EXHIBIT 10.24
CONFIDENTIAL TREATMENT
MEMORANDUM OF UNDERSTANDING
Revised P&GP / ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ Collaboration
This Memorandum represents a summary of the Parties' interests in renegotiating
their current Collaboration and it is binding as set forth in the final
paragraph hereof.
OVERVIEW AND MANAGEMENT OF THE COLLABORATION
Scope: P&GP and Alexion propose to revise the Collaboration Agreement (the
"Collaboration Agreement") dated January 25, 1999 in accordance with this
Memorandum. P&GP and Alexion agree to negotiate in good faith to restate
the Collaboration Agreement (the "Restatement") in accordance with this
Memorandum.
Collaboration Agreement. Except as specifically set forth herein, all terms
of the Collaboration Agreement shall continue with full force and effect
following the execution and delivery of this Memorandum.
Definitions. Capitalized terms used but not defined herein have the
meanings set forth in the Collaboration Agreement.
Decisions - R&D, Health Registrations and Supply Issues: Alexion and P&GP
will have equal decision-making authority for all R&D, Health Registration
and Product Supply/Process Development issues. Such issues will be
addressed and resolved through the R&D Steering Committee. Either party may
refer an issue for further review and resolution to the President of
Alexion and the President of Procter & ▇▇▇▇▇▇ Pharmaceuticals (the
"Presidents"). Action will be delayed until such meeting or discussion
between the Presidents. If the Presidents cannot resolve the issue within
[*****] business days of such reference (or longer period mutually agreed
by the Presidents), the matter will be submitted to a neutral arbitrator
(the "Neutral") within [*****]
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EXHIBIT 10.24
business days thereafter. Both Parties agree to select a Neutral with
experience in the U.S. pharmaceutical industry and to use their best
efforts promptly to cooperate with any investigations and deliberations of
the Neutral. The Parties will present to the Neutral their respective
issues with proposed solutions for the Neutral to make a determination. The
Neutral's determination will be limited to either Party's solution. The
Neutral's determination will be final and binding on the Parties. The fees
and costs of the Neutral will be shared equally between the Parties. The
Parties agree to identify and engage a mutually acceptable Neutral promptly
after execution of the Restatement, to avoid delay in the event the
Neutral's determinations become necessary.
Decisions - Commercialization Issues: The Parties shall form a
Commercialization Steering Team (the "CST"), that will analyze, discuss and
agree on all commercialization strategies, plans and budgets for
commercialization of the product in the U.S. This team will have equal
membership from both P&GP and Alexion. The CST will establish an annual
commercialization plan, which shall be binding on the Parties. The CST will
resolve all commercialization issues, including but not limited to
Marketing, Promotion, Labeling, Phase IIIb/IV studies, Scientific Exchange
and Education. Either party may refer a commercialization issue for further
review and resolution to the Presidents. Action will be delayed until such
meeting or discussion between the Presidents. If the Presidents cannot
resolve the issue within [*****] business days of such meeting or
discussion, the matter will be resolved by [*****].
The development and execution of all commercialization strategies and plans
in the ROW will remain the sole responsibility of P&GP.
Executional Responsibilities:
The executional responsibility of each Party for clinical programs is
outlined on Schedule I which is attached and incorporated herein. While an
individual Party has lead executional responsibility, the Parties agree
there will be no unilateral decision-making by either Party on any aspect
of the clinical program's execution. Both Parties will as soon as practical
but in no event later than within [*****], share all significant
information relating to the development of pexelizumab received from any
Third Party related to the project, including but not limited to, FDA,
CROs, clinical sites, or suppliers, about the programs. All other
information relating to the development
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EXHIBIT 10.24
of pexelizumab will be shared at weekly updates. Prior to meeting with any
such Third Party regarding the development of pexelizumab, each Party will
give the other Party adequate advance notice and full ability to
meaningfully participate. Unless otherwise agreed by the Parties, the
executional teams, including the Clinical Strategy Team and Clinical
Execution Team, will meet at a minimum of every week to discuss issues,
including but not limited to, any executional changes to the protocol or
plan, the status on any budgetary or spending changes, the status on
recruitment rates, IRB approvals, etc. When a study is unblinded, each
Party will participate equally in developing a consistent interpretation of
the data. A senior management team consisting of Vice Presidents or
Directors with senior authority for a function, will meet quarterly to
review, resolve issues as necessary and comment on the status of the
various clinical and product supply/ process development executional teams,
including but not limited to, spending versus budget and progress against
project milestones.
[*****] will have full responsibility for management of the preparation of
the global marketing applications with input from [*****]. [*****] will
lead interactions with FDA regarding the BLA preparation (e.g., pre-BLA
meetings). [*****] will be responsible for supplying global modular
documents with input from [*****] to use in completing the CMC section of
the global marketing applications. [*****] will have full responsibility
for preparation, content and maintenance of the Product's labeling, subject
to [*****] prior review and opportunity to comment.
