Document:

Amendment 2010 Equity Incentive Plan Exhibit 10.71

		
			AMENDMENT TO THE
		

		
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			TOWER INTERNATIONAL, INC. 2010 EQUITY INCENTIVE PLAN
		

		
			(as amended and restated effective as of March 6, 2014)
		

		
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			WHEREAS, Tower International, Inc. (the “Company”) sponsors and maintains the Tower International, Inc. 2010 Equity Incentive Plan, as amended and restated effective as of March 6, 2014 (the “Plan”); and
		

		
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			WHEREAS, the Compensation Committee of the Board of Directors of the Company (the “Committee”) desires to amend the Plan to allow for tax withholdings consistent with current accounting principles and to clarify the scope of any non-disclosure restrictions applicable to awards under the Plan; and
		

		
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			WHEREAS, the Board of Directors of the Company has delegated to the Committee authority to amend the Plan;
		

		
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			NOW, THEREFORE, the Plan is hereby amended, effective the date hereof, as follows:
		

		
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			1.Section 16.2 of the Plan is hereby amended by adding the following sentence to the end thereof:
		

		
			“Notwithstanding the foregoing, the confidentiality restrictions set forth in an Award Agreement shall not, and shall not be interpreted to, impair a Participant from exercising any legally protected whistleblower rights (including under Rule 21 of the Exchange Act). 
		

		
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			2.Section 17.5 of the Plan is hereby amended in its entirety, to read as follows:
		

		
			“Section 17.5Tax Withholding.  
		

		
			(a)The Company or an Affiliate, as applicable, shall have the power and the right to deduct or withhold, or require a Participant to remit to the Company, any federal, state and/or local taxes, domestic or foreign, required by law or regulation to be withheld with respect to any taxable event arising under the Plan or with respect to an Award. If permitted under an Award Agreement or authorized by the Committee, a Participant may satisfy such withholding amount, in whole or in part, (i) by causing the Company or such Affiliate to withhold shares of Common Stock otherwise issuable to the Participant, (ii) by delivering to the Company or such Affiliate shares of Common Stock already owned by the Participant, or (iii) if a broker-assisted exercise procedure described in Section 6.5 is used with respect to the exercise of a Stock Option, by remitting to the Company or such Affiliate the proceeds from a sale of a sufficient number of shares of Common Stock resulting from such exercise. The shares of Common Stock so withheld or delivered shall have an aggregate Fair Market Value sufficient to satisfy, in whole or in part, such withholding amount. The Fair Market Value of the shares of Stock used to satisfy such withholding amount shall be determined by the Company or such Affiliate as of the date on which the amount of tax to be withheld is to be determined. A Participant may not satisfy such Participant’s withholding amount with shares of Common Stock that are subject to any repurchase, forfeiture, unfulfilled vesting, or other similar conditions or restrictions. The maximum number of shares of Common Stock that may be withheld from any Award to satisfy any federal, state, or local tax withholding requirements upon the exercise, vesting, or lapse of restrictions applicable to any Award or payment of shares of Common Stock pursuant to such Award, as applicable, may not exceed such number of shares of Common Stock having a Fair Market Value equal to (i) the minimum statutory amount required by the Company or the applicable Affiliate to be withheld and paid to any such 
		

		 

 

		federal, state, or local taxing authority with respect to such exercise, vesting, lapse of restrictions, or payment of shares of Common Stock or, (ii) if permitted by the Company, such other withholding amount as will not cause adverse accounting consequences and is permitted under applicable law. 
		

		
			(b)Notwithstanding the foregoing, a Participant may not use shares of Common Stock to satisfy the withholding requirements to the extent that (i) there is a substantial likelihood that the use of such form of payment or the timing of such form of payment would subject the Participant to a substantial risk of liability under Section 16 of the Exchange Act; or (ii) such withholding would constitute a violation of the provisions of any law or regulation (including the Sarbanes-Oxley Act of 2002).
		

		
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			[Signature Page Follows]
		

		
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			IN WITNESS WHEREOF, the undersigned being a duly authorized officer of the Company has executed this Amendment to the Plan as evidence of its adoption by the Committee.
		

		
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			TOWER INTERNATIONAL, INC.
		

		
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			By: /s/James C. Gouin
		

		
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			Title: President
		

		
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			Date: 12/01/16
		

		
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			Witness:
		

		
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			/s/Nanette Dudek
		

		
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			3Malcom Agreement re_Retention and Transistion Bonus Ex 10.72

		

			

		

		

			17672 N. Laurel Park Drive

		

		

			Suite 400 E

		

		

			Livonia, MI  48152

		

		
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			January 10, 2017
		

		
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			Mark Malcolm
		

		
			1364 Maple Street
		

		
			Plymouth, MI  48170
		

		
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			Re: Retention and Transition Bonuses 
		

		
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			Dear Mark,
		

		
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			Reference is made to the “Retention Bonus” and “Transition Bonus” (collectively, the Bonuses”) set forth in Sections 4.6 and 4.7, respectively, of the Second Amended and Restated Employment Agreement, dated as of July 28, 2014 (the “Employment Agreement”), between you and Tower Automotive Operations USA I, LLC (the “Company”).
		

		
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			As discussed, in light of the requirements of Section 409A of the Internal Revenue Code of 1986, as amended, and other considerations, the Company will pay the Bonuses to you on or about July 14, 2017.  Because of the delay in payment, the Company will add interest to the Bonuses for the period from January 17, 2017 through the date immediately preceding the date of payment at a simple rate of six percent (6.0%) per annum.
		

		
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			Except as provided by this letter, the provisions of the Employment Agreement which survived your retirement from the Company effective December 31, 2016, as set forth in Section 7.15 of the Employment Agreement, remain in full force and effect, as does the General Release entered into between you and the Company dated December 2, 2016.
		

		
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			Please acknowledge your agreement with the foregoing by countersigning this letter below and returning it to me.
		

		
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			Regards,
		

		
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			Tower Automotive Operations USA I, LLC
		

		
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			/s/ Jeffrey L. Kersten ________________________
		

		
			Jeffrey L. Kersten, Vice President and CFO
		

		
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			Acknowledged and agreed:
		

		
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			/s/ Mark M. Malcolm ____________________________
		

		
			Mark MalcolmBlueprint

 

 Exhibit
4.72

Extension of Debenture Maturity Date

 

 

TO                

Intellipharmaceutics
International Inc. (the "Company")

 

RE: 

Debenture
dated January 1, 2013, for a face amount of US $1,500,000 issued by
the Company to Isa Odidi and Amina Odidi (the "Debenture") and the
Maturity Date (as defined in the Debenture) of such
Debenture

 

	
 

 

The
undersigned hereby agree that the current Maturity Date of the
Debenture of July 1, 2016, is extended to December 1,
2016.

 

 

DATED as of May 26th,
2016.

 

	

/s/ Dr. Isa Odidi
                                             

Dr.
Isa Odidi

	

/s/ Dr. Amina
Odidi

Dr.
Amina OdidiBlueprint

 

 Exhibit
4.73

Extension of Debenture Maturity Date

 

 

TO                

Intellipharmaceutics
International Inc. (the "Company")

 

RE: 

Debenture
dated January 1, 2013, for a face amount of US $1,500,000 issued by
the Company to Isa Odidi and Amina Odidi (the "Debenture") and the
Maturity Date (as defined in the Debenture) of such
Debenture

 

	
 

 

This
is in respect of the US $1,500,000 Debenture. Kindly pay the amount
of US $150,000 out of the US $1,500,000 to Isa Odidi. The
undersigned hereby agree that the current Maturity Date of the
remainder of the Debenture of December 1, 2016, is extended to
April 1, 2017.

DATED as of December 1st,
2016.

 

 

	

/s/ Dr. Isa Odidi
                                             

Dr.
Isa Odidi

	

/s/ Dr. Amina
Odidi

Dr.
Amina OdidiBlueprint

Exhibit 4.74

 

CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED PORTIONS ARE MARKED
AS “[*]” ALONG WITH A FOOTNOTE INDICATING THAT THE
INFORMATION HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. AN UNREDACTED COPY OF THIS EXHIBIT HAS BEEN FILED
SEPARATELY WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.

 

LICENSE
AND COMMERCIAL SUPPLY AGREEMENT

THIS
LICENSE AND COMMERCIAL SUPPLY AGREEMENT (“Agreement”) is
made and entered into
effective this October 11, 2016 (“Effective Date”) by and
between Mallinckrodt LLC, a Delaware
limited liability company (for and on behalf of its affiliated
entities) (“Mallinckrodt”)
and Intellipharmaceutics Corp., a company organized under the laws
of Canada (for and on behalf
of its affiliated entities) (“Intellipharmaceutics”).

RECITALS

WHEREAS,
Intellipharmaceutics and its affiliates are in the business of
selling various generic
pharmaceutical dosage products in the United States as well as in
other countries, WHEREAS,
Mallinckrodt has a significant sales and marketing presence in the
United States generic
market as a consequence of its sales of a portfolio various
proprietary and licensed generic products
and, thus, also has the capability effectively to distribute
Intellipharmaceutics’ generic
pharmaceutical products in the United States, and

WHEREAS,
Intellipharmaceutics wishes to giant to Mallinckrodt the exclusive
right in the United States
to market, sell and distribute certain generic pharmaceutical
dosage products once they have been
approved for sale in the United States by the United States Food
and Drug Administration
(“FDA”)
and to ensure that Mallinckrodt will be continuously supplied a
sufficient quantity of
finished product for each generic pharmaceutical dosage product for
which rights are granted to
Mallinckrodt hereunder,

NOW
THEREFORE, in consideration of the premises and of the covenants
herein and for

other
good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the
parties agree as follows:

1. Marketing and Sale
Rights.

(a) Subject to the
terms and limitations set forth herein, Intellipharmaceutics
hereby
grants to Mallinckrodt an exclusive right and license (with the
right to sublicense to a third party subject to
approval and written consent of Intellipharmaceutics, such consent
not to be unreasonably
withheld) to market, sell, offer for sale and distribute only in
the United States and, if allowed, in
Puerto Rico and in any United States territories, protectorates or
those areas with commonwealth status
(collectively hereinafter referred to as the “Exclusive Market”), for
its own account, a
bioequivalent generic dosage pharmaceutical version of every
approved strength of each of the following
generic dosage pharmaceutical products: (1) Quetiapine ER, a
product to be AB- rated to the
branded pharmaceutical product known as Seroquel XR
(“Product
One”), (ii) Desvenlafaxine, a
product to be AB-rated to the branded pharmaceutical product known
as Pristiq (“Product
Two”) and (iii) Lamotrigine ER, a product to be
AB-rated to the branded pharmaceutical product known as
Lamictal XR (“Product Three”). Products
One, Two and Three shall hereinafter be jointly referred
to as “Products” or,
individually and generically, as a “Product.” The
Products will be supplied by
Intellipharmaceutics to Mallinckrodt in finished and fully labeled
(in accordance with
Section 1(b) set forth immediately below) and packaged form, and in
all approved strengths. The
foregoing rights shall be coextensive with this Agreement and,
subject to any

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specific provisions
set forth in Section 11 hereof, shall terminate on and as of the
effective date of termination or
expiration hereof. In no event and on no occasion shall the
exclusive rights granted to Mallinckrodt
hereunder be interpreted as permitting Mallinckrodt to sell Product
outside of the Exclusive
Market.

