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 1st, 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 :

 

1.

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.

 

2.

Clause 1.1 of the Agreement is amended as follows:

 

 

a.

by inserting the following additional definition in to that clause in
alphabetical order:

“Monthly Report” has the meaning set out in Clause 5.10.2(a)”;

 

 

b.

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

 

 

c.

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.”.

 

3.

Clause 3.2 of the Agreement is amended by adding at the end of that clause:

 

“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.”

 

4.

Clause 3.5.1 of the Agreement is amended as follows:

 

In the first sentence, the words “the Chief Executive Officer of Emergent” are
replaced with “the President of Emergent”.

 

5.

Clause 4.1 of the Agreement is amended as follows:

 

 

a.

in the second sentence the word “to” is deleted; and

 

 

b.

in the fourth sentence “SC” is replaced with “JPT”.

 

 

6.

Clause 5.2 of the Agreement is amended as follows:

 

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.”

 

7.

Clause 5.3 of the Agreement is amended as follows:

 

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.”

 

8.

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:

 

“5.10.2 Additional Reports. In addition to the quarterly and annual reports
referred to in Clause 5.10.1:

 

 

(a)

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

 

 

(b)

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

 

 

(c)

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

 

 

(d)

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.

 

The Protein Report will substantially conform to the format set out in Schedule
12.”

 

9.

Clause 5.11 of the Agreement is supplemented by:

 

 

a.

adding the following provision as new Clause 5.11.1:

 

“5.11.1 Performance by Emergent Scientists. EMERGENT shall ensure that the
Emergent scientists conduct the Emergent Activities:

 

 

(a)

in accordance with this Agreement, the Development Plan and Annual Development
Plan;

 

 

(b)

in accordance with those policies, standards, procedures, conventions and
techniques that are of a high, recognised and acceptable professional standard,
including generally acceptable standards of quality for work performed in the
scientific community, including, where necessary to comply with such standards,
by dating laboratory records and including in such records sufficient detail to
permit another scientist working to such standards to reproduce the work
described; and

 

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(c)

in accordance with all Applicable Laws.

 

Subject to Clause 5.11.2, Emergent shall use its best reasonable efforts to
expeditiously complete all Emergent Activities within the term specified in the
applicable Development Plan and/or in this Agreement.”

 

 

b.

renumbering the current Clause 5.11 as Clause 5.11.2, adding the sub-heading
“Emergent FTEs” to Clause 5.11.2 as renumbered, and adding at the end of the
first sentence of Clause 5.11.2 the words “or Transition Plan.”

 

10.

Clause 5.13 of the Agreement is deleted and replaced by the following:

 

 

“5.13

Development Funding

 

5.13.1

FTE Costs. sanofi pasteur shall pay Emergent the aggregate FTE Cost for all FTEs
monthly in arrears. On or after submission of a Monthly Report to sanofi pasteur
in accordance with Clause 5.10.2(a), Emergent shall issue a pro forma invoice
showing the overall FTE Costs relating to the Emergent Activities undertaken
during that month as further detailed in the Monthly Report. Within ten (10)
Business Days of receipt of such pro-forma invoice, sanofi pasteur shall either
(a) notify Emergent that sanofi pasteur is satisfied with the Monthly Report and
associated pro forma invoice, in which case Emergent shall be entitled to submit
its final invoice for such FTE Costs; or (b) if sanofi pasteur reasonably
believes that all or a specified portion of the Emergent Activities described in
the Monthly Report have not been performed in accordance with the standards
listed in Clause 5.11.1 (the “Standards”), notify Emergent that it disputes the
amount of the pro forma invoice (the “Dispute Notice”) in which case sanofi
pasteur shall be entitled to withhold the payment of the disputed amount
relating to the FTE Costs with respect to those Emergent Activities which sanofi
pasteur reasonably believes have been adversely affected by such failure (the
“Affected Activities”) pending resolution of such dispute in accordance with
this Clause 5.13. With respect to the Affected Activities, the Dispute Notice
shall identify the FTE Costs for the disputed FTEs (each a “Disputed Amount”)
and shall describe in reasonable detail the reasons why sanofi pasteur believes
that such FTEs are not in accordance with the Standards. The Dispute Notice
shall also identify the undisputed FTE Costs for the relevant month (including,
where sanofi pasteur believes that the Affected Activity has been performed in
accordance with the Standards except with respect to the number of FTEs utilised
as stated in the Monthly Report for