Clinical Databases: Clinical databases for CABG and AMI will continue to
use P&GP systems and specifications and remain under P&GP control and
ownership, in accordance with the Collaboration Agreement. P&GP will give
Alexion current access to all such databases. Both Parties must agree prior
to granting access to any portion of the database to a Third Party. In the
event P&GP exercises the Opt Out option and the Collaboration Agreement is
terminated, P&GP will without further consideration promptly transfer
ownership of such databases to Alexion, and will provide Alexion other
access reasonably needed by Alexion, including but not limited to,
introducing Alexion to database vendors that P&GP license from and
providing Alexion licenses to P&GP owned software exclusively for use in
connection with the CABG and AMI clinical database, so Alexion is able to
assume control of and to exploit the databases to the same extent as P&GP
had been capable of internally.
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EXHIBIT 10.24
RESEARCH AND DEVELOPMENT PLAN
U.S. R&D Funding: P&GP will continue to control AMI Phase II and fund all
out-of-pocket costs and in-house FTE costs for work performed pursuant to
the R&D Plan for the AMI Phase II program. Alexion and P&GP will each pay
50% of all pre-agreed out-of-pocket costs to Third Parties for work
performed pursuant to the R&D Plan for the AMI Phase III U.S. program and
the CABG Phase III U.S. program, plus mutually agreed Alexion and P&GP FTE
costs in connection therewith. Prior to commencement of a program an
overall budget ("Budget") must be pre-agreed in writing by the Parties.
This Budget will be updated no less than every 6 months and all changes
must be agreed to in writing. Out-of-pocket costs include any mutually
agreed-to payments to Third Parties. Studies conducted outside the United
States that are used to support either Phase III U.S. program shall be
considered U.S. program costs. Any expenses incurred by either Party that
were not pre-agreed to in writing as part of the Budget process will be the
sole responsibility of the Party that incurred the expense.
CABG. Alexion agrees to pay the first 50% of the total pre-agreed
estimated costs in respect of the CABG Phase III U.S. program (i.e.,
$[*****]). For clarity, P&GP's previous expenditure for CABG Phase
III, the amount of which will be agreed as set forth below, will not
be counted as part of Alexion's first 50% of costs. Unless agreed
otherwise by the Parties in writing as part of the establishment of
the Budgets, Alexion will pay the first $[*****] of such costs, P&GP
will pay the second $[*****] of such costs, and the Parties will
simultaneously, evenly pay any additional mutually-agreed costs. Upon
completion or jointly agreed termination of the CABG Phase III U.S.
program, if either Party has paid more than the other Party in
connection therewith, the Party having paid less will promptly make a
reconciliation payment to the other Party, such that each party has
paid 50% of the total of such mutually-agreed costs. Each Party
acknowledges that the other has incurred costs directly related to the
CABG Phase III program prior to execution of this Memorandum.
Accordingly, each Party will be credited with having already spent
such amounts in evening the total costs to be absorbed by the Parties.
A full accounting will be completed upon signing this Memorandum to
itemize the specific CABG Phase III costs incurred by the Parties as
of that date.
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EXHIBIT 10.24
AMI. Alexion and P&GP will determine a structure to result in their
paying their respective 50% of AMI Phase III costs simultaneously.
Clinical Supply Costs. All clinical supply costs incurred prior to
initiation of the CABG Phase III program shall be expensed on
initiation of the trial, and further such costs will be expensed when
incurred.
ROW R&D Funding: P&GP is free to re-use, outside the U.S., any data or
information generated from any study performed for U.S. Health
Registration, without incurring any additional expense. Alexion is free to
use, within the U.S., any data or information generated by P&GP from any
study performed solely for a ROW Health Registration, without incurring any
additional expense. P&GP may elect to include ROW sites in U.S. led Phase
IIIb and Phase IV studies. In the event ROW sites are included in such
studies, P&GP will pay for the expenses specifically associated with
patients enrolled solely for the ROW needs. If pre-agreed Phase IIIb and
Phase IV studies are used in the U.S. and ROW for new marketing or labeling
claims, P&GP will pay [*****] of the cost and Alexion will pay [*****]. All
additional R&D expenses specifically and uniquely required for the Health
Registration or commercialization of pexelizumab outside of the U.S. will
be the responsibility of P&GP.
P&GP OPT-OUT OPTION: P&GP may terminate ("Opt-Out") the Collaboration in
its sole discretion by providing six months notice following [*****] and no
later than the earlier of (i) 30 days after receipt of [*****] and (ii)
[*****].
