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LICENSE AND SUPPLY AGREEMENT

Requirements Supplier Agreement

LICENSE AND SUPPLY AGREEMENT | Document Parties: AMARILLO BIOSCIENCES INC | CYTO BIOTECH INC You are currently viewing:
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AMARILLO BIOSCIENCES INC | CYTO BIOTECH INC

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Title: LICENSE AND SUPPLY AGREEMENT
Date: 3/2/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENSE AND SUPPLY AGREEMENT, Parties: amarillo biosciences inc , cyto biotech inc
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LICENSE AND SUPPLY AGREEMENT

 

 

 

 

 

 

 

 

Between

 

 

 

 

 

 

 

 

CYTO BIOTECH INC.

 

 

 

 

 

&

 

 

 

 

 

AMARILLO BIOSCIENCES, INC.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

February 2009

 

 

 

 

 

 

 

 

 

 

 

 

CYTOB-AMAR License  Supply Agree 2-25-2009 redacted   Final Agreement

 

1


 

 

 

TABLE OF CONTENTS

 

ARTICLE I:  DEFINITIONS

5

 

 

ARTICLE II: RESEARCH AND DEVELOPMENT

11

 

 

SECTION 2.01.  AMAR OBLIGATIONS

11

SECTION 2.02.  CYTOB OBLIGATIONS

12

SECTION 2.03.  AVAILABILITY OF RESOURCES; COOPERATION

13

SECTION 2.04.  REPORTING OBLIGATIONS OF CYTOB

13

 

 

ARTICLE III: LICENSE

13

 

 

SECTION 3.01.  LICENSE AND SUPPLY GRANT

13

SECTION 3.02.  RESTRICTIONS

14

SECTION 3.03.  RETAINED RIGHTS

14

 

 

ARTICLE IV: PAYMENTS

14

 

 

SECTION 4.01.  INITIAL FEE

14

SECTION 4.02.  STOCK PURCHASE

14

SECTION 4.03.  MINIMUM YEARLY PURCHASE ORDER AND MINIMUM SALES

15

SECTION 4.04.  REPORTS

15

SECTION 4.05.  RECORDS AND AUDITS

15

SECTION 4.06.  EXCHANGE RATE; MANNER AND PLACE OF PAYMENT

16

SECTION 4.07.  LATE PAYMENTS

16

SECTION 4.08.  TAXES

16

SECTION 4.09.  OTHER PAYMENTS

16

 

 

ARTICLE V: TERM AND TERMINATION

17

 

 

SECTION 5.01.  TERM

17

SECTION 5.02.  TERMINATION BY CYTOB

17

SECTION 5.03.  TERMINATION BY AMAR

17

SECTION 5.04.  TERMINATION UPON CERTAIN EVENTS

18

SECTION 5.05.  REMEDIES

18

SECTION 5.06  EFFECT OF TERMINATION

18

SECTION 5.07.  BANKRUPTCY

19

SECTION 5.08.  CONTINUING OBLIGATIONS

19

SECTION 5.09.  RETURN OF CONFIDENTIAL INFORMATION

19

 

 

ARTICLE VI: SUPPLY, MANUFACTURE AND PURCHASE OF PRODUCT

19

 

 

SECTION 6.01.  SUPPLY OF PRODUCT AND BULK INTERFERON

19

SECTION 6.02.  SUPPLY AND MANUFACTURING RIGHTS

20

SECTION 6.03.  QUALITY ASSURANCE

20

SECTION 6.04.  AMAR'S DUTIES

20

SECTION 6.05.  CYTOB'S DUTIES IF MANUFACTURING

21

SECTION 6.06.  FAILURE TO SUPPLY

21

SECTION 6.07.  ALLOCATION

22

SECTION 6.08.  RECORDS AND AUDITS

22

 

 

ARTICLE VII: PURCHASE AND SALE

23

 

 

SECTION 7.01.  PURCHASE PRICE, PAYMENT, AND ROYALTY

23

SECTION 7.02.  LABELING AND ARTWORK

23

SECTION 7.03.  PURCHASE FORMS

24

SECTION 7.04.  CONFIRMATION

24

SECTION 7.05.  DELIVERY

24

SECTION 7.06.  FORECASTS AND ORDERS

24

 

 

ARTICLE VIII: WARRANTY, REJECTION AND INSPECTIONS

25

 

 

SECTION 8.01.  AMAR WARRANTY

25

SECTION 8.02.  REJECTION OF PRODUCT FOR FAILURE TO CONFORM TO SPECIFICATIONS

25

SECTION 8.03.  CYTOB INSPECTIONS

26

 

 

ARTICLE IX: REGULATORY COMPLIANCE

26

 

 

SECTION 9.01.  MAINTENANCE OF MARKETING AUTHORIZATIONS

26

SECTION 9.02.  ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE

27

SECTION 9.03.  COMMERCIAL SALE TESTING AND REPORTING

27

SECTION 9.04.  ASSISTANCE

28

SECTION 9.05.  COMPLIANCE

28

 

 

ARTICLE X: REPRESENTATIONS, WARRANTIES AND COVENANTS

28

 

 

