees and agents to the same
extent as to its directors and Board-elected officers, as set forth in the
Certificate of Incorporation and in this Article VII of the Bylaws of the
Corporation, and, if so indemnified, such persons shall be included in the term
"indemnitee" or "indemnitees" as used in this Article VII of the Bylaws.
SECTION 7.03. UNDERTAKINGS FOR ADVANCES OF EXPENSES. If and to the extent
the Delaware General Corporation Law requires, an advancement by the Corporation
of expenses incurred by an indemnitee pursuant to clause (iii) of the last
sentence of Section 6.1 of the Certificate of Incorporation (hereinafter an
"advancement of expenses") shall be made only upon delivery to the Corporation
of an undertaking (hereinafter an "undertaking"), by or on behalf of such
indemnitee, to repay all amounts so advanced if it shall ultimately be
determined by final judicial decision from which there is no further right to
appeal (hereinafter a "final adjudication") that such indemnitee is not entitled
to be indemnified for such expenses under Article VI of the Certificate of
Incorporation or otherwise.
SECTION 7.04. CLAIMS FOR INDEMNIFICATION. If a claim for indemnification
under Section 6.1 of the Certificate of Incorporation is not paid in full by the
Corporation within 60 days after it has been received in writing by the
Corporation, except in the case of a claim for an advancement of expenses, in
which case the applicable period shall be 20 days, the indemnitee may at any
time thereafter bring suit against the Corporation to recover the unpaid amount
of the claim. If the indemnitee is successful in whole or in part in any such
suit, or in a suit brought by the Corporation to recover an advancement of
expenses pursuant to the terms of an undertaking, the indemnitee shall be
entitled to be paid also the expense of prosecuting or defending such suit. In
any suit brought by the indemnitee to enforce a right to indemnification
hereunder (but not in a suit brought by the indemnitee to enforce a right to an
advancement of expenses) it shall be a defense that, and in any suit by the
Corporation to recover an advancement of expenses pursuant to the terms of an
undertaking the Corporation shall be entitled to recover such expenses only upon
a final adjudication that, the indemnitee has not met the applicable standard of
conduct set forth in Section 145 of the Delaware General Corporation Law (or any
successor provision or provisions). Neither the failure of the Corporation
(including the Board of Directors, independent legal counsel, or its
shareholders) to have made a determination prior to the commencement of such
suit that indemnification of the indemnitee is proper in the circumstances
because the indemnitee has met the applicable standard of conduct set forth in
Section 145 of the Delaware General Corporation Law (or any successor provision
or provisions), nor an actual determination by the Corporation (including the
Board of Directors, independent legal counsel, or its shareholders) that the
indemnitee has not met such applicable standard of conduct, shall create a
presumption that the indemnitee has not met the applicable standard of conduct
or, in the case of such a suit brought by the
II-2
<PAGE> 5
indemnitee, be a defense to such suit. In any suit brought by the indemnitee to
enforce a right to indemnification or to an advancement of expenses hereunder,
or by the Corporation to recover an advancement of expenses pursuant to the
terms of an undertaking, the burden of proving that the indemnitee is not
entitled to be indemnified, or to have or retain such advancement of expenses,
under Article VI of the Certificate of Incorporation or this Article VII or
otherwise, shall be on the Corporation.
SECTION 7.05. INSURANCE. The Corporation may maintain insurance, at its
expense, to protect itself and any director, trustee, officer, employee or agent
of the Corporation or another enterprise against any expense, liability or loss,
whether or not the Corporation would have the power to indemnify such person
against such expense, liability or loss under the Delaware General Corporation
Law.
SECTION 7.06. SEVERABILITY. In the event that any of the provisions of
this Article VII (including any provision within a single section, paragraph or
sentence) is held by a court of competent jurisdiction to be invalid, void or
otherwise unenforceable, the remaining provisions are severable and shall remain
enforceable to the full extent permitted by law.
Section 145 of the Delaware General Corporation law empowers Vaxcel to
indemnify its officers and directors under certain circumstances. The pertinent
provisions of that statute read as follows:
"(a) A corporation may indemnify any person who was or is a party or
is threatened to be made a party to any threatened, pending or completed
action, suit or proceeding, whether civil, criminal, administrative or
investigative (other than an action by or in the right of the corporation)
by reason of the fact that he is or was a director, officer, employee or
agent of the corporation, or is or was serving at the request of the
corporation as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise, against
expenses (including attorneys' fees), judgments, fines and amounts paid in
settlement actually and reasonably incurred by him in connection with such
action, suit or proceeding if he acted in good faith and in a manner he
reasonably believed to be in or not opposed to the best interests of the
corporation, and, with respect to any criminal action or proceeding, had no
reasonable cause to believe his conduct was unlawful. The termination of
any action, suit or proceeding by judgment, order, settlement, conviction,
or upon a plea of nolo contendere or its equivalent, shall not, of itself,
create a presumption that the person did not act in good faith and in a
manner which he reasonably believed to be in or not opposed to the best
interests of the corporation, and, with respect to any criminal action or
proceeding, had reasonable cause to believe that his conduct was unlawful.
"(b) A corporation may indemnify any person who was or is a party or
is threatened to be made a party to any threatened, pending or completed
action or suit by or in the right of the corporation to procure a judgment
in its favor by reason of the fact that he is or was a director, officer,
employee or agent of the corporation, or is or was serving at the request
of the corporation as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise against
expenses (including attorneys' fees) actually and reasonably incurred by
him in connection with the defense or settlement of such action or suit if
he acted in good faith and in a manner he reasonably believed to be in or
not opposed to the best interests of the corporation and except that no
indemnification shall be made in respect of any claim, issue or matter as
to which such person shall have been adjudged to be liable to the
corporation unless and only to the extent that the Court of Chancery or the
court in which such action or suit was brought shall determine upon
application that, despite the adjudication of liability but in view of all
the circumstances of the case, such person is fairly and reasonably
entitled to indemnity for such expenses which the Court of Chancery or such
other court shall deem proper.
"(c) To the extent that a director, officer, employee or agent of a
corporation has been successful on the merits or otherwise in defense of
any action, suit or proceeding referred to in subsections (a) and (b) of
this section, or in defense of any claim, issue or matter therein, he shall
be indemnified against expenses (including attorneys' fees) actually and
reasonably incurred by him in connection therewith.