(b) All Products sold
or offered for sale by Mallinckrodt shall be labeled with
Mallinckrodt’s
name, trademarks and trade dress as per label artwork provided and
paid for by Mallinckrodt, in a
manner consistent with all applicable laws, rules and regulations,
in accordance with the
requirements of the approved Abbreviated New Drug Application
(“ANDA”) relative to
each
Product and otherwise in a manner reasonably agreed upon by the
parties. In particular, it is agreed that the
phrase (or a substantially similar phrase) “Licensed from and
manufactured by Intellipharmaceutics
(IPCI) for Mallinckrodt,” shall be evident on the packaging
and labeling for all Products.
Mallinckrodt shall not alter the labeling or package inserts
associated with Product that are received
from Intellipharmaceutics without the advance written permission
of Intellipharmaceutics
and, upon receipt of such approval, only in compliance with any
applicable laws, rules and
regulations. Intellipharmaceutics shall own the ANDA for each of
the Products for which exclusive
rights are granted hereunder and, subject to any express terms
herein to the contrary, shall
thus have the responsibility and expense to maintain each of the
ANDAs in full force and effect
for so long as this Agreement is in effect with respect to any such
ANDA, which responsibility
includes, but is not limited to, meeting all applicable regulatory
requirements that exist with respect
to the Products under all applicable laws, rules and
regulations.

(c) It is understood by
the parties that (i) none of the Products are, as of the
Effective Date,
approved for marketing and sale in the United States by the FDA and
(ii) the value of the exclusive
rights granted hereunder to Mallinckrodt is intimately related to
the time when such Products can
be marketed and sold. Therefore, in addition to any other rights of
termination that Mallinckrodt
may have hereunder, Mallinckrodt shall have the right, upon thirty
(30) days advance written
notice of Mallinckrodt’s intention to terminate the Agreement
to Intellipharmaceutics
hereunder (and, with respect to any given Product, before it has
been approved by the
FDA), to terminate this Agreement (i) as to Product One if the FDA
has not approved the ANDA
for Product One on or before December 31, 2017, (ii) as to Product
Two if the FDA has not
approved the ANDA for Product Two on or before December 31, 2018,
(iii) as to Product Three if
the FDA has not approved the ANDA for Product Three on or before
December 31, 2018 and (iv)
in its entirety, if any two (2) or more of the Products are not
approved by the FDA on or before
the dates specified in clauses (ii) or (iii) of this sentence, as
such clauses may be applicable in
any given case. Notwithstanding the immediately preceding sentence,
prior to providing any
notice of termination of this Agreement in accordance with the
immediately preceding sentence,
Mallinckrodt shall inform Intellipharmaceutics of any commercial or
other reasons that may
underlie Mallinckrodt’s decision to terminate this Agreement
in whole or in part.

(d) Notwithstanding the
other provisions of this Section 1, Intellipharmaceutics
retains
all rights in and to the Products if and to the extent such rights
are not specifically granted to Mallinckrodt
hereunder, including (without limitation) the right to sell,
distribute and to appoint distributors for
Products outside the Exclusive Market.

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2016

 

 

2. Term.

Unless
sooner terminated in accordance herewith, this Agreement will have
an initial term of ten (10)
Contract Years (as defined in the immediately succeeding sentence)
and shall be automatically
renewed for additional and consecutive terms of one (1) Contract
Year, absent written notice of
non-renewal given by one party to the other at least one hundred
and eighty (180) days prior to the
end of the initial term or any renewal term, as applicable. For
purposes hereof, the term
“Contract
Year” shall mean the first and each successive twelve
(12) month period (coinciding with
Mallinckrodt’s regularly established fiscal months) elapsing
while this Agreement is in
full force and effect, commencing with the first full fiscal month
in which the first commercial sale of
any of the Products by Mallinckrodt in the Exclusive Market occurs;
provided that, the last
Contract Year hereof shall end on and as of the effective date of
termination hereof, whether or not such
Contract Year is a full twelve (12) month period.

3. Consideration.

(a) In partial
consideration for the grant of exclusive rights hereunder by
Intellipharmaceutics
to Mallinckrodt, within ten (10) days after the Effective Date and
by wire transfer of
immediately available funds to an account designated in advance
by Intellipharmaceutics,
Mallinckrodt shall pay to Intellipharmaceutics the total sum of the
Three Million Dollars
($3,000,000) in United States currency, allocated to each of the
Products to which exclusive rights
are granted hereunder, specifically allocable to each Product as
follows: (i) [*] Dollars ($[*]) for the exclusive rights for
Product One, (ii) [*] Dollars ($[*]) for
the exclusive rights for Product Two and (iii) [*]
Dollars
($[*]) for the exclusive rights for Product Three. The amount paid
to Intellipharmaceutics
by Mallinckrodt pursuant to this Section 3(a) shall not be
refundable by Intellipharmaceutics
to Mallinckrodt for any reason, absent fraud.

(b) In further and
partial consideration for the grant hereunder by
Intellipharmaceutics
to Mallinckrodt of the rights for the Products in the Exclusive
Market, Mallinckrodt shall
make a payment to Intellipharmaceutics, with respect to each
strength of each Product (each a
“Product
SKU”), on a quarterly basis coinciding with
Mallinckrodt’s fiscal quarters (the end
dates of such fiscal quarters are as listed on Schedule 1 attached
hereto), based on a percentage of
Mallinckrodt’s Standard Margin (as defined below in this
Section 3(b)) earned on sales of
Products in the Exclusive Market, calculated in accordance with the
percentages in Section 3(c) set
forth immediately below (the aggregate of all such payments for any
given fiscal quarter of
Mallinckrodt hereinafter referred to as “Quarterly Aggregate Standard
Margin Payments” and, with
respect to any given Product SKU, a “Quarterly Standard Margin
Payment”). For purposes
hereof, (i) the term “Standard Margin” shall
mean, with respect to any given volume of any Product SKU
and for any given fiscal quarter of Mallinckrodt, the Net Sales of
such volume of any Product SKU
minus the Cost of Goods Sold for such volume of any such Product
SKU, (ii) the term
“Cost of Goods
Sold” shall mean, with respect to any given volume of
any Product SKU included in any
calculation of Standard Margin for purposes of this Section 3(b)
the applicable Transfer Price (as
defined below in Section 6(a)) of any such volume of any Product
SKU in finished, labeled
and fully packaged form (the calculation and meaning of Standard
Cost being defined herein
below in Section 6(d)), and (iii) the term “Net Sales” shall mean,
with respect to any Product SKU and
for any given fiscal quarter of Mallinckrodt, the remainder of (A)
the gross

*Omitted and filed
separately with the Securities and Exchange Commission under a
request for confidential treatment.

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2016

 

sales
price of all amounts of any Product SKU invoiced and booked by
Mallinckrodt as gross revenue in such fiscal quarter minus (B) the
sum of (1) the amount of all discounts, chargebacks, rebates,
product returns and any similar allowances allocable to such
Product SKU and taken against the gross revenue of such Product SKU
in such fiscal quarter, (2) the allocable amount of freight and
delivery cost incurred by Mallinckrodt with respect to such Product
SKU and in such quarter (i.e., the freight cost to ship Products
from Intellipharmaceutics to any Mallinckrodt designated location)
and (3) the allocable amount of sales and use taxes and other
governmental charges incurred by Mallinckrodt with respect to such
Product SKU and in such fiscal quarter. In no event will any
amounts covered by any one or more of clauses (1), (2) and/or (3)
set forth in the immediately preceding sentence be deducted more
than once in connection with the calculation of Net Sales for any
given period of time. If, for any given fiscal quarter, the Cost of
Goods Sold for the volume of any Product SKU sold in such fiscal
quarter exceeds the Standard Margin of any such Product SKU
properly allocable to such fiscal quarter (“Negative SKU Balance”),
then (i) Mallinckrodt shall not be required to make any payment in
accordance with this Section 3 and with respect to such Product SKU
for such fiscal quarter and (ii) any Negative SKU Balance with
respect to a Product SKU shall be deducted from the Quarterly
Standard Margin Payment otherwise due by Mallinckrodt to
Intellipharmaceutics for such fiscal quarter. In calculating the
amount of any payments due under this Section 3 by Mallinckrodt to
Intellipharmaceutics, the amount of any Negative SKU Balances
applicable to all Product SKUs and in any fiscal quarter, to the
extent in excess of the aggregate Standard Margin owed by
Mallinckrodt on all other Product SKUs will be carried forward for
the calculation of payments (if any) for any subsequent fiscal
quarters.

(c) The Quarterly
Standard Margin Payment for each Product SKU shall be equal to [*]
Percent ([*]%) of Mallinckrodt’s Standard Margin for each
such Product SKU in any given fiscal quarter. Notwithstanding the
immediately preceding sentence, the Quarterly Standard Margin
Payment for all Product SKUs included in any given Product shall be
reduced to [*] Percent ([*]%) of Mallinckrodt’s Standard
Margin in any given fiscal quarter for each Product SKU included in
any given Product from and after the point at which the following
aggregate Standard Margin payment targets have been met as to any
given Product:

(i) with respect to
Product One, at such time (and for every dollar of Standard Margin
earned thereafter) as [*] ([*]) of the total amount of all
Quarterly Aggregate Standard Margin Payments due by Mallinckrodt
hereunder and allocable to Standard Margin earned in respect of
Product One equals [*] Dollars ($[*]) in United States
currency,

(ii) with
respect to Product Two, at such time (and for every dollar of
Standard Margin earned thereafter) as [*] ([*]) of the total amount
of all Quarterly Aggregate Standard Margin Payment due by
Mallinckrodt hereunder and allocable to Standard Margin earned in
respect of Product Two equals [*] Dollars ($[*]) in United States
currency, and

(iii) with
respect to Product Three, at such time (and for every dollar of
Standard Margin earned thereafter) as [*] ([*]) of the total amount
of all Quarterly Aggregate Standard Margin Payments due by
Mallinckrodt hereunder

 

*Omitted and filed
separately with the Securities and Exchange Commission under a
request for confidential treatment.

 

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2016

 

and
allocable to Standard Margin earned in respect of Product Three
equal [*] Dollars ($[*]) in United States currency.

