Exhibit 10.1

Execution Version

AMENDMENT NO. 1

TO

CO-DEVELOPMENT AND LICENSE AGREEMENT

This AMENDMENT NO. 1 TO CO-DEVELOPMENT AND LICENSE AGREEMENT (this “Amendment”),
dated as of June 13, 2017 (the “Amendment Execution Date”), is made by and
between Janssen Pharmaceutica NV, a corporation organized and existing under the
laws of Belgium (“Janssen”) and Minerva Neurosciences, Inc., a corporation
organized under the laws of the State of Delaware (“Minerva”). Janssen and
Minerva are sometimes referred to herein individually as a “Party” and
collectively as the “Parties.”

WHEREAS, the Parties have previously entered into that certain Co-Development
and License Agreement dated as of February 13, 2014 (the “License Agreement”)
(capitalized terms used herein but not otherwise defined shall have the meaning
ascribed to such terms in the License Agreement); and

WHEREAS, the Parties now desire to amend the License Agreement as set forth
herein;

NOW, THEREFORE, in consideration of the foregoing, of the mutual promises set
forth herein, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties hereto, intending
legally to be bound, hereby agree as follows:

ARTICLE I

AMENDMENT OF LICENSE AGREEMENT

1.1. The amendments to the License Agreement set forth in this Article I shall
take effect on the Amendment Effective Date.

1.2. Clause (ii) of Section 2.1 of the License Agreement is hereby deleted in
its entirety and replaced with the following:

“(ii) solely for purposes of seeking Regulatory Approval of Licensed Products in
the Minerva Territory in the Field or solely for purposes of supporting
Regulatory Approval of Licensed Products in the Janssen Territory in the
insomnia indication (provided, however, that such license shall not alter the
rights and obligations of the Parties under Section 3.11)”

1.3. Clause (ii) of Section 2.3 of the License Agreement is hereby deleted in
its entirety and replaced with the following:

“(ii) solely for purposes of seeking Regulatory Approval of Licensed Products in
the Minerva Territory in the Field (outside of the insomnia indication) or
solely for purposes of supporting Regulatory Approval of Licensed Products in
the Janssen Territory in the insomnia indication (provided, however, that such
license shall not alter the rights and obligations of the Parties under
Section 3.11)”

 

1

--------------------------------------------------------------------------------

1.4. Clause (i) of Section 3.3(c) of the License Agreement is hereby deleted in
its entirety and replaced with the following:

“(i) If the disputed matter relates to the Development or Manufacture of a
Licensed Product, including any amendment of the Development Plan or Development
Budget, then (A) Minerva shall have final decision making authority to the
extent such matter relates to the Development of a Licensed Product for the
insomnia indication (provided, however, that Minerva shall not have the right to
amend the preclinical studies, safety studies or Phase I Trials set forth on
Annex 1 (the “Ongoing Preclinical/Safety/Phase I Studies”) without the prior
written approval of Janssen) and (B) otherwise, Janssen shall have final
decision making authority (provided, however, that if Janssen and Minerva
disagree on whether any action in respect of quality, regulatory and medical
safety issues that Janssen is taking in the Development of a Licensed Product
for any indication other than the insomnia indication (or Minerva is taking in
relation to the insomnia indication) could have an adverse impact on the
Development of a Licensed Product for the insomnia indication (or any indication
other than the insomnia indication, in the case of Janssen), the matter (an
“Expert Dispute”) will be referred upon the request of either Party to an
independent Third Party expert in accordance with Section 13.6).”

1.5. Clause (i) of Section 3.10(f) of the License Agreement is hereby deleted in
its entirety and replaced with the following:

“(i) Cost Sharing.

 

  (A)

After the Amendment Effective Date, Janssen shall be solely responsible for all
Development Costs (including any Development Costs payable by Minerva but not
yet paid as of the Amendment Effective Date (which Janssen hereby expressly
waives)) for the Phase II Trials MDD2001, MDD2002, and ISM2005, the Ongoing
Preclinical/Safety/Phase I Studies, the preclinical studies, safety studies and
Phase I Trials set forth on Annex 2 (collectively, the “DP4 Activities”).
Minerva shall have no further obligation to share in any Development Costs for
DP4 Activities. Minerva may not exercise its final decision making authority
under Section 3.3(c)(i) to amend the Development Plan or the Development Budget
in a manner that would increase Development Costs for the DP4 Activities above
(or would accelerate such Development Costs, so that they would be incurred
sooner) than the total amounts budgeted for the DP4 Activities in (x) the
preliminary budget attached hereto as Annex 3 or (y) if the JSC has approved a
Development Budget, the latest Development Budget approved by the JSC (without
the exercise of final decision making authority by either Party).
Notwithstanding the foregoing, if Janssen does not consent to any such increase
or acceleration, then (1) Minerva may

 

2

--------------------------------------------------------------------------------

  elect to fund one hundred percent (100%) of such additional or accelerated
Development Costs and (2) if Minerva makes such an election, the JSC will update
the applicable activity in the Development Plan to reflect such increase or
acceleration.

