Exhibit 10.39
DEVELOPMENT AND TRANSITION
SERVICES AGREEMENT
T HIS D EVELOPMENT AND T RANSITION S ERVICES A GREEMENT (the “ Agreement ”) is made
and entered into as of June 11, 2009 (the “ Effective
Date ”) by and between N EUROMED D EVELOPMENT I NC . , a
corporation organized and existing under the laws of Barbados
(“ Neuromed ”), and M
ALLINCKRODT
I NC . , a
Delaware corporation (the “ Mallinckrodt ”).
Each of Neuromed and Mallinckrodt may be referred to in this
Agreement individually as a “ Party ”,
and collectively as the “ Parties
.”
R ECITALS
A. Concurrently with this Agreement, Neuromed and
Mallinckrodt are entering into that certain Asset Purchase
Agreement between Neuromed and Mallinckrodt (the “
Purchase Agreement ”) pursuant to which Neuromed is
selling and assigning to Mallinckrodt, and Mallinckrodt is
purchasing from Neuromed, all of Neuromed’s tangible and
intangible assets relating to Product (as such term is defined in
the Purchase Agreement).
B. In connection with such sale, the Parties desire
that Neuromed shall perform, at Mallinckrodt’s cost and
expense, certain clinical development and regulatory activities
through approval by the FDA of an NDA covering Product, and certain
transition services for Mallinckrodt’s benefit in order to
facilitate the smooth transition of the Transferred Assets to
Mallinckrodt.
The Parties therefore agree as
follows:
A GREEMENT
1. D EFINITIONS . The following terms, when used herein with
initial capital letters, will have the meanings ascribed to such
terms in this Article 1. Capitalized terms used in this Agreement
but otherwise not defined herein have the meanings given such terms
in the Purchase Agreement.
1.1
“Development” means the conduct of clinical development and
regulatory activities relative to Product, through achievement of
regulatory approval by the FDA of an NDA filed by Neuromed covering
Product, as conducted by Neuromed and in accordance with this
Agreement and the Development Plan.
1.2 “Development
Costs” means all
internal and external costs incurred by Neuromed after the
Effective Date for its conduct of Development of Products in
accordance with the Development Plan, including any pre-clinical
research or development activities, clinical trials, related
regulatory activities (including preparing and making regulatory
filings) and REMS activities, which Development activities are
necessary or useful to seek or obtain regulatory approval by the
FDA with respect to Product (or a specific indication for Product)
in the Territory. The costs and reasonable expenses of Neuromed
employees to the extent actually engaged in Development shall be
included in Development Costs at the applicable portion of the FTE
Rate, based on the number of days or portion of any days spent by
the applicable employee (during any particular time period) in
conducting Development.
Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 promulgated under the Securities Act of
1933, as amended; [*] denotes omissions.
1.3 “Development
Plan” means the
summary plan for conducting clinical development and regulatory
activities, through achievement of regulatory approval by the FDA
of a NDA filed by Neuromed covering Product, attached as
Appendix A of this Agreement, as such plan may be modified
or amended in writing by the Parties.
1.4 “FTE
Rate” means, for
one full time equivalent employee working for one full-time year
(equal to [*]days of work during the year, holidays, vacation and
sick-days included), an amount equal to $[*] per such full-time
equivalent year of work.
1.5 “Joint Development
Committee” or
“JDC” means the committee formed by the Parties
as provided in Section 2.2.
1.6 “Neuromed
Personnel” means
all employees, agents, subcontractors, and representatives of
Neuromed (or of Neuromed’s Affiliate) who perform any
Development or Transition Services under this Agreement, which
personnel are listed on Appendix D , attached hereto (which
list may be updated from time to time by Neuromed with the consent
of Mallinckrodt, such consent not to be unreasonably withheld or
delayed).
1.7 “Past Development
Costs” means the
Reimbursed Development Costs and Assumed Development Cost
Liabilities, each as defined in the Purchase Agreement.
