EXHIBIT 10.38.5
CONFIDENTIAL TREATMENT
REQUESTED. CONFIDENTIAL PORTIONS OF
THIS DOCUMENT HAVE BEEN
REDACTED AND HAVE BEEN SEPARATELY
FILED WITH THE
COMMISSION.***
DEVELOPMENT
AGREEMENT
THIS DEVELOPMENT AGREEMENT
(this “
Agreement ”) is entered into and effective
as of this 8th day of September, 2005 (the “
Effective Date ”), by and between KING
PHARMACEUTICALS, INC., a Tennessee corporation (“
King ”), and INYX, INC., a Nevada
corporation (“ Inyx ”).
WHEREAS , King owns certain technology and proprietary
materials related to the drugs Intal and Tilade;
WHEREAS , Inyx is a developer and manufacturer of
pharmaceutical aerosol products; and
WHEREAS , the parties have entered 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 (as defined herein);
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
agree as follows:
1.
DEFINITIONS
1.1
Definitions. (a) Unless otherwise specifically defined in
this Agreement, each capitalized term used herein will have the
meaning assigned to such term in the Collaboration
Agreement.
(b) In addition to the terms defined elsewhere
herein, as used in this Agreement, the following terms have the
meanings specified below when used in this Agreement:
“ Agreement ” means
this Agreement, together with all appendices, exhibits, and
schedules referenced herein or attached hereto, and as the same may
be amended or supplemented from time to time hereafter pursuant to
the provisions hereof.
“ Approved New Product
” has the meaning set forth in Section 4.2.
“ Collaboration Agreement
” has the meaning set forth in the recitals.
“ development ” or
“ develop ” means, with respect to a
Product or Excluded New Product, all research, preclinical,
pharmaceutical, and clinical activities and other activities
undertaken in order to obtain Regulatory Approval of such Product
or Excluded New Product, including all preclinical and clinical
drug development activities, research, test method development and
stability testing, toxicology, animal studies, statistical analysis
and report writing, clinical trial design and performance prior to
obtaining Regulatory Approvals, and regulatory affairs related to
the foregoing. “ development ” will
also include relevant formulation, process development,
manufacturing, manufacturing scale-up, current Chemistry and
Manufacturing Controls section of an IND, development-stage
manufacturing, quality assurance, and quality control
development.
“ Effective Date ”
has the meaning set forth in the recitals.
“ Excluded New Product
” has the meaning set forth in Section 4.2.
“ Excluded New Product
Costs ” has the meaning set forth in Section
4.4(b).
“ Excluded Patent Costs
” has the meaning set forth in Section 4.4(a).
“ Excluded Product Notice
” has the meaning set forth in Section 4.3(a).
“ Excluded Regulatory
Costs ” has the meaning set forth in Section
4.4(b).
“ Good Clinical Practices
” means the international ethical and scientific quality
standards for designing, conducting, recording, and reporting
trials that involve the participation of human subjects. Good
Clinical Practices are established through FDA guidances (including
ICH E6).
“ Good Laboratory
Practices ” means the minimum standards for
conducting nonclinical laboratory studies that support or are
intended to support applications for research or marketing permits
for products regulated by the FDA, including food and color
additives, animal food additives, human and animal drugs, medical
devices for human use, biological products, and electronic
products. Good Laboratory Practices are established through FDA
regulations (including 21 CFR Part 58), FDA guidances, FDA current
review and inspection standards, and current industry
standards.
“ Good Manufacturing
Practices ” means the minimum standards for methods
to be used in, and the facilities or controls to be used for, the
manufacture, processing, packing, or holding of a drug to assure
that such drug meets the requirements of the Federal Food, Drug and
Cosmetic Act of 1938, as amended, as to safety, and has the
identity and strength and meets the quality and purity
characteristics that it purports or is represented to possess. Good
Manufacturing Practices are established through FDA regulations
(including 21 CFR Parts 210-211), FDA guidance, FDA current review
and inspection standards, and current industry
standards.
“ Intal HFA Documentation
” has the meaning set forth in Section 5.1.
“ Inyx ” has the
meaning set forth in the recitals.
“ King ” has the
meaning set forth in the recitals.
“ New Product Report
” has the meaning set forth in Section 4.1.
“ Offer Notice ”
has the meaning set forth in Section 4.3(d).
“ Plan of Execution
” has the meaning set forth in Section 5.2(a)(i).
“ Term ” has the
meaning set forth in Section 7.1.
* * * .
“ Unmarketed Excluded New
Product ” has the meaning set forth in
Section 4.3(c).
1.2
Interpretation . When a reference is made in this Agreement to
Articles, Sections, Exhibits, or Schedules, such reference will be
to an Article or Section of or Exhibit or Schedule to this
Agreement unless otherwise indicated. 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.