 

  (B) After the Amendment Effective Date, Janssen shall be solely responsible
for all Development Costs described in clause (e) of the definition of
“Development Costs” set forth in Section 1.27 that are incurred on or prior to
Decision Point 4 (including any such Development Costs payable by Minerva but
not yet paid as of the Amendment Effective Date (which Janssen hereby expressly
waives)) (any such Development Costs incurred during such period, the “DP4 PDMS
Costs”). Minerva shall have no further obligation to share in any DP4 PDMS
Costs. Minerva may not exercise its final decision making authority under
Section 3.3(c)(i) to amend the Development Plan or the Development Budget in a
manner that would increase DP4 PDMS Costs above (or would accelerate such
Development Costs, so that they would be incurred sooner) than the total amounts
budgeted for the DP4 PDMS Costs in (x) the preliminary budget attached hereto as
Annex 3 or (y) if the JSC has approved a Development Budget, the latest
Development Budget approved by the JSC (without the exercise of final decision
making authority by either Party). Notwithstanding the foregoing, if Janssen
does not consent to any such increase or acceleration, (1) Minerva may elect to
fund one hundred percent (100%) of such additional or accelerated Development
Costs and (2) if Minerva makes such an election, the JSC will update the
applicable activity in the Development Plan to reflect such increase or
acceleration. Janssen may not exercise its final decision making authority under
Section 3.3(c)(i) to amend the Development Plan or the Development Budget in a
manner that would decrease DP4 PDMS Costs below (or would delay such Development
Costs, so that they would be incurred later) than the total amounts budgeted for
the DP4 PDMS Costs in (x) the preliminary budget attached hereto as Annex 3 or
(y) if the JSC has approved a Development Budget, the latest Development Budget
approved by the JSC (without the exercise of final decision making authority by
either Party).

 

  (C)

Minerva shall be solely responsible for all Development Costs for Phase III
Trials of a Licensed Product in the insomnia indication and related Development
activities, including activities related to initiation of such Phase III

 

3

--------------------------------------------------------------------------------

  Trials (collectively, “PIII Insomnia Activities”). For purposes of this
Section 3.10(f)(i)(C), any clinical trial that satisfies both the definition of
Phase II Trial set forth in Section 1.71 and the definition of Phase III Trial
set forth in Section 1.74 shall be deemed to be a Phase III Trial. If the
Parties disagree as to whether a proposed Phase II Trial in the insomnia
indication also satisfies the definition of Phase III Trial, such matter shall
be an Expert Dispute that will be referred upon the request of either Party to
an Expert in accordance with Section 13.6.

 

  (D) The Parties shall share, on a sixty percent (60%) to forty percent (40%)
basis (Janssen:Minerva), all Development Costs that are not related to DP4
Activities or PIII Insomnia Activities or that are not DP4 PDMS Costs.
Notwithstanding the foregoing sentence, the provisions of Section 3.10(c)(ii)
shall still apply in the event a Party elects not to share Development Costs in
accordance with the provisions of such Section 3.10(c)(ii).

 

  (E) Notwithstanding the provisions of Section 3.10(f)(i)(D) to the contrary,
if either Party exercises its final decision-making authority under
Section 3.3(c)(i) to start any activity that is not set forth on Annex 1 or
Annex 2 (whether or not such activity is in the Development Plan as of the
Amendment Effective Date) prior to Decision Point 4, such Party shall bear one
hundred percent (100%) of the Development Costs for such activity that are
incurred on or prior to Decision Point 4. For clarity, Development Costs
incurred for such activity after Decision Point 4 shall be shared in accordance
with Section 3.10(f)(i)(D).”

1.6. Clause (iv) of Section 3.10(f) of the License Agreement is hereby deleted
in its entirety.

1.7. Clause (ii) of Section 3.10(g) of the License Agreement is hereby deleted
in its entirety and replaced with the following:

“(ii) At any time following Decision Point 4, Minerva shall have the right, but
not the obligation, to opt out of further joint Development of the Licensed
Products for the Initial Indications and Initial Formulations by giving Janssen
written notice of such election, which election shall be effective thirty
(30) days after providing such notice and shall constitute a termination of this
Agreement pursuant to Section 11.5(a), subject to Section 11.6(b).”

