CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. [*****] indicates the redacted confidential portions of this...
EXHIBIT
4.52
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT
BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD LIKELY CAUSE
COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.
2
[*****]
indicates the redacted confidential portions of this
exhibit.
THIS LICENSE AND COMMERCIAL SUPPLY AGREEMENT
(“Agreement”) is
made and entered into as of November 1, 2019 (“Effective Date”), by and among
Tris Pharma, Inc, with offices at ▇▇▇▇ ▇▇ ▇▇ ▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇, ▇▇
▇▇▇▇▇ (“Tris”)
and Intellipharmaceutics Corp, with offices at ▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇,
▇▇▇▇▇▇▇, ▇▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇▇ (“IPC”), with respect to the
manufacture, supply, sales, licensing and distribution of the
generic pharmaceutical Product set forth below. Tris and IPC are
sometimes hereafter referred to individually as a
“Party” and
collectively as the “Parties.”
RECITALS
WHEREAS, Tris and its subsidiaries are
engaged in the sale, marketing and distribution of generic
pharmaceutical products; and
WHEREAS, IPC is engaged in the
development, manufacturing and supply of pharmaceutical products;
and
WHEREAS, IPC desires to manufacture and
supply Tris the Product for sale in the Territory (as defined
below);
NOW, THEREFORE, in consideration of the
foregoing premises, and the mutual covenants and obligations set
forth herein, Tris and IPC hereby agree to be legally bound as
follows:
ARTICLE
1 –
DEFINITIONS
1.1 “Act”
means the United States Federal Food, Drug, and Cosmetic Act, as
amended, and regulations promulgated thereunder.
1.2 “AG
Product” means any product, other than the Innovator
Product, promoted, distributed, marketed, offered for sale and/or
sold as a branded or non-branded generic product under or pursuant
to the Innovator Pharmaceutical Company’s approved New Drug
Application filed with the FDA pursuant to and under 21 U.S.C.
Section 355(b) of the Act, for the Innovator Product.
1.3 “API”
means the bulk active pharmaceutical ingredient for the
Product.
1.4 “Adulterated
Product” means product which is adulterated or
misbranded within the meaning of the Act or an article which may
not be introduced into interstate commerce in the United States
under the provisions of Sections 404 or 505 of the
Act.
1.5 “Affiliate”
means any Person who owns, is owned by or is under common ownership
with another Person. For the purposes of this definition, the term
“owns” (including, with correlative meanings, the terms
“owned by” and “under common ownership
with”) as used with respect to any Party, shall mean the
possession (directly or indirectly) of more than 50% of the
outstanding voting securities or other equity or voting interest of
a Person.
1.6 “ANDA”
means an Abbreviated New Drug Application pursuant to the Act and
all Applicable Laws.
1.7 “Anticipated
Inability to Deliver” has the meaning set forth in
Section 3.11.
1.8 “Applicable
Laws” means all laws, rules and regulations that are
applicable to the manufacture, import, use, offer to sell, sale or
distribution of the Product in the Territory or the performance of
either Party’s obligations under this Agreement, including
(but not limited to) the Act and the PDMA.
1.9 “cGMP”
means current Good Manufacturing Practices promulgated by the FDA
as the same may be amended from time to time, and their equivalent
promulgated by the governing health authority of any other country
in which the Product is manufactured by IPC under this
Agreement.
1.10 “Commercially
Reasonable Efforts” means a Party’s reasonable
efforts and diligence in manufacturing, supplying and
commercializing the Product in accordance with its business, legal,
medical and scientific judgment, such reasonable efforts and
diligence to be in accordance with the efforts and resources the
Party would use for a product owned by it or to which it has
rights, which is of similar market potential at a similar stage in
its product life, taking into account the competitiveness of the
marketplace, the proprietary position of the compound, the
regulatory structure involved, the profitability of the applicable
Product, and other relevant factors.
1.12 “Confidential
Information” has the meaning set forth in Section 12.1
hereof.
1.13 “Control”
means, with respect to Intellectual Property Rights, the possession
of the ability by ownership, license or otherwise (other than by
operation of the license and other rights pursuant to this
Agreement) to freely assign or grant a license or sublicense or
disclose as provided for herein under such Intellectual Property
Rights without violating the terms of any agreement or other
arrangement, express or implied, with any Third Party.
1.14 “Cover”
has the meaning set forth in Section 3.11.
1.15 “Excess
Order” has the meaning set forth in Section
3.3.
1.16 “Expiry
Dating”. The date as on each Certificate of Analysis
and Label, until which the Product is good for sale, dispensing and
use, determined based on the stability data as per cGMP
guidelines.
1.17 “FDA”
means the United States Food and Drug Administration, and any
successor agency thereto.
1.18 “Freight
Charges” has the meaning set forth in Section
3.4
1.19 “GDUFA
Fees” shall mean the fees imposed under the Generic
Drug Users Fee Act and the Generic Drug User Fee Amendments of
2012, as amended to date or as further amended.
1.20 “Generic
Equivalent” means a generic pharmaceutical product
that is therapeutically equivalent to the Innovator Product, where
“therapeutically equivalent” means: an AB rating is
assigned to such product’s entry in the list of drug products
with effective approvals published in the then-current edition of
FDA’s publication “Approved Drug Products with Therapeutic
Equivalence Evaluations” and any current supplement to
the publication (also known as the “Orange Book”)
referred to in 21 C.F.R. 314.3 and such product is covered by an
ANDA.
1.21 “Indemnified
Party” has the meaning set forth in Section10.4
hereof.
1.22 “Indemnifying
Party” has the meaning set forth in Section 10.4
hereof.
1.23 “Innovator
Pharmaceutical Company” means the holder of any
approved NDA or ANDA for such Innovator Product, including, its
successors and assigns.
1.24 “Innovator
Product” means Effexor XR having Venlafaxine
Hydrochloride as its active ingredient, or if Effexor XR is no
longer the product which serves as the reference listed drug then
the product which serves as the reference listed drug for the
Product.
1.25 “Intellectual
Property Rights” means Know-How, registered
trademarks, trademark applications, unregistered trademarks, trade
dress, copyrights, and Patent Rights.
1.26 “Invoice”
means a statement of the amount in US dollars due for a list of the
Product supplied or services provided that is presented for
payment.
1.27 “Know-How”
means any information related to the product formulation and all
technology and all technical and clinical information, data and
know-how related to the development, formulation, manufacture or
use of a product, including (but not limited to), trade secrets,
designs, research and development, methods, techniques,
derivations, processes, formulations, dosage forms, concepts,
ideas, preclinical, clinical, biological, chemical,
pharmacological, toxicological, pharmaceutical or other data,
validation information, stability history, testing methods and
results, experimental methods and results, product specifications,
assays, in vitro data, in vivo data, material and product
information, test methods for raw materials, components,
work-in-process and finished product, stability, descriptions,
specifications, scientific plans, depictions, discoveries, new
technologies, product ideas, modifications, improvements and
extensions, equipment, medical support information (including data
bases), and any other written, printed, electronically stored or
humanly perceivable information and materials, including
combinations or applications thereof, data summaries and
compilations of data, whether or not patentable, relating to the
development, manufacture, importation or use of a
product.
1.28 “Label,”
“Labeled” or “Labeling” means all
labels and other written, electronic, printed or graphic matter
upon (i) a Product or any container or wrapper utilized with the
Product, or (ii) any written material accompanying a Product,
including, without limitation, package inserts.
1.29 “Market
Share” means the number of capsules of Product
(aggregating all strengths) sold by Tris, its Affiliates, its
distributors, wholesalers and sublicensees divided by the total
number of capsules of Generic Equivalents of Innovator Product
(other than AG Product or the Innovator Product) in 37.5, 75 and
150 mg strengths sold by Tris and others in the
Territory.
1.30 “Materials”
has the meaning set forth in Section 4.5.
1.31 “Minimum
Period” has the meaning set forth in Section
3.7.
1.32 “NDA”
means a New Drug Application filed with the FDA pursuant to and
under 21 U.S.C. Section 355(b) of the Act.
1.33 “Net
Profits” has the meaning set forth in Section
4.7.
1.34 “Net
Sales” has the meaning set forth in Section
4.4.
1.35 “Packaging”
or “Package”
means all primary containers, including bottles, blisters, cartons,
shipping cases or any other like matter used in packaging or
accompanying a Product.
1.36 “Patent
Rights” means patents issued by and patent
applications filed with the U.S. Patent and Trademark Office, the
Canadian Intellectual Property Office, or other similar
governmental intellectual property administration agencies, and all
divisionals, continuations, continuations in part, reissues,
extensions, supplementary protection certificates and foreign
counterparts thereof.
1.37 “PDMA”
means the Prescription Drug Marketing Act, as amended, and rules
and regulations promulgated thereunder, as in effect from time to
time.
1.38 “Person”
means an individual, a corporation, a general partnership, a
limited partnership, a limited liability company, a limited
liability partnership, an association, a trust or any other entity
or organization, including a governmental entity.
1.39 “Production
Facility” means the facility of IPC located at
Toronto, Canada and
all the equipment therein, including without limitation, all
equipment used in the manufacture, processing, production,
packaging, handling, storage, holding, labeling, testing,
analyzing, sampling, shipping and release of the Product
therein.
1.40 “Product(s)”
means the Venlafaxine ER capsules approved by the FDA under the
Product ANDA, which is the therapeutic equivalent of the Innovator
Product, in all strengths thereof, as set forth in Exhibit A hereto as
manufactured in accordance with the IPC ANDAs.
1.41 “Product
ANDA” means ANDA #: 201272, as the same may be
supplemented or amended from time to time.
1.42 “Product
Warranties” has the meaning set forth in Section
5.1.
1.43 “Profit
Share Statement” has the meaning set forth in Section
3.9.
1.44 “Purchase
Order” has the meaning set forth in Section 3.3
hereof.
1.45 “Regulatory
Approval” means the license or marketing approval by
the FDA that is necessary as a prerequisite for marketing the
Product in the Territory.
