Exhibit 10.1

 

EXECUTION VERSION

CONFIDENTIAL

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

DEVELOPMENT AND SUPPLY AGREEMENT

THIS DEVELOPMENT AND SUPPLY AGREEMENT (this “Agreement”) is made as of September
4, 2018 (the “Effective Date”), by and between Noramco, Inc., a Georgia
corporation, with offices at 500 Swedes Landing Road, Wilmington, Delaware
19801, USA (“Noramco”), and RespireRx Pharmaceuticals Inc., a Delaware
corporation located at 126 Valley Road, Suite C, Glen Rock, NJ 07452 (“Buyer”).
Noramco and Buyer may be referred to herein each as a “Party” or together as the
“Parties”, as the context may require.

WHEREAS, Noramco is engaged in the business of manufacturing and selling active
pharmaceutical ingredients;

WHEREAS, Buyer is engaged in the business of research and development,
manufacturing and/or selling finished pharmaceutical products;

WHEREAS, Buyer wishes Noramco to provide, and Noramco wishes to provide, certain
active pharmaceutical ingredient(s) and other products and services, during the
research and development and commercial preparatory phase of its dronabinol
based products;

WHEREAS, Buyer wishes, for commercialization, to purchase certain active
pharmaceutical ingredient(s) for its use in the manufacture of the Product (as
defined below), and Noramco is willing to provide and supply such active
pharmaceutical ingredient(s), on the terms and subject to the conditions of this
Agreement.

NOW THEREFORE, in consideration of the mutual representations, warranties and
covenants set forth in this Agreement, the Parties agree as follows:

1.       DEFINITIONS

1.1       For purposes of this Agreement, the following words or expressions
have the meanings provided below:

“Action” has the meaning set forth in Section 12.1.

“Affiliate” means with respect to either Party, any individual, partnership,
association, corporation, limited liability company, trust or other legal person
or entity that is controlled by, controls or is under common control with that
Party. As used herein, “control” of a corporation or other business entity means
direct or indirect beneficial or legal ownership of fifty percent (50%) or more
of the voting interest in, or more than fifty percent (50%) of the equity of, or
the right to appoint fifty percent (50%) or more of the board of directors or
board of managers of, that corporation or other business entity.

“Agreement” has the meaning set forth in the introductory paragraph.

“API(s)” means the active pharmaceutical ingredient(s) listed on Appendix A.

“Breaching Party” has the meaning set forth in Section 15.2.

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

“Buyer” has the meaning set forth in the introductory paragraph.

“Buyer Indemnitee” has the meaning set forth in Section 12.2.

“cGMP” means current good manufacturing practices within the meaning of the
rules and regulations of the FDA, including 21 C.F.R. Parts 210 and 211, as
applicable to the manufacturing, packaging, handling, storage and control of
API, as amended from time to time during the Term.

“Commercialization” means, with respect to any Product, the point in time when
all required regulatory approvals have been obtained, and the Buyer, or a
licensee or sub-licensee of Buyer, begins selling the Product for public use,
either directly or through wholesale or other retail channels.

“Confidential Information” means all information, data and know-how disclosed by
or for a Party to the other Party concerning the business, marketing strategies,
pricing, technology or processes of the disclosing Party or any of its
Affiliates, customers or vendors, whether written, verbal, electronic, visual
(e.g., obtained by observation of facilities) or in any other medium, whether
tangible or intangible, and whether disclosed prior to or subsequent to the
Effective Date. Confidential Information includes any summaries, analyses,
compilations, technical information and other materials prepared by either
Party, their respective Affiliates, or any of its or their respective officers,
directors, employees or agents that contain or are based in whole or in part on
any other Confidential Information. Confidential Information also includes the
existence and terms of this Agreement. However, Confidential Information does
not include information, data or know-how that the receiving Party can show by
competent proof:

(a)       was in the public domain at the time of the disclosure to the
receiving Party, or thereafter became part of the public domain without any
fault of the receiving Party provided that Confidential Information shall not be
deemed to have entered the public domain where it is merely embraced by or
contained in more general information that is in the public domain;by

(b)       rightfully was in the receiving Party’s possession prior to the
disclosure by or for the disclosing Party (it being understood that Confidential
Information shall not be deemed to be in the receiving Party’s prior possession
where it is merely embraced by or contained in more general information that was
in the receiving Party’s prior possession);;

(c)       was lawfully obtained by the receiving Party from a third party who
had the right to make such disclosures; or

(d)       was developed by or for the receiving Party independently of that
disclosure.

(e)       is required to be disclosed (i) under the United States securities
laws or the rules and regulations promulgated thereunder by the United States
Securities and Exchange Commission, or any similar state, district, territory or
local laws, rules or regulations or similar laws, rules or regulations in
foreign jurisdictions, (ii) under the Freedom of Information Act, or any other
Federal statute, or (iii) by or to the FDA, DEA or any other governmental
agency, bureau or instrumentality or foreign equivalent, as part of an NDA, IND,
or ANDA filing or otherwise.

“DEA” means the Drug Enforcement Administration of the United States Department
of Justice or any successor organization.

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

“DMF” means the Drug Master File with respect to an API, as filed with the FDA
by Noramco or any of its Affiliates.

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

“Exchange Rate Change” has the meaning set forth in Section 6.2.2.

“FDA” means the United States Food and Drug Administration or any successor
organization.

“First-Generation Product” means a Product using a current form of an available
branded or generic gel capsule and containing a first-generation formulation of
the API, or a variation thereof, for the treatment of sleep related breathing
disorders.

“Forecast” has the meaning set forth in Section 5.1.1.

“IND” means an Investigational New Drug Application filed or prepared to be
filed with the FDA.

“Initial Price Period” has the meaning set forth in Section 6.1.1.

“Invention” means any innovation, improvement, development, discovery, method,
know-how, process, technique or the like, whether or not written or otherwise
fixed in any form or medium and whether or not patentable or copyrightable, that
is generated, conceived, or reduced to practice by either Party (or any of its
Affiliates or its or their respective employees, independent contractors,
subcontractors or agents), or jointly by the Parties, in connection with this
Agreement; and all intellectual property rights therein.

“Losses” has the meaning set forth in Section 12.1.

“Manufacturing Interruptions” has the meaning set forth in Section 10.1.

“Manufacturing Quota” means the amount of quota allotted to Noramco by the DEA
pursuant to applicable DEA regulations so that Noramco may manufacture API.

“Manufacturing Quota Restrictions” has the meaning set forth in Section 10.2.

“NDA” means a New Drug Application filed or prepared to be filed with the FDA.

“Nonconforming API” has the meaning set forth in Section 8.1.

“Noramco” has the meaning set forth in the introductory paragraph.

“Noramco Indemnitee” has the meaning set forth in Section 12.1.

“Party” and “Parties” have the meaning set forth in the introductory paragraph.

“Price” has the meaning set forth in Section 6.1.1.

“Procurement Quota” means the amount of quota allotted to Buyer by the DEA
pursuant to applicable DEA regulations so that Buyer may receive shipments of
API from Noramco.

“Procurement Quota Restrictions” has the meaning set forth in Section 10.3.

3

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

“Product(s)” means any drug product, in any dosage form or strength,
manufactured by or for Buyer that contains API(s), including without limitation
the First-Generation Product and the Second-Generation Product.

“Proprietary IP” has the meaning set forth in Section 14.1.

“Purchase Order” means a written order from Buyer given in accordance with this
Agreement requesting API(s) to be manufactured by Noramco and supplied to Buyer
hereunder.

“Recall” has the meaning set forth in Section 9.3.

“Regulatory Authority” means any and all governmental bodies and organizations
regulating the manufacture, importation, distribution, use and/or sale of any
Product.

“Representatives” has the meaning set forth in Section 13.1.

“Second-Generation Product” means a Product containing an optimized formulation
of the API for the treatment of sleep related breathing disorders.

“Specification(s)” means Noramco’s API specification(s) contained in Appendix B,
subject to Section 4.3.2.

“Term” has the meaning set forth in Section 15.1.

“Year” means, (i) with respect to the first year of the Term, the period from
the Effective Date up to and including December 31 of the same calendar year,
(ii) with respect to the last year of the Term, the period from January 1 of
such last calendar year up to and including the date of termination or
expiration of this Agreement, and (iii) for all periods of the Term in between,
a calendar year.

