Certain information identified with brackets (“[***]”) has been excluded from
this exhibit because it both (i) is not material and (ii) would be competitively
harmful if publicly disclosed.

EXECUTION VERSION

EXHIBIT 10.1

 

COMMERCIAL SUPPLY AGREEMENT

MIN-101 Tablets

THIS COMMERCIAL SUPPLY AGREEMENT (“Agreement”) is made as of this 2 day of
September, 2019 (“Effective Date”)

BETWEEN

(1)

Minerva Neurosciences, Inc., an US company, with a place of business at 1601
Trapelo Road, Suite 286, Waltham, Massachusetts 02451 USA (“Client”); and

(2)

Catalent Germany Schorndorf GmbH, a German company., with a place of business at
Steinbeisstrasse 1-2, 73614 Schorndorf, Germany (“Catalent”).

RECITALS

A.

Client is a company that develops, markets and sells pharmaceutical products.

B.

Catalent is a leading provider of advanced technologies, and development,
manufacturing and packaging services for pharmaceutical, biotechnology and
consumer healthcare companies.

C.

Client desires to engage Catalent to provide certain services to Client in
connection with the processing of Client’s Product, and Catalent desires to
provide such services, all pursuant to the terms and conditions set out in this
Agreement.

THEREFORE, the parties agree as follows:

1.

DEFINITIONS

The following terms have the following meanings in this Agreement:

1.1“Acknowledgement” has the meaning set out in Clause 4.3.

1.2“Affiliate(s)” means, with respect to Client or any third party, any company,
corporation, firm, partnership or other entity that controls, is controlled by
or is under common control with such entity; and with respect to Catalent, Inc.
and any company, corporation, firm, partnership or other entity controlled by
Catalent, Inc.  For the purposes of this definition, “control” means the
ownership of at least 50% of the voting share capital of an entity or any other
comparable equity or ownership interest.

1.3“Agreement” has the meaning set out in the introductory paragraph, and
includes all its Attachments and other appendices (all of which are incorporated
herein by reference).

1.4“API” means the compound MIN-101 (Roluperidone), as further described in the
Specifications.

1.5“API Inventions” has the meaning set out in Clause 11.  

 

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EXECUTION VERSION

 

1.6“Applicable Laws” means, with respect to Client, all laws, statutes,
statutory provisions or subordinate legislation, currently in effect or enacted
or promulgated during the Term, and as amended from time to time, of each
jurisdiction in which API or Product is produced, marketed, distributed, used or
sold; and with respect to Catalent, all laws, statutes, statutory provisions and
subordinate legislation, currently in effect or enacted or promulgated during
the Term, and as amended from time to time, of the jurisdiction in which
Catalent Processes Product, including cGMP.

1.7“Batch” means a defined quantity of Product that has been or is being
Processed in accordance with the Specifications.

1.8“Catalent Defective Processing” has the meaning set out in Clause 5.2.

1.9“Catalent” has the meaning set out in the introductory paragraph.  Catalent
shall have the right to cause any of its Affiliates to perform any of its
obligations hereunder, and Client shall accept such performance as if it were
performance by Catalent. Catalent may not subcontract its obligations under this
Agreement without Client’s written consent.

1.10“Catalent Indemnitees” has the meaning set out in Clause 13.2.

1.11“Catalent IP” has the meaning set out in Clause 11.

1.12“cGMP” means current Good Manufacturing Practices promulgated by the
Regulatory Authorities in the jurisdictions included in Applicable Laws (as
applicable to Client and Catalent respectively).  This includes 2003/94/EEC
Directive (as supplemented by Volume 4 of EudraLex published by the European
Commission), as amended, if and as implemented in the relevant constituent
country.

1.13“Client” has the meaning set out in the introductory paragraph, or any
successor or permitted assign.

1.14“Client Indemnitees” has the meaning set out in Clause 13.1.

1.15“Client IP” has the meaning set out in Clause 11.

1.16“Client-supplied Materials” means any materials to be supplied by or on
behalf of Client to Catalent for Processing, as provided in Attachment A,
including API and reference standards.

1.17“Commencement Date” means the first date upon which a Regulatory Authority
approves Catalent as a manufacturer of any Product.

1.18“Confidential Information” has the meaning set out in Clause 10.1.

1.19“Contract Year” means each consecutive 12 months period beginning on the
Commencement Date or anniversary thereof, as applicable.

1.20“Defective Product” has the meaning set out in Clause 5.2.

1.21“Delayed Approval Fee” has the meaning set out in Clause 7.3.

1.22“Discloser” has the meaning set out in Clause 10.1.

1.23“Effective Date” has the meaning set out in the introductory paragraph.

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EXECUTION VERSION

 

1.24“Exception Notice” has the meaning set out in Clause 5.2.

1.25“Facility” means Catalent’s facility located in Schorndorf, Germany or such
other facility as agreed by the parties.

1.26“Firm Commitment” has the meaning set out in Clause 4.2.

1.27“Invention” has the meaning set out in Clause 11.  

1.28“Losses” has the meaning set out in Clause 13.1.

1.29“Minimum Revenue Requirement” has the meaning set out in Clause 4.1.

1.30“Process” or “Processing” means the compounding, filling or pressing,
producing and bulk packaging and secondary or retail packaging of
Client-supplied Materials and Raw Materials into Product by Catalent, in
accordance with the Specifications and under the terms of this Agreement.

1.31“Processing Date” means the day on which the first step of physical
Processing is scheduled to occur, as identified in an Acknowledgement.

1.32“Process Inventions” has the meaning set out in Clause 11.

1.33“Product” means the bulk pharmaceutical product containing the API, as more
specifically described in the Specifications.

1.34“Purchase Order” has the meaning set out in Clause 4.3.

1.35“Quality Agreement” has the meaning set out in Clause 9.7.

1.36“Raw Materials” means all raw materials, supplies, components and packaging
necessary to manufacture and ship Product in accordance with the Specifications,
as provided in Attachment A, but excluding Client-supplied Materials.

1.37“Recall” has the meaning set out in Clause 9.6.

1.38“Recipient” has the meaning set out in Clause 10.1.

1.39“Regulatory Approval” means any approvals, permits, product and/or
establishment licences, registrations or authorisations, including European
marketing authorisations and  applications and U.S. Investigational New Drug
applications, New Drug Applications and Abbreviated New Drug Applications, as
applicable, of any Regulatory Authorities that are necessary or advisable in
connection with the development, manufacture, testing, use, storage,
exportation, importation, transport, promotion, marketing, distribution or sale
of API or Product in the Territory.

1.40“Regulatory Authority” means the regulatory bodies or agencies in the
Territory that are responsible for (A) the regulation (including pricing) of any
aspect of pharmaceutical or medicinal products intended for human use or (B)
health, safety or environmental matters generally.  This includes the European
Medicines Agency; and in the United States, this includes the United States Food
and Drug Administration.

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EXECUTION VERSION

 

1.41“Representatives” of an entity means such entity’s duly-authorized officers,
directors, employees, agents, accountants, attorneys or other professional
advisors.

1.42“Review Period” has the meaning set out in Clause 5.2.

1.43“Rolling Forecast” has the meaning set out in Clause 4.2.

1.44“Specifications” means the procedures, requirements, standards, quality
control testing and other data and the scope of services as set out in
Attachment A, as modified from time to time in accordance with Clause 8.

1.45“Term” has the meaning set out in Clause 16.1.

1.46“Territory” means the European Union, United Kingdom, and the United States
of America, and any other country that the parties agree in writing to add to
this definition of Territory in an amendment to this Agreement; except shall not
include countries that are targeted by the comprehensive sanctions, restrictions
or embargoes administered by the United Nations, European Union, United Kingdom,
or the United States.

1.47“Unit Pricing” has the meaning set out in Clause 7.1(B).

1.48“Vendor” has the meaning set out in Clause 3.2(B).

2.

VALIDATION, PROCESSING & RELATED SERVICES

2.1Validation Services and Tech Transfer Services.  Catalent shall perform the
Product qualification, validation and stability services and the tech transfer
services as outlined in a separately agreed quotation.

2.2Supply and Purchase of Product.  Catalent shall Process Product in accordance
with the Specifications, Applicable Laws and this Agreement.    

2.3Other Related Services.  Catalent shall provide any other Product-related
services as the parties may agree in writing.  The terms and conditions of this
Agreement shall govern such services.

3.

MATERIALS

3.1Client-supplied Materials.

A.Client shall supply to Catalent for Processing, at Client’s cost, all
Client-supplied Materials, in quantities sufficient to meet Client’s
requirements for Product.  Client shall deliver such items and associated
certificates of analysis to the Facility no later than 60 days (but not earlier
than 90 days) before the Processing Date.  Client shall be responsible at its
cost for securing necessary export or import, or similar clearances, permits or
certifications required in respect of such supply. Catalent shall use such items
solely for Processing.  Prior to delivery of any such items, Client shall
provide to Catalent a copy of all associated material safety data sheets, safe
handling instructions and health and environmental information and any
regulatory certifications or authorizations that may be required under
Applicable Laws relating to the API and Product, and shall promptly provide any
updates thereto.