SECTION 10.01. CORPORATE POWER

28

SECTION 10.02. DUE AUTHORIZATION

28

SECTION 10.03. BINDING OBLIGATION

28

SECTION 10.04. OWNERSHIP OF AMAR RIGHTS

29

SECTION 10.05. MATERIAL AGREEMENTS

29

SECTION 10.06. ADVERSE PROPERTIES

29

SECTION 10.07. PRESERVATION OF NAME AND REPUTATION

29

SECTION 10.08. DEBARMENT

30

SECTION 10.09. LIMITATION ON WARRANTIES

30

SECTION 10.10. LIMITATION OF LIABILITY

30

 

 

ARTICLE XI: PATENTS AND TRADEMARK

30

 

 

SECTION 11.01.  FILING, MAINTENANCE AND PROTECTION OF PATENTS

30

 

 

ARTICLE XII: COVENANTS OF CYTOB AND AMAR

30

 

 

SECTION 12.01. FURTHER ACTIONS

30

SECTION 12.02. EQUITABLE RELIEF

31

 

 

ARTICLE XIII: INDEMNIFICATION

31

 

 

SECTION 13.01. CYTOB INDEMNIFIED BY AMAR

31

SECTION 13.02. AMAR INDEMNIFIED BY CYTOB

31

SECTION 13.03. PROMPT NOTICE REQUIRED

32

SECTION 13.04. INDEMNITOR MAY SETTLE

32

 

 

ARTICLE XIV: DISPUTE RESOLUTION

32

 

 

SECTION 14.01. DISPUTES

32

SECTION 14.02. TRIAL WITHOUT JURY

33

SECTION 14.03. PERFORMANCE TO CONTINUE

33

SECTION 14.04. PROVISIONAL REMEDIES

33

SECTION 14.05. DETERMINATION OF PATENTS AND OTHER INTELLECTUAL PROPERTY

33

 

 

ARTICLE XV: CONFIDENTIALITY

33

 

 

SECTION 15.01. CONFIDENTIALITY

33

SECTION 15.02. PUBLICITY REVIEW

34

 

 

ARTICLE XVI: MISCELLANEOUS

34

 

 

SECTION 16.01. COMMERCIALLY REASONABLE EFFORTS

34

SECTION 16.02. CYTOPHARM

35

SECTION 16.03. BUMIMEDIC

35

SECTION 16.04. BIOVET

35

SECTION 16.05. NOTICES

35

SECTION 16.04. SEVERABILITY

36

SECTION 16.05. ENTIRE AGREEMENT/MERGER

36

SECTION 16.06. AMENDMENT

36

SECTION 16.07. COUNTERPARTS

36

SECTION 16.08. NO WAIVER OF RIGHTS

37

SECTION 16.09. FORCE MAJEURE

37

SECTION 16.10. FURTHER ASSURANCES

37

SECTION 16.11. ASSIGNMENT AND SUBLICENSE

37

SECTION 16.12. EXPENSES

37

SECTION 16.13. BINDING EFFECT

37

SECTION 16.14. GOVERNING LAW

38

SECTION 16.15. SURVIVAL OF REPRESENTATIONS AND WARRANTIES

38

SECTION 16.16. NO STRICT CONSTRUCTION

38

SECTION 16.17. INDEPENDENT CONTRACTORS

38          

 

Exhibit I - HBL License and Supply Agreement

 

Exhibit II - Specifications

 

Exhibit III - Certificate of Compliance

 

 

 

CYTOB-AMAR License  Supply Agree 2-25-2009 redacted   Final Agreement

 

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LICENSE AND SUPPLY AGREEMENT

 

 

This License and Supply Agreement (“Agreement”) is made as of February 6, 2009 (the “Effective Date”), by and between CytoBiotech, Inc. (CYTOB), a corporation, having a principal place of business at 6F., No.6, Sec.1, Jhongshing Rd.,Wugu Shiang, Taipei county 24872, Taiwan ,  and Amarillo Biosciences, Inc., a Texas corporation (“AMAR”), with its principal place of business located at 4134 Business Park Drive, Amarillo, Texas 79110, USA. AMAR and CYTOB are sometimes referred to collectively herein as the “Parties” and individually as a “Party.”

 

 

WHEREAS, AMAR has substantial expertise in the oral use of human interferon alpha (“IFN”) and have proprietary rights and Know-How in the field of formulation of oral IFN;

 

 

WHEREAS, AMAR is willing to disclose to CYTOB the AMAR Know-How consisting of human clinical data and all other data, including but not limited to, safety, bioavailability, and clinical trial data necessary for CYTOB to obtain regulatory approval for a product for the treatment of human diseases in the Territory; and

 

 

WHEREAS, AMAR has an exclusive worldwide license (except Japan) to market and distribute the oral formulation of Hayashibara (known as “HBL”) IFN, and desires to provide HBL oral IFN to CYTOB on the terms and conditions herein set forth, and CYTOB desires to obtain the right to perform clinical trials on, distribute and market, HBL IFN on the terms and conditions herein set forth;

 

 

WHEREAS, AMAR owns certain proprietary information, intellectual property, Patents and AMAR Know-How, and other rights relating to the use of low dose oral IFN for the treatment or prevention of human and animal diseases;

 

 

WHEREAS, subject to the terms of this Agreement, AMAR desires to grant to CYTOB, and CYTOB wishes to obtain from AMAR, an exclusive supply agreement and distribution license, subject to existing rights, to such Know-How and related intellectual property rights in the Territory in connection with the Product; and

 

 

WHEREAS, AMAR is willing to grant such rights and licenses to CYTOB under the terms and conditions hereinafter set forth.