2.       PRE-COMMERCIALIZATION AND DEVELOPMENT

2.1       Provision of API Free of Charge. Noramco shall provide, at no cost to
Buyer, 100% of all API required in the development process of (i) a
First-Generation Product and (ii) a Second-Generation Product. The amount of API
provided will be sufficient for all research and development purposes, including
without limitation, sufficient API to be included in the three validation
batches and to create sufficient Product for initial wholesale and retail
channels, subject to the limitations in this subsection. Notwithstanding the
foregoing, the API to be supplied by Noramco free of charge shall include (i) up
to [***] of API for the development of the First-Generation Product, (ii) up to
[***] of API in connection with the development of the Second-Generation
Product, (iii) up to [***] of API in connection with the commercial launch of
the First-Generation Product, and (iv) at least [***] of API, in connection with
the commercial launch of the Second-Generation Product. The amounts to be
provided free of charge shall be provided by Noramco or its designee, which may
include an encapsulation service provider, in such quantities as requested by
Buyer, subject to the limitations set forth in this Section 2.1, and shall be
provided within 30 days of Buyers request for such API in writing.

2.2       FDA Documentation and Support. In support of any such IND or NDA
filings or other FDA requests, Noramco, at its sole cost and expense, has filed
or will file and shall maintain during the Term valid DMF(s), in accordance with
all applicable laws, rules and regulations of the FDA or any other Regulatory
Authority expressly identified in the Specifications. Noramco shall provide
Buyer with an access or right of reference letter entitling Buyer to make
continuing reference to the Noramco DMF(s) during the Term in connection with
any regulatory filings made with the FDA by Buyer with respect to Product(s).

4

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

2.3       Development Committee. In order to further coordinate the development
efforts of the Parties, the Parties shall, within 30 days of the execution of
this agreement, establish a Development Committee (“the DC”), with at least 1
member and up to 3 members appointed by each Party, which shall meet monthly or
as needed during the Term, at least until the Commercialization of the
Second-Generation Product. The DC will assist the Parties in coordinating the
efforts of each party in developing the First-Generation Product and the
Second-Generation Product, including setting timelines, goals and establishing
procedures for communication between the Parties.

2.4       Encapsulation Services. Noramco shall, within 30 days of the date of
this Agreement, suggest by name for Buyer, free of charge, third parties that
provide encapsulation services, packaging and labeling of clinical trial gel
capsule services and a vendor that offers developmental and optimization
services. Noramco will use “best efforts” to provide third party encapsulation
service provider with any regulatory, technical or similar support as it relates
to the API DMF on behalf of Buyer in order to facilitate product launch of the
First-Generation Product and, if appropriate, the Second-Generation Product and
will otherwise collaborate with such vendor to facilitate such product launches.

2.5       Other Services. Noramco shall, free of charge, assist the Buyer in
identifying third party service providers that can provide packaging and
labeling of the Buyer’s Products. For avoidance of doubt, Noramco’s efforts in
this regard would be free of charge, but Buyer would pay the cost of the third
party service provider.

Noramco shall, free of charge, assist the Buyer in identifying third party
service providers that can assist in the development of a Second-Generation
Product. For avoidance of doubt, Noramco’s efforts in this regard would be free
of charge, but Buyer would pay the cost of the third party service provider.

2.6       Regulatory Consulting. Noramco shall, free of charge, collaborate with
any regulatory consulting firm or firms engaged by the Buyer to assist in
developing a strategy for the use of the API in obtaining regulatory approval to
market the First-Generation Product and/or the Second-Generation Product. In
addition, Noramco shall, free of charge, make available its own regulatory
consultants, including those specializing in scheduled drugs, beginning within
10 days of the date of this Agreement. Noramco’s regulatory consultants shall
assist in preparing for and shall participate in all meetings, as appropriate
and as relates to the API, with the FDA or Drug Enforcement Administration free
of charge. For avoidance of doubt, Noramco’s efforts in this regard would be
free of charge, but Buyer would pay the cost of consultants engaged by the
Buyer.

2.7       Collaboration Generally. Notwithstanding the more specific
requirements set forth above in this Section 2, Noramco shall, free of charge,
collaborate with other suppliers, vendors, partners or subsidiaries or
affiliates of Buyer in connection with the use of the API for the development of
the First-Generation Product and Second-Generation Product, as required to
facilitate a successful regulatory filing, review, approval and
commercialization of such products.

2.8       Buyer and Noramco agree to establish a definitive quality agreement
(“Quality Agreement”) prior to the first delivery of API.

3.       SUPPLY AND PROFIT SHARE POST-COMMERCIALIZATION

3.1       Supplier Qualification. Buyer shall use commercially reasonable
efforts to qualify Noramco’s API as soon as practicable for use in sufficient
SKUs of its Product(s) to meet the requirements of Section 3.2. New or next
generation API or a new manufacturing site: Within six (6) months of Noramco
validating a new manufacturing process or manufacturing site (“New API”), Buyer
shall file for such New API to be qualified for use in all of its Products
containing such previous generation API whether pursuant to a NDA, an ANDA, or
an SNDA. Buyer shall provide Noramco with written notification of filings made
in accordance with the terms of this Section.

5

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

3.2       Purchase and Sale.

3.2.1       Volume. Beginning in the calendar year after the Commercialization
of the First-Generation Product and subject to the terms and conditions of this
Agreement, Noramco, or any of its Affiliates, shall supply to Buyer and Buyer
shall purchase from Noramco the quantities described in Section 5 of this
Agreement.

3.3       Product Discontinuation. Buyer shall use commercially reasonable
efforts to provide at least twelve (12) months’ advance notice to Noramco if it
intends to no longer order one or more API(s) due to its election to discontinue
or otherwise withdraw from the market any Product.

3.4       Profit Share. Buyer shall pay to Noramco, in accordance with Section
3.4.1, an amount equal to [***] percent ([***]%) of the Buyer’s positive
earnings before interest, tax, depreciation and amortization (“EBITDA”) from
Products until the earlier of five (5) years after the Effective Date of this
Agreement or a cumulative aggregate amount of $[***] has been received by
Noramco (“Profit Share”). For the avoidance of doubt, the Years in which EBITDA
is negative shall not be considered.

3.4.1       Reporting and Payment. Not later than forty-five (45) days after the
end of each calendar quarter other than at Buyer’s fiscal year end where the
timeframe shall be ninety (90) days, Buyer shall:

(a)       deliver to Noramco a written report that specifies the Profit Share
with respect to such calendar quarter; and

(b)       pay to Noramco the amount owed to Noramco with respect to such
calendar quarter in accordance with Section 3.4(a).

(c)       with respect to the year-end calculation, it shall include both
payment for the fourth quarter and a review of each of the prior three quarters,
with any correction to be incorporated into the year-end calculation, report and
payment.

3.4.2       Maintenance of Records; Audit. Upon 30 days’ prior written notice
and not more than once per calendar year, Noramco may at its cost send to Buyer
an internationally-recognized accounting firm, reasonably acceptable to Buyer,
to audit Buyer’s calculation of Profit Share. If such accounting firm identifies
a discrepancy in any report made during the period audited leading to an
underpayment in payments required to be made to Noramco under this Agreement,
Buyer shall pay Noramco the amount of the discrepancy within thirty (30) days of
the date such accounting firm’s written report was delivered to Noramco and
Buyer. If such accounting firm identifies a discrepancy in any report made
during the period audited leading to an overpayment in payments required to be
made to Noramco under this Agreement, Noramco shall pay Buyer the amount of the
discrepancy within thirty (30) days of the date such accounting firm’s written
report was delivered to Noramco and Buyer. The fees charged by such accounting
firm shall be paid by Noramco, provided, however, that if such audit requires a
payment by Buyer to Noramco, then the fees of such accounting firm shall be paid
by Buyer.

4.       PERMITS AND COAs

4.1       Permits. Noramco, at its sole cost and expense, will be responsible
for obtaining all licenses, permits and other governmental approvals necessary
for the manufacture of the API(s); provided, that Manufacturing Quota is
addressed in Section 8. Buyer, at its sole cost and expense, will be responsible
for obtaining all licenses, permits and other governmental approvals necessary
in connection with possessing, handling, storing and using API(s) following
tender of delivery by Noramco and in connection with Product(s); provided, that
Procurement Quota is addressed in Section 8.