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EXECUTION VERSION

 

B.Following receipt of Client-supplied Materials, Catalent shall inspect such
items to verify their identity.  Unless otherwise expressly required by the
Specifications, Catalent shall have no obligation to test such items to confirm
that they meet the associated specifications or certificate of analysis or
otherwise; but in the event that Catalent detects a nonconformity with
Specifications, Catalent shall give Client prompt notice of such
nonconformity.  Catalent shall not be liable for any defects in Client-supplied
Materials, or in Product as a result of defective Client-supplied Materials,
unless Catalent failed to properly perform the foregoing obligations.  Catalent
shall follow Client’s reasonable written instructions in respect of return or
disposal of defective Client-supplied Materials, at Client’s cost.  

C.Client shall retain title to Client-supplied Materials at all times and shall
bear the risk of loss thereof.

3.2Raw Materials.  

A.Catalent shall be responsible for procuring Raw Materials as necessary to meet
the Firm Commitment.  Catalent shall not be liable for any delay in delivery of
Product if (i) Catalent is unable to obtain, in a timely manner, a particular
Raw Material necessary for Processing and (ii) Catalent placed orders for such
Raw Materials promptly following receipt of Client’s Firm Commitment.  In the
event that any Raw Material becomes subject to purchase lead time beyond the
Firm Commitment time frame, the parties will negotiate in good faith an
appropriate amendment to this Agreement, including Clause 4.2.

B.Catalent shall exercise control over its supply chain and shall audit its own
suppliers according to Catalent’s supplier qualification processes.  In certain
instances, Client may require a specific supplier, manufacturer or vendor
(“Vendor”) to be used for Raw Material.  In such an event, (i) such Vendor will
be identified in the Specifications and (ii) the Raw Materials from such Vendor
shall be deemed Client-supplied Materials for purposes of this Agreement.  If
the cost of the Raw Material from any such Vendor is greater than Catalent’s
costs for the same raw material of equal quality from other vendors, Catalent
shall add the difference between Catalent’s cost of the Raw Material and the
Vendor’s cost of the Raw Material to the Unit Pricing.  Client will be
responsible for all costs associated with qualification of any such Vendor who
has not been previously qualified by Catalent.

C.In the event of (i) a Specification change for any reason, (ii) obsolescence
of any Raw Material or (iii) termination or expiry of this Agreement, Client
shall bear the cost of any unused Raw Materials (including packaging), so long
as Catalent purchased such Raw Materials in quantities consistent with Client’s
most recent Firm Commitment and the vendor’s minimum purchase obligations.

3.3Artwork and Labeling.  Client shall provide or approve, prior to the
commencement of Processing, all artwork, advertising and labeling information
necessary for Processing, if any.  Such artwork, advertising and labeling
information is and shall remain the exclusive property of Client, and Client
shall be solely responsible for the content thereof.  Such artwork, advertising
and labeling information or any reproduction thereof may not be used by Catalent
in any manner other than performing its obligations hereunder.

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EXECUTION VERSION

 

4.

MINIMUM COMMITMENT, PURCHASE ORDERS & FORECASTS

4.1Minimum Revenue Requirement.  First starting with the Commencement Date,
during each Contract Year, Client shall commit to an annual Minimum Revenue
Requirement of one million five hundred thousand Euro (€1.500.000) .

4.2Forecast.  On or before [***] of each calendar month, beginning at least
[***] prior to the anticipated Commencement Date, Client shall furnish to
Catalent a written [***] rolling forecast of the quantities of Product that
Client intends to order from Catalent during such period (“Rolling Forecast”);
provided, that as of the second Contract Year the quantities forecasted to  be
purchased in any rolling [***] period shall not be less than [***] of the
minimum threshold to be purchased according to the Minimum Revenue Requirement
for the relevant Contract Year.   The first [***] of such Rolling Forecast shall
constitute a binding order for the quantities of Product specified therein
(“Firm Commitment”) and the following [***] of the Rolling Forecast shall be
non-binding, good faith estimates.  

4.3Consequences of Minimum Revenue Requirements and Firm Commitment. If Client
does not purchase the quantities of Product equivalent to the Minimum Revenue
Requirement during any Contract Year, then within 30 days after the end of such
Contract Year, Client shall pay Catalent the difference between (A) the total
amount Client would have paid to Catalent if the Minimum Revenue Requirement had
been fulfilled for the Product and (B) the sum of all purchases of Product from
Catalent during such Contract Year.  Additionally, if Client fails to place
Purchase Orders sufficient to satisfy the Firm Commitment, Client shall pay to
Catalent in accordance with Clause 7 the Unit Pricing for all Units that would
have been Processed if Client has placed Purchase Orders sufficient to satisfy
the Firm Commitment.

4.4Purchase Orders.    

A.From time to time as provided in this Clause 4.3(A), Client shall submit to
Catalent a binding, non-cancelable purchase order for Product specifying the
number of Batches to be Processed, the Batch size (to the extent the
Specifications permit Batches of different sizes) and the requested delivery
date for each Batch (“Purchase Order”); provided, that no Purchase Order may be
for less than one (1) Batch.  Concurrently with the submission of each Rolling
Forecast, Client shall submit a Purchase Order for the Firm
Commitment.  Purchase Orders for quantities of Product in excess of the Firm
Commitment shall be submitted by Client at least [***] in advance of the
delivery date requested in the Purchase Order.  

B.Promptly following receipt of a Purchase Order, Catalent shall issue a written
acknowledgement (“Acknowledgement”) that it accepts or rejects such Purchase
Order.  Each acceptance Acknowledgement shall either confirm the delivery date
set out in the Purchase Order or provide a reasonable alternative delivery date,
and shall include the Processing Date.  Catalent may reject any Purchase Order
in excess of the Firm Commitment or otherwise not given in accordance with this
Agreement.    

C.Notwithstanding Clause 4.3(B), Catalent shall use commercially reasonable
efforts to supply Client with quantities of Product which are up to [***] in
excess of the quantities specified in the Firm Commitment, subject to Catalent’s
other supply commitments and manufacturing, packaging and equipment capacity.  

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EXECUTION VERSION

 

D.In the event of a conflict between the terms of any Purchase Order or
Acknowledgement and this Agreement, the terms of this Agreement shall control.  

E.In the event of any Inability to Supply, Supplier will immediately notify
Minerva as to the cause and anticipated extent of the delay.  

F.

4.5Catalent’s Cancellation of Purchase Orders. Notwithstanding Clause 4.5,
Catalent reserves the right to cancel all, or any part of, a Purchase Order upon
written notice  to Client, and Catalent shall have no further obligations or
liability with respect to such Purchase Order, if Client refuses or fails to
timely supply conforming Client-supplied Materials in accordance with Clause
3.1.  Any such cancellation of Purchase Orders shall not constitute a breach of
this Agreement by Catalent nor shall it absolve Client of its obligation in
respect of the Minimum Revenue Requirement.

4.6Client’s Modification or Cancellation of Purchase Orders.

A.Client may modify the delivery date or quantity of Product in a Purchase Order
only by submitting a written change order to Catalent at least 60 days in
advance of the earliest Processing Date covered by such change order.  Such
change order shall be effective and binding against Catalent only upon the
written approval of Catalent, and notwithstanding the foregoing, Client shall
remain responsible for the Firm Commitment.

B.Neither changes to nor postponement of any Batch of Product by Client, nor the
payment of the fees described in this Clause 4.5, will reduce or in any way
effect Client’s Minimum Revenue Requirement obligations set out in Clause 4.1.

4.7Unplanned Delay or Elimination of Processing.  In case of an unplanned delay
in Processing, Catalent shall use commercially reasonable efforts to meet the
Purchase Orders, subject to the terms and conditions of this
Agreement.  Catalent shall provide Client with as much advance notice as
practicable if Catalent determines that any Processing will be delayed or
eliminated for any reason.

5.

TESTING; SAMPLES; RELEASE

5.1Batch Records and Data; Release.  Unless otherwise agreed to by the parties
during their ordinary course of dealings, after Catalent completes Processing of
a Batch, Catalent shall provide Client with copies of Batch records prepared in
accordance with the Specifications; provided, that if testing reveals an
out-of-Specification result, Catalent shall provide such Batch records promptly
following resolution of the out-of Specification result.  After Catalent
completes Processing of a Batch, Catalent shall also provide Client or its
designee with a certificate of analysis for such Batch.  Issuance of a
certificate of analysis constitutes release of the Batch by Catalent to
Client.  Client shall be responsible for final release of Product (including
testing), at its cost to the market.  

