CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.*** MANUFACTURING AND SUPPLY AGREEMENT
EXHIBIT
10.38.2
CONFIDENTIAL
TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF
THIS
DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY
FILED
WITH THE COMMISSION.***
THIS
MANUFACTURING AND SUPPLY AGREEMENT (this “Agreement”)
dated
as of September 8, 2005 (the “Effective
Date”)
is
made and entered into by and between Inyx, Inc., a company organized and
existing under the laws of Nevada (“Inyx”),
and
King Pharmaceuticals, Inc., a Tennessee corporation (“King”).
Capitalized terms used in this Agreement shall have the meanings ascribed
to
them in Article 1 hereof or as otherwise set forth herein.
RECITALS
WHEREAS,
Inyx is engaged in the manufacture in finished product form of the compounds
cromolyn sodium and nedocromil sodium as sold in the United States and
Canada;
WHEREAS,
King desires to have Inyx manufacture and supply it with Products (as defined
herein) during the Term in accordance with this Agreement;
WHEREAS,
Inyx agrees to manufacture and supply to King Products upon the terms and
subject to the conditions provided herein; and
WHEREAS,
the parties have entered into that certain Collaboration Agreement, dated
as of
the date hereof (the “Collaboration
Agreement”),
for
the purpose of pursuing a collaboration relating to the development, marketing
and promotion of Products;
NOW,
THEREFORE, in consideration of the mutual covenants and agreements set forth
in
this Agreement, and for other good and valuable consideration, the receipt
and
sufficiency of which are hereby acknowledged, the parties hereto hereby agree
as
follows:
ARTICLE
1
DEFINITIONS
Unless
otherwise specifically defined in this Agreement, each capitalized term used
herein will have the meaning assigned to such term in the Collaboration
Agreement. In addition, the following terms shall have the meanings set forth
below. Unless the context indicates otherwise, the singular shall include
the
plural and the plural shall include the singular.
CONFIDENTIAL
TREATMENT
1.1 “Agreement”
means
this Manufacturing and Supply Agreement and all schedules and annexes attached
hereto, and as the same may be amended or supplemented from time to time
hereafter pursuant to the provisions hereof.
1.2 “Bulk
Form”
means
cromolyn sodium micronized stage 9 (the “Intal
Bulk Form”)
and
nedocromil sodium dried stage 11 (the “Tilade
Bulk Form”).
1.3 “Business
Day”
means a
day other than Saturday, Sunday or any day on which a commercial bank in
New
York is authorized to close. Any reference in this Agreement to “day” whether or
not capitalized shall refer to a calendar day, not a Business Day.
1.4 “cGMP”
means
current Good Manufacturing Practices (i) as promulgated under the Act at
21 CFR
(chapters 210 and 211), as the same may be amended or re-enacted from time
to
time and (ii) as required by Law in Canada, as applicable.
1.5 “Collaboration
Agreement”
has the
meaning set forth in the recitals.
1.6 “Collaboration
Documents”
means
collectively, this Agreement, the Technology Transfer Agreement, the
Collaboration Agreement, the Marketing and Promotion Agreement, the Quality
Agreement and the Development Agreement, as each such term is defined in
the
Collaboration Agreement.
1.7 “Confidential
Information”
has the
meaning set forth in Section 8.1(a).
1.8 “Discretionary
Manufacturing Changes”
has the
meaning set forth in Section 2.8(b).
1.9 “Effective
Date”
has the
meaning set forth in the recitals.
1.10 “indemnitee”
has the
meaning set forth in Section 10.3.
1.11 “indemnitor”
has the
meaning set forth in Section 10.3.
1.12 “Initial
Bulk Form”
has the
meaning set forth in Section 2.10(b).
1.13 *
* *
.
1.14 *
*
*.
1.15 “Intal
CFC Inhaler Product”
means
the cromolyn sodium inhaler pharmaceutical product in a chloro-fluoro-carbon
(CFC) propellant driven inhaler and more particularly identified in NDA #18-887,
and amendments thereto.
1.16 “Intal
HFA Formulation Product”
means
the cromolyn sodium inhaler pharmaceutical product in a hydro-fluoro-alkane
(HFA) propellant driven inhaler and more particularly described in NDA #20-957,
and amendments thereto.
1.17 “Intal
Tech Transfer”
has the
meaning set forth in Section 2.10(b).
CONFIDENTIAL
TREATMENT
2
1.18 “Inyx”
has the
meaning set forth in the recitals.
1.19 “King”
has the
meaning set forth in the recitals.
1.20 “Laws”
means
all laws, statutes, rules, regulations, ordinances and other pronouncements
having the effect of law of the United States, any foreign country,
supra-national entity or any domestic or foreign state, province, county,
city
or other political subdivision of any Regulatory Authority.
1.21 “Products”
means
the finished product forms of Intal CFC Inhaler Product, Intal HFA Formulation
Product, and Tilade CFC Inhaler Product, and will include any Approved New
Product, but will not include an Excluded New Product, and “Product”
shall
mean any of the foregoing individually as the context may require.
1.22 “Raw
Materials”
means
all active pharmaceutical ingredients (including all Bulk Form), excipients,
components, labeling and packaging materials and other materials required
to
manufacture a Product.
1.23 “Required
Manufacturing Changes”
has the
meaning set forth in Section 2.8(a).
1.24 “Specifications”
means,
with respect to each Product, the written specifications for each such Product
as set forth in applicable NDAs.
1.25 “Term”
has the
meaning set forth in Section 4.1.
1.26 “Tilade
CFC Inhaler Product”
means
the nedocromil sodium pharmaceutical product in a chloro-fluoro-carbon (CFC)
propellant driven inhaler and more particularly identified in NDA #19-660,
and
any amendments thereto.
1.27 “Tilade
Tech Transfer”
has the
meaning set forth in Section 2.10(b).
ARTICLE
2
MANUFACTURE,
PURCHASE AND SALE OF PRODUCT
2.1 Supply.
(a) Pursuant
to the terms and conditions of this Agreement, during the Term Inyx agrees
to
manufacture, package and test for King, at Inyx’s Manati, Puerto Rico facility,
Product for purchase and sale by King in the Territory. Inyx shall maintain
sufficient supplies of Raw Materials and other required resources to perform
the
services required under this Agreement.
(b) Inyx
shall manufacture all Products delivered hereunder in (a) accordance with
the
Specifications, this Agreement and the Quality Agreement and (b) material
compliance with Laws applicable to the manufacturing of Product to be marketed
and sold in the Territory.
CONFIDENTIAL
TREATMENT
3
2.2 Forecasts.
(a) Not
later
than thirty (30) days after receiving FDA approval for manufacturing, packaging
and testing to be performed by Inyx and by July 1 of each calendar year for
the
Term, King shall furnish Inyx with a long range monthly forecast of the
quantities of each Product that King intends to order for the shorter of
(i) the
remaining Term or (ii) three (3) years. Such forecasts shall represent the
most
current estimates for planning purposes, but shall not be purchase commitments.
(b) In
addition to the non-binding, long range forecasts provided in
Section 2.2(a), not later than thirty (30) days after receiving FDA
approval for manufacturing, packaging and testing to be performed by Inyx,
and
at least six (6) months prior to the first day of each calendar month
thereafter, King shall furnish Inyx with a short range non-binding rolling
forecast of the quantities of each Product that King intends to order by
month
during the eighteen month (18) month period commencing with that calendar
month
or such shorter period as remains in the Term. For example, a forecast submitted
by King on January 1, 2006 would cover the period from July 1, 2006 through
December 31, 2007.