1.8 “Transition
Services” means the
transition services, functions and tasks of Neuromed described in
Appendix B of this Agreement, as they may be changed or
supplemented during the term of this Agreement pursuant to the
terms of this Agreement. If any service, function or responsibility
not specifically described in this Agreement is an inherent or
necessary part of the performance of the Transition Services, it
will be deemed included within the scope of the Transition
Services.
1.9 “ Territory ” means the
United States and its possessions and territories.
2. P RODUCT D EVELOPMENT AND NDA A PPROVAL
2.1 Neuromed Development
Activities. Notwithstanding that Mallinckrodt has purchased
the Transferred Assets pursuant to the Purchase Agreement, the
Parties agree that Neuromed shall continue to be involved in
Development, through NDA Approval, of Product, under the terms of
this Agreement. Neuromed shall conduct any Development efforts in
accordance with the Development Plan, using Commercially Reasonable
Efforts and at Mallinckrodt’s cost and expense as provided
herein. Neuromed will be responsible for using Commercially
Reasonable Efforts to conduct the Development of Product through
obtaining NDA Approval for Product, including the planning, filing
and prosecution of the NDA with the FDA, all in accordance with the
Development Plan, subject to Section 2.4 below and review of
its Development activities by appropriate Mallinckrodt personnel.
Neuromed may utilize
2.
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 promulgated under the
Securities Act of 1933, as amended; [*] denotes
omissions.
consultants and contractors (such as CROs) to
conduct significant portions of the Development activities under
this Section 2.1 (and the costs of such third parties shall be
included in the Development Costs reimbursed by Mallinckrodt as
provided in Section 2.3 below). Neuromed will use its
Commercially Reasonable Efforts to conduct all the tasks and meet
on a timely basis all the objectives and milestones under the
Development Plan. Neuromed will comply (and cause its Affiliates to
comply) with all applicable federal, state and local laws and
regulations, and will obtain all applicable Governmental Permits,
in connection with its performance of the Development work under
this Section. The JDC shall oversee Neuromed’s Development
efforts, and Neuromed shall keep the JDC fully informed of all
development activities taken and results, including all regulatory
actions and communications with the FDA relating to the NDA.
Neuromed will provide all services in connection with Development
with at least the same level of skill, quality, care, timeliness
and cost-effectiveness as such services, functions and tasks were
performed by Neuromed and/or its Affiliates internally prior to the
Closing Date and in a manner that is reasonably calculated to
result in approval of the NDA for Product at the earliest possible
date and for the indications covered by the Development Plan.
Neuromed will perform, and will cause its Affiliates to perform,
the Development in a prompt and professional manner, utilizing
appropriately qualified and knowledgeable personnel and all tasks
will be performed in accordance with industry standards for
services of the type performed.
2.2 Joint Development
Committee. Promptly after
the Effective Date, the Parties shall form a Joint Development
Committee (the “ JDC ” ). The JDC shall
(a) oversee Neuromed’s Development of the Product under
the Development Plan, (b) act as the forum for Mallinckrodt to
provide its input into Development and to keep informed about its
progress, and (c) offer its advice to expedite or aid the
progress of Development work. The JDC shall be comprised of a total
of six (6) appropriately qualified members (or such other even
number of members as is agreed to in writing by the Parties), with
each of Neuromed and Mallinckrodt designating one half of the total
number of members as its representatives. Either Party may replace
any of its respective JDC representatives with an appropriately
qualified representative at any time with reasonable prior written
notice to the other Party. The JDC will meet at least once each
month so long as Product is being developed by Neuromed under this
Agreement, provided that the JDC may agree from time-to-time to
meet at a greater or lesser frequency if appropriate under the
circumstances. JDC meetings may be conducted by videoconference,
teleconference or in person, as requested by a Party, except that
at least one of the meetings per year will be conducted in person.