5.2Testing; Rejection.  Following Client’s receipt of a shipment of a Batch,
Client or Client’s designee may test samples of such Batch to confirm that the
Specifications have been met.  Unless within 20 days after Client’s receipt of a
Batch or, in the case of a latent defect within the meaning of section 377
German Commercial Code (HGB) that was not detectable through customary testing
within such 20-day period, without any undue delay after discovery of such
latent defect (“Review Period”), Client or its designee notifies Catalent in
writing (an “Exception Notice”) that such Batch is not in compliance with Clause
12.1 (“Defective Product”), and provides a sample of the alleged Defective
Product, the Batch shall be deemed accepted by Client

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EXECUTION VERSION

 

and Client shall have no right to reject such Batch.  Upon timely receipt of an
Exception Notice from Client, Catalent shall conduct an appropriate
investigation in its discretion to determine whether or not it agrees with
Client that Product is Defective Product and to determine the cause of any
nonconformity.  If Catalent agrees that Product is Defective Product and
determines that the cause of nonconformity is attributable to Catalent’s
negligence or willful misconduct (“Catalent Defective Processing”), then Clause
5.4 shall apply.  For avoidance of doubt, where the cause of nonconformity
cannot be determined or assigned, it shall be deemed not Catalent Defective
Processing.

5.3Discrepant Results.  If the parties disagree as to whether Product is
Defective Product and/or whether the cause of the nonconformity is Catalent
Defective Processing, and this is not resolved within 30 days of the Exception
Notice date, the parties shall cause a mutually acceptable independent third
party to review records, test data and to perform comparative tests and/or
analyses on samples of the alleged Defective Product and its components,
including Client-supplied Materials.  The independent party’s results as to
whether or not Product is Defective Product and the cause of any nonconformity
shall be final and binding. Unless otherwise agreed to by the parties in
writing, the costs associated with such testing and review shall be borne by
Catalent if Product is Defective Product attributable to Catalent Defective
Processing, and by Client in all other circumstances.  

5.4Defective Processing.  Catalent shall, at its option, either (A) re-Process
at its cost another Batch of Product (as a replacement for any Batch of
Defective Product attributable to Catalent Defective Processing) using
Client-supplied Materials provided at Client's cost or (B) credit any payments
made by Client for such Batch.  This shall be Client’s sole and exclusive remedy
under this Agreement for Defective Product.

6.

DELIVERY

6.1Delivery.  Catalent shall deliver Product Ex Works (Incoterms 2010) the
Facility promptly following Catalent’s release of Product.  Catalent shall
segregate and store all Product until tender of delivery.  Title to Product
shall transfer to Client upon Catalent’s tender of delivery.  Client shall
qualify at least 3 carriers to ship Product and then designate the priority of
such qualified carriers to Catalent.  All Product shall be bulk-packaged and
shall be accompanied by the appropriate documentation as defined in the
applicable Quality Agreement.

6.2Storage Fees.  If Client fails to take delivery of any Product on any
scheduled delivery date, Catalent shall store such Product and Client shall be
invoiced on the first day of each month following such scheduled delivery for
reasonable administration and storage costs. Catalent shall store and handle all
Products in accordance with the applicable Product Specifications and under
appropriate conditions of temperature, humidity, light and cleanliness as
outlined in the Quality Agreement to avoid any material adverse effect on the
identity, strength, quality and purity of such Products.  In addition to the
foregoing, Catalent shall store and handle all Products so as to prevent the
commingling of same with Catalent’s own inventories and supplies, or those held
by Catalent for third parties.

6.3Bill and Hold. From time to time, at the Client’s request, the agreed
delivery date of the Purchase Order may be extended under a bill and hold
arrangement as more fully set forth below.  For each such Batch of stored
Product, Client agrees that: (A) Client has made a fixed commitment to purchase
the Product, (B) risk of loss for such Product passes to Client upon placement
into storage, (C) such Product shall be on a bill and hold basis for legitimate
business purposes, (D) the Client shall identify a fixed delivery date for the
Product and (E) Client  agree to be invoiced and to pay such invoice in
accordance with the Payment terms set forth in this Agreement.  Upon making a
request for a bill and hold arrangement, Client shall provide Catalent with a
letter confirming items (A) through (E) of this Section for each Batch of stored
Product.

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EXECUTION VERSION

 

7.

PAYMENTS

7.1Fees.  In consideration for Catalent performing services hereunder:

A.Client shall pay to Catalent the fees for validation and tech transfer
services as set out in the separately agreed quotation.

B.Client shall pay Catalent the unit pricing for Product set out on Attachment B
(“Unit Pricing”).  Catalent shall submit an invoice to Client for such fees upon
tender of delivery of Product as provided in Clause 6.1.

C.Other Fees.  Client shall pay Catalent for all other fees and expenses of
Catalent owing in accordance with the terms of this Agreement, including
pursuant to Clauses 2.4, 4.1, 6.2 and 16.4.  Client shall pay Catalent for
serialization maintenance fees and capacity reservation fees as outlined in
Attachment B. Catalent shall submit an invoice to Client for such fees as and
when appropriate.  

7.2Unit Pricing Increase. The Unit Pricing shall be adjusted on an annual basis,
effective on each January 1st of every calendar year, upon 60 days’ prior
written notice from Catalent to Client provided, however, than no such
adjustment shall result in an increase of Unit Pricing exceeding [***] in any
one calendar year or [***] in the aggregate during the Term. In addition, price
increases for raw materials, labor, utilities and components shall be passed
through to Client upon reasonable documentation.  

7.3Product Approval.  If any Regulatory Approval necessary for Catalent to
commence Processing at the Facility has not been obtained by Client within 12
months following the Effective Date, then Client shall pay to Catalent a fee as
provided in Attachment B (“Delayed Approval Fee”) until such Regulatory Approval
has been obtained and Catalent is able to commence Processing.

7.4 Payment Terms.  Payment of all Catalent invoices shall be due [***] days
after the date of invoice.  Client shall make payment in Euro, and otherwise as
directed in the applicable invoice.  If any payment is not received by Catalent
by its due date, then Catalent may, in addition to any other remedies available,
charge interest on the outstanding sum from the due date (both before and after
any judgment) at [***] per month until paid in full (or, if less, the maximum
amount permitted by Applicable Laws). .  

7.5Advance Payment.  Notwithstanding any other provision of this Agreement, if
at any time Catalent determines that Client’s credit is impaired, Catalent may
require payment in advance before performing any further services or making any
further shipment of Product.  If Client shall fail, within a reasonable time, to
make such payment in advance, or if Client shall fail to make any payment when
due, Catalent shall have the right, at its option, to suspend any further
performance hereunder until such default is corrected, without thereby releasing
Client from its obligations under this Agreement.

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7.6Taxes.  

A.All taxes, duties and other levies assessed (excluding tax based on net
income) on or in connection with Client-supplied Materials, services or Product
in connection with provision or sale to Catalent or Client, shall be reimbursed
by Client to Catalent (and shall be included in invoices) and all charges are
exclusive of any applicable taxes, duties and levies which shall be added to
invoices directed at Client.  If any deduction or withholding in respect of tax
or otherwise is required by law to be made from any of the sums payable
hereunder, Client shall be obliged to pay to Catalent such greater sum as will
leave Catalent, after deduction or withholding, with the same amount as it would
have been entitled to receive in the absence of such deduction or withholding.

B.If any amount paid by one party pursuant to an indemnity provision in this
Agreement is or will be chargeable to tax, such payer shall pay an increased
amount as will, after payment of the tax, leave the other party with the same
amount that would otherwise have been payable under the provision if tax had not
been so chargeable.  

7.7Client and Third Party Expenses.  Except as may be expressly covered by
Product Maintenance Service fees, Client shall be responsible for 100% of its
own and all third-party expenses associated with the development, Regulatory
Approvals and commercialization of Product, including regulatory filings and
post-approval marketing studies.

7.8Development Batches.  Each Batch produced under this Agreement, including
those necessary to support the validation portion of Client’s submissions for
Regulatory Approvals, will be considered to be a “development batch” unless and
until Processing has been validated.  Client shall be responsible for the cost
of each such Batch, even if such Batch fails to meet the Specifications, unless
Catalent was grossly negligent in the Processing of the out-of-Specification
Batch.  Catalent and Client shall cooperate in good faith to resolve any
problems causing the out-of-Specification Batch.

8.