In the event P&GP elects to exercise its Opt-Out option, P&GP has no
responsibility for CABG Phase III expense other than (i) the mutually
agreed expenses incurred prior to exercise of the Opt-Out that otherwise
would be payable by P&GP pursuant to "CABG", above, and (ii) CABG Phase III
amounts paid by P&GP prior to execution of this Memorandum. By way of
example, if P&GP exercises the Opt-Out option and $[*****] has been
expended on CABG Phase III, and it is determined that P&GP paid $[*****]
prior to execution of this agreement in connection with CABG Phase III,
Alexion would have paid $[*****] and P&GP [*****]. During the six month
notice period, P&GP will continue to provide continuing executional support
for AMI and CABG Phase
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EXHIBIT 10.24
III hereunder but will have no financial liability for any AMI or CABG
Phase III expenses, other than in-house P&GP FTE costs, to be paid 100% by
P&GP, provided such FTE costs and expenses are consistent with pre-agreed
Budgets and provided the work will be transferred to Alexion as soon as
practicable.
In the event P&GP elects to exercise its Opt-Out option, Alexion agrees to
purchase from P&GP all mutually pre-agreed pexelizumab related
manufacturing assets at current book value and to reimburse P&GP for all
[*****] including but not limited to, [*****]. Alexion will also agree to
assume any mutually pre-agreed [*****] including, but not limited to,
[*****]. All asset transfers, contract assignments, and payments must be
complete prior to the end of the [*****] notice period. This paragraph
shall apply only to [*****] of P&GP's assets, and commitments and fees, if
within [*****] of P&GP's Opt-Out exercise Alexion certifies that it too
[*****].
PRODUCT SUPPLY AND PROCESS DEVELOPMENT:
PS/PDC. The Parties will form a Product Supply / Process Development
Committee (PS/PDC) with equal representation from each Party. The PS/PDC
will be sponsored by the R&D Steering Committee. The PS/PDC will analyze,
discuss and agree on decisions related to process development, clinical and
commercial product supply, including but not limited to, choice of
supplier(s), capital expenditures and product development activities. The
PS/PDC will be responsible for and have decision-making authority for
process development and production of Product for the R&D Plan and for
commercialization. If the PS/PDC cannot reach agreement on a product supply
issue, either Party may refer the issue to the R&D Steering Committee. If
the R&D Steering Committee does not reach agreement within five business
days of the referral, the matter will be addressed through the R&D Steering
Committee Dispute Resolution process established above. The PS/PDC will
develop and agree in writing to a Process Development Plan ("PDP") and a
Product Supply Sourcing Plan ("PSSP") for the U.S. P&GP and Alexion will
jointly share project leadership for execution of the Product Supply
Sourcing Plan, and P&GP will be the primary vendor contact to provide a
single and focused point of contact to leverage existing relationships and
corporate purchasing scale; Alexion will provide input on the vendor
contacts on a co-equal basis. Alexion and P&GP will jointly share project
leadership for process development. The process development execution will
be conducted consistent with P&GP and Alexion
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EXHIBIT 10.24
requirements. Alexion will perform bulk drug development and
characterization and P&GP will provide input on a co-equal basis. P&GP will
take the lead on vialing and other supply chain activities and Alexion will
provide input on a co-equal basis. All U.S. process development and product
supply agreements will be mutually agreed. P&GP will be sole signatory on
all process development and product supply agreements. Within [*****] of
the PS/PDC agreeing upon a viable source of commercial supply for
pexelizumab, the PS/PDC will agree to the Product Supply Sourcing Plan. The
PSSP will include, among other items, detail on validation timing, launch
readiness requirements and longer-term forecasted volumes.
The Parties acknowledge that certain vendors may support supply for both
the U.S. and ROW. In such cases, the PS/PDC will ensure that vendor costs
for U.S. and ROW supply are equal on a unit basis.
In the event that supplies are insufficient for worldwide demand forecasted
as of launch, [*****] will be [*****]. P&GP will provide Alexion the ROW
product sourcing plan for review and input. Following launch, if supply is
insufficient to meet total demand, available supply will be allocated based
on the past [*****] volume. In the event of a likely shortage of product in
[*****], P&GP agrees not to [*****]. Unless otherwise agreed by the
Parties, the PS/PDC will strive to meet these non-binding objectives of the
PS/PDC that include but are not limited to: (i) the primary commercial
source(s) of pexelizumab shall be validated in accordance with all relevant
regulations [*****] before the currently anticipated first BLA filing date
and (ii) [*****] of commercial supply shall be ready for sale before the
currently anticipated United States launch date. Meeting these non-binding
objectives will be balanced against technical and commercial feasibility
and required investment.
Capital. Capital expenditures will be [*****]. P&GP will purchase all
capital as agreed to by the PS/PDC in the PSSP and all assets will be
maintained on P&GP's ledgers. Until the first launch of pexelizumab,
[*****] of the annual capital depreciation will be charged to Alexion.
Following the first launch, depreciation will be charged to the [*****].
Alexion will thereby be charged [*****]. Assets will be depreciated based
on P&GP's corporate accounting policy, which includes a determination of
useful life on an asset-by-asset basis. In the event that P&GP is required
to write
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EXHIBIT 10.24
down pexelizumab assets due to project failure, etc. (not including assets
related to [*****]), Alexion will reimburse P&GP for [*****] expense
associated with the write down.