Whenever the words “include,”“includes,” or
“including” are used in this Agreement, they will be
deemed to be followed by the words “without
limitation.” Unless the context otherwise requires, (i)
“or” is disjunctive but not necessarily exclusive, (ii)
words in the singular include the plural and vice versa, and (iii)
the use in this Agreement of a pronoun in reference to a party
hereto includes the masculine, feminine, or neuter, as the context
may require. The Schedules and Exhibits hereto will be deemed part
of this Agreement and included in any reference to this Agreement.
This Agreement will not be interpreted or construed to require any
Person to take any action, or fail to take any action, if to do so
would violate any applicable law.
2.
Development RIGHTS
2.1
License . The
parties acknowledge and agree that during the Term the license
granted to Inyx under Section 4.1 of the Collaboration Agreement
will include a non-exclusive right to perform development work with
respect to the Technology and Patent Rights in the Territory,
subject to the terms of this Agreement and the Collaboration
Agreement.
2.2 Technical
Reports . Inyx will
keep the AMC fully informed about the status of Inyx’s
development work hereunder, including furnishing the AMC with
regular reports relating to such work. In particular, without
limitation, Inyx will (a) provide periodic reports in reasonable
detail to the AMC each Calendar Quarter and as requested from time
to time by the AMC; (b) provide, upon request, King with access to,
and copies of, all Improvements arising out of such development
work; (c) provide King with copies of all materials furnished to
the AMC and such other information concerning such development work
as King may reasonably request; and (d) from time to time consult
with King, upon request, with respect to Inyx’s development
work hereunder.
3.
Improvements
3.1 Ownership of
Improvements . As
provided in Article 5 of the Collaboration Agreement, King will own
all right, title, and interest on a worldwide basis in and to any
and all Improvements, including all Improvements developed pursuant
to Inyx’s exercise of its rights hereunder.
3.2 Improvements
Disclosure and Generally . As provided in Article 5 of the Collaboration
Agreement, Inyx will promptly provide the AMC with written notice
concerning all Improvements conceived, made, or developed during
the Term.
3.3 Record
Keeping . During the
Term, Inyx will maintain records regarding its development work in
sufficient detail and in accordance with Good Laboratory Practice,
Good Clinical Practice, and Good Manufacturing Practice and as will
properly reflect and document, in a manner appropriate for purposes
of supporting the filing of potential patent applications and the
filing and obtaining of all Regulatory Approvals, all work done and
results achieved in the performance of Inyx’s development
work hereunder (including all data in the form required under any
applicable laws). All such records will be deemed Improvements.
Inyx hereby grants King the right to inspect and copy such records
to the extent King deems necessary for the performance of its
obligations or exercise of its rights under the Collaboration
Documents.
4.
New Products
4.1 * *
*
4.2 * *
* .
4.3
* *
*
4.4
* *
*
5.
Development of HFA Products
5.1 Development
of Intal HFA Documentation . Inyx will prepare, and provide to King, all
documentation necessary for King to make all required Regulatory
Filings with all Regulatory Authorities with respect to Intal HFA
in connection with the development and manufacturing of such
Product, including documentation necessary to support any responses
to questions raised by the applicable Regulatory Authority with
respect to such filings (such documentation, collectively the
“ Intal HFA Documentation
”).
5.2 Intal HFA
Payments . (a) In
consideration for the development of the Intal HFA Documentation,
King will make the following payments to Inyx in connection with
obtaining FDA approval of Intal HFA in accordance with the
following schedule:
(i) *** to be
paid upon submission by Inyx to King of a detailed plan of
execution for such FDA approval (the “ Plan of
Execution ”), which plan must be reasonably
acceptable to King and must describe in sufficient detail
milestones for achieving such approval and a timetable for such
achievement;
(ii) *** to be
paid upon submission by Inyx to King of a detailed status report
reasonably acceptable to King setting forth Inyx’s
achievement of at least certain milestones set forth in the Plan of
Execution. The selection of which milestones must be achieved for
Inyx to be entitled to such payment will be established by the AMC
following King’s acceptance of the Plan of Execution.
Notwithstanding successful completion of the milestone described in
this clause (ii), this payment will in no event become due sooner
than *** following completion of the milestone giving rise to the
first payment described in clause (i);
(iii) *** to be
paid upon submission of the chemistry, manufacturing, and controls
(CMC) sections for the Intal HFA for filing with the FDA, in a form
mutually acceptable to King and Inyx;
(iv) *** to be
paid upon receipt of approval of Intal HFA from the FDA;
and
(v) *** to be
paid upon release of Intal HFA commercially.
(b) Subject to
Section 5.2(a)(ii), all payments from King to Inyx pursuant to this
Section 5.2 will be due within thirty (30) days of King’s
receipt of Inyx’s invoice therefor. All payments due
hereunder will be sent to Inyx by wire transfer of funds via the
Federal Reserve Wire Transfer System to ***, or such other
financial institution as Inyx may designate to King in writing from
time to time in accordance with Section 9.1 hereof. King will
notify the following person prior to the value date of each wire
transfer, or such other person as Inyx may designate to King from
time to time in accordance with Section 9.1 hereof: