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
XXXXXXX LABORATORIES, INC. ("Xxxxxxx") and INyX PHARMA LIMITED ("INyX"). INyX is
a company organized under the laws of England and Wales with its principal place
of business at 0 Xxxxxxx Xxxxx, Xxxxx Xxxx, Xxxxxxx, Xxxxxxxx XX0 0XX. Xxxxxxx
is a New York corporation with its principal place of business at 000 Xxxxxxxx
Xxxxxx, Xxxxx Xxxxxx, Xxxxxxx 00000.
BACKGROUND:
Subject to the terms and conditions contained in this Agreement, Xxxxxxx
desires to engage INyX to assist in Xxxxxxx'x 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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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 Xxxxxxx. INyX shall, when requested by Xxxxxxx, execute all such
assignments, consents and other documents reasonably necessary to assign to
Xxxxxxx 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 Xxxxxxx in the development of the Products, as
set forth in Exhibit B attached hereto.
3.2 Xxxxxxx 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
Xxxxxxx for submission in a Health Registration (including without limitation
those documents listed in Exhibit C attached hereto) and to actually support
Xxxxxxx in responding to communications from the FDA.
3.4 Xxxxxxx and INyX acknowledge that INyX must validate three (3) batches
of the Products prior to selling any Products to Xxxxxxx. INyX shall complete
such validation within
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sixteen (16) weeks of Xxxxxxx'x request. Xxxxxxx shall be obligated to purchase
such Batches in accordance with the terms of the Manufacturing and Supply
Agreement.
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 Xxxxxxx 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 Xxxxxxx of any FDA inspections which may
affect any or all of the Products, allow Xxxxxxx to be available to answer FDA
questions, and keep Xxxxxxx informed to the maximum practicable extent as to the
inspection's progress.
4.4 INyX agrees to provide to Xxxxxxx, promptly upon Xxxxxxx'x 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) Xxxxxxx 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)
Xxxxxxx 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) Xxxxxxx shall pay INyX the balance of its Total Development Cost within
thirty (30) days of Xxxxxxx'x 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.
6.2 Termination for Cause. Either party may terminate this Agreement on
written notice to the other party, effective immediately if:
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(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,
Xxxxxxx may terminate this Agreement with respect to any or all of the Products
on ninety (90) days prior written notice to INyX, provided that Xxxxxxx 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 Xxxxxxx'x liability for any
such costs, plus amounts paid by Xxxxxxx 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 Six Hundred Thousand Pounds Sterling (GBP 600,000).
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.
ARTICLE 7
INDEMNIFICATION AND INSURANCE
-----------------------------
7.1 Indemnification. INyX hereby indemnifies and agrees to defend and hold
Xxxxxxx harmless from and against losses, claims, damages, liabilities, costs
and expenses (including, without limitation, attorneys' fees and court costs)
incurred by Xxxxxxx as a result of any breach of
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this Agreement by INyX. Xxxxxxx 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 Xxxxxxx,
Xxxxxxx'x storage, sale or distribution of the Products, or any Products
labeling, Specifications, instructions, directions, warnings, pamphlets or other
information provided by Xxxxxxx 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 Xxxxxxx 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' 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' 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 Connetics
Corporation under the provisions of the Amended and Restated Manufacturing
and Supply Agreement between Miza Pharmaceuticals, Inc. and Connetics
Corporation, in performing its obligations hereunder.
8.2 Additional Representations and Warranties of Xxxxxxx. Xxxxxxx hereby
additionally represents and warrants to INyX the following:
(a) Xxxxxxx is a corporation duly organized and existing under the
laws of the State of New York.
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(b) There are no material adverse claims pending or, to the best of
Xxxxxxx'x knowledge, threatened against Xxxxxxx by any entity with respect
to any of its Products or business; and
(c) Xxxxxxx 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.
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
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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.
Xxxxxxx Xxxxx
Xxxxx Xxxx
Xxxxxxx, Xxxxxxxx XX0 0XX
Attention:
If to Xxxxxxx: Xxxxxxx Laboratories, Inc.
0000 Xxxxx 000
Xxx Xxxx, Xxx Xxxx 00000
Attention: Purchasing Department
With a copy to: Xxxxxxx Laboratories, Inc.
000 Xxxxxxxx Xxxxxx
Xxxxx Xxxxxx, Xxxxxxx 00000
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.
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.
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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 Xxxxxxx 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.
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.
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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/ Xxxxx Xxxxxx
----------------
Director
"Xxxxxxx"
XXXXXXX LABORATORIES, INC.
By: /S/ Xxxxxx X. Xxxxxxx
-----------------------------------------
Title: Vice President, CEO and Treasurer
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EXHIBIT A
SPECIFICATIONS
TO BE PROVIDED BY XXXXXXX 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: * * *
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.
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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 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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