 

 

NOW, THEREFORE, in consideration of the mutual promises, covenants and agreements hereinafter set forth, the Parties mutually agree as follows:

 

 

ARTICLE I:

 

 

DEFINITIONS

 

 

(a)   The following terms as used in the Agreement shall, unless the context clearly indicates to the contrary, have the meaning set forth below:

 

 

AMAR Know-How ” means all Know-How under the Control of AMAR as of the Effective Date and at any time during the TERM related to (but not claimed under) the AMAR Patent Rights and which is necessary or useful to develop, Manufacture and/or commercialize the Product, including all information, reports, results, inventions, materials, and any other

 

 

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technical and scientific data, specifications and formulae directly related to the development, regulato­ry approval, Manufacture, testing, use, marketing and/or sale of Product, including non-patentable Improvements, and any nonpublic information relevant to the AMAR Patent Rights, including preclinical and clinical data from AMAR's past, current or future studies, relating to safety or bioavailability, or preclinical or clinical data relating to the use of HBL oral IFN and/or IFN for the treatment or prevention of human diseases.

 

 

AMAR Patent Rights ” means all Patent Rights that are under the Control of AMAR as of the Effective Date under US patent laws’ protection, and at any time during the TERM that are necessary or useful to the use, development, Manufacture, marketing, promotion, distribution, sale and/or commercialization of the Product for use in the treatment of the Licensed Indications, and Improvements thereto developed by or on behalf of AMAR during the TERM.

 

 

AMAR Technology ” means the AMAR Patent Rights and the AMAR Know-How.

 

 

 “ Affiliate ” means any entity, which directly or indirectly controls, is controlled by or is under common control with either CYTOB or AMAR. The term “control” as used in the preceding sentence means the power to direct or control the affairs of such entity, and control shall be presumed where CYTOB or AMAR or their Affiliates (as the case may be) own Fifty percent (50%) or more of the voting stock or other equity interests of such entity.  CYTOB ownership in AMAR is excluded as an Affiliate.

 

 

Applicable Laws ” means all applicable laws, rules, Regulations and guidelines within or without the Territory that may apply to the marketing or sale of the Product in the Territory or the performance of either Party's obligations under this Agreement including laws, Regulations and guidelines governing the marketing, distribution and sale of the Product in the Territory, to the extent applicable and relevant, and including all cGMP or current Good Clinical Practices standards or guidelines promulgated by the FDA or the Governmental Authorities and including trade association guidelines. The laws are also under the designated Territory.

 

 

Certificate of Compliance means the certificate of compliance in the form attached hereto as Exhibit B or otherwise requested by regulatory agencies in the Territory .

 

 

 “ CFR ” means the United States Code of Federal Regulations.

 

 

           “ DOH ” means the Department of Health in a country in the Territory.

 

 

 

 

 

 

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(a)   is now, or hereafter becomes, through no act or failure to act on the part of the receiving Party, generally known or available or accessible through public domains;

 

 

(b)   is known by the receiving Party at the time of receiving such information, as evidenced by its written records maintained in the ordinary course of business;

 

 

(c)   is hereafter furnished to the receiving Party by a Third Party, as a matter of right and without restriction on disclosure;

 

 

(d)   is independently developed by the receiving Party, as evidenced by its written records, without knowledge of, and without the aid, application or use of, the disclosing Party's Confidential Information; or

 

 

(e)   is the subject of a written permission to disclose provided by the disclosing Party.

 

 

Any Confidential Information will be marked as “Confidential & Proprietary Information” at the foot or head of every page throughout the documents.

 

 

Control ” means the possession of the ability to grant a license or sublicense as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.

 

 

 “ Existing License ” means, the HBL Agreement, attached into this document as Exhibit I.

 

 

FDA ” means the United States Food and Drug Administration.

 

 

First Commercial Sale ” means after obtaining the necessary Governmental Approval, the first sale for use, consumption or resale of a Product by CYTOB, its Affiliates or its sublicensees in the Territory (excluding any transactions for clinical trials). A sale to an Affiliate shall not constitute a First Commercial Sale unless the Affiliate is the end user of the Product.

 

 

GAAP ” means United States generally accepted accounting principles, consistently applied in accordance with past practice.

 

 

“IFRS” means International Financial Reporting Standards.

 

 

Good Clinical Practices ” means good clinical practices as defined in 21 CFR § 50 et. seq. and § 312 et. seq.

 

 

Governmental Approval ” means all permits, licenses and authorizations, including Marketing Authorizations, required by any Governmental Authority in the Territory as a prerequisite to the Manufacturing, packaging, marketing and selling of the Product.