 

4

--------------------------------------------------------------------------------

1.8. Clause (iii) of Section 3.10(g) of the License Agreement (excluding
subclauses (A) through (G) thereof) is hereby deleted in its entirety and
replaced with the following:

“(iii) At any time following Decision Point 4, Janssen shall have the right, but
not the obligation, to opt out of further joint Development of the Licensed
Products by giving Minerva written notice of such election, which election shall
be effective ninety (90) days after providing written notice of such election.
In the event that Janssen makes such election (and provided that Minerva does
not make a corresponding election pursuant to Section 3.10(g)(ii)):”

1.9. Subclause (F) of Clause (iii) of Section 3.10(g) of the License Agreement
is hereby deleted in its entirety and replaced with the following:

“(F) the royalties payable by Minerva pursuant to Section 6.2(a) with respect to
Net Sales of Licensed Products sold by Minerva and its Affiliates and
Sublicensees in the Minerva Territory (as such territory is amended pursuant to
Section 3.10(g)(iii)(A)) that are allocable to an indication other than the
insomnia indication shall be reduced to six percent (6%) of such Net Sales,
subject to potential further adjustment pursuant to Section 3.10(c)(ii),
Section 6.2(b) or Section 6.2(c) (for clarity Minerva is not obligated to pay to
Janssen royalties on Net Sales of any Licensed Products sold by Minerva or its
Affiliates and Sublicensees in the Minerva Territory (as such territory is
amended pursuant to Section 3.10(g)(iii)(A)) allocable to the insomnia
indication); and”

1.10. Section 6.2(a) of the License Agreement is hereby deleted in its entirety
and replaced with the following:

“(a) Royalty Rate and Royalty Term. In accordance with the terms of this
Section 6.2, Minerva shall pay to Janssen royalties in the amount of seven
percent (7%) of Net Sales of all Licensed Products sold by Minerva and its
Affiliates and Sublicensees in the Minerva Territory that are allocable to an
indication other than the insomnia indication, subject to any royalty rate
reduction made pursuant to Section 3.10(c)(ii), Section 3.10(g)(iii),
Section 6.2(b) or Section 6.2(c). Such royalties shall be payable, on a
country-by-country and Licensed Product-by-Licensed Product basis, beginning
upon First Commercial Sale of a Licensed Product in a particular country in the
Minerva Territory that is allocable to an indication other than the insomnia
indication until the latest of: (i) the ten (10) year anniversary of the First
Commercial Sale of such Licensed Product in such country that is allocable to an
indication other than the insomnia indication; (ii) the expiration of the last
to expire Janssen Patent or Program Patent Covering (x) the Compound of the
Licensed Product as a composition of matter in such country in the Minerva
Territory or (y) the labeled use of such Licensed Product for an indication
other than the insomnia indication in such country in the Minerva Territory; or
(iii) the end of the period during which such Licensed Product is subject to
Regulatory Exclusivity in such country (such period for a particular Licensed
Product in a particular country, the “Minerva Royalty Term”). For clarity,
Minerva is not obligated to pay to Janssen royalties on Net Sales of any
Licensed Products sold by Minerva or its Affiliates and Sublicensees in the
Minerva Territory that are allocable to the insomnia indication. If (A) a
Licensed Product is approved in any country in the Minerva Territory for any
indication, (B) the Parties expect or anticipate that such Licensed Product will
be approved in such country for a second indication and (C) either of such
indications is the insomnia indication, then, at least six (6) months before the
expected date of approval of

 

5

--------------------------------------------------------------------------------

such Licensed Product in such country for the second indication, the JSC will
develop and approve a methodology that will be used to allocate Net Sales of
such Licensed Product in such country by indication using primary and/or
secondary market product level data from Third Party reporting services, such as
IMS Health; provided, however, that if such data is not available with respect
to such country, the JSC will develop and approve an alternate methodology to
allocate Net Sales of such Licensed Product in such country by indication.
Notwithstanding Section 3.3(c)(ii), in the event the JSC does not approve such a
methodology at least three (3) months prior to the anticipated approval of such
Licensed Product for such second indication, then the Parties shall mutually
select and engage an independent Third Party accounting firm that has no
auditing or other financial relationship with either Party or any of its
Affiliates to determine such methodology. Such accounting firm shall, as soon as
reasonably practicable after such firm is engaged, deliver a report to each
Party with its analysis and determination of such methodology. The determination
of such firm shall be final and binding on the Parties, and the costs of such
firm’s services shall be shared equally by the Parties.”

