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EXHIBIT 10.27
AMENDMENT NO. 2
TO THE
LICENSE AND RESEARCH COLLABORATION AGREEMENT
THIS AMENDMENT NO. 2 ("Amendment No. 2") to that certain License and
Research Collaboration Agreement dated April 24,1995 (the "KH Agreement"), as
amended by Amendment No. 1 thereto dated July 15, 1995 ("Amendment No. 1") is
made as of March 23,1997, by and between Geron Corporation, a Delaware
corporation having its principal place of business at 000 Xxxxxxxxxxxx Xxxxx,
Xxxxx Xxxx, XX 00000 XXX ("Geron"), and Kyowa Hakko Kogyo Co., Ltd., a Japan
corporation having its principal place of business at 0-0-0 Xxxxxxxxx,
Xxxxxxx-xx, Xxxxx, Xxxxx ("Kyowa Hakko"). All terms not otherwise defined
herein shall have the meaning given such terms in the KH Agreement. This
Amendment No. 2 shall become effective upon the effective date of the P&U
Agreement (as defined below).
RECITALS
WHEREAS, Geron and Kyowa Hakko entered into the KH Agreement to
discover and develop inhibitors of telomerase for the treatment of cancer in
humans for sale by Kyowa Hakko in the Asian Territory and by Geron or its
licensees in the rest of the world;
WHEREAS, on December 20, 1996, Geron entered into a Heads of Agreement
with Pharmacia & Upjohn, S.p.A, an Italian corporation ("P&U"), that describes
a collaboration to discover and develop inhibitors of telomerase for the
treatment of cancer in humans for sale by P&U on a worldwide basis, subject to
the terms and conditions of the KH Agreement and Amendment No. 1, as amended by
this Amendment No. 2;
WHEREAS, simultaneous with the execution of this Amendment No. 2,
Geron and P&U will enter into a License and Research Collaboration Agreement on
substantially the terms set forth in the Heads of Agreement (the "P&U
Agreement"), and Geron, P&U and Kyowa Hakko will enter into that certain
Three-Way Collaboration Agreement in the form attached hereto as Exhibit 1 (the
"Three-Way Agreement");
WHEREAS, Geron and Kyowa Hakko desire to enter into this Amendment No.
2 and the Three-Way Agreement to integrate the collaborations between Geron and
P&U and Geron and Kyowa Hakko to achieve worldwide development and
commercialization of telomerase inhibitors for the treatment of cancer in
humans;
NOW THEREFORE, for good and valuable consideration, the receipt and
adequacy of which is hereby acknowledged, the parties hereby agree as follows.
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ARTICLE 1
RESEARCH
1.1 Research Term. Unless extended by mutual agreement of the
parties, the Research Term of the KH Agreement is hereby amended to terminate
on the first to occur of (i) termination of the KH Agreement by either party
under Article 16 of the KH Agreement or (ii) on the third anniversary of the
effective date of the P&U Agreement.
1.2 Collaborative Research. Section 3.1 of the KH Agreement is
hereby amended to include the efforts of P&U as provided in the Three-Way
Agreement.
1.3 Selection of compounds for Development. Section 3.5 of the KH
Agreement is hereby amended to allow Kyowa Hakko to select compounds Controlled
by P&U for development as provided in the Three-Way Agreement.
1.4 Screening of Kyowa Hakko Compounds. Section 3.6 of the KH
Agreement and all references thereto in the KH Agreement and Amendment No. 1 in
its entirety are hereby rendered null and void. Kyowa Hakko shall have the
right during the Research Term at its discretion to screen compounds for
telomerase inhibitory activity or to submit such compounds to Geron for
screening.
ARTICLE 2
DEVELOPMENT
2.1 Product. For purposes of this Amendment No. 2, "Product"
shall have the meaning set forth in the Three-Way Agreement.
2.2 Development in the [*]. Section 4.3 of the KH Agreement is
hereby amended to provide P&U the rights to participate in the development and
commercialization of Products in the [*] as provided in the Three-Way Agreement.
2.3 Development Outside the [*]. Section 4.4 of the KH
Agreement is hereby amended to grant to P&U the rights granted to Geron to
develop Products outside the [*] and to grant Kyowa Hakko the right to
participate in the development and commercialization of Products for sale in the
[*] as provided in the Three-Way Agreement.
2.4 Development Collaboration. Section 4.5 of the KH Agreement is
hereby amended to grant P&U the right to conduct the United States clinical
trials and to collect the United States clinical data in place of Geron.
Section 4.6 of the KH Agreement is hereby rendered null and void.
ARTICLE 3
LICENSES
* Certain portions of this Exhibit have been omitted for which confidential
treatment has been requested and filed separately with the Securities and
Exchange Commission.
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3.1 License to Kvowa Hakko. Section 5.1 of the KH Agreement is
hereby amended to:
(a) subject to Section 9.2 of the Three-Way Agreement,
grant Kyowa Hakko a royalty-bearing license under Geron Technology and Geron's
interest in Joint Patents to make, have made, use, sell and have sold Products
comprising Geron Compounds (as defined in the Three-Way Agreement) or KH
Compounds (as defined in the Three-Way Agreement) in the [*] on an exclusive
basis;
(b) grant Kyowa Hakko a royalty-bearing license under
Geron Technology and Geron's interest in Joint Patents to make, have made, use,
sell and have sold Products [*] on a co-exclusive basis; [*] and
(c) acknowledge (i) P&U's grant of [*] with regard to
Products to Kyowa Hakko in the [*] all as provided in and in accordance with the
Three-Way Agreement and (ii) subject to Section 9.2 of the Three-Way Agreement,
the grant to P&U of a royalty-bearing license under Geron Technology and Geron's
interest in Joint Patents to make, have made, use, sell and have sold Products
comprising P&U Compounds (as defined in the Three-Way Agreement) in the [*] on
an exclusive basis.