1.46 “Rejection
Notice” has the meaning set forth in Section
5.2(a).
1.47 “Selling
Price” has the meaning set forth in Section
4.3.
1.48 “Selling
& Distribution Costs” has the meaning set forth in
Section 4.6.
1.49 “Specifications”
means the specifications for each Product as included in the ANDA
for the Product.
1.50 “Standard
Operating Procedures” means process, steps and
procedures as documented for each activity including but not
restricted to sourcing, manufacturing, packaging, testing,
labeling, storage, supply, handling of the Product at all stages
through the value chain.
1.51 “Statement
of Work” means a description, agreed upon by both
Parties, of auditor responsibilities and work-product delivery
deadlines, as well as a reasonable description of the types of
documents or data which may be reviewed and personnel who may be
interviewed, in undertaking an audit pursuant to this
Agreement.
1.52 “Territory”
means the United States of America, its territories, possessions
and military bases, and the Commonwealth of Puerto
Rico.
1.53 “Third
Party” means a Person other than Tris, IPC and their
respective Affiliates.
1.54 “Transfer
Price” means the prices Tris shall pay IPC for the
Product(s) as set forth in Section 4.5 and Exhibit B hereto.
1.55 “Valid”
means, with respect to Patent Rights in a particular country, such
Patent Rights have not (A) expired or been cancelled, (B) been
declared invalid or unenforceable by a decision of a court or other
appropriate body of competent jurisdiction, from which no appeal is
or can be taken, (C) been admitted to be invalid or unenforceable
through reissue, disclaimer or otherwise, or (D) been abandoned or
disclaimed either affirmatively or by operation of
law.
ARTICLE
2–
LICENSE, PRODUCT & TERM
2.1 License.
Subject to the terms and limitations set forth herein, IPC hereby
grants to Tris an exclusive right and license (even as to IPC and
its Affiliates), with the right to sublicense to an Affiliate
and/or, subject to the prior approval and written consent of IPC
(which consent shall not be unreasonably withheld, delayed or
conditioned) to a Third Party (provided that no sublicense of
rights by Tris in accordance with this Agreement shall relieve Tris
of any liability or obligation to IPC hereunder) to use,
distribute, offer for sale, sell, have sold, have offered for sale
and commercialize the Product in the Territory, including, without
limitation, through wholesalers, distributors, sublicensees and
resellers during the Term. The rights granted herein shall include
a license to Intellectual Property Rights Controlled by IPC, for
the Territory, which are necessary or desirable to distribute the
Product in the Territory. IPC will maintain all ownership of the
Product and responsibility to manufacture the Product as per cGMP
and delivery of the Product to Tris. The foregoing rights will be
co-terminus with this Agreement and, subject to any specific
provisions set forth in Section 11.5 [(Surviving Terms]), 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 Tris hereunder be interpreted to permit
Tris to sell Product outside of the Territory.
2.2 Non-Compete.
IPC and its Affiliates shall not, and shall not negotiate to or
agree to, (1) develop, file for Regulatory Approval, acquire,
license, manufacture anywhere for use in the Territory, or (2)
market or otherwise commercialize in or for the Territory, any
pharmaceutical product that is (A) a Generic Equivalent to the
Innovator Product (excluding the Product subject to this
Agreement), (B) the Innovator Product, or (C) an AG Product, either
alone or with a Third Party (each, a “Competing Product”), from the
Effective Date until the earlier of (i) the expiration of the Term
or the termination of this Agreement or (ii) Tris’ license
has become nonexclusive pursuant to Section 4.2.
2.3 Exclusivity.
During the Term, Tris will exercise Commercially Reasonable Efforts
to successfully launch and sell the Product in the Territory on an
exclusive basis, meaning Tris shall not sell another Generic
Equivalent to the Innovator Product, except pursuant to Section
3.11 or if the IPC license grant to Tris has become
non-exclusive.
2.4 Term
of Agreement. The initial term (“Initial Term”) of this Agreement
shall be five (5) year from the Effective Date. Thereafter this
Agreement shall automatically renew for successive two-year terms
(each, a “Renewal Term”, and together with the Initial
Term, the “Term”) unless one party notifies
the other of its intent to terminate the agreement, for
convenience, on no less than 180 days advance written
notice..
ARTICLE
3 –
MANUFACTURE, FORECASTS, PURCHASE ORDERS AND SUPPLY
3.1 Subject
to the terms and conditions of this Agreement, from and after the
Effective Date and during the Term, IPC shall use Commercially
Reasonable Efforts to timely manufacture, Label, Package and supply
Tris’, its sublicensees’ and their respective
Affiliates’ requirements of Product, for use and marketing in
the Territory in accordance with Tris’ Purchase Orders, the
Specifications, cGMP requirements and all other Applicable
Law.
3.2 Forecasts.
On or before the tenth (10th) day of every
calendar month during the Term, Tris shall share a rolling twelve
(12) month forecast (each a “Forecast”) of the Product which
forecasts Tris’, its sublicensees’ and their respective
Affiliates’ requirements for each strength of the Product
commencing the first full month after the date of the Forecast, of
which only the first three (3) months would be binding and would be
confirmed with a formal Purchase Order.
3.3 Purchase
Orders. During the Term, Tris shall make all purchases
hereunder by submitting firm purchase orders to IPC (a
“Purchase
Order”). Each such Purchase Order shall be in writing
in a form reasonably acceptable to IPC, and shall specify the
Product ordered, the quantity ordered, the Transfer Price, the
required delivery date thereof, which shall be no later than ninety
(90) days after the date of Purchase Order unless otherwise agreed
upon in writing by IPC. IPC shall confirm acceptance of the PO in
writing within five (5) business days and IPC shall supply to Tris,
Product ordered pursuant to such Purchase Orders on the requested
delivery date at the Production Facility. In the event of a
conflict between the terms and conditions of any Purchase Order and
this Agreement, the terms and conditions of this Agreement shall
prevail. The quantities contained in Purchase Orders for a Product
to be delivered during any one month period shall not exceed
[*****] percent ([*****]%) of the amounts set forth in the
immediately preceding forecasts for such Product for the same time
period (an “Excess
Order”), unless Tris
has obtained IPC’s prior written consent for such Excess
Orders which consent shall not be unreasonably withheld,
conditioned or delayed. IPC shall respond to any request by Tris
for an Excess Order within ten (10) business days of a written
request from Tris. Such response shall indicate the amount of the
Excess Order, if any, that IPC will manufacture and deliver. IPC
will use commercially reasonable efforts to fill an Excess Order as
promptly as practicable, but will not be in breach hereof if,
notwithstanding such efforts, it will be unable to fill such Excess
Order.
3.4 Freight
Charges. All freight, insurance charges, export and other
custom duties, other charges applicable to the sale and transport
in Temperature Controlled Containers of Product purchased by Tris
hereunder (collectively, “Freight Charges”), from the
Production Facility to Tris’ designated US facility shall be
negotiated for and paid by Tris.
3.5 Delivery
of Product. On the applicable delivery date contemplated in
a Purchase Order, IPC shall deliver the Product(s) in its final
packaged form to the carrier selected by Tris at the Production
Facility. The Product shall be shipped by IPC to Tris by such
method as Tris shall reasonably designate. Tris shall be
responsible for the selection of the carrier and if Freight Charges
are paid by IPC (which it is under no obligation to pay), such
charges shall be promptly reimbursed by Tris upon written request,
which request shall be accompanied by all relevant supporting
documentation. Title to any shipped Product sold hereunder shall
transfer to Tris and Tris shall bear all risk of loss with respect
to shipped Product when delivered by IPC to the carrier designated
by Tris. Tris shall be solely responsible for proper storage of the
Product in accordance with applicable specifications once the
Product has been delivered, but IPC shall be solely responsible for
all pre-shipment quality assurance testing and/or release of the
Product for distribution, in accordance with all Applicable Laws.
For clarity, Tris shall pay for all Freight Charges.
3.6 Expiry
Dating. All Product delivered by IPC pursuant to this
Agreement shall have, upon delivery to the carrier in accordance
herewith, the greater of either [*****] percent ([*****]%) of its
maximum approved shelf life OR at least twenty (20) months of shelf
life remaining in accordance with the ANDA (“Minimum Period”); except, however,
where Tris has authorized in writing, in advance, the shipment of a
Product that does not meet the Minimum Period.
3.7 Invoicing.
Upon shipment of Product, IPC shall submit invoices therefor to
Tris. All invoices shall be in US Dollars and, to the extent the
terms of any invoice submitted by IPC or any Purchase Order
submitted by Tris conflict with the terms of this Agreement, the
terms of this Agreement shall prevail and be binding upon the
Parties.
3.8 Payment.
Payment terms shall be as follows:
(a) Tris shall pay each
invoice in full within thirty (30) days after the date of receipt
of invoice, except that Tris shall pay for Product within thirty
(30) days of the later of receipt of invoice or delivery of the
Product to which the invoice relates to Tris’ carrier in
accordance with Section 3.5.
(c) Within
thirty (30) days of the end of each calendar quarter, Tris shall
provide a Profit Share Statement (the “Profit Share Statement”) and Tris
shall remit to IPC, IPC’s share of Net Profits along with the
Profit Share Statement within ten (10) business days of the
calculation of the “Profit
Share Statement” for the quarter; provided, that if
Net Profits are negative for any fiscal quarter, such negative
profits shall be carried forward (and deducted from Net Profits for
any subsequent fiscal quarters prior to the Parties sharing the
balance of Net Profits, if any). If IPC’s share of negative
profits continues for two (2) consecutive calendar quarters, Tris
may deduct such negative profits from payments owed for Transfer
Price or any other amounts owed to IPC. If IPC’s share of
negative Net Profits (including carryforwards) has not been repaid
or offset on or before termination or expiration of this Agreement,
then IPC shall pay to Tris, IPC’s share of such negative Net
Profits within thirty (30) days of Tris’ delivery of an
invoice therefor and reasonable and customary supporting
documentation. The Profit Share Statement shall be consolidated to
clearly reflect Net Profits (whether positive or negative) from
Tris and each Tris Affiliate and Third Party sublicensee, if any,
consistent with U.S. GAAP, and in a form reasonably acceptable to
IPC.