Supplier Advances. Until the first launch of pexelizumab, all supplier
advances that are required to be expensed due to cancellations (other than
ROW cancellations), will be [*****] between the Parties. Following the
first launch, all expensed supplier advances will be [*****].
Expenses. All other outside expense pre-agreed in writing that is
associated with process development and production, including but not
limited to all validation and test run costs, will be [*****] insofar as
the same are uniquely and specifically required to support production
capacity for U.S. commercialization, including in-house FTE costs for
process development and product supply work conducted under the R&D Plan. A
process development and product supply Budget must be pre-agreed in writing
by the Parties. This Budget must be established in conjunction with PS/PDC
agreement to the Process Development Plan and Product Supply Sourcing Plan.
This Budget will be updated no less than every 6 months and all changes
must be agreed to in writing. Any expenses incurred by either Party that
were not pre-agreed to in writing as part of the Budget process will be the
sole responsibility of the Party that incurred the expense. Any expense
that is uniquely and specifically required to support production capacity
for ROW commercialization shall be borne by [*****] and not reimbursed by
[*****], and if such expense supports both U.S. and ROW commercialization,
P&GP will pay [*****] and Alexion will pay [*****] of the expense.
HEALTH REGISTRATIONS:
Sponsorship. Within the U.S., Alexion will be the Sponsor of the IND for
CABG and P&GP will be the Sponsor of the IND for AMI. Both Parties will
jointly plan, prepare for, and participate in all FDA interactions. All
meetings with FDA will be led by the Sponsor. The Parties agree to adhere
to the protocol for involving each other as outlined in Schedule II, which
is attached and hereby incorporated by reference. P&GP will sponsor the BLA
and all subsequent sBLAs and be responsible for filing, prosecuting and all
FDA interactions concerning the BLA or any subsequent sBLAs. In order for
P&GP to prepare for filing the BLA, Alexion agrees to transfer the IND for
CABG to P&GP no later than practically required before the expected filing
of the BLA, but in no event later than the pre-BLA meeting. Outside of the
U.S., P&GP will be the sponsor of all Health
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EXHIBIT 10.24
Registrations. In the event P&GP exercises the Opt Out option and the
Collaboration is terminated, P&GP will without further consideration
promptly transfer sponsorship of its INDs and BLAs throughout the world to
Alexion or its nominated agent(s), and will provide Alexion access
reasonably needed by Alexion to assume control of and to exploit such INDs
and BLAs to the same extent as P&GP had been capable of internally.
Funding. All mutually agreed out-of-pocket and in-house FTE costs
associated with filing or maintaining the U.S. Health Registration will
[*****]. All out of pocket and in-house FTE costs associated with filing or
maintaining Health Registrations outside of the U.S. will be borne by P&GP.
MARKETING AND PROMOTION:
Commercialization Costs. P&GP and Alexion agree to [*****] all mutually
agreed out-of-pocket and FTE costs associated with the commercialization of
the Product [*****]. [*****] shall be responsible for all such costs
[*****]. The CST will establish an annual U.S. commercialization plan and
Budget agreed to in writing on or before July 1 of each year. Any expenses
incurred by either Party that were not pre-agreed to in writing as part of
the Budget process will be the sole responsibility of the Party that
incurred the expense. All mutually agreed out-of-pocket and internal
Alexion and P&GP FTE U.S. costs shall include but are not limited to the
following:
1. costs for marketing, market research, advertising, sampling, and
promoting the Product, such as advertising agency fees,
advertising development costs, sales materials, development
costs, training materials and public communication costs, speaker
programs and conferences and other scientific education and
exchange program (SEEP) costs incurred prior to and following
Product approval;
2. costs related to creating and distributing any communication
notice mandated by a government authority (e.g. Dear Doctor
letters);
3. costs associated with manufacturing, distributing and shipping
the Product samples to Third Parties and the handling and
disposing of return shipments;
4. costs associated with obtaining, maintaining or enforcing Product
related trademarks and logos;
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EXHIBIT 10.24
5. costs for Phase IIIb, Phase IV and grant studies mutually agreed
by the parties;
6. epidemiological modeling and pharmacoeconomic study costs; and
7. costs associated with effecting any Product recall (i.e.,
communication, shipping and reimbursement costs).
[*****]
1. P&GP will [*****]. P&GP will discuss all matters related to [*****] with
Alexion and provide Alexion an opportunity to comment thereon; provided
that the final decisions on all such matters shall be made by ▇▇▇▇▇▇▇ &
▇▇▇▇▇▇ in its sole discretion. Alexion will be notified of and invited to
all meetings [*****]. Each party will bear its own internal costs, and P&GP
will bear all P&GP outside costs and expense [*****], in connection with
[*****]. Alexion has the right [*****]. If [*****], P&GP and Alexion
[*****]. [*****] agrees to grant [*****] a sublicense [*****] necessary to
carry out the Agreement. [*****] shall reimburse [*****] all amounts
[*****], except that (i) subject to Clause 2 below, [*****] shall be
responsible for [*****] in respect of [*****] in the United States, [*****]
and (ii) [*****] shall be responsible [*****] in respect of [*****] outside
the United States. [*****] will not be entitled to amend or otherwise
modify [*****] without the prior, written consent of [*****].
