Exhibit 10.13.4
---------------
CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF
THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY
FILED WITH THE COMMISSION***
CONFIDENTIAL TREATMENT
DEVELOPMENT AGREEMENT
---------------------
THIS DEVELOPMENT AGREEMENT (the "Agreement") is made and entered into
as of the fourth _ day of March, 2003 (the "Effective Date"), by and between
▇▇▇▇▇▇▇ LABORATORIES, INC. ("▇▇▇▇▇▇▇") and INyX PHARMA LIMITED ("INyX"). INyX is
a company organized under the laws of England and Wales with its principal place
of business at ▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇. ▇▇▇▇▇▇▇
is a New York corporation with its principal place of business at ▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇.
BACKGROUND:
Subject to the terms and conditions contained in this Agreement,
▇▇▇▇▇▇▇ desires to engage INyX to assist in ▇▇▇▇▇▇▇'▇ development of the
"Products" (as hereinafter defined), and INyX desires to accept such
appointment.
NOW, THEREFORE, FOR AND IN CONSIDERATION of the premise, the mutual
promises, covenants and agreements contained herein, and other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
parties hereto hereby agree as follows:
ARTICLE 1
DEFINITIONS
-----------
The following words, terms and phrases, when used herein, shall have
the following respective meanings:
1.1 "Batch" shall mean the quantity of cans as agreed between both
parties of the Products, produced pursuant to a single purchase order during the
same cycle of manufacture.
1.2 "BioBatch" shall mean a quantity of cans of the Products that is
smaller than a Batch but not less than cans, whichever is greater.
1.3 "cGMPs" shall mean current Good Manufacturing Practices, as
published at 21 CFR parts 210 and 211 and amended during the term of this
Agreement.
1.4 "FDA" shall mean the United States Food and Drug Administration or
any successor agency thereof.
1.5 "Health Registrations" shall mean the Abbreviated New Drug
Application approval issued by the FDA with respect to the Products and any
other governmental or regulatory consents, registrations, approvals or permits
necessary to sell or manufacture the Products or applications for the same.
1.6 "Product" and "Products" shall mean ***.
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CONFIDENTIAL TREATMENT
1.7 "Specifications" shall mean the specifications for the
manufacturing, packaging, storage and labeling of the Products described on
Exhibit A attached hereto and incorporated herein by reference. The
Specifications shall be automatically amended upon each review and issuance of
the Health Registrations to include the information set forth in the Health
Registrations.
1.8 "Total Development Cost" shall mean, with respect to each Product,
the amount designated as such on Exhibit B attached hereto.
ARTICLE 2
RIGHTS TO PRODUCTS
------------------
2.1 For greater clarity, INyX acknowledges that all intellectual
property created specifically in connection with the Products (the "Intellectual
Property"), including formulations, inventions or discoveries (first made or
reduced to practice in the performance of INyX's obligations hereunder) shall be
the property of ▇▇▇▇▇▇▇. INyX shall, when requested by ▇▇▇▇▇▇▇, execute all such
assignments, consents and other documents reasonably necessary to assign to
▇▇▇▇▇▇▇ all right, title and interest in and to all the Intellectual Property,
and shall use best efforts to cause its employees, agents and subcontractors to
execute the necessary documents to give effect to this provision.
2.2 The Customer hereby grants INyX a royalty-free, non-exclusive,
worldwide right and license to make, use and sell products incorporating
Intellectual Property, subject always to INyX's obligations hereunder.
ARTICLE 3
DEVELOPMENT
-----------
3.1 INyX agrees to assist ▇▇▇▇▇▇▇ in the development of the Products,
as set forth in Exhibit B attached hereto.
3.2 ▇▇▇▇▇▇▇ agrees to reimburse INyX' efforts in the development of the
Products, within thirty (30) days of its receipt of invoices from INyX. With
respect to each Product, INyX agrees to timely complete all activities set forth
in Exhibit B attached hereto in exchange for the respective Total Development
Cost set forth therein.
3.3 INyX agrees to provide in a timely fashion all documents requested
by ▇▇▇▇▇▇▇ for submission in a Health Registration (including without limitation
those documents listed in Exhibit C attached hereto) and to actually support
▇▇▇▇▇▇▇ in responding to communications from the FDA.
3.4 ▇▇▇▇▇▇▇ and INyX acknowledge that INyX must validate three (3)
batches of the Products prior to selling any Products to ▇▇▇▇▇▇▇. INyX shall
complete such validation within sixteen (16) weeks of ▇▇▇▇▇▇▇'▇ request. ▇▇▇▇▇▇▇
shall be obligated to purchase such Batches in accordance with the terms of the
Manufacturing and Supply Agreement.