6

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

4.2       CoAs. Noramco shall provide a certificate of analysis with each
shipment of API. Buyer shall be solely responsible for releasing API(s) in
connection with the manufacture of Product(s).

5.       FORECASTS AND PURCHASE ORDERS

5.1       Forecasts.

5.1.1       Rolling Monthly Forecasts. On the first day of the month throughout
the Term, beginning eighteen months prior to the date of anticipated
Commercialization of the First Generation Product, Buyer shall provide to
Noramco an eighteen (18) month rolling forecast (each, a “Forecast”) of its
anticipated purchases of each API under this Agreement. The first nine (9)
months of each Forecast shall be binding on Buyer and shall constitute a firm
commitment to issue a purchase order for the API indicated for such months
subject to permissible variations described in Section 5.1.2. The balance of
each Forecast shall be a non-binding, good faith estimate of Buyer’s anticipated
purchases of each API during such period. Each Forecast will include information
regarding quantities suitable for planned regulatory filings, including
Manufacturing Quota and Procurement Quota filings. Buyer acknowledges that any
failure by Buyer to timely provide Forecasts in accordance with this Section
5.1.1 that are reasonable in light of Buyer’s historic sales data may prevent
Noramco and Buyer from obtaining Manufacturing Quota and Procurement Quota,
respectively and may prevent Noramco or other inventory related vendors from
delivering API and Product, respectively, as actually ordered by Buyer, on a
timely basis.

5.1.2       Variations. With respect to Forecasts submitted hereunder, the
quantity of API(s) forecast may not deviate, during the first six (6) months
after Commercialization of the applicable Product, by more than twenty-five
percent (25%), by more than twenty percent (20%), in each forecast period
thereafter for the remainder of the Term, (for example, the quantity of an API
forecasted for the fourth month of a given Forecast shall not vary by more than
the applicable percentage from the quantity of such API forecasted for the
fourth month in the immediately prior Forecast; the quantity of an API
forecasted for the first month of a given Forecast shall not vary by more than
the applicable percentage from the quantity of such API forecasted for the first
month in the immediately prior Forecast; etc.). For the avoidance of doubt, and
except for any changes in monthly forecast amounts pursuant to the last sentence
of Section 5.1.1, in the event any Forecast overlaps with any prior Forecast
with respect to the binding period described in Section 5.1.1, Buyer
acknowledges that, notwithstanding such overlap, the quantity of API in each
binding period is fixed upon the submission of the first applicable Forecast and
may not be changed (by any subsequent Forecast or otherwise) without Noramco’s
prior written consent.

5.1.3       Inventory Build. Any Buyer API inventory build or targeted API
inventory quantities shall be built into the Forecast.

 

5.1.4       Planning. With respect to each Forecast, Noramco may, within nintey
(90) calendar days of receipt thereof, notify Buyer that it will not be able to
meet Buyer’s anticipated demand for any API as reflected for any of months seven
(7) through eighteen (18). In such event, the Parties shall promptly meet to
discuss in good faith to revise such Forecast, which shall be resubmitted by
Buyer to Noramco with quantities mutually acceptable to both Parties.

7

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

5.2       Purchase Orders.

5.2.1       Submission. Buyer shall place Purchase Orders for the API(s) with
Noramco from time to time in accordance with this Section 5.2.1. Each Purchase
Order shall (i) specify in kilograms the quantity of each API requested (subject
to Section 6.1.2); (ii) request only quantities of API consistent with the
applicable binding portion of the applicable Forecast delivered in accordance
with Section 5.1.1, but subject to any variances in accordance with Section
5.1.2; (iii) specify a delivery date for each API requested consistent with
Section 5.2.2; and (iv) include the documentation required by Section 5.2.3.
Noramco shall accept all Purchase Orders that comply with the foregoing
requirements. Noramco may, in its sole discretion and without liability to
Buyer, reject any Purchase Order that does not comply with any one or more of
the foregoing requirements. Noramco shall notify Buyer in writing of any such
Purchase Order rejection within five (5) business days of receiving such
Purchase Order. Purchase Orders shall be binding upon Buyer when submitted to
Noramco, and binding on Noramco when accepted (or not timely rejected).
Notwithstanding anything to the contrary in this Section 5.2.1, all Purchase
Orders remain subject to Section 8.

5.2.2       Delivery Dates. For each API, Appendix A shall indicate the Purchase
Order lead time for such API. The delivery date requested by Buyer in any
Purchase Order for such API may not be sooner than the number of months
indicated in Appendix A from the date on which Buyer submitted the Purchase
Order to Noramco.

5.2.3       Documentation. If applicable, Buyer must submit with each Purchase
Order a certificate of available Procurement Quota or a completed DEA Form 222
(as set forth below), on an API-by-API basis, evidencing that Buyer will be able
to take delivery of the API(s) requested by such Purchase Order. Buyer shall
submit a completed DEA Form 222 forty five (45) days in advance of the confirmed
delivery date for each order.

6.       PRICE AND PAYMENT

6.1       Pricing.

6.1.1       Base Price. The price of each API to be sold to Buyer under this
Agreement (“Price”) is as set forth in Appendix A. Such price is valid for the
first Year of the Term (i.e., from the Effective Date until December 31 of the
same calendar year) (the “Initial Price Period”).

6.1.2       Repackaging Fee. The Price includes Noramco’s standard commercial
packaging and fill amounts. If Buyer requests a quantity of API lower than the
standard commercial fill quantity (e.g., a partial drum), Noramco shall have the
right to charge the repackaging fee set forth on Appendix A.

6.2       Annual Price Adjustments.

6.2.1       Inflation Adjustment. Effective on January 1 of each Year following
the Initial Price Period, the Price shall automatically be adjusted to reflect
inflation, [***].

6.2.2       Foreign Currency Adjustment. There shall be no foreign currency
adjustment. Noramco shall invoice Buyer in US dollars.

6.2.3       Failure to Purchase binding amounts subject to variances. During the
fourth quarter of the first full year of Commercialization, Noramco and Buyer
agree to review actual purchases and open orders for the year. If the total
actual purchases and open orders for the Year do not meet the binding purchases
pursuant to Section 5.1.1, subject to the variances of Section 5.1.2 for the
year, then Noramco shall have the right to: (i) adjust the Price on the open
orders in the remaining portion of the fourth quarter, taking into consideration
the volume of API actually purchased by Buyer during the months of year up to
the date of the review (“Adjusted Price for Actual Purchases”); and (ii) issue
an invoice to Buyer for the volume of API purchased by Buyer during to date with
the Adjusted Price for Actual Purchases (“Price Adjustment Invoice”). To
calculate the amount of Price Adjustment Invoice, Noramco shall calculate the
theoretical invoice amount of the minimum amount that Buyer would have been
required to purchase subject to variances in accordance with Section 5.1.2 and
compare that to the invoice amount of actual purchases. The difference shall be
divided by two and that shall be the amount of the Price Adjustment Invoice.
Noramco may invoice Buyer for, and Buyer shall pay, any such Price Adjustment
Invoice.

8

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

6.2.4       Annual Adjustments Procedure. Noramco will provide written notice to
Buyer of all Price adjustments made pursuant to Section 6.2.1 as soon as
reasonably practicable following January 1 of each Year following the Initial
Price Period; provided, that no delay in providing such notice shall impair
Noramco’s right to charge such adjusted Prices. Adjusted Prices shall apply to
all deliveries of API(s) made on or after the effective date of the Price
adjustment, regardless of when the Purchase Order for such API(s) was submitted.

6.3       Other Price Adjustments.

6.3.1       Due to Technical Changes. Changes to the Specifications or the
applicable Quality Agreement requested by either Party will be implemented only
following a technical and cost review by the Parties and a written, signed
amendment detailing the change, and are subject to the Parties reaching
agreement on appropriate revisions to the Price and allocation of any other
resulting costs. If the Parties agree to proceed with such amendment and Buyer
accepts a proposed Price adjustment, Noramco shall implement the proposed change
on the agreed timeframe, and the adjusted Price shall apply only to API(s) that
are manufactured under the amended Specifications or Quality Agreement, as
applicable. In addition, Buyer shall reimburse Noramco for any inventory of raw
materials, packaging or other components rendered obsolete as a result of such
amendment.