2. Notwithstanding Clause 1 above, [*****] shall be responsible for [*****] of
United States [*****] under the [*****] until the difference between the
amount payable under this Clause 2 and the amount otherwise payable under
Clause 1 above exceeds the lesser of (i) [*****] in respect of United
States [*****] and (ii) [*****]. Thereafter, this Clause 2 shall no longer
apply.
3. The [*****] in the United States and outside the United States will be
identical under [*****], and all [*****] shall be apportioned [*****]
between [*****] in the United States and [*****] outside the United States,
respectively.
4. All other [*****] (other than as set forth in [*****] of the Collaboration
Agreement) related to [*****] in the United States shall be handled
pursuant to Section [*****] of the
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EXHIBIT 10.24
Collaboration Agreement (i.e., [*****] will [*****]). All other [*****]
(other than as set forth in [*****]) related to [*****] Product outside the
United States shall be handled pursuant to Section [*****] of the
Collaboration Agreement (i.e., [*****] will [*****]).
5. [*****]
6. Example. Following is an example of the operation of this [*****]
provision:
Assuming:
[*****]
[*****]
[*****]
[*****]
[*****]
Then:
[*****]
[*****]
[*****]
[*****]
Sales Efforts. It is expected that each Party [*****] selling efforts in
the U.S., including but not limited to, the efforts of liaisons and
hospital representatives as mutually agreed. The Parties will each pay
their own sales force and liaison costs (salaries, benefits, autos, bonuses
or other incentive program costs, etc.). In the event [*****] selling
effort would not be possible, the Party assigned more than [*****] will be
reimbursed for the extra costs borne by that Party.
One year before launch of the Product, the Parties will enter into a
Marketing Services Agreement (MSA). The MSA will describe but not be
limited to, terms on budgeting, forecasting, co-promotion services
(including requirements for accounting for requisite Details or other calls
on target prescribers, coordination of sales effort, compliance with laws
and applicable authorities,
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EXHIBIT 10.24
etc.), sales penalties, penalties for under performance, responsibilities
and procedures for Product returns and recalls.
ROYALTIES AND MILESTONES:
U.S. Contribution: Alexion shall receive [*****]% of U.S. Contribution
(Contribution is defined as Net Sales minus COGS ) on sales of pexelizumab
in the United States. Sections 8.2(a), 8.2(b) and 8.2(c) of the original
Agreement are eliminated.
ROW Return: Alexion will receive [*****]% of ROW Net Sales.
Milestones: All milestones in the Collaboration Agreement are eliminated
and replaced by the following non-refundable, non-creditable one-time
milestone payments. Each of these milestones is contingent upon P&GP not
having terminated the Collaboration prior to achievement of the milestone
event.
MILESTONE AMOUNT
--------- ------
(U.S. $ Million)
PRE-HEALTH REGISTRATION EVENTS
At initiation of dosing of CABG Phase III clinical trial program
which the Research & Development Steering Committee agreed would
constitute a pivotal trial for approval of a Product for a CABG
Indication [*****]
At initiation of dosing of AMI Phase III clinical trial program
which the Research & Development Steering Committee agreed would
constitute a pivotal trial for approval of a Product for an AMI
Indication [*****]
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EXHIBIT 10.24
U.S. HEALTH REGISTRATION EVENTS
On FDA acceptance for filing of the first U.S. Health Registration of a Product for an
AMI Indication [*****]
On first U.S. Health Registration approval of a Product for a CABG Indication [*****]
On first U.S. Health Registration approval of a Product for an AMI Indication [*****]
FOREIGN HEALTH REGISTRATION EVENTS (European Union
filing/approval means in any country of the European Union.)
On first filing for European Union Health Registration of
a Product for a CABG Indication [*****]
On first filing for European Union Health Registration of
a Product for an AMI Indication [*****]
On first European Union Health Registration approval of a Product
for a CABG Indication [*****]
On first European Union Health Registration approval of a Product
for an AMI Indication [*****]
MISCELLANEOUS
FTE Funding. The cost of each internal FTE will be calculated at $[*****],
multiplied by the percentage of such employee's time devoted to the
Collaboration. The R&D Steering Committee will determine FTE effort of each
Party in respect of R&D, Health Registration and Supply issues.
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EXHIBIT 10.24
The Parties will mutually agree on all other FTE efforts, and the
categories of employee chargeable to the Collaboration.
Term: The term of the Collaboration Agreement will continue in each country
of the world until pexelizumab is no longer sold in such country.
Termination by P&GP: In addition to both Parties rights to terminate under
the original Agreement, as amended hereby, P&GP has the right to exercise
the Opt-Out option.