(c) Inyx
will
use commercially reasonable efforts to fill orders in excess of the firm
purchase orders.
2.3 Firm
Orders.
(a) King
shall place purchase orders with Inyx for Products. All purchase orders must
be
received by Inyx at least six (6) months prior to the delivery date specified
in
each respective order. Each purchase order shall specify the delivery schedule
within the month, and Inyx shall deliver against each such purchase order
in
accordance with Section 2.5. King shall be obligated to purchase all such
Products ordered and delivered by the delivery date specified in King’s purchase
order, provided that such Products meet the Specifications. Unless otherwise
specified in writing by Inyx, all orders placed by King with Inyx hereunder
shall be addressed as follows:
Inyx,
Inc.
000
Xxx
Xxxx Xxxx
Xxxxx
Xxxxx Xxxxxxxxxx Xxxx
Xxxxxx,
XX 00000
or
X.X.
Xxx
000
Xxxxxx,
XX 00000
Facsimile:
(000) 000-0000
Telephone:
(000) 000-0000
Attn:
Xxxxxxx Xxxxxxxxx
CONFIDENTIAL
TREATMENT
4
(b) Inyx
shall accept each purchase order submitted in accordance with this Section
2.3.
Inyx shall be obligated to manufacture and deliver the specified quantity
of
each Product in accordance with the delivery schedule set forth in such purchase
order. In addition, at all times during the Term, Inyx shall maintain at
its
facility one month of inventory of each Product calculated as the average
monthly unit sales for the prior six (6)-month period. If at any time during
the
term of this Agreement, the manufacturer believes it will be unable to supply,
on a timely basis, King with the full quantity of Product forecasted to be
or
actually ordered by King, Inyx shall promptly notify King.
(c) Any
purchase orders, purchase order releases, confirmations, acceptances, advices
and similar documents submitted by either party in conducting the activities
contemplated under this Agreement are for administration purposes only and
shall
not add to or modify the terms of this Agreement. To the extent of any conflict
or inconsistency between this Agreement and any such document, the terms
and
conditions of this Agreement shall control as to a particular order unless
otherwise agreed to in writing by the parties.
2.4 Changes
in Orders.
Inyx
shall exercise its commercially reasonable efforts to comply with proposed
amendments to purchase orders that King may request after sending a purchase
order to Inyx.
2.5 Delivery.
(a) Inyx
agrees to meet the delivery dates and order quantities indicated in King’s
binding and accepted firm orders for all Products. Any shipment delivered
that
is within plus or minus *** of the quantity ordered will be considered as
meeting such order quantity and any shipment ready to be shipped on a date
within plus or minus five (+/-5) Business Days of the delivery date specified
on
the relevant firm order will be considered as delivered on time.
(b) Inyx
shall ship Product on a carrier or carriers specified by King. Product shall
be
shipped under the designated procedures provided by King for transportation
of
Product. Title and risk of loss as to any Product purchased by King shall
pass
to King upon the earlier of (i) a common carrier accepting possession or
control
of such Product and (ii) the passage of such Product from the loading dock
of
Inyx’s facility to any employee, agent or contractor of King or such common
carrier. The costs of all freight, insurance, handling, fees, taxes and other
costs associated with the shipment of Product, as well as all export licenses,
import licenses and customs formalities for the import and export of goods
should be considered Collaboration Costs and ***.
2.6 Rejected
Goods/Shortages.
(a) King
shall notify Inyx in writing of (i) any claim relating to Product that fails
to
meet the Specifications or (ii) any shortage in quantity of any shipment
of
Product as soon as reasonably practical, but not later than forty-five (45)
days
of receipt of such Product. If the parties agree that such Product is defective
(and such defect is not related to the handling, storage and use by any Third
Party) or that there is a shortage, Inyx shall replace the defective Product
or
use its commercially reasonable efforts to make up the shortage, as applicable,
at the next practical delivery date, at no additional cost to King. King
shall
make arrangements with Inyx for the return or disposal of any rejected Product;
the costs of such return or disposal shall be paid by Inyx. In the event
that
only a limited supply of Product is available to replace or supply such
rejection or shortage, then Inyx shall ship to King such quantities of Product
as are available, and King will be promptly reimbursed or credited against
future orders, at King’s option, for amounts paid for the remaining quantity of
rejected Product.
CONFIDENTIAL
TREATMENT
5
(b) If
Inyx
disagrees with King’s claim that such Product fails to meet the applicable
Specifications, Inyx and King representatives shall attempt to resolve such
dispute. If the representatives cannot resolve such dispute, a sample of
such
Product shall be submitted by Inyx and King to a mutually agreed-to qualified
laboratory for testing against the Specifications, and the test results obtained
by such laboratory shall be final and controlling. The fees and expenses
of such
laboratory testing shall be borne entirely by the party whose Product analysis
was in error. In the event the test results indicate that the Product in
question does not conform to the Specifications, Inyx shall replace such
Product
at no additional cost to King as soon as reasonably possible after receipt
of
such results; provided,
however,
Inyx
shall have no liability to King if such Product fails to meet the
Specifications, if the Product: (i) has been tampered with or otherwise altered
other than by Inyx; (ii) has been subject to misuse, negligence or accident
other than by Inyx; or (iii) has been stored, handled or used by others in
a
manner contrary to applicable regulatory requirements. In the event that
only a
limited supply of Product is available to replace or supply such rejection
or
shortage, then Inyx shall ship to King such quantities of the applicable
Product
as are available, and King will be promptly reimbursed or credited against
future orders, at King’s option, for amounts paid for the remaining quantity of
rejected Product.
2.7 Capacity.
(a) In
the
event that Inyx, upon receiving a forecast under Section 2.2(b) or a purchase
order under Section 2.3, is, or anticipates that it will be, unable to meet
such
forecast or purchase order, either in whole or in part, due to any reason,
Inyx
shall give written notice of such inability to King within ten (10) Business
Days of receipt of such forecast or firm order. If such inability is partial,
Inyx shall fulfill firm orders with such quantities of Product as are available.
Inyx shall use its commercially reasonable efforts to ensure that firm orders
are supplied in full on a timely basis.
(b) Inyx
and
King shall meet within thirty (30) days of such written notice pursuant to
Section 2.7(a) to consider alternative arrangements for meeting King’s
requirements for Product, including obtaining King’s unfulfilled requirements
from a Third Party. Any alternative arrangements entered into pursuant to
this
Section 2.7(b) shall act in no way as a waiver of any other rights or remedies
which King or Inyx may have under this Agreement or otherwise; provided,
however,
King
shall have no obligation to pay for orders of Product that Inyx is unable
to
provide.
(c) In
the
event that Inyx’s inability to meet firm orders or forecasts is due to a
shortage of production capacity at Inyx’s facility, in addition to the
requirements of Sections 2.7(a) and 2.7(b) above, Inyx shall promptly
notify King of such shortage of production capacity, and, if possible, the
date
such shortage of production capacity is expected to end. Inyx shall give
priority to King’s firm orders, and satisfy and fulfill deliveries of Product
ordered pursuant to King’s firm orders prior to utilizing such production
capacity to produce products for any other Person, including Inyx and its
Affiliates.