(d) The calculation of
any Quarterly Standard Margin Payments shall be based on
information contained in a quarterly sales report
(“Quarterly
Report”), in form and substance reasonably
satisfactory to both parties, delivered by Mallinckrodt to
Intellipharmaceutics in writing within [*] ([*]) days after the end
of any Mallinckrodt fiscal quarter to which the report relates, and
the Quarterly Aggregate Standard Margin Payments that are due, if
any, by Mallinckrodt to Intellipharmaceutics with respect to any
fiscal quarter to which any such Quarterly Report relates shall be
made within [*] ([*]) days after the end of Mallinckrodt’s
fiscal quarter. All calculations of amounts due by Mallinckrodt to
Intellipharmaceutics will be made in accordance with generally
accepted accounting principles as consistently applied by
Mallinckrodt and will be based on accruals, as consistently and
typically made by Mallinckrodt. Further, at the same time as any
Quarterly Aggregate Standard Margin Payment is made to
Intellipharmaceutics for any given fiscal quarter, Mallinckrodt
will also deduct from or add to such payment to reflect any true-up
of actual results with respect to rebates, chargebacks and other
relevant expenses to the extent related to quarterly periods
occurring prior to the quarter for which any such Quarterly
Aggregate Standard Margin Payment is being submitted, the
underlying details of any such true-up additions or deductions to
be submitted by Mallinckrodt to Intellipharmaceutics in connection
with any Quarterly Report related to the payment then being
made.

(e) On or before the
fifteenth (15th) day after the end
of each month of this Agreement, Mallinckrodt shall provide a
report detailing the estimated monthly Standard Margin amounts due
to Intellipharmaceutics for that month. It is the understanding of
both parties that such monthly Standard Margin estimates may change
once actual amounts are known and can be adjusted prospectively in
accordance herewith.

4. Audit Rights.

(a) At any time while
this Agreement is in effect with respect to any given
Product and for a period of
ninety (90) days after this Agreement expires or is terminated with
respect to such Product,
appropriate representatives of Mallinckrodt shall have the right on
an annual basis or at any reasonable time for
cause, and at Mallinckrodt’s own expense (except as otherwise
specifically

noted
in this Section 4(a)), (i) to review all batch records and other
records relevant to manufacture, testing and release
of any volume of any Product SKU and (ii) to audit any records
relating to any calculation of, or
increase or decrease in, the Standard Cost of any Product SKU based
on any calculation,
increase or decrease by Intellipharmaceutics of, its Standard Cost
of manufacture whether or not in
connection with any Annual Standard Cost Notice provided to
Mallinckrodt in accordance with
Section 6(d) (“Standard Cost
Calculation”), provided that, Mallinckrodt shall not
be allowed to audit
any records or data on more than one occasion or more often than
annually or, with respect to any
Standard Cost Calculation, more than six (6) months following the
effective date hereunder of
the establishment of or a change in any Standard Cost for any one
or more Product SKUs in
accordance with the procedures set forth below in Section 6(d), and
provided further and subject
to the procedures set forth below in this Section 4(a), in the
event that any audit of any Standard
Cost Calculation applicable to any one or more Product SKUs
reveals, and Intellipharmaceutics
does not dispute in good faith and with substantial reason, that
the amount of any such Standard
Cost Calculation for any one or more Product SKUs was overstated
for any

 

*Omitted and filed
separately with the Securities and Exchange Commission under a
request for confidential treatment.

 

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applicable period
by an amount in excess of [*] percent ([*]%), Intellipharmaceutics
shall promptly refund the amount
of any overcharge, as well as the amount of the [*] percent ([*]%)
additional charge levied
hereunder to reach the Transfer Price for any Product SKU or SKUs
allocable to the volume of any
Product SKUs and the period of time for which such overcharge is
applicable; the cost and expense of
any audit by Mallinckrodt to the extent allocable to any such
overstated Standard Cost shall
be for the account and expense of Intellipharmaceutics. Consistent
with the immediately
preceding sentence, in the event that, as a consequence of any such
audit or examination, Mallinckrodt
reasonably disagrees with any amounts invoiced by or payable to
Intellipharmaceutics

hereunder to the
extent such amount relates to the Standard Cost of any one or more
Product SKUs, Mallinckrodt shall
inform Intellipharmaceutics in writing and in reasonable detail of
the amounts to be refunded and the
specific manner in which any Standard Cost Calculation was
inaccurate and, unless and to the
extent Intellipharmaceutics disputes, in good faith and with
substantial reason, the amount set forth by
Mallinckrodt in any such notice from Mallinckrodt,
Intellipharmaceutics will refund to
Mallinckrodt any such undisputed amounts within thirty (30) days of
the receipt of any such notice from
Mallinckrodt. In the event Intellipharmaceutics does dispute all or
any portion of any refund claimed by
Mallinckrodt, Intellipharmaceutics will so notify Mallinckrodt
within such thirty (30) day period and
the parties will attempt thereafter to resolve such dispute
amicably and if, within thirty (30) days
thereafter, the parties are unable to resolve such dispute, the
matter will be referred to an independent
third party expert selected by and acceptable to both parties. The
decision of such expert shall be
final and binding upon both parties as to whether any refund is
owed and, if so, the appropriate amount
of such refund, and the costs and expenses of such independent
third party expert shall be paid as
follows herein. Where it is determined that a full or partial
refund is owed to Mallinckrodt, the
costs of such expert shall be allocated as between the parties in
inverse proportion to the percent of
refund request actually recovered. For greater certainty, and by
way of example only, if Mallinckrodt
obtains 70% of a requested refund, it will be required to pay 30%
of the expert costs and
Intellipharmaceutics will be required to pay 70% of such costs. The
amount of any refund finally determined to be
due to Mallinckrodt in accordance with the agreement or deemed
agreement of the parties or in
accordance with the dispute resolution procedures set forth above
in this Section 4(a)

may be
deducted by Mallinckrodt from any calculation of the Cost of Goods
Sold used in connection with the
calculation of Standard Margin for the applicable Product relative
to the next occurring fiscal quarter for which
any Quarterly Standard Margin Payment is or may be due. In
connection with any audit by
Mallinckrodt, Intellipharmaceutics will provide copies of all
relevant documentation and

appropriate
personnel will be made available to answer questions and provide
information in connection with any
such audit.

(b) At any time while
this Agreement is in effect with respect to any given
product
and for a period of ninety (90) days after this Agreement expires
or is terminated with respect to such
Product, appropriate representatives of Intellipharmaceutics shall
have the right, on an annual basis
or at any reasonable time for cause, and at Intellipharmaceutics
expense (except as otherwise
specifically noted in this Section 4(b)), (i) to audit
Mallinckrodt’s compliance with applicable laws,
rules and regulations in connection with the marketing, sale,
offering for sale and handling of
Products and (ii) any records and data that support, explain or
relate to any Quarterly Aggregate Standard
Margin Payments or that relate to the information contained in any
Quarterly Report, provided
that, Intellipharmaceutics shall not be allowed to audit any such
records and data on more than one
occasion or more often than annually or, with respect to the
matters referred to in clause (ii) of
this sentence, more than one (1) year following the issuance of any
Quarterly Report or the
making of any Quarterly Aggregate Standard Margin Payment to which
it relates,

*Omitted and filed
separately with the Securities and Exchange Commission under a
request for confidential treatment.

 

6

	
 CSK/Intellipharmaceutics
CommercializationAgr5 

	
 September 28,
2016

 

 

and
provided further that and subject to the procedures set forth in
this Section 4(b), in the event that any such audit
reveals, and Mallinckrodt does not dispute in good faith and with
substantial reason, that the
amount of any Quarterly Aggregate Standard Margin Payment was
understated by an amount in excess
of [*] percent ([*]%) as a result of the information contained or
that reasonably should have been
contained in any relevant Quarterly Report or any other relevant
information concerning any
Quarterly Aggregate Standard Margin, Mallinckrodt shall promptly
pay Intellipharmaceutics
any such shortfall, and the cost and expense of any audit by
Intellipharmaceutics
to the extent allocable to such Quarterly Report shall be for the
account and expense of
Mallinckrodt. Consistent with the immediately preceding sentence,
in the event that, as a consequence of
any such audit or examination, Intellipharmaceutics reasonably
disagrees with any amounts payable
to Intellipharmaceutics hereunder to the extent such amount relates
to any Quarterly Aggregate
Standard Margin Payment and the correlative Quarterly
Report, Intellipharmaceutics
shall inform Mallinckrodt in writing and in reasonable detail of
the amounts still owed and the
specific manner in which any Quarterly Aggregate Standard Margin
Payment was deficient and the
information in any correlative Quarterly Report that was inaccurate
and/or misleading and,
unless and to the extent Mallinckrodt disputes, in good faith and
with substantial reason, the amount
set forth by Intellipharmaccutics as being owed in any such notice
from Intellipharmaceutics,
Mallinckrodt will pay to Intellipharmaceutics any such undisputed
amounts within thirty (30)
days of the receipt of any such notice from Intellipharmaceutics.
In the event Mallinckrodt does
dispute all or any portion of any amount claimed by
Intellipharmaccutics, Mallinckrodt will
so notify Intellipharmaceutics within such thirty (30) day period
and the parties will attempt thereafter
to resolve such dispute amicably and if, within thirty (30) days
thereafter, the parties are unable to
resolve such dispute, the matter will be referred to an independent
third party expert selected by and
acceptable to both parties. The decision of such expert shall be
final and binding upon both parties
as to whether any additional payment is owed and, if so, the
appropriate amount of such payment, and
the costs and expenses of such independent third party expert shall
be paid as follows herein.
Where it is determined that a full or partial additional payment
request is owed to Intellipharmaceutics,
the costs of such expert shall be allocated as between the parties
in inverse proportion to the
percent of additional payment request actually recovered. For
greater certainty, and by way of example
only, if Intellipharmaceutics obtains 70% of a requested additional
payment, it will be required to
pay 30% of the expert costs and Mallinckrodt will be required to
pay 70% of such costs. In
connection with any audit by Intellipharmaceutics, Mallinckrodt
will provide copies of all relevant
documentation and appropriate personnel will be made available to
answer questions and provide information
in connection with any such audit.

 

5. Manufacture and Supply of
Products.

(a) It is understood
that, for so long as this Agreement is in effect,
Intellipharmaceutics
will be the exclusive manufacturer and supplier of Products to
Mallinckrodt, such Products to be
manufactured at Intellipharmaceutics’ Toronto, Canada
manufacturing plant (“Facility”).
Manufacturing of Products will be accomplished by
Intellipharmaceutics in accordance with
current Good Manufacturing Practices (“cGMP”) as defined by the
United States Food, Drug and
Cosmetic Act, as amended, and regulations issued thereunder, and as
administered by the FDA. All raw
materials (including, without limitation, all active pharmaceutical
ingredients and intermediates)
and other resources required in connection with production
hereunder shall be provided by
Intellipharmaceutics. Intellipharmaceutics represents and warrants
that it currently has access to, and
during the entire term hereof will make commercially reasonable
efforts to ensure that

*Omitted and filed
separately with the Securities and Exchange Commission under a
request for confidential treatment.