"(d) Any indemnification under subsections (a) and (b) of this section
(unless ordered by a court) shall be made by the corporation only as
authorized in the specific case upon a determination that indemnification
of the director, officer, employee or agent is proper in the circumstances
because he has
II-3
<PAGE> 6
met the applicable standard of conduct set forth in subsections (a) and (b)
of this section. Such determination shall be made (1) by a majority vote of
the directors who are not parties to such action, suit or proceeding, even
though less than a quorum, or (2) if there are no such directors, or if
such directors so direct, by independent legal counsel in a written
opinion, or (3) by the shareholders.
"(e) Expenses (including attorneys' fees) incurred by an officer or
director in defending any civil, criminal, administrative or investigative
action, suit or proceeding may be paid by the corporation in advance of the
final disposition of such action, suit or proceeding upon receipt of an
undertaking by or on behalf of such director or officer to repay such
amount if it shall ultimately be determined that he is not entitled to be
indemnified by the corporation as authorized in this section. Such expenses
(including attorneys' fees) incurred by other employees and agents may be
so paid upon such terms and conditions, if any, as the board of directors
deems appropriate.
"(f) The indemnification and advancement of expenses provided by, or
granted pursuant to, the other subsections of this section shall not be
deemed exclusive of any other rights to which those seeking indemnification
or advancement of expenses may be entitled under any bylaw, agreement, vote
of shareholders or disinterested directors or otherwise, both as to action
in his official capacity and as to action in another capacity while holding
such office.
"(g) A corporation shall have power to purchase and maintain insurance
on behalf of any person who is or was a director, officer, employee or
agent of the corporation, or is or was serving at the request of the
corporation as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise against
any liability asserted against him and incurred by him in any such
capacity, or arising out of his status as such, whether or not the
corporation would have the power to indemnify him against such liability
under this section.
"(h) For purposes of this section, references to 'the corporation'
shall include, in addition to the resulting corporation, any constituent
corporation (including any constituent of a constituent) absorbed in a
consolidation or merger which, if its separate existence had continued,
would have had power and authority to indemnify its directors, officers,
and employees or agents, so that any person who is or was a director,
officer, employee or agent of such constituent corporation, or is or was
serving at the request of such constituent corporation as a director,
officer, employee or agent of another corporation, partnership, joint
venture, trust or other enterprise, shall stand in the same position under
this section with respect to the resulting or surviving corporation as he
would have with respect to such constituent corporation if its separate
existence had continued.
"(i) For purposes of this section, references to 'other enterprises'
shall include employee benefit plans; references to 'fines' shall include
any excise taxes assessed on a person with respect to any employee benefit
plan; and references to 'serving at the request of the corporation' shall
include any service as a director, officer, employee or agent of the
corporation which imposes duties on, or involves services by, such
director, officer, employee or agent with respect to an employee benefit
plan, its participants or beneficiaries; and a person who acted in good
faith and in a manner he reasonably believed to be in the interest of the
participants and beneficiaries of an employee benefit plan shall be deemed
to have acted in a manner 'not opposed to the best interests of the
corporation' as referred to in this section.
"(j) The indemnification and advancement of expenses provided by, or
granted pursuant to, this section shall, unless otherwise provided when
authorized or ratified, continue as to a person who has ceased to be a
director, officer, employee or agent and shall inure to the benefit of the
heirs, executors and administrators of such a person.
"(k) The Court of Chancery is hereby vested with exclusive
jurisdiction to hear and determine all actions for advancement of expenses
or indemnification brought under this section or under any bylaw,
agreement, vote of shareholders or disinterested directors, or otherwise.
The Court of Chancery may summarily determine a corporation's obligation to
advance expenses (including attorneys' fees)."
As permitted by applicable statutes, the Registrant has purchased a
standard directors' and officers' liability policy that will, subject to certain
limitations, indemnify the Registrant and its officers and directors
II-4
<PAGE> 7
for damages they become legally obligated to pay as a result of any negligent
act, error, or omission committed by directors or officers while acting in their
capacities as such.
The indemnification provisions in the Bylaws may be sufficiently broad to
permit indemnification of the Registrant's officers and directors for
liabilities arising under the Securities Act.
ITEM 21. EXHIBITS.
The following exhibits are filed herein:
<TABLE>
<CAPTION>
EXHIBIT NO. DESCRIPTION
- ----------- ---------------------------------------------------------------------------------
<S> <C> <C>
*2.1 -- Agreement and Plan of Merger, dated as of December 6, 1996, by and among CytRx
Corporation, Vaxcel, Inc., Vaxcel Merger Subsidiary, Inc., and Zynaxis, Inc.
(included as Appendix A to the Proxy Statement/Prospectus included in this
Registration Statement)
*3.1 -- Amended and Restated Certificate of Incorporation of Vaxcel, Inc.
*3.2 -- Bylaws of Vaxcel, Inc.
*4.1 -- Warrant to purchase shares of common stock of Vaxcel, Inc., to be issued to
certain shareholders of Zynaxis, Inc. (included as Appendix H in the Proxy
Statement/Prospectus included in this Registration Statement)
*4.2 -- Warrant to purchase shares of the common stock of Vaxcel, Inc., to be issued to
CytRx Corporation (included as Appendix I to the Proxy Statement/Prospectus
included in this Registration Statement)
*5.1 -- Form of opinion of Alston & Bird as to the legality of the shares of the common
stock of Vaxcel, Inc. being issued
*8.1 -- Form of opinion of Alston & Bird regarding certain tax matters
*10.1 -- Agreement of Sublease dated January 18, 1996 by and between Vaxcel, Inc. and
SeaLite Sciences, Inc.
*10.2 -- Amendment to Sublease dated October 15, 1996 by and between Vaxcel, Inc. and
SeaLite Sciences, Inc.
*10.3 -- Amended and Restated License Agreement (OPTIVAX(R)) dated October 10, 1996 by and
between Vaxcel, Inc. and CytRx Corporation
10.4 -- Amended and Restated Supply Agreement dated October 10, 1996 by and between
Vaxcel, Inc. and CytRx Corporation
*10.5 -- Employment Agreement dated August 16, 1993 by and between Vaxcel, Inc. and Paul
J. Wilson
*10.6 -- Amendment No. 1 to Employment Agreement dated March 6, 1994 by and between
Vaxcel, Inc. and Paul J. Wilson
*10.7 -- Form of amendment No. 1 to Non-Qualified Stock Option Agreement by and between
Vaxcel, Inc. and Paul J. Wilson
*10.8 -- Facilities Use Agreement dated October 16, 1996 by and between Vaxcel, Inc. and
Proceutics, Inc.
*10.9 -- Feasibility Evaluation/Development Option Agreement dated August 4, 1995 by and
between Vaxcel, Inc. and Connaught Laboratories, Inc.
