EXHIBIT 10.28
[ * ] = 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.
First Amendment to Collaboration
and License Agreement
This First Amendment to Collaboration and
License Agreement (the “Amendment” ) is entered
into on April 1, 2007 (the “Amendment Effective
Date” ) between AFFYMAX, INC. , a Delaware
corporation, with its principal place of business at 4001 Miranda
Avenue, Palo Alto, CA 94304, U.S.A. (
“Affymax” ), and TAKEDA PHARMACEUTICAL
COMPANY LIMITED , a company incorporated under the laws of
Japan, with its principal place of business at 1-1, Doshomachi
4-chome, Chuo-ku, Osaka, 540-8645, Japan (
“Takeda” ).
RECITALS
WHEREAS , Affymax and Takeda have entered into a certain
Collaboration and License Agreement dated as of February 13,
2006, under which Affymax has granted Takeda a certain right and
license for the development and commercialization in Japan of
Affymax’s proprietary pegylated [ * ] drug candidate
designated by Affymax as Hematide™ (the “ Japan
Agreement ”);
WHEREAS , Affymax and Takeda have also entered into
another Collaboration and License Agreement dated as of
June 27, 2006, under which Affymax has granted Takeda a
certain right and license for the development and commercialization
of the same drug candidate worldwide outside Japan (the “
Global Agreement ”);
WHEREAS , Affymax and Takeda have been discussing,
pursuant to Section 6.8 of the Global Agreement, the amendment
of the Japan Agreement to reflect the fact that Takeda is now the
exclusive collaborator of the drug candidate not only in Japan but
also all over the world;
NOW THEREFORE,
in consideration of the foregoing
premises and mutual promises, covenants and conditions contained in
this Amendment, the Parties agree as follows:
1.
Amendments to
Section 1 .
The Parties hereby agree to amend each of the following Sections of
the Japan Agreement by replacing each such Section, in its
entirety, with the phrase “{SECTION INTENTIONALLY LEFT
BLANK}”: Sections 1.70, 1.77, and 1.79.
2.
Addition of
Section 1.84 .
The Parties hereby agree to append, at the end of Section 1,
new Section 1.84 as follows:
1.84
“ Global Agreement
” means that certain Collaboration and License Agreement
between the Parties, dated as of June 27, 2006, pursuant to
which Affymax has granted Collaborator certain rights and licenses
with respect to the development and commercialization of Hematide
and the Product worldwide outside Japan.
3.
Amendment to
Section 2.4(c)(iii) . The Parties hereby agree to amend and
restate Section 2.4(c)(iii) of the Japan Agreement by
replacing such Section, in its entirety, with the
following:
(iii)
altering the [ * ] or
otherwise proposing to conduct or conducting any Development
activities in a manner that would reasonably be expected to [ *
] development or commercialization efforts for Products [ *
] other than for purposes of [ * ] or pursuant to a
requirement imposed by the Regulatory Authorities in the Licensed
Territory or the external monitoring board for such
trial.
4.
Amendment to
Section 3.3(d) . The Parties hereby agree to amend and
restate Section 3.3(d) of the Japan Agreement by
replacing such Section, in its entirety, with the
following:
(d)
using Diligent Efforts not to
unreasonably adversely impact the Development or Commercialization
efforts for Products pursuant to the Global Agreement, including
without limitation, and where reasonably practicable, using and
filing in the Licensed Territory regulatory filings that are
equivalent to all MAAs and related filings for Products that are
provided by Affymax and/or Collaborator pursuant to the Global
Agreement, to ensure that all Collaborator’s filings and
specifications for Products in the Licensed Territory remain
consistent, as far as reasonable, with those for the relevant
Products outside the Licensed Territory.
5.
Amendment to
Section 3.6 .
The Parties hereby agree to amend the first sentence of
Section 3.6 of the Japan Agreement by replacing such sentence,
in its entirety, with the following: “If, during the ten
(10) year period following the Effective Date, Affymax
develops a potential Backup Product(s) in the Field,
Collaborator shall have a right of first refusal to develop and
commercialize such Backup Product(s) for the Licensed
Territory as provided in this Section 3.6.”