 

7

	
 CSK/Intellipharmaceutics
CommercializationAgr5 

	
 September 28,
2016

 

it will
continue to have access to, sufficient supplies of raw materials
and all other required items to perform the
services required of it hereunder without interruption, subject to
the occurrence of any events covered by
the provisions of Section 13(a) hereof. In the event there is a
shortage of any raw materials to be
supplied by Intellipharmaceutics for the purpose of manufacturing
hereunder to the

extent
that Intellipharmaceutics, without some form of allocation or
rationing, is unable to supply Mallinckrodt and
all other parties with whom Intellipharmaceutics has supply
arrangements, Intellipharmaceutics
agrees to use commercially reasonable efforts to allocate its
supply of such raw materials among all
of its customers in a manner reasonably designed not unfairly to
disadvantage

Mallinckrodt.

 

(b) All Products
supplied by Intellipharmaceutics hereunder shall be
manufactured in
accordance with the specifications for Product that have been
developed by Intellipharmaceutics,
which specifications for each of the Products as they currently
exist are set forth and described
in detail on Exhibit A attached hereto. If the specifications for
any Product are not currently
available, because the ANDA for any Product has not yet been
approved by the FDA,
Intellipharmaceutics will ensure that, when finalized, any such
specifications are promptly attached hereto as
part of Exhibit A. Intellipharmaceutics will not change the
specifications for any Product unless
deemed reasonably necessary by Intellipharmaceutics to comply
with applicable law or
regulatory requirements, in which case such changes will be made no
sooner than necessary to
comply with any applicable legal and regulatory requirements and,
in any event, will only become
effective upon written notice by Intellipharmaceutics to
Mallinckrodt. In the event Mallinckrodt
requests a change in specifications for Product (which request
shall be set forth with particularity
in a written notice to Intellipharmaceutics) and
Intellipharmaceutics believes that any specification
change requested by Mallinckrodt is reasonably necessary to meet
any applicable law or regulatory
requirements or is reasonably necessary to allow the effective
sale, marketing and distribution of
that Product in the Exclusive Market, then such specification
change shall be made by
Intellipharmaceutics as promptly as reasonably possible, and
Intellipharmaceutics shall inform Mallinckrodt
in writing of the effective date of any such change. All cost and
expense associated with any
changes in specifications requested by Mallinckrodt shall be paid
for by Mallinckrodt and
any changes in specifications required to be made as a result of
any applicable laws, rules or
regulations shall be the cost and expense of Intellipharmaceutics.
Regardless of the reason and nature
of any change in specifications, Exhibit A hereto will be formally
amended to reflect any changes
in specifications for any Product.

 

(c) Products
manufactured by Intellipharmaceutics shall be manufactured
in accordance with
Intellipharmaceutics’ manufacturing processes and in material
compliance with all applicable
laws, rules and regulations. Further, Intellipharmaceutics
represents and warrants that the Facility
has all, and will continue to have all relevant regulatory permits
and approvals necessary for the
manufacture of Products hereunder. Intellipharmaceutics shall, at
its own expense, take
whatever actions are reasonably necessary to ensure that all
manufacturing and related processes
used are and remain validated for any Product for so long as
Intellipharmaceutics is supplying
Mallinckrodt with any quantities of that Product hereunder.
Intellipharmaceutics shall retain all batch
records and other documentation relative to its manufacture of
Products hereunder to the extent
necessary to demonstrate its compliance with the provisions of this
Section 5 and as otherwise may be
required by cGMP or the requirements of any other applicable law,
rule or regulation.

 

8

	
 CSK/Intellipharmaceutics
CommercializationAgr5 

	
 September 28,
2016

 

 

6. Purchase of
Product.

(a) While this
Agreement is in effect, Mallinckrodt shall purchase all of
its requirements for
each strength of each of the Products in multiples of the minimum
batch size from
Intellipharmaceutics hereunder at Standard Cost plus [*] percent
([*]%) (for each strength of each Product, its
“Transfer
Price”). For absolute clarity, no purchase order shall
be less than the minimum batch size
for each SKU of the Product. All purchases of Products shall be
made by written purchase
order delivered to Intellipharmaceutics at least ninety (90) days
prior to the requested date of
shipment for Products so ordered. Each purchase order shall specify
the amount of each strength of
any Product being ordered and the requested delivery date for all
ordered Products.
Intellipharmaceutics will acknowledge each purchase order received
in writing to Mallinckrodt within
five (5) business days of receipt and Intellipharmaceutics shall
not withhold its acceptance of
any purchase order absent substantial and justifiable reasons. No
term, condition or provision of any
purchase order, acknowledgement or any other document issued by a
party in connection herewith
shall be deemed in any case to create any requirements or specify
any terms that are in
conflict with or (except for volume and delivery terms) are
additional to the terms and conditions hereof,
and any such conflicting or additional terms and requirements are
hereby expressly rejected.
Payment for all Products invoiced and shipped hereunder by
Intellipharmaceutics
shall be made by Mallinckrodt in United States dollars within [*]
([*]) days after the date
Mallinckrodt receives any invoice from Intellipharmaceutics.
Intellipharmaceutics may issue an
invoice for any shipment of Product on or after the date on which
any volume of Product to be
shipped has been delivered by Intellipharmaceutics to an
appropriate carrier for shipment. All
Products shall be shipped by Intellipharmaceutics to Mallinckrodt
by such method as Mallinckrodt
shall reasonably designate and Mallinckrodt shall be responsible
for the selection of the carrier and
for the payment of all freight and transportation charges, which,
if paid by Intellipharmaceutics,
shall be reimbursed by Mallinckrodt to Intellipharmaceutics
promptly upon written request,
which request shall be accompanied by all relevant supporting
documentation. Title to any
shipped Products sold hereunder shall transfer to Mallinckrodt and
Mallinckrodt shall bear all risk of
loss with respect to shipped Products when delivered by
Intellipharmaceutics to the carrier designated
by Mallinckrodt. Mallinckrodt shall be solely responsible for
proper storage of Product in
accordance with applicable specifications once Products have been
delivered, but Intellipharmaceutics
shall be solely responsible for all pre-shipment quality assurance
testing and/or release of
Products for distribution, in accordance with all applicable laws,
rules and regulations.

 

(b) Orders for Products
placed by Mallinckrodt may be decreased or cancelled
by
Mallinckrodt after they have been acknowledged by
Intellipharmaceutics upon written notice to
Intellipharmaceutics. Mallinckrodt shall pay Intellipharmaceutics,
with respect to a decreased or cancelled order,
an amount equal to Intellipharmaceutics’ actual direct costs
with respect to such decreased
portion of such order or such cancelled order (including the cost
to Intellipharmaceutics
of documented and no cancellable commitments to third parties, if
reasonable in amount and
reasonably related to supply by Intellipharmaceutics hereunder)
incurred prior to the date
Mallinckrodt notifies Intellipharmaceutics of such decrease or
cancellation; provided that, in no event shall
Mallinckrodt be required to pay Intellipharmaceutics more than
Mallinckrodt would have paid
Intellipharmaceutics had Mallinckrodt not decreased or cancelled
any such order. All costs payable
in accordance with this Section 6(b) must be invoiced by
Intellipharmaceutics

 

*Omitted and filed
separately with the Securities and Exchange Commission under a
request for confidential treatment.

9

	
 CSK/Intellipharmaceutics
CommercializationAgr5 

	
 September 28,
2016

 

with
appropriate supporting documentation, and such invoice shall be
payable by Mallinckrodt within [*] ([*])
days of its receipt of an appropriate invoice.

(c) Mallinckrodt shall,
for every Mallinckrodt fiscal quarter during the term hereof and
beginning with the first full fiscal quarter occurring after the
first date of commercial sale in the Exclusive Market by
Mallinckrodt of any of the Products, submit to Intellipharmaceutics
in writing a rolling forecast of its requirements for each of the
Product SKUs then available for marketing and sale by Mallinckrodt
in the Exclusive Market during the next twelve (12) months
(“Rolling
Forecast”). In no event shall any such forecasted
amounts be deemed to represent an order for Products hereunder, but
each such Rolling Forecast shall be submitted by Mallinckrodt to
Intellipharmaceutics in good faith and shall be as accurate as
possible under the applicable circumstances. In no event shall
Intellipharmaceutics be required to supply during any period
covered by any Rolling Forecast more than one hundred twenty five
percent (125%) of the total amount of Products covered by such
forecast, but Intellipharmaceutics shall use reasonable commercial
efforts to supply any amounts of Product ordered hereunder by
Mallinckrodt to the extent in excess of such amount.

(d) For purposes hereof
“Standard
Cost” shall mean, with respect to any unit of any
Product SKU, the standard manufacturing cost incurred by
Intellipharmaceutics to manufacture and package in labeled and
fully finished form any such unit, calculated as of any given time
in accordance with generally accepting accounting principles as
consistently applied and otherwise in accordance with the
principles set forth on Exhibit A attached hereto and excluding the
amount of any capital expenditure unless and to the extent (i)
related solely to the supply of Products hereunder and (ii)
approved in advance by Mallinckrodt (which approval shall not
unreasonably be withheld) (collectively the “Calculation Principles”).
The Standard Cost of each Product SKU then available or that will
soon be available shall be notified in writing to Mallinckrodt by
Intellipharmaceutics at least thirty (30) days prior to the
beginning of each Contract Year during the term hereof along with
all supporting information and documentation necessary to
demonstrate that the calculation of (including any increase or
decrease of) each such Standard Cost was accomplished in accordance
with the Calculation Principles (“Annual Standard Cost
Notice”). Any Standard Costs so notified to
Mallinckrodt will be effective as of the beginning of the
applicable Contract Year and shall remain firm for orders placed
for any Products by Mallinckrodt at any time during such Contract
Year. Standard Cost for all Product SKUs will be adjusted effective
for the immediately subsequent Contract Year (for each Contract
Year that occurs during the term hereof), upward or downward, based
on manufacturing variances experienced during the immediately
preceding Contract Year (i.e., increases or decreases in the cost
to Intellipharmaceutics of all raw materials, directly associated
regulatory compliance costs, directly allocated labor costs, any
allocation of directed overhead and burden) consistent in all cases
with the Calculation Principles, and the calculation of and
supporting information and documentation associated with any such
increase or decrease of the Transfer Price of any Product SKU shall
form part of the Annual Standard Cost Notice required to be given
by Intellipharmaceutics to Mallinckrodt in accordance with this
Section 6(d).