 

 

Governmental Authority ” means any federal, state, local or other government, administrative or regulatory agency, authority, body, commission, court, tribunal or similar entity, including other entities in each country in the Territory responsible for the regulation of medicinal products intended for human use.

 

 

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HBL ” means Hayashibara Biochemical Laboratories, Inc. of Okayama, Japan.

 

 

HBL Agreement ” means the Joint Development and Manufacturing/Supply Agreement by and between HBL and AMAR dated as of March 13, 1992 (Exhibit Ia), as amended by the First Amendment to Joint Development and Manufacturing/Supply Agreement dated as of January 17, 1996 (Exhibit Ib) and the Addendum to Manufacturing/Supply Agreements dated as of May 10, 1996 (Exhibit Ic) and September 7, 2001 (Exhibit Id).

 

 

HBL IFN ” means the cell culture derived human lymphoblastoid IFN produced by HBL.

 

 

Improvements ” means any and all developments, inventions or discoveries in the Licensed Indication relating to the AMAR Patent Rights developed by AMAR, or acquired by AMAR at any time during the TERM and shall include developments intended to enhance the safety and/or efficacy of the Product.

 

 

IFN ” means human interferon alpha.

 

 

 “ Know-How ” means all know-how, trade secrets, inventions, data, processes, techniques, procedures, compositions, devices, methods, formulas, protocols and information, whether or not patentable, which are not generally publicly known, including, without limitation, all chemical, biochemical, toxicological, and scientific research information, whether in written, graphic or video form or any other form or format, used to produce human interferon alpha and its oral formulation.

 

 

Licensed Indications ” means all human and animal clinical indications.

 

 

Manufacture ” or “ Manufacturing Process ” means the storage, handling, production, processing and packaging of the Product, in accordance with this Agreement and Applicable Laws.

 

 

Marketing Authorization ” means all necessary and appropriate regulatory approvals, including Pricing and Reimbursement Approvals, where applicable, to put the Product on the market in the Territory.

 

 

Material Agreements ” means the Existing License.

 

 

NDA ” means a new drug application, biological license application or establishment license application, as applicable, and all amendments and supplements thereto, filed or to be filed, with the FDA seeking authorization and approval to Manufacture, package, ship and sell the Product as more fully described in the Regulations.

 

 

“Net Sales” means the invoice amounts actually received for sales of the Product by CYTOB, its Affiliates or sublicensees in a bona fide arm's length transaction, less the following items, provided that they are bona fide transactions designed to optimize the sales of Product (a) cash discounts and trade allowances actually granted, (b) rebates and chargebacks required by Applicable Laws or made pursuant to agreements with customers, (c) credits or allowances actually granted upon claims, damaged goods, outdated goods, rejections or returns of such Product, including recalls, (d) taxes, tariffs and similar obligations, duties or other governmental charges (other than income taxes) levied on, absorbed or otherwise imposed on sales of such Product in the Territory and shown separately on the invoice, (e) shipping charges and (f) insurance costs related to shipping.

 

 

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Components of Net Sales shall be determined in the ordinary course of business in accordance with historical practice and using the accrual method of accounting in accordance with GAAP or IFRS, but shall not include any sales of the Product for pre-clinical or clinical testing or for other than commercial purposes.

 

 

In the event CYTOB transfers the Product to a Third Party in a bona fide arm's length transaction, for consideration, in whole or in part, other than cash or to a Third Party in other than a bona fide arm's length transaction, the Net Sales price for such Product shall be deemed to be the standard invoice price then being invoiced by CYTOB in an arms length transaction with similar customers for similar amounts less the items set forth in (a) through (f) above.

 

 

Patent Rights ” means all rights related to human interferon alpha under patents and patent applications, and any and all patents issuing there from (including utility, model and design patents and certificates of invention), together with any and all substitutions, extensions (including supplemental protection certificates), registrations, confirmations, reissues, divisional, continuations, continuations-in-part, re-examinations, renewals and foreign counterparts of the foregoing and all Improvements, supplements, modifications or additions during the term.

 

 

Phase IV ” means, as applicable, a study or program designed to obtain additional safety or efficacy data, detect new uses for a drug, or to determine effectiveness for labeled indications under conditions of widespread usage, which is commenced after Government Approval of the Product in the applicable country in the Territory or any such study or program required by the FDA or other applicable Governmental Authority.

 

 

 “ Pricing and Reimbursement Approvals ” means any pricing and reimbursement approval, by government agency in the Territory, that must be obtained before placing the Product on the market in the Territory in which such approval is required.

 

 

Prime Rate of Interest ” means the prime rate of interest published from time to time in The Wall Street Journal as the prime rate; provided, however that if The Wall Street Journal does not publish the prime rate of interest, then the term “Prime Rate of Interest” shall mean the rate of interest publicly announced by Bank of America, N.A., as its prime rate, base rate, reference rate or the equivalent of such rate, whether or not such bank makes loans to customers at, above, or below said rate.

 

 

Product ” means a formulation or composition containing HBL IFN and designated, detailed, or labeled for oral use in the treatment of the Licensed Indications.