Publicity: The Parties will jointly prepare and agree upon the public
announcement of execution of this Memorandum and the Restatement.
Thereafter, each Party agrees to publish or otherwise disclose the
material, non-public results of the R&D Plan or of development studies or
of the commercialization plan (a "Disclosure") only upon prior written
approval of the other Party, not to be unreasonably withheld or delayed. In
the event either Party is aware of an upcoming Disclosure, the Party will
strive to provide the other Party [*****] advance notice of the Disclosure
and its content. If specific wording is not available at a minimum the
Party proposing the Disclosure will provide the other Party information on
the general content and key messages proposed. The Parties agree whenever
possible to provide press releases containing any Disclosure [*****] prior
to proposed release. Notwithstanding the foregoing, this restriction does
not prohibit a party from making Disclosures required by, or highly
advisable under, law or government regulation (as determined by opinion of
counsel of the party proposing such Disclosure). If a Party decides, upon
the advice of counsel that a Disclosure is required or highly advisable,
the Party will, insofar as is reasonably practical, notify the other Party
of the decision and provide the other Party an advance copy for review and
comment.
Indemnification: Section 12.1 (b), "Indemnification for Marketing", in the
Collaboration Agreement remains in full force. Notwithstanding the above,
P&GP will not indemnify and hold harmless Alexion from and against any
losses to the extent due to Alexion's gross negligence or willful or
intentional misconduct. In the event that the Collaboration is terminated,
Alexion agrees to provide an indemnification to P&GP in respect of Product
commercialized by Alexion after termination, consistent with
"Indemnification for Marketing" Section 12.1(b) in the Collaboration
Agreement.
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EXHIBIT 10.24
CHANGE IN CONTROL
1. Change in Control. Except as set forth in this provision ("Change in
Control"), neither Party's consent is necessary to a Change in Control
of the other Party, and the Collaboration Agreement shall be binding
upon and inure to the benefit of either Party's successors in interest
following any such Change in Control transaction. Section 13.7(a), (b)
13.9 (c) of the Collaboration Agreement are deleted.
2. Notice. At any time during the Term, either P&GP or Alexion (the
"Acquired Party") may notify (the "Notice") the other Party (the
"Continuing Party") that it is contemplating a Change of Control
transaction with a Third Party Company. All information provided in
the Notice and otherwise provided in connection with the proposed
Change of Control shall be maintained by the Continuing Party in the
strictest confidence, including the fact that a Change of Control has
been discussed and the name of the relevant Third Party Company, and
the Continuing Party will restrict knowledge of such matters only to
those of its employees who have a need to know the same.
3. Valuation Election. Within [*****] following receipt of the Notice,
the Continuing Party may elect in writing (the "Election") delivered
to the Acquired Party to cause a valuation to be made of the Acquired
Company's entire interest in the Collaboration Agreement (the
"Acquired Company's Agreement Interest") and the Continuing Company's
entire interest in the Collaboration (the "Continuing Company's
Agreement Interest", and together with the Acquired Company's
Agreement Interest, the "Agreement Interest(s)"). Failure of the
Continuing Party to provide such notice shall constitute waiver of its
rights under this provision ("Change in Control"), and consent for the
Change in Control to occur.
4. Valuation Process. Within [*****] of receipt of the Election, the
Acquired Party and the Continuing Party shall each retain an
internationally recognized investment banking firm to determine the
value of the Agreement Interests (the "Prices"). If either Party fails
to deliver notice to the other Party of its selection of an investment
banking firm within such period, the Price determinations shall be
rendered by the single investment banking firm so selected. If the
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EXHIBIT 10.24
Continuing Party has elected to cause the valuation to be made, it
shall pay all fees and expenses of the investment bank(s). The
investment banking firms selected in accordance with the foregoing
procedure shall each determine the values of the Agreement Interests
and submit their determinations of such values to the Parties within
seven days following their selection. The values of Alexion's
Agreement Interest and P&GP's Agreement Interest will be determined as
set forth in Clause 9 below. The Price of each Party's Agreement
Interest shall be the sum of the relevant values determined by each
firm therefor, divided by two; provided, however, that if there is
more than a [*****] percent ([*****]%) difference between the two such
values for either or both such Agreement Interests, then within
[*****] of when they have determined such values, the first two firms
shall select a third internationally recognized investment banking
firm to determine the Price of the Agreement Interest(s) that diverged
more than [*****] (which shall be determined by such firm [*****] of
selection, and in no event be outside the range determined by the
first two investment banking firms).
5. Put/Call Election. Within [*****] ([*****]) [*****] following
determination of the Price, the Continuing Party will irrevocably
elect to (i) allow the Change in Control to occur, (ii) require the
Third Party Company to purchase the Continuing Party's Agreement
Interest at the relevant price, (iii) purchase the Acquired Party's
Agreement Interest at the relevant price.