1.11. The License Agreement is hereby amended by adding a new Section 6.4 as
follows:

“6.4 Additional Payments and Undertakings.

(a) As partial consideration for entering into the Amendment, Janssen shall pay
a one-time, non-refundable, non-creditable, payment of thirty million dollars
($30,000,000) to Minerva two (2) Business Days after the Amendment Effective
Date.

(b) As partial consideration for entering into the Amendment, Janssen shall pay
to Minerva certain milestone payments (“Milestone Payments”) following the first
occurrence of certain milestone events with respect to a Licensed Product, as
set forth in the following table (the “Milestone Events”):

 

Milestone Event

   Milestone Payment  

Dosing of the fifth patient in a Phase III Trial for the insomnia indication

   $ 20,000,000  

50% of the patients are enrolled in the first Phase III Trial for the insomnia
indication, based upon the expected patient enrollment as described in the
protocol for such Phase III Trial

   $ 20,000,000  

Janssen shall pay to Minerva the applicable Milestone Payment in the manner
described below after the first occurrence of such applicable Milestone Event
with respect to the first Licensed Product. For clarity, each Milestone Payment
is payable only once; no Milestone Payment shall be payable for subsequent or
repeated achievements of such Milestone Event with one or more of the same or
different Licensed Products. Each of the Milestone Payments shall be
non-refundable and non-creditable. Minerva shall report to Janssen its
achievement of each Milestone Event for which payment to Minerva is due, within
ten (10) days after such achievement has occurred, and Minerva shall
concurrently therewith invoice Janssen for the applicable Milestone Payment.
Janssen will pay each such invoice within sixty (60) days of its receipt
thereof.”

 

6

--------------------------------------------------------------------------------

1.12. The License Agreement is hereby amended by adding a new Section 13.6 as
follows:

“13.6 Disputes Relating to Development. In the event either Party requests the
resolution of an Expert Dispute by an independent Third Party expert in
accordance with Section 3.3(c)(i), such Expert Dispute shall be resolved as
described in this Section 13.6.

(a) Following such request, the Parties shall select and agree upon a mutually
acceptable independent, disinterested and impartial Third Party who is
knowledgeable in the field of pharmaceutical drug development (the “Expert”). If
the Parties do not mutually agree upon an Expert within fifteen (15) Business
Days, then upon request by either Party, an arbitrator appointed by JAMS shall
select the Expert from a list of three (3) potential Third Parties provided by
each Party.

(b) Within five (5) Business Days following selection or appointment of the
Expert, each Party shall provide the Expert and the other Party with a concise
written proposal for resolution of the Expert Dispute and the reasons such
proposed resolution should be adopted. If so requested by the Expert, each Party
shall make oral submissions to the Expert based on such Party’s written proposal
delivered pursuant to this Section 13.6(b), and each Party shall have the right
to be present during any such oral submissions.

(c) The Expert shall select one of the Party’s proposals as his or her final
decision no later than five (5) Business Days after the submission of the
written proposals and, if any, oral submissions. In making his/her
determination, the Expert shall take into account as a key criteria not causing
a material cost and/or delay to the Development of Licensed Products for the
insomnia indication. The Expert shall not have the authority to modify either
Party’s proposal or render any substantive decision other than to so select the
proposal of a Party as set forth in its respective written proposal. The
Expert’s determination shall be the final and binding remedy of the Expert
Dispute.

(d) Unless otherwise mutually agreed upon by the Parties, the in-person portion
(if any) of such proceedings shall be conducted in New York, New York. The
Parties shall share equally the costs and fees of the Expert in connection with
any proceeding under this Section 13.6. Each Party shall bear its own costs and
attorneys’ and witnesses’ fees and associated costs and expenses incurred in
connection with any proceeding under this Section 13.6.

(e) The Parties shall use, and shall direct the Expert to use, diligent efforts
to resolve any Expert Dispute under this Section 13.6 within twenty
(20) Business Days after the selection of the Expert, or if resolution within
twenty (20) Business Days is not reasonably achievable, as determined by the
Expert, then as soon thereafter as is reasonably practicable.”

 

7

--------------------------------------------------------------------------------

ARTICLE II

CONTINUATION OF LICENSE AGREEMENT

2.1. Except as expressly modified in Article I, the License Agreement shall
remain in full force and effect following the Amendment Effective Date.