*10.10 -- Lease Agreement dated November 23, 1993 by and between Vaxcel, Inc. and New
England Mutual Life Insurance Company
*10.11 -- First Amendment to Lease Agreement dated January 23, 1996 by and between Vaxcel,
Inc. and Regency Holdings, Inc.
*10.12 -- Second Amendment to Lease Agreement dated October 15, 1996 by and between Vaxcel,
Inc. and Regency Holdings, Inc.
*10.13 -- License Agreement (OPTIVAX(R) Copolymer Adjuvant) dated April 9, 1996 by and
between Vaxcel, Inc. and Corixa Corporation
</TABLE>
II-5
<PAGE> 8
<TABLE>
<CAPTION>
EXHIBIT NO. DESCRIPTION
- ----------- ---------------------------------------------------------------------------------
<S> <C> <C>
*10.14 -- Option Agreement dated October 15, 1995 by and between Vaxcel, Inc. and Medeva
Europe Limited
*10.15 -- Services and Facilities Use Agreement dated October 10, 1996 by and between
Vaxcel, Inc. and CytRx Corporation
*10.16 -- Vaxcel, Inc. 1993 Stock Option Plan
*13.1 -- Zynaxis' Annual Report to Shareholders for the year ended December 31, 1995
(Incorporated herein by reference to Zynaxis' Annual Report on Form 10-K/A-1 for
the fiscal year ended December 31, 1995)
*23.1 -- Consent of Ernst & Young LLP, independent auditors for Vaxcel, Inc.
*23.2 -- Consent of Arther Andersen LLP, independent public accountants for Zynaxis, Inc.
*23.3 -- Consent of Alston & Bird (included in Exhibit 5.1 and 8.1)
*24.1 -- Power of Attorney (contained on the signature page hereof)
*27.1 -- Financial Data Schedule
*99.1 -- Form of Proxy of Zynaxis, Inc.
</TABLE>
- ---------------
* Previously filed.
ITEM 22. UNDERTAKINGS.
A. The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being
made, a post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after
the effective date of the registration statement (or the most recent
post-effective amendment) which, individually or in the aggregate,
represent a fundamental change in the information set forth in the
registration statement. Notwithstanding the foregoing, any increase or
decrease in volume of securities offered (if the total dollar value of
securities offered would not exceed that which was registered) and any
deviation from the low or high end of the estimated maximum offering
range may be reflected in the form of prospectus filed with the
Commission pursuant to Rule 424(b)) if, in the aggregate, the changes in
volume and price represent no more than 20% change in the maximum
aggregate offering price set forth in the "Calculation of Registration
Fee" table in the effective registration statement.
(iii) To include any material information with respect to the plan
of distribution not previously disclosed in the registration statement
or any material change to such information in the registration
statement.
(2) That, for the purposes of determining any liability under the
Securities Act of 1933, each such post-effective amendment shall be deemed
to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed
to be the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment
any of the securities being registered which remain unsold at the
termination of the offering.
B. Insofar as indemnification for liabilities arising under the Securities
Act of 1933 may be permitted to directors, officers and controlling persons of
the Registrant pursuant to the foregoing provisions, or otherwise, the
Registrant has been advised that in the opinion of the Securities and Exchange
Commission, such indemnification is against public policy as expressed in the
Act and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the
Registrant of expenses incurred or paid by a director, officer or controlling
person of the Registrant in the successful defense of any
II-6
<PAGE> 9
action, suit or proceeding) is asserted by such director, officer or controlling
person in connection with the securities being registered, the Registrant will,
unless in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the Act and
will be governed by the final adjudication of such issue.
C.(1) The undersigned Registrant hereby undertakes as follows: that prior
to any public reoffering of the securities registered hereunder through use of a
prospectus which is a part of this registration statement, by any person or
party who is deemed to be an underwriter within the meaning of Rule 145(c), the
issuer undertakes that such reoffering prospectus will contain the information
called for by the applicable registration form with respect to reofferings by
persons who may be deemed underwriters, in addition to the information called
for by the other items of the applicable form.
(2) The Registrant undertakes that every prospectus: (i) that is filed
pursuant to paragraph (1) immediately preceding, or (ii) that purports to meet
the requirements of Section 10(a)(3) of the Act and is used in connection with
an offering of securities subject to Rule 415, will be filed as a part of an
amendment to the registration statement and will not be used until such
amendment is effective, and that, for purposes of determining any liability
under the Securities Act of 1933, each such post-effective amendment shall be
deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
D. The undersigned Registrant hereby undertakes to respond to requests for
information that are incorporated by reference into the prospectus pursuant to
Item 4, 10(b), 11, or 13 of this form within one business day of receipt of such
request, and to send the incorporated documents by first class mail or other
equally prompt means. This includes information contained in documents filed
subsequent to the effective date of the registration statement through the date
of responding to the request.
E. The undersigned Registrant hereby undertakes to supply by means of a
post-effective amendment all information concerning a transaction, and the
company being acquired involved therein, that was not the subject of and
included in the registration statement when it became effective.
II-7
<PAGE> 10
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant
has duly caused this amendment to Registration Statement to be signed on its
behalf by the undersigned, thereunto duly authorized, in the City of Norcross,
State of Georgia on this the 13th day of February, 1997.
VAXCEL, INC.
(Registrant)
By: /s/ PAUL J. WILSON III
------------------------------------
PAUL J. WILSON III
PRESIDENT AND CHIEF EXECUTIVE
OFFICER
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed below by the following persons in the
capacities and on the dates indicated.
<TABLE>
<CAPTION>
SIGNATURES CAPACITY DATE
- ---------------------------------------- ------------------------------ -------------------
<C> <S> <C>
JACK J. LUCHESE* Chairman of the Board, February 13, 1997
- ---------------------------------------- Director
JACK J. LUCHESE
/s/ PAUL J. WILSON III Director, President and Chief February 13, 1997
- ---------------------------------------- Executive Officer
PAUL J. WILSON III (Principal Executive
Officer)
JACK L. BOWMAN* Director February 13, 1997
- ----------------------------------------
JACK L. BOWMAN
RAYMOND C. CARNAHAN, JR.* Director February 13, 1997
- ----------------------------------------
RAYMOND C. CARNAHAN, JR.
HERBERT H. MCDADE, JR.* Director February 13, 1997
- ----------------------------------------
HERBERT H. MCDADE, JR.