6.4       Invoicing. Noramco shall invoice Buyer for API(s) purchased hereunder
upon tender of delivery in accordance with Section 7.1. Invoices shall be
submitted by fax or email as Buyer may specify in writing from time to time, and
a copy of the invoice shall also be enclosed in the applicable shipment. Each
invoice shall, to the extent applicable, identify Buyer’s Purchase Order number,
API batch numbers, names and quantities, Price, Incoterms, and the total amount
to be remitted by Buyer.

6.5       Payment Terms. Subject to Section 6.6, Buyer shall pay Noramco all
amounts due hereunder within [***] calendar days from the date of invoice;
provided, that Buyer is not obligated to pay any invoice for API with respect to
which Buyer has delivered a written objection pursuant to Section 6 until such
dispute has been resolved. Buyer shall make payments by electronic transfer of
United States dollars to the account designated by Noramco in the applicable
invoice (or otherwise in writing).

6.6       Payment Issues.

6.6.1       Non-Payment. Noramco shall be entitled to interest on any overdue
sum at a rate equal to one and a half percent (1.5%) per month, or the highest
rate permissible under applicable law, if lower. In addition, Noramco will not
be obligated to accept or honor Buyer’s Purchase Orders or to make any shipments
of API(s) hereunder should Buyer’s account with Noramco fall greater than thirty
(30) calendar days in arrears. Buyer agrees to pay all costs and expenses,
including reasonable attorneys’ fees, incurred by Noramco in the collection of
any sum payable by Buyer to Noramco.

9

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

6.6.2       Recurring Non-Payment. If Buyer’s payment is overdue (i) for two (2)
or more consecutive invoices or (ii) more than three (3) times (whether or not
consecutive) in any Year, then Noramco shall have the right, in its sole
discretion, to change Buyer’s payment terms under Section 6.5 effective
immediately upon written notice to Buyer.

6.6.3       Remedies Cumulative. For the avoidance of doubt, Noramco’s rights
under this Section 6.6 are cumulative and in addition to any other rights or
remedies to which it may be entitled at law or in equity.

6.7       Taxes. In addition to the price for API(s), Buyer shall pay Noramco
any and all governmental taxes, charges or duties of every kind (excluding any
tax based upon Noramco’s net income) that Noramco may be required to collect or
pay upon sale, transfer or shipment of API(s) under this Agreement.

7.       SHIPMENT OF API

7.1       Delivery. Noramco shall make deliveries of API(s) outside the United
States to Buyer’s legal designate LDP (Landed Duty Paid Price) Destination. Risk
of loss of API(s) shall pass to Buyer in accordance with such Incoterm. Title to
API(s) shall transfer to Buyer concurrently with risk of loss. Noramco shall
tender of delivery within ten (+/- 10) days of the delivery date set forth in
the applicable Purchase Order.

7.2       Packing. Noramco shall pack and label shipping containers in
accordance with applicable law and transport guidelines, and the Specifications.

8.       PRODUCT CLAIMS

8.1       Inspection and Rejection. All API may be inspected by Buyer and
rejected if the API does not meet the warranty set forth in Section 11.1(iii)
(any such API, “Nonconforming API”). API will be deemed accepted if Noramco does
not receive written notice from Buyer to the contrary, setting forth in
reasonable detail the claimed nonconformity and providing a sample of the
alleged Nonconforming API, within forty-five (45) calendar days after tender of
delivery to Buyer of such API. If Buyer provides a written notice of
Nonconforming API, Buyer shall have no payment obligation with respect to such
Nonconforming API unless and until such API is deemed conforming pursuant to
this Section 8.

8.2       Assessment. Upon receipt of a timely-delivered rejection notice and
sample pursuant to Section 8.1, Noramco will have thirty (30) calendar days to
inspect the alleged Nonconforming API and make a reasonable assessment of the
alleged nonconformance. If Noramco agrees, or there is a determination under
Section 8.3, that any API is Nonconforming API, then Noramco, at its sole cost
(including shipping), and as Buyer’s sole remedy, shall promptly replace the
Nonconforming API. Buyer shall, at Noramco’s election and expense, either return
the Nonconforming API to Noramco or destroy the Nonconforming API and have an
authorized officer of Buyer certify such destruction in writing.

8.3       Dispute Resolution. Any dispute between the Parties concerning whether
rejected API is in fact Nonconforming API that the Parties are unable to resolve
within a sixty (60) day period from Buyer’s rejection notice will be
investigated in accordance with the Quality Agreement. If the Parties still
cannot agree after such investigation whether rejected API is in fact
Nonconforming API, the Parties will arrange to have samples submitted to a
qualified independent laboratory mutually agreed to by Noramco and Buyer for
testing; or, in the event of a dispute related to cGMP, then to a mutually
agreed upon third party expert for resolution. Such laboratory will use the test
methods contained in the applicable Specifications. The determination as to
whether all or part of such API is Nonconforming API by such laboratory or
expert, as the case may be, will be final and binding on the Parties absent
manifest error. The fees and expenses of the laboratory or expert, as the case
may be, incurred in making such determination will be paid by Noramco if the API
is determined to be Nonconforming API, and by Buyer in all other cases.

10

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

9.       PRODUCT COMPLAINTS AND RECALLS

9.1       Customer Complaints. During the Term, Noramco shall reasonably
cooperate with Buyer in connection with any necessary investigation arising from
customer complaints relating to Product in accordance with the Quality
Agreement. Without in any manner limiting the foregoing, each of Buyer and
Noramco shall comply with FDA requirements for complaint handling. Buyer shall
maintain a system for monitoring, investigating, and following up on adverse
event reports received by it involving Product(s), and shall provide prompt
notice to Noramco of any Product complaints, including, but not limited to,
information concerning adverse drug events that are required to be reported to
FDA, side effects, injury, toxicity, or sensitivity reaction.

9.2       Regulatory Action. Each Party shall notify the other Party of any
regulatory action or other action concerning the safety of any API or Product in
accordance with the Quality Agreement, including but not limited to FDA
inspection reports, warning letters or import alerts.

9.3       Product Recall. In the event of a Product recall, field alert,
withdrawal or field correction (“Recall”) that does not result from
Nonconforming API, then, as between Noramco and Buyer, Buyer shall (i) be
responsible for the expenses of the recall and (ii) reimburse Noramco for any
costs reasonably expended by Noramco to assist Buyer to investigate and/or
effect the Recall. Noramco shall, subject to Sections 12.4 and 12.5, bear the
direct expenses of a Recall if the Recall would not have resulted but for
Noramco’s breach of its warranty set forth in Section 11.1(iii). For the
purposes of this Section 9.3, the direct expenses of recall shall mean the
expenses of notification and destruction or return of the Recalled Product and
the cost of the API(s) used in the Recalled Product.

10.       SUPPLY ISSUES

10.1       Manufacturing Interruptions. Buyer acknowledges that the day-to-day
manufacturing operation of the facilities used by Noramco to produce API(s) may
be subject to interruptions, fluctuations, slow-downs, suspensions and
reductions in the ordinary course of business due to a variety of reasons
(“Manufacturing Interruptions”). If Noramco believes that a Manufacturing
Interruption is reasonably likely to result in a material reduction of any API
available to be delivered to Buyer, Noramco shall notify Buyer and consult with
Buyer about such Manufacturing Interruption prior to or as soon as reasonably
possible after the commencement of such Manufacturing Interruption. After any
Manufacturing Interruption resulting in a material reduction of any API
terminates, Noramco shall promptly communicate to Buyer regarding such
Manufacturing Interruption, the reason therefor, the actions taken, and any
corrective actions possible to prevent a repeat event.

10.2       Manufacturing Quota Restrictions. Buyer acknowledges that the
production and supply of API(s) is contingent upon DEA rules, orders, or
directives related to manufacturing quotas for API(s), which may limit or
restrict the manufacture or supply of API(s) by Noramco to Noramco’s customers
(“Manufacturing Quota Restrictions”). If Noramco believes that a Manufacturing
Quota Restriction is reasonably likely to result in a material reduction or
suspension of the delivery of an API to Buyer, Noramco shall promptly consult
with Buyer to coordinate with respect to their respective obligations, in
accordance with Sections 10.4 and 10.5.

