EXHIBIT 10.1
EXECUTION COPY
AMENDMENT NO 1 TO THE LICENSE AND
CO-DEVELOPMENT AGREEMENT
BY and BETWEEN:
Sanofi Pasteur S.A.,
a company organized and existing
under the laws of the Republic of France, registered under the
number 349 505 370 – Lyon (France), having its registered
office at 2 avenue Pont Pasteur, 69007 LYON, France.
Represented by Michel De Wilde, its
Senior Vice President of Research & Development.
(hereinafter referred to as "sanofi
pasteur"),
AND:
EMERGENT EUROPE
LIMITED, a company
organized and existing under the laws of England (Company number
03270465) and having its registered office at 545 Eskdale Road,
Winnersh Triangle, Wokingham, Berkshire, RG41 5TU,
England,
Represented by Dr Stephen Lockhart,
its President,
(hereinafter referred to as
“Emergent”).
PREAMBLE:
Whereas sanofi pasteur and Emergent entered into a
License and Co-Development Agreement effective as of April 1
st , 2006 ("the Agreement"), for the performance of a
collaborative Development Program for a vaccine to prevent
Neisseria meningitidis serogroup B infections, and under
which Emergent granted sanofi pasteur a license to Develop
Programme Antigens and to exploit any Products (each as defined in
the Agreement).
Whereas for scientific and technical reasons, the
original Development Plan has not been completed as originally
scheduled and the Parties have agreed to extend the said
Development Plan, and to revisit and redistribute the Development
Programme work; and by decision of the Steering Committee in June
and September 2007, the new Annual Development Plan and associated
Annual Budget for the period starting on November 1st, 2007 and
ending on December 31, 2008, in the form set forth in Appendix 1 to
this Amendment Agreement (the “ First Amendment
Agreement ”), was approved.
Whereas the Steering Committee has agreed that Emergent
will issue monthly reports as well as specific reports for each
Candidate Antigen.
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Whereas the Parties wish therefore to amend the
Agreement as set out in this First Amendment Agreement.
Now, therefore, it is agreed
as follows
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1.
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Unless otherwise defined in this
First Amendment Agreement or the context otherwise requires, all
capitalized words and phrases used in this First Amendment
Agreement shall have the same meaning as in the
Agreement.
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2.
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Clause 1.1 of the Agreement is
amended as follows:
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a.
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by inserting the following
additional definition in to that clause in alphabetical
order:
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“ Monthly Report” has
the meaning set out in Clause 5.10.2(a) ”;
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b.
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the definition of “Emergent
Activities” is supplemented by adding at the end of that
definition: “ or, where the context requires, activities
allocated to Emergent in a Transition Plan. ”
and
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c.
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the last line of the definition of
“Emergent Expenses” is supplemented as shown (in
italic): “provided for in an Annual Budget or Transition
Plan and without any mark-up.”.
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3.
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Clause 3.2 of the Agreement is
amended by adding at the end of that clause:
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“ The Steering Committee
may also make decisions and determinations by way of written
resolution without convening a meeting; provided that such
resolution is recorded in accordance with this clause. No decision
or determination of the Steering Committee (whether in a meeting or
otherwise) shall be effective unless and until (a) a draft written
document recording such decision or determination has been first
circulated amongst the members of the Steering Committee, with a
copy to the Legal Affairs and Business Development representatives
of each of the Parties, (b) the Parties have agreed on the content
of such draft document and finally (c) the approved written
document recording such decision or determination has been signed
by at least two members of the Steering Committee, one of which
shall have been appointed by sanofi pasteur and one of which shall
have been appointed by Emergent, and has been provided to each of
the Project Leaders; provided that if the decision or determination
was
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made at a meeting of the SC and
the draft written document recording such decision or determination
is so circulated within ten (10) Business Days of the meeting at
which such decision or determination was made, such decision or
determination, in the form so recorded and circulated, shall be
deemed to be effective twenty (20) Business Days following the date
of such meeting unless, within twenty (20) Business Days of such
meeting, either Party notifies the other Party that the draft
document recording such decision or determination is not agreed. If
either Party gives such notice, it shall include with such notice
its reasons for not agreeing the draft and on receipt of such
notice any member of the SC may convene a meeting of the SC on not
less than five (5) Business Days’ notice. The relevant
decision or determination may be recorded in the minutes of the
meeting provided that such decision or determination is clearly
identified and the minutes are circulated and approved, or deemed
to be approved, in accordance with this Clause 3.2. For the
avoidance of doubt, a written document recording a decision or
determination of the Steering Committee does not constitute a
Notice for the purpose of Clause 17.1. Such document may be signed
in counterparts and may be exchanged between members of the
Steering Committee and provided to the Project Leaders by facsimile
or as an attachment to an e-mail. Any notice that a draft document
recording a decision or determination is not approved shall be
given in accordance with Clause 17.1.”