MARK W. REYNOLDS* Chief Financial Officer February 13, 1997
- ---------------------------------------- (Principal Financial and
MARK W. REYNOLDS Principal Accounting
Officer)
*By: /s/ PAUL J. WILSON III
- ----------------------------------------
PAUL J. WILSON III
AS ATTORNEY-IN-FACT
</TABLE>
II-8
<PAGE> 11
EXHIBIT INDEX
<TABLE>
<CAPTION>
SEQUENTIALLY
EXHIBIT NUMBERED
NUMBER DESCRIPTION PAGE
- ------ ------------------------------------------------------------------------ ------------
<C> <C> <S> <C>
*3.1 -- Certificate of Incorporation of Vaxcel, Inc. ...........................
*3.2 -- Bylaws of Vaxcel, Inc. .................................................
*5.1 -- Form of opinion of Alston & Bird as to the legality of the shares of the
Securities being issued.................................................
*8.1 -- Form of opinion of Alston & Bird regarding certain tax matters..........
*10.1 -- Agreement of Sublease dated January 18, 1996 by and between Vaxcel, Inc.
and SeaLite Sciences, Inc. .............................................
*10.2 -- Amendment to Sublease dated October 15, 1996 by and between Vaxcel, Inc.
and SeaLite Sciences, Inc. .............................................
*10.3 -- Amended and Restated License Agreement (OPTIVAX(R)) dated October 10,
1996 by and between Vaxcel, Inc. and CytRx Corporation..................
10.4 -- Amended and Restated Supply Agreement dated October 10, 1996 by and
between Vaxcel, Inc. and CytRx Corporation..............................
*10.5 -- Employment Agreement dated August 16, 1993 by and between Vaxcel, Inc.
and Paul J. Wilson......................................................
*10.6 -- Amendment No. 1 to Employment Agreement dated March 6, 1994 by and
between Vaxcel, Inc. and Paul J. Wilson.................................
*10.7 -- Form of amendment No. 1 to Non-Qualified Stock Option Agreement 1997 by
and between Vaxcel, Inc. and Paul J. Wilson.............................
*10.8 -- Facilities Use Agreement dated October 16, 1996 by and between Vaxcel,
Inc. and Proceutics, Inc. ..............................................
*10.9 -- Feasibility Evaluation/Development Option Agreement dated August 4, 1995
by and between Vaxcel, Inc. and Connaught Laboratories, Inc. ...........
*10.10 -- Lease Agreement dated November 23, 1993 by and between Vaxcel, Inc. and
New England Mutual Life Insurance Company...............................
*10.11 -- First Amendment to Lease Agreement dated January 23, 1996 by and between
Vaxcel, Inc. and Regency Holdings, Inc. ................................
*10.12 -- Second Amendment to Lease Agreement dated October 15, 1996 by and
between Vaxcel, Inc. and Regency Holdings, Inc. ........................
*10.13 -- License Agreement (OPTIVAX(R) Copolymer Adjuvant) dated April 9, 1996 by
and between Vaxcel, Inc. and Corixa Corporation.........................
*10.14 -- Option Agreement dated October 15, 1995 by and between Vaxcel, Inc. and
Medeva Europe Limited...................................................
*10.15 -- Services and Facilities Use Agreement dated October 10, 1996 by and
between Vaxcel, Inc. and CytRx Corporation..............................
*10.16 -- Vaxcel, Inc. 1993 Stock Option Plan.....................................
*23.1 -- Consent of Ernst & Young, LLP independent auditors of Vaxcel, Inc. .....
*23.2 -- Consent of Arthur Andersen, independent public accountants for Zynaxis,
Inc. ...................................................................
*23.3 -- Consent of Alston & Bird, counsel to Vaxcel, Inc. (included in Exhibit
5.1 and 8.1)............................................................
*27.1 -- Financial Data Schedule.................................................
*99.1 -- Form of Proxy of Zynaxis, Inc. .........................................
</TABLE>
- ---------------
* Previously filed.
<PAGE> 1
EXHIBIT 10.4
AMENDED AND RESTATED SUPPLY AGREEMENT
(OPTIVAX(R) COPOLYMER)
This SUPPLY AGREEMENT is made and executed as of October 10, 1996, by
and between CYTRX CORPORATION, a Delaware corporation ("CytRx"), and VAXCEL,
INC., a Delaware Corporation ("Vaxcel").
RECITALS
WHEREAS, CytRx and Vaxcel have entered into an Optivax(TM) License
Agreement amended and restated as of October 10, 1996 (the "License
Agreement") whereby CytRx has granted to Vaxcel the exclusive worldwide right
to market and distribute or to sublicense the marketing and distribution of
products containing a certain Copolymer (as defined hereinafter) of CytRx, in
accordance with the terms specified therein; and
WHEREAS, Vaxcel wishes to have CytRx supply Vaxcel with its
requirements for the Copolymer, which Vaxcel will use for purposes of the
License Agreement, and CytRx is willing to supply such Copolymer to Vaxcel,
subject to the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants and agreements hereinafter set forth, the parties hereto,
intending to be legally bound hereby, agree as follows:
ARTICLE I
DEFINITIONS
1.1 For purposes of this Agreement, the following terms shall have the
corresponding meaning set forth below:
"Copolymer" means the polyoxyethylene/polyoxypropylene copolymer
designated as CRL-1005 in the License Agreement.
"FDA" means the U.S. Food and Drug Administration, or any successor
agency thereto.
"FDA Standards" means the facility license requirements and the Good
Manufacturing Practice regulations of the FDA applicable to the
Copolymer or the Manufacturing Facility.
"GMP Grade" means Copolymer that has been produced in accordance with
Good Manufacturing Practice regulations as defined by the FDA.
<PAGE> 2
"Manufacturing Facility" means the manufacturing facility of CytRx, or
any manufacturing facility of a third party licensed and engaged by
CytRx to supply the Copolymer in accordance with Section 2.1.
"Manufacturing Procedures" means (i) the CytRx manufacturing
procedures used to make the Copolymer and (ii) the form of master
batch record for the Copolymer.
"Specifications" means the specifications for the Copolymer as agreed
to by the parties and made a part of this Agreement as Exhibit A
hereto. The specifications may be changed from time to time by mutual
consent of the parties.
1.2 Capitalized terms not otherwise defined herein shall have the
corresponding meaning specified in the License Agreement.