(e) Mallinckrodt shall
collect and pay all customs duties or sales, use, excise,
or
other similar taxes and any personal property taxes or other
similar taxes (but not any income taxes) in
connection with any transactions contemplated hereby.
Intellipharmaceutics agrees to collect and remit
any such taxes, if and as required to do so under the laws of any
jurisdiction. To

*Omitted and filed
separately with the Securities and Exchange Commission under a
request for confidential treatment.

10

	
 CSK/Intellipharmaceutics
CommercializationAgr5 

	
 September 28,
2016

 

the
extent any such taxes must be paid by Intellipharmaceutics,
Mallinckrodt shall pay Intellipharmaceutics
for the amount of such taxes no later than ten (10) days
before Intellipharmaceutics
is required to remit the amount of such taxes to any governmental
authorities, if and to the
extent Mallinckrodt has been made aware of such payment deadline
by Intellipharmaceutics
at least thirty (30) days in advance of the occurrence of such
deadline. Each party shall
cooperate with the other party and take any action reasonably
requested which docs not cause such party to
incur any material cost or inconvenience in order to minimize any
such taxes that may be payable
in connection with any transactions contemplated hereby, including
providing sales and use
exemption certificates or other documentation necessary to support
sales or use tax exemptions.
Intellipharmaceutics and Mallinckrodt agree to provide each other
information and data that each may
from time to time reasonably request and otherwise fully cooperate
with each other in connection
with (i) the reporting of any such taxes payable, (ii) any relevant
audit, and (iii) any
assessment, refund claim or proceeding relating to any such taxes
payable.

 

7. Certain Other Matters Relative to
Supply of Products.

(a) If, within twenty
(20) days after its receipt of any volume of any Product
(or, in the case of
latent defects, within twenty (20) business days after any defect
becomes known), Mallinckrodt
reasonably determines that any volume of any Product is defective
in material or workmanship, not in
conformance with the applicable specifications, is adulterated or
otherwise fails to meet any
requirement hereof (any Product meeting any or all of the foregoing
circumstances being hereinafter
referred to as “Defective Product”), then
Mallinckrodt, at its sole option, may reject and
return
any such Defective Product. At the time of any such rejection,
Mallinckrodt shall provide Intellipharmaceutics
with a written notice describing in detail the circumstances
surrounding the rejection and
Mallinckrodt’s reasons therefor. Any Product received by
Mallinckrodt from Intellipharmaceutics
that has not been rejected by Mallinckrodt within twenty (20) days
after receipt (or, in the case of
latent defects, within twenty (20) days after any defect becomes
known) shall be deemed to have been
accepted for all purposes hereof. If, within twenty (20) days of
being notified by Mallinckrodt of
its rejection of any Product as Defective Product,
Intellipharmaceutics reasonably disagrees that such
Product was properly rejected by Mallinckrodt as Defective
Product, Intellipharmaceutics
shall notify Mallinckrodt in writing of such fact and the specific
reasons therefor, but if
Intellipharmaceutics fails to so notify Mallinckrodt within such
twenty (20) day period, the Product in question
will be deemed properly to have been rejected by Mallinckrodt.
After receipt by Mallinckrodt of any
such notice from Intellipharmaceutics, Intellipharmaceutics and
Mallinckrodt will attempt
amicably to settle the dispute concerning any allegedly Defective
Product, but if they are unable to do so
within thirty (30) days after the date of any Intellipharmaceutics
notice, the parties will jointly select
a third party expert acceptable to each party to make a final
determination as to whether or not
Product in question was Defective Product and therefore properly
rejected. The fees and expenses of
such third party expert will be paid by the party whose
determination was in error as to whether or not
Product was Defective Product and therefore properly rejected. If
Mallinckrodt has properly rejected
Defective Product, the Defective Product will be destroyed by
Mallinckrodt in a manner meeting all
applicable laws, rules and regulations and Intellipharmaceutics
shall be responsible for the
costs of any such destruction or disposal. The amount already paid
(if any) by Mallinckrodt to
Intellipharmaceutics for any properly rejected Defective Product
that is destroyed or disposed of shall
be refunded by Intellipharmaceutics to Mallinckrodt or credited
against other payments due
hereunder (at Mallinckrodt’s option) promptly upon written
request from Mallinckrodt. Intellipharmaceutics
shall, if no refund is to be issued or credited, replace any
Defective Product

11

	
 CSK/Intellipharmaceutics
CommercializationAgr5 

	
 September 28,
2016

 

properly rejected
by Mallinckrodt in accordance herewith at no additional cost to
Mallinckrodt, and it is understood
that Mallinckrodt’s sole remedy for Product that has been
properly rejected shall be either the
refund or crediting of any amounts paid for such Product or the
replacement of any properly rejected
Product with new Product that meets all applicable specifications
and all other requirements
hereof.

(b) Mallinckrodt shall
be responsible for handling all complaints relating to and
any
recalls or similar actions with respect to Product distributed and
sold by Mallinckrodt, but Intellipharmaceutics
will make available appropriate personnel to provide consultation
and assistance to
Mallinckrodt at all reasonable times to help Mallinckrodt provide
the appropriate response to any
Product complaints it receives. If Mallinckrodt reasonably decides
to or is required to initiate a
product recall or withdrawal with respect to, or if there is any
governmental seizure of, any Product sold or
offered for sale in the Exclusive Market, Mallinckrodt will
notify Intellipharmaceutics
promptly of the details regarding such action, including providing
copies of all relevant
documentation concerning such action. Notwithstanding the preceding
provisions of this Section 7(b),
Intellipharmaceutics shall have the right to initiate any recall or
product withdrawal of Product sold or
offered for sale in the Exclusive Market in the event Mallinckrodt
fails to do so if, in any given set of
circumstances, Intellipharmaceutics becomes aware of facts or
circumstances from which it determines
that any such action is reasonably necessary given the requirements
of applicable law. Regardless of
which party initiates a recall or withdrawal, each party will
assist the other as required in
investigating any such situation, and the party initiating any such
action will handle required contact
and communication with regulatory agencies. If any such recall,
withdrawal or seizure occurs due
solely to (i) a failure of any lot of Product manufactured by
Intellipharmaceutics hereunder to
conform to applicable specifications, required manufacturing
processes, or any warranty or other
requirement set forth in this Agreement, (ii) the failure by
Intellipharmaceutics (or anyone on its behalf) to
comply in all material respects with any applicable law, rule,
regulation, standard, court order or decree or
(iii) the negligent or intentional wrongful act or omission of
Intellipharmaceutics in connection with
the production of any such Product, then Intellipharmaceutics shall
bear the full cost and expense
of, any such seizure, recall, withdrawal or field correction,
including without limitation finished
product replacement to the market from which there was a seizure,
recall, withdrawal or field
correction and any and all third party fees such as (by way of
example) fees charged by
wholesalers whose aid might be required in connection with the
recall process; provided that, such cost and
expense shall be limited to reasonable, actual and documented
expense incurred by Mallinckrodt for
such seizure, recall, withdrawal or correction, and replacement of
or refund for Product withdrawn
or recalled. If any such recall, withdrawal or seizure occurs due
solely to (i) the failure by
Mallinckrodt (or anyone on its behalf) to comply with any
applicable law, rule, regulation, standard court
order or decree, (ii) the negligent or intentional wrongful act or
omission of Mallinckrodt in
connection with this Agreement or (iii) any act or omission to act
by Mallinckrodt (or anyone on its
behalf) in connection with the use, marketing, promotion, sale,
distribution, storage, possession,
handling or transportation of Product, then Mallinckrodt shall bear
the full cost and expense of any such
seizure, recall or withdrawal in a manner consistent with the
limitations set forth in the immediately
preceding sentence. If both Intellipharmaceutics and Mallinckrodt
contribute to the cause of a
seizure, recall or withdrawal, the cost and expenses thereof will
be shared in proportion to each
party’s contribution to the problem in accordance with the
principles of responsibility and

limitations set
forth in this Section 7(b).

12

	
 CSK/Intellipharmaceutics
CommercializationAgr5 

	
 September 28,
2016

 

 

(c) Upon request,
Intellipharmaceutics will furnish to Mallinckrodt pertinent
portions of all
inspection reports and correspondence from any governmental
authority (including the FDA) related to or
in any manner affecting Intellipharmaceutics’ supply of
Product hereunder as and when these become
available to Intellipharmaceutics. Intellipharmaceutics will also
notify Mallinckrodt
promptly (i.e., within five (5) business days) of any warning
(including any FDA Form 483), citation,
indictment, claim, lawsuit or proceeding issued or instituted by
any governmental entity or agency
(including the FDA) against Intellipharmaceutics or any of its
affiliates or of any revocation of any relevant
license or permit issued to Intellipharmaceutics, to the extent
that any relate directly to
Intellipharmaceutics’ supply of Product or performance of its
other obligations hereunder. Mallinckrodt shall,
finally, have the right, once during each Contract Year, upon
reasonable advance written request,
and during the term hereof, to inspect Intellipharmaceutics’
batch records relative to production
hereunder.

(d) In the event either
party becomes aware of (i) any adverse drug experience or
reaction or other
information indicating that any Products have any toxicity,
sensitivity reactions or have otherwise been
alleged to cause illness or injury of any kind or are adulterated,
(ii) any product complaints made by
customers or that will or could cause a field alert to be issued or
(iii) any out-of- specification
results or deviations from the approved manufacturing process that
might in any manner adversely affect
any Product or its supply hereunder, that party shall provide the
other party with all data or other
information reasonably available that the other party may
reasonably require in connection with any
reports or correspondence that either party is required to file
with any governmental
authority relative to the Product(s) in question. At all times
during the term hereof, either party will
notify the other promptly (i.e., within three (3) business days) if
a party becomes aware of an
occurrence of any of the events described in clauses (i), (ii) or
(iii) of the immediately preceding sentence.
It is understood by the parties that Mallinckrodt shall, with
respect to the Products sold and
offered for sale in the Exclusive Market, have sole and complete
responsibility for responding to any
adverse drug reaction reports or product complaints or for making
any contact with customers or any
regulatory agencies concerning any such problems, consistent with
Mallinckrodt’s then existing
procedures for handling such matters; provided that,
Intellipharmaceutics shall provide Mallinckrodt with
any available information or data, or with any available expertise
that Mallinckrodt reasonably requires
in connection therewith. Notwithstanding the provisions of Section
1(b), Mallinckrodt shall
be solely responsible for conducting and paying for any
required pharmacovigilance
program relative to the Products consistent with then applicable
laws, rules and regulations in the
Territory.

(e) Within five (5)
business days of Intellipharmaceutics’ discovery that any lot
of Product is
out-of-specification (which would include, without limitation, any
stability failure or trend analysis
indicating a likely stability failure prior to lot expiration
date), Intellipharmaceutics will notify Mallinckrodt
of such fact along with details concerning the nature of any such
failure to meet applicable
specifications. Intellipharmaceutics will make such further
internal investigation of any failure to meet
applicable specifications that is appropriate under the
circumstances and otherwise consistent with its
obligations hereunder.