6. Purchase Consummation. Any purchase and sale of an Agreement Interest
effected pursuant to this provision ("Change in Control") shall be
consummated at a closing at the offices of the Continuing Party on a
business day within [*****] following the determination of the
relevant Price upon at least [*****] notice by the Third Party Company
to the other parties to the transaction; or the earliest time
thereafter following receipt of necessary governmental or regulatory
approvals with respect to such transaction and the Change in Control
transaction contemplated by Clause 2 above. At such closing, the Third
Party Company (or its designee) or the Continuing Party (or its
designee), as the case may be, shall pay the relevant Price by
certified check or wire transfer of funds. In no event will such
purchase and sale of an Agreement Interest occur unless and until the
Third Party Company identified under Clause 2 above consummates the
Change in Control transaction with the Acquired Company contemplated
by the Notice.
16
EXHIBIT 10.24
7. Purchase Documentation. Upon the closing of the transactions
contemplated by Clause 6 above, the Parties and the Third Party
Company shall execute such customary instruments of transfer, licenses
and other agreements as are necessary to transfer all of the relevant
Agreement Interest to assure that the party acquiring such interest
shall be able to enjoy the benefits thereof. The Party whose Agreement
Interest is acquired shall license or sublicense all of its
intellectual property necessary for the manufacture, use or sale of
Products in the Field, and the party acquiring such Agreement Interest
shall assume all obligations, including payment obligations, to any
Third Party from whom the party whose Agreement Interest is acquired
licenses such intellectual property. All other necessary agreements
(e.g., supply) will also be transferred; or if not transferable, the
benefits thereof will otherwise be provided.
8. Third Party Company. "Third Party Company" shall mean, in the case of
P&GP, the five companies listed by it on Schedule III (together with
their majority owned, direct or indirect subsidiaries), and in the
case of Alexion, the five companies listed by it on Schedule III
(together with their majority owned, direct or indirect subsidiaries).
Each Party shall supply its initial list to the other following
execution and delivery of this Memorandum. Either Party may revise its
list by written notice to the other delivered within [*****] on or
after [*****] and [*****] during the Term. Within [*****] on or after
[*****] and [*****] during the Term, Alexion agrees to provide P&GP a
written reminder of P&GP's rights under this Section. Neither Party
shall have the right to amend its list of 5 companies after the
Acquired Party publicly announces, or confidentially notifies the
Continuing Party, that it proposes a Change of Control transaction
with a company that is not on the list.
9. Agreement Interests. The retained investment banks shall be instructed
to value P&GP's Agreement Interest at the amount that, on the basis of
market and other conditions prevailing at such time could reasonably
be expected to be paid by a third party in an arm's-length transaction
for [*****]. The retained investment banks shall be instructed to
value Alexion's Agreement Interest at the amount that, on the basis of
market and other conditions prevailing at such time is the difference
between what could reasonably be expected to be paid by a third party
in (i) an arm's-length transaction for [*****].
17
EXHIBIT 10.24
10. Closing Condition. Consummation of any Change In Control transaction
will require that the Third Party Company agree to be bound by the
terms of this provision ("Change in Control").
SUBSTANTIAL STOCK ACCUMULATION: Section 13.8 of the Collaboration Agreement
applies only to accumulation in the equity of one Party hereto by a
Third Party Company listed by the other Party hereto. Further, Section
13.8 has no force or effect in regard to a Third Party following a
Change of Control involving such Third Party.
EXECUTIONOF THIS MEMORANDUM OF UNDERSTANDING: Upon execution, the terms of this
Memorandum will be in full force and effect. The Parties agree to
diligently negotiate the terms of the Restatement. Prior to the
Restatement being executed, in the event an issue is not addressed in
this Memorandum but is in the Collaboration Agreement, the Parties
will operate under the Collaboration Agreement on the issue. Prior to
the Restatement being executed, the Parties agree Section 13.2 of the
Collaboration Agreement, "Termination", remains in full force;
provided, however, Section 13.2(a) of the Collaboration Agreement is
deleted, and replaced by the following:"Procter & ▇▇▇▇▇▇ may terminate
the Agreement upon six (6) months prior written notice to Alexion."
18
EXHIBIT 10.24
IN WITNESS WHEREOF, the Parties have signed this Memorandum as of
December 11, 2001.
ALEXION PHARMACEUTICALS, INC.
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇
------------------------------------
Name:
Title:
PROCTER & ▇▇▇▇▇▇ PHARMACEUTICALS, INC.