 

 

Regulations ” means regulations, statutes, rules, guidelines and procedures promulgated by the FDA or other governmental agency pursuant to the Act or other law, including without limitation, those regulations currently contained in Title 21 of the CFR.

 

 

SFDA ” means the State Food and Drug Administration of a country in the Territory.

 

 

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Shipment ” or “ Shipped ” means each individual group of Product received by CYTOB from AMAR or its agent.

 

 

“Specifications” means the specifications for the Product.  The initial Specifications are attached hereto as Exhibit V.

 

 

Territory ” Cambodia, Indonesia, Philippines, Thailand, Vietnam and (subject to the existing license and supply agreement with CytoPharm) China, Taiwan and Malaysia (see Miscellaneous 16.02 and 16.03).

 

 

Third Party ” means any entity other than AMAR or CYTOB or an Affiliate of AMAR or CYTOB.

 

 

Unit ” means a single finished dosage form of Product in the form designated by CYTOB, which initially, for clinical supplies, shall consist of a 200 mg by weight, with up to 200  international units (IU) by activity, tablet or lozenge. Clinical testing may result in a change in the optimal dose and require a new definition of “ Unit.

 

 

(b)   Each of the following terms is defined in the Section or under the defined term set forth opposite such term below:

 

 

 

AMAR Preamble

ADE Section 9.02

Agreement Preamble

Clinical Records Section 2.02(c)

Disputed Amount Section 5.03(a)

DMF Section 2.02(b)

Effective Date Preamble

Force Majeure Section 16.10

CYTOB Preamble

Indemnitee Section 13.03

Indemnitor Section 13.03

Loss Section 13.01

Parties Preamble

Party Preamble

Purchase Price Section 7.01

Representatives Section 15.01

Milestone Payments Section 4.02

SEC Section 15.02

SOP Section 9.02

TERM Section 5.01

 

(c)   Interpretation. The section headings contained in this Agreement are for reference purposes only and shall not affect the meaning or interpretation of this Agreement. Except where the context clearly requires to the contrary: (i) each reference in this Agreement to a designated “Section” or “Exhibit” is to the corresponding Section or Exhibit of or to this Agreement; (ii) instances of gender or entity-specific usage (e.g., “his” “her” “its” “person” or “individual”) shall not be interpreted to preclude the application of any provision of this Agreement to any individual or entity; (iii) the word “or” shall not be applied in its exclusive sense; (iv) “including” shall mean “including, without limitation”; (v) references to laws, Regulations and other governmental rules, as well as to contracts, agreements and other instruments, shall mean such rules and instruments as in effect at the time of

 

 

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determination (taking into account any amendments thereto effective at such time without regard to whether such amendments were enacted or adopted after the effective date of this Agreement) and shall include all successor rules and instruments thereto; (vi) references to “$” or “dollars” shall mean the lawful currency of the United States; (vii) references to “Federal” or “federal” shall be to laws, agencies or other attributes of the United States (and not to any State or locality thereof); (viii) the meaning of the terms “domestic” and “foreign” shall be determined by reference to the United States; (ix) references to “days” shall mean calendar days; (x) references to months or years shall be to the actual calendar months or years at issue (taking into account the actual number of days in any such month or year); (xi) days, business days and times of day shall be determined by reference to local time in Amarillo, Texas; and (xii) the English language version of this Agreement shall govern all questions of interpretation relating to this Agreement, notwithstanding that this Agreement may have been translated into, and executed in, other languages.

 

 

ARTICLE II:

 

 

RESEARCH AND DEVELOPMENT

 

 

Section 2.01.  AMAR Obligations.

 

(a)   As soon as reasonably practicable after the Effective Date, AMAR will make available all AMAR Know-How to CYTOB for CYTOB's inspection and at CYTOB's request will provide CYTOB with a copy of all AMAR Know-How in tangible form and a written summary of all AMAR Know-How not in tangible form. In the event CYTOB request that more than 1,000 pages be copied in connection with the foregoing, CYTOB shall reimburse AMAR for AMAR’s actual out of pocket costs for making copies in excess of 1,000 pages, CYTOB shall pay AMAR such amounts within 30 days following CYTOB’s receipt of an invoice therefore accompanied by documentation reasonably supporting such invoice.

 

 

(b)   AMAR agrees to maintain, or ask HBL to maintain, the Drug Master File (“DMF”) for HBL IFN up-to-date at all times during the TERM. AMAR shall cooperate fully with CYTOB in order to obtain all the Marketing Authorizations, which now are or later become necessary to develop, Manufacture, use, market or sell any Product. Such cooperation shall include, but not be limited to, AMAR providing CYTOB with the AMAR Know-How and AMAR appearing at and participating in meetings with regulatory agencies at the reasonable request of CYTOB to assist CYTOB in obtaining such Marketing Authorizations as are now required, or may in the future be required to Manufacture, use, market or sell any Product. AMAR shall execute, or ask third parties to execute, upon request by CYTOB, any and all documents reasonably necessary to obtain such Marketing Authorizations. CYTOB (with its written pre-approval) shall reimburse AMAR for any reasonable out-of-pocket costs, including reasonable attorney's fees, employee salary and travel expenses incurred by AMAR in connection with such cooperation.  If CYTOB will not approve the reimbursement, then AMAR shall not be required to perform the task.