CONFIDENTIAL
TREATMENT
6
(d) Inyx
shall notify King as soon as possible of the date upon which such shortage
of
production capacity will cease. Upon resumption of production of Products,
King
shall resume obtaining its requirements for Products from Inyx to the extent
such resumption is consistent with any contractual arrangements entered into
with Third Parties pursuant to Section 2.7(b).
2.8 Manufacturing
Changes.
(a) For
changes to the Specifications or manufacturing processes that are required
by
applicable Laws (collectively “Required
Manufacturing Changes”),
Inyx
and King shall cooperate in making such changes timely.
(b) For
changes to the Specifications or manufacturing process that are not Required
Manufacturing Changes (collectively “Discretionary
Manufacturing Changes”),
Inyx
and King must each agree to any Discretionary Manufacturing Changes and shall,
to the extent commercially reasonable under the circumstances, cooperate
in
making such changes, and each agrees that it shall not unreasonably withhold
its
consent to such Discretionary Manufacturing Changes. Notwithstanding the
foregoing, King’s standard change control procedures shall be utilized in
reviewing such changes.
(c) Notwithstanding
the foregoing, all internal and external costs, including, without limitation,
obsolete raw materials, work-in-process, Product, packaging and labeling
materials (i) associated with Required Manufacturing Changes shall be born
***,
and (ii) all such costs associated with Discretionary Manufacturing Changes
shall be borne by ***.
2.9 Labeling
and Packaging.
King
shall provide to Inyx master labeling specification documents and camera-ready
proofs of labeling for, and other printed materials to be included as part
of,
each Product, and King warrants that all such labeling and printed material
will
comply in all respects with all applicable Laws and the registration for
such
Product.
2.10 Raw
Materials.
(a) Except
with respect to the Initial Bulk Form, Inyx shall be solely responsible for
obtaining all Raw Materials required for the manufacture of each
Product.
(b) *
* * .
(c) In
the
event that any Initial Bulk Form purchased by Inyx pursuant to this Section
2.10
does not meet the quality standards applicable to such Initial Bulk Form,
King
will reimburse Inyx an amount equal to *** Initial Bulk Form. If King disagrees
with Inyx’s claim that such Initial Bulk Form fails to meet the applicable
quality standards, Inyx and King representatives shall attempt to resolve
such
dispute. If the representatives cannot resolve such dispute, a sample of
such
Initial Bulk Form shall be submitted by Inyx and King to a mutually agreed-to
qualified laboratory for testing, and the test results obtained by such
laboratory shall be final and controlling. The fees and expenses of such
laboratory testing shall be borne entirely by the party whose analysis was
in
error.
CONFIDENTIAL
TREATMENT
7
(d) Within
ten (10) days of receipt of notice from King that the Initial Bulk Form is
available for shipment to Inyx, Inyx will make all arrangements necessary,
at
its sole cost, to cause the Initial Bulk Form to be shipped to its manufacturing
facility. Title and the risk of loss of the Initial Bulk Form shall pass
to Inyx
upon the receipt of the Initial Bulk Form by a common carrier designated
by
Inyx.
(e) After
the
Initial Bulk Form has been received by such common carrier, King will invoice
Inyx for the amount of Initial Bulk Form being sold to Inyx. Payment shall
be
due within thirty (30) days of the date of such invoice. Interest on any
part of
the payment that is past due will be determined as described in Section 3.2.
Neither Inyx’s payment for the Initial Bulk Form nor the costs of transportation
or storage thereof will be Collaboration Costs.
ARTICLE
3
PRICING
AND PAYMENT
3.1 *
* *
.
3.2 Payment
/ Terms.
All
payments required by this Agreement shall be made in United States Dollars
by
wire transfer to an account designated by Inyx. All invoices are to be paid
in
full within thirty (30) days from the date of invoice. Invoices should be
submitted within thirty (30) days after the end of each calendar quarter
during
the Term. At the end of the year Inyx shall prepare a reconciliation statement
for the expenses incurred related to the COGS during the calendar year. If
such
reconciliation statement shall show that either party reasonably incurred
and
paid expenses in excess of the amount payable by such party, and that the
other
party paid expenses below the amount payable by such party, then within thirty
(30) days after such reconciliation statement is submitted to King, the
underpaying party shall reimburse the overpaying party for the amount of
such
underpayment up to the amount payable by to such overpaying party. In the
case
of a good faith dispute regarding payment, King may in its discretion determine
to pay such disputed amounts claimed by Inyx to be due, and, in the event
amounts are finally determined not to be due by King, Inyx shall repay to
King
such excess amounts determined not to be due, and interest shall accrue on
any
such amount, at the lesser of (i) the prime rate as reported by the Wall
Street
Journal, New York Edition, or any reputable publication mutually agreed to
by
the parties plus an additional *** or (ii) the maximum rate permitted by
Law,
with such interest to begin accruing on a daily basis from the date such
disputed payment was received by Inyx.
ARTICLE
4
TERM
AND TERMINATION
4.1 Term;
Supply of Product.
The
term of this Agreement (the “Term”)
will
commence upon the Effective Date and will continue, unless terminated earlier
in
accordance with the provisions of this Article 4, until the later of December
31, 2015 and the last date on which any Approved New Product is sold.
CONFIDENTIAL
TREATMENT
8
4.2 Early
Termination.
Either
King or Inyx may terminate this Agreement forthwith by notice in writing
to the
other party upon the occurrence of any of the following events:
(a) if
such
other party breaches in a material way any of the representations, warranties,
covenants, or agreements set forth in this Agreement or otherwise materially
defaults in the performance of any of its duties or obligations under this
Agreement, which breach or default is not cured within sixty (60) days after
written notice is given to the breaching party specifying the breach or
default;
(b) if
there
are two or more similar or substantially similar material breaches of this
Agreement by the breaching party within any 12 month period, which termination
will be effective thirty (30) days following such written notice; provided,
however, that any failure of a non-breaching party to exercise this termination
right with respect to certain breaches will not be deemed a waiver of the
ability of such non-breaching party to exercise this right upon any subsequent
breach;
(c) if
such
other party is declared bankrupt or insolvent, if there is an assignment
for the
benefit of creditors, or if a receiver is appointed or proceedings commenced
(and not dismissed within sixty (60) days), voluntarily or involuntarily,
under
any bankruptcy or similar law; or
(d) if
either
party provides at least three (3) years’ written notice to the other party.
4.3 Termination
by King.
i)
Subject
to the terms of Section 4.3(b) below, King will have the right to terminate
this
Agreement immediately upon written notice to Inyx if there is a Change of
Control of Inyx.
(b) *
* *
.
4.4 Consequences
of Termination and Survival.
Termination of this Agreement for whatever reason shall not affect the accrued
rights and obligations of either Inyx or King arising under or out of this
Agreement. The obligations under Article 6 (Product Recalls), Article 7
(Warranties), Article 8 (Nondisclosure and Confidentiality), Article 9
(Intellectual Property Rights), Article 10 (Indemnification and Insurance),
or
any other provision which expressly or by implication is intended to survive
expiration or termination shall survive expiration or termination of this
Agreement.
4.5 Payments
Upon Termination.
(a) The
expiration or termination of this Agreement pursuant to this Article 4 will
not
release either party from any obligation to pay to the other party any amounts
accrued under any of the Collaboration Documents in connection with activities
completed, Collaboration Costs incurred, and revenue realized with respect
to
the period prior to the effective date of such expiration or termination.