3.9 Currency.
All Purchase Orders, Invoice and payments will be in United States
Dollars (US$) and shall be paid by international wire transfer of
immediately available funds, using the banking advice attached at
Exhibit
E.
3.10 Failure
to Supply. If IPC is unable (or anticipates an inability) to
manufacture or deliver all or a portion of a Product to Tris as
required by a confirmed or accepted Purchase Order pursuant to
Section 3.3 of this Agreement, IPC shall promptly notify Tris in
writing of the period for which such inability (or anticipated
inability) to so manufacture or deliver is expected (an
“Anticipated Inability to
Deliver”). For avoidance of doubt, so long as IPC uses
Commercially Reasonable Efforts and the anticipated inability is a
force majeure event, IPC shall not be in breach of the Purchase
Order(s) affected nor this Agreement, however, regardless of
whether or not IPC has breached a Purchase Order or this Agreement
it shall still be liable for Cover and the other obligations set
forth in this Section 3.10. In the event IPC is unable to meet
Tris’s Purchase Orders or IPC issues a notice of an
Anticipated Inability to Deliver, IPC’s obligation to supply
shall continue but Tris’ obligation to purchase the Product
that IPC is unable to timely supply in accordance with Section 3.3
above shall be suspended and Tris, without relieving IPC of its
obligations under Section 3.3, may mitigate its damages by
purchasing from another Person the quantity of substitute product
that it requires beyond what IPC is able to deliver. Tris shall use
Commercially Reasonable Efforts to obtain such substitute product
at a reasonable price and communicate same to IPC in writing. Tris
shall be entitled to deduct the difference in cost paid by Tris for
such substitute product over the cost of the Product
(“Cover”), if
any, from any amounts otherwise payable to IPC hereunder, and, to
the extent not so offset, IPC shall reimburse Tris for such Cover ,
within thirty (30) days of receipt of invoice from Tris. IPC will
not be entitled to any share of positive Net Profits for sale of
substitute product not sourced by Tris from IPC hereunder (provided
IPC shall continue to fund its share of negative Net Profits),
except to the extent IPC has fully reimbursed Tris for the Cover
expense with respect to such product. If at any time thereafter
during the Term, IPC is able to timely deliver Product in
satisfaction of Tris’ Purchase Orders, IPC shall so notify
Tris in writing and, subject to Tris’ contractual commitments
to third parties, Tris shall undertake commercially reasonable
efforts to limit such contractual commitment in order not to exceed
IPC’s volume and period it is unable to supply, Tris will
resume purchasing the Product from IPC. If IPC’s inability to
timely deliver to Tris the quantity of the Product described in
this Section 3.3 continues for a period beyond three (3) months,
Tris may terminate this Agreement upon thirty (30) days’
notice in writing to IPC. IPC shall reimburse Tris for any failure
to supply and late supply penalties and/or damages charged to Tris
for late supply or non-supply caused by IPC’s failure to
timely supply Product pursuant to Purchase Orders delivered to IPC
in accordance with this Agreement. For clarity and audit purposes,
such failure to supply penalties shall be supported by appropriate
invoices detailing the failure to supply penalties issued by the
affected customers and wholesallers of Tris. IPC shall reimburse
Tris for such penalties and damages, within ten (10) days of
receipt of invoice for same from Tris, provided that if such
invoice is not timely paid, Tris may at its option offset such
amounts owed against other amounts payable by Tris to
IPC.
3.11 Safety
Stock. During the Term, IPC will maintain a minimum
inventory of Materials equal to the Materials required to produce
an amount of Product equal to the average quantity of Product
required for the next [*****] ([*****]) months as set forth in
Tris’ latest Forecast, And Tris shall maintain at all times
at least [*****] ([*****]) months safety stock of
Product.
ARTICLE
4 –
SALES, MARKETING ALLOWANCE AND PROFIT SHARE
4.1 Marketing.
Tris shall use Commercially Reasonable Efforts during the term of
this Agreement to market, sell and distribute the Product in the
Territory.
4.2 Tris
Sales Responsibilities. For all Product sales, Tris shall
have the sole right and the obligation to (1) receive, accept and
fill orders for the Product; (2) distribute the Product to
customers; (3) control invoicing, order processing and collection
of accounts receivable for Product sales; (4) record Product sales
in its book of account; (5) payment and reconciliation of the
proper profit sharing allocation among the Parties hereto; and (6)
use Commercially Reasonable Efforts to gain and maintain an annual
minimum unit Market Share of [*****] percent ([*****]%) Venlafaxine
ER based on prescriber volume in the Territory, as reported by
IQVIA (or SYMPHONY if IQVIA is not reporting). Failure to maintain
such minimum Market Share on an annual basis for [*****] ([*****])
consecutive [*****] month periods, each ending on or after the
second anniversary of the Effective Date, shall not be a breach of
this Agreement, provided that, on thirty (30) days’ written
notice by IPC to Tris within sixty (60) days of such event,
notwithstanding anything to the contrary contained herein: (i)
Tris’ license under Section 2.1 shall become nonexclusive;
(ii) Sections 2.2 and 2.3 shall no longer apply; (iii) Tris may
source Generic Equivalents from other vendors and such Generic
Equivalents shall not be Products hereunder and IPC shall not be
entitled to Net Profits generated from sales thereof; and (iv) Tris
shall be relieved of the obligation to use Commercially Reasonable
Efforts to maintain any Market Share or sell Product. In no
circumstance shall Tris permit the sale of the Product to be a loss
leader.
4.3 Selling
Price. Tris shall have sole discretion in setting the
customer pricing for the sale of the Product in the Territory
(“Selling
Price”).
4.4 Net
Sales. In this Agreement, the term “Net Sales” means, with respect to
the Product for any period, the total gross amount of sales (i.e.,
the number of units shipped times the invoiced price, cash
equivalent or other consideration per unit) invoiced by Tris, its
Affiliates, and authorized Third Party sublicensees for the sale of
the Product in the Territory during such period, less each of the
following to the extent paid or incurred by Tris, its Affiliates or
Third Party sublicensees:
(a) The amount of
chargebacks, rebates and fees or commissions paid to any Third
Party, promotional allowances, coupons, normal quantity discounts,
cash discounts actually granted, discounts to patients, customers
and/or payers, allowed or incurred in the ordinary course of
business in connection with the sale of the Product and allowance
for doubtful accounts and bad debt written off;
(b) sales and excise
taxes, and any other taxes, all to the extent added to the sale
price and paid by the selling party and not refundable in
accordance with applicable law and without reimbursement from any
Third Party (but not including taxes assessed against the income
derived from such sale);
(c) freight, insurance
and other transportation charges from Tris to its customers to the
extent added to the sale price and set forth separately as such in
the total amount invoiced and without reimbursement from any Third
Party; and Freight Charges as per 3.6.
(d) amounts to be paid
or credited by reason of rejections, defects, recalls or returns or
because of retroactive price reductions; and
(e) rebates or
allowances actually granted or allowed to group purchasing
organizations, managed health care organizations and to
governments, including their agencies, or to trade customers, in
each case that are not Affiliates of Tris.
(f) The monthly
allocated pharmacovigilance expense pertaining to the Product that
is paid by Tris, if any, pursuant to Section 7.4 of this
Agreement.
The
calculation of Net Sales shall be made in accordance with U.S.
GAAP, applied by Tris in a manner consistent with its other generic
Product, and based on, or valued as if based on, bona fide
arms’ length transactions and not on any loss-leading selling
or transfer price. Sales between or among Tris, its permitted
sublicensees and their respective Affiliates, shall be excluded
from the computation of Net Sales, but shall be included in Net
Sales upon first sale to a Third Party, provided that sales for end
use by such sublicensees and Affiliates shall be at the same price
as in a bona fide arms’ length transaction.
In no
event will any particular amount identified above be deducted more
than once in calculating Net Sales (i.e., no “double counting”
of deductions).
Product
shall be considered “sold” when billed or
invoiced.
4.5 Transfer
Price. The initial Transfer Price shall be as set forth in
Exhibit B. At any
time either Party may request a review of the Transfer Price, if in
its reasonable judgment the Selling Price of the Product cannot
support the level of Transfer Price or if the Transfer Prices are
not commercially viable. In connection with such review the Parties
will review and adjust Transfer Price. The Transfer Price may not
be raised without Tris’ prior written consent. In connection
with such review, the Parties shall consider the Selling Price, IPC
or its Affiliate’s fully burdened costs in manufacturing or
acquiring the Materials, the manufacturing, testing and analysis of
the finished dosage of the Product, labeling, packaging including
Direct Labor and Benefits and Overhead all determined in accordance
with International Financial Accounting Standards. Transfer Price
shall not include any allocation or absorption of excess or idle
capacity or any costs attributable to failed batches or Product
which do not comply with the relevant Product manufacturing
requirements, except as provided in the definition of Overhead.
“Direct Labor and
Benefits” means that portion of basic wages, labor and
related payroll taxes and employee benefits spent in production and
quality control of the Product which are directly related to the
Product and charged to the manufacturing and supply of the Product,
all determined in accordance with International Financial
Accounting Standards. “Materials” shall mean all
materials and pharmaceutical ingredients, including API, required
for the manufacturing, labeling and packaging of the Product.
“Overhead” means
all customary and usual operating expenses directly related to the
Product incurred by and in support of the particular manufacturing
cost centers, purchasing department and quality assurance
operations, related to the Product (including labor related payroll
taxes and employee benefits), depreciation, general taxes, rent,
repairs and maintenance, supplies, utilities and factory
administrative expense. Overhead shall include a reasonable
allocation of idle Production Facility charges, provided the
Production Facility shall be presumed to be operating at a level of
at least [*****]v ([*****]%) capacity (based on one
shift).