ARTICLE II
MANUFACTURE AND SUPPLY OF PRODUCT
2.1 Supply of Copolymer. During the term of this Agreement, CytRx will
supply or cause to be supplied to Vaxcel 100% of Vaxcel's direct
requirements for the Copolymers as well as 100% of Vaxcel's indirect
requirements for sublicensees, and Vaxcel will purchase all of its
requirements for the Copolymer from CytRx. CytRx shall use reasonable
efforts to ensure the supply of Copolymer to Vaxcel based on Vaxcel's
production forecasts per section 2.2 of this Agreement. CytRx, at its
discretion, may use a reputable, qualified third party to supply the
Copolymer on its behalf. In such event, CytRx shall notify Vaxcel of
the identity of such third party and CytRx shall be responsible at
CytRx's expense for the qualification of and the performance of such
third party. If CytRx or its licensed third party chemical
manufacturer is unwilling or unable to supply the Copolymer, then
Vaxcel and/or its sublicensees shall have the right to make or have
made the Copolymer. In such instance, CytRx agrees to make
appropriate manufacturing know how available to Vaxcel or its
designee.
2.2 Production Forecasts. Vaxcel will deliver to CytRx, on the first day
of each calendar quarter, a requirements forecast indicating Vaxcel's
monthly requirements for quantities of the Copolymer during the twelve
(12) months, beginning with the next calendar month. The specified
quantities for the first four (4) months of each 12-month forecast
shall be deemed a firm purchase commitment for such quantities and
shall be documented by purchase order per section 2.3 of this
Agreement. CytRx shall not accept any production forecasts from
Vaxcel sublicensees.
Page 2
<PAGE> 3
2.3 Purchase Orders
(a) Vaxcel shall submit a purchase order for Copolymer at
least 120 days prior to the shipment specified in the order.
The purchase order shall constitute a firm commitment by
Vaxcel to purchase the Copolymer.
(b) The parties understand the potential seasonal nature of
requirements for the Copolymer. In order to ensure adequate
lead time for significant increases in requirements, Vaxcel
shall submit a firm commitment purchase order at least 210
days in advance of requesting shipment of Copolymer greater
than 125% of the average monthly quantity shipped over the
preceding twelve months.
(c) All orders for Copolymer shall be ordered in full batches
from one of the following Batch Categories:
"Small Pilot" X X X kilograms
"Large Pilot" greater than X kilograms
"Small Commercial" greater than XX kilograms
"Large Commercial" greater than XX kilograms
(d) CytRx shall from time to time provide Vaxcel with batch
sizes available within each Batch Category. CytRx shall
consult with Vaxcel prior to changing batch sizes.
2.4 Price.
(a) The Purchase Price ("Purchase Price") for quantities of
Copolymer will be determined by Batch Category. Batch
Category Purchase Prices as of January 1, 1995 is made part of
this Agreement as Exhibit B hereto.
(b) The Purchase Price shall automatically be increased or
decreased as of January 1 of each year based on the percentage
change up or down in the Producer Price Index (PPI) as
reported by the U.S. Department of Labor over the immediately
preceding twelve months.("the PPI Change Percent"). The
initial base year for this price adjustment shall be 1995.
The Purchase Price shall be adjusted as follows: The Purchase
Price multiplied by the PPI Change Percent equals the amount
of change in the Purchase Price ("the Adjustment Amount").
Where the PPI has increased, the Adjustment amount shall be
added to the Purchase Price; where the PPI has decreased, the
Adjustment Amount shall be subtracted from the Purchase Price
Page 3
<PAGE> 4
2.5 Payment
(a) CytRx shall invoice Vaxcel for the Purchase Price of the
Copolymer when shipped. Each shipment of Copolymer shall
constitute a separate sale obligating Vaxcel to pay therefor.
Each CytRx invoice shall be due and payable within thirty (30)
days after the date thereof. Payments received after the due
date shall be subject to penalty for late payment accruing
from the date of shipment at Prime Rate plus two percent
calculated on the total invoice amount.
(b) All payments shall be made in legal currency of the
United States of America, by corporate check to CytRx at the
address specified in Section 5.3 hereof.
2.6 Shipping Requirements.
(a) CytRx will choose a commercially reasonable method of
shipment and a carrier for each shipment of Copolymer unless
Vaxcel has specified a particular method of shipment in its
purchase order. Title and risk of loss, delay or damage in
transit shall pass to Vaxcel upon delivery by CytRx of the
Copolymer to a common carrier or other means of transport at
the Manufacturing Facility. All purchase orders shall be
designated FOB point of origin.
(b) If Vaxcel takes delivery at the Manufacturing Facility,
title and risk of loss, delay or damage shall pass to Vaxcel
upon actual delivery. Should Vaxcel request, and CytRx agree
to storage by CytRx of Copolymer so delivered, such storage
shall be at Vaxcel's expense.
(c) Vaxcel at its option may specify direct delivery by CytRx
of all or part of a batch to a third party as designated by
Vaxcel. All third party designated shipments shall have the
full drop shipment address indicated on the purchase order.
(d) Vaxcel shall promptly reimburse CytRx in U.S. currency
for the costs of insurance and freight with respect to the
Copolymer, FOB the Manufacturing Facility. Vaxcel shall
provide CytRx, on request, with properly completed exemption
certificates for any tax from which Vaxcel claims exemption.
(e) Vaxcel shall be responsible for payment of any tariffs,
customs duty or similar costs and fees associated with the
shipment of Copolymer to Vaxcel or to a third party designated
by Vaxcel.
(f) CytRx shall make reasonable efforts to deliver Copolymer
as specified in the purchase order. However, any shipment by
CytRx of Copolymer
Page 4
<PAGE> 5
within the following variances shall constitute compliance by
CytRx with the applicable purchase order requirements:
(i) the quantity in kilograms may vary by plus or
minus 10% from the batch sizes specified on each purchase
order; and
(ii) the delivery date may vary plus or minus 30
days from the date specified in the purchase order.
2.7 Warranties. CytRx warrants that each shipment of the Copolymer shall
be manufactured, temporarily stored, packaged, labeled, and controlled
by CytRx in accordance with the Specifications, the Manufacturing
Procedures and applicable FDA Standards. EXCEPT AS SET FORTH IN THE
PRECEDING SENTENCE, CYTRX MAKES NO EXPRESS OR IMPLIED WARRANTIES,
STATUTORY OR OTHERWISE, CONCERNING THE PRODUCT. SPECIFICALLY, BUT
WITHOUT LIMITING THE FOREGOING, CYTRX MAKES NO EXPRESS OR IMPLIED
WARRANTY OF MERCHANTABILITY, FITNESS (FOR A PARTICULAR PURPOSE OR
OTHERWISE), QUALITY OR USEFULNESS OF THE PRODUCT. CYTRX SHALL IN NO
EVENT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES INCURRED
BY VAXCEL.
2.8 Quality Assurance Requirements
(a) Concurrent with each shipment, CytRx will provide to
Vaxcel a Certificate of Analysis that the Copolymer conforms
to the Specifications.