CONFIDENTIAL
TREATMENT
9
(b) Inyx
will
fulfill its obligations hereunder with respect to any orders received from
King
and accepted by Inyx prior to any expiration or termination of this
Agreement.
(c) Within
thirty (30) days after the expiration or termination of this Agreement, each
party will provide to the other a reasonably detailed statement of Collaboration
Costs incurred by such party hereunder or under any of the other Collaboration
Documents during the period of January 1 of the calendar year in which such
expiration or termination occurs through the effective date of such expiration
or termination; and (ii) any final reports with respect to revenue or net
sales
with respect to the Products during such period, as required by any of the
other
Collaboration Documents.
(d) Within
thirty (30) days after receipt of such information, the AMC will determine
the
net amounts due and or payable by Inyx and King, and such amounts will be
paid
by the parties within thirty (30) days after such AMC
determination.
(e) Inyx
will
deliver to King all Improvements and all documents, material, data, records,
analyses, and information related thereto.
4.6 Technical
Assistance.
Upon
expiration or termination of this Agreement, upon the requests of King, Inyx
shall provide King with the assistance of its employees and access to its
other
internal resources to provide King with a reasonable level of technical
assistance and consultation with the transfer of the Products to, and the
regulatory qualification of, a finished goods supplier of King’s
election.
ARTICLE
5
CERTIFICATES,
ACCESS AND REGULATORY MATTERS
5.1 Testing;
Certificate of Analysis.
Inyx
shall perform, or cause to be performed the tests required to be performed
by
Inyx pursuant to the Quality Agreement on each lot of Product manufactured
pursuant to this Agreement before delivery to King. Each test report shall
set
forth the items tested, Specifications and test results in a certificate
of
analysis, containing the types of information which shall have been approved,
by
mutual agreement of the parties, for each lot delivered. Inyx shall send,
or
cause to be sent, such certificates to King prior to delivery of each lot
unless
otherwise agreed. In addition, Inyx will supply King with reference standards
for normal commercial testing at Inyx’s expense. All other reference standards
requested by King shall be provided by Inyx to King at King’s
expense.
5.2 Notice
of Failure to Meet Specifications.
Upon
Inyx’s discovery that any batch or lot of Product fails to conform to the
applicable Specifications, Inyx will notify King within forty-eight hours
of
such failure to meet the applicable Specifications and of the nature thereof
in
detail, including, but not limited to, supplying King with all investigatory
reports, data, and communications, out-of-specification reports and data
and the
results of all outside laboratory testing and conclusions, if any. Inyx shall
investigate all such failures promptly, and at its expense, cooperate with
King
in determining the cause for the failure and a corrective action to prevent
future failures.
CONFIDENTIAL
TREATMENT
10
5.3 Records.
Inyx
shall maintain all manufacturing, packaging, analytical and stability records,
all records of shipment, and all validation data relating to the Product
to the
extent and for the time periods required by applicable Laws with respect
to the
Product.
5.4 Regulatory
Compliance.
Inyx
shall advise King promptly if an authorized agent of a Regulatory Authority
visits its manufacturing facilities where the Product is being manufactured
or
quality tested. Inyx shall furnish to King all material information supplied
to,
or supplied by, any Regulatory Authority, including the Form 483 observations
and responses, to the extent that such report relates to the Product, or
the
ability of Inyx to supply such Product, within forty-eight hours of their
receipt of such information or delivery of such information, as the case
may be.
King shall have fifteen (15) days to review and provide comments to Inyx
prior
to Inyx responding to any Regulatory Authority. Should Inyx choose not to
include or address King’s comments when responding to the Regulatory Authority,
then Inyx shall provide King a reason as to why King’s comments were not
included or addressed. Before Inyx responds to any Regulatory Authority,
King
shall have the right to review and approve such final response.
5.5 Changes.
In
addition to the requirements of Section 2.8, Inyx shall not change the critical
specified raw materials, packaging materials, their source, analytical test
procedures or critical manufacturing conditions or critical manufacturing
equipment used in the manufacture of Product without the prior written consent
of King, which consent shall not be unreasonably withheld.
5.6 Access
to Facilities.
Upon
the reasonable prior written request of King, King shall have the right to
inspect those portions of the manufacturing, storage and testing facilities
of
Inyx where Product is being manufactured, stored or tested, as the case may
be,
during regular business hours, to ascertain compliance with cGMPs and the
Specifications. If the FDA or other applicable Regulatory Authority asserts
any
notice to the effect that Inyx has failed to comply with any applicable Law
in
connection with the manufacture of Product, or if Inyx delivers Product that
does not meet the applicable Specifications, then King shall have the right
to
inspect such portions of the manufacturing facilities of Inyx that relate
to the
manufacture and testing of such Product upon reasonable notice and during
normal
business hours. Notwithstanding the provisions of this Section 5.6, King
shall
have no obligation nor be deemed to have an obligation to inspect the facilities
of Inyx.
5.7 Product
Inquiries and Complaints.
Inyx
will promptly submit to King all Product safety and efficacy inquiries, Product
quality complaints and adverse drug event reports received by Inyx, together
with all available evidence and other information relating thereto, in
accordance with procedures to be agreed upon by the parties. Except as otherwise
required by Law or governmental regulation, King, as the party holding the
applicable NDA, will be responsible for investigating and responding to all
such
inquiries, complaints and adverse events regarding Product. It shall be the
responsibility of King, as the party holding the applicable NDA, to comply
with
all applicable national, federal, state and local governmental reporting
requirements regarding adverse drug events and Product quality
matters.
CONFIDENTIAL
TREATMENT
11
5.8 Response
to Complaints and/or Adverse Drug Events.
(a) Pursuant
to a reported complaint and/or adverse drug event, if the nature of the reported
complaint and/or adverse drug event requires testing during the period, Inyx
will, upon King’s request and approval and at Inyx’s reasonable expense, perform
analytical testing of corresponding retention samples and provide the results
thereto to King as soon as reasonably practicable. King as the party holding
the
applicable NDA shall remain responsible for reporting to the FDA or any other
Regulatory Authority. Such testing shall be performed using NDA approved
testing
procedures as set forth in the applicable NDA.
(b) If
the
parties disagree as to which party is responsible, Inyx and King representatives
shall attempt to resolve such dispute. If the representatives cannot resolve
such dispute, the retention samples shall be submitted by Inyx and King to
a
mutually agreed-to qualified laboratory for testing, and the test results
obtained by such laboratory shall be final and controlling. The fees and
expenses of such laboratory testing shall be borne entirely by the party
whose
analysis was in error.
5.9 Additional
Information.
Each
party shall provide to the other in a timely manner, but in no event less
than
sixty (60) days prior to the due date of such party’s annual report to the FDA
or any other Regulatory Authority with respect to the Products, all information
in written form which such party requests regarding the Products in order
to
comply with applicable Laws.
5.10 Quality
Agreement.
Each
party shall perform the duties required of it pursuant to the Quality Agreement
to be entered into by the parties. To the extent the Quality Agreement conflicts
with this Agreement with respect to a quality issue, the Quality Agreement
shall
control.
ARTICLE
6
PRODUCT
RECALLS
6.1 Product
Recalls.