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CONFIDENTIAL TREATMENT
ARTICLE 4
COMPLIANCE
----------
4.1 Each party shall promptly deliver to the other a copy of all
written communications received by it from the FDA during the term of this
Agreement relating to the design, manufacture, packaging, shipping, storage or
sale of the Products and allow the other party an opportunity to comment upon
its proposed response.
4.2 ▇▇▇▇▇▇▇ may perform audits of INyX to establish INyX' compliance
with cGMPs and the Health Registrations or regarding other manufacturing,
quality or regulatory matters affecting the Products, with reasonable prior
notice.
4.3 INyX shall immediately notify ▇▇▇▇▇▇▇ of any FDA inspections which
may affect any or all of the Products, allow ▇▇▇▇▇▇▇ to be available to answer
FDA questions, and keep ▇▇▇▇▇▇▇ informed to the maximum practicable extent as to
the inspection's progress.
4.4 INyX agrees to provide to ▇▇▇▇▇▇▇, promptly upon ▇▇▇▇▇▇▇'▇ request,
duly authenticated copies of all documents required to obtain and maintain the
Health Registrations and all documents related to manufacturing the Products,
including without limitation those documents listed in Exhibit C.
ARTICLE 5
PRICES, TERMS OF PAYMENT
------------------------
5.1 Payment. With respect to each Product: (a) ▇▇▇▇▇▇▇ shall pay INyX
an amount equal to fifty percent (50%) of the Total Development Cost, within
thirty (30) days after INyX' duly authorized representative signs this
Agreement; (b) ▇▇▇▇▇▇▇ shall pay INyX an amount equal to twenty-five percent
(25%) of the Total Development Cost, within thirty (30) days after INyX
completes the development work set forth in Exhibit B attached hereto with
respect to such Product; and (c) ▇▇▇▇▇▇▇ shall pay INyX the balance of its Total
Development Cost within thirty (30) days of ▇▇▇▇▇▇▇'▇ filing an Abbreviated New
Drug Application in its own name with respect thereto.
ARTICLE 6
TERM AND TERMINATION
--------------------
6.1 Term. Unless earlier terminated in accordance with the provisions
hereof, the term of this Agreement shall commence on the Effective Date and
shall thereafter continue in effect until the third (3rd) anniversary of the
Effective Date.
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6.2 Termination for Cause. Either party may terminate this Agreement on
written notice to the other party, effective immediately if:
(a) the other party commits a material breach of any of its
obligations hereunder which is not cured within ninety (90) days of
written notice from the other party specifying the breach; or
(b) the other party is dissolved or liquidated, files or has
filed against it a petition under any bankruptcy or insolvency law,
makes an assignment to the benefit of its creditors, has a receiver
appointed for all or substantially all of its property, or has a
petition under any bankruptcy or insolvency law filed against it which
is not dismissed within sixty (60) days.
Such right of termination shall be in addition to any other remedy a
non-defaulting party may have at law or in equity due to the other party's
breach of is obligations hereunder.
6.3 Termination for Market Conditions. At any time and from time to
time, ▇▇▇▇▇▇▇ may terminate this Agreement with respect to any or all of the
Products on ninety (90) days prior written notice to INyX, provided that ▇▇▇▇▇▇▇
shall accept and pay for all development work performed by INyX in accordance
with Exhibit B attached hereto prior to INyX' receipt of such notice and
reasonable shut-down costs, provided that in no event shall ▇▇▇▇▇▇▇'▇ liability
for any such costs, plus amounts paid by ▇▇▇▇▇▇▇ prior to such notice exceed (a)
with respect to any Product, such Product's Total Development Cost; or (b) in
the aggregate for all Products ***.
6.4 Changed Circumstances. In the event that the market for the
Products materially changes or either party, in good faith, believes that a
material change in such party's circumstances beyond their control has occurred
which materially affects its ability to perform its obligations pursuant to this
Agreement, the parties hereto shall, in good faith, negotiate towards mutually
acceptable revisions to this Agreement to address the impact of such material
changes; provided, however, the terms of this Agreement shall continue in full
force and effect unless and until the parties hereto agree otherwise.