6.
Amendment to
Section 3.6 .
The Parties hereby agree to amend the final sentence of
Section 3.6 of the Japan Agreement by replacing such sentence,
in its entirety, with the following: “For clarity, if and as
far as a Backup Product is developed outside the Field by Affymax,
then Collaborator shall have no rights under this Section 3.6
with respect to such Backup Product.”
7.
Amendment to
Section 4.1(a)(i) . The Parties hereby agree to amend the
final sentence of Section 4.1(a)(i) of the Japan
Agreement by replacing such sentence, in its entirety, with the
following: “Collaborator shall have the full right, without
any additional consideration, to use any and all such data and
reports supplied by Affymax under this
Section 4.1(a)(i) in connection with the Development
and/or Commercialization of the Product in the Licensed Territory,
including the incorporation of such data or reports in any
MAA.”
[ * ] = 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.
8.
Amendment to
Section 4.1(a)(ii) . The Parties hereby agree to amend and
restate Section 4.1(a)(ii) of the Japan Agreement by
replacing such Section, in its entirety, with the
following:
(ii)
Within thirty (30) days after the
Effective Date, Affymax shall provide Collaborator with copies of
all clinical data resulting from [ * ] completed or ongoing
(where available) as of the Effective Date and Controlled by
Affymax. Thereafter, Affymax shall, in a timely manner and
compliant with requirements of the Regulatory Authority in the
Licensed Territory, provide Collaborator with copies of all
preclinical, non-clinical, analytical, manufacturing, and clinical
data relating to the Product and generated by Affymax or on behalf
of Affymax by any Third Party, provided that information regarding
adverse events and serious adverse events shall be provided
promptly as set forth in Section 4.8.
Collaborator shall have the full right, without any additional
consideration, to use any and all such data supplied by Affymax
pursuant to this Section 4.1(a)(ii) and any data
generated by Collaborator under the Global Agreement in connection
with the Development and/or Commercialization of the Product
pursuant to this Agreement and the Global Agreement, including the
incorporation of such data or reports in any MAA or other
regulatory filings.
9.
Amendment to
Section 4.1(a)(iii) . The Parties hereby agree to amend and
restate Section 4.1(a)(iii) of the Japan Agreement by
replacing such Section, in its entirety, with the
following:
(iii)
The terms of the Global Agreement,
including Section 4.1 of such agreement, will govern with
respect to the Parties’ rights outside of the Licensed
Territory to access and use any clinical data generated by the
Parties pursuant to the Global Agreement. In addition, Collaborator
shall have the full right, without any additional consideration, to
use any and all such data generated by Collaborator under this
Agreement in connection with the Development and/or
Commercialization of the Product pursuant to the Global Agreement,
including the incorporation of such data or reports in any MAA or
other regulatory filing.
10.
Deletion of Certain
Sections . The
Parties hereby agree to delete the following Sections of the Japan
Agreement in their entirety: Sections 4.1(a)(iv), 4.1(a)(v), and
4.1(a)(vi).
11.
Amendment to
Section 4.1(b) . The Parties hereby agree to amend
Section 4.1(b) of the Japan Agreement by replacing such
Section, in its entirety, with the phrase
“{SECTION INTENTIONALLY LEFT BLANK}”.
12.
Amendment to
Section 4.1(c) . The Parties hereby agree to amend and
restate Section 4.1(c) of the Japan Agreement by
replacing such Section, in its entirety, with the
following:
(c)
Data Generated by or on Behalf of
Collaborator .