(a) At any time, Tris
may request a review of the Transfer Price, if in its reasonable
judgement the Selling Price of the Product cannot support the level
of Transfer Price. In connection with such review the Parties will
negotiate in good faith a reduction in Transfer Price, provided
that neither Party shall be obligated to agree to any such
reduction. At any time, IPC may request a review of the Transfer
Price, if in its reasonable judgement it has incurred material
increases in its costs of manufacturing a Product. In connection
with such review the Parties will negotiate in good faith an
increase in Transfer Price, provided that neither Party shall be
obligated to agree to any such increase. Neither Party shall
request a review more than twice per year.
(b) The Parties may
conduct a review of the Transfer Prices and adjust such price to
meet market requirements. The prices shall be subject
to review as and when there is change +/- [*****]% change in
the minimum Net Sales Price of Tris or the manufacturing costs of
IPC, but not more than twice (2) a year during the
Term.
4.6 Selling
& Distribution Expense. Tris will be allowed a fixed
[*****] ([*****]%) percent of Selling Price of Product as allowable
selling and distribution expense (“Selling & Distribution Costs”)
to meet all storage, selling, distribution and other related costs
associated with marketing, sales and distribution of the
Product.
4.7 Net
Profits. In this Agreement, the term “Net Profits” shall equal Net Sales
in a given period less the sum of the following in respect of such
period: (a) Transfer Price or amounts payable to a Person other
than IPC with respect to the supply of Product and (b) Selling
& Distribution Costs as described in Section 4.6.
4.8 Profit
Sharing. The Parties shall split Net Profits for the
distribution of the Product in the Territory, in the ratio of
[*****] percent ([*****]%), collectively, to IPC and each IPC
Affiliate, and [*****] percent ([*****]%), collectively, to Tris
and each Tris Affiliate and Third Party sublicensee.
Tris
shall manage, administer and collect from each Tris Affiliate and
Third Party sublicensee, if any, the profit share from Net Profits
due to IPC and any IPC Affiliate hereunder, and tender the profit
share to IPC, along with reporting thereon in a Profit Share
Statement, within the time periods required in the Section
captioned “Payments” hereunder.
4.9 Audit
Rights.
(a) IPC and its
Affiliates shall maintain complete and accurate records in
reasonably sufficient detail to permit Tris to confirm the accuracy
of the calculation of Transfer Price. Upon no less than fifteen
(15) days prior notice, such records shall be made available during
regular business hours, for a period of three (3) years from the
end of the calendar year to which they pertain, for examination,
not more often than once each calendar year, by an independent
certified public accountant selected by Tris and reasonably
acceptable to IPC, for the sole purpose of verifying the accuracy
of the IPC Invoices pursuant to this Agreement and subject to the
provision of and agreed Statement of Work for the auditor
(inclusive of any auditor’s fees and compensation guidelines)
by the parties to the selected auditor. Audits shall be undertaken
in a manner which does not disrupt IPC’s normal course of
business. Any such auditor shall enter into a confidentiality
agreement with IPC and shall not disclose IPC’s Confidential
Information, except to the extent such disclosure is necessary to
verify the accuracy of the financial reports furnished by IPC or
the amount of payments due from IPC to Tris under this Agreement.
Any amounts shown to be owed but unpaid shall be paid, and any
amounts showed to be overpaid will be refunded, within forty-five
(45) days from the accountant’s report. Tris shall bear the
full cost of such audit unless such audit discloses an underpayment
to or overpayment by Tris of more than $[*****], in which case IPC
shall bear the full cost of such audit.
(b) Tris, and each
Affiliate and Third Party sublicensee of Tris shall maintain
complete and accurate records in reasonably sufficient detail to
permit IPC to confirm the accuracy of the calculation of
IPC’s share of Net Profits and other amounts billed to IPC or
to which IPC is entitled (collectively, such records, which may
include reports, statements, notices, invoices and documents, are
referred to as “Tris
Statements”). Upon no less than fifteen (15) days
prior notice, such records shall be available during regular
business hours for a period of three (3) years from the end of the
calendar year to which they pertain for examination, not more often
than once each calendar year, by an independent certified public
accountant selected by IPC and reasonably acceptable to Tris, for
the sole purpose of verifying the accuracy of the Tris Statements
pursuant to this Agreement and subject to the provision of and
agreed Statement of Work (inclusive of any auditor’s fees and
compensation guidelines) by the parties to the selected auditor.
Audits shall be undertaken in a manner which does not disrupt
Tris’ normal course of business. Any such auditor shall enter
into a confidentiality agreement with Tris, or the germane
Affiliate(s) or Third Party sublicensee(s) and shall not disclose
Confidential Information, except to the extent such disclosure is
necessary to verify the accuracy of the financial reports furnished
by audited party or the amount of payments due from Tris or other
audited party to IPC under this Agreement. Any amounts shown to be
owed but unpaid shall be paid, and any amounts showed to be
overpaid will be refunded, within forty-five (45) days from the
accountant’s report. IPC shall bear the full cost of such
audit unless such audit discloses an underpayment to or overpayment
by IPC of more than $[*****], in which case Tris shall bear the
full cost of such audit.
ARTICLE
5 –
PRODUCT REPRESENTATIONS, LABELING, QUALITY AND
REJECTIONS
5.1 Product
Warranties, Authorizations and Quality
Assurance.
(a) Product Warranties. IPC
represents and warrants that the Product supplied to Tris pursuant
to this Agreement: (a) shall be manufactured, packaged, tested,
stored and handled in accordance with the Specifications, cGMPs,
all Applicable Laws and otherwise in accordance with all product
manufacturing requirements; (b) will meet and be capable of
maintaining the purity, potency and other product characteristics,
as contained in its Specifications and approved ANDA, until the
expiration date for the Product; and (c) will, at the time of the
delivery of the Product to Tris: (1) have a remaining shelf life of
at least the Minimum Period (as defined in Section 3.6 above) and
(2) not be Adulterated Product. IPC will make no changes in the
excipients, raw materials or packaging components thereof without
informing Tris at least three months in advance in writing and
without supplementing the Product ANDA. The foregoing text of and
representations and warranties in this Section 5.1(a) are referred
to as the “Product
Warranties”. Following delivery of the Product to
Tris, Tris shall handle, store and market the Product with the
skill and care reasonably expected of an experienced and competent
distributor of pharmaceutical products, consistent with cGMPs and
all Applicable Laws in the United States.
(b) Governmental Authorization
Responsibility. IPC shall be responsible for obtaining all
applicable regulatory state and local approvals for the manufacture
of the Product, for filing all periodic reports and notifications
as required by the regulatory authorities and for instituting and
maintaining such stability and sample retention programs as are
required by all Applicable Laws.
(c) Certificates of Analysis and
Certificate of Compliance. IPC shall provide Tris with a
certificate of analysis for each shipment of the Product
manufactured and supplied hereunder confirming that the Product in
such shipment has been tested in accordance with the
Specifications. The results of such testing shall accompany each
certificate of analysis. IPC shall also provide a Certificate of
Compliance stating that the Product manufactured batch, the methods
used, and the facilities and controls used for, the manufacture,
processing, packaging, labeling and in process and finished Product
controls conform with current good manufacturing processes in
accordance with applicable parts of 21 CFR parts 210 and 211 of the
Code of Federal Regulations and the Product
Warranties.
5.2 Product
Acceptance or Rejection.
(a) Product Rejection. Within
thirty (30) days
from the date of
receipt of delivery of a Product, Tris may inspect the Product
using generally accepted inspection methods to determine whether or
not the Product is acceptable and shall advise IPC in writing (a
“Rejection
Notice”) if such inspection shows that a shipment of
Product is not in conformity with the Specifications, in which case
IPC shall be obligated to take back the Product that is not in
conformity. If no Rejection Notice is provided by Tris within such
time periods, then Tris shall be deemed to have accepted the
shipment; except for defects not discovered or discoverable by Tris
in such inspection with the use of generally accepted inspection
methods (“Latent
Defects”) for which such Rejection Notice will be
provided within 30 days upon discovering the non-conformity. Any
Rejection Notice shall contain a reasonably detailed statement of
Tris’s reasons for rejection and shall be accompanied by a
report of any pertinent analysis performed by Tris or any licensee
on the allegedly nonconforming Product, together with the methods
and procedures used.
(b) IPC shall notify
Tris as promptly as reasonably possible, but in any event within
thirty (30) calendar days after receipt of a Rejection Notice,
whether it accepts the assertions of nonconformity made by or on
behalf of Tris. If Tris delivers a Rejection Notice in respect of
all or any part of a shipment of Product, then IPC and Tris shall
have sixty (60) days from the date of IPC’s receipt of
such notice to resolve any dispute regarding whether all or any
part of such shipment of Product fails to conform with the
Specifications thereof or is otherwise defective. Disputes between
the Parties as to whether all or any part of a shipment rejected by
Tris conforms with the Specifications that are not resolved in the
sixty (60) day period shall be resolved by an independent testing
laboratory or a consultant (if not a laboratory analysis issue),
which shall be selected by mutual agreement of both Parties. The
decision of the consultant or testing laboratory mutually agreed to
by the Parties shall be final and binding on the Parties. The cost
of the review or testing shall initially be paid by Tris, but if
IPC is not successful in such dispute as determined by such
independent testing laboratory or consultant, IPC will reimburse
Tris for the cost of such testing and analysis within
15 business days of receiving the results. If the independent
lab confirms the batch is in compliance, Tris will accept the
Product.
(c) In the event any
Product is appropriately rejected by Tris as aforesaid (being
Product which do not satisfy the Specifications, the Product
Warranties provided in Section 5.1(a) or are otherwise defective as
a result of any act by or omission of IPC or those for which IPC is
otherwise responsible), IPC shall replace such Product with
conforming goods within sixty (60) days or, if requested by Tris,
provide a credit to Tris for the Transfer Price (including Freight
Charges) of the Product shipment(s) in question. The credit shall
be provided immediately following the expiry of the period during
which IPC may dispute a Rejection Notice as discussed in Subsection
(b) above (unless the Rejection Notice is disputed by IPC, in which
event such credit shall only be given upon resolution of the
dispute). Tris may, at the cost and expense of IPC, destroy the
rejected Product or, at IPC’s request (to be made within
thirty (30) business days of the final determination hereunder that
the Product were appropriately rejected) and expense, return the
rejected Product to IPC, which costs and expenses shall be paid by
IPC to Tris within forty-five (45) days of the receipt of
Tris’s Invoice.