CHANGES TO SPECIFICATIONS

All Specifications and any changes thereto agreed to by the parties from time to
time shall be in writing, dated and signed by the parties.  Any change to the
Process shall be deemed a Specification change. No change in the Specifications
shall be implemented by Catalent, whether requested by Client or requested or
required by any Regulatory Authority, until the parties have agreed in writing
to such change, the implementation date of such change, and any increase or
decrease in costs, expenses or fees associated with such change (including any
change to Unit Pricing).  Catalent shall respond promptly to any request made by
Client for a change in the Specifications, and both parties shall use
commercially reasonable, good faith efforts to agree to the terms of such change
in a timely manner.  As soon as possible after a request is made for any change
in Specifications, Catalent shall notify Client of the costs associated with
such change and shall provide such supporting documentation as Client may
reasonably require.  Client shall pay all costs associated with such agreed upon
changes. If there is a conflict between the terms of this Agreement and the
terms of the Specifications, this Agreement shall control. Catalent reserves the
right to postpone effecting changes to the Specifications until such time as the
parties agree to and execute the required written amendment.  

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9.

RECORDS; REGULATORY MATTERS

9.1Record Keeping.  Catalent shall maintain materially complete and accurate
Batch, laboratory data, reports and other technical records relating to
Processing in accordance with Catalent standard operating procedures.  Such
information shall be maintained for a period of at least 2 years from the
relevant finished Product expiry date or longer if required under Applicable
Laws or the Quality Agreement.

9.2Regulatory Compliance.  Catalent shall obtain and maintain all permits and
licences with respect to general Facility operations required by any Regulatory
Authority in the jurisdiction in which Catalent Processes Product. Client shall
obtain and maintain all other Regulatory Approvals, authorizations and
certificates, including those with respect to API and Product and those that are
necessary for Catalent to commence Processing. Client shall not identify
Catalent in any regulatory filing or submission without Catalent’s prior written
consent. Such consent shall not be unreasonably withheld and shall be
memorialized in a writing signed by authorized representatives of both Parties.
Upon written request, Client shall provide Catalent with a copy of any
Regulatory Approvals required to distribute, market and sell Product in the
Territory. If Client is unable to provide such information, Catalent shall have
no obligation to deliver Product to Client, notwithstanding anything to the
contrary in this Agreement.  During the Term, Catalent will assist Client with
all regulatory matters relating to Processing, at Client’s request and expense.
The parties intend and commit to cooperate to allow each party to satisfy its
obligations under Applicable Laws relating to Processing under this Agreement.

9.3Governmental Inspections and Requests.  Catalent shall promptly advise Client
if an authorised agent of any Regulatory Authority notifies Catalent that it
intends to or does visit the Facility for the purpose of reviewing the
Processing.  Upon request, Catalent shall provide Client with a copy of any
report issued by such Regulatory Authority received by Catalent following such
visit, redacted as appropriate to protect any confidential information of
Catalent and Catalent’s other customers.  Client acknowledges that it may not
direct the manner in which Catalent fulfills its obligations to permit
inspection by and to communicate with Regulatory Authorities.  Client shall
reimburse Catalent for all reasonable and documented costs associated with
inspections by Regulatory Authorities in connection with Product.

9.4Client Facility Audits.  During the Term, Client’s Representatives shall be
granted access upon at least 10 business days’ prior notice, at reasonable times
during regular business hours, to (A) the portion of the Facility where Catalent
performs Processing, (B) relevant personnel involved in Processing and (C)
Processing records described in Section 9.2, in each case solely for the purpose
of verifying that Catalent is Processing in accordance with cGMPs, the
Specifications and the Product master Batch records.  Client may not conduct an
audit under this Section more than once during any 12-month period; provided,
that additional inspections may be conducted in the event there is a material
quality or compliance issue concerning Product or its Processing.  Client’s
Quality Assurance Manager will arrange Client audits with Catalent Quality
Management.  Audits shall be designed to minimize disruption of operations at
the Facility.  Client’s Representatives shall be required to sign Catalent’s
standard visitor confidentiality agreement prior to being allowed access to the
Facility.  Such Representatives shall comply with the Facility’s rules and
regulations.  Client shall indemnify and hold harmless Catalent for any action
or activity of such Representatives while on Catalent’s premises.  

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9.5Recall.  If Catalent believes a recall, field alert, Product withdrawal or
field correction (“Recall”) may be necessary with respect to any Product
supplied under this Agreement, Catalent shall promptly notify Client. Catalent
will not act to initiate a Recall without the express prior written approval of
Client, unless otherwise required by Applicable Laws.  If Client believes a
Recall may be necessary with respect to any Product supplied under this
Agreement, Client shall promptly notify Catalent and Catalent shall provide all
necessary cooperation and assistance to Client.  Client shall provide Catalent
with an advance copy of any proposed submission to a Regulatory Authority in
respect of any Recall, and shall consider in good faith any comments from
Catalent.  The cost of any Recall shall be borne by Client, and Client shall
reimburse Catalent for expenses incurred in connection with any Recall, in each
case reduced to the extent such expenses are caused solely by Catalent’s breach
of its obligations under this Agreement, violation of Applicable Laws or its
negligence or willful misconduct, then such cost shall be borne by
Catalent.  For purposes hereof, such cost shall be limited to reasonable, actual
and documented administrative costs incurred by Client for such Recall and
replacement of the Product subject to Recall in accordance with Clause 5.  

9.6Quality Agreement.  Within 6 months after the Effective Date, and in any
event prior to the first Processing of Product hereunder, the parties shall
negotiate in good faith and enter into a quality or technical agreement on
Catalent’s standard template (the “Quality Agreement”).  The Quality Agreement
shall in no way determine liability or financial responsibility of the parties
for the responsibilities set out therein.  In the event of a conflict between
any of the provisions of this Agreement and the Quality Agreement with respect
to quality-related activities, including compliance with cGMP, the provisions of
the Quality Agreement shall govern.   In the event of a conflict between any of
the provisions of this Agreement and the Quality Agreement with respect to any
commercial matters, including allocation of risk, liability and financial
responsibility, the provisions of this Agreement shall govern.

9.7Regulatory Authority Fees.  Catalent reserves the right to assess Client for
any Regulatory Authority fees that may be established by any regulatory
authority, which fees result directly from Catalent’s formulation, development,
manufacturing, processing, filling, packaging, storing or testing of Client’s
product or Client-supplied materials. Without limiting the foregoing, Client
shall reimburse Catalent for any Regulatory Authority fees Catalent may be
required to pay pursuant to the Generic Drug User Fee Amendments of 2017,
(“GDUFA Fees”), where such fees result directly from Catalent’s formulation,
development, manufacturing, processing, filling, packaging, storing or testing
of Client’s product or Client-supplied materials.  A Catalent facility incurs
GDUFA Fees when that Catalent facility is referenced in an approved ANDA.  GDUFA
Fees are assessed by the FDA on October 1st of each year and shall be paid by
Client annually, where applicable.  On or after October 1st of each year,
Catalent will invoice Client for Client’s pro-rata share of the annual GDUFA Fee
Catalent incurs for each Catalent manufacturing or packaging facility identified
in Client’s approved ANDA(s). This includes, but is not limited to, any Catalent
facility which manufactured or packaged Client’s registration batches.  Catalent
will invoice Client for reimbursement of all other payments or fees at the time
they are incurred by Catalent.  Client shall pay all such invoices within 30
days from the date of such invoice.

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10.

CONFIDENTIALITY AND NON-USE

10.1Definition.  As used in this Agreement, the term “Confidential Information”
includes all information furnished by or on behalf of Catalent or Client (the
“Discloser”), its Affiliates or any of its or their respective Representatives,
to the other party (the “Recipient”), its Affiliates or any of its or their
respective Representatives, whether furnished before, on or after the Effective
Date and furnished in any form, including written, verbal, visual, electronic or
in any other media or manner and information acquired by observation or
otherwise during any site visit at the other party’s facility.  Confidential
Information includes all proprietary technologies, know-how, trade secrets,
discoveries, inventions and any other intellectual property (whether or not
patented), analyses, compilations, business or technical information and other
materials prepared by either party, their respective Affiliates, or any of its
or their respective Representatives, containing or based in whole or in part on
any information furnished by the Discloser, its Affiliates or any of its or
their respective Representatives.  Confidential Information also includes the
existence of this Agreement and its terms.

10.2Exclusions.  Notwithstanding Clause 10.1, Confidential Information does not
include information that (A) is or becomes generally available to the public or
within the industry to which such information relates other than as a result of
a breach of this Agreement, (B) is already known by the Recipient at the time of
disclosure as evidenced by the Recipient’s written records, (C) becomes
available to the Recipient on a non-confidential basis from a source that is
entitled to disclose it on a non-confidential basis or (D) was or is
independently developed by or for the Recipient without reference to the
Confidential Information of the Discloser as evidenced by the Recipient’s
written records.

10.3Mutual Obligation.  The Recipient agrees that it will not use the
Discloser’s Confidential Information except in connection with the performance
of its obligations hereunder and will not disclose, without the prior written
consent of the Discloser, Confidential Information of the Discloser to any third
party, except that the Recipient may disclose the Discloser’s Confidential
Information to any of its Affiliates and its or their respective Representatives
that (A) need to know such Confidential Information for the purpose of
performing under this Agreement, (B) are advised of the contents of this Clause
and (C) are bound to the Recipient by obligations of confidentiality at least as
restrictive as the terms of this Clause.  Each party shall be responsible for
any breach of this Clause by its Affiliates or any of its or their respective
Representatives.