(b) CytRx will provide Vaxcel with sufficient samples of each
production run of the Copolymer as Vaxcel may reasonably
request.
(c) CytRx will not modify the Specifications or any of the
Manufacturing Procedures without obtaining the prior consent
of Vaxcel, which consent shall not be unreasonably withheld,
and/or appropriate regulatory authorities.
2.9 Testing and Rejection of the Copolymer.
(a) CytRx shall conduct the testing of the Copolymer before
shipment using the validated analytical methodology specified
in Exhibit C, and shall provide Vaxcel with a certification of
the test results. Vaxcel may either accept the Copolymer
based on the CytRx test results or may elect to test samples
of the corresponding production run using the approved testing
methodology per Exhibit C.
(b) Within 30 days after receipt of each shipment of
Copolymer by CytRx, Vaxcel or its designee shall have the
right to reject any shipment
Page 5
<PAGE> 6
that fails to meet the applicable Specifications or FDA
Standards. Vaxcel's right of rejection may be exercised by
delivery of notice to CytRx within the 30 day period,
identifying the rejected Copolymer by production lot number
and stating the basis for rejection. If Vaxcel does not
reject the shipment within 30 days, it will be deemed to have
accepted the shipment. Upon the request of CytRx, Vaxcel
shall furnish evidence of nonconformity of the shipment of
Copolymer. If CytRx disagrees with Vaxcel's determination,
the parties shall submit the dispute to a mutually acceptable
laboratory for a binding determination of the conformity or
nonconformity of the Copolymer. The nonprevailing party shall
pay the costs and expenses of the laboratory tests. If Vaxcel
properly rejects the Copolymer, Vaxcel shall receive a credit
for any amounts already paid to CytRx for the rejected
Copolymer against the Purchase Price for the next shipment of
Copolymer accepted by Vaxcel, or shall be reimbursed for such
payment with interest at the prevailing prime rate per annum
at the option of CytRx. Vaxcel shall be responsible for the
destruction of all rejected Copolymer (in compliance with
applicable law) or the return of the shipment, at the expense
of CytRx, at the discretion of CytRx.
(c) If Vaxcel or its designee rejects a shipment per section
2.9(b), at Vaxcel's request, CytRx shall use every reasonable
effort to provide an equivalent quantity in a timely fashion
to replace the batch in question until such time as a
definitive disposition of the batch in question is
forthcoming. The terms and conditions of this Agreement shall
apply for this provisional quantity.
(d) Vaxcel shall be responsible for all stability testing of
the Copolymer. If so requested by Vaxcel, CytRx shall pull
samples of Copolymer for stability testing purposes, and shall
ship such samples at Vaxcel's expense in accord with
instructions from Vaxcel.
2.10 Record Keeping. CytRx will maintain the manufacturing, production and
control records for the Copolymer for the periods required by
applicable FDA Standards and, in any event, will provide Vaxcel the
opportunity to take possession of such records before they are
destroyed.
2.11 Regulatory Approvals. CytRx shall obtain and maintain any
establishment license, facility license or other license,
authorization or approval required by the FDA or any other federal,
state or local governmental authority for the manufacture of the
Copolymer as contemplated hereunder. Vaxcel shall reimburse CytRx for
meeting any additional requirements imposed by international
regulatory agencies.
2.12 Manufacturing Information. CytRx hereby grants Vaxcel permission to
reference CytRx's Drug Manufacturing File (DMF) concerning the
manufacture of the Copolymer as shall be required by Vaxcel to obtain
regulatory approvals.
Page 6
<PAGE> 7
2.13 Compliance with Laws. Vaxcel and its sublicensees shall comply with
all applicable laws in the manufacture of finished product using the
Copolymer and in the promotion, marketing and sale of all such
products.
2.14 Notification. Vaxcel shall notify CytRx of any adverse or unexpected
results, or any potential government action relevant to the Copolymer.
ARTICLE III
TERM AND TERMINATION
3.1 Term of the Agreement. The term of this Agreement shall begin as of
the effective date hereof and shall end on the date of termination of
the License Agreement, unless this Agreement is terminated earlier in
accordance with the provisions of Sections 3.2 or 3.3 hereof.
3.2 Termination by CytRx. CytRx shall have the right to terminate this
Agreement by giving written notice of termination, such termination
effective with the giving of such notice, upon (i) failure of Vaxcel
to pay any amount payable to CytRx that is continuing (30) calendar
days after CytRx gives Vaxcel written notice of such non payment; or
(ii) termination of the License Agreement by CytRx in accordance with
its terms.
3.3 Termination by Either Party. This Agreement may be terminated by
either party before expiration of its stated term, by giving written
notice of termination, such termination effective upon the giving of
such notice, as follows:
(a) breach by the other party of any covenant (other than a
payment covenant covered by Section 3.2) or of any
representation or warranty contained in this Agreement that is
continuing sixty (60) calendar days after the non-breaching
party gives the breaching party written notice of such breach;
or
(b) the non-terminating party becomes insolvent, or voluntary
or involuntary proceedings by or against the non-terminating
party are instituted in bankruptcy or under any insolvency
law, or a receiver or custodian is appointed for the non-
terminating party, or proceedings are instituted by or against
the non-terminating party for corporate reorganization or the
dissolution of the non-terminating party, which proceedings,
if involuntary, shall not have been dismissed within sixty
(60) days after the date of filing, or the non-terminating
party makes an assignment for the benefit of creditors; or
(c) The cessation of operations by the non-terminating party
(other than pursuant to a merger, reorganization or
consolidation in which the non-
Page 7
<PAGE> 8
terminating party is not the surviving corporation or a sale
by the non-terminating party of all or substantially all of
its assets); or
(d) the seizure or attachment of all or substantially all of
the assets of the non-terminating party, in conjunction with
any action against it by any third party, which seizure or
attachment is not released within forty-five (45) days after
such seizure or attachment and which is contested in good
faith by the non-terminating party.
Upon the occurrence of any Event of Default (as defined in the License
Agreement), CytRx shall have the right to terminate this Agreement by
giving written notice of termination, such termination to be effective
with the giving of such notice.
No exercise by CytRx of any right of termination will constitute a
waiver of any right of CytRx for recovery of any moneys then due to it
hereunder or any other right or remedy it may have by law or by this
Agreement.
3.4 Survival. Notwithstanding the termination of this Agreement, however
caused, Vaxcel's obligations to pay for Copolymer shipped prior the
date of termination shall survive such termination until satisfied in
full. In addition, Article IV and any other provisions required to
interpret this Agreement shall survive the termination of this
Agreement to the extent required for the full observation and
performance of the surviving terms and rights and obligations of the
parties arising prior to the termination hereof.