6.5 Force Majeure. The failure of either of the parties hereto to
perform any obligation under this Agreement solely by reason of any cause beyond
its control (and due to no fault of its own), including, without limitation,
acts of God, acts of government, riots, wars, strikes and accidents in
transportation, shall not be deemed to be a breach of this Agreement; provided,
however, that the party so prevented from complying herewith shall continue to
take all actions within its power, including payment of outstanding invoices, to
comply as fully as possible herewith.
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CONFIDENTIAL TREATMENT
ARTICLE 7
INDEMNIFICATION AND INSURANCE
-----------------------------
7.1 Indemnification. INyX hereby indemnifies and agrees to defend and
hold ▇▇▇▇▇▇▇ harmless from and against losses, claims, damages, liabilities,
costs and expenses (including, without limitation, attorneys' fees and court
costs) incurred by ▇▇▇▇▇▇▇ as a result of any breach of this Agreement by INyX.
▇▇▇▇▇▇▇ hereby indemnifies and agrees to defend and hold INyX harmless from and
against losses, claims, damages, liabilities, costs and expenses (including,
without limitation, attorneys' fees and court costs) incurred by INyX as a
result of any breach of this Agreement by ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇'▇ storage, sale or
distribution of the Products, or any Products labeling, Specifications,
instructions, directions, warnings, pamphlets or other information provided by
▇▇▇▇▇▇▇ that differs from those provided by INyX.
7.2 Insurance. Each party hereto shall maintain with a financially
sound and reputable insurer, from the date of the first purchase of Products
through the remainder of the term of this Agreement, comprehensive general
liability insurance, including, without limitation, Products liability insurance
with liability limits of at least Five Million Pounds Sterling
((pound)5,000,000) per occurrence and in the aggregate. Each party hereto shall
also name the other party as an additional insured party on its policy and
provide the other party with such evidence thereof as is reasonably requested by
the other party from time to time.
ARTICLE 8
WARRANTIES AND REPRESENTATIONS OF THE PARTIES
---------------------------------------------
8.1 Additional Representations and Warranties of INyX. INyX hereby
additionally represents and warrants to ▇▇▇▇▇▇▇ the following:
(a) INyX is a corporation duly organized and existing in good
standing under the laws of England;
(b) There are no material adverse claims pending or, to the
best of INyX's knowledge, threatened against INyX by any entity with
respect to the Products;
(c) INyX is neither a party to nor otherwise bound by any
agreement or instrument which prohibits or prevents it from performing
its obligations under this Agreement; and
(d) INyX's manufacturing, packaging and storage facilities
comply in all material respects with all applicable federal, state and
local laws, rules and regulations in the Territory.
(e) INyX will make no use of Confidential Information of ***
under the provisions of the Amended and Restated Manufacturing and
Supply Agreement between *** and ***, in performing its obligations
hereunder.
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CONFIDENTIAL TREATMENT
8.2 Additional Representations and Warranties of ▇▇▇▇▇▇▇. ▇▇▇▇▇▇▇
hereby additionally represents and warrants to INyX the following:
(a) ▇▇▇▇▇▇▇ is a corporation duly organized and existing under
the laws of the State of New York.
(b) There are no material adverse claims pending or, to the
best of ▇▇▇▇▇▇▇'▇ knowledge, threatened against ▇▇▇▇▇▇▇ by any entity
with respect to any of its Products or business; and
(c) ▇▇▇▇▇▇▇ is neither a party to nor otherwise bound by any
agreement or instrument which prohibits or prevents it from performing
its obligations under this Agreement.
ARTICLE 9
CONFIDENTIALITY AND NONSOLICITATION OF PERSONNEL
------------------------------------------------
9.1 Confidentiality. Each party hereto acknowledges that it has been
and will be exposed to certain "Confidential Information" and "Trade Secrets"
(both as hereinafter defined) of the other party in connection with the
transactions contemplated by this Agreement and that its unauthorized use or
disclosure of such information or data could cause immediate and irreparable
harm to such other party. Accordingly, except to the extent that it is necessary
to use such information or data to perform its obligations under this Agreement,
neither party shall, without the express prior written consent of the other
party, redistribute, market, publish, disclose or divulge to any person or
entity, or use or modify for use, directly or indirectly, in any way for any
person or entity: (a) any of the other party's Confidential Information during
the term of this Agreement and for a period of three (3) years after any
expiration or termination of this Agreement; and (b) any of the other party's
Trade Secrets at any time during which such information constitutes a trade
secret under applicable law. For purposes hereof, "Confidential Information"
shall mean all competitively sensitive, non-public information (other than
"Trade Secrets") of or about a party which is not generally known by or
available to such party's competitors, and "Trade Secrets" shall mean "Trade
Secrets" as defined under applicable law.
