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DEVELOPMENT AGREEMENT

Development Agreement

DEVELOPMENT AGREEMENT | Document Parties: INYX INC | KING PHARMACEUTICALS, INC. You are currently viewing:
This Development Agreement involves

INYX INC | KING PHARMACEUTICALS, INC.

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Title: DEVELOPMENT AGREEMENT
Governing Law: New York     Date: 11/23/2005
Law Firm: Jones Day; Bennett Jones LLP    

DEVELOPMENT AGREEMENT, Parties: inyx inc , king pharmaceuticals  inc.
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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.

 

CONFIDENTIAL TREATMENT


 

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.

 

CONFIDENTIAL TREATMENT

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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.

 

CONFIDENTIAL TREATMENT

3


 

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;

 

 

CONFIDENTIAL TREATMENT

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(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:

 

Ms. Rima Goldshmi


 
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