 

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that activity (the “FTE Numbers”), the FTE Cost for the number of FTEs sanofi
pasteur reasonably believes should have been included in the FTE Cost for that
activity in that month) (the “Undisputed Amount”). Identification of the
Undisputed Amount is intended to provide Emergent with the means to submit a
final invoice covering all uncontested activities and amounts associated
therewith, so as to provide Emergent with all money properly due to Emergent for
work performed during the previous month. If sanofi pasteur does not identify
the Undisputed Amount in the Dispute Notice, Emergent shall be entitled to issue
a final invoice for the FTE Costs included in the pro-forma invoice less the
Disputed Amount. If sanofi pasteur does not issue a Dispute Notice within ten
(10) Business Days following receipt of the pro-forma invoice, sanofi pasteur
will be deemed to have approved the pro-forma invoice and Emergent shall be
entitled to submit its final invoice for all FTE Costs included in the pro-forma
invoice. On receipt of a final invoice issued by Emergent in accordance with
this Clause 5.13.1, sanofi pasteur shall pay such invoice on the tenth (10th)
day of the month following the month of receipt of such invoice.

 

 

5.13.2

Steering Committee Review. Notwithstanding the notice requirements set out in
Clause 3.2, the Steering Committee shall on issue of a Dispute Notice convene
one or more emergency meetings, to be held by teleconference or similar means,
and shall discuss in good faith the relevant Monthly Report, the pro forma
invoice and sanofi pasteur’s reasons for withholding payment. If, within ten
(10) Business Days of Emergent’s receipt of a Dispute Notice the Steering
Committee cannot agree how much of each Disputed Amount should be paid, such
dispute (the “Dispute”) shall be referred to the Senior Officers for resolution.

 

 

5.13.3

Expert Determination. If, or to the extent that, the Senior Officers are unable
to resolve the Dispute within five (5) Business Days of it being referred to
them, the Parties shall appoint an independent expert with expertise in the
field of pharmaceutical research reasonably acceptable to both Parties to
determine whether the Affected Activity has been performed (a) in accordance
with the Standards, or (b) in accordance with the Standards except with respect
to the FTEs Numbers, in which case the expert shall determine the number of FTEs
to be included in the FTE Cost for that Affected Activity for that month. Within
five (5) Business Days of either Party notifying the other that it desires the
appointment of such expert, sanofi pasteur shall provide the names of three
suitably qualified, independent individuals willing to act as an expert for the
purposes of this Section 5.13, and Emergent shall, within five (5) Business Days
of

 