9.2 Nonsolicitation of Personnel. Neither party hereto shall, without
the prior written consent to the other party, either directly or indirectly,
alone or in conjunction with any other person or entity, solicit or attempt to
solicit any "key or material" employee, consultant, contractor or personnel of
such other party to terminate, alter or lessen his or her affiliation with such
other party at any time during the term of this Agreement and for a period of
one (1) year thereafter.
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CONFIDENTIAL TREATMENT
ARTICLE 10
ARBITRATION OF DISPUTES
-----------------------
10.1 All disputes arising out of or in connection with the present
contract shall be finally settled under the Rules of Arbitration of the
International Chamber of Commerce by one or more arbitrators appointed in
accordance with the said Rules, in effect at the time the arbitration is
commenced. Such arbitration shall be conducted in a mutually convenient location
within an approximately equal geographic distance between the addresses of the
parties in effect. The decision of the arbitrators, which may include interest,
shall be final and binding on the parties hereto and may be entered and enforced
in any court of competent jurisdiction by any party. The arbitration shall be
pursued and brought to conclusion as rapidly as possible.
ARTICLE 11
NOTICES
-------
11.1 Delivery. All notices, consents, requests and other communications
hereunder shall be in writing and shall be sent by hand delivery, by certified
or registered mail (return-receipt requested), or by a recognized national
overnight courier service as set forth below:
If to INyX: INyX, Inc.
▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇
Attention:
If to ▇▇▇▇▇▇▇: ▇▇▇▇▇▇▇ Laboratories, Inc.
▇▇▇▇ ▇▇▇▇▇ ▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Attention: Purchasing Department
With a copy to: ▇▇▇▇▇▇▇ Laboratories, Inc.
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: General Counsel
11.2 Effective Time. Notices delivered pursuant hereto shall be deemed
given: (a) at the time delivered, if personally delivered; (b) at the time
received, if mailed; and (c) one (1) business day after timely delivery to the
courier, if by overnight courier service.
11.3 Changes. Either party hereto may change the address to which
notice is to be sent by written notice to the other party in accordance with the
provisions of this Article 11.
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CONFIDENTIAL TREATMENT
ARTICLE 12
MISCELLANEOUS
-------------
12.1 Severability. If any provision of this Agreement is held to be
invalid, illegal or unenforceable, the validity, legality and enforceability of
the remaining provisions shall not in any way be affected or impaired, and the
parties shall use their best efforts to substitute a valid, legal and
enforceable provision, which, insofar as practical, implements the purpose of
this Agreement.
12.2 Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, but all of which
together shall be deemed one and the same instrument.
12.3 Governing Law. This Agreement shall be governed by, and any matter
or dispute arising out of this Agreement shall be determined by, the laws of
England.
12.4 Headings; Gender. "Article," "Section" and other headings
contained in this Agreement are for reference purposes only and shall not affect
in any way the meaning or interpretation of this Agreement. All personal
pronouns used in this Agreement shall include the other genders, whether used in
the masculine, feminine or neuter gender, and the singular shall include the
plural and vice versa, whenever and as often as may be appropriate.
12.5 Entire Agreement. This Agreement represents the entire agreement
of the parties with respect to its subject matter. Any and all prior discussions
or agreements with respect hereto are merged into and superseded by the terms of
this Agreement. This Agreement may be modified or amended only in writing signed
by both parties which expressly refers to this Agreement and states an intention
to modify or amend it. No such amendment or modification shall be effected by
use of any purchase order, acknowledgment, invoice or other form of either party
and in the event of conflict between the terms of this Agreement and any such
form, the terms of this Agreement shall control.
12.6 Notices. Any notice or payment required or permitted hereunder
shall be in writing and sent by certified mail, overnight express, or personally
delivered, addressed to the party to receive the notice as set out above.
12.7 No Assignment. Neither party hereto may assign this Agreement, in
whole or in part, without the prior written consent of the other party (which
consent shall not be unreasonably withheld or delayed), and any attempted
assignment not in accordance herewith shall be null and void and of no force or
effect; provided that ▇▇▇▇▇▇▇ may assign its rights (but not its obligations)
hereunder to any of its subsidiaries.
12.8 Binding Effect. This Agreement shall be binding upon and shall
inure to the benefit of the parties hereto and their respective successors,
heirs, representatives and permitted assigns.