10.3       Procurement Quota Restrictions. It is the sole responsibility of
Buyer, and Buyer shall use commercially reasonable efforts, to obtain
Procurement Quota for API(s). Noramco acknowledges that Buyer’s receipt of API
manufactured by Noramco is contingent upon DEA rules, orders, or directives
related to procurement quotas for API(s) that may limit or restrict Noramco’s
customers from receiving API(s) manufactured by Noramco (“Procurement Quota
Restrictions”). If Buyer believes that a Procurement Quota Restriction is
reasonably likely to result in Buyer’s inability to take delivery of any API
from Noramco on the delivery date set forth in the applicable Purchase Order,
Buyer shall promptly consult with Noramco to coordinate with respect to their
respective obligations, in accordance with Section 10.4.

11

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

10.4       Failure to Obtain Quota. Each Party shall use commercially reasonable
efforts to prepare and plan for the supply and purchase of API(s) against
Purchase Orders given in accordance with this Agreement, in anticipation of each
Party receiving applicable quota from the DEA. However, in the event that a
Party has not obtained the necessary Manufacturing Quota or Procurement Quota,
as the case may be, to allow it to perform its obligations under this Agreement,
such Party shall promptly inform the other Party in writing. In the event that
there is not sufficient Manufacturing Quota or Procurement Quota with respect to
an outstanding Purchase Order for an API, such Purchase Order shall nonetheless
remain valid and binding upon the Parties; provided, that the Parties shall
adjust the delivery date set forth in such Purchase Order for a period not to
exceed two (2) months, so as to permit receipt of the necessary Manufacturing
Quota or Procurement Quota, as the case may be. In the event that Manufacturing
Quota is not received within two (2) months of the originally scheduled API
delivery date, then such Purchase Order may be, but is not required to be,
cancelled by Buyer by written notice to Noramco. Cancellation of such Purchase
Order shall be Buyer’s sole and exclusive remedy due to a Manufacturing Quota
Restriction. In the event that Buyer has not obtained Procurement Quota within
one (1) month of the originally scheduled API delivery date, then such Purchase
Order may be, but is not required to be, cancelled by Noramco by written notice
to Buyer. Cancellation of such Purchase Order shall be Noramco’s sole and
exclusive remedy due to a Procurement Quota Restriction; provided, however that
Buyer shall not be relieved of its binding purchase requirement, subject to
variance under Section 5.. Alternatively, Noramco may elect, in lieu
cancellation, to store such API subject to such Procurement Quota Restriction
for a period not to exceed three (3) months after the originally scheduled API
delivery date at Buyer’s reasonable expense. If Buyer still has not obtained
Procurement Quota by the end of such three (3) month period, Noramco may, in its
sole discretion, dispose of such API at Buyer’s reasonable expense and invoice
Buyer for full payment for such API under the applicable Purchase Order.

10.5       Allocation and Cooperation. Buyer recognizes that, due to
Manufacturing Interruptions or Manufacturing Quota Restrictions, Noramco may
produce less API in any given time period than anticipated, and that Noramco
may, at its discretion, allocate its available supply of API among its
customers, itself, and its Affiliates on such basis as Noramco deems fair and
reasonable. Notwithstanding the above, Noramco shall (i) use commercially
reasonable efforts to minimize interruptions in the supply of API to Buyer and
(ii) use commercially reasonable efforts to coordinate with Buyer to mitigate
against the consequences of any shortages related to Manufacturing Interruptions
or Manufacturing Quota Restrictions.

10.6       No Liability for Interruptions and Restrictions. Noramco shall not be
liable to Buyer for any damage, inconvenience, penalty or other consequence that
may arise from any Manufacturing Interruptions, Manufacturing Quota Restrictions
or Procurement Quota Restrictions.

11.       WARRANTIES; DISCLAIMER

11.1       Noramco Warranties. Noramco hereby represents, warrants and covenants
to Buyer that (i) it has the corporate authority to enter into this Agreement
and to perform its obligations hereunder; (ii) it is not subject to any legal,
contractual or regulatory restriction, limitation or conditions that could
reasonably be expected to affect adversely its ability to perform hereunder,
subject to Article 8; and (iii) all API sold to Buyer under this Agreement
shall, as of tender of delivery in accordance with Section 7.1 from the Noramco
facility designated on Appendix A, have been manufactured in accordance with
cGMP and conform to the Specifications.

12

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

11.2       Buyer Warranties. Buyer hereby represents, warrants and covenants to
Noramco that (i) it has the corporate authority to enter into this Agreement and
to perform its obligations hereunder; (ii) it is not subject to any legal,
contractual or regulatory restriction, limitation or conditions that could
reasonably be expected to affect adversely its ability to perform hereunder,
subject to Section 8; and (iii) all API supplied to Buyer by Noramco hereunder
shall be held, used and disposed of by Buyer in accordance with all applicable
laws, rules and regulations, and Buyer will otherwise comply with all laws,
rules and regulations applicable to Buyer’s performance under this Agreement and
its manufacture, distribution and/or sale of Product(s).

11.3       Disclaimer of Warranties. THE PARTIES AGREE THAT, EXCEPT AS EXPRESSLY
SET FORTH IN THIS SECTION 9, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS
ANY WARRANTIES OF ANY KIND, AND THE LIMITED REPRESENTATIONS AND WARRANTIES
CONTAINED IN THIS SECTION 9 ARE THE SOLE REPRESENTATIONS AND WARRANTIES WITH
RESPECT TO THE API(s) AND THE PRODUCT(s) AND ARE MADE EXPRESSLY IN LIEU OF AND
EXCLUDE ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, OR NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS AND ALL
OTHER EXPRESS OR IMPLIED WARRANTIES PROVIDED BY APPLICABLE LAW, INCLUDING BUT
NOT LIMITED TO THE UCC AND THE UN CONVENTION ON CONTRACTS FOR THE INTERNATIONAL
SALE OF GOODS.

12.       INDEMNIFICATION; LIMITATIONS OF LIABILITY; INSURANCE

12.1       Indemnification by Buyer. Buyer shall indemnify, defend and hold
Noramco and each of its Affiliates and its and their respective officers,
directors, employees and agents (each, a “Noramco Indemnitee”) harmless from and
against any liability, loss, costs, damage and/or expense, including without
limitation, reasonable attorneys’, experts’ and consultants’ fees and
disbursements (“Losses”) in connection with any and all suits, investigations
(governmental or otherwise), claims, proceedings or demands (each, an “Action”)
initiated or filed against a Noramco Indemnitee by a third party to the extent
resulting from or arising out of (i) any breach of any representation, warranty
or covenant hereunder by any Buyer Indemnitee (ii) a Buyer Indemnitee’s
negligence or willful misconduct or (iii) the manufacture, use or sale of
Product by or for Buyer, including in connection with intellectual property or
product liability; in each case except to the extent of Noramco’s indemnity
obligations pursuant to Section 12.2. In addition, Buyer shall indemnify, defend
and hold the Noramco Indemnitees harmless from and against any Losses to the
extent resulting from or arising out of any filings with any regulatory
authority (including the FDA) by or for Buyer or any of its Affiliates or
licensees, including filings under 21 U.S.C. 355 and/or Section 505 of the U.S.
Food and Drug Act, as now or hereafter in effect, or under similar law
(including non United States law), and related claims or proceedings (including
Losses associated with Noramco’s obligation to respond to third party
subpoenas).

12.2       Indemnification by Noramco. Noramco shall indemnify, defend and hold
Buyer and each of its Affiliates and its and their respective officers,
directors, employees and agents (each, a “Buyer Indemnitee”) harmless from and
against any Losses in connection with any Action by a third party to the extent
resulting from or arising out of (i) any breach of any representation, warranty
or covenant hereunder [(including in the Quality Agreement attached as Appendix
C hereto)] by any Noramco Indemnitee or (ii) a Noramco Indemnitee’s negligence
or willful misconduct; in each case except to the extent of Buyer’s indemnity
obligations pursuant to Section 12.1.