For
purposes of this Agreement, once a Product is rejected by Tris,
Tris’s obligation to pay for such Product shall be suspended
until such time as it is determined: by the independent testing
laboratory or consultant that the Product should not have been
rejected by Tris; or by the Parties’ mutual agreement. IPC
shall reimburse Tris within ten (10) business days the payments
related to the non-conforming Product if the independent testing
laboratory positively confirms the defects in case of Latent
Defects discovered after payments were made by Tris.
(d) Replacement of Product. In
accordance with the terms set forth in this Agreement, IPC shall
replace, at its sole expense, any Product that does not comply with
the Product Warranty in Section 5.1(a) or, at Tris’s
election, refund the Transfer Price thereof subject to the ruling
of the consultant or the independent testing
laboratory.
5.3 Labeling
and Packaging.
(a) Labeling. The Product sold or
offered for sale by Tris shall be labeled with Tris’s name,
trademarks and trade dress as per label artwork provided and paid
for by Tris, in a manner consistent with all applicable laws, rules
and regulations, in accordance with the requirements of the
approved Product ANDA and otherwise in a manner reasonably agreed
upon by the parties. In particular, it is agreed that the phrase
(“manufactured by Intellipharmaceutics”), shall be
evident on the packaging and labeling for the Product. Tris shall
not alter the labeling or package inserts associated with Product
that are received from IPC. IPC shall acquire all Labeling and
Packaging for the Product supplied to Tris under this Agreement.
IPC shall advise Tris in writing within ten (10) business days
should IPC be required by the FDA or other governmental agency or
authority to make any change in any such Label or Labeling,
including but not limited to DCSCA serialization and transfer of
data. Tris shall be responsible for the updating and approving of
all artwork and text associated with such change, provided that the
cost and expense of implementing such changes shall be borne by
IPC.
(b) Trademarks. Except as expressly
provided in the second sentence of Section 5.3(a), Tris shall own
and have exclusive rights to the trademarks related to the Product
Packaging. In connection with IPC’s performance of this
Agreement, Tris hereby grants to IPC the right to reproduce and
print on the Labeling and Packaging of the Product for the
Territory, Tris’s trademark, and/or other trademarks, trade
dress and/or trade names of Tris which Tris may designate in
writing from time to time. Tris reserves the right to review and
approve all uses by IPC of Tris’s trademarks and/or other
trademarks, trade dress and/or trade names of Tris as permitted
herein. The permission granted herein is restricted to the Product
supplied to Tris under this Agreement and extends only with respect
to the Product for the Term and for the period after the Term when
Tris is selling the Product in its possession. IPC shall
exclusively own all right, title and interest in and to IPC’s
name, logo and any IPC ▇▇▇▇ on the Labeling or Packaging. In
connection with the performance by Tris, a Tris Affiliate, or a
Third Party sublicensee of this Agreement, IPC hereby grants to
Tris and any Tris Affiliate and Third Party sublicensee the right
to reproduce and use in any sales collateral for sale of the
Product in the Territory, IPC’s trademark, and/or other
trademarks, trade dress and/or trade names or logo of IPC which IPC
may designate in writing from time to time.
5.4 IPC
will retain such samples of the Product as are required and
specified by IPC’s Standard Operating Procedures and
Applicable Law to comply with the general retention requirements as
set forth in cGMPs, perform stability testing as described and
required to conform with the Product’s stability protocol and
as specified in the Supplier Quality Agreement, a form of which is
attached as Exhibit
C.
5.5 IPC
may make changes in the manufacturing process / material of the
Product subject to FDA regulations, instructions and Applicable
Laws and share appropriate information with Tris. Depending on the
change, IPC shall use Commercially Reasonable Efforts to provide
necessary time for Tris to make any necessary changes to ensure no
sales interruptions and continued compliance and uninterrupted
supply of the Product. All such changes shall be in conformity with
the requirements of Section 5.1(a) and Applicable
Laws.
ARTICLE
6 –
COMPLIANCE, AUDIT & INSPECTION
6.1 IPC
shall produce Product in compliance with cGMP as the same are or,
from time to time, shall be, established by applicable statue and
regulation of the FDA and the Supplier Quality Agreement executed
by both Parties, a copy of which is attached to this Agreement as
Exhibit
C.
6.2 Upon
Tris’ request and upon not less than fifteen (15) days’
notice, IPC will grant employees or authorized representatives of
Tris access to its Production Facility and records related to the
manufacture of Product, in order to audit IPC’s compliance
with GMP and with clauses of this Agreement. Audits shall be
undertaken in a manner which does not disrupt IPC’s normal
course of business.
6.3 IPC
shall give Tris and any governmental authority reasonable access to
documents and information regarding manufacture of the Product and
shall allow inspections by governmental authorities of all
facilities involved in the manufacture and shipment of Product. IPC
shall notify Tris immediately, and in no event, no later than seven
(7) days, after it receives any communication from any governmental
or regulatory authority, including without limitation the FDA,
which in any way relates to or may have an impact on a Product. IPC
will communicate as to the outcome of any inspection by the FDA, no
later than ten (10) business days after receipt of the inspection
report.
6.4 IPC
shall not change the location of the Production Facility at which
Product is manufactured without written notice to
Tris.
ARTICLE
7 –
REGULATORY, RETURNS AND RECALLS
7.1 Regulatory
File Maintenance. IPC shall be responsible for maintaining
any ANDA and all other applicable FDA approvals and registrations
to permit the sale of the Product by Tris in accordance with the
terms of this Agreement; provided, however, that Tris shall
reasonably cooperate and provide all necessary data and
documentation required under the Act and all Applicable Laws for
such file maintenance. IPC shall be responsible for payment of all
GDUFA Fees.
7.2 Returns.
Tris shall be solely responsible for processing all customer
returns of the Product either directly or through a selected Third
Party return vendor, provided that if the return is due to Product
failing to meet Product Warranties or is otherwise defective then
IPC shall reimburse Tris for all costs associated with such returns
including Product destruction and Transfer Price.
7.3 Product
Recall. In the event either Party believes it may be
necessary to conduct a recall, field correction, market withdrawal,
stock recovery, or other similar action with respect to any Product
which were sold by IPC or its Affiliates to Tris or its Affiliates
under this Agreement (a “Recall”), IPC and Tris shall
consult with each other as to how best to proceed, it being
understood and agreed that the final decision as to any Recall of
any Product shall be made by Tris; provided, however, that IPC
shall not be prohibited hereunder from taking any action that it is
required to take by Applicable Law. To the extent the Recall arises
from acts or omissions of Tris, a Tris Affiliate or Third Party
sublicensee of Tris in the distribution, storage, sale or marketing
of such Product or Tris’ breach of its representations,
warranties or obligations hereunder, the Transfer Price for the
goods sold, distribution expenses and third-party expenses that are
directly related to the recall (collectively, “Recall Costs”) shall be borne by
Tris. To the extent the Recall arises from any other reasons, the
Recall Costs shall be borne by IPC. Each Party shall maintain
records of all sales of Product and customers sufficient to
adequately administer a Recall for the period required by
Applicable Law.
7.4 Adverse
Events and Product Complaints. Tris or its Affiliates will
communicate to IPC or the agent contracted by IPC to manage Adverse
Events pertaining to the Product on its behalf, any adverse event
or product complaint (quality defect) reports received within (3)
business days of Tris first learning of any such adverse event or
complaint. IPC or its agent shall confirm receipt to Tris. If Tris
does not receive confirmation of their receipt of the adverse event
or product complaint report from IPC or its agent, Tris will
re-send the report within forty-eight (48) hours and ▇▇▇▇ the
report as resent. The cost of any such agent shall be borne
entirely by IPC; provided, however, that if such agent was
recommended by Tris and the rates negotiated by Tris, the initial
set-up cost shall be fully borne by IPC and the monthly allocated
cost associated with Adverse Event reporting for the Product for
such agent (determined in accordance with such negotiated rates)
shall be initially paid by Tris and deducted from Gross Sales in
determining Net ▇▇▇▇▇.▇▇ the event either party becomes aware of
(i) any adverse drug experience or reaction or other information
indicating that any Product has 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.
7.5
Quality Agreement and Pharmacovigilance
Agreement.
Within
(60) days of the Effective Date, the parties will enter into a
mutually acceptable Supplier Quality Agreement, attached hereto as
Exhibit C and the
Pharmacovigilance Agreement, attached hereto as Exhibit D. 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.
7.6
Further Obligations of the
Parties. During the term of this Agreement::
(a) Each Party shall promptly notify the
other, and provide copies as deemed necessary to or requested by
the other Party (redacting any confidential information of Third
Parties or information not pertaining to the Product), of
any written comments, responses or notices received from the FDA,
or other applicable state or federal regulatory authorities, which
relate to or reasonably could be expected to impact the Product or
the sale or manufacture of the Product.
(b) IPC at its own
cost, shall obtain, maintain and comply with any and all Federal
and state regulations and/or licenses with respect to the
manufacture and licensing for sale of the Product, including,
without limitation, maintaining the Product ANDA. Tris, at its own
cost, shall obtain, maintain and comply with any and all Federal
and state regulations and/or licenses applicable to distributors
with respect to the sale and marketing of the Product in the
Territory
(c) Each Party shall
provide ongoing technical, sales, marketing or other support to the
other, as reasonably requested from time to time, in responding to
any important Product inquiries, and Product complaints and adverse
experience reports within the time required by Applicable Law or
regulation, and in evaluating the need for Recall.