Collaborator shall, in a timely manner and compliant with
requirements of the FDA and the EMEA, provide Affymax with copies
of all preclinical, non-clinical, analytical,
[ * ] = 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.
manufacturing, and clinical data
relating to the Product and generated by Collaborator or on behalf
of Collaborator by any Third Party under this Agreement, provided
that information regarding adverse events and serious adverse
events shall be provided promptly as set forth in
Section 4.8. If Affymax requests that copies of such
data be provided in compliance with requirements of other
Regulatory Authorities pursuant to the Global Agreement,
Collaborator shall reasonably consider such request. Affymax
shall have the full right, without any additional consideration, to
use any and all such data supplied by Collaborator pursuant to this
Section 4.1(c) in connection with the Development of the
Product pursuant to this Agreement and the Global Agreement and/or
in connection with the Commercialization of the Product in U.S.
pursuant to the Global Agreement, including the incorporation of
such data or reports in any MAA or other regulatory
filings.
13.
Amendment to
Section 4.1(d) . The Parties hereby agree to amend and
restate Section 4.1(d) of the Japan Agreement by
replacing such Section, in its entirety, with the phrase
“{SECTION INTENTIONALLY LEFT BLANK}”.
14.
Amendment to
Section 4.2(b) . The Parties hereby agree to amend and
restate Section 4.2(b) of the Japan Agreement by
replacing such Section, in its entirety, with the
following:
(b)
Rights of Reference to Regulatory
Materials. Each Party hereby grants to the other Party a
right of reference to all Regulatory Materials filed by such Party
pursuant to this Agreement and/or the Global Agreement for Product
as follows: The right of reference granted to Affymax herein
shall be solely for the purpose of Affymax or its Affiliates
obtaining Regulatory Approval in U.S. for the Product pursuant to
the Global Agreement. The right of reference granted to
Collaborator herein shall be solely for the purpose of obtaining
Regulatory Approval for the Products in and outside the Licensed
Territory pursuant to this Agreement and/or the Global Agreement.
For the avoidance of doubt, Collaborator shall have a right of
reference, for the purpose of obtaining the Regulatory Approval for
the Products in the Licensed Territory pursuant hereto, to all
Regulatory Materials filed by Collaborator pursuant to the Global
Agreement, and vice versa.
15.
Amendment to
Section 4.2(c)(iv) . The Parties hereby agree to amend and
restate Section 4.2(c)(iv) of the Japan Agreement by
replacing such Section, in its entirety, with the
following:
(iv)
The terms of the Global Agreement,
including Section 4.2(a) of such agreement, will govern
the right to file Regulatory Materials or Regulatory Approvals
regarding the Product outside the Licensed Territory.
16.
Amendment to
Section 4.5 .
The Parties hereby agree to amend and restate the final sentence of
Section 4.5 of the Japan Agreement by replacing such sentence,
in its entirety, with the following: “The terms of the Global
Agreement, including Section 4.6 of such agreement,
[ * ] = 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.
will govern the right and procedures for the
communication regarding the Product with any Regulatory Authorities
outside the Licensed Territory.”
17.
Amendment to
Section 4.6 .
The Parties hereby agree to amend and restate the final sentence of
Section 4.6 of the Japan Agreement by replacing such sentence,
in its entirety, with the following: “The terms of the Global
Agreement, including Section 4.2 of such agreement, will
govern the filing of any Regulatory Materials for Peptide, [ *
] , Hematide and/or Product outside of the Licensed
Territory.”
18.
Amendment to
Section 4.8 .
The Parties hereby agree to amend and restate the first sentence of
Section 4.8 of the Japan Agreement by replacing such sentence,
in its entirety, with the following: “The Parties agree that
Collaborator shall be primarily responsible for the monitoring of
all clinical experiences and filing of all required reports
throughout clinical Development and Commercialization of the
Product in the Licensed Territory, and that the primary
responsibility for the monitoring of all clinical experiences and
filing of all required reports concerning the Product in the
Affymax Territory will be as set forth in the Global
Agreement.”
19.
Amendment to Sections
4.8(c) and (d) . The Parties hereby agree to amend and
restate Sections 4.8(c) and (d) of the Japan Agreement by
replacing such Sections, in their entirety, with the
following:
(c)
provides that Collaborator shall
have regulatory reporting responsibilities in the Licensed
Territory, and the Party who shall have regulatory reporting
responsibilities in the