(f) [*] during the
term, Mallinckrodt, through its employees, consultants or other
representatives, will have the right during normal business hours
and upon advance arrangement with Intellipharmaceutics to inspect
Intellipharmaceutics’ operations at the Facility to determine
whether or not Intellipharmaceutics is complying in all material
respects with

*Omitted and filed
separately with the Securities and Exchange Commission under a
request for confidential treatment.

 

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any of
its manufacturing obligations hereunder. Mallinckrodt warrants that
all such inspections and audits shall be carried out in a manner
calculated not to unreasonably interfere with
Intellipharmaceutics’ conduct of business at the Facility and
to insure the continued confidentiality of
Intellipharmaceutics’ other business and technical
information. Further, Mallinckrodt agrees to comply with all of
Intellipharmaceutics’ safety and security requirements during
any visits to the Facility.

(g) Within sixty (60)
days after the date hereof, the parties will enter into a mutually
acceptable quality and pharmacovigilance agreement relative to the
supply and commercial distribution of the Products hereunder, which
shall be attached hereto as Exhibit B. In the event of any conflict
or inconsistency between the provisions of this Agreement and the
provisions of any quality and pharmacovigilance agreement, the
provisions of this Agreement shall prevail in every
case.

8. Distribution by
Mallinckrodt.

(a) Mallinckrodt shall
have the right to sell Products in the Exclusive Market and,
subject to any amounts due and payable by Mallinckrodt to
Intellipharmaceutics in accordance with the express provisions
hereof (including, without limitation, any payments to be made in
accordance with Section 3 hereof), all revenues, profits and other
amounts derived by Mallinckrodt from any such sales shall be for
the sole account of Mallinckrodt. Further, the prices at which
Mallinckrodt resells Products shall, in every case, be entirely at
the discretion of Mallinckrodt and Mallinckrodt shall not seek
consultation with Intellipharmaceutics on the appropriate level of
pricing to be invoiced or quoted in any one or more
circumstances.

(b) During the
existence of this Agreement, Mallinckrodt shall use commercially
reasonable efforts to market and sell Products in the Exclusive
Market. In particular, but without limitation, Intellipharmaceutics
and Mallinckrodt are also agreed on the following:

(i)

Mallinckrodt shall
establish and maintain such places of business and shall maintain
such sales force as shall be necessary to provide good customer
service and support and good marketing coverage and promotion for
the Products throughout the Exclusive Market.

(ii)

Mallinckrodt will
utilize, at its own expense, such advertising relative to the sale,
marketing and use of Products as may be commercially useful and
necessary. Mallinckrodt shall be responsible for printing and
providing all product literature and promotional brochures (if any)
relative to Products at its own cost and expense, provided that,
the substantive content of all such literature will be subject to
review and approval by Intellipharmaceutics prior to use by
Mallinckrodt, which approval will not unreasonably be withheld or
delayed. During the existence of this Agreement, Mallinckrodt shall
not discount the Product to promote other products of
Mallinckrodt.

(iii)

In order to focus
its marketing efforts to achieve maximum results Mallinckrodt shall
confine its marketing and sales efforts relative to Products to the
Exclusive Market, absent the advance written agreement
of

 

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Intellipharmaceutics
to the contrary; provided that, the foregoing shall not be
interpreted as preventing Mallinckrodt from continuing or
commencing, in any market or to any set of customers, the sale or
marketing of any current or future product offering of Mallinckrodt
or any of its affiliates.

(iv)

At no time during
the performance of its duties hereunder will Mallinckrodt disparage
Products, cast Products in an unfavorable light, or misrepresent in
any fashion the capabilities, qualities or characteristics of
Product.

(v)

Mallinckrodt shall
comply in all material respects with all applicable laws, rules and
regulations affecting or relating to the purchase, storage,
handling, registration, distribution and sale of Products (as
applicable).

(vi)

Mallinckrodt shall
maintain for a period of at least five (5) years from the date of
creation, accurate and transparent books and records in accordance
with generally accepted accounting principles for all sales,
transactions, marketing or other activities relating to
Product.

(vii)

Mallinckrodt will
book all sales of Products in accordance with generally accepted
accounting principles, as consistently applied by Mallinckrodt, and
will, in connection therewith, process and settle all Product
returns, discounts, chargebacks, rebates and other allowances and
adjustments.

(vii)

Mallinckrodt shall
pay all disbursements, costs and expenses incidental to
Mallinckrodt’s performance under this Agreement, including,
without limitation, (i) sales and office expenses, (ii) travel,
salary, commission or other compensation expenses of
Mallinckrodt’s employees, representatives, agents,
contractors and consultants, and (iii) postal, courier, telephone
and facsimile charges.

(ix)

Mallinckrodt shall
not appoint sub-distributors or other representatives or agents, or
otherwise subcontract any of Mallinckrodt’s duties hereunder,
without Intellipharmaceutics’ prior written consent (which
shall not unreasonably be withheld or delayed), and Mallinckrodt
will, in any event, remain responsible for performance of its
obligations as distributor for Products in the Exclusive
Market.

(x)

Mallinckrodt will
perform any other tasks and obligations reasonably necessary for or
incident to the commercially reasonable marketing, sale and
distribution of Products to the Exclusive Market.

(xi)

During the Term,
neither Party nor its Affiliates will, directly or through a Third
Party, develop, make, have made, import, market or sell a
“Competing Product” in the Exclusive Market. A
“Competing Product”, for this purpose shall mean any
product that is not the Product and is not sold under the
Intellipharmaceutics ANDA, which is AB-Rated to the Reference
Product. Notwithstanding the preceding portions of this clause
(xi), the foregoing restriction shall not apply with respect to any
product or

 

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line of
products (whether or not they are Competing Products for purposes
hereof) that may be acquired by Mallinckrodt from any third party
in connection with the acquisition by Mallinckrodt of any entity or
entities, or business unit from such third party (regardless of the
form of any transaction or that may be acquired in connection with
any acquisition of all or a relevant portion of the Mallinckrodt
family of companies or its assets, or in connection with any merger
with or combination of Mallinckrodt and/or its affiliates with any
third party (regardless of the form of any transaction) provided
that the aggregate revenue of any product or line of products so
acquired that would otherwise be treated as Competing Products
hereunder represent no more than [*] percent ([*]%) of the total
revenue of the business, entity or entities or assets so acquired
by Mallinckrodt. In the event that Mallinckrodt continues to
market, sell or offer for sale any such Competing Product in the
Exclusive Market for a period extending more than one (1) year
beyond the effective date of acquisition of such Competing Product,
Intellipharmaceutics shall have the right to terminate this
Agreement effective upon thirty (30) days’ notice to
Mallinckrodt as to the Product hereunder affected by the continued
commercialization of such Competing Product by Mallinckrodt and, if
and only if the Product has been commercialized by Mallinckrodt for
a period of at least [*] ([*]) [*] prior to the effective date of
termination, shall receive from Mallinckrodt a termination payment
equal to the sum of the Aggregate Standard Margin Payments due in
respect of the Product with respect to the [*] ([*]) [*] elapsing
immediately prior to the effective date of
termination.

9. Confidentiality.

(a) Except as otherwise
provided in this Section 9, while this Agreement is in effect and
for a period of five (5) years thereafter, each party shall
maintain in confidence and use only for purposes specifically
authorized under this Agreement all confidential and/or proprietary
information and data, received from the other party (whether in
written or recorded form, disclosed orally or disclosed by means of
examination or inspection), which information and data shall be
referred to hereinafter as “Information.”

(b) To the extent it is
reasonably necessary or appropriate to fulfill its obligations or
exercise its rights under this Agreement, a party may disclose
Information to its affiliates, consultants, agents and
representatives it is otherwise obligated under this Section 9 not
to disclose, only on a need-to-know basis and only on condition
that such entities or persons agree to keep the Information
confidential for the same time periods and to the same extent as
such party is required to keep the Information confidential and
agree to use such Information only for purposes relevant to the
performance by a party of its obligations under this Agreement, or
any agreement entered into in connection herewith.

(c) In addition to the
exceptions to non-disclosure set forth in Section 9(b) above, the
obligation not to disclose or to misuse Information shall not apply
to any part of such Information that: (i) is or becomes part of the
public domain other than by unauthorized acts of the party
obligated not to disclose such Information or those of its
affiliates, or its or their consultants,

*Omitted and filed
separately with the Securities and Exchange Commission under a
request for confidential treatment.

 

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agents
and representatives, (ii) can be shown by competent evidence to
have been disclosed to the receiving party or its affiliates, or to
its or their consultants, agents and representatives, by a third
party without violation of an obligation of confidentiality with
respect to such disclosure, (iii) can be demonstrated by competent
evidence already to have been in possession of the receiving party
or its affiliates, or its or their consultants, agents,
representatives and clinical investigators prior to disclosure
under this Agreement, provided such Information was not obtained
directly or indirectly from any third party that was under an
obligation of confidentiality with respect to such Information and
in violation of such obligation, (iv) can be demonstrated by
competent evidence to have been independently developed by the
receiving party or its affiliates, or by its or their consultants,
agents and representatives, without breach of any of the provisions
of this Agreement, or (v) is disclosed by the receiving party or
its affiliates, or by its or their consultants, agents and
representatives, pursuant to interrogatories, requests for
information or documents, subpoenas or civil investigative demands
(or similar process) issued by a court or governmental agency or
pursuant to any other requirement of law, provided that the party
so disclosing, if at all possible, notifies the other party prior
to any such disclosure so that such other party (at its own
expense, but with the cooperation of the receiving party) can seek
a protective order or other order limiting or preventing disclosure
(if and to the extent available under the circumstances), and
provided further that the party so disclosing furnishes only that
portion of the Information which it is legally required to disclose
under the circumstances. The party relying on one or more of the
above exceptions shall have the burden of establishing the
applicability of such exception in any particular set of
circumstances.

(d) Intellipharmaceutics
and Mallinckrodt each agree not to disclose any terms or conditions
of this Agreement (or any agreement entered into in connection
herewith) to any third party without the prior consent of the other
party, except as required by applicable law. If either party
determines that it is required to file this Agreement (or any
agreement entered into in connection herewith) with any
governmental agency for any reason, such party shall request
confidential treatment of such portions of this Agreement (or such
other agreement) as either party hereto shall deem
appropriate.

(e) In protecting the
other party’s Information from improper use or disclosure,
the receiving party shall exercise the same degree of care in
protecting such Information as it uses in protecting the
confidentiality of its own Information, but in any event shall
exercise no less than a reasonable degree of care.

(f) The parties hereto
agree that remedies at law may be inadequate to protect a party
against any breach by the other party (or any other person acting
in concert with such other party or on its behalf) of any of the
provisions of this Section 9. Accordingly, each party shall be
entitled to seek the granting of injunctive relief or other
equitable relief (or any similar remedy) from a court of competent
jurisdiction against any action that constitutes any breach of this
Section 9, in addition to any monetary damages or other similar
relief to which a party may be entitled, without the necessity of
posting a bond or any other form of financial
assurance.