ARTICLE III

GENERAL

3.1. Governing Law; Service of Process. This Amendment shall be governed by and
construed under the substantive laws of the State of New York, without regard to
conflicts of law or choice of law rules that would provide for application of
the law of a jurisdiction outside New York. The Parties agree that service of
process upon them in any legal action may be made if delivered in person, by
courier service, by telegram, by facsimile or by first class mail, and shall be
deemed effectively given upon receipt. Any dispute, claim or controversy that
may arise under, out of, in connection with or relating to this Amendment shall
be governed by the provisions of Article 13 of the License Agreement.

3.2. Amendments. No subsequent alteration, amendment, change or addition to this
Amendment shall be binding upon the Parties unless reduced to writing and signed
by an authorized officer of each Party.

3.3. Headings. All paragraph headings in this Amendment are for convenience of
reference only and will not be construed as a limitation of the scope of the
particular sections to which they refer.

3.4. Counterparts. This Amendment may be executed in two or more counterparts,
each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument. Facsimile signatures, including
signatures in a fixed electronic format such as PDF, shall have the same effect
as originals.

3.5. Successors and Assigns. This Amendment may only be assigned by a Party in
connection with an assignment of the License Agreement in accordance with the
provisions of Section 14.7 of the License Agreement. This Amendment will apply
to, inure to the benefit of and be binding upon the Parties hereto and upon
their respective successors and permitted assigns. The Parties agree that this
Amendment is not intended by either Party to give any benefits, rights,
privileges, actions or remedies to any person, partnership, firm or corporation
as a third party beneficiary or otherwise under any theory of law, except as
expressly set forth herein.

3.6. Severability. If any one or more of the provisions of this Amendment is
held to be invalid or unenforceable by any court of competent jurisdiction from
which no appeal can be or is taken, the provision shall be considered severed
from this Amendment and shall not serve to invalidate any remaining provisions
hereof. The Parties shall make a good faith effort to replace any invalid or
unenforceable provision with a valid and enforceable provision such that the
objectives contemplated by the Parties when entering this Amendment may be
realized.

 

8

--------------------------------------------------------------------------------

3.7. Entire Agreement. The License Agreement, as amended by this Amendment,
constitutes the entire understanding among the Parties with respect to the
subject matter hereof and thereof and supersedes all prior discussions, writings
and agreements (oral or written) relating to the subject matter hereof and
thereof.

3.8. Effectiveness.

(a) For purposes of this Amendment, “Amendment Effective Date” means the Closing
Date (as defined in the Stock Repurchase Agreement, dated as of the Amendment
Execution Date, by and between Minerva and Johnson & Johnson Innovation-JJDC
Inc. (f/k/a Johnson & Johnson Development Corporation), an Affiliate of Janssen
(the “Stock Repurchase Agreement”)).

(b) This Amendment shall automatically terminate, without any further action on
the part of either Party, if (i) the Amendment Effective Date does not occur on
or prior to August 31, 2017, unless the Parties mutually agree to a later date
or (ii) the Stock Repurchase Agreement is terminated in accordance with its
terms prior to the occurrence of Amendment Effective Date. In the event of the
termination of this Amendment, neither Janssen nor Minerva shall have any
liability or obligation to the other under or in respect of this Amendment,
except to the extent of any fraud or intentional or willful breach of this
Amendment. In the event of any such termination, (i) the License Agreement shall
continue in full force and effect in accordance with its terms, (ii) this
Amendment shall become void and have no effect and (iii) the amendments to the
License Agreement set forth in Article I shall be abandoned without further
action by the Parties hereto, except that the provisions of this Article III
shall survive the termination of this Amendment.

 

9

--------------------------------------------------------------------------------

IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be executed
and delivered as of the Amendment Execution Date.

 

JANSSEN PHARMACEUTICA NV

 

By:     /s/ Tom Aelbrecht                                        

Name: Tom Aelbrecht

Title: Head Janssen Campus Office

Member of the Management Board

 

By:     /s/ Stef Heylen                                        

Name: Stef Heylen

Title: Chief Operating Officer, Janssen R&D

Managing Director – Chairman of the Management Board

 

MINERVA NEUROSCIENCES, INC.

 

By:     /s/ Remy Luthringer                            

Name: Remy Luthringer, Ph.D.

