Exhibit 10.1 D
THIRD AMENDMENT TO COLLABORATION AND LICENSE AGREEMENT
Third amendment, dated March 25, 2002, (this "Amendment"), to the
Collaboration and License Agreement and the Subscription Agreement dated June
12, 1998, each as amended through Amendment No. 1 dated May 10, 2000 and through
Amendment No. 2 dated July 2, 2001, and each by and between Aphton Corporation,
a company organized under the laws of Delaware with its principal executive
offices at the World Trade Center, 00 XX Xxxxx Xxxxxx, Xxxxx 0000, Xxxxx,
Xxxxxxx (hereinafter "Aphton"), and SmithKline Xxxxxxx PLC, having a place of
business at New Horizon Court, Great Xxxx Xxxx, Xxxxxxxxx, Xxxxxxxxx XX0 0XX,
Xxxxxx Xxxxxxx (hereinafter "SB"). All capitalized terms used herein but not
otherwise defined herein shall have the respective meanings given to such terms
in the Collaboration and License Agreement.
W I T N E S S E T H:
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WHEREAS, Aphton and SB are parties to a Collaboration and License
Agreement and a Subscription Agreement dated June 12, 1998, amended through
Amendment No. 1 to the Collaboration and License Agreement and the Subscription
Agreement dated May 10, 2000 (hereinafter "Amendment No. 1") and through
Amendment No. 2 to the Collaboration and License Agreement and the Subscription
Agreement dated July 2, 2001; and
WHEREAS, Aphton and SB wish to amend certain provisions of the
Collaboration and License Agreement (the "Agreement") as amended through
Amendments No. 1 and No. 2, as herein provided.
NOW, THEREFORE, it is agreed:
1. Section 3.1 (i) of the Agreement, as previously revised
through Amendment No. 1 shall be further amended to read as follows:
3.1.(i) Before end of April 2002, Aphton undertakes to deliver to
SB a full and detailed report describing preclinical and clinical activities
performed and results obtained so far as well as an Updated Development Plan to
be accepted by the Steering Committee. The Steering Committee shall either
accept or reject Aphton's proposed Updated Development Plan within thirty (30)
days of submission by Aphton to the Steering Committee. If the Steering
Committee rejects Aphton's proposed Updated Development Plan, it will provide to
Aphton the reasons for such rejection and Aphton shall be entitled to submit a
revised Updated Development Plan to the Steering Committee within thirty (30)
days thereof. If the Steering Committee rejects such revised Updated Development
Plan, SB shall be entitled to terminate forthwith the Agreement by giving Aphton
a written notice of its election to do so. Upon acceptance of the Updated
Development Plan, SB shall provide the Conjugate (being defined in Amendment No.
1 as anti-GnRH conjugate manufactured under contract for SB) at no expense to
Aphton for its clinical use while stocks of GMP lot DD1DTP002 last. After such
stock has run out, SB shall not provide any more Conjugate to Aphton. After
April 1st, 2002, Aphton shall be responsible
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for verifying at its expense adequate stability of the Conjugate before
formulation into clinical lots, will provide SB with documented evidence of such
stability and will bear all liability related to any lack of stability of
Conjugate supplied after April 1st, 2002. The parties agree to replace the
Development Plan contained in schedule B of the Agreement and amended by
Amendment No. 1 with the New Development Plan, as approved by the Steering
Committee. The Development Program Term shall be amended accordingly.
2. The sixth sentence of Section 3.1 (ii) of the Agreement, as
previously revised through Amendment Xx. 0 xxx Xxxxxxxxx Xx. 0, xxxxx xx further
amended to read as follows:
"In no event shall the Presentation Date be later than [ Redacted]*."
3. The first sentence of Section 13.3.1 of the Agreement, as
previously revised through Amendment Xx. 0 xxx Xxxxxxxxx Xx. 0, xxxxx xx further
amended to read as follows:
"Prior to the Acceptance Date, SB shall have the right to
terminate this Agreement by serving notice of no less than 30 days to Aphton
which will be effective as from September 30, 2003."
4. This Amendment is limited as specified and shall not
constitute a modification, acceptance or waiver of any other provision of the
Collaboration and License Agreement and the Subscription Agreement dated June
12, 1998, as amended through Amendment No. 1 dated May 10, 2000 and through
Amendment No. 2 dated July 2, 2001.
5. This Amendment may be executed in any number of counterparts
and by the different parties hereto on separate counterparts, each of which
counterparts when executed and delivered shall be an original, but all of which
shall together constitute one and the same instrument.
6. This Amendment and the rights of the parties hereunder shall
be governed by, and interpreted in accordance with, the laws of the State of New
York, without giving effect to the principles of conflict of law thereunder.
7. This Amendment shall become effective on the date (the
"Amendment Effective Date") when each of the Parties shall have signed a
counterpart hereof (whether the same or different counterparts).
8. From and after the Amendment Effective Date, all references in
the Agreement shall be deemed to be references to the Agreement as amended by
this Amendment, Amendment No. 1 and Amendment No. 2.
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* The redacted portion of this document has been omitted pursuant to a
request for confidential treatment and such redacted portion has been filed
separately with the Securities and Exchange Commission.
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IN WITNESS WHEREOF, the parties hereto have duly executed this
Amendment as of the date and year first above written.
APHTON CORPORATION
/s/ Xxxxxx X. Xxxxx
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Name: Xxxxxx X. Xxxxx
Title: Chairman, President and
Chief Executive Officer
SMITHKLINE XXXXXXX PLC
/s/ Jean Stephenne
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Name: Jean Stephenne
Title: Attorney- in-fact
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