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receiving such names from sanofi pasteur, notify sanofi pasteur which of those
individuals it has chosen to act as the expert. Emergent’s choice of the expert
from the names provided by sanofi pasteur shall be final and binding on both
Parties. The expert so appointed shall be provided with a copy of the relevant
Monthly Report, pro-forma invoice and any other information relating to the
Dispute provided to, or considered by, the Steering Committee together with such
additional information as may be reasonably requested by the expert as being
necessary or reasonably useful for the expert to make his determination
(subject, in each case, to such obligations of confidentiality and non-use as
may be reasonably required by Emergent). The expert shall be required by the
Parties to use all reasonable efforts to render his decision within ten (10)
Business Days of his appointment and in any event within twenty (20) Business
Days of such appointment and such decision shall be final and binding upon each
of the Parties. The Parties shall procure that if, for whatever reason, the
selected expert determines that, due to time constraints or complexity, he or
she will be unable to render a decision within twenty (20) Business Days then he
or she will notify the Parties immediately and provide a reasonable best
estimate of the time required to make such determination. If the expert
determines that an Affected Activity was performed in accordance with the
Standards, Emergent shall issue a final invoice for the related Disputed Amount
and sanofi pasteur shall be required to pay the Disputed Amount for that
activity. If the expert determines that an Affected Activity was performed in
accordance with the Standards except with respect to the FTE Numbers, Emergent
shall issue a final invoice for the appropriate number of FTEs for that Affected
Activity for that month as determined by the expert and sanofi pasteur shall pay
the relevant FTE Cost. If the expert determines that the Affected Activity has
not been performed in accordance with the Standards and does not adjust the
number of FTEs to be included in the FTE Cost for that Affected Activity, sanofi
pasteur shall not be required to pay the Disputed Amount for that activity. If
all or any part of the Disputed Amount is payable, sanofi pasteur shall pay the
amount determined to be payable on the tenth (10th) day of the month following
the month of receipt of the invoice together with interest on such sum,
calculated in accordance with Clause 7.8, from the date of the pro-forma invoice
to the date of actual payment. If the expert determines that sanofi pasteur
should pay all or at least fifty per cent (50%) of the Disputed Amount, then
sanofi pasteur shall pay the fees and expenses of the expert. If the expert
determines that sanofi pasteur should pay less than fifty per cent (50%) of the
Disputed Amount, then Emergent shall pay the fees and expenses of the expert.

 

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5.13.4

Repeating Emergent Activities. If the Senior Officers or, if and to the extent
the matter is referred to the expert appointed pursuant to Clause 5.13.3
determine(s) on an activity-by activity basis that a particular Affected
Activity has not been performed in accordance with the Standards, sanofi pasteur
may, unless such failure relates to the FTE Numbers, at its sole discretion, on
written notice to Emergent ask Emergent to repeat that Affected Activity within
a reasonable time and the time period for the performance of that activity as
stated in the Development Plan, Annual Development Plan or Transition Plan shall
be extended accordingly. If Emergent repeats an Affected Activity at sanofi
pasteur’s request, sanofi pasteur shall reimburse Emergent for the FTE Costs
incurred in repeating such Affected Activity in accordance with Clause 5.13.1.
Should Emergent be unable or unwilling to repeat that Affected Activity in
compliance with the Standards in a timely manner and should sanofi pasteur be
willing and able to perform that Affected Activity in compliance with the
Standards, then sanofi pasteur may, on written notice to Emergent, assume
responsibility for performing that Affected Activity and Emergent shall forfeit
the right to do so and any payments that would otherwise be due and payable to
Emergent for the conduct of that Affected Activity as provided for in the Annual
Budget.

 

 

5.13.5

Credit against other Invoices. If sanofi pasteur disputes a pro-forma invoice in
accordance with Clause 5.13.1 but does not withhold the Disputed Amount,
Emergent shall, if the expert determines that Emergent did not perform the
Affected Activity in accordance with the Standards, credit any excess amount
paid to Emergent by sanofi pasteur for such Affected Activity against invoices
submitted by Emergent in accordance with this Clause 5.13.

 

 

5.13.6

Suspension of Emergent Activities pending resolution of a Dispute. If the
Parties are unable to resolve the issues raised in any Dispute Notice with
respect to a particular Candidate Antigen within thirty-five (35) Business Days
of the date of such notice and the aggregate amount then in dispute pursuant to
this Clause 5.13 together with any overdue invoices for undisputed or expert
determined FTE Costs exceeds (i) €50,000, Emergent shall be entitled to cease
performing any ongoing Emergent Activities with respect to that Candidate
Antigen or which are the same or substantially similar to the Emergent
Activities which sanofi pasteur has identified as not having been performed in
accordance with the Standards in that Dispute Notice, or (ii) €100,000, Emergent
shall be entitled to cease performing all or any Emergent Activities, in each
case pending resolution of such dispute and the anticipated timelines for
performance of

 

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any suspended Emergent Activities shall be extended by a period equal to the
period of suspension.