10.4Permitted Disclosure.  The Recipient may disclose the Discloser’s
Confidential Information to the extent required by law or regulation; provided,
that prior to making any such legally required disclosure, the Recipient shall
give the Discloser as much prior notice of the requirement for and contents of
such disclosure as is practicable under the circumstances.  Any such disclosure,
however, shall not relieve the Recipient of its obligations contained herein.

10.5No Implied Licence.  Except as expressly set out in Clause 10.1, the
Recipient will obtain no right of any kind or licence under any Confidential
Information of the Discloser, including any patent application or patent, by
reason of this Agreement.  All Confidential Information will remain the sole
property of the Discloser, subject to Clause 11.

10.6Return of Confidential Information.  Upon expiry or termination of this
Agreement, the Recipient will (and will cause its Affiliates and its and their
respective Representatives to) cease its use and, upon written request, within
30 days either return or destroy (and certify as to such destruction) all
Confidential Information of the Discloser, including any copies thereof, except
for a single copy which may be retained for the sole purpose of ensuring
compliance with its obligations under this Agreement.

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10.7Survival.  The obligations of this Clause will terminate 5 years from the
expiry or termination of this Agreement, except with respect to trade secrets,
for which the obligations of this Clause will continue for so long as such
information remains a trade secret under applicable law.

11.

INTELLECTUAL PROPERTY

For purposes hereof, “Client IP” means all intellectual property and embodiments
thereof owned by or licenced to Client as of the date hereof or developed by
Client other than in connection with this Agreement; “Catalent IP” means all
intellectual property and embodiments thereof owned by or licenced to Catalent
as of the date hereof or developed by Catalent other than in connection with
this Agreement; “Invention” means any intellectual property developed by either
party or jointly by the parties in connection with this Agreement; “API
Inventions” means any Invention that relates exclusively to the Client IP or
Client’s patented API; and “Process Inventions” means any Invention, other than
an API Invention, that relates exclusively to the Catalent IP or relates to
developing, formulating, manufacturing, filling, processing, packaging,
analyzing or testing pharmaceutical products generally.  All Client IP and API
Inventions shall be owned solely by Client and no right therein is granted to
Catalent under this Agreement, except that Catalent shall have during the Term a
non-exclusive, royalty-free licence to such items solely to the extent necessary
to perform its obligations under this Agreement.  All Catalent IP and Process
Inventions shall be owned solely by Catalent and no right therein is granted to
Client under this Agreement.  The parties shall cooperate to achieve the
allocation of rights to Inventions anticipated herein and each party shall be
solely responsible for costs associated with the protection of its intellectual
property.  

12.

REPRESENTATIONS AND WARRANTIES

12.1Catalent.  Catalent represents, warrants and undertakes to Client that at
the time of delivery by Catalent as provided in Clause 6.1, Product shall have
been Processed in accordance with Applicable Laws and in conformance with the
Specifications and shall not be adulterated, misbranded or mislabeled within the
meaning of Applicable Laws; provided, that Catalent shall not be liable for
defects attributable to Client-supplied Materials (including artwork,
advertising and labeling).

12.2Client.  Client represents, warrants and undertakes to Catalent that:

A.all Client-supplied Materials shall have been produced in accordance with
Applicable Laws, shall comply with all applicable specifications, including the
Specifications, shall not be adulterated, misbranded or mislabeled within the
meaning of Applicable Laws, and shall have been provided in accordance with the
terms and conditions of this Agreement;

B.the content of all artwork provided to Catalent shall comply with all
Applicable Laws;

C.all Product delivered to Client by Catalent will be held, used and disposed of
by or on behalf of the Client in accordance with all Applicable Laws, and Client
will otherwise comply with all laws, rules, regulations and guidelines
applicable to Client’s performance under this Agreement;

D.Client will not release any Batch of Product if the required certificates of
conformance indicate that Product does not comply with the Specifications or if
Client does not hold all necessary Regulatory Approvals to market and sell the
Product;

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E.Client has all necessary authority to use and to permit Catalent to use
pursuant to this Agreement all intellectual property related to Product or
Client-supplied Materials (including artwork), and the Processing of the
foregoing, including any copyrights, trademarks, trade secrets, patents,
inventions and developments; there are no patents owned by others related to the
Client IP utilised with the Product that would be infringed or misused by
Client’s performance of the Agreement; and, to its knowledge, no trade secrets
or other proprietary rights of others related to the Client IP utilised with the
Product that would be infringed or misused by Client’s performance of this
Agreement; and

F.the work to be performed by Catalent under this Agreement will not violate or
infringe upon any trademark, tradename, copyright, patent, trade secret, or
other intellectual property or other right held by any person or entity.

12.3Mutual representation. Furthermore, Catalent and Client both represent,
warrant and undertake that no transactions or dealings under this Agreement
shall be conducted with or for an individual or entity that is designated as the
target of any sanctions, restrictions or embargoes administered by the United
Nations, European Union, United Kingdom, or the United States.  

12.4Limitations.  Save as expressly set out in this Agreement, neither party
gives any representation or warranty in respect of the subject matter of this
Agreement, and all representations and warranties that may be implied (by
statute or otherwise) are hereby excluded to the maximum extent permitted by
law.

13.

INDEMNIFICATION

13.1Indemnification by Catalent.  Catalent shall indemnify and hold harmless
Client, its Affiliates, and their respective directors, officers and employees
(“Client Indemnitees”) from and against any and all claims, losses, demands,
liabilities, damages, costs and expenses (including reasonable attorneys’ fees
and reasonable investigative costs) in connection with any claim or action by
any third party (“Losses”) arising out of or resulting from (A) any breach of
its representations, warranties or obligations set out in this Agreement or (B)
any negligence or willful misconduct by Catalent; in each case except to the
extent that any of the foregoing arises out of or results from any Client
Indemnitee’s negligence, willful misconduct or breach of this Agreement.

13.2Indemnification by Client.  Client shall indemnify and hold harmless
Catalent, its Affiliates, and their respective directors, officers and employees
(“Catalent Indemnitees”) from and against any and all Losses arising out of or
resulting from (A) any breach of its representations, warranties or obligations
set out in this Agreement, (B) any manufacture, packaging, sale, promotion,
distribution or use of or exposure to Product or Client-supplied Materials,
including product liability or strict liability, (C) Client’s exercise of
control over the Processing, to the extent that Client’s instructions or
directions violate Applicable Laws, (D) the conduct of any clinical trials
utilising Product or API, (E) any actual or alleged infringement or violation of
any third party patent, trade secret, copyright, trademark or other proprietary
rights by intellectual property or other information provided by Client,
including Client-supplied Materials, or (F) any negligence or willful misconduct
by Client; in each case except to the extent that any of the foregoing arises
out of or results from any Catalent Indemnitee’s negligence, willful misconduct
or breach of this Agreement.  

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13.3Indemnification Procedures.  All indemnification obligations in this
Agreement are conditioned upon the indemnified party (A) promptly notifying the
indemnifying party of any claim or liability of which the indemnified party
becomes aware (including a copy of any related complaint, summons, notice or
other instrument); provided, that failure to provide such notice within a
reasonable period of time shall not relieve the indemnifying party of any of its
obligations hereunder except to the extent the indemnifying party is prejudiced
by such failure, (B) allowing the indemnifying party, if the indemnifying party
so requests, to conduct and control the defense of any such claim or liability
and any related settlement negotiations (at the indemnifying party’s expense),
(C) cooperating with the indemnifying party in the defense of any such claim or
liability and any related settlement negotiations (at the indemnifying party’s
expense) and (D) not compromising or settling any claim or liability without
prior written consent of the indemnifying party.

14.

LIMITATIONS OF LIABILITY

14.1Client-supplied Materials.  Catalent shall have no liability under this
Agreement for any and all claims for lost, damaged or destroyed Client-supplied
Materials, whether or not such Client-supplied Materials are incorporated into
Product.

14.2Total Liability.  Catalent’s total liability under this Agreement shall in
no event exceed the total charges paid by Client to Catalent under this
Agreement in the previous twelve (12) months period from the Batch or services
giving rise to the claim.  

14.3Nothing in this Agreement shall, to the extent applicable, limit the
liability of Catalent for:

A.its indemnification obligations for death or personal injury arising from
Catalent’s negligence;

B.death or personal injury arising from Catalent’s or any of its Affiliate’s
negligence;

C.direct or conditional intent, gross negligence or the fraud of Catalent; or

D.any matter for which it would be illegal for Catalent or any of its Affiliates
to exclude or to attempt to exclude liability.