13

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

12.3       Indemnification Procedure. Upon the occurrence of an event that
entitles a Noramco Indemnitee or a Buyer Indemnitee to indemnification under
Section 12.1 or 12.2, respectively, the indemnified Party shall give prompt
written notice to the indemnifying Party providing reasonable details of the
nature of the event and basis of the indemnity claim and further expressly
stating therein that it is seeking indemnity pursuant to this Agreement. For the
avoidance of doubt, and without prejudice to the indemnified Party’s obligation
to give prompt written notice, an indemnifying Party’s knowledge of events or
circumstances pursuant to which an indemnified Party might seek indemnification,
including but not limited to correspondence between the Parties regarding a
matter for which indemnity is not expressly sought, shall not constitute the
notice required by this provision, and any attorneys, experts or consultant fees
or expenses incurred by an indemnified Party prior to proper notice shall be the
sole responsibility of such Party; provided, that any failure to give such
timely notice shall not bar any indemnification claim unless and to the extent
the indemnifying Party shall be or has been materially prejudiced by failure to
receive such timely notice. The indemnifying Party will have the right, at its
expense and with counsel of its choice, to defend, contest, or otherwise protect
against any Action subject to indemnity. The indemnified Party will also have
the right, but not the obligation, to participate, at its own expense, in the
defense thereof with counsel of its choice. The indemnified Party shall
cooperate to the extent reasonably necessary to assist the indemnifying Party in
defending, contesting or otherwise protesting against any Action subject to
indemnity so long as the reasonable cost in doing so is paid for by the
indemnifying Party. If the indemnifying Party fails, within thirty (30) calendar
days after receipt of a notice described in the first sentence of this Section
12.3 (i) to notify the indemnified Party of its intent to defend or (ii) to
defend, contest or otherwise protect against any Action subject to indemnity or
fails to diligently continue to provide the defense after undertaking to do so,
the indemnified Party will have the right, upon ten (10) calendar days’ prior
written notice to the indemnifying Party, to defend, settle and satisfy any
Action subject to indemnity and recover the costs of the same from the
indemnifying Party. No Action subject to indemnity may be settled other than by
the Party defending the same, and then only with the consent of the other Party,
which shall not be unreasonably withheld; provided, however, that the
indemnifying Party shall have no obligation to obtain the consent to any
settlement that does not impose on the indemnified Party (including any Buyer
Indemnitee or Noramco Indemnitee, as the case may be) any liability or
obligation, whether financial or otherwise, and does not admit to any wrongdoing
by the indemnified Party (including any Buyer Indemnitee or Noramco Indemnitee,
as the case may be).

12.4       No Consequential Damages. Neither Party shall be liable to the other
Party for special, indirect, incidental, punitive or consequential damages, or
lost profits, revenues, anticipated savings, opportunity, business, goodwill or
data, even if designated direct damages, whether in contract, warranty,
negligence, tort, strict liability or otherwise, even if such Party has been
advised of the possibility thereof.

12.5       Limitation on Liability. Noramco’s maximum liability under this
Agreement for any reason whatsoever, including its indemnity obligations, shall
not exceed the total Price paid to Noramco for the API giving rise to the claim;
provided, that the foregoing shall not limit Noramco’s liability for damages
arising from its gross negligence or willful misconduct.

12.6       Insurance. Each Party shall, at its own expense, obtain and maintain
during the Term and for three (3) years thereafter, insurance on a claims-made
basis, in amounts and types that would reasonably be expected to cover any
liabilities arising from such Party’s indemnification obligations under this
Agreement. Such insurance shall be maintained with companies having an A.M.
Best’s rating of A- VII or better. Each Party shall provide the other Party,
upon request, with certificates of insurance evidencing the insurance hereunder.
Each Party shall name the other Party and its officers, directors, employees and
agents as additional insureds on all applicable policies of insurance hereunder.

13.       CONFIDENTIALITY

13.1       Obligations of Non-Disclosure. Each Party agrees that (i) it will not
disclose any Confidential Information to any third party at any time during the
Term without the prior written consent of the disclosing Party and (ii) it will
not make use of any Confidential Information for any purpose other than the
performance of its obligations under this Agreement. Notwithstanding the
foregoing, a Party may disclose Confidential Information to its Affiliates, and
to its and their respective officers, directors, employees, independent
contractors, professional consultants (including attorneys and accountants), and
agents (“Representatives”), in each case who have a specific need to know such
Confidential Information, who are bound by obligations of confidentiality and
non-use at least as stringent as those set forth in this Agreement, and who have
been made aware of the receiving Party’s obligations under this Agreement. The
receiving Party shall be liable to the disclosing Party for any breach of this
Section 11 caused by the receiving Party’s Representatives.

14

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

13.2       Compelled Disclosure. Notwithstanding Section 13.1, either Party may
disclose Confidential Information as required by law, regulation or court order
or by the listing standards, rules or agreements of any public exchange on which
any securities of the receiving Party are listed so long as the receiving Party
(i) uses commercially reasonable efforts to give the disclosing Party as much
prior notice of such required disclosure as circumstances permit, (ii) allows
the disclosing Party to contest such disclosure or to seek a protective order or
similar remedy, and reasonably cooperates with the disclosing Party in such
efforts, and (iii) limits the disclosure to only the information required to be
disclosed. The receiving Party may disclose Confidential Information without
notice to any regulatory authority in connection with any routine examination,
investigation, regulatory sweep or other regulatory inquiry not specifically
targeted to the disclosing Party.

13.3       Ownership. As between the Parties, Confidential Information is and
shall remain the property of the disclosing Party, and the disclosing Party
shall retain all right, title and interest in and to its Confidential
Information. Neither this Agreement nor the disclosure of Confidential
Information hereunder grants or implies to the receiving Party any right or
license to use or practice any intellectual property of the disclosing Party.

13.4       Return. Upon the expiration or termination of this Agreement, or upon
the disclosing Party’s earlier written request, the receiving Party shall
immediately cease using all Confidential Information and shall return all
Confidential Information to the disclosing Party within thirty (30) calendar
days (or, with the disclosing Party’s permission, destroy it and certify as to
such destruction), along with all copies and reproductions. Notwithstanding the
foregoing, (i) the receiving Party may retain a single copy of Confidential
Information in the files of its confidential archives or its legal counsel for
the purposes of monitoring compliance with the confidentiality provisions of
this Agreement and for the purposes of proving what was disclosed, (ii) the
receiving Party is not required to return or destroy any Confidential
Information if doing so would violate any law, regulation or court order, (c)
the receiving Party shall not be required to expunge any minutes or written
consents of its board of directors (or equivalent governance body), and (iv) to
the extent that the receiving Party’s computer back-up or archiving procedures
create copies of Confidential Information, the receiving Party may retain such
copies for the period it normally archives backed-up computer records, so long
as such copies are not readily accessible and are not used or consulted for any
purpose other than disaster recovery. Any Confidential Information retained
pursuant to the foregoing sentence shall remain subject to this Agreement until
destroyed or no longer deemed Confidential Information based on the exclusions
to the definition of Confidential Information.

13.5       Duration. The confidentiality and non-use obligations of this Section
11 shall remain in effect throughout the Term and for a period of five (5) years
thereafter; provided, that Confidential Information that is otherwise protected
by law or regulation (e.g., trade secret and data privacy) shall remain
protected as, and for as long as, such law or regulation requires.

14.       INtellectual Property

14.1       Proprietary IP. For purposes of this Agreement: (i) all intellectual
property owned by a Party or any of its Affiliates as of the Effective Date
shall be deemed owned by such Party; (ii) all intellectual property licensed to
a Party or any of its Affiliates by a third party at any time during the Term
shall be deemed owned by such Party; and (iii) all intellectual property
generated, conceived or reduced to practice by or for a Party or any of its
Affiliates outside the scope of activities under this Agreement shall be deemed
owned by such Party (the foregoing collectively, a Party’s “Proprietary IP”).

15

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

14.2       Inventions. All Inventions, to the extent (i) specific to the
development, manufacture, use or sale of any Product(s) or (ii) dependent on
Buyer’s Proprietary IP, shall be the exclusive property of Buyer. All other
Inventions shall be the joint property of Buyer and Noramco. The Parties shall
cooperate to achieve the allocation of rights to Inventions anticipated herein.
Each Party shall be solely responsible for the costs of filing, prosecution and
maintenance of patents and patent applications on, and otherwise protecting, its
Inventions.