 

5.13.7 Emergent Expenses. sanofi pasteur shall pay Emergent the amount of all
Emergent Expenses incurred by Emergent in accordance with any Annual Budget or
Transition Plan. On or before the first day of each Quarter, sanofi pasteur
shall make a payment in pounds sterling (£) equal to the estimated Emergent
Expenses for the Quarter then commencing as reflected in the then-current Annual
Budget or Transition Plan; provided that each such payment shall be made against
an invoice issued by Emergent. Emergent acknowledges that sanofi pasteur may not
be able to pay invoices received by sanofi pasteur in a particular month before
the tenth day of the following month. Each of the Parties will use reasonable
endeavours to ensure that invoices for Emergent Expenses for each Quarter are
issued at least one month prior to end of the immediately preceding Quarter to
enable payment by sanofi pasteur against such invoice on or before the first day
of each Quarter. Emergent shall provide sanofi pasteur with annual
reconciliation statements that specify the actual Emergent Expenses for the last
four (4) Quarters in the aggregate within sixty (60) days of the completion of
each Year. If, with respect to a particular Year:

 

 

(a)

the actual Emergent Expenses specified in such annual reconciliation statement
are less than the amount paid by sanofi pasteur to Emergent with respect to
Emergent Expenses in that Year, such excess shall be set against the amounts due
to Emergent with respect to forthcoming Emergent Activities until such balance
is zero or if no such activities are contemplated, repaid to sanofi pasteur; or

 

 

(b)

the actual Emergent Expenses specified in such annual reconciliation statement
are more than the amount actually paid by sanofi pasteur to Emergent with
respect to Emergent Expenses in that Year, sanofi pasteur shall pay the
deficiency within thirty (30) days of the date of such statement.”

 

11.

Clause 14.2.3(d) is amended as follows:

The second sentence is supplemented by adding at the end of that sentence:

“; provided that if the dispute relates to the payment of FTE Costs sanofi
pasteur shall be required to notify Emergent of such dispute

 

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in accordance with Clause 5.13.1 and such dispute shall be resolved in
accordance with Clause 5.13.”

 

12.

The Agreement is amended by inserting as Schedule 12 to the Agreement, the
Pro-forma Protein Report set out in the Schedule to this First Amendment
Agreement.

 

13.

Reference to “this Agreement” in Clause 16.2 of the Agreement shall include this
First Amendment Agreement.

 

14.

This First Amendment Agreement shall be effective as of March 1st, 2008.

 

15.

This First Amendment Agreement shall be governed and construed in accordance
with the laws of the State of Delaware, without giving effect to the conflicts
of laws principles thereof.

 

16.

The Parties agree that the Agreement, as amended by this First Amendment
Agreement, remains in full force and effect. In the event of a conflict between
a term of this First Amendment Agreement and any term of the Agreement, this
First Amendment Agreement shall prevail and the Agreement is to such extent
hereby amended as necessary to conform to the terms of this First Amendment
Agreement. Any provision of the Agreement not inconsistent with this First
Amendment Agreement remains unchanged.

 

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IN WITNESS WHEREOF, the Parties have caused this First Amendment Agreement to be
executed by their duly authorised representatives.

 

 

For Sanofi Pasteur S.A.

For Emergent Product Development UK Limited

 

 

 

/s/Michel De Wilde

 

 

 

/s/Dr. Stephen Lockhart

Michel De Wilde

Dr Stephen Lockhart

Senior VP Research & Development

President

Date :6/16/08

Date :5/21/08

 

 

 

/s/Dominque Carouge

Chief Financial Officer

Sanofi pasteur’ Finance Department

Date: 6/12/08

 

 

 

 

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