The JDC will agree upon the time and location of the meetings. A
Neuromed representative of the JDC will act as the chair, and such
chair (or a designee) shall coordinate, prepare and circulate an
agenda for each JDC meeting reasonably in advance of the meeting. A
reasonable number of additional representatives of a Party may
attend meetings of the JDC in a non-voting capacity. The JDC shall
seek to reach consensus on matters coming before it, but will not
have any authority to decide development matters that are
Neuromed’s responsibility under this Agreement.
Notwithstanding the preceding provisions of this Section 2.2,
Mallinckrodt shall have the right to give its prior written
approval for those Development activities or actions set forth and
described on Appendix C attached hereto, such approval not
to be unreasonably withheld.
3.
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 promulgated under the
Securities Act of 1933, as amended; [*] denotes
omissions.
2.3 Payment of Development
Costs. Mallinckrodt shall
reimburse Neuromed on a monthly basis for all Development Costs (up
to the maximum amount as set forth below) actually incurred by
Neuromed in conducting the development of Product under this
Agreement through Neuromed obtaining NDA Approval. On a monthly
basis and no later than the tenth (10 th ) day of each calendar month for so long as
this Agreement is in effect with respect to Development, Neuromed
shall submit an invoice to Mallinckrodt setting forth the
Development Costs incurred in the prior month (accompanied by such
detail and supporting documentation as to the percentage of such
invoice attributable to work performed in the United States and as
to the internal and external costs and expenses, as Mallinckrodt
may reasonably request), and Mallinckrodt shall pay each such
invoice within thirty (30) days of receipt (provided, that any
such amounts paid by Mallinckrodt pursuant to this sentence may be
subject to later adjustment pursuant to the audit provisions of
Section 5 below). All payments due hereunder will be made in
United States dollars and, unless otherwise agreed in writing, will
be made by wire transfer to such bank as Neuromed may designate in
writing. The maximum amount of reimbursement by Mallinckrodt of
Neuromed development costs and expenses under this
Section 2.3, combined with any payment by Purchaser for Past
Development Costs under and pursuant to the Purchase Agreement, is
Sixteen Million Dollars ($16,000,000). At such time as Mallinckrodt
has paid such maximum amount of reimbursement to Neuromed,
Mallinckrodt shall not be obligated to reimburse Neuromed for any
additional Development Costs, and Neuromed shall not be required to
continue Development efforts on the Product until such time as
Mallinckrodt has given approval for Neuromed’s continued
efforts (as contemplated in Section 2.4 below). Neuromed will
use good faith, diligent efforts to complete all the tasks covered
by the Development Plan within such maximum amount of
reimbursement.
2.4 Limitation on Neuromed
Development. Neuromed
shall not be obligated to conduct Development tasks or efforts
beyond those tasks set forth in the Development Plan. If FDA
requirements, or other matters, require that development efforts
and/or tasks, beyond those set forth in the Development Plan, be
undertaken in order to achieve NDA approval for the Product (the
“Additional Development Efforts” ), then the JDC
shall discuss in good faith and seek to agree on whether Neuromed
should conduct such required Additional Development Efforts. If the
Parties agree that Neuromed shall undertake any specific Additional
Development Efforts, Mallinckrodt and Neuromed shall amend the
Development Plan to reflect such Additional Development Efforts,
and Mallinckrodt shall reimburse Neuromed for all such Additional
Development Efforts undertaken under such amended Development Plan
(in accordance with the applicable procedures set forth in
Section 2.3 and even if the costs of such efforts exceed the
limitation in Section 2.3). If the Parties cannot agree on
whether Neuromed shall conduct any particular Additional
Development Efforts, then Mallinckrodt may, but shall not be
required, to conduct any such Additional Development Efforts needed
to obtain NDA Approval.
3. T RANSITION S ERVICES
3.1 Provision of Transition
Services . Neuromed will
use Commercially Reasonable Efforts to provide, and as necessary
will cause its Affiliates to provide, the Transition Services to
Mallinckrodt commencing promptly after the Effective Date,
as
4.