14.3       Licenses. Buyer hereby grants to Noramco a non-exclusive, paid-up,
royalty-free, non-transferable, sublicensable (solely to Noramco’s
subcontractors), license during the Term to use any intellectual property
(including Buyer’s Inventions pursuant to Section 14.2) necessary for the
performance of Noramco’s obligations under this Agreement, including any
Buyer-provided Specifications.

14.4       Infringement. If Noramco’s process of manufacture of an API becomes
or is likely to become the subject of an infringement claim or action, Noramco
shall notify Buyer of such infringement claim or action (or potential claim or
action) within 10 days. If Noramco’s process of manufacture of an API becomes or
is likely to become the subject of an infringement claim or action, Noramco may,
in its sole discretion, (i) procure, at a cost to be reasonably allocated
between the Parties, the right to use the applicable intellectual property in
the process for manufacture of such API, (ii) change the process of manufacture
with the intent of overcoming such allegation of infringement or (iii) if, in
Noramco’s sole discretion, neither (i) nor (ii) above are commercially
reasonable, terminate this Agreement. If Noramco’s process of manufacture of an
API becomes the subject of an infringement claim or action and Buyer determines,
in its sole discretion, that its supply of API may be threatened, Buyer may (i)
terminate this agreement, or (ii) notwithstanding the exclusive nature of this
Agreement, enter into a contract with an alternative provider of API. The
foregoing, together with any right to indemnity pursuant to Section 12.2 shall
be Buyer’s sole remedy in respect of any breach of the warranty set forth in
Section 11.1(iii).

15.       TERM AND TERMINATION

15.1       Term. The initial term of this Agreement shall commence as of the
Effective Date and shall expire five (5) years after commercialization of first
and second generation Products unless sooner terminated as expressly provided
for in this Agreement. Thereafter, the term of this Agreement shall
automatically renew for successive periods of two (2) calendar year each, unless
written notice of termination is given by a Party to the other at least six (6)
months before the expiration of the initial term or the completion of the
then-current renewal term, as the case may be, or unless sooner terminated as
expressly provided for in this Agreement. The initial term and any renewal term
are referred to as the “Term”.

15.2       Termination for Breach. This Agreement may be terminated by either
Party if the other Party (the “Breaching Party”) is in material breach of any of
its obligations hereunder (including, without limitation, any payment
obligations) as follows: (i) the terminating Party must send written notice of
the material breach to the Breaching Party, (ii) if the breach is of a payment
obligation, the termination becomes effective ninety (90) calendar days after
the date of such written notice if the Breaching Party has not cured such breach
within such period, and (iii) for all other breaches, the termination becomes
effective ninety (90) calendar days after the date of such written notice if the
Breaching Party has not cured such breach within such period; provided, that if
the material breach is not capable of being cured within that ninety (90) day
period, and the Breaching Party has commenced within that ninety (90) day period
activities reasonably expected to cure that material breach and thereafter uses
diligent efforts to complete the cure as soon as practicable, the Breaching
Party shall have up to an additional ninety (90)) days to cure such breach (for
an aggregate cure period equal to one hundred eighty (180) calendar days from
the date written notice of the material breach was first given).

16

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

15.3       Termination for Bankruptcy. Either Party may terminate this Agreement
without prior notice to the other upon the occurrence of any of the following
involving the other Party:

(a)       that other Party files a petition seeking an order for relief under
the Federal Bankruptcy Code (Title 11 of the United States Code), as now or
hereafter in effect, or under similar law (including non United States law), or
files a petition in bankruptcy or for reorganization or for an arrangement
pursuant to any state bankruptcy law or any similar state law (including non
United States law); or

(b)       an involuntary case against that Party as debtor is commenced by a
petition under the Federal Bankruptcy Code (Title 11 of the United States Code),
as now or hereafter in effect, or under similar law (including non United States
law), or a petition or answer proposing the adjudication of that Party as a
bankrupt or its reorganization pursuant to any state bankruptcy law or any
similar state law (including non United States law) is filed in any court and
not dismissed, discharged or denied within sixty (60) calendar days after the
filing thereof; or

(c)       a custodian, receiver, United States Trustee, trustee or liquidator of
that Party or of all or substantially all of that other Party's property is
appointed in any proceedings brought by that Party; or if any custodian,
receiver, United States Trustee, trustee or liquidator is appointed in any
proceedings brought against that Party and is not be discharged within sixty
(60) calendar days after that appointment, or if that Party consents to or
acquiesce in that appointment; or

(d)       if that other Party makes an assignment for the benefit of creditors,
or admits in writing its inability to pay its debts generally as they become
due.

15.4       Other Termination Rights. Either Party may terminate this Agreement
upon written notice as provided in Section 18.2; and Noramco may terminate this
Agreement upon written notice to Buyer as provided in Section 14.4.

15.5       Obligations on Termination. Any expiration or termination of this
Agreement does not release the Parties from any liabilities or obligations that
accrued as of the date thereof. In addition, the obligations undertaken by each
Party under Sections 3.2.1, 6.1, 6.4 through 6.7, 11.3, and 15.5, as well as
Sections 8, 9, 12, 13, 14, and 16 through 27 (excluding 24.2), shall survive
termination or expiration of this Agreement indefinitely or for such shorter
period as is provided in such Sections.

16.       INDEPENDENT CONTRACTORS

The status of the Parties under this Agreement is that of independent
contractors. Nothing is this Agreement may be construed as establishing a
partnership or joint venture relationship between the Parties. Neither Party has
the right to enter into any agreements on behalf of the other Party, nor may it
represent to any person that it has that right or authority.

17.       NOTICES

All notices, requests, demands and other communications under this Agreement
shall be in writing, shall be deemed to have been duly given if addressed and
sent to the contact information below, and shall be deemed to have been made:
(i) on the date of service if served personally on the Party; (ii) on the second
business day after delivery to an overnight courier service if first available
delivery is indicated and paid for; (iii) on the third business day after
mailing if mailed to the Party to whom notice is to be given, by first class
mail, registered or certified, postage prepaid; or (iv) on the date of
transmission, if sent by email with confirmation of transmission. Either Party
may change its contact information for purposes of this Section 15 by giving the
other Party written notice of the new contact information in the manner set
forth above.

17

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

  If to Buyer: RespireRx Pharmaceuticals Inc.     126 Valley Road, Suite C    
Glen Rock, NJ 07452     Facsimile No.: 415-887-7814     Email:
jmargolis@respirerx.com with copies to alippa@respirerx.com and    
rpurcell@respirerx.com and james.fischer@dbr.com         If to Noramco: Noramco,
Inc.     500 Swedes Landing Road     Wilmington, Delaware 19801     Attention:
Vice President Marketing & Business Development     Facsimile No.: 302-761-2913

 

18.       FORCE MAJEURE

18.1       Force Majeure Events. Neither Party will be liable for
non-performance or delay in the fulfillment of its obligations when that
non-performance or delay is occasioned by any cause beyond the reasonable
control of such Party, including without limitation, acts of God, fire, flood,
earthquakes, explosions, sabotage, strikes, or labor disturbances (regardless of
the reasonableness of the demands of the labor force), civil commotion, riots,
military invasions, wars, failure of utilities, failure of carriers, inability
to obtain any required raw material, energy source, equipment, labor or
transportation, at prices and on terms Noramco deems practicable from its usual
sources of supply or any acts, restraints, requisitions, regulations, or
directives issued by a competent government authority, including changes in law
or regulation (“Force Majeure Events"); provided, that a Force Majeure Event
shall never excuse a Party from paying any sum of money owed under the terms of
this Agreement.

18.2       Discharge of Obligations. In the event that either Party is prevented
from discharging its obligations under this Agreement on account of a Force
Majeure Event, that Party shall promptly notify the other, and shall
nevertheless make every reasonable endeavor, in the utmost good faith, to
discharge its obligations, even if in a partial or compromised manner. In the
event that a Force Majeure Event continues for a period of one hundred eighty
(180) consecutive calendar days, or for periods which aggregate one hundred
eighty (180) days during any three hundred sixty five (365) day cycle, the Party
not claiming the Force Majeure Event will be entitled to terminate this
Agreement on written notice to the affected Party, but without penalty or
liability to the affected Party, subject to Section 15.5.

