EXHIBIT 10.38.3
CONFIDENTIAL TREATMENT
REQUESTED. CONFIDENTIAL PORTIONS OF
THIS DOCUMENT HAVE BEEN
REDACTED AND HAVE BEEN SEPARATELY
FILED WITH THE
COMMISSION.***
TECHNICAL TRANSFER AGREEMENT
THIS TECHNICAL
TRANSFER AGREEMENT is made and entered into this 8th day of
September, 2005 (the “ Effective Date ”),
by and between
INYX, INC. , having an address at 825 Third
Avenue, 40 th Floor, New York, New York 10022 (“
Inyx ”) and KING PHARMACEUTICALS,
INC. , having an address at 501 Fifth Street, Bristol,
Tennessee 37620 (“ King ”) (each individually a
“ Party ” and collectively the “
Parties ”).
WITNESSETH
THAT
WHEREAS, Inyx
has expertise and experience in conducting development and
technical transfer services related to the formulation and/or
finishing of pharmaceutical products and has both pilot plant and
commercial scale facilities to manufacture and package such
products and is interested in providing such development, technical
transfer and manufacturing services to King in the pharmaceutical
area;
WHEREAS, King has a commercial interest in the
manufacture and packaging of certain pharmaceutical products
presently sold under the Intal® and Tilade® trademarks
(hereinafter each individually “ Product ” and
collectively referred to as the “ Products ”),
and, concurrently herewith, the Parties are executing other
Collaboration Documents (as defined below) including a definitive
Manufacturing and Supply Agreement (the “ Supply
Agreement ”) pursuant to which Inyx would be the
manufacturer, packager and supplier of the Products to King;
and
WHEREAS, the parties have entered into that
certain Collaboration Agreement between King and Inyx, dated of
even date herewith (the “ Collaboration Agreement
”), for the purpose of pursuing a collaboration relating to
the development, marketing and promotion of Products;
and
WHEREAS, in anticipation of the Supply Agreement
and the goods and services that Inyx will supply thereunder, the
Parties desire to enter into a binding agreement pursuant to which
Inyx would undertake certain technical transfer services for King
in order to validate and scale up King’s technology package
and prepare Inyx’s facilities for the manufacture and
packaging of the Products.
NOW, THEREFORE,
in consideration of the mutual covenants contained herein, Inyx and
King 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, whether
used in the singular or plural, shall have the meanings assigned to
them below for purposes of this Agreement:
“Agreement” means this Technical
Transfer Agreement, and all schedules and annexes attached hereto,
as it may from time to time be supplemented or modified by written
amendment(s) signed by the parties.
“Assignor” has the meaning set forth
in Section 2.9.
“cGMP Regulation” means Current Good
Manufacturing Practices (i) as promulgated under the Act, at 21 CFR
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.
“Chemicals and Materials” means the
chemicals (other than Drug Substance) and other materials, such as
cartons and bottles, required to manufacture the
Product.
“Collaboration Agreement” has the
meaning set forth in the recitals.
“Collaboration Documents” means,
collectively, this Agreement, the Collaboration Agreement, the
Quality Agreement, the Supply Agreement, the Marketing and
Promotion Agreement, and the Development Agreement.
“Confidential Information” has the
meaning set forth in Section 3.1(a).
“Drug Substance” means with respect
to the Products, the active ingredient cromolyn sodium micronized
stage 9 for Intal and nedocromil sodium dried stage 11 for Tilade
in a form intended for further processing into a pharmaceutical
formulation, and which contains at least each active ingredient and
may contain inert ingredients but is not in a final formulation
intended for administration to patients, and shall not include
other Chemicals and Materials.
“Effective Date” has the meaning set
forth in the recitals.
“Facility” means Inyx’s
production facility located in Manati, Puerto Rico or other Inyx
facilities as mutually agreed upon, and as approved by the
FDA.
“Intal” 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.
“Inyx” has the meaning set forth in
the recitals.
“King” has the meaning set forth in
the recitals.
“Laws” means all laws, statutes,
rules, regulations, ordinances and other pronouncements having the
effect of law of the United States, any foreign country,
supranational entity or any domestic or foreign state, province,
county, city or other political subdivision of any regulatory
authority.
“Manufacturing Process” means the
process for manufacturing the Product which is developed, adapted,
validated and/or confirmed during Inyx’s performance of the
Services hereunder using King’s technology
package.
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“Services” mean the services
described in Exhibit 1 .
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“Specifications” means the
specifications established or otherwise approved by King for the
Products .
“Term” has the meaning set forth in
Section 7.1.
“Tilade” 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.
ARTICLE
2
SERVICES
2.1
Description of Services . Inyx shall perform the Services
(as outlined in Exhibit 1 hereto) including any
modifications and additions thereto agreed upon by the Parties to
develop and confirm the Manufacturing Process, and to establish
Specifications for manufacturing and packaging Tilade and packaging
Intal. Inyx shall use its commercially reasonable efforts to
complete the Services in a timely fashion in accordance with a
schedule agreed upon by the Parties.