 

 

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(c)   AMAR shall provide to CYTOB or any sub-licensee of CYTOB, at CYTOB's request and, unless otherwise set forth in this Agreement, CYTOB’s sole expense, with AMAR Technology reasonably necessary to enable CYTOB or such sub-licensee to exercise fully its rights and fulfill its obligations under this Agreement.

 

 

(d)   AMAR and CYTOB will review the Patent Rights related to CYTOB’s activities in the Territory.  Once the Parties agree to a strategy, CYTOB will make its best efforts to maintain all necessary AMAR Technology in the Territory (see Section 11.01).

 

 

Section 2.02.  CYTOB Obligations.

 

 

 

(b)   CYTOB shall use commercially reasonable efforts to timely secure any and all Governmental Approvals in the Territory and shall own and maintain all Governmental Approvals and related information as provided herein. The Parties agree and acknowledge that Governmental Approval for the Product will be sought in the Territory.

 

 

(c)   CYTOB shall maintain records in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes and shall properly reflect all work done and results achieved in the performance of its duties hereunder (including all data in the form required to be maintained under any Applicable Laws), and any subsequent pre-clinical or clinical studies (the “Clinical Records”). The Clinical Records generated in the Territory shall be owned by CYTOB and shall be considered Confidential Information of CYTOB and AMAR.  AMAR may request the Clinical Records, and CYTOB shall provide the Clinical Records to AMAR.  These records include books, records, reports, research notes, charts, graphs, comments, computations, analyses, compilations, recordings, photographs, computer programs and documentation thereof, computer information storage means, samples of materials and other graphic or written data generated in connection with CYTOB's research and development activities with respect to the Product, except for those records and data prohibited to bring out of the Territory.

 

 

(d)   In the event AMAR requests that more than 1,000 pages be copied in connection with the foregoing, AMAR shall reimburse CYTOB for CYTOB’s actual out of pocket costs for making copies in excess of 1,000 pages, AMAR shall pay CYTOB such amounts within 30 days following AMAR’s receipt of an invoice therefore accompanied by documentation reasonably supporting such invoice.

 

 

(e)   AMAR has the right, upon fifteen business days’ prior written notice to CYTOB, to review the Clinical Records associated with human oral IFN upon request and during normal business hours, and CYTOB shall, subject to Applicable Laws, provide AMAR upon request with a copy of all requested Clinical Records, at AMAR’s cost, to the extent reasonably required for the exercise of AMAR's rights under this Agreement . AMAR may use the Clinical Records and the summaries thereof for commercial and regulatory approval purposes. If AMAR wants to provide a non-governmental entity Third Party with the Clinical Records or a summary thereof or use information contained in such records for a commercial purpose, AMAR may do so as long as the non-governmental entity Third Party agrees to the Confidentiality provisions of Section 15.01.

 

 

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(f)   Failure of CYTOB to commercialize any Product in a country of the Territory within two (2) years from the date of AMAR’s first FDA approval to treat a human or animal disease shall cause that country to be deleted from the Territory.

 

 

(g)   Failure of CYTOB to commercialize Product for a clinical indication within two (2) years from the date of AMAR’s first FDA approval to treat a human or animal disease shall cause that clinical indication to be deleted from the Agreement.

 

 

Section 2.03.  Availability of Resources; Cooperation.

 

Each Party shall maintain laboratories, offices and/or other facilities reasonably necessary to carry out the activities to be performed by such Party hereunder. Upon reasonable advance notice, each Party agrees to make its employees and non-employee consultants reasonably available at their respective work locations to consult with the other Party on issues arising during the collaboration and in connection with any request from any Governmental Authority, including regulatory, scientific, technical and clinical testing issues.  Such meeting may be arranged through the internet or site visit. The meetings should be arranged within 15 working days after the requests, where feasible.

 

 

Section 2.04.  Reporting Obligations of CYTOB.

 

On or prior to December 31st of each year during the TERM of this Agreement CYTOB shall provide AMAR with a report of ongoing development efforts, including a report of efforts by CYTOB with respect to clinical testing, regulatory approval efforts, marketing/sales strategy, and any other areas into which CYTOB's reasonable business efforts in accordance with this paragraph may reasonably be categorized. Such report shall be provided in English and shall be accompanied by samples of labeling, instructions, promotional and other support materials, if any, developed for CYTOB's sales force, patients, physicians, or other outside parties.

 

 

ARTICLE III:

 

 

LICENSE

 

 

Section 3.01.  License and Supply Grant.

 

Subject to the terms of this Agreement and the Existing Licenses, AMAR hereby grants to CYTOB:

 

 

(a)   an exclusive sublicense, with rights to sublicense (subject to Section 16.12), under the AMAR Technology to use the AMAR Technology to market, advertise, promote, Manufacture, offer for sale, sell, and distribute the Product in the Territory; and

 

 

(b)   an exclusive sublicense, with rights to sublicense (subject to Section 16.10), under all rights granted to AMAR pursuant to the HBL Agreement to market, advertise, promote, Manufacture, offer for sale, sell, and distribute the Product in the Territory.