In the
event (i) any Regulatory Authority issues a request, directive or order that
Product be recalled, (ii) a court of competent jurisdiction orders such a
recall, or (iii) King as holder of the applicable NDA shall reasonably determine
that Product should be recalled, withdrawn or a field correction issued,
the
parties shall take all appropriate corrective actions, and shall cooperate
in
the investigations surrounding the recall. In the event that King as applicable
NDA holder determines that Product should be recalled, to the extent possible,
King shall consult with Inyx prior to taking any corrective actions. In the
event of any Product recall, withdrawal, or field correction resulting solely
from Inyx’s negligence or any cause or event arising from the failure of Inyx to
manufacture, test, store or handle Bulk Forms or Products in accordance with
cGMP and the Specifications, (a) Inyx shall bear all reasonable costs associated
with such recall, withdrawal, or field correction, which shall include the
expenses of notification and destruction or return of the recalled Product
and
all other documented out-of-pocket costs incurred in connection with such
recall, and (b) Inyx shall, subject to King’s election, either supply the
Product, without charge to King, in an amount sufficient to replace the amount
of the Product recalled, withdrawn or subject to field correction, or refund
King, or give credit to King against outstanding receivables due from King
against the purchase price for shipments of the Product to be delivered to
King
in the future, in amounts equal to *** for Products so recalled, withdrawn
or
subjected to field correction, plus reasonable transportation costs incurred
by
King with respect to such Product. All costs associated with any other type
of
Product recall, withdrawal, or field correction shall be deemed Collaboration
Costs and will be ***.
CONFIDENTIAL
TREATMENT
12
6.2 Disputes.
If
there is any dispute concerning which party’s acts or omissions gave rise to
such recall of Product, such dispute shall be referred for decision to an
independent expert, acting as an expert and not as an arbitrator, to be
appointed by agreement between King and Inyx. The decision of such independent
expert shall be in writing and, except for manifest error on the face of
the
decision, shall be binding on both King and Inyx. The costs of such independent
expert shall be borne by the party who is found to be responsible for the
recall
by the independent expert. After such determination, costs shall be paid
by the
responsible party in accordance with Section 6.1.
ARTICLE
7
WARRANTIES
7.1 Compliance
with cGMP.
Inyx
warrants that all Product will be manufactured in conformity with
cGMP.
7.2 Conformity
with Specifications.
Inyx
warrants that Product manufactured by Inyx and sold to King pursuant to this
Agreement will meet the Specifications at the time of delivery to the common
carrier for such Product in effect at the time of manufacture.
7.3 Compliance
with the Act.
Inyx
warrants that all Product delivered to King pursuant to this Agreement will,
at
the time of such delivery, not be adulterated within the meaning of the Act
and
will not be an article which may not, under the provisions of such Act, be
introduced into interstate commerce.
7.4 No
Liens.
Inyx
warrants that all Product delivered to King pursuant to this Agreement will,
at
the time of such delivery, be free and clear of all liens, encumbrances,
security interests and other encumbrances.
7.5 Compliance
with Applicable Laws.
During
the term of this Agreement, Inyx shall comply in all material respects with
all
Laws applicable to the conduct of its business in the performance of this
Agreement.
7.6 Raw
Materials and Components.
Inyx
represents and warrants to King that it currently has access to sufficient
supplies of Raw Materials and other required resources to perform the services
required under this Agreement.
7.7 FDA
Debarment.
As of
the Effective Date, neither Inyx nor any of its employees or agents, in their
capacity as such, have been disqualified or debarred by the FDA, pursuant
to 21
U.S.C. §§ 335(a) or (b), or been charged with or convicted under United States
law for conduct relating to the development or approval, or otherwise relating
to the regulation of any Product under the Generic Drug Enforcement Act of
1992,
or any other relevant law, rule, or regulation or been disbarred, disqualified,
or convicted under or for any equivalent or similar applicable foreign law,
rule, or regulation.
CONFIDENTIAL
TREATMENT
13
7.8 Exclusion
of Other Warranties.
EXCEPT
WHERE OTHERWISE SET FORTH IN THIS AGREEMENT OR THE OTHER COLLABORATION
DOCUMENTS, SECTIONS 7.1, 7.2, 7.3, 7.4, 7.5, 7.6 AND 7.7 ARE IN LIEU OF ALL
CONDITIONS, WARRANTIES AND STATEMENTS IN RESPECT OF PRODUCT AND THE SERVICES
PROVIDED HEREUNDER, WHETHER EXPRESSED OR IMPLIED BY STATUTE, CUSTOM OF THE
TRADE
OR OTHERWISE, INCLUDING BUT WITHOUT LIMITATION ANY SUCH CONDITION, WARRANTY
OR
STATEMENT RELATING TO THE DESCRIPTION OR QUALITY OF PRODUCT, ITS MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE OR USE UNDER ANY CONDITIONS, AND ANY
SUCH
CONDITION, WARRANTY OR STATEMENT IS HEREBY EXCLUDED.
7.9 Limitation
of Liability.
IN NO
EVENT SHALL INYX OR KING AND/OR THEIR RESPECTIVE AFFILIATES BE LIABLE UNDER
OR
WITH RESPECT TO THIS AGREEMENT FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL,
SPECIAL OR PUNITIVE DAMAGES OF ANY KIND, INCLUDING BUT NOT LIMITED TO LOSS
OF
PROFITS OR DUE TO BREACH OF WARRANTY, TORT, BREACH OR REPUDIATION OF ANY
TERM OR
CONDITION OF THIS AGREEMENT.
ARTICLE
8
NONDISCLOSURE
AND CONFIDENTIALITY
8.1 Nondisclosure
Obligations.
(a) Each
party acknowledges that it may receive confidential or proprietary information
(the “Confidential
Information”)
of the
other party in the performance of the Collaboration Documents, including
information obtained or reviewed in connection with any audits or investigations
performed pursuant to this Agreement. Each party will hold confidential and
will
not, directly or indirectly, disclose, publish, or use for the benefit of
any
Third Party or itself, except in carrying out its duties under the Collaboration
Documents, any confidential or proprietary information of the other party
or
confidential or proprietary information jointly developed by the parties,
without first having obtained the furnishing party’s written consent to such
disclosure or use. “Confidential
Information”
will
include know-how, scientific information, clinical data, efficacy and safety
data, adverse event information, formulas, methods and processes,
specifications, pricing information (including discounts, rebates, and other
price adjustments), and other terms and conditions of sales, customer
information, business plans, and all other intellectual property. The Patent
Rights and Technology will be deemed the Confidential Information of King.