(d) IPC shall
reasonably cooperate with Tris in its sales and marketing
activities by, among other things, supplying pertinent Product
documentation as requested, including without limitation Packaging
and Labeling. Tris shall reasonably cooperate with IPC by promptly
responding to, among other things, reasonable inquiries from IPC
pertaining to the supply of the Product, and the existing and
expected inventory levels of the Product held by Tris and any
Affiliate and Third Party sublicensee.
ARTICLE
8–
REPRESENTATIONS AND WARRANTIES
8.1 Mutual
Representations and Warranties. Each Party hereby represents
and warrants and covenants (in the case of clause (e)) to the other
Party as follows:
(a) Corporate Existence. Such Party
is a corporation duly organized, validly existing and in good
standing under the laws of the jurisdiction in which it is
incorporated.
(b) Authorization and Enforcement of
Obligations. Such Party (a) has the corporate power and
authority and the legal right to enter into this Agreement and to
perform its obligations hereunder, and (b) has taken all necessary
corporate action on its part to authorize the execution and
delivery of this Agreement and the performance of its obligations
hereunder. This Agreement has been duly executed and delivered on
behalf of such Party, and constitutes a legal, valid, binding
obligation, enforceable against such Party in accordance with its
terms.
(c) Consents. All necessary
consents, approvals and authorizations of all governmental
authorities and other Persons required to be obtained by such party
in connection with its performance of this Agreement have been
obtained.
(d) No Conflict. The execution and
delivery of this Agreement and the performance of such
Party’s obligations hereunder (a) do not conflict with or
violate any requirement of applicable laws or regulations, and (b)
do not conflict with, or constitute a default under, any material
contractual obligation of such Party.
(e) Debarment. Such party is not
debarred under Section 2 of the Generic Drug Enforcement Act of
1992, and it does not and will not use in any capacity the services
of any Person debarred under the Act.
8.2 Additional
Representations, Warranties and Covenants of
IPC.
IPC
represents, warrants and covenants to Tris that: (i) it has all
rights necessary to validly grant the licenses set forth in Section
2.1; and (ii) any Patent Rights covering the Product are Valid and
have not expired and any maintenance fees have been and will be
paid when due or within any permitted extension; (iii) it is not
subject to any court proceedings, judgment or order related to the
subject matter of this Agreement; (iv) it has not received any
written claim or allegation of infringement from a Third Party for
the infringement of Third Party Intellectual Property Rights based
on the making, using, or selling of the Product or from filing for
Regulatory Approval of the Product; (v) it and its Affiliates shall
at all times materially comply with all applicable laws relating to
or pertaining to their obligations under this Agreement; (vi) it
has not assigned and/or granted licenses, to its Intellectual
Property Rights nor shall it assign and/or grant licenses, to its
Intellectual Property Rights to any Third Party that would restrict
or impair the rights granted hereunder, and it has not granted to
anyone any rights that cover the Product in the Territory that
remain in effect; (vii) the Product and any Intellectual Property
Rights incorporated in the Product (a) do not infringe any valid
claim in a granted patent owned by a Third Party and (b) has not
been misappropriated from a Third Party; (viii) to its actual
knowledge any issued patents included in the Intellectual Property
Rights incorporated in the Product are valid and enforceable; (ix)
any Patent Rights and other Intellectual Property Rights covering
the Product are and during the Term, will be, free and clear of all
liens; and (x) the Product ANDA was approved by the FDA on
November 23,
2018.
8.3 Additional
Representations, Warranties and Covenants of
Tris.
Tris
represents, warrants and covenants to IPC that: (i) it is not
subject to any court proceedings, consent decree, judgment or order
related to the subject matter of this Agreement; and (ii) it, its
Affiliates, and its sublicensees shall at all times materially
comply with all applicable laws relating to or pertaining to their
obligations under this Agreement.
8.4 Limitation
of Liability. EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, AND
EXCEPT FOR EACH PARTY’S INDEMNIFICATION OBLIGATIONS SET FORTH
IN ARTICLE 10 AND ANY OTHER INDEMNIFICATION OBLIGATIONS OF SUCH
PARTY UNDER THIS AGREEMENT WITH RESPECT TO THIRD PARTY CLAIMS, OR
IPC’S BREACH OF SECTION 2.2, NEITHER PARTY SHALL BE LIABLE TO
THE OTHER PARTY OR ANY OF ITS AFFILIATES OR SUBLICENSEES FOR ANY
SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES,
INCLUDING LOST PROFITS OR LOST REVENUES, WHETHER UNDER ANY
CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR
EQUITABLE THEORY.
ARTICLE
9 –
INSURANCE.
9.1 During
the Term and for five years thereafter, IPC shall maintain
comprehensive general liability insurance including product
liability insurance against claims and recall insurance coverage
covering the manufacture of the Product under this Agreement of not
less than $[*****] per occurrence, with a deductible
of no more than $[*****], to be in place prior to the commercial
launch and for so long as the Product is being sold pursuant to
this Agreement Upon execution of this Agreement, and annually
thereafter, IPC shall furnish Tris with a certificate of insurance
evidencing such coverage and stating that such insurance shall not
be cancelled, materially amended or allowed to lapse without at
least thirty (30) days prior written notice to Tris. Such insurance
shall be maintained with an insurance company rated at least
“aa” by A.M. Best .
9.2 During
the Term and for five years thereafter, Tris shall maintain
comprehensive general liability insurance against claims regarding
the sales, marketing and commercialization of the Product under
this Agreement of not less than $ [*****] per occurrence, with a deductible
of no more than $[*****], to be in place prior to the commercial
launch and for so long as the Product is being sold pursuant to
this Agreement. Upon execution of this Agreement, and annually
thereafter, Tris shall furnish IPC with a certificate of insurance
evidencing such coverage and stating that such insurance shall not
be cancelled, materially amended or allowed to lapse without at
least thirty (30) days prior written notice to IPC. Such insurance
shall be maintained with an insurance company rated at least
“aa” by A.M. Best.
ARTICLE
10 –
INDEMNIFICATION
10.1 By
IPC. IPC shall defend, indemnify and hold harmless Tris, its
Affiliates and their respective successors and permitted assigns
(and the respective officers, directors, and employees of each)
from and against any and all losses, liabilities, claims, actions,
proceedings, damages and expenses, including without limitation
reasonable attorneys’ fees and expenses, (herein collectively
referenced as “Damages”) relating to or arising
from any claims, suits, proceedings or causes of action brought by
a Third Party relating to or arising from (a) IPC’s
manufacture, supply, or delivery of a Product to Tris hereunder,
(b) the infringement of any Third Party intellectual property right
by the manufacture, supply or use of a Product; (c) the
misappropriation of any intellectual property by IPC or its
Affiliates, (d) injury to Persons as a result of use of the Product
; or (e) a material breach of any obligations, representations or
warranty of IPC contained in this Agreement, except to the extent
such Damages give rise to an indemnification claim of IPC under
Section 10.2 below.
10.2 By
Tris. Tris agrees to defend, indemnify and hold harmless
IPC, its Affiliates and their respective successors and permitted
assigns, and the respective officers, directors, stockholders,
partners and employees of each, from and against any and all
Damages relating to or arising from any claims, suits, proceedings
or causes of action brought by a Third Party relating to or arising
from (a) improper acts of marketing, distribution or sale of the
Product by Tris or the Affiliates or Third Party sublicensees of
Tris in the Territory (excluding the supply of product that does
not meet Product Warranties or Adulterated Product supplied by
IPC), to the extent not the fault of IPC or (b) any claim that
marketing materials of Tris or the Affiliates or Third Party
sublicensees of Tris (other than Labeling as approved and set forth
in the applicable regulatory approval and other than any trademark
or service ▇▇▇▇ of IPC) infringes the rights of a Third Party or
(c) a material breach of any obligation, representation or warranty
of Tris contained in this Agreement, except in each case to the
extent such Damages give rise to an indemnification claim of IPC
under Section 10.1 above.
10.3 Limitations
on Indemnification. Notwithstanding provision in this
Agreement to the contrary, neither Party shall be entitled to
indemnification with respect to any claim or suit to the extent
such claim or suit results from its own negligence or willful
misconduct. In addition, the indemnification pursuant to this
Article 10 shall be available only with respect to claims made by
third-parties and not for a claim made solely by one Party against
the other.
10.4 Procedures
for Control of Third Party Claims. The Party entitled to
make a claim for indemnification under this Article 10 shall be
referred to as the “Indemnified Party” and the Party
required to indemnify such claim shall be referred to as the
“Indemnifying
Party.” In order for an Indemnified Party to be
entitled to any indemnification provided for under this Agreement
in respect of, arising out of or involving a claim or demand, made
by any Third Party against the Indemnified Party (a
“Third Party
Claim”), such Indemnified Party must notify the
Indemnifying Party in writing of the Third Party Claim within
thirty (30) business days after receipt by such Indemnified Party
of written notice of the Third Party Claim; provided, however, that
failure to give such notification shall not affect the
indemnification provided hereunder except to the extent the
Indemnifying Party shall have been actually materially prejudiced
as a result of such failure. If a Third Party Claim is made against
an Indemnified Party, the Indemnifying Party shall be entitled to
control the defense thereof; provided, that the Indemnifying Party
shall thereafter consult with the Indemnified Party upon the
Indemnified Party’s reasonable request for such consultation
from time to time with respect to such suit, action or proceeding.