2.3
King’s Responsibilities . To assist Inyx in its
performance of this Agreement, King shall provide Inyx, in a timely
fashion, with all relevant information, documentation and data
(including without limitation information, any documentation and
data relating to product safety and information, documentation and
data, including NDA numbers, NDC codes, etc., necessary for Inyx to
drug list the product) necessary or appropriate for Inyx’s
performance hereunder. If requested by Inyx to provide support or
information, King shall provide such reasonable and necessary
support or information in order to perform the Services under this
Agreement (or an explanation of the legitimate reason for any delay
and a projected date by which such support or information will be
provided) within five (5) business days of Inyx’s request. In
the event King is to review or approve any information,
documentation, data or samples prepared or supplied by or on behalf
of Inyx, it shall complete such review and approval process within
five (5) business days. Inyx shall cooperate with King in the
performance of this Agreement and shall deal honestly and in good
faith with King. It is understood and acknowledged by the Parties
that King shall retain ownership of the NDA to the Products and any
supplements thereto, and is responsible for the NDA submission
documents and all correspondence with the FDA.
2.4
Inyx Responsibilities . Inyx shall ensure that any
and all Drug Substance, components, and materials supplied by Inyx
are suitable for use under this Agreement, comply with all
applicable Laws and regulations (including without limitation those
relating to the import of such materials) and receive all required
governmental and regulatory approvals, including without limitation
customs and FDA approvals. Furthermore, Inyx shall provide to King
all documentation necessary to support King’s submissions to
the FDA, or any responses to questions raised by the FDA, which are
necessary for FDA approval of Inyx’s Manati, Puerto Rico site
as the manufacturing, testing and packaging site for King’s
Products. Inyx shall notify King promptly if an authorized agent of
a regulatory agency visits its manufacturing and packaging facility
where the Products are being manufactured, packaged or quality
tested. Inyx shall provide copies of all regulatory correspondence
related to the Products to King within forty-eight (48) hours of
receipt. King shall have fifteen (15) days to review such
correspondence and to provide comments to Inyx. Should Inyx choose
not to include or address King’s comments when responding to
the regulatory agency, then Inyx shall provide King a reason in
writing as to why King’s comments were not included or
addressed.
2.5
Reporting/Transfer of Results / Project Managers . Inyx
shall respond to King’s inquiries regarding the status of the
Services on an ongoing basis, and Inyx shall endeavor to keep King
informed of interim results. Inyx shall provide copies of all
analytical, cleaning, and process validation protocols and
summaries for King’s review, comments and approval prior to
implementation and execution. Once such protocols and summaries
have been approved and executed, copies shall be provided to King.
Upon request, Inyx shall provide to King an Intal and Tilade
development report which summarizes the implementation efforts of
the Services at the Facility. Inyx and King will each appoint a
Project Manager, who will meet as needed to resolve any issues or
problems associated with the Services. Upon reasonable request by
King and without unduly interfering with Inyx’s business
operations, King shall have the right to visit the Inyx
manufacturing, packaging and testing site for the
Products.
(a) The Parties
recognize that disputes may arise from time to time during the term
of this Agreement that relate to either Party’s rights and/or
obligations hereunder. It is the objective of the Parties to
establish procedures to facilitate the resolution of disputes
arising under this Agreement in an expedient manner by mutual
cooperation. To accomplish this objective, the parties agree to
follow the procedures set forth in this Section 2.6 if and
when a dispute arises under this Agreement.
(b) Unless
otherwise specifically recited in the Agreement, disputes between
the Parties under this Agreement shall be first referred to the AMC
by either Party as soon as reasonably possible after such dispute
has arisen. If the AMC is unable to resolve such a dispute within
fifteen (15) days of being requested by a Party to resolve such
dispute, either Party may, by written notice to the other, have
such dispute referred to their respective executive officers
designated below or their designees, for attempted resolution by
negotiations within fifteen (15) days after such notice is
received. The designated officers are as follows:
For
King: Brian Markison, President & CEO
King
Pharmaceuticals, Inc.
Facsimile:
(423) 989-8006
For
Inyx: Dr. Jack Kachkar, Chairman & CEO
825 Third
Avenue, 40 th Floor
Telephone:
(212) 838-1111
Facsimile:
(212) 838-0060
Email:
jkachkar@inyxinc.com
In the event
such designated officers are unable to resolve such dispute, the
decision of King, with respect to regulatory and manufacturing
matters relating to the Product(s) shall be binding on the parties,
as long as Inyx’s cGMP status as to regulatory and
manufacturing matters is not compromised by such decision.
Notwithstanding the foregoing, this Paragraph shall not apply to
determinations as to whether either Party is in breach of any of
its obligations under this Agreement.
2.7
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 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 the Services. Any such Confidential Information,
documents, and materials shall be subject to Article 3 .
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 all 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;
provided that
such ownership of right, title, and interest does not extend to the
Inyx Respiratory Products.
2.8
Inventions Disclosure and Generally . Each Party will
promptly provide the AMC with written notice concerning all
Improvements that are conceived, made, or developed by employees or
Consultants of either of them or their Affiliates, whether alone or
jointly with the other Party or its Affiliates or with permitted
Third Parties. Such notice will be treated as the Confidential
Information of King hereunder. The provisions of Section 2.7 and
2.8 and 2.9 will apply to rights in Improvements conceived,
made, or developed by King or Inyx, or both, during the course of
carrying out the Collaboration Program.
2.9
Assignment . Inyx agrees to, and hereby does, and
will cause each of its employees, Consultants, Affiliates, and
permitted sublicensees (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.
2.10
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 all 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.
2.11
Non-Compete . Inyx acknowledges and agrees that it is
subject to the non-competition provisions of Section 7.1 of the
Collaboration Agreement, which provisions will continue throughout
the term of the Collaboration Agreement notwithstanding the
termination or expiration of this Agreement.
ARTICLE
3
CONFIDENTIALITY
3.1
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 3 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;
(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 I
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