 

 

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In addition to the purchase price of Product, if CYTOB licenses the right to a third unrelated party (except for those who are CYTOB’s subsidiaries), AMAR shall receive _____ percent (_____%) of any license fee, option fee, or other payment, which CYTOB may receive for the sublicense of rights under this Agreement to the sale and/or use of Product.

 

 

Section 3.02.   Restrictions.

 

CYTOB shall have the right to use and sell Product only in the Territory and only for use in the treatment of the Licensed Indications. CYTOB shall not seek customers, establish any branch or maintain any distribution depot for Product in any country outside the Territory. CYTOB shall not sell Product to any customer in any country outside the Territory or to any customer in the Territory if, to the knowledge of CYTOB, such customer intends to resell such Product in any country outside the Territory.

 

 

Section 3.03.   Retained Rights.

 

AMAR retains all rights other than as set forth in this Agreement to HBL IFN and IFN, including without limitation, the right to test, develop, license, sublicense, market, distribute or otherwise use IFN and HBL IFN for treatment of the Licensed Indications outside the Territory.

 

 

ARTICLE IV:

 

 

PAYMENTS

 

 

Section 4.01.  Initial Fee.

 

On the Effective Date, as an initial license fee, CYTOB shall pay to AMAR a sum equal to _______________ US Dollars ($________).  This fee will be wired into AMAR’s designated bank account within 5 days of the Effective Date. Failure to make this initial payment shall cause the Agreement to be terminated and to be of no further force or effect (except for Article XV). Upon receipt of the initial license fee, AMAR shall provide CYTOB with all the existing regulatory documents in AMAR’s possession that are needed to obtain government approval for trials in a country in the Territory.  The documents include those that submitted to FDA and SFDA for clinical trials.

 

 

Section 4.02.  Stock Purchase.

 

(a)   On the Effective Date, CYTOB shall purchase via a private placement three million shares of common stock at $0.10 per share from AMAR for a total investment of three hundred thousand ($300,000) dollars.  CYTOB shall be granted three million warrants to purchase common stock in the next 3 years for twenty cents ($0.20) per share.  The Stock shall be restricted under SEC Rule 144 and con not be sold for 6 months.  Since this is a Stock purchase, the full amount of three hundred thousand dollars will be delivered.  Stock purchase funds will be wired into AMAR’s designated bank account on or before February 16, 2009. Failure to make this stock purchase payment shall cause the Agreement to be terminated and to be of no further force or effect (except for Article XV).

 

 

12


 

 

(b)   Subject in each case to AMAR’s Bylaws and Securities and Exchange Commission Rules and Regulations (including those applicable to the solicitation of proxies for annual and special meetings of shareholders), AMAR’s management shall, upon completion of the stock purchase described herein above, take such steps as may be required and lawfully permitted to elect a nominee of CYTOB to the Board of Directors of AMAR; and to have such Director (or other nominee of CYTOB) reelected at the next ensuing annual meeting of shareholders of AMAR.

 

 

Section 4.03. Minimum Yearly Purchase Order and Minimum Sales.

 

CYTOB shall meet or exceed the following annual minimum total sales. If CYTOB does not achieve these levels, AMAR will have the right to terminate the Agree­ment. Year 1 means the first 12 months after all approvals are obtained in one country in the territory:

Year 1                                                      $__________

Year 2                                                      $__________

Year 3 and Beyond                                $__________

 

Section 4.04.  Reports.

 

CYTOB shall furnish to AMAR a quarterly written report (in sufficient detail to determine the relevant amounts and dates specified in this Section 4.05), which report shall contain at a minimum (a) the number of lozenges sold; (b) the calculation of Net Sales; (c) royalties payable in U.S. dollars, if any, which shall have accrued hereunder based upon Net Sales; (d) withholding taxes, if any, required by law to be deducted with respect to such sales; (e) the dates of the First Commercial Sale of any Product; and (f) the exchange rates, if any, used to determine the amount of United States dollars (collectively, the “Royalty Statement”). Reports shall be due on the 45 th day following the close of each quarter.

 

 

Section 4.05. Records and Audits.

 