The
restrictions in this Article 8 will not apply to any information
that:
(i) is
or
becomes part of the public domain other than by unauthorized acts of the
receiving party or its Affiliates, sublicensees, Consultants, and contractors,
as applicable;
CONFIDENTIAL
TREATMENT
14
(ii) can
be
shown by written documentation to have been disclosed to the receiving party
or
its Affiliates or sublicensees by a Third Party who was not otherwise prohibited
from transmitting the information to the receiving party by a contractual,
legal, or fiduciary obligation of confidence to the disclosing
party;
(iii) prior
to
disclosure under this Agreement, was already in the possession of the receiving
party or its Affiliates or sublicensees, provided such information was not
obtained directly or indirectly from the other party hereto pursuant to a
confidentiality agreement;
(iv) can
be
shown by written documentation to have been independently developed by the
receiving party or its Affiliates without breach of any of the provisions
of
this Agreement, including without reference to the Confidential Information
of
the disclosing party;
(v) is
disclosed by the receiving party pursuant to oral questions, interrogatories,
requests for information or documents, subpoena, or a civil investigative
demand
of a court or governmental agency; provided, however, that the receiving
party
notifies the other party promptly following receipt thereof so that the other
may seek a protective order or other appropriate remedy to prevent or limit
such
disclosure; and provided further that the receiving party furnishes only
that
portion of the information that it is advised by counsel is legally required
and
imposes such obligations of secrecy as are possible in that regard;
(vi) is
required or permitted to be disclosed by the receiving party under any
statutory, regulatory, or similar legislative requirement or any rule of
any
stock exchange to which it or any Affiliate is subject; provided, however,
that
the other party will be allowed to review the proposed disclosure and the
receiving party agrees to consider in good faith any proposed revisions thereof
provided to the receiving party within two (2) business days of the other
party’s receipt of the proposed disclosure, and the parties will seek
confidential treatment for such disclosure as permitted by applicable law;
or
(vii) is
required by authorities to obtain Regulatory Approval.
(b) The
receiving party agrees that it will disclose the Confidential Information
only
to its employees and Consultants who need to know such Confidential Information
for such party to perform its obligations hereunder. The receiving party
agrees
(i) to inform all of its employees and Consultants who receive Confidential
Information of the confidential nature thereof and to direct all such employees
and Consultants to treat the Confidential Information confidentially in
accordance with this Agreement; (ii) to be responsible for any breach of
the
Agreement by any of its employees and Consultants; and (iii) to make all
reasonable, necessary, and appropriate efforts to safeguard the Confidential
Information from disclosure other than as permitted hereby, which will include
requiring all employees and Consultants who have access to Confidential
Information of the disclosing party to execute written obligations to maintain
the same in confidence and not to use such information except as expressly
permitted under the Collaboration Documents. Each party agrees to enforce
confidentiality obligations to which its employees and Consultants are
obligated.
CONFIDENTIAL
TREATMENT
15
(c) Upon
the
expiration or termination of this Agreement or upon request of the disclosing
party, the receiving party will return to the disclosing party any and all
Confidential Information of the disclosing party and any reproductions
thereof.
(d) The
obligations set forth in this Article 8 will survive the termination or
expiration of this Agreement for a period of five (5) years (or, in the case
of
any Confidential Information identified as a trade secret by the disclosing
party at the time of disclosure, for so long as such trade secret Confidential
Information is susceptible of remaining a trade secret).
8.2 Terms
of this Agreement.
The
parties agree not to disclose any terms or conditions of this Agreement to
any
Third Party without the prior consent of the other parties, except as required
by applicable Laws.
8.3 Injunctive
Relief.
The
parties hereto understand and agree that remedies at Law may be inadequate
to
protect against any breach of any of the provisions of this Article 8 by
either
party or their employees, agents, officers or directors or any other person
acting in concert with it or on its behalf. Accordingly, each party may be
entitled to the granting of injunctive relief by a court of competent
jurisdiction against any action that constitutes any such breach of this
Article
8.
8.4 Production
of Generics.
During
the Term, and for two (2) years following the termination or expiration of
this
Agreement, Inyx shall not, and shall not permit any of its Affiliates to,
sell,
produce, manufacture, market or distribute any generic product identical
to the
Product in the Territory.
ARTICLE
9
INTELLECTUAL
PROPERTY RIGHTS
9.1 Ownership
of Tangible Materials.
King
shall retain ownership of all information, documents and materials which
King
provides to Inyx in connection with the performance of the services by Inyx
hereunder, and King shall have the right to use, all reports, documents and
other tangible materials which Inyx provides to King in the performance of
such
services. Any such Confidential Information, documents, and materials shall
be
subject to Article
8.
Furthermore, King will have sole and exclusive ownership of all right, title,
and interest on a worldwide basis, with full rights to license or sublicense,
subject to the licenses granted Inyx in the Collaboration Documents, in and
to
any and all
(a) the
Products and New Products,
(b) Technology
transferred to Inyx’s facilities pursuant to this Agreement,
(c) Technology
and Patent Rights as they exist as of the Effective Date, and
(d) any
Improvements to the Technology and associated Patent Rights, developed after
the
Effective Date during the Term, whether developed by King or Inyx or jointly
by
King and Inyx and any permitted Third Parties, including all rights to any
Technology and Patent Rights related to Excluded New Products;
CONFIDENTIAL
TREATMENT
16
provided
that such ownership of right, title, and interest does not extend to the
Inyx
Respiratory Products.
9.2 Inventions
Disclosure and Generally.
Each
Party will promptly provide the AMC with written notice concerning all
Improvements that are conceived, made, or developed in the course of carrying
out the Collaboration Program by employees or Consultants of either of them
or
their Affiliates, alone or jointly with employees or Consultants of the other
Party or its Affiliates or permitted Third Parties. Such notice will be treated
as the Confidential Information of King hereunder.
9.3 Assignment.
Inyx
agrees to, and hereby does, and will cause each of its employees, Consultants,
Affiliates and permitted submanufacturers (collectively with Inyx, the
“Assignors”)
to,
transfer, assign, and convey exclusively to King, its successors and assigns,
forever, the entire right, title, and interest in and to all Improvements
developed by each such Assignor, alone or jointly with each other or King,
including all intellectual property rights associated therewith. Inyx further
agrees, and will cause the other Assignors, (i) to promptly provide King
with
written notice, in sufficient detail, of any Improvements such Assignor makes
pursuant to the Collaboration Documents and (ii) to provide King with such
additional information and to execute and deliver, and to cause the other
Assignors to execute and deliver, any documents or take any other actions
or
otherwise cooperate with King as may reasonably be necessary, or as King
may
reasonably request, to document, enforce, protect, or otherwise perfect King’s
rights in any Improvement, including filing any applicable patent
applications.
9.4 Employees.
Inyx
agrees to have each employee enter into a written agreement with Inyx that
includes an assignment to Inyx, or directly to King with respect to
Improvements, of all right, title and interest in and to all work product
and
all inventions arising during the course of his or her employment with Inyx
in
connection with such Improvements or the Collaboration Program, and all
intellectual property rights attaching thereto.
ARTICLE
10
LIMITATION
OF LIABILITY, INDEMNIFICATION AND INSURANCE
10.1 Indemnification
by King.
Except
as otherwise specifically provided, King and/or its Affiliates shall indemnify
and hold harmless Inyx and its Affiliates against all claims, actions, costs,
expenses, including court costs and legal fees on a full indemnity basis,
or
other liabilities (“Liabilities”)
whatsoever in respect of:
(a) any
negligence or willful misconduct by King and/or its Affiliates in relation
to
the use, marketing, manufacture, storage, distribution, handling or sale
of
Product;
(b) any
labeling of any Product to the extent that such labeling has been supplied
by or
at the direction of King and/or its Affiliates and applied in accordance
with
instructions from King; and
CONFIDENTIAL
TREATMENT
17
(c) any
representation or warranty made by King and/or its Affiliates to its customers
or users with respect to Product, other than representations or warranties
contained in Sections 7.1, 7.2, 7.3, 7.4, 7.5, 7.6 or 7.7;
provided,
however, that King will not be required to indemnify Inyx with respect to
any
such Liability hereunder to the extent the same is caused primarily by any
breach of contract, negligent act or omission or intentional misconduct by
Inyx
or any or its Affiliates or is otherwise covered by Inyx’s indemnification
obligation in Section 10.2.