10. Indemnification and Limitations of
Liability.

(a) Subject to all of
the applicable provisions of this Section 10, Intellipharmaceutics
agrees to defend, indemnify and hold Mallinckrodt and its
affiliates harmless

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from
and against any and all demands, claims, actions, causes of action,
assessments, losses, damages, injuries, liabilities, costs and
expenses (including, without limitation, reasonable
attorneys’ fees and expenses) of Mallinckrodt and its
affiliates, directly or indirectly related to, arising out of or
resulting from:

(i) any breach or
failure of or liability under any of the representations,
warranties or covenants of Intellipharmaceutics contained
herein,

(ii) actual
or asserted violations of any applicable law by
Intellipharmaceutics or its affiliates,

(iii) Intellipharmaceutics’
manufacture and supply of Products hereunder, and

(iv) any
negligent or wrongful act or omission to act by
Intellipharmaceutics or its affiliates in any manner in connection
with performance hereunder.

(b) Subject to all of
the applicable provisions of this Section 10, Mallinckrodt agrees
to defend, indemnify and hold Intellipharmaceutics and its
affiliates harmless from and against any and all demands, claims,
actions, causes of action, assessments, losses, damages, injuries,
liabilities, costs and expenses (including, without limitation,
reasonable attorneys’ fees and expenses) of
Intellipharmaceutics and its affiliates, directly or indirectly
related to, arising out of or resulting from:

(i) any breach or
failure of or liability under any of the representations,
warranties and covenants of Mallinckrodt contained
herein,

(ii) actual
or asserted violations of any applicable law by Mallinckrodt or any
of its affiliates or representatives,

(iii) Mallinckrodt’s,
its affiliates’ and its representatives’ marketing,
distribution, sale, offer for sale, handling and storage of
Product, and

(iv) any
negligent or wrongful act or omission to act by Mallinckrodt or its
affiliates or representatives in any manner in connection with
performance hereunder.

(c) Unless and to the
extent otherwise specifically provided herein, a party or any of
its affiliates (the “Indemnitee”) that intends
to claim indemnification under this Section 10 with respect to any
third party claim or action shall promptly notify the other party
(the “Indemnitor”) of any loss,
claim, damage, or liability arising out of any third party claim or
action in respect of which the Indemnitee intends to claim such
indemnification, and the Indemnitor shall assume the defense
thereof with counsel of its own choosing; provided, however, that
an Indemnitee shall have the right to retain its own counsel, with
the fees and expenses to be paid by the Indemnitor only if
representation of such Indemnitee by the counsel retained by the
Indemnitor, in the opinion of an independent counsel chosen by both
parties, would be inappropriate due to actual or potential
differing interests between such Indemnitee and any other party
represented by such counsel in such proceedings. An Indemnitee
shall not be entitled to indemnification under

 

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this
Section 10 if any settlement or compromise of a third party claim
is effected by the Indemnitee without the consent of the
Indemnitor, which consent shall not be unreasonably withheld or
delayed. An Indemnitee shall not be entitled to indemnification
with respect to any third party claim in an amount in excess of the
amount which such third party has unequivocally, without other
conditions and in writing agreed with the Indemnitor it is willing
to accept in settlement or compromise of any such third party
claim. An Indemnitor shall not enter into any settlement or
compromise of any third party claim or consent to the entry of any
judgment or other order with respect to any claim which does not
contain, as a part thereof, an unconditional release of the
Indemnitee for liability for all loss, cost or damage that may
arise from such claim or which does contain any injunctive or other
non-monetary relief that might in any way interfere with the future
conduct of business by the Indemnitee. The failure by the
Indemnitee to deliver notice to the Indemnitor within a reasonable
time after the commencement of any such third party claim or
action, if materially prejudicial to the Indemnitor’s ability
to defend such action, shall relieve such Indemnitor of any
liability to the Indemnitee under this Section 10. An Indemnitee,
and its employees, agents and representatives, shall cooperate
fully with the Indemnitor and its legal representatives, at the
Indemnitor’s expense for out-of-pocket costs, in the
investigation of any action, claim or liability covered by this
indemnification.

(d)           In
no event shall either party (or any of its affiliates) be liable
for any special, indirect,
consequential, exemplary or punitive damages of any nature
(including, without
limitation, lost profits, business interruption, lost opportunities
or loss of goodwill) relating to its
performance hereunder, regardless of whether such damages arise out
of this Agreement or out
of any form of action arising in tort, strict liability or
otherwise, and regardless  of whether a
party has been advised of the possibility of such damages and
whether or not such damages are
reasonably foreseeable under the circumstances.

11. Termination and
Expiration.

(a) In addition to any
other rights a party may have to terminate set forth elsewhere in
this Agreement (including, without limitation, Mallinckrodt’s
rights to terminate this Agreement pursuant to Section 1(c) above),
this Agreement may be terminated by either party, as to all or any
one or more Products, effective upon notice (i) by reason of a
material breach or breaches of this Agreement (other than as
provided in clauses (ii) or (iii) below) if the breaching party
fails to remedy such breach or breaches within sixty (60) days
after written notice thereof by the non-breaching party, (ii) if
the other party fails to make any payments of any kind as and when
due hereunder and such failure is not remedied within sixty (60)
days after written notice thereof by the nonbreaking party (unless
and to the extent there exists a good faith dispute as to the
amount of any such payment due), or (iii) upon the bankruptcy,
insolvency, dissolution or winding up the other party, except, in
the case of a petition relative to any of the immediately foregoing
filed involuntarily against a party if such petition is dismissed
within sixty (60) days of the date of its filing. Notwithstanding
the immediately preceding portions of this Section 11(a), a party
shall not be deemed to be in breach hereof if any acts or omissions
to act that would otherwise constitute a breach hereunder are the
subject of a good faith dispute that is subject to resolution in
accordance with internal procedures established herein unless and
until such internal procedures have been fully
exhausted.

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(b) Unless and to the
extent otherwise explicitly set forth herein, the expiration or
termination of this Agreement for any reason shall not relieve the
parties of any obligation that accrued hereunder or under any
agreement entered into in connection herewith prior to such
expiration or termination.

(c) In the event that
this Agreement expires or is rightfully terminated by either party
pursuant to Section 11(a), or by Mallinckrodt pursuant to Section
1(c) above, as to any one or more Products, the following shall
apply:

(i) Subject to clause
(ii) of this Section 11(c) set forth below, Mallinckrodt, and any
permitted distributor or sub-licensee, shall cease the marketing,
sale and distribution of any applicable Product(s) effective upon
the date of expiration or termination as to such Product(s) except
that Mallinckrodt shall have one (1) year subsequent to the
effective date of any expiration or termination to sell or
otherwise dispose of its inventory of such Product(s) on hand as of
the effective date of termination or expiration as well as the
amount of any such Product(s) purchased by Mallinckrodt or such
permitted distributor or sub-licensee pursuant to purchase orders
accepted by Intellipharmaceutics prior to the effective date of
termination or expiration (unless and to the extent the parties
agree on the cancellation of any such purchase
orders),

(ii) Mallinckrodt
shall, from and after the effective date of termination or
expiration hereof, (A) continue to perform all of its obligations
as a distributor hereunder with respect to any sales of applicable
Product(s) made after the date of termination or expiration
pursuant to clause (i) of this Section 11(c), (B) continue to
perform its obligations under any contracts or arrangements it has
entered into with third parties relative to the supply or sale of
Product(s) if and to the extent any such contracts are not
terminable on or before the effective date of termination or
expiration without penalty, (C) continue to honor all warranty or
service obligations or any other standard commercial obligations
(e.g., product returns, rebates, allowances, chargebacks, etc.)
made by Mallinckrodt or anyone on Mallinckrodt’s behalf with
respect to Product(s) sold either before or after the effective
date of termination or expiration, until the expiration of all such
warranties or other obligations, and (D) continue to fulfill all
regulatory obligations under the quality and pharmacovigilance
agreement between the parties,

(iii) all
amounts payable by one party to the other hereunder with respect to
any Product as to which this Agreement has been terminated or
expired shall become due and payable within one hundred twenty
(120) days after the effective date of any termination or
expiration, and

(iv) upon
any termination of this Agreement with respect to any Product or
Products, all rights in such Product or Products shall revert
forthwith and in full to Intellipharmaceutics, including all rights
to license or sell such Product or Products to third parties in the
sole discretion of Intellipharmaceutics.

 

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(d) The provisions of
this Agreement shall survive termination or expiration hereof in
whole or in part, to the extent necessary for them to be fully
performed in accordance with their express terms or in accordance
with the intent of the parties hereto.

12. Licenses.

(a) Mallinckrodt hereby
grants to Intellipharmaceutics a non-exclusive license in and to
Mallinckrodt’s trade names, trademarks and trade dress for
the sole purpose and only to the extent necessary for carrying out
Intellipharmaceutics’ obligations to label Product in a
manner consistent with the requirements of Section 1(b) above. The
foregoing license shall be co-extensive with this Agreement and,
therefore, will automatically terminate on the date of expiration
or termination hereof, subject only to the requirements of Section
11(c) above. The goodwill associated with the trade names,
trademarks and trade dress licensed under this Section 12(a) shall
remain the property of and inure to the benefit of Mallinckrodt,
and Intellipharmaceutics shall follow all of Mallinckrodt’s
reasonable directions concerning the use of such trade names,
trademarks and trade dress and shall take no action or omit to take
any action that might disparage or otherwise damage the goodwill or
any other value associated therewith.

(b) Intellipharmaceutics
will grant to Mallinckrodt a non-exclusive license in and to the
ANDA for each Product (as and when granted by the FDA) for the sole
purpose and only to the extent necessary for carrying out
Mallinckrodt’s obligations hereunder to market, sell and
distribute Products in the Exclusive Market. The foregoing license
shall be coextensive with this Agreement and, therefore, will
automatically terminate on the date of expiration or termination
hereof, subject only to the requirements of Section 11(c)
above.

13. Miscellaneous.

(a) Neither party shall
be held liable or responsible to the other party nor be deemed to
have defaulted under or breached this Agreement for failure or
delay in fulfilling or performing any term of this Agreement when
such failure or delay is caused by or results from causes beyond
the reasonable control of the affected party, including but not
limited to fire, floods, earthquakes, embargoes, war, acts of war
(whether war is declared or not), epidemics, insurrections, riots,
civil commotions, the existence or administration of any laws,
rules or regulations, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by
any governmental authority or the other party; provided, however,
that the party so affected shall use reasonable commercial efforts
to avoid or remove such causes of nonperformance, and shall
continue performance hereunder with reasonable dispatch whenever
such causes are removed, and provided further that such occurrence
is not the result of any failure by such party to perform fully its
obligations hereunder, which failure is not itself caused by an
event of force majeure. Each party shall provide the other party
with prompt written notice of any delay or failure to perform that
occurs by reason of force majeure. The parties shall mutually seek
a resolution of the delay or the failure to perform as noted
above.