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12.9 Interpretation. This Agreement was fully negotiated by both
parties hereto and shall not be construed more strongly against either party
hereto regardless of which party is responsible for its preparation. In the
event of a conflict or inconsistency between the Manufacturing and Supply
Agreement between the parties and this Agreement, the relevant provision of the
Manufacturing and Supply Agreement shall be given effect over the relevant
provision of this Agreement.
12.10 No Consequential Damages. Neither party to this Agreement shall
have any liability to the other party for any consequential or indirect damages
arising out of any breach of this Agreement, including, without limitation, loss
of profit, loss of use or business stoppage.
12.11 Further Assurances. Upon the reasonable request of the other
party, each party hereto agrees to take any and all actions necessary or
appropriate to give effect to the terms set forth in this Agreement.
[Signature Page Follows]
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IN WITNESS WHEREOF, the parties hereto have caused their duly
authorized representatives to execute this Agreement as of the day and year
first above written.
"INyX"
INyX PHARMA LIMITED.
By: /S/ ▇▇▇▇▇ ▇▇▇▇▇▇
-----------------------------------------
Director
"▇▇▇▇▇▇▇"
▇▇▇▇▇▇▇ LABORATORIES, INC.
By: /S/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
-----------------------------------------
Title: Vice President, CEO and Treasurer
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EXHIBIT A
SPECIFICATIONS
TO BE PROVIDED BY ▇▇▇▇▇▇▇ LABS
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EXHIBIT B
SCHEDULE OF DEVELOPMENT ACTIVITIES
I. Task Name: *** Start Date Finish Date
***
1. Project definition and scope.
2. Acquisition, Testing, and Evaluation of drugs, excipients, and
components as agreed by both parties.
3. Formulation and manufacturing process assessments to facilitate
production of the product by INyX.
4. Assessment and assistance, as necessary, in the development of mutually
acceptable test methods required to secure health registrations.
5. Development and Exhibit batch preparation.
6. Development and preparation of necessary clinical supplies.
7. Assistance, as necessary with mutually agreed testing activities to
support health registrations.
8. Support in preparation and review of CMC documentation necessary to
secure health registrations.
TOTAL DEVELOPMENT COST: ***
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II. Task Name: *** Start Date Finish Date
***
1. Project definition and scope.
2. Acquisition, Testing, and Evaluation of drugs, excipients, and
components as agreed by both parties.
3. Formulation and manufacturing process assessments to facilitate
production of the product by INyX.
4. Assessment and assistance, as necessary, in the development of mutually
acceptable test methods required to secure health registrations.
5. Development and Exhibit batch preparation.
6. Development and preparation of necessary clinical supplies.
7. Assistance, as necessary with mutually agreed testing activities to
support health registrations.
8. Support in preparation and review of CMC documentation necessary to
secure health registrations.
TOTAL DEVELOPMENT COST: ***
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III. Task Name:*** Start Date Finish Date
***
1. Project definition and scope.
2. Acquisition, Testing, and Evaluation of drugs, excipients, and
components as agreed by both parties.
3. Formulation and manufacturing process assessments to facilitate
production of the product by INyX.
4. Assessment and assistance, as necessary, in the development of mutually
acceptable test methods required to secure health registrations.
5. Development and Exhibit batch preparation.
6. Development and preparation of necessary clinical supplies.
7. Assistance, as necessary with mutually agreed testing activities to
support health registrations.
8. Support in preparation and review of CMC documentation necessary to
secure health registrations.
TOTAL DEVELOPMENT COST: ***
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EXHIBIT C
DOCUMENTATION TO BE PROVIDED BY INyX
Documentation Required for the ANDA Submission:
-----------------------------------------------
o cGMP Certification
o Debarment Statement
o Methods - Raw material and Products
o Specifications (Raw material and Products) - these may be updated based
upon stability data, FDAs comment, etc.
o Packaging component tests, specifications, and methods.
o Batch records (manufacturing and packaging) for the exhibit batch with
lab pages of testing performed and Certificates of Analysis ("COAs")
o Proposed Commercial Manufacturing and Packaging Batch Records
o COA, lab pages, and manufacturer's COA for the active ingredient/raw
materials
o Stability data/reports - accelerated and long term (updated in
accordance with the stability schedule)
o Proposed Post Marketing Stability Protocol
o Standard Operating Procedures (various)
o Description of INyX facilities
o Method Validation Package
Documentation Required for Production Batches
---------------------------------------------
o Releases of Raw Materials
o Manufacturing and Packaging Batch Records
o In-Process and Finished Products Testing Results (including COAs, Test
Records, etc.)
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