ARTICLE IV
INDEMNIFICATION
4.1 Indemnification by CytRx. CytRx shall indemnify and hold harmless
Vaxcel and its Affiliates, employees, officers, directors,
stockholders and agents (a "Vaxcel Indemnified Party") from and
against any and all liability, loss, damages, costs, or expenses
(including reasonable attorneys' fees) which the Vaxcel Indemnified
Party may incur, suffer or be required to pay resulting from or
arising in connection with (i) the breach by CytRx of any covenant,
representation or warranty contained in this Agreement, including
without limitation, the breach of CytRx's warranty contained in
Section 2.7 hereof (a "CytRx Liability"), or (ii) the enforcement by a
Vaxcel Indemnified Party of any of the foregoing.
4.2 Indemnification by Vaxcel. Vaxcel shall indemnify and hold harmless
CytRx and its Affiliates, employees, officers, directors, stockholders
and agents (a "CytRx Indemnified Party") from and against any and all
liability, loss, damages, costs, or expenses (including reasonable
attorneys' fees) which the CytRx Indemnified Party may incur, suffer
or be required to pay resulting from or arising in
Page 8
<PAGE> 9
connection with (i) the breach by Vaxcel of any covenant,
representation or warranty contained in this Agreement, (ii) the
manufacturing, marketing, sale or distribution of products containing
the Copolymer by Vaxcel or any person on behalf of Vaxcel, (iii) the
use by any person of any product containing the Copolymer that was
manufactured, marketed, sold or distributed by Vaxcel or any Affiliate
or sublicensee of Vaxcel, or (iv) the successful enforcement by a
CytRx Indemnified Party of any of the foregoing.
4.3 Additional Rights and Obligations. The rights and obligations of each
party under this Article IV are in addition to any indemnification
rights and obligations of the parties set forth in the License
Agreement.
4.4 Certain Procedures. Either party shall, within 10 days of its notice
of any claim or suit brought in connection with the Copolymer, notify
in writing the other party of such claim or suit. Either party shall
have the right at its own expense to participate in the defense of any
claim or suit brought in connection with the Copolymer and the parties
agree to coordinate their efforts in this regard.
ARTICLE V
MISCELLANEOUS
5.1 Representations of the Parties. Each party represents and warrants to
the other party that this Agreement has been duly authorized, executed
and delivered and that the performance of its obligations under this
Agreement does not conflict with any order, law, rule or regulation or
any agreement or understanding by which such party is bound.
5.2 Force Majeure. Failure of CytRx to make, or Vaxcel to take, any one
or more deliveries when due, if caused by fire, storms, floods,
strikes, lockouts, accidents, war, riots or civil commotions,
inability to obtain railroad cars or raw materials, embargoes, any
State or Federal regulation, law, or restriction, seizure or
acquisition of Copolymer by the Government of the United States or of
any state, or of any agency thereof or by reason of any compliance
with a demand or request for such product for any purpose for national
defense, or any other cause or contingency beyond the reasonable
control of said party (whether or not of the same kind or nature as
the causes or contingencies above enumerated) shall not subject the
party so failing to any liability to the other, and the total contract
quantity shall be reduced to the extent of the deliveries so omitted.
5.3 Notices. Any notice or other communication required or permitted to
be made or given to either party hereto pursuant to this Agreement
shall be sufficiently made or given if sent to such party by either
telecopy transmission or certified or registered first class mail,
postage prepaid, return receipt requested addressed to it as follows:
Page 9
<PAGE> 10
If to CytRx:
CytRx Corporation
154 Technology Parkway
Norcross, GA 30092
FAX No. (770) 448-3357
Attention: Vice President, Finance
with a copy to:
Alston & Bird
One Atlantic Center
1201 West Peachtree Street
Atlanta, Georgia 30309-3424
FAX No. (404) 881-7777
Attention: George M. Maxwell, Jr.
If to Vaxcel:
Vaxcel Corporation
154 Technology Parkway
Norcross, GA 30092
FAX No. (770) 453-0194
Attention: President
or to such other address as either party shall designate by written
notice, similarly given, to the other party. Any notice if given or
made by certified or registered first class mail letter, return
receipt requested, shall be deemed to have been received on the
earlier of the date actually received and the date three (3) days
after the same was posted (and in proving such it shall be sufficient
to prove that the envelope containing the same was properly addressed
and posted as aforesaid) and if given or made by telecopy transmission
shall be deemed to have been received at the time of dispatch, unless
such date of deemed receipt is not a business day, in which case the
date of deemed receipt shall be the next succeeding business day.
5.4 Entire Agreement; Amendment. This Agreement, together with the
Exhibits annexed hereto sets forth and constitutes the entire
agreement between the parties hereto with respect to the subject
matter hereof, and supersedes any and all prior agreements,
understandings, promises, and representations made by either party to
the other concerning the subject matter hereof and the terms
applicable hereto. This Agreement may not be released, discharged,
amended or modified in any
Page 10
<PAGE> 11
manner except by an instrument in writing signed by duly authorized
representatives of Vaxcel and CytRx.
5.5 Parties Independent. In making and performing this Agreement, the
parties act and shall act at all times as independent entities and
nothing contained in this Agreement shall be construed or implied to
create an agency, partnership or employer and employee relationship
between Vaxcel and CytRx. Except as specifically provided herein, at
no time shall either party make commitments or incur any charges or
expenses for or in the name of the other party.
5.6 Governing Law. This Agreement shall be deemed to have been entered
into and shall be construed and enforced in accordance with the laws
of the State of Delaware.
5.7 Waivers. The failure of either party to insist, in any one or more
instances, upon the performance of any of the terms, covenants or
conditions of this Agreement and to exercise any right hereunder,
shall not be construed as a waiver or relinquishment of the future
performance of any such term, covenant or condition or the future
exercise of such right, but the obligations of the other party with
respect to such future performance shall continue in full force and
effect.
5.8 Headings. The headings of the articles, sections and paragraphs used
in this Agreement are included for convenience only and are not to be
used in construing or interpreting this Agreement.
5.9 Assignability. This Agreement shall not be assignable by either party
without the prior written consent of the other party, except that such
consent is not required in connection with the assignment of either
party's rights or obligations hereunder to an Affiliate thereof.
