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TECHNICAL TRANSFER AGREEMENT

Receivables Purchase Transfer Agreement

TECHNICAL TRANSFER AGREEMENT

 | Document Parties: INYX INC | KING PHARMACEUTICALS, INC. You are currently viewing:
This Receivables Purchase Transfer Agreement involves

INYX INC | KING PHARMACEUTICALS, INC.

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

TECHNICAL TRANSFER AGREEMENT

, Parties: inyx inc , king pharmaceuticals  inc.
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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:

 

CONFIDENTIAL TREATMENT


 

“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.

 

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“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.

 

 

“Services” mean the services described in Exhibit 1 .

 

“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.

 

2.2      * * *

 

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.

 

CONFIDENTIAL TREATMENT

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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.

 

2.6       Dispute Resolution .

 

(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:

 

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For King:   Brian Markison, President & CEO

King Pharmaceuticals, Inc.

501 Fifth Street

Bristol, Tennessee 37620

Facsimile: (423) 989-8006

 

For Inyx:   Dr. Jack Kachkar, Chairman & CEO

Inyx, Inc.

825 Third Avenue, 40 th Floor

New York, NY 10022

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. 

 

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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:

 

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(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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