14.4Indirect Damages.  Unless it has caused such damages or losses of the other
party intentionally, neither party shall be liable to the other party for
indirect, incidental, special, punitive or consequential loss or damages, or for
loss of revenues, profits or data, arising out of performance under this
Agreement, whether in contract or in tort or otherwise, even if such party has
been advised of the possibility of such damages.  

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15.

INSURANCE

Each party shall, at its own cost and expense, obtain and maintain in full force
and effect during the Term the following in US dollars or foreign currency
equivalent:  (A) Commercial General Liability Insurance with a per-occurrence
limit of not less than US $1,000,000; (B) Products and Completed Operations
Liability Insurance with a per-occurrence limit of not less than US $10,000,000;
and (C) Workers’ Compensation Insurance with statutory limits and Employers
Liability Insurance with limits of not less than $1,000,000 per
accident.  Client shall maintain All Risk Property Insurance, including transit
coverage, in an amount equal to the full replacement value of its property while
in, or in transit to, a Catalent facility as required under this
Agreement.  Each party may self-insure all or any portion of the required
insurance as long as, together with its Affiliates, its US GAAP or foreign
currency equivalent net worth is greater than US $100 million or its annual
EBITDA (earnings before interest, taxes, depreciation and amortization) is
greater than US $75 million.  Each required insurance policy, other than
self-insurance, shall be obtained from an insurance carrier with an A.M. Best
rating of at least A- VII.  If any of the required policies of insurance are
written on a claims made basis, such policies shall be maintained throughout the
Term and for a period of at least 3 years thereafter.  Each party shall obtain a
waiver of subrogation clause from its property insurance carriers in favor of
the other party, and such waivers will operate the same whether insurance is
carried through third parties or self-insured. Upon the other party’s written
request from time to time, each party shall promptly furnish to the other party
a certificate of insurance or other evidence of the required insurance.  

16.

TERM AND TERMINATION

16.1Term.  This Agreement shall commence on the Effective Date and shall
continue until the end of the fifth Contract Year, unless earlier terminated in
accordance with Clause 16.3 (as may be extended in accordance with this Clause,
the “Term”).  

16.2Renewal. The Term shall automatically be extended for successive 1-year
periods unless and until one party gives the other party at least 12 months’
prior written notice of its desire to terminate as of the end of the
then-current Term.

16.3Termination.  This Agreement may be terminated immediately without further
action:

A.by either party if steps are taken by or against the other party for the
appointment of a liquidator, an administrator, a receiver, administrative
receiver, manager, interim receiver, trustee, trustee in bankruptcy, nominee or
supervisor or the other party proposes or enters into an agreement or
arrangement with its creditors generally or makes an assignment for the benefit
of its creditors generally, or otherwise suffers or permits the taking of any
steps for adjudicating it to be bankrupt or insolvent and any such process, if
reasonably shown to be warranted, frivolous or vexatious, is not withdrawn,
dismissed or discharges within 20 days, or any equivalent or similar action to
the above in consequence of the insolvency of that party is taken in any
jurisdiction and is not withdrawn, dismissed or discharged in the circumstances
described above; or

B.by either party if the other party materially breaches any of the provisions
of this Agreement and such breach is not cured within 60 days after the giving
of written notice requiring the breach to be remedied; provided, that in the
case of a failure of Client to make payments in accordance with the terms of
this Agreement, Catalent may terminate this Agreement if such payment breach is
not cured within 10 days of receipt of notice of non-payment from Catalent.

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C.by either party if any Regulatory Approval necessary for Catalent to commence
Processing at the Facility has not been obtained by Client within 12 months
following the Effective Date and Catalent is unable to commence Processing.

D.by either party upon 12 months’ prior written notice to the other party if
Regulatory Approval has been withdrawn, or Client has ceased commercialization
of the Product.

16.4Effect of Termination.  Expiry or termination of this Agreement shall be
without prejudice to any rights or obligations that accrued to the benefit of
either party prior to such expiry or termination.  In the event of a termination
of this Agreement:

A.Catalent shall promptly return to Client, at Client’s expense and direction,
any remaining inventory of Product or Client-supplied Materials; provided, that
all outstanding invoices have been paid in full;

B.Client shall pay Catalent all invoiced amounts outstanding, plus, upon receipt
of invoice therefor, for any (i) Product that has been shipped pursuant to
Purchase Orders but not yet invoiced, (ii) Product Processed pursuant to
Purchase Orders that has been completed but not yet shipped, and (iii) in the
event that this Agreement is terminated for any reason other than by Client
pursuant to Clause 16.3(A) or (B), or by Catalent pursuant to Clause 16.3(C),
all Product in process of being Processed pursuant to Purchase Orders (or,
alternatively, Client may instruct Catalent to complete such work in process,
and the resulting completed Product shall be governed by clause (ii)); and

C.in the event that this Agreement is terminated for any reason other than by
Client pursuant to Clause 16.3(A) or (B), or by Catalent pursuant to Clause
16.3(C), Client shall pay Catalent for all costs and expenses incurred, and all
noncancellable commitments made, in connection with Catalent’s performance of
this Agreement, so long as such costs, expenses or commitments were made by
Catalent consistent with Client’s most recent Firm Commitment and the vendor’s
minimum purchase obligations.

16.5Survival.  The rights and obligations of the parties shall continue under
Clauses 11 (Intellectual Property), 13 (Indemnification), 14 (Limitations of
Liability), 17 (Notice), 18 (Miscellaneous); under Clauses 10 (Confidentiality
and Non-Use) and 15 (Insurance), in each case to the extent expressly stated
therein; and under Clauses 7.4 (Payment Terms), 7.6 (Taxes), 7.7 (Client and
Third Party Expenses), 9.2 (Recordkeeping), 9.6 (Recall), 12.3 (Limitations on
Warranties), 16.4 (Effect of Termination) and 16.5 (Survival), in each case in
accordance with their respective terms if applicable, notwithstanding expiry or
termination of this Agreement.

17.

NOTICE

All notices and other communications hereunder shall be in writing and shall be
deemed given:    (A) when delivered personally or by hand; (B) when delivered by
facsimile transmission (receipt verified); or (C) when received or refused, if
sent by registered or certified or recorded post (return receipt requested),
postage prepaid; in each case, to the parties at the following addresses (or at
such other address for a party as shall be specified by like notice; provided,
that notices of a change of address shall be effective only upon receipt
thereof):

 

To Client:

Minerva Neurosciences, Inc.

 

1601 Trapelo Road, Suite 286

 

Waltham, Massachusetts 02451 USA

 

Attn:  President

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With a copy to:

Minerva Neurosciences, Inc.

 

1601 Trapelo Road, Suite 286

 

Waltham, Massachusetts 02451 USA

 

Attn:  General Counsel

 

To Catalent:

Catalent Germany Schorndorf GmbH

 

Steinbeisstrasse 1 -2

 

71643 Schorndorf

 

Germany

 

Attn:  General Manager

 

Facsimile:  +49 7181 7000 100

 

With a copy to:

Catalent Pharma Solutions

 

14 Schoolhouse Road

 

Somerset, NJ  08873

 

USA

 

Attn:  General Counsel (Legal Department)

 

GenCouns@catalent.com

 

18.

MISCELLANEOUS

18.1Entire Agreement; Amendments.  This Agreement, together with the Quality
Agreement and each Purchase Order, constitutes the entire understanding between
the parties, and supersedes any contracts, agreements or understandings (oral or
written) of the parties, with respect to the subject matter hereof.  For the
avoidance of doubt, this Agreement does not supersede any existing generally
applicable confidentiality agreement between the parties as it relates to time
periods prior to the date hereof or to business dealings not covered by this
Agreement.  No term of this Agreement may be amended except upon written
agreement of both parties, unless otherwise expressly provided in this
Agreement.

18.2Captions; Certain Conventions.  The headings used in this Agreement are for
convenience only and are not to be interpreted or construed as a substantive
part of this Agreement.  Unless otherwise expressly provided herein or the
context of this Agreement otherwise requires, (A) words of any gender include
each other gender, (B) words such as “herein”, “hereof”, and “hereunder” refer
to this Agreement as a whole and not merely to the particular provision in which
such words appear, (C) words using the singular shall include the plural, and
vice versa, (D) the words “include(s)” and “including” shall be deemed to be
followed by the phrase “but not limited to”, “without limitation” or words of
similar import, (E) the word  “or” shall be deemed to include the word “and”
(e.g., “and/or”) and (F) references to “Clause” or other subdivision, or to an
Attachment or other appendix, without reference to a document are to the
specified provision or Attachment of this Agreement.  This Agreement shall be
construed as if it were drafted jointly by the parties.

18.3Further Assurances.  The parties agree to execute such further instruments
and to undertake such other acts as may be reasonably necessary or appropriate
to give full effect to the terms of this Agreement.