Title: President and CEO

SIGNATURE PAGE TO AMENDMENT NO. 1 TO

LICENSE AGREEMENT

 

--------------------------------------------------------------------------------

Annex 1

Ongoing Preclinical/Safety/Phase I Studies

 

  1. 428479922EDI1014 SD Elderly PK Study [Completed]

 

  2. 42847922EDI1008 C-14 ADME (AM) Study

 

  3. Carc study 2y rats [started March 2017] 1

 

  4. Carc 1mo rep [started June 2017] 2

 

 

1  Note: The budgeted amount for this study is included in the line item
entitled “DSSc” on Annex 3.

2  Note: The budgeted amount for this study is included in the line item
entitled “DSSc” on Annex 3.

 

--------------------------------------------------------------------------------

Annex 2

Planned Preclinical/Safety/Phase I Studies

 

  1. 42847922MDD1003 Oral Contraceptives DDI [scheduled to start Sept 2017]

 

  2. 42847922MDD1004 Relative BA & Food Effect [scheduled to start 1H 2018]

 

  3. 42847922MDD1007 Thorough QT Study [scheduled to start Dec 2017]

 

  4. 42847922MDD1009 Phase 1b MDD Monotherapy Trial [scheduled to start July
2017] 3

 

  5. Rat fertility [scheduled to start Mar 2018], if determined to be necessary.
4

 

  6. EDI1015 / DDI1015 [scheduled to start 2018, following consultation with
Health Authorities to potentially replace with modeling]

 

  7. Renal Impairment [protocol still to be developed]

 

  8. Hepatic Impairment [protocol still to be developed]

The following studies are scheduled to start after Decision Point 4, but if
Janssen exercises its final decision-making authority to commence any of such
studies prior to Decision Point 4, such studies shall be considered DP4
Activities:

 

  1. 42847922MDD1006 Driving Study in Elderly HV

 

  2. 42847922MDD1005 Driving Study in Healthy Volunteers

 

  3. 42847922M1008 Abuse Liability

 

  4. Juv. tox 3mo rat 5

 

 

3  Note: The proposed budgeted amount for this study has not yet been presented
to or discussed by the JDT or approved by the JSC, so is not shown on Annex 3.
For clarity, this does not affect Janssen’s obligations under Section 3.10(f)(i)
to be solely responsible for all Development Costs for this study.

4  Note: The budgeted amount for this study is included in the budget line item
entitled “DSSc” on Annex 3.

5  Note: The budgeted amount for this study is included in the budget line item
entitled “DSSc” on Annex 3.

 

--------------------------------------------------------------------------------

Annex 3

Preliminary Development Budget

[See attached.]

Note: The FTE numbers and dollar amounts shown on Annex 3 reflect the number of
employees expected to be necessary to conduct the budgeted Development Plan
studies. The Parties acknowledge that Minerva sent a proposal to Janssen on
April 28 that includes FTE numbers and dollar amounts for Minerva employees.
Because the JDT has not yet discussed and the JSC has not yet approved this
proposal, it is not reflected on Annex 3. The Parties agree that the JDT will
discuss this proposal at its first meeting that occurs after the Amendment
Effective Date.

 

--------------------------------------------------------------------------------

LOGO [g413527dsp019.jpg]

Preliminary budget 2017, 2018 & 2019 Orexin II April 7, 2017

--------------------------------------------------------------------------------

LOGO [g413527dsp020.jpg]

Preliminary budget: Summary Prelim 2017 Prelim 2018 Prelim 2019 Total Total
Total Group Description per function aMDD ISM aMDD + ISM aMDD ISM aMDD + ISM
aMDD ISM aMDD + ISM PDMS Subtotal 12,018 155 12,173 10,323 - 10,323 4,245 -
4,245 DSSc Subtotal 2,520 225 2,746 1,336 - 1,336 3,834 186 4,020 Clinical aMD
42847922EDI1008 C-14 ADME (AM) Study 910 2 - Clinical aMD 42847922EDI1014 SD
Elderly PK Study 1,235 - - Clinical aMD 42847922MDD1003 Oral Contraceptives DDI
371 808 - Clinical aMD 42847922MDD1004 Relative BA & Food Effect St 775 1,051 -
Clinical aMD 42847922MDD1005 Driving Study in Healthy Volunteers 1,293 1,170
Clinical aMD 42847922MDD1006 Driving Study in Elderly HV 1,293 1,170 Clinical
aMD 42847922MDD1007 Thorough QT Study 1,312 1,342 - Clinical aMD 42847922MDD1008
Abuse Liability Study 823 - Clinical aMD 42847922MDD2001 2-stage Phase 2B Study
of A 8,150 15,359 1,744 Clinical aMD 42847922EDI1015 Fluvoxamine DDI Study
(Placeholder) 181 - Clinical aMD 42847922MDD2002 Phase 2B H2H Differentiatio
4,668 8,677 3,464 Clinical aMD Study in Patients with Renal Impairment - 64
Clinical aMD Study in Patients with Hepatic Impairment - 78 Clinical aMD Ph III
MDD Long-Term Safety/Efficacy #2 2,450 8,050 Clinical aMD Ph III Pivotal Dose
Confirmation Study #1 175 7,700 Clinical aMD Ph III Relapse Prevention Study 175
7,700 Clinical aMD Ph III Pivotal Dose Confirmation Study #2 175 10,850 Clinical
aMD Ph III MDD Long-Term Safety/Efficacy #1 3,150 9,450 Clinical ISM
42847922ISM2005 Ph IIB Dose-Range Differentiation Study 2,819 23,598 6,456
Clinical ISM Ph III Pivotal Dose Confirmation Study #1 - 3,579 Clinical ISM Ph
III Pivotal Dose Confirmation Study #2 - 3,579 Clinical ISM Ph III Parallel
Group Differentiation Trial #1 - 1,465 Clinical ISM Ph III Parallel Group
Differentiation Trial #2 - 525 Clinical aMD General Clinical 1,768 700 700
Clinical ISM General Clinical 333 - 350 Clinical Subtotal 19,188 3,152 22,340
37,654 23,598 61,252 52,140 15,954 68,094 Other general support 2,545 525 3,070
5,950 1,050 7,000 7,000 1,400 8,400 Total Orexin 2 Spend (ex BU) 36,271 4,057
40,328 55,262 24,648 79,910 67,219 17,540 84,759