If the Indemnifying Party controls such defense, the Indemnified
Party shall have the right (but not the duty) to participate in the
defense thereof and to employ counsel, at its own expense, separate
from the counsel employed by the Indemnifying Party. The
Indemnifying Party shall be liable for the fees and expenses of
counsel employed by the Indemnified Party for any period during
which the Indemnifying Party has not assumed the defense thereof,
but the Indemnifying Party shall not be liable to the Indemnified
Party for any legal expenses subsequently incurred by the
Indemnified Party in connection with the defense thereof. Whether
or not the Indemnifying Party defends or prosecutes any Third Party
Claim, the Parties hereto shall cooperate in the defense or
prosecution thereof. Such cooperation shall include the retention
and (upon the Indemnifying Party’s request) the provision to
the Indemnifying Party of records and information which are
reasonably relevant to such Third-Party Claim and making employees
or any other Indemnified Party available on a mutually convenient
basis to provide additional information and explanation of any
material provided hereunder. Whether or not the Indemnifying Party
shall have assumed the defense of a Third Party Claim, the
Indemnified Party shall not admit any liability with respect to, or
settle, compromise or discharge, such Third Party Claim without the
Indemnifying Party’s prior written consent, which shall not
be unreasonably withheld, conditioned or delayed. In no event shall
the Indemnifying Party settle any Third Party Claim if such
settlement would impose any obligation or burden on the Indemnified
Party, without the prior written consent of the Indemnified
Party.
ARTICLE
11 –
TERMINATION
11.2 Bankruptcy or
Insolvency. Either Party shall be entitled to immediately
terminate this Agreement upon the filing or institution of
bankruptcy, reorganization (in connection with any insolvency),
liquidation or receivership proceedings, or upon an assignment of a
substantial portion of the assets for the benefit of creditors by
the other Party, or in the event a receiver or custodian is
appointed for such other Party’s business, or if a
substantial portion of such other Party’s business is subject
to attachment or similar process, or of a Party otherwise admits in
writing its inability to pay its debts generally as they become
due; provided, however, that in the case of any involuntary
bankruptcy proceeding or the attachment of a substantial portion of
a Party’s assets, such right to terminate shall only become
effective if the proceeding or attachment is not dismissed within
sixty (60) days after the filing thereof.
11.3
Termination
(a) Notwithstanding any
other provision of this Agreement, either Party may terminate this
Agreement at any time upon [*****] ([*****]) days prior written
notice to the other Party, if it determines, in its reasonable
judgment and discretion, that the market for or pricing of the
Product (including the Transfer Price of a Product) is such that it
is not economically viable to continue to market the
Product.
(b) Tris may terminate
this Agreement as provided in Section 3.10.
(c) A
Party not under force majeure may terminate in the circumstances
set out in Section 14.1.
(d) Either
Party shall have the right to terminate this Agreement by giving a
[*****] ([*****]) day written notice to the other Party if: (i)
such other Party fails to pay any undisputed amount due under this
Agreement on the due date for payment and remains in default not
less than [*****] ([*****]) business days after written notice to
make such payment, provided such [*****] day notice is sent after
such [*****] business days and prior to the curing of such default;
or (ii) such other Party undergoes a change of control, meaning a
merger, reorganization or consolidation involving such other Party,
or any parent company of such other Party and a Third Party and the
Party not undergoing a change of control determines in its
reasonable discretion that such reorganization or change of control
will provide access to such other Party a Competing Product that
will negatively impact future sales of the Product in the
Territory; or (iii) either Party assigns this Agreement to a Person
which as of the time of the assignment markets, or is developing or
whose Affiliate markets or is developing, a Competing Product,
provided that in the case of (ii) and (iii) such [*****] ([*****])
day notice is delivered within [*****] ([*****]) days of written
notice of the change of control event or assignment given to the
terminating Party. The forgoing are in addition to any other rights
and obligations the Parties have under this Agreement, which shall
continue in the event the Agreement is not terminated.
11.4 Effect of Termination. Expiration
or termination of this Agreement shall be without prejudice to the
rights of the Parties and shall not release any payment, liability
or other obligation incurred between the Parties prior to the date
of such expiration or termination or arising as a result of such
expiration or termination. IPC shall remit to Tris its shares of
negative Net Profits as provided in Section 3.9(c) In the event of termination or
expiration (I) unless otherwise provided herein, Tris shall take
delivery of binding Purchase Orders and (II) may continue selling
inventory of Product in its possession (whether acquired
pre-termination/expiration or post termination/expiration) for one
(1) year from date of Termination, provided however, if this
Agreement is terminated by Tris pursuant to Section 11.1, 11.2, or
11.3(b) or 11.3(d) there shall be no such one (1) year limitation.
In the event this Agreement is terminated by Tris pursuant to
Sections 11.1, 11.2, 11.3(b) or 11.3(d) at Tris’ option (i)
it may return some or all Product in its possession for a full
refund; and/or (ii) take delivery of some or all Product previously
ordered or subject to binding portions of Forecasts and/or cancel
some or all of such orders or portions of binding Forecasts. In the
event this Agreement is terminated by IPC pursuant to Sections 11.1
or 11.2, or 11.3(d), at IPC’s option, it may order Tris to
destroy, or return to IPC, all or part of the remaining inventory
of Product under the control or in the possession of Tris, at the
sole cost and expense of IPC, provided that IPC advances to Tris
any potential service level or non-supply penalties or damages and
reimburses Tris for amounts paid for unsold Products.
11.5 Surviving
Terms. The provisions of this Agreement which by their terms
are to be performed or complied with subsequent to the termination
or expiration of this Agreement shall survive such termination or
expiration and shall continue in full force and effect in
accordance with their respective terms. For the avoidance of doubt,
in addition to the foregoing, Articles 1 (and other definitions in
the Agreement, in each case to the extent definitions are used in
the other surviving provisions), 2.1 (pertaining to sublicences),
4.9, 8, 10, 11, 12, 13 and 14 shall survive such termination or
expiration and shall continue in full force and effect in
accordance with their respective terms.
ARTICLE
12 –
CONFIDENTIALITY
12.1 Definition
of Confidential Information. The term “Confidential Information” includes
all information treated by the disclosing Party as confidential or
proprietary, including but not limited to, any formulae, methods,
techniques, processes, work papers, concepts, strategies,
components, programs, reports, studies, memoranda, correspondence,
materials, manuals, records, technology, products, plans, research,
service, design information, documentation, policies, pricing,
billing, customer lists and leads, and any other data, information
and know-how, technical or non-technical, whether written, graphic,
computer-generated which relate to the disclosing Party’s
products or customers or potential customers or are otherwise
useful in the disclosing Party’s business, and which the
disclosing Party desires to maintain confidential. Confidential
Information includes any copies thereof. Confidential Information
will be entitled to protection hereunder whether or not such
information is oral or written, whether or not such information is
identified as such by an appropriate stamp or marking on each
document.
12.2 Confidentiality.
Each Party shall maintain all Confidential Information under the
strictest possible terms and shall only use such Confidential
Information in furtherance of this Agreement. Both Parties agree
that any of its officers, employees or agents provided or given
access to the other Party’s Confidential Information shall be
bound by confidentiality obligations essentially the same as those
set forth herein and that it shall be fully responsible for the
performance of the obligations under this Section 12.2 by each such
officer, employee and agent. The foregoing obligations of
confidentiality and use restrictions shall not apply, however, to
the extent that such Confidential Information:
(a) was already known
to the receiving Party or its Affiliate, other than under an
obligation of confidentiality, at the time of disclosure by the
other Party;
(b) was generally
available to the public or otherwise part of the public domain at
the time of its disclosure to the receiving Party;
(c) became generally
available to the public or otherwise part of the public domain
after its disclosure and other than through any act or omission of
the receiving Party in breach of this Agreement;
(d) was disclosed to
the receiving Party or its Affiliate by a Third Party who has a
legal right to make such disclosure and who did not obtain such
information directly or indirectly from the other Party;
or
(e) was independently
discovered or developed by the receiving Party or its Affiliate
without access to or aid, application or use of the other
Party’s Confidential Information, as evidenced by a
contemporaneous writing.
12.3 Authorized
Disclosure. Notwithstanding the obligations set forth in
Section 12.2, a Party may disclose the other Party’s
Confidential Information and the terms of this Agreement to the
extent:
(a) such disclosure is
reasonably necessary to its employees, agents, consultants,
contractors, officers, licensees or sublicensees on a need-to-know
basis for the sole purpose of performing its obligations or
exercising its rights under this Agreement; provided that in each
case, the Party disclosing is bound by written obligations of
confidentiality and non-use consistent with those contained in this
Agreement; or
(b) such disclosure is
reasonably necessary to comply with Applicable Laws, including
regulations promulgated by the U.S. Securities and Exchange
Commission, applicable stock exchanges, court order, administrative
subpoena or order; provided that the Party subject to such
Applicable Laws shall promptly notify the other Party of such
required disclosure and shall use reasonable efforts to obtain, or
to assist the other Party in obtaining, a protective order
preventing or limiting the required disclosure.
(c) Prior Confidentiality Agreement. Nothing
herein shall relieve any Party of any breach of that certain
Confidentiality Agreement, dated as of March 6, 2017 (the
“Prior Confidentiality Agreement”), by and between the
Parties with respect to the information disclosed between the
Parties prior to the date hereof, provided any information
disclosed under such agreement shall also be deemed disclosed under
this Agreement and such agreement shall not apply to any
information disclosed after the date hereof, which disclosure shall
be governed by this Agreement.