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18.4No Waiver.  In no event shall any delay, failure or omission (in whole or in
part) in enforcing, exercising or pursuing any right, power, privilege, claim or
remedy conferred by or arising under this Agreement or by law, be deemed to be
or construed as a waiver of that or any other right, power, privilege, claim or
remedy in respect of the circumstances in question, or operate so as to bar the
enforcement of that, or any other right, power, privilege, claim or remedy, in
any other instance at any time or times subsequently.

18.5Severability.  If any term of this Agreement is declared invalid or
unenforceable by a court or other body of competent jurisdiction, the remaining
terms of this Agreement will continue in full force and effect.

18.6Independent Contractors.  The relationship of the parties is that of
independent contractors, and nothing in this Agreement is intended to create or
will be construed as creating between the parties the relationship of joint
venture, co-partners, employer/employee or principal/agent.  

18.7Successors and Assigns.  Neither party may assign this Agreement, in whole
or in part, without the prior written consent of the other party, except that
either party may, without the other party’s consent (but subject to prior
written notice), assign this Agreement in its entirety to an Affiliate or to a
successor to substantially all of the business or assets of the assigning party
or the assigning party’s business unit responsible for performance under this
Agreement.

18.8Third Party Rights.  This Agreement shall not confer any rights or remedies
upon any person or entity other than the parties to this Agreement and their
respective successors and permitted assigns, and a person or entity who is not a
party to this Agreement has no rights to enforce any term of this Agreement.

18.9Governing Law.  This Agreement shall be governed by and construed under the
laws of New York, USA, provided that any conflicts of laws provisions or
principles to the contrary shall be inapplicable.  The United Nations Convention
on Contracts for the International Sale of Goods shall not apply to this
Agreement.

18.10Alternative Dispute Resolution.  Any dispute that arises between the
parties in connection with this Agreement shall first be presented to the senior
executives of the parties for consideration and resolution.  If such executives
cannot reach a resolution of the dispute within a reasonable time, then such
dispute shall be resolved by binding alternative dispute resolution in
accordance with the Swiss Rules of International Arbitration of the Swiss
Chambers by one (1) or three (3) arbitrators appointed in accordance with the
said Rules. The place of the arbitration shall be Zurich, Switzerland. The
language of the arbitration shall be English.

 

18.11Prevailing Party.  In any dispute resolution proceeding between the parties
in connection with this Agreement, the prevailing party will be entitled to
recover its reasonable attorney’s fees and costs in such proceeding from the
other party.

18.12Publicity.  Neither party will make any press release or other public
disclosure regarding this Agreement or the transactions contemplated hereby
without the other party’s express prior written consent, except as required
under Applicable Laws, by any governmental agency or by the rules of any stock
exchange on which the securities of the disclosing party are listed, in which
case the party required to make the press release or public disclosure shall use
commercially reasonable efforts to obtain the approval of the other party as to
the form, nature and extent of the press release or public disclosure prior to
issuing the press release or making the public disclosure.

20

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EXECUTION VERSION

 

18.13Right to Dispose and Settle.  If Catalent requests in writing from Client
direction with respect to disposal of any inventories of Product,
Client-supplied Materials, equipment, samples or other items belonging to Client
and is unable to obtain a response from Client within a reasonable time period
after making reasonable efforts to do so, Catalent shall be entitled in its sole
discretion to (A) dispose of all such items and (B) set-off any and all amounts
due to Catalent or any of its Affiliates from Client against any credits Client
may hold with Catalent or any of its Affiliates.  

18.14Force Majeure.  Except as to payments required under this Agreement,
neither party shall be liable in damages for, nor shall this Agreement be
capable of termination by reason of, any delay in such party’s performance, or
breach of its obligations, hereunder if such delay or breach is caused by events
beyond such party’s reasonable control, including acts of God, law or regulation
or other action or failure to act of any government or agency thereof, war or
insurrection, civil commotion, destruction of production facilities or materials
by earthquake, fire, flood or weather, labor disturbances, epidemic or failure
of suppliers, public utilities or common carriers.  If the events shall continue
unabated for 180 days, then both parties shall meet to discuss and negotiate in
good faith what modifications to this Agreement should result from such events.

18.15Counterparts.  This Agreement may be executed in one or more counterparts,
each of which will be deemed an original but all of which together will
constitute one and the same instrument.  

IN WITNESS WHEREOF, the parties have caused their respective duly authorised
representatives to execute this Agreement effective as of the Effective Date.

Catalent Germany Schorndorf GmbH

 

Minerva Neuroscienes, Inc.

 

 

 

 

 

 

 

By:

 

/Hanns-Cord Walter/

 

By:

 

/Remy Luthringer/

 

 

 

 

 

 

 

Name:

 

Dr. Hanns-Cord Walter

 

Name:

 

Dr. Remy Luthringer

 

 

 

 

 

 

 

Title:

 

Managing Director

 

Title:

 

Chief Executive Officer

 

 

 

 

 

 

 

By:

 

/Roel de Nobel/

 

 

 

 

 

 

 

 

 

 

 

Name:

 

Roel de Nobel

 

 

 

 

 

 

 

 

 

 

 

Title:

 

Global VP Ops CSS

 

 

 

 

 

 

 

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ATTACHMENT A

 

SPECIFICATIONS

 

 

I.  Client-Supplied Materials (and associated specifications)

 

II.Raw Materials (and associated specifications)

 

III.Product Specifications (including Batch size)

 

To be agreed by the parties and attached separately before Commencement Date.

 

 

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EXECUTION VERSION

 

ATTACHMENT B

 

UNIT PRICING AND FEES

Section 1.

Executive summary and scope of work

Catalent Germany Schorndorf GmbH (“Catalent”) is delighted to quote for the
commercial manufacturing and packaging of MIN-101 for Minerva (“Minerva” or
“Customer”) using MIN-101 (“MIN-101” or API).

This quote is based on the forecast as detailed in Section 3.1.  

Section 2.

Project overview

The following is an overview of the various steps in this project.

 

Section reference

Activity

Section 3

Commercial price estimate

Section 4

Pharmaceutical details

Section 5

Packaging details

Section 6

Analytical service

Section 7

Serialization and aggregation

Section 8

Project price proposal

 

Section 3.

Commercial Price estimate

 

[***]

 

Section 4.

Pharmaceutical details

 

[***]

 

Section 5.

Packaging technical details

 

[***]

 

Section 6.

Analytical support

 

[***]

 

Section 7.

Serialization and Aggregation

 

[***]

 

Section 8.

Project price proposal

 

[***]

 

 

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EXECUTION VERSION

 

Section 9.

General other costs

 

[***]

 

Section 10.

Quote subject to

 

•

Customer will sign the quote and provide a PO to cover the project.  The project
will start once the written purchase order, with billing address and delivery
address has been received by Catalent.

•

The Customer will supply Catalent with up to date information on the API for an
OEB assessment.  Catalent will perform an internal OEB assessment once all
information has been provided.  All products with an OEB 3 or 4 classification,
will be sent for an external assessment if such an assessment has not been
provided by the Customer.  The same will apply for the ignition energy of the
API.

•

API’s with an OEB assessment of up to OEB 3 can be handled on the small scale
development equipment in the R&D area.  For scale-up to pilot scale and
commercial batch sizes, the use of equipment and processes in our commercial
manufacturing and packaging area is required.  In this area some process
restrictions for the handling of products containing OEB3 substances are in
place. Every product with an OEB 3 assessment will have to be evaluated on a
case to case basis to determine whether it is possible to handle these in the
commercial area, as well as the necessary safety measure required.  Additional
safety measures may include additional costs and or investments.

•

Customer will provide specification for all API’s, excipients and packaging
materials that will be used.  In cases where these are not supplied by Customer,
Catalent materials, as agreed with the customer, will be used.

•

Supplied by Customer, free of charge:

 

▪

Analytical methods

 

▪

Customer will provide released API in sufficient quantity with a CoA, and
Catalent will only do ID testing on receipt.  If the analytical methods for the
goods-in analytical testing of the API have to be validated, then additional
costs will incur.

 

▪

All other excipients and or components will be purchased by Catalent.  It is
assumed that Catalent already qualified raw materials can be used.  If raw
materials with special specifications have to be used then the manufacturing
prices have to be adjusted and additional costs for goods-in analytical testing
and possible analytical method validation may incur.

 

▪

Print artwork

•

If according to the MSDS there will be additional Safety Equipment needed and as
such additional costs arose.  These costs will be invoiced according to
expenditure. (See section “Other costs”)

•

Reference compounds and other cost-intensive chemicals, consumables
chromatographic columns need to be provided by Customer, if not, the costs can
be charged separately. In this case where Customer supplies these materials, the
supplier names as well as article numbers have to be stated.  Possible required
analytical validations and/or other change control tests are charged
separately.  If unforeseeable problems occur, Catalent reserves the right to
charge for these extra, errors and omissions excluded.