--------------------------------------------------------------------------------

LOGO [g413527dsp021.jpg]

Preliminary budget: OOP Prelim 2017 Prelim 2018 Prelim 2019 TOTAL TOTAL TOTAL
aMDD + aMDD + aMDD + Group Indication Description per function aMDD ISM ISM aMDD
ISM ISM aMDD ISM ISM PDMS 4,211 - 4,211 3,323 - 3,323 745 745 DSSc 1,867 114
1,981 1,196 - 1,196 3,484 186 3,670 Clinical aMDD 42847922EDI1008 C-14 ADME (AM)
Study 598 2 Clinical aMDD 42847922EDI1014 SD Elderly PK Study 759 - Clinical
aMDD 42847922MDD1003 Oral Contraceptives DDI 196 458 Clinical aMDD
42847922MDD1004 Relative BA & Food Effect Study 443 701 Clinical aMDD
42847922MDD1005 Driving Study in Healthy Volunteers 593 470 Clinical aMDD
42847922MDD1006 Driving Study in Elderly HV 593 470 Clinical aMDD
42847922MDD1007 Thorough QT Study 689 992 Clinical aMDD 42847922MDD1008 Abuse
Liability Study 123 Clinical aMDD 42847922MDD2001 2-stage Phase 2B Study of Adj.
Treatment 7,379 13,609 1,044 Clinical aMDD 42847922EDI1015 Fluvoxamine DDI Study
(Placeholder) 181 Clinical aMDD 42847922MDD2002 Phase 2B H2H Differentiation
Study vs Qu 3,736 7,977 3,114 Clinical aMDD Study in Patients with Renal
Impairment 64 Clinical aMDD Study in Patients with Hepatic Impairment 78
Clinical ISM 42847922ISM2005 Ph IIB Dose-Range Differentiation Study 2,497
21,848 5,756 Clinical ISM Ph III Pivotal Dose Confirmation Study #1 2,879
Clinical ISM Ph III Pivotal Dose Confirmation Study #2 2,879 Clinical ISM Ph III
Parallel Group Differentiation Trial #1 940 Clinical 13,800 2,497 16,297 25,229
21,848 47,077 5,240 12,454 17,694 Other TOTAL Orexin 2 Lead Program Spend JnJ
OOP $ 19,878 2,611 22,489 29,747 21,848 51,595 9,469 12,640 22,109

--------------------------------------------------------------------------------

LOGO [g413527dsp022.jpg]