5.10 Effect of Invalidity of Certain Provisions. Any term or provision of
this Agreement which is invalid or unenforceable in any jurisdiction
shall, as to such jurisdiction, be ineffective to the extent of such
invalidity or unenforceability without rendering invalid or
unenforceable the remaining terms and provisions of this Agreement.
5.11 Counterparts. This Agreement shall become binding when any one or
more counterparts hereof, individually or taken together, shall bear
the signatures of each of the parties hereto. This Agreement may be
executed in any number of counterparts, each of which shall be an
original as against either party whose signature appears thereon, but
all of which together shall constitute but one and the same
instrument.
5.12 Additional Copolymers. If Vaxcel requests CytRx to synthesize and
supply a copolymer(s) different than CRL-1005 (including CRL-1005
synthesized by SCF process) in the Field as defined in the License
Agreement, CytRx will offer to
Page 11
<PAGE> 12
supply such copolymer(s) to Vaxcel upon terms substantially similar to
those set forth in this Agreement if they are substantially similar in
structure and require similar manufacturing procedures with similar
cost. In the event the cost of CytRx supplying such copolymer(s) to
Vaxcel is not similar to CRL-1005 or involves other manufacturing
processes (such as SCF), the parties will negotiate a revised Purchase
Price and all other terms of this Agreement will remain substantially
unchanged. Quantities of such copolymer(s) for initial evaluation and
testing shall be subject to increased costs for experimental
synthesis, development, scale-up, and documentation of manufacturing
processes.
5.13 Agreement not to Solicit. Vaxcel agrees that during the term of this
Agreement and for a period of five years following the termination of
the Agreement that it will not, either directly or indirectly, on
Vaxcel's behalf or on behalf of others, solicit or attempt to solicit
for the purpose of being employed any person then employed in chemical
synthesis or manufacturing by CytRx or its Affiliates, whether or not
employment of any such person is pursuant to a written agreement, for
a determined period or at will.
5.14 Confidentiality.
(a) Vaxcel agrees that during the term of this Agreement and
for a period of five years following the termination of the
Agreement to keep all technical information regarding the
Copolymer in trust and confidence and not to disclose to
others, nor to use for any purpose other than that
specifically outlined in this Agreement and the License
Agreement. This agreement of confidentiality includes
information received in writing or verbally, whether received
intentionally or unintentionally, during the course of
Vaxcel's business with CytRx, its Affiliates, or its third
party subcontractors.
(b) CytRx agrees that during the term of this Agreement and
for a period of five years following the termination of the
Agreement to keep all information gained in administering the
Agreement in trust and confidence and not to disclose to
others, nor to use for any purpose other than that
specifically outlined in this Agreement and the License
Agreement. This agreement of confidentiality includes
information received in writing or verbally, whether received
intentionally or unintentionally, during the course of CytRx's
business with Vaxcel, its Affiliates, or its sublicensees.
IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement as of
the date first above written.
VAXCEL, INC. CYTRX CORPORATION
By /s/ PAUL J. WILSON By /s/ JACK J. LUCHESE
-------------------------- -----------------------------
Paul J. Wilson Jack J. Luchese
President and CEO President and CEO
Page 12
<PAGE> 13
EXHIBIT A
SPECIFICATIONS FOR COPOLYMER CRL-1005
POE-POP-POE block copolymer 1305, CRL-1005, is a clear, colorless to slightly
yellow viscous liquid.
Names: POE-POP-POE block copolymer 311
CRL-1005
Oxirane, methyl-, polymer with oxirane
alpha-Hydro-omega-hydroxy-poly(oxyethylene)a-poly(oxypropylene)b-poly
(oxyethylene)a block copolymer
Empirical formula:
H-(C2H4O)a-(C3H6O)b-(C2H4O)2-OH
in which a = 9 plus/minus 1. and b = 216 plus/minus 27 (based on peak
MW)
Molecular Mass:
Peak MW 13.300 plus/minus 1.700 daltons
Wt. Avg. MW 11.100 plus/minus 1.300 daltons
CAS #: 9003-11-6
Page 13
<PAGE> 14
EXHIBIT B
PURCHASE PRICE FOR QUANTITIES OF COPOLYMER
AS OF JANUARY 1, 1995
<TABLE>
<CAPTION>
BATCH CATEGORY PRICE PER KILOGRAM*
-------------- -------------------
<S> <C>
"Small Pilot" (XXXXX kg) $XXXXXX
-----------
"Large Pilot" (XXXXXX kg) $XXXXXX
------------
"Small Commercial" (XXXXXXX kg) $XXXXXX
----------------
"Large Commercial" (XXXX kg) $XXXXXX
----------------
</TABLE>
* Prices are FOB Manufacturing Facility and specifically exclude freight,
insurance, customs fees, etc.
Page 14
<PAGE> 15
<TABLE>
<CAPTION>
EXHIBIT C
VALIDATION OF CRL-1005
Specifications and Acceptance Limits
Specification Acceptance limits Analytical method
- -----------------------------------------------------------------------------------------------------------------------------
<S> <C> <C>
Appearance Clear, colorless to slightly yellow, Visual observation
viscous liquid
Identification Conforms to FTTR spectrogram of FTTR method LM56
standard by visual comparison
Molecular weight: GPC method LM34
Peak 13.300 plus/minus 1.700 daltons
Weight average 11.100 plus/minus 1.300 daltons
Less than 7000 dalton NMT 25%
Weight % poly(oxyethylene) *NLT 5% and NMT 7% (1)H-NMR per NF monograph
(poloxamer)
Unsaturation NMT 0.10 mEq/gm Titration method LM41
Volatile organic impurities:
benzene NMT 100 ppm GC Method LM61
chloroform NMT 50 ppm
methylene chloride NMT 100 ppm
trichloroethylene NMT 100 ppm
1,4-dioxane NMT 5 ppm
ethylene oxide NMT 5 ppm
propylene oxide NMT 5 ppm
ethylene glycol Report result GC Method LM60-2
propylene glycol Report result
pH of 2.5% aqueous soln. NLT 4.0 and NMT 7.0 CytRx method LM67
at 2 plus/minus 2 degrees C
XXXXXXX XXXXXXX XXX XX XXX XXXXXXXXX XXXX XXXXXX
XXXXXX XXXXXX XXXXXXXXXXX
Heavy metals NMT 0.002% NF monograph (poloxamer)
Cloud Point NLT 4.0 degrees C and NMT 7.0 degrees C CvtRx method LM47-2
- ----------------------------------------------------------------------------------------------------------------------------
NLT = not less than. NMT = not more than
Storage
Store at 2 to 8 degrees C in a tightly closed container under a blanket of Nitrogen or Argon gas.
</TABLE>
Page 15