(b) This Agreement may
not be assigned or otherwise transferred by either party without
the prior written consent of the other party, except that either
party may, without such consent, assign its rights and obligations
under this Agreement (i) in connection with a corporate
reorganization to any affiliate or (ii) to an unrelated third party
in connection with a

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merger,
consolidation or a sale of substantially all of its assets relating
to the performance of its obligations hereunder. Any purported
assignment in violation of the preceding sentence shall be void.
Any permitted assignee shall be deemed to have assumed all
obligations of its assignor under this Agreement.

(c) Should one or more
provisions of this Agreement be or become invalid or unenforceable,
the parties hereto shall substitute, by mutual consent, valid and
enforceable provisions for such invalid or unenforceable provisions
which new provisions, in their economic and other effects, are
sufficiently similar to the invalid or unenforceable provisions
that it can be reasonably assumed that the parties would have
originally entered into this Agreement with such new provisions. In
case such new provisions cannot be agreed upon, the invalidity or
unenforceability of one or several provisions of this Agreement
shall not affect the validity of this Agreement as a whole or the
validity of any portions hereof, unless the invalid or
unenforceable provisions are of such essential importance to this
Agreement that it is to be reasonably assumed that the parties
would not originally have entered into this Agreement without such
invalid or unenforceable provisions.

(d) Any consent, notice
or report required or permitted to be given or made under this
Agreement by one of the parties hereto to the other shall be in
writing, delivered personally or by facsimile (and promptly
confirmed by telephone, personal delivery or courier) or courier,
postage prepaid (where applicable), addressed to such other party
at its address indicated below, or to such other address as the
addressee shall have last furnished in writing to the addressor and
shall be effective upon receipt by the addressee.

If to
Intellipharmaceutics: 

Intellipharmaceutics
Corp.

30
Worcester Road,

Toronto,
Ontario

Canada
M9W 5X2

Attn:
Dr. Amina Odidi, President

Telephone: (416)
798-3001 Ext. 103

Facsimile: (416)
798-3007

Email:
aodidi@intellipharmaceutics.com

 

with a copy
to: 

Intellipharmaceutics
Corp.

30
Worcester Road,

Toronto,
Ontario

Canada
M9W 5X2

Attn:
Vice President, Legal Affairs & Licensing

Telephone: (416)
798-3001 Ext. 104

Facsimile: (416)
798-3007

 

If to
Mallinckrodt: 

Mallinckrodt
LLC

675
McDonnell Boulevard

Hazelwood, Missouri
63042

Attn:
George Kegler, Interim President Multisource

 
and
VIP, Finance

   
           
           
           
           
           
           
            Telephone:
314-654-6883

 

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with a copy
to: 

Mallinckrodt
LLC

325
McDonnell Boulevard

Hazelwood, Missouri
63042

Attn:
Jerad G. Seurer, Vice President and Group

General
Counsel

   
           
           
           
           
           
           
            Telephone:
(314) 654-3814

(e) This Agreement
shall be governed by and construed in accordance with the laws of
the State of New York, United States of America, without giving
effect to its conflict of laws provisions that might apply the law
of another jurisdiction.

(f) Unless and to the
extent there is already a dispute resolution mechanism provided
herein with respect to any dispute or controversy relative to one
or more specific issues that is expressly applicable to such
dispute or controversy, in the event of any dispute between the
parties, they will work in good faith to resolve any such dispute
as soon as possible through discussion and negotiation between
appropriate members of their executive management. In the event
that, within a reasonable period of time, not to exceed sixty (60)
days from and after the date when such dispute arises, they are
unable to resolve any such dispute, each party submits to the
exclusive jurisdiction of any court sitting in the State of New
York (but with preference for a United States federal court in the
Southern District of New York with appropriate subject matter
jurisdiction), in any action or proceeding arising out of or
relating to this Agreement. Each party will waive any defense of
inconvenient forum to the maintenance of any such action or
proceeding and waives any bond, surety, or other security that
might be required of any other party with respect thereto. Each
party will agree that a final judgment in any such action or
proceeding shall be conclusive and may be enforced anywhere in the
world by suit on the judgment or in any other manner provided by
law or in equity. Notwithstanding the preceding portions of this
subsection (f), including the immediately preceding sentence,
neither party shall not be precluded from filing a lawsuit or other
action with a court of appropriate jurisdiction in New York at any
time, for any legal or equitable remedy (including injunctive
relief), to redress any violation of Section 9 hereof.

(g) This Agreement,
together with the exhibits and appendices hereto, contains the
entire understanding of the parties with respect to the subject
matter hereof. All express or implied agreements and
understandings, either oral or written, heretofore made are
expressly merged in and made a part of this Agreement. This
Agreement may be amended, or any term hereof modified, only by a
written instrument duly executed by authorized representatives of
both parties hereto.

(h) The captions to the
several articles and sections hereof are not a part of this
Agreement, but are merely guides or labels to assist in locating
and reading the several articles and sections hereof.

(i) The waiver by a
party hereto of any right hereunder or the failure of a party to
object on any occasion to a breach or failure of performance by the
other party shall not be deemed a waiver of a party’s other
rights hereunder or its right, on any subsequent occasion, to
object to a breach by the other party of any terms hereof or to
insist upon the performance by the other party of its obligations
hereunder.

 

23

	
 CSK/Intellipharmaceutics
CommercializationAgr5

	
September 28,
2016

 

 

(j) This Agreement may
be executed in two or more counterparts, each of which shall be
deemed an original, but all of which together shall constitute one
and the same instrument.

(k) This Agreement will
not constitute or create any relationship of agency, partnership or
joint venture between Mallinckrodt and Intellipharmaceutics and
neither Mallinckrodt nor Intellipharmaceutics will have power to
incur any obligations on behalf of or to pledge the credit of the
other party in any manner whatsoever. No provision of this
Agreement is intended or shall be construed to benefit any third
party.

(l) Each party
acknowledges that: (i) it has had the opportunity to seek legal
counsel with respect to the negotiation and drafting of this
Agreement, (ii) the terms of this Agreement are the result of
arms’ length negotiations, and (iii) the terms of this
Agreement shall not be construed against either party as the
drafter.

(m) Neither party will
issue any press release or make any other public disclosure of the
nature of or existence of this Agreement without the prior written
consent of the other party; provided that, either party may make
such disclosure of the nature and existence of this Agreement as
its counsel shall determine, in the exercise of reasonable
judgment, is legally required.

IN
WITNESS WHEREOF, the parties have executed this Agreement as of the
date first set forth above.

INTELLIPHARMACEUTICS
CORP.

By:
/s/ Amina
Odidi

MALLINCKRODT
LLC

By:
/s/ Matthew
Harbaugh

 

24

	
 CSK/Intellipharmaceutics
CommercializationAgr5

	
 September 28,
2016

 

 

Location of Defined Terms

 

	

Term

 

	

Location

 

	

Agreement

	

Preamble

	

ANDA

	

Section
1(b)

	

Annual
Standard Cost Notice

	

Section
6(d)

	

Calculation
Principles

	

Section
6(d)

	

Competing
Product

	

Section
8(b)(xi)

	

Contract
Year

	

Section
2

	

Cost of
Goods Sold

	

Section
3(b)

	

Defective
Product

	

Section
7(a)

	

Effective
Date

	

Preamble

	

Exclusive
Market

	

Section
1(a)

	

Facility

	

Section
5(a)

	

Indemnitee

	

Section
10(c)

	

Indemnitor

	

Section
10(c)

	

Information

	

Section
9(a)

	

Intellipharmaceutics

	

Preamble

	

Mallinckrodt

	

Preamble

	

Negative
SKU Balance

	

Section
3(b)

	

Net
Sales

	

Section
3(b)

	

Product
One

	

Section
1(a)

	

Product
SKU

	

Section
3(b)

	

Product
Three

	

Section
1(a)

	

Product
Two

	

Section
1(a)

	

Product,
Products

	

Section
1(a)

	

Quarterly
Aggregate Standard Margin Payments

	

Section
3(b)

	

Quarterly
Report

	

Section
3(d)

	

Quarterly
Standard Margin Payment

	

Section
3(b)

	

Standard
Cost

	

Section
6(d)

	

Standard
Cost Calculation

	

Section
4(a)

	

Standard
Margin

	

Section
3(b)

	

Transfer
Price

	

Section
6(a)

 

 

25

	
 CSK/Intellipharmaceutics
CommercializationAgr5 

	
 September 28,
2016

 

Schedule
1

Mallinckrodt Fiscal
Quarter End Dates

 

 

 

JDE
Period End

Dates

	
 

	
 

	
 

	
 

	
 

	

Leap Year

	
 

	
 

	
 

	

Leap Year

	
 

	
 

	

Period

	

Day

	

Calendar 2017

	

Calendar 2018

	

Calendar 2019

	

Calendar 2020

	

Calendar 2021

	

Calendar 2022

	

Calendar 2023

	

Calendar 2024

	

Calendar 2025

	

Calendar 2026

	

3

	

Friday

	

03/31/17

	

03/30/18

	

03/29/19

	

03/27/20

	

03/26/21

	

04/01/22

	

03/31/23

	

03/29/24

	

03/28/25

	

03/27/26

	

6

	

Friday

	

06/30/17

	

06/29/18

	

06/28/19

	

06/26/20

	

06/25/21

	

07/01/22

	

06/30/23

	

06/28/24

	

06/27/25

	

06/26/26

	

9

	

Friday

	

09/29/17

	

09/28/18

	

09/27/19

	

09/25/20

	

09/24/21

	

09/30/22

	

09/29/23

	

09/27/24

	

09/26/25

	

09/25/26

	

12

	

Friday

	

12/29/17

	

12/28/18

	

12/27/19

	

12/25/20

	

12/31/21

	

12/30/22

	

12/29/23

	

12/27/24

	

12/26/25

	

12/25/26

	
 

	
 

	
 

	
 

	
 

	
 

	

53weeks

	
 

	
 

	
 

	
 

	
 

 

 

 

EXHIBIT
A

Products
Specifications

[*]

[Redacted in its entirety—1 page
omitted]

*Omitted and filed
separately with the Securities and Exchange Commission under a
request for confidential treatment.

 

 

 

EXHIBIT
B

Quality
Agreement

[*]

[Redacted in its entirety—32 pages
omitted]

*Omitted and filed
separately with the Securities and Exchange Commission under a
request for confidential treatment.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00267-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00267-of-00352.parquet"}], [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00267-of-00352.parquet"}], [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00267-of-00352.parquet"}], [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00267-of-00352.parquet"}]]