10.2 Indemnification
by Inyx.
Except
as otherwise specifically provided, Inyx shall indemnify and hold harmless
King
against all Liabilities whatsoever in respect of:
(a) Inyx’
and/or its Affiliates’ failure to comply with the Specifications, cGMP, or
applicable Laws; and
(b) any
breach of a representation or warranty made by Inyx and/or its Affiliates
in
Article 7;
(c) any
negligence or willful misconduct by Inyx and/or its Affiliates in the
manufacture, testing, storage and handling of Product;
provided,
however, that Inyx will not be required to indemnify King with respect to
any
such Liability hereunder to the extent the same is caused primarily by any
breach of contract, negligent act or omission or intentional misconduct by
King
or any or its Affiliates or is otherwise covered by King’s indemnification
obligation in Section 10.1.
10.3 Procedures
for Indemnification for Third-Party Claims.
A party
(the “indemnitee”)
that
intends to claim indemnification under this Article 10 will notify the other
party (the “indemnitor”)
within
a reasonable time in writing of any action, claim, or liability in respect
of
which the indemnitee believes it is entitled to claim indemnification; provided
that the failure to give timely notice to the indemnitor will not release
the
indemnitor from any liability to the indemnitee except to the extent the
indemnitor is actually prejudiced thereby. The indemnitor will have the right,
by notice to the indemnitee, to assume the defense of any such action or
claim
within the fifteen (15) day period after the indemnitor’s receipt of notice of
any action or claim with counsel of the indemnitor’s choice and at the sole cost
of the indemnitor. If the indemnitor does not so assume the defense of such
Third Party claim, the indemnitee may assume such defense with counsel of
its
choice and at the sole cost of the indemnitor. If the indemnitor so assumes
such
defense, the indemnitee may participate therein through counsel of its choice,
but at the sole cost of the indemnitee. The party not assuming the defense
of
any such claim will render all reasonable assistance to the party assuming
such
defense, and all reasonable out-of-pocket costs of such assistance will be
for
the account of the indemnitor. No such claim will be settled other than by
the
party defending the same, and then only with the consent of the other party,
which will not be unreasonably withheld; provided that the indemnitee will
have
no obligation to consent to any settlement of any such action or claim that
imposes on the indemnitee any liability or obligation that cannot be assumed
and
performed in full by the indemnitor, and the indemnitee will have no right
to
withhold its consent to any settlement of any such action or claim if the
settlement involves only the payment of money by the indemnitor or its
insurer.
CONFIDENTIAL
TREATMENT
18
10.4 Distribution/
Product Liability Insurance.
King
and Inyx shall obtain and maintain in effect for the term of this Agreement,
liability insurance or indemnity policies, in an amount not less than ***
in the
aggregate with an indemnity to principals clause with respect to products
liability and distribution. Such policies shall be blanket policies and shall
insure against liability on the part of each party and any of its Affiliates,
as
their interests may appear, due to injury, disability or death of any person
or
persons, or injury to property, arising from the distribution of Products.
Upon
the execution of this Agreement and thereafter on January 1 of each year
during
the Term, Inyx shall provide to King a certificate of insurance (i) summarizing
the insurance coverage and (ii) identifying any exclusions. Each party shall
promptly notify the other of any material adverse alterations to the terms
of
this policy or decreases in the amounts for which insurance is provided.
Either
party may satisfy its obligations hereunder through self-insurance to the
same
extent.
10.5 Product
Liability Claims.
As soon
as it becomes aware, each party will give the other prompt written notice
of any
defect or alleged defect in a Product, any injury alleged to have occurred
as a
result of the use or application of the Product, and any circumstances that
may
give rise to litigation or recall of a Product or regulatory action that
may
affect the sale or manufacture of a Product, specifying, to the extent the
party
has such information, the time, place and circumstances thereof and the names
and addresses of the persons involved. Each party will also furnish promptly
to
the other copies of all papers received in respect of any claim, action or
suit
arising out of such alleged defect, injury or regulatory action.
ARTICLE
11
GENERAL
PROVISIONS
11.1 Notices.
Except
as otherwise specifically provided herein, any notice or other documents
to be
given under this Agreement will be in writing and will be deemed to have
been
duly given if sent by registered post, nationally recognized overnight courier,
or confirmed facsimile transmission to a party (followed by hard copy by
mail),
or delivered in person to a party at the address or facsimile number set
out
below for such party or such other address as the party may from time to
time
designate by written notice to the other:
If
to
King:
King
Pharmaceuticals, Inc.
000
Xxxxx
Xxxxxx
Xxxxxxx,
Xxxxxxxxx 00000
Attn:
President
Facsimile:
(000) 000-0000
CONFIDENTIAL
TREATMENT
19
with
a
copy to:
King
Pharmaceuticals, Inc.
000
Xxxxx
Xxxxxx
Xxxxxxx,
Xxxxxxxxx 00000
Attn:
Executive Vice President and General Counsel
Facsimile:
(000) 000-0000
and
Xxxxx
Day
000
Xxxx
00xx Xxxxxx
Xxx
Xxxx,
Xxx Xxxx 00000
Attn:
Xxxx X. Xxxxxx, Esq.
Facsimile:
(000) 000-0000
If
to
Inyx:
Inyx,
Inc.
000
Xxxxx
Xxxxxx
00xx
Xxxxx
Xxx
Xxxx,
Xxx Xxxx 00000
Attn:
Chairman and CEO
Facsimile:
(000) 000-0000
with
a
copy to:
Xxxxxxx
Xxxxx LLP
10th
Floor, 00000-000 Xxxxxx
Xxxxxxxx,
Xxxxxxx
Xxxxxx
X0X 0X0
Attn:
Xxxx X. Xxxxxxxxxx, Q.C.
Facsimile:
(000) 000-0000
Any
such
notice or other document will be deemed to have been received by the addressee
three (3) business days following the date of dispatch of the notice or other
document by post or, where the notice or other document is sent by overnight
courier, by hand, or is given by facsimile, simultaneously with the transmission
or delivery thereof.
11.2 Entire
Agreement.
This
Agreement with the Exhibits and Schedules attached hereto, together with
the
other Collaboration Documents, contains all of the terms agreed to by the
Parties regarding the subject matter hereof and thereof and supersede any
prior
agreements, understandings, or arrangements between them, whether oral or
in
writing. This Agreement may not be amended, modified, altered, or supplemented
except by means of a written agreement or other instrument executed by both
of
the parties hereto. No course of conduct or dealing between the parties will
act
as a modification or waiver of any provisions of this Agreement. Any other
terms
and conditions, including without limitation any terms and conditions contained
in any purchase order or sales invoice issued pursuant to this Agreement,
are
hereby expressly excluded.
CONFIDENTIAL
TREATMENT
20
11.3 Equitable
Relief.
The
parties understand and agree that, in view of the uniqueness of the Product
and
the long term supply of the Product contemplated hereunder, King shall be
entitled to equitable relief in the event that Inyx breaches its obligations
to
supply the Product hereunder in addition to any other remedy to which King
may
be entitled by law.
11.4 Force
Majeure.