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 promulgated under the
Securities Act of 1933, as amended; [*] denotes
omissions.
reasonably requested by Mallinckrodt or as
needed to transition the Business and the Transferred Assets to
Mallinckrodt. Except as otherwise expressly provided in this
Agreement, Mallinckrodt will reimburse Neuromed for its reasonable
internal and out-of-pocket costs and expenses incurred in providing
the Transition Services, based on monthly invoices provided by
Neuromed. Neuromed will use Commercially Reasonable Efforts to
provide the facilities, personnel and other resources required for
performance of the Transition Services.
3.2 General Standards of
Performance . Neuromed
will provide, and will cause its Affiliates to provide, the
Transition Services with at least the same level of skill, quality,
care, timeliness and cost-effectiveness as such services, functions
and tasks were performed by Neuromed and/or its Affiliates
internally prior to the Closing Date and in a manner that would be
reasonably expected to enable Mallinckrodt to conduct the Business
related to the Transferred Assets after the Closing. Neuromed will
perform, and will cause its Affiliates to perform, the Transition
Services in a timely and professional manner and in accordance with
industry standards for services of the type performed. Neuromed
will comply, and will cause its Affiliates to comply, with all
applicable Laws and will obtain all applicable Governmental Permits
in connection with the performance of the Transition Services under
this Agreement.
3.3 Skills, Training, and
Experience . Neuromed
will ensure that Neuromed Personnel performing Transition Services
have sufficient skills, training and experience to enable them to
perform the Transition Services with the same level of skill,
quality, care, timeliness and cost-effectiveness as similar
services, functions and tasks are performed for
Neuromed.
3.4 Reduction in
Services . Mallinckrodt
may elect to suspend or not to receive any of the Transition
Services at any time, with or without cause, upon written notice to
Neuromed. If Mallinckrodt suspends or elects not to receive a
Transition Service, Mallinckrodt will pay to Neuromed all amounts
due for such discontinued service prior to the effective date of
discontinuance.
3.5 Additional
Services . If
Mallinckrodt reasonably requests that Neuromed perform additional
services not included within the scope of the Transition Services
described on Appendix B, then the Parties will promptly
negotiate in good faith with a view toward adding such additional
services to Schedule B on terms and conditions substantially
similar to those set forth in this Agreement.
3.6 Service Fees
. In consideration for the
Transition Services to be performed by Neuromed, Mallinckrodt shall
pay Neuromed internal, at the applicable portion FTE Rate based on
the actual amount of time any given individual is engaged in the
performance of Transition Services, and external costs incurred by
Neuromed in performing the Transition Services, as reflected in
monthly invoices to Mallinckrodt. Mallinckrodt shall pay each such
invoice within thirty (30) days of receipt. All payments due
hereunder will be made in United States dollars and, unless
otherwise agreed in writing, will be made by wire transfer to such
bank as Neuromed may designate in writing.
5.
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 promulgated under the
Securities Act of 1933, as amended; [*] denotes
omissions.
4. Compensation and Benefits.
All Neuromed Personnel performing
Development work or providing Transition Services under this
Agreement will be deemed to be employees or representatives solely
of Neuromed (or its Affiliates) for purposes of all compensation
and employee benefits and not to be employees or representatives of
Mallinckrodt. Neuromed (or its Affiliates) will be solely
responsible for payment of (a) all income, disability,
withholding and other employment taxes and (b) all medical
benefit premiums, vacation pay, sick pay or other fringe benefits
for any employees, agents or contractors of Neuromed who perform
any tasks or services hereunder. All Neuromed Personnel will be
under the direction, control and supervision of Neuromed, and
Neuromed will have the sole right to exercise all authority with
respect to the employment, termination, assignment and compensation
of such Neuromed Personnel.
5. Audit Rights.
Upon at least thirty (30) days
prior written notice from Mallinckrodt and not more than twice in
each calendar year, Neuromed shall permit, and shall require its
Affilia