3.2 Sublicensing. Section 5.3 of the KH Agreement is hereby
amended to confirm that Kyowa Hakko shall not be entitled to share in the
compensation paid to Geron for P&U's use of KH Technology pursuant to the P&U
Agreement. Further, P&U shall not be entitled to share in the compensation
paid to Geron for Kyowa Hakko's use of P&U Technology pursuant to the KH
Agreement. Kyowa Hakko shall have no right to sublicense its rights to sell
Products comprising P&U Compounds (as defined in the Three-Way Agreement) or
its [*] rights.
3.3 New Technology. Section 5.7 of the KH Agreement is hereby
amended to provide that Gerona's share of the costs of and royalties associated
with any licenses to technology in the Field acquired after the Effective Date
of this Amendment No. 2 shall be shared by P&U, Geron and Kyowa Hakko in
accordance with the provisions of the Three-Way Agreement.
ARTICLE 4
COMMERCIALIZATION
4.1 Advertising and Trademarks. Section 6.2 of the KH Agreement
is hereby amended to provide that Products shall be advertised and named as
provided in the Three-Way Agreement.
4.2 Manufacturing. Section 7.1 of the KH Agreement is hereby
amended to provide that Products shall be acquired or manufactured as provided
in the Three-Way Agreement.
* Certain portions of this Exhibit have been omitted for which confidential
treatment has been requested and filed separately with the Securities and
Exchange Commission.
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ARTICLE 5
SHARING OF INFORMATION
Sections 12.1, 13.1, and 15.1 of the KH Agreement are hereby amended to
provide that Geron shall not be obligated to disclose to KH during the Research
Term any Information concerning a telomerase inhibitor compound Controlled by
P&U until such time as P&U [*] as provided in the Three-Way Agreement.
ARTICLE 6
PATENT RIGHTS
6.1 Enforcement and Defense Rights. Section 13.4 of the KH
Agreement is hereby amended to provide that the right to institute, prosecute
and control any action or proceeding with respect to the infringement or
defense of a Geron Patent, Kyowa Hakko Patent or Joint Patent relating to a
Product shall be as provided in the Three-Way Agreement.
6.2 Infringement. Section 13.6 of the KH Agreement is hereby
amended to provide that if a claim of patent infringement is brought against
Kyowa Hakko or Geron on account of the use, manufacture or sale of a Product,
then the defense against such claim shall be conducted as provided in the
Three-Way Agreement.
6.3 Back-up Rights. Section 13.7 of the KH Agreement is hereby
amended to provide that should either Geron or Kyowa Hakko determine not to
file, prosecute, maintain or issue a Geron Patent, Kyowa Hakko Patent, or Joint
Patent, then the rights of the party not making such determination shall be
subject to P&U's rights, as provided in the Three-Way Agreement.
ARTICLE 7
REPRESENTATIONS AND WARRANTIES
Kyowa Hakko and Geron agree that this Amendment No. 2, the P&U
Agreement, and the Three-Way Agreement do not violate the representations and
warranties of Article 14 of the KH Agreement.
ARTICLE 8
TERMINATION
Section 16.2 of the KH Agreement is hereby amended to provide that, in
the event of a termination for breach, the non-breaching party's license after
termination shall be subject to the rights of and licenses granted to P&U in
the P&U Agreement and the Three-Way Agreement.
* Certain portions of this Exhibit have been omitted for which confidential
treatment has been requested and filed separately with the Securities and
Exchange Commission.
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ARTICLE 9
INDEMNIFICATION, DISCLAIMERS AND LIMITATIONS
Except as otherwise may be provided in the supply agreements referenced in
Section 5.4 of the Three-Way Agreement, Section 17.2 of the KH Agreement is
hereby amended to provide that (i) Kyowa Hakko shall not be obligated to
indemnify and hold Geron harmless from and against any liability, damage, loss,
cost (including reasonable attorneys' fees) and expense resulting from any
claim of bodily injury or property damage relating to the development,
manufacture, use, distribution or sale of any Product by P&U; and (ii) Geron
shall not be obligated to indemnify and hold Kyowa Hakko harmless from and
against any liability, damage, loss, cost (including reasonable attorneys'
fees) and expense resulting from any claim of bodily injury or property damage
relating to the development, manufacture, use, distribution or sale of any
Product by P&U.
ARTICLE 10
GENERAL
10.1 Three-Way Agreement. Kyowa Hakko and Geron agree and
acknowledge that certain of the rights and privileges set forth in the KH
Agreement, as amended by this Amendment No. 2, are subject to the terms and
conditions of the Three-Way Agreement. Kyowa Hakko and Geron further agree and
acknowledge that in the event of a conflict between the terms and conditions of
the KH Agreement, as amended by this Amendment No. 2, and the terms and
conditions of the Three-Way Agreement, the terms and conditions of the
Three-Way Agreement shall prevail.
10.2 Limited Amendment. Except as otherwise set forth in this
Amendment No. 2, the KH Agreement shall remain in full force and effect.
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IN WITNESS WHEREOF, the parties have executed this Amendment No. 2 as
of the first date written above.
GERON CORPORATION
By: /s/ Xxxxxx X. Xxxxxxx
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KYOWA HAKKO KOGYO CO., LTD.
By: /s/ X. Xxxxx
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Senior Managing Director