During the TERM and for a period of two years thereafter or upon written notice to CYTOB received prior to the expiration of such two year period as otherwise required in order for AMAR to comply with Applicable Law, CYTOB shall keep complete and accurate records in sufficient detail to permit AMAR to confirm the completeness and accuracy of the information presented in each Royalty Statement and all payments due hereunder. CYTOB shall permit an independent, certified public accountant reasonably acceptable to CYTOB to audit and/or inspect those records of CYTOB (including financial records) that relate to number of lozenges sold and Net Sales for the sole purpose of verifying the completeness and accuracy of the Royalty Statements and, the calculation of Minimum Royalties, Net Sales and confirming royalty payments for the Product, during the preceding calendar year. Such inspection shall be conducted during CYTOB’s normal business hours, no more than once in any 12-month period and upon at least thirty (30) days’ prior written notice by AMAR to CYTOB. If such accounting firm concludes that such payments were underpaid during the periods reviewed by such accountants, CYTOB shall pay AMAR the amount of any such underpayments, within thirty (30) days of the date AMAR delivers to CYTOB such accounting firm's report so concluding that such payments were underpaid.  If CYTOB fails to remit the payment within thirty (30) days, interest at a rate equal to the Prime Rate of Interest shall be imposed starting from the 31 st day.  If such accounting firm concludes that such payments were overpaid during such period, AMAR shall pay to CYTOB the amount of any such overpayments, without interest, within thirty (30) days of the date AMAR delivers to CYTOB such accounting firm's report so concluding that such payments were overpaid. If AMAR fails to remit payment within 30 days, interest at a rate equal to the Prime Rate shall be imposed starting from the 31 st day.  Provisions in this Section 4.06 requiring either Party to pay interest shall not prevent the other Party from immediately taking all actions necessary to collect all amounts due, or to enforce any other remedy under this Agreement.  AMAR shall bear the full cost of such audit unless such audit discloses an underpayment by more than 5% of the amount due during such period. In such case, CYTOB shall bear the full cost of such audit. CYTOB shall provide AMAR a copy of the CYTOB audited financial statements with sufficient detail to show the portion of revenue from oral interferon sales each year to be delivered to AMAR within 3 months of the end of CYTOB’s fiscal year.

 

 

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Section 4.0 6.  Exchange Rate; Manner and Place of Payment.

 

All payments hereunder shall be payable in United States dollars. With respect to each calendar quarter, whenever conversion of payments from any foreign currency shall be required, such conversion shall be made at the rate of exchange reported in The Wall Street Journal on the last business day of the applicable calendar quarter. All payments owed under this Agreement shall be made by wire transfer to a bank account designated in writing by AMAR, unless otherwise specified in writing by AMAR.

 

 

Section 4.07. Late Payments.

 

Unless otherwise provided in this Agreement, upon the failure of CYTOB to pay any amount due under this Agreement within fifteen (15) days after receipt of notice by AMAR that such amount has become due and payable and has not been paid, CYTOB shall pay interest to AMAR on such amount from the date such amount is due under this Agreement at the rate of 12% per annum calculated on the number of days such payment is delinquent.  Nothing in this Section 4.05 shall relieve CYTOB of CYTOB’s obligation to make payments.

 

 

Section 4.08.   Taxes.  

 

All taxes levied on account of the payments accruing to AMAR under this Agreement shall be paid by AMAR for its own account, including taxes levied thereon as income to AMAR. If provision is made in law or regulation for withholding, such tax shall be deducted from the payment made by CYTOB, paid to the proper taxing authority and a receipt of payment of the tax secured and promptly delivered to AMAR.

 

 

 

 

Section 4.09.  Other Payments

 

Further payments shall be made as provided in ARTICLE VII or elsewhere in this agreement.

 

 

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ARTICLE V:

 

 

TERM AND TERMINATION

 

 

Section 5.01. Term.

 

This Agreement will take effect on the Effective Date and will remain in force through February 28, 2024 (the “TERM”) after which it shall automatically be renewed for successive periods of one year each, unless terminated earlier under provisions of this Article V or if notice of termination is given by either Party at least one hundred twenty (120) days prior to the December 31 st anniversary of any year after 2023.

 

 

Section 5.02. Termination By CYTOB.

 

CYTOB may terminate this Agreement by notice to AMAR as follows:

 

 

(a)   immediately, if CYTOB reasonably determines based upon the clinical trials and after consultation with AMAR that receipt of Governmental Approval for a Product is unlikely, and/or

 

 

(b)   immediately, if CYTOB reasonably determines based upon the market competition and after consultation with AMAR that the profitability of the Product is unlikely.

 

 

Section 5.03.  Termination by AMAR.

 

AMAR may terminate this Agreement by written notice to CYTOB, upon any of the following conditions:

 

 

(a)   if CYTOB shall fail to make any payments to AMAR on the date on which such payments are due hereunder and such failure continues for more than 10 days after CYTOB’s receipt of notice of such failure to pay; or

 

 

(b)   if CYTOB shall commit any material breach of the provisions of this Agreement other than a breach set forth in subsections (a) above, provided that AMAR has first given CYTOB notice specifying the details of the material breach, and CYTOB has not cured such material breach, if such breach is capable of being cured within such time period, within 45 days of the effective date of such notice; or

 

 

(c)   if CYTOB fails to launch and diligently market the product in the Territory within twelve (12) months after obtaining all necessary government approvals.

 

 

(d)   if CYTOB fails to use commercially reasonable efforts as required in Section 2.02 regarding at least one Licensed Human Indication, such failure shall be cause for Termination of this Agreement.  For example, if CYTOB fails to enroll patients in human clinical trials in one or more Clinical Indications within two (2) years of the Effective Date, then the Agreement shall be terminated.

 

 

(e)   anytime after 2/28/2024 with or without cause upon 3 months prior written notice to CYTOB, or,

 

 

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(f) if the HBL Agreement is terminated, 120 days after such termination; provided, how


 
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