 

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EXECUTION VERSION

 

•

In order to produce GMP batches, at least one technical batch per strength is
required to confirm the manufacturing process parameters.  If more technical
batches are required, these will be done in agreement with Customer.  In the
case where Customer decides not to have at least one technical batch
manufactured, any costs that may arise out of deviations and Out of Spec (“OOS”)
product and OOS investigations, will be for the account of Customer.

•

Each batch of Product manufactured under this Quotation will be considered a
“Development Batch” unless and until the manufacturing process has been
validated, and is not for commercial sale or distribution.  Client shall be
responsible for the cost of each Development Batch, even if such batch fails to
meet the specifications, unless Catalent was grossly negligent in the
manufacture of the out-of-specification batch.  Catalent and Client shall
cooperate in good faith to resolve any problems causing the out-of-specification
batch. All shipment terms are Ex Works Catalent.

•

Customer shall pay for all product batches including batches that do not conform
to applicable specifications, unless all methods and processes associated with
the manufacture, testing, and storage of that product have been fully validated
in accordance with generally accepted standards of the pharmaceutical industry.

•

This quote is subject to:

 

▪

Exact material specification

 

▪

Agreement regarding the aim of the quote needs to be reached.

 

▪

Confirmation of the manufacturing and or packaging details

 

▪

The supply of a product sample (where available)

 

▪

Analytical methods and specifications

 

▪

Significant changes in project scope or design will be re-quoted.

 

▪

Final results and process parameters from the development and validation
activities by R&D.

 

▪

Agree and signing of the relevant LOI’s and Supply Agreement

 

▪

Agreement on all quality and regulatory details with the responsible Qualified
Person and product specialist.

 

▪

Catalent retains the right to renegotiate prices after the validation or
technical trials, if significantly different parameters than estimated occurred.

 

▪

Final packaging requirements (such as pallet load, pallet height, etc.)

•

Catalent may revise the prices provided in this quotation if reasonably
unforeseeable circumstances affect the work required to complete the
Project.  Catalent will notify Customer immediately if the costs to complete the
project exceed the prices stated in this quotation.  Catalent will not commence
work involving charges in excess of those stated in this quotation without
Customer approval unless such advance notice was not possible due to the
circumstances. In addition the quoted costs are subject to annual review to
account for changes in inflation, increased overhead charges, changes in scope
etc. Any additional work will be performed based on written agreement from
Customer and will be documented on a Catalent Quotation Amendment Record (QAR).

•

Quality by design (QbD) and Design of Experiments (DoE) strategies and details
will be discussed and agreed with the customer based on critical process
parameters and based on the critical material attributes impacting the quality
of the drug products.  These costs will be quoted for separately if required,
and when defined.

 

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EXECUTION VERSION

 

10.1

Minimum order quantities (MOQ)

Costs for materials which exceed the ordered call off quantities are not
included in the unit prices. When these materials cannot be used for following
orders, Catalent would charge the surplus materials according the procurement
costs plus handling fee (organization, financing, storage etc.) and either ship
it back to your company at your expenses. Alternatively the option can be to
have these destroyed at the abovementioned costs after issuing a formal order
for this destruction activity.

Section 11.

Scheduling and deliverables

11.1

Scheduling

Catalent must receive a signed Quotation, a signed protocol, and all raw
materials / intermediates / final product samples in order for this project to
be scheduled.  Subsequently, a Purchase Order number (where applicable) must be
received within [***] of receipt of the signed quote. Once scheduled, Customer
will be notified by Catalent of the anticipated start and completion date of the
project activities.

11.2

Deliverables

11.2.1

Reports and certificates of analysis

A report and/or Certificate of Analysis will be issued upon completion of each
project phase/the project.

11.2.2

Communication

In order to establish a collaborative relationship between Customer and
Catalent, both parties will appoint a Project Manager to serve as a point of
contact to oversee progress on this project.  Upon initiation of the project,
Catalent and Customer will establish a communication plan that may include
conference calls, visits, and timelines.  To foster project planning,
reviews/updates, and coordination meetings, Catalent will administer project
team conference calls as reasonably required.

The project’s viability from a regulatory and quality systems standpoint will be
assessed by Catalent and Customer in collaboration throughout the project to
determine if the project should proceed to validation and commercial launch.

Section 12.

Additional project terms

12.1

Safety

12.1.1

Catalent’s responsibilities

Catalent will assess all vendor and Customer MSDS and all handling data for the
samples/materials associated with this project.  If categorized as a Controlled
API (CDS) and/or Category 4 or 5 and OEB 3 above, the samples/materials will
require special handling precautions and will be subject to a Hazardous Material
Fee for all handling and testing directly associated with the samples/materials.
If applicable, this Hazardous Materials Handling Surcharge has been included in
the project costs.

 

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EXECUTION VERSION

 

12.1.2

Customer’s responsibilities

Customer will provide MSDS and all sample/material handling data for the
samples/materials associated with this project.  If any sample/material has any
special handling considerations, Customer will notify Catalent prior to the
initiation of the project.

12.2

Patent challenges and litigation

Catalent reserves the right to invoice Customer for Catalent’s costs and
expenses (including reasonable attorneys’ fees) associated with Catalent’s
obligation to respond to third party or government subpoenas relating to
Customer, this Project or the Product, including without limitation, such costs
and expenses incurred with respect to disputes regarding the filing of an ANDA
Paragraph IV patent challenge which involves this Project and/or Product(s)
hereunder, such as Catalent’s time and materials costs of responding to subpoena
(es), compiling and delivering documents, providing access to Catalent personnel
for depositions, in-house and outside counsel review, and any other items
related to such  Paragraph IV challenge.

12.3

Import of APIs into the European Union (EU)

12.3.1

Requirements for the import of API’s into the EU

As of 2 July 2013 EU regulation requires that any API manufactured outside of
the EU, that is intended for import into the EU, must be accompanied by a
"written confirmation" issued by the competent authority of the country where
the API manufacturer is located.  This "written confirmation" states that:

•

Standards of good manufacturing practices (GMP) at the plant in question are at
least equivalent to those of EU GMP requirements for APIs

•

That the plant is subject to regular inspections

•

That findings of non-compliance are reported to the EU authorities

A copy of the "written confirmation" must accompany each API batch or shipment. 
Without this “written confirmation” API will not be allowed to enter the EU, and
even when, Catalent will not be able to use this API for manufacturing of
pharmaceutical products.  When the API is supplied by the Customer, it is the
responsibility of the Customer to ensure that this “written confirmation” is
provided with the shipment.

12.3.2

Import tax on expensive API’s

Please note that materials imported from non-EU countries, Catalent generally
cross-charges any costs associated with the importation (import sales tax,
customs, etc.) according to expenses, unless the materials are sent back to the
country of origin in full.

12.4

Methods/Documentation

12.4.1

Catalent’s responsibilities

Catalent will review all project-related documentation and methods received from
Customer associated with this project.

 

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EXECUTION VERSION

 

12.4.2

Customer’s responsibilities

Customer will provide all available project-related documentation and methods to
be used for this project.

12.4.3

Samples/Materials

If available, Customer will provide all samples/materials necessary to perform
this project.  The samples/materials should arrive at Catalent with all proper
documentation.  If samples/materials are not available, upon request from
Customer, Catalent will purchase all samples/materials necessary to perform the
project.  Where standard materials, such as excipients or columns are required,
or needed to maintain the Project timeline, Catalent will purchase such
materials.  Catalent will invoice Customer monthly at cost plus reasonable and
customary acquisition and handling costs for any material purchased as described
above.  Non-standard or special instrumentation or equipment required solely for
this project will be invoiced to Customer following Customer’s approval.

If return shipment is requested, Customer will notify Catalent prior to the
disposition of samples/materials.

All materials shipped to Catalent on wood pallets must be heat treated in
accordance with IPPC-ISPM 15 International Export regulations.  Specifically,
Heat Treated (HT) pallets must be marked with the IPPC logo in accordance with
the International Standard.  No chemicals or chemical treatments, including
Haloanisoles or brominated phenols including 2, 4, 6-tribromianisole (TBA) or 2,
4, 6-trichloroanisole (TCA), shall be applied to any wood pallets used to ship
materials to Catalent.

Upon issuance of the final report or Certificate of Analysis, Catalent will
issue a request for approval of destruction of any remaining clinical supply
materials/samples, during which time samples/materials will be stored at
Catalent for a period of 30 days.  After a 30-day period, if additional storage
is required, Catalent will issue a QAR for the additional cost.

12.5

Equipment failure

Catalent is not in any manner responsible for material, scheduling or financial
losses due to equipment failure (beyond the direct cost of materials contained
within the respective product container).  In the event of equipment failure,
every effort will be made to repair the equipment and reschedule the order in
the timeliest manner.

12.6

Analytical rush

Rush services are available at the Customer request.  If rush services are
agreed between Customer and Catalent, additional costs will be invoiced based on
the schedule below.

[***]