19.       ENTIRE AGREEMENT; MODIFICATION

This Agreement, including the appendices hereto, which are hereby incorporated
by reference, constitutes the entire agreement of the Parties with respect to
its subject matter and supersedes all prior agreements, arrangements, dealings
and writings between the Parties that relate to the matters covered herein. Any
terms and conditions of an invoice, acknowledgement or similar document provided
by Noramco for API, or any terms and conditions of purchase orders or similar
document provided by Buyer for API which are inconsistent with or in addition to
the terms of this Agreement shall be null and void. In the event of a conflict
between the terms and conditions of this Agreement and the terms and conditions
of the Quality Agreement set forth in Appendix C, this Agreement shall prevail.
Except as expressly provided herein, this Agreement may not be amended or
modified except in writing executed by the duly authorized representatives of
both Parties.

18

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

20.       WAIVER

No waiver of a breach or default hereunder will be considered valid unless in
writing and signed by the Party giving that waiver, and no waiver will be deemed
a waiver of any subsequent breach or default of the same or similar nature.

21.       DISPUTE RESOLUTION

21.1       Mediation. Any controversy or claim arising out of or relating to
this Agreement, including any such controversy or claim involving any Affiliate
of any Party (a “Dispute”), shall first be submitted to non-binding mediation
according to the Commercial Mediation Procedures of the American Arbitration
Association (“AAA”) (see www.adr.org). Such mediation shall be attended on
behalf of each Party for at least one session by a senior business person with
authority to resolve the Dispute. Any period of limitations that would otherwise
expire between the initiation of a mediation and its conclusion shall be
extended until twenty (20) calendar days after the conclusion of the mediation.

21.2       Arbitration. Any Dispute that cannot be resolved by mediation within
forty-five (45) calendar days of notice by one party to the other of the
existence of a Dispute (unless the Parties agree to extend that period) shall be
resolved by arbitration in accordance with the Commercial Arbitration Rules of
the AAA (“AAA Rules”; see www.adr.org) and the Federal Arbitration Act, 9 U.S.C.
§1 et seq.. The arbitration shall be conducted in Delaware, by one arbitrator
appointed in accordance with the AAA Rules.

21.3       Limited Discovery. The arbitrator shall follow the ICDR Guidelines
for Arbitrators Concerning Exchanges of Information in managing and ruling on
requests for discovery. The arbitrator, by accepting appointment, undertakes to
exert her or his best efforts to conduct the process so as to issue an award
within eight (8) months of her or his appointment; provided, that failure to
meet that timetable shall not affect the validity of the award.

21.4       Governing Law. The arbitrator shall decide the Dispute in accordance
with the substantive law of Delaware. All documents and proceedings in
connection with any Dispute shall be in the English language.

21.5       Awards. The arbitrator may not award any damages inconsistent with
Section 10, nor may the arbitrator apply any multiplier to any award of actual
damages, except as may be required by statute. The Party that prevails in any
Dispute resolution proceeding shall have the right to recover from the other
Party its costs and expenses incurred in such Dispute, including reasonable fees
for attorneys, expert witnesses and court costs, in addition to any other relief
awarded. The award of the arbitrator may be entered in any court of competent
jurisdiction.

21.6       Injunctive Relief. Notwithstanding anything to the contrary in this
Section 19, in connection with any actual or threatened breach of Section 11,
the parties acknowledge and agree that, due to the unique nature of the
Confidential Information, a breach of Section 11 may cause irreparable damage to
the disclosing Party for which monetary damages would be inadequate.
Accordingly, the disclosing Party shall be entitled to seek injunctive relief or
other remedies from any court of competent jurisdiction, and the Parties waive
the requirement of any bond being posted as security in any application for such
relief.

19

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

22.       SEVERABILITY

Should any part or provision of this Agreement be held unenforceable or in
conflict with applicable law, the invalid or unenforceable part or provision
will, provided that it does not go to the essence of this Agreement, be replaced
with a revision that accomplishes, to the extent possible, the original
commercial purpose of that part or provision in a valid and enforceable manner,
and the balance of this Agreement remains in full force and effect and binding
upon the Parties.

23.       SUCCESSORS AND ASSIGNS

This Agreement may not be assigned or otherwise transferred by a Party without
the prior written consent of the other Party; provided, that either Party may,
without such consent, but with notice to the other Party, assign this Agreement,
in whole, (i) in connection with the transfer or sale of all or substantially
all of its assets or the line of business for the API or Product to which this
Agreement relates, (ii) to a successor entity or acquirer in the event of a
merger, consolidation or change of control, or (iii) to any Affiliate. Any
purported assignment in violation of the preceding sentence will be void. Any
permitted assignee will assume the rights and obligations of its assignor under
this Agreement.

24.       THIRD PARTIES

24.1       No Benefit to Third Parties. The representations, warranties,
covenants and agreements set forth in this Agreement are for the sole benefit of
the Parties and their successors and permitted assigns, and shall not be
construed as conferring any rights on any other persons or entities.

25.       PUBLICITY

Neither Party may make any press release or public statement regarding the
subject matter of this Agreement or the existence thereof or use the other
Party’s or its Affiliates’ names, trademarks, logos, symbols or other image in
any form of advertising, promotion or publicity without the prior written
consent of the other Party, except to the extent that the press release or
public statement may be required by applicable law.

26.       CONSTRUCTION

The division of this Agreement into sections, subsections and Appendices and the
insertion of headings are for convenience of reference only and shall not affect
the interpretation of this Agreement. Unless otherwise indicated, any reference
in this Agreement to a Section or Appendix refers to the specified Section or
Appendix to this Agreement. In this Agreement, the terms “this Agreement”,
“hereof”, “herein”, “hereunder” and similar expressions refer to this Agreement
as a whole (including the Appendices) and not to any particular part, Section,
Appendix or the provision hereof. The word “including” (with its grammatical
variations) means “including without limitation,” “including but not limited
to”, or words of similar import. The language in this Agreement is to be
construed in all cases according to its fair meaning. Noramco and Buyer
acknowledge that each Party and its counsel have reviewed and revised this
Agreement and that any rule of construction, to the effect that any ambiguities
are to be resolved against the drafting party, are not to be employed in the
interpretation of this Agreement.

20

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

27.       COUNTERPARTS

This Agreement may be executed in counterparts, each of which will be an
original as against either Party whose signature appears thereon, but all of
which together constitutes one and the same instrument. This Agreement may be
delivered electronically by email of a signed PDF copy.

 

[Remainder of Page is Intentionally Blank]

21

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

IN WITNESS WHEREOF, each of the Parties has caused its duly authorized
representative to execute this Agreement as of the Effective Date.

RESPIRERX PHARMACEUTICALS, INC.   NORAMCO, INC.       Signature: /s/ Jeff Eliot
Margolis   Signature: /s/ William B. Grubb III        Print Name: Jeff Eliot
Margolis   Print Name: William B. Grubb III        Title: Senior Vice President,
Chief Financial Officer, Treasurer and Secretary   Title: VP Global Business
Development and Innovation

 

Signature page to Development and Supply Agreement

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

APPENDIX A

API(s), Pricing and Firm Purchase Order Lead Time with Forecast
Post-Commercialization

 

API

Minimum Percentage per Year

(§1.2.1)

Price per [***] (US$) for Initial Price Period

(§4.1.1)

Standard Packaging, Fill & Weight*

(§4.1.2)

Minimum Quantity per Year

(§1.2.2)

Manufacturing Facility Location(s)

(§9.1)

Firm PO Lead Time with Forecast

(§3.2.2)

Exchange Rate Adjustment

(§4.2.3)

Dronabinol [***] [***]% $ [***] [***] [***] [***] [***] NO (to be invoiced in US
dollars

 

* Purchase Orders for API not in full standard packaging increments listed shall
be subject to a repackaging fee of $[***] per repack.

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH
THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION IN CONNECTION WITH AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

APPENDIX B

Specifications

[ex2-1_001.jpg]

Dronabinol [***] Specifications

 

Test Parameter Acceptance Criteria Test Methods       [***] [***] [***]      

  

CONFIDENTIAL