ARTICLE
13–
DISPUTE RESOLUTION
13.1 IPC
and Tris agree to use good faith efforts to resolve any and all
disputes (“Dispute”) arising out of or relating to this
Agreement. If after forty five (45) days following receipt of
notice by one Party from the other of a dispute under this
Agreement, the Parties are unable to resolve the dispute, then the
matter shall by fully and finally resolved by arbitration. A Party
that desires to arbitrate a dispute shall serve a written notice
upon another requesting arbitration of a dispute pursuant to this
Section 13.1. Any such arbitration shall be submitted to final and
binding arbitration under the then current commercial arbitration
rules of the American Arbitration Association (the
“AAA”) in
accordance with this Section 13.1. The place of arbitration of any
dispute shall be State of New Jersey. Such arbitration shall be
conducted by one (1) arbitrator mutually agreed to by the Parties,
but if such agreement cannot be reached within ten (10) days of the
commencement of the arbitration, then an arbitrator shall be
appointed by the AAA. The arbitrator shall be a retired judge, or
attorney with no less than 10 years of relevant experience in the
pharmaceutical industry. The arbitration proceeding shall be held
as soon as practicable but in any event within sixty (60) days of
appointment of the arbitrator. Any award rendered by the
arbitrators shall be final and binding upon the Parties. Judgment
upon any award rendered may be entered in any court having
jurisdiction, or application may be made to such court for a
judicial acceptance of the award and an order of enforcement, as
the case may be. The arbitrator shall render a formal, binding,
non-appealable resolution and award, along with a written opinion
not to exceed twenty (20) pages which reasonable explains the
ruling, as expeditiously as possible, but not more than forty-five
(45) days after the hearing. Each Party shall pay its own expenses
of arbitration, and the expenses of the arbitrator shall be equally
shared between the Parties unless the arbitrator assesses as part
of the award all or any part of the arbitration expenses of a Party
(including reasonable attorneys’ fees) against the other
Party. A Party may make application to the arbitrator for the award
and recovery of its fees and expenses (including reasonable
attorneys’ fees). This Section 13.1 shall not prohibit a
Party from seeking injunctive relief from a court located in the
State of New Jersey in the event of a breach or prospective breach
of this Agreement by any other Party which would cause irreparable
harm to the first Party.
ARTICLE
14–
MISCELLANEOUS
14.1 Force
Majeure. Except as provided in Section 3.10, neither Party
shall be responsible or liable to the other Party as a result of,
any failure to perform any of its obligations hereunder, if such
failure results from wars, riots, disease, an act of God, civil
commotion, fire, failure of public utilities or any other
circumstances similar to the foregoing whether or not similar to
the above causes and whether or not foreseeable (a
“Force Majeure
Event”). The affected Party shall use Commercially
Reasonable Efforts to avoid or remove any such causes and shall
resume performance under this Agreement as soon as practicable
whenever such cause is removed; provided, however, that the
foregoing shall not be construed to require either Party to settle
any Third Party dispute, to commence, continue or settle any
litigation, or to incur any unusual or extraordinary expenses. If a
Party is affected by a Force Majeure Event for more than ninety
(90) days which impacts its performance under this Agreement the
other Party may terminate this Agreement effective upon written
notice to the affected Party.
14.2 Amendments.
No waiver, amendment or modification of the terms of this Agreement
shall be binding on either Party unless reduced to writing and
signed by both Parties.
14.3 No
Waiver. The failure of either Party to enforce any provision
of this Agreement at any time or for any period of time shall not
be construed to be a waiver of any right of either Party hereunder
nor to prevent the subsequent enforcement thereof or of any other
provision hereof in accordance with its terms.
14.4 Entire
Agreement. This Agreement, including the Appendixes and
Exhibits hereto which are hereby incorporated herein at each point
of reference thereto, constitutes the entire understanding between
the Parties with respect to the subject matter hereof and
supersedes all prior contracts, Agreements and understandings
related to the same subject matter between the Parties (except for
the Prior Confidentiality Agreement which shall be governed as
provided in Section 12.3(c)). For the avoidance of doubt, this
Agreement and any other agreement between the Parties or any of
their Affiliates related to any product other than the Product are
independent agreements. For the avoidance of doubt, a breach of any
provision of any other such other agreement shall not be a breach
of this Agreement. This Agreement shall govern and control to the
extent of any conflict between the terms of this Agreement and
terms in any of the Appendixes or Exhibit hereto, or Purchase
Orders issued hereunder.
14.5 Assignment.
(a) Neither this
Agreement nor any or all of the rights or obligations of either
Party hereunder shall be assigned, delegated, sold, transferred,
sublicensed or otherwise disposed of or encumbered, by operation of
law or otherwise, to any Third Party without the prior written
consent, which consent shall not be unreasonably withheld,
conditioned or delayed, of the other except as otherwise provided
in this Agreement and as permitted in the immediately following
sentence. Subject to Section 11.3(d), this Agreement may be
assigned by either Party in connection with the transfer (by sale,
merger or otherwise) of its line of business to which this
Agreement relates. Any attempted assignment, delegation, sale,
transfer, sublicense or other disposition, by operation of law or
otherwise, of this Agreement or any rights or obligations hereunder
by or on behalf of either Party contrary to this Section 14.5(a)
shall be a material breach of this Agreement and shall be void and
without force or effect. Notwithstanding the foregoing, or anything
to the contrary contained in this Agreement, nothing contained in
this Agreement shall prohibit or restrict a Party’s ability
to collaterally assign this Agreement to a bank or other financial
institution, and such bank’s or financial institution’s
exercise of its rights in conjunction therewith.
(b) Any assignment,
sublicense or other transfer permitted by this Section 14.5 shall
not operate to release such Party from its responsibilities under
this Agreement.
14.6 Severability.
If any provision of this Agreement, under any set of circumstances,
whether or not foreseeable by the Parties, is hereafter held to be
invalid, illegal or unenforceable in its present form and scope in
any jurisdiction or proceeding, the remaining provisions of this
Agreement shall continue to be given full force and effect, without
regard to the invalid, illegal or unenforceable provision in such
jurisdiction or proceeding, and shall be liberally construed in
order to carry out the intentions of the Parties hereto as nearly
as may be possible, and such holding shall not affect the validity,
legality or enforceability of this Agreement in its entirety in any
other jurisdiction or proceeding. Furthermore, if any of the
provisions of this Agreement are held to be unenforceable in any
jurisdiction or proceeding because of their duration or scope, the
Parties agree that the court, or other authority making such
determination shall have the power, and is hereby directed, to
reduce or alter the duration and/or scope of such provision so
that, in its reduced form, the provision is enforceable and
effective as nearly as possible for the purposes expressed in this
Agreement. To the extent permitted by applicable law, IPC and Tris
hereby waive any provision of law that would render any provision
hereof prohibited or unenforceable in any respect.
14.7 Choice
of Law/Jurisdiction/Venue. This Agreement shall be
interpreted, construed and enforced in accordance with the
substantive laws of the State of New Jersey, as applied to
agreements performed wholly within State of New Jersey, without
reference to choice of law principles. Any dispute or proceeding
not subject to arbitration (such as a request for injunctive relief
as provided in Section 13.1) shall be adjudicated exclusively in
courts located in the State of New Jersey and each Party agrees to
submit to the personal jurisdiction of such courts, and not to
assert in any suit, action or proceeding any claim that is not
subject to the jurisdiction of any such court, that such suit
action or proceeding is improper or is an inconvenient venue for
such proceeding.
14.8 Each
Party irrevocably consents to service of process in such dispute or
proceeding to by written notice provided in Section 14.8 (other
than by telefax). The Parties hereby exclude the United Nations
Convention on Contracts for the International Sale of Goods from
this Agreement.
14.9 Notices.
Any notice to be given by either party shall be in writing and
shall be deemed given when delivered personally, by postpaid
registered, certified or Express mail, by UPS, DHL or Federal
Express, overnight, second day or three day service, or by telefax
to the parties at the following addresses:
If to
Tris, to it at:
Tris
Pharma Inc.
▇▇▇▇ ▇▇
▇▇ ▇▇▇
▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇, ▇▇▇
Attn:
▇▇▇▇▇ ▇▇▇▇▇
Email:
▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇.▇▇▇
Tel.:
▇▇-▇▇▇-▇▇▇-▇▇▇▇
Fax:
▇▇-▇▇▇-▇▇▇-▇▇▇▇
If to
IPC, to it at:
Intellipharmaceutics
Corp,
▇▇
▇▇▇▇▇▇▇▇▇ ▇▇▇▇,
▇▇▇▇▇▇▇, ▇▇ ▇▇▇
▇▇▇, ▇▇▇▇▇▇
Attn:
▇▇. ▇▇▇▇▇ ▇▇▇▇▇
Email:
▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇
Tel.:
Fax: ▇▇ ▇▇▇-▇▇▇-▇▇▇▇
14.10 Public
Announcements. Neither Party will make any press release or
other public disclosure regarding this Agreement or the
transactions contemplated hereby without the other Party’s
express prior written consent, such consent not to be unreasonably
delayed, except as required under Applicable Law or by any
governmental agency or as required in connection with the
performance of this Agreement.
14.11 Counterparts.
This Agreement may be executed in facsimile or email (pdf)
counterparts each of which is hereby agreed to have the legal
binding effect of an original signature.
Rest
of page intentionally left blank. Signature page is on next
page.
IN WITNESS WHEREOF, the Parties have
caused this License and Commercial Supply Agreement to be executed
by their respective duly authorized officers as of the date first
above written.
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TRIS PHARMA, INC.
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INTELLIPHARMACEUTICS CORP
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By:
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/s/
▇▇▇▇▇ ▇▇▇▇▇▇
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By:
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/s/
▇▇. ▇▇▇▇▇ ▇▇▇▇▇
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Name:
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▇▇▇▇▇
▇▇▇▇▇▇
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Name:
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▇▇.
▇▇▇▇▇ ▇▇▇▇▇
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Title:
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President,
Generics
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Title:
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President
& COO
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EXHIBIT A
IPC ANDA GENERIC PRODUCT
|
Product / Form
|
Strength (mg) / Form
|
ANDA NO.
|
RLD
|
|
Venlafaxine ER Caps
|
37.5 mg, 75 mg and 150 mg
|
201272
|
Effexor XR
|
EXHIBIT B
IPC VENLAFAXINE ER TRANSFER PRICES (USD)
|
Venlafaxine
ER
|
Pack
Size (HDPE Bottles)
|
||
|
Strength
|
30
|
90
|
1,000
|
|
37.5
Mg
|
$
[*****]
|
$
[*****]
|
$
[*****]
|
|
75
Mg
|
$
[*****]
|
$
[*****]
|
$
[*****]
|
|
150
Mg
|
$
[*****]
|
$[*****]
|
$
[*****]
|
EXHIBIT C
SUPPLIER QUALITY AGREEMENT
EXHIBIT D
PHARMACOVIGILANCE AGREEMENT
EXHIBIT E
INTERNATIONAL WIRE TRANSFER ADVICE