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇
------------------------------------
Name:
Title:
19
EXHIBIT 10.24
SCHEDULE 1
Executional Responsibilities: Clinical Programs
-------------------------------------------------------------------------------------------------------------
CABG Phase III Program AMI Phase III Program
---------------------- ---------------------
------------------------------------------------------------------
Task R I R I
-
-------------------------------------------------------------------------------------------------------------
Project Leadership* Shared Shared Shared Shared
-------------------------------------------------------------------------------------------------------------
Program Physician-Global/NA [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
Program Physician- [*****] [*****] [*****] [*****]
Europe/ROW
-------------------------------------------------------------------------------------------------------------
CRO/Vendor Contracts, Bids and Scope [*****] [*****] [*****] [*****]
Changes
-------------------------------------------------------------------------------------------------------------
Site Contracts and Budgets [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
Statistics and Biometrics including DSMB [*****] [*****] [*****] [*****]
data flow
-------------------------------------------------------------------------------------------------------------
Clinops-NA [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
CRO Interaction-NA [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
Vendor (e.g., Core Labs) Interaction [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------
Site Interaction-NA [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
Clinops-Europe/ROW [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
CRO/Vendor Interaction- Europe/ROW [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
Site Interaction- Europe/ROW [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
Clinical Supplies [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
Clinical QA [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------
Pharmacovigilance NA *** [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
20
EXHIBIT 10.24
------------------------------------------------------------------------------------------------------------
Pharmacovigilance EU [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
PK and PD [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
Pharmacoeconomics [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
Regulatory U.S. [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
Regulatory [*****] [*****] [*****] [*****]
ROW
-------------------------------------------------------------------------------------------------------------
Clinical Data Management [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
Medical Writing [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
Global Marketing Application Prep/Mgmt [*****] [*****] [*****] [*****]
-------------------------------------------------------------------------------------------------------------
Abbreviations: R = Responsibility; I = Input; P = P&GP: A = Alexion
* Each company will appoint a project leader.
** [*****] to have ability to set up initial site budget and contract in
select cases
*** [*****] will have global responsibility for collecting and analyzing
adverse events and will own the database. Sponsor will be responsible for
filing the information with all regulatory authorities.
21
EXHIBIT 10.24
SCHEDULE II
[*****]
This document provides some expectations for involvement of the partner company
in FDA interactions (Alexion for BB IND 8651 [AMI] and P&GP for BB IND 6592
[CPB]). These expectations apply to all aspects of the project, including CMC.
The primary expectation is that the partner should be involved in all FDA
interactions where strategic and executional issues are discussed, unless both
partners have agreed in advance that it is not necessary.
Both partners should be involved in all scheduled FDA interactions, unless there
is an agreement in advance. When possible, the Regulatory Affairs Managers in
both companies should discuss and anticipate FDA interactions and reach
agreements about the need for involvement in advance of the FDA interaction. In
the event of an unscheduled FDA interaction, both partners agree to use best
efforts to involve the other partner. Unscheduled FDA interactions with a
Sponsor company should be communicated immediately to the non-Sponsor company.
Strategic decisions should not be made with FDA unless both companies are
present in the conversation, or an agreement to make such decisions has been
made by both companies in advance.
Partner involvement is not expected for administrative FDA interactions which
include discussions about scheduling of interactions, response to FDA requests
for additional copies of IND submissions, response to FDA requests for updates
on status of DSMB review, etc.
Nearly all FDA interactions should be easily managed in one of these ways. It is
recognized that in rare instances an "informal" interaction may occur where
FDA's willingness to share perspective could be hampered by a delay or by the
presence of additional participants in the interaction. In those rare instances
it is expected that the partner company will be contacted immediately following
the interaction and fully informed in writing as to the content of the
discussion. Strategic decisions should not be made with FDA unless both
companies are present in the conversation or an agreement to make such decisions
has been made by both companies in advance. It is also expected that every
effort will be made to keep
22
EXHIBIT 10.24
those advantageous informal discussions separate from the formal interactions
where partner presence is desired.
Each Party maintains the right to directly contact FDA, other regulatory
agencies, or other clinically responsible third parties (e.g., investigators,
IRBs, ) on any urgent safety or other medically significant concerns; provided,
however, that a non-Sponsor Party must first provide the Sponsor all information
regarding such concern and allow the Sponsor to be the Party that contacts the
FDA or such other agencies or third parties. If the Sponsor does not address the
non-Sponsor's concerns, and the non-Sponsor deems there is a regulatory or legal
requirement for reporting, the non-Sponsor reserves the right to directly
contact FDA, other regulatory agencies or other clinically responsible third
parties on the urgent safety or other medically significant concern. Prior to
making any third party contact the non-Sponsor will inform the Sponsor of its
decision.
23
EXHIBIT 10.24
SCHEDULE III
CHANGE IN CONTROL - THIRD PARTY COMPANIES
-------------------------------------------------------------------------------
Companies selected by Alexion: Companies selected by P&GP:
-------------------------------------------------------------------------------
1.[*****] 1. [*****]
-------------------------------------------------------------------------------
2.[*****] 2. [*****]
-------------------------------------------------------------------------------
3.[*****] 3. [*****]
-------------------------------------------------------------------------------
4.[*****] 4. [*****]
-------------------------------------------------------------------------------
5.[*****] 5. [*****]
-------------------------------------------------------------------------------
[Each party to provide the other its list following execution and delivery of
this Memorandum]
24