Neither
party will be liable to the other party for any failure to perform as required
by this Agreement if the failure to perform is due to circumstances reasonably
beyond such party’s control including acts of God, civil disorders or
commotions, acts of aggression, fire, explosions, floods, drought, war,
sabotage, embargo, utility failures, material shortages, a national health
emergency, or appropriations of property. A party whose performance is affected
by a force majeure event will take prompt action using its reasonable best
efforts to remedy the effects of the force majeure event. If, as a result
of a
force majeure event, a party is unable to fully perform its obligations
hereunder for any consecutive period of one hundred eighty (180) days, the
other
party will have the right to terminate this Agreement, upon providing written
notice to the nonperforming party, such termination to be effective thirty
(30)
days from the date of such notice.
11.5 Relationship
of the Parties.
The
parties hereto are acting and performing as independent contractors, and
nothing
in this Agreement creates the relationship of partnership, joint venture,
sales
agency, or principal and agent. Neither party is the agent of the other,
and
neither party may hold itself out as such to any other party. All financial
obligations associated with each party’s business will be the sole
responsibility of such party.
11.6 Publicity.
Any
press release, publicity or other form of public written disclosure related
to
this Agreement prepared by one party shall be submitted to the other party
prior
to release for approval, which approval shall not be unreasonably withheld
by
such other party.
11.7 Use
of
Party’s Name.
Except
as expressly provided or contemplated hereunder and except as otherwise required
by applicable law, no right is granted pursuant to this Agreement to either
party to use in any manner the trademarks or name of the other party, or
any
other trade name, service xxxx, or trademark owned by or licensed to the
other
party in connection with the performance of the Agreement. Notwithstanding
the
above, either party shall be permitted to use the other party’s name and marks,
as may be required under applicable law, in connection with securities or
other
public filings.
11.8 Severability.
In the
event that any of the provisions or a portion of any provision of this Agreement
is held to be invalid, illegal, or unenforceable by a court of competent
jurisdiction or a governmental authority, such provision or portion of provision
will be construed and enforced as if it had been narrowly drawn so as not
to be
invalid, illegal, or unenforceable, and the validity, legality, and
enforceability of the enforceable portion of any such provision and the
remaining provisions will not be adversely affected thereby.
CONFIDENTIAL
TREATMENT
21
11.9 Assignment.
Inyx
may not assign or otherwise transfer this Agreement or any interest herein
or
right hereunder without the prior written consent of King, and any such
purported assignment, transfer, or attempt to assign or transfer any interest
herein or right hereunder will be void and of no effect. King may freely
assign
and otherwise transfer this Agreement or any interest herein or right hereunder
without Inyx’s consent. Subject to the foregoing, this Agreement will be binding
upon and inure to the benefit of the parties hereto and their respective
permitted successors and assigns. In addition, King may assign its rights
under
this Agreement as security to one or more financial institutions providing
financing to King and may be assigned pursuant to the terms of the security
agreement.
11.10 Governing
Law.
This
Agreement will be construed under and in accordance with, and governed in
all
respects by, the laws of the State of New York, without regard to its conflicts
of law principles.
11.11 Consent
to Jurisdiction.
Each of
the parties hereby submits to the exclusive general jurisdiction of the courts
of the State of New York and the courts of the United States of America for
the
Eastern District of New York in any action or proceeding arising out of or
relating to this Agreement and to the jurisdiction of the appellate courts
to
which appeals are required to be taken from any of the foregoing. Each of
the
parties waives any defense of inconvenient forum to the maintenance of any
such
action or proceeding. Any party may make service on any other party by sending
or delivering a copy of the process to the party to be served at the address
and
in the manner provided for the giving of notices in Section
11.1
above.
Nothing in this Section
11.11,
however, will affect the right of any party to serve legal process in any
other
manner permitted by law or equity.
11.12 Headings.
The
headings contained in this Agreement are for reference purposes only and
will
not affect in any way the meaning or interpretation of this
Agreement.
11.13 Non-Waiver.
The
failure of either party to enforce or to exercise, at any time or for any
period
of time, any term of or any right arising pursuant to this Agreement does
not
constitute, and will not be construed as, a waiver of such term or right,
and
will in no way affect that party’s right later to enforce or exercise such term
or right.
11.14 Interpretation.
The
parties hereto acknowledge and agree that: (a) each party and its
representatives have reviewed and negotiated the terms and provisions of
this
Agreement and have contributed to its revision; and (b) the terms and provisions
of this Agreement will be construed fairly as to each party hereto and not
in
favor of or against either party regardless of which party was generally
responsible for the preparation or drafting of this Agreement.
11.15 Third
Party Beneficiaries.
This
Agreement is not intended to confer upon any non-party rights or remedies
hereunder, except as may be received or created as part of a valid
assignment.
11.16 Further
Assurances.
Each of
Inyx and King agrees to duly execute and deliver, or cause to be duly executed
and delivered, such further instruments and do and cause to be done such
further
acts and things, including the filing of such additional assignments,
agreements, documents, and instruments, that may be necessary or as the other
party hereto may at any time and from time to time reasonably request in
connection with the Collaboration Documents or to carry out more effectively
the
provisions and purposes of, or to better assure and confirm unto such other
party its rights and remedies under, the Collaboration Documents.
CONFIDENTIAL
TREATMENT
22
11.17 Certain
Expenses and Commissions.
Except
as otherwise expressly set forth in this Agreement or the other Collaboration
Documents, the parties hereto will each pay all their costs and expenses,
including legal and accounting fees, incurred in connection with the
preparation, negotiation, execution, and delivery of the Collaboration Documents
and will indemnify and hold the other harmless from and against any and all
other claims or liabilities for such costs and expenses incurred by reason
of
any action taken by any such party.
11.18 Counterparts.
This
Agreement will become binding when any one or more counterparts hereof,
individually or taken together, will bear the signatures of each of the parties
hereto. This Agreement may be executed in any number of counterparts, each
of
which will be deemed an original as against the party whose signature appears
thereon, but all of which taken together will constitute but one and the
same
instrument.
[Signatures
on Following Page]
IN
WITNESS WHEREOF, the parties hereto have each caused this Agreement to be
duly
executed as of the Effective Date.
INYX, INC. | ||
|
|
|
By: | /s/ Xxxx Xxxxxxx | |
Xxxx Xxxxxxx |
||
Chairman and CEO |
KING PHARMACEUTICALS, INC. | ||
|
|
|
By: | /s/ Xxxxx Xxxxxxxx | |
Xxxxx Xxxxxxxx |
||
President and CEO |
CONFIDENTIAL
TREATMENT
SCHEDULE
3.1
INITIAL
PRODUCT COSTS
Intal
8.1 gm; 112 dose
***/unit
for Intal CFC Inhaler Product
*
Intal
HFA Formulation Product will cost approximately *** more due to increased
component costs for such Product’s metered dose inhalers (“MDIs”).
Intal
14.2 gm; 200 dose
***/unit
for Intal CFC Inhaler Product
*
Intal
HFA Formulation Product will cost approximately *** more due to increased
component costs for such Product’s MDIs.
Tilade
16.2 gm; 104 dose
***/unit
for Tilade CFC Inhaler Product
*
Tilade
HFA version will cost approximately *** more due to increased component costs
for such product’s MDIs.
The
costs
indicated above do not include the costs associated with the Initial Bulk
Form,
for which, as provided in Section 2.10, Inyx will be solely
responsible.
CONFIDENTIAL
TREATMENT