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4.
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Clause 3.5.1 of the Agreement is
amended as follows:
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In the first sentence, the words
“the Chief Executive Officer of Emergent” are replaced
with “ the President of Emergent ”.
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5.
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Clause 4.1 of the Agreement is
amended as follows:
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a.
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in the second sentence the word
“to” is deleted; and
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b.
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in the fourth sentence
“SC” is replaced with “ JPT
”.
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6.
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Clause 5.2 of the Agreement is
amended as follows:
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a. in
the second paragraph, the third sentence is supplemented as shown
(in italic):
“For the Purpose of this
Agreement any change to the Development Plan or an Annual
Development Plan shall be considered major...”;
and
b. in
the last paragraph, the second sentence is supplemented as shown
(in italic):
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“No major amendment to the
Development Plan shall be effective until approved by the SC and
such approval is recorded in accordance with Clause
3.2.”
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7.
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Clause 5.3 of the Agreement is
amended as follows:
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At the end of the Paragraph the
penultimate sentence is supplemented as shown (in
italic):
“No major amendment to the
Annual Development Plan shall be effective until approved by the SC
and such approval is recorded in accordance with Clause 3.2. An
amendment will be considered major in the circumstances set out in
Clause 5.2. ”
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8.
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Clause 5.10 of the Agreement is
supplemented by renumbering the current Clause 5.10 as Clause
5.10.1, adding the sub-heading “ General
Reports ” to Clause 5.10.1 as renumbered and adding
the following provision as new Clause 5.10.2:
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“5.10.2 Additional
Reports . In addition to the quarterly and annual reports
referred to in Clause 5.10.1:
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(a)
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within ten (10) Business Days of
the end of each calendar month, Emergent shall send to sanofi
pasteur a report describing in reasonable detail the Emergent
Activities conducted during that month including a statement
detailing the number of FTEs engaged in each of those activities
(and the names associated to those FTEs provided that sanofi
pasteur shall treat such information as Emergent Confidential
Information), as well as a summary and key data for the
intermediate and final results observed or obtained by Emergent
during that month in the course of conducting such activities (the
“ Monthly Report ”); and
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(b)
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if Emergent determines that a
Candidate Antigen does not meet the expression criteria agreed by
the JPT for the progression of Candidate Antigens into protein
purification, Emergent shall, within twenty (20) Business Days of
the completion of efforts by Emergent to clone that Candidate
Antigen in accordance with the cloning strategy agreed for that
Candidate Antigen by the JPT, send to sanofi pasteur a report
describing in detail for that Candidate Antigen (Protein) the
specific activities performed and key data observed or obtained
(the “ Protein Report ”); or
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(c)
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if Emergent determines that a
Candidate Antigen does meet the expression criteria agreed by the
JPT for the progression of Candidate Antigens into
protein
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purification Emergent shall,
within twenty (20) Business Days of production of sufficient
protein to the agreed purity specification to allow immunisations
to proceed, send to sanofi pasteur a Protein Report for that
Candidate Antigen (Protein); and
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(d)
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if, based on the report prepared
in accordance with Clause 5.10.2(c), the JPT agrees that the
Parties should undertake further development activities with
respect to a particular Candidate Antigen, the Party conducting the
relevant activity will, within twenty (20) Business Days following
each of the milestones specified below and at such other times as
may be determined by the JPT, provide to the other Party an update
of the Protein Report for that Candidate Antigen describing in
detail the specific activities performed and key data observed or
obtained by it in connection with such milestone. Unless otherwise
agreed by the JPT, the Protein Report for each Candidate Antigen
shall be updated by the Party undertaking the relevant activity
following (i) production of eight (8) weeks’ stability data,
(ii) generation of both ELISA and Western blot data, (iii)
generation of flow cytometry (FACs) or opsonophagocytosis data, or
data from any other immunological assay performed in accordance
with the Development Plan, in each case with respect to that
Candidate Antigen.
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The Protein Report will
substantially conform to the format set out in Schedule
12.”
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9.
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Clause 5.11 of the Agreement is
supplemented by:
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a.
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adding the following provision as
new Clause 5.11.1:
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“5.11.1 Performance by
Emergent Scientists . EMERGENT shall ensure that the Emergent
scientists conduct the Emergent Activities:
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(a)
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in accordance with this
Agreement, the Development Plan and Annual Development
Plan;
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(b)
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in accordance with those
polic
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