Preliminary budget: FTE $ Prelim 2017 Prelim 2018 Prelim 2019 TOTAL TOTAL TOTAL
Group Indication aMDD ISM aMDD + ISM aMDD ISM aMDD + ISM aMDD ISM aMDD + ISM
PDMS 7,807 155 7,962 7,000 - 7,000 3,500 - 3,500 - - DSSc 654 111 765 140 - 140
350 - 350 - - Clinical aMDD 42847922EDI1008 C-14 ADME (AM) Study 312 - Clinical
aMDD 42847922EDI1014 SD Elderly PK Study 476 - Clinical aMDD 42847922MDD1003
Oral Contraceptives DDI 175 - 350 Clinical aMDD 42847922MDD1004 Relative BA &
Food Effect Study 333 - 350 Clinical aMDD 42847922MDD1006 Driving Study in
Elderly HV - - 700 700 Clinical aMDD 42847922MDD1005 Driving Study in Healthy
Volunteers - - 700 700 Clinical aMDD 42847922MDD1007 Thorough QT Study 623 - 350
Clinical aMDD 42847922MDD1008 Abuse Liability Study - - 700 Clinical aMDD
42847922MDD2001 2-stage Phase 2B Study of Adj. Treatment in 771 - 1,750 700
Clinical aMDD 42847922MDD2002 Phase 2B H2H Differentiation Study vs Que 933 -
700 350 Clinical aMDD Ph III MDD Long-Term Safety/Efficacy #2 - - 2,450 8,050
Clinical aMDD Ph III Pivotal Dose Confirmation Study #1 - - 175 7,700 Clinical
aMDD Ph III Relapse Prevention Study - - 175 7,700 Clinical aMDD Ph III Pivotal
Dose Confirmation Study #2 - - 175 10,850 Clinical aMDD Ph III MDD Long-Term
Safety/Efficacy #1 - - 3,150 9,450 Clinical ISM 42847922ISM2005 Ph IIB
Dose-Range Differentiation Study - 322 1,750 700 Clinical ISM Ph III Pivotal
Dose Confirmation Study #1 - - 700 Clinical ISM Ph III Pivotal Dose Confirmation
Study #2 - - 700 Clinical ISM Ph III Parallel Group Differentiation Trial #2 - -
525 Clinical ISM Ph III Parallel Group Differentiation Trial #1 - - 525 Clinical
aMDD General Clinical support 1,768 - 700 700 - Clinical ISM General Clinical
support - 333 350 - - Clinical 5,389 655 6,043 12,425 1,750 14,175 46,900 3,500
50,400 Other general support 2,545 525 3,070 5,950 1,050 7,000 7,000 1,400 8,400
TOTAL Orexin 2 Lead Program Spend JnJ FTE # 16,394 1,446 17,839 25,515 2,800
28,315 57,750 4,900 62,650

--------------------------------------------------------------------------------

LOGO [g413527dsp023.jpg]

Preliminary budget: FTE # Prelim 2017 Prelim 2018 Prelim 2019 TOTAL TOTAL TOTAL
Group Indication aMDD ISM aMDD + ISM aMDD ISM aMDD + ISM aMDD Ism aMDD + ISM
PDMS 22 0 23 20 - 20 10 0 10 DSSc 2 0 2 0 - 0 1 - 1 Clinical aMDD
42847922EDI1008 C-14 ADME (AM) Study 1 - Clinical aMDD 42847922EDI1014 SD
Elderly PK Study 1 - Clinical aMDD 42847922MDD1003 Oral Contraceptives DDI 1 1
Clinical aMDD 42847922MDD1004 Relative BA & Food Effect Study 1 1 Clinical aMDD
42847922MDD1006 Driving Study in Elderly HV 2 2 Clinical aMDD 42847922MDD1005
Driving Study in Healthy Volunteers 2 2 Clinical aMDD 42847922MDD1007 Thorough
QT Study 2 1 Clinical aMDD 42847922MDD1008 Abuse Liability Study 2 Clinical aMDD
42847922MDD2001 2-stage Phase 2B Study of Adj. Treatme 2 5 2 Clinical aMDD
42847922MDD2002 Phase 2B H2H Differentiation Study vs 3 2 1 Clinical aMDD Ph III
MDD Long-Term Safety/Efficacy #2 7 23 Clinical aMDD Ph III Pivotal Dose
Confirmation Study #1 1 22 Clinical aMDD Ph III Relapse Prevention Study 1 22
Clinical aMDD Ph III Pivotal Dose Confirmation Study #2 1 31 Clinical aMDD Ph
III MDD Long-Term Safety/Efficacy #1 9 27 Clinical ISM 42847922ISM2005 Ph IIB
Dose-Range Differentiation Study 1 5 2 Clinical ISM Ph III Pivotal Dose
Confirmation Study #1 2 Clinical ISM Ph III Pivotal Dose Confirmation Study #2 2
Clinical ISM Ph III Parallel Group Differentiation Trial #2 2 Clinical ISM Ph
III Parallel Group Differentiation Trial #1 2 Clinical aMDD General Clinical
support 5 2 2 Clinical ISM General Clinical support 1 1 Clinical 15 2 17 36 5 41
134 10 144 Other aMDD Other Project Support 7 17 20 Other ISM Other Project
Support 2 3 4 Other general support 7 2 9 17 3 20 20 4 24 TOTAL Orexin 2 Lead
Program Spend JnJ FTE # 47 4 51 73 8 81 165 14 179