EXCLUSIVE LICENSE AGREEMENT FOR MANUFACTURING, SALES, MARKETING, AND DISTRIBUTION IN THE VETERINARY MARKET
Exhibit 6.5
EXCLUSIVE LICENSE AGREEMENT FOR MANUFACTURING,
SALES, MARKETING, AND
DISTRIBUTION IN THE VETERINARY MARKET
Between
Cytonics Corporation
and
Astaria Global, LLC
Dated: June 30, 2019
1
Exclusive License Agreement for Manufacturing, Sales, Marketing, and Distributing in the Veterinary Market
This agreement (the “Agreement”), made effective as of the 30th day of June, 2019 the (“Effective Date”) by and between:
Cytonics Corporation (“Cytonics”), a Florida Corporation, with principal place of business at 000 X. Xxxxxxxxxx Xxxx, Xxxxx 000, Xxxxxxx, XX 00000, and Astaria Global, LLC (“Astaria”), a Texas Limited Liability Company, with principal place of business at 00000 X Xxxxxx Xxxx, Xxxxx 000, Xxxxxxx, XX 00000. Cytonics and Astaria shall each be referred to herein as a “Party” and collectively as “Parties”.
As used in this Agreement, the following terms have the following respective meanings:
1.1 “Affiliate” shall mean, with respect to any Person (as defined herein), any Person directly or indirectly controlling, controlled by, or under common control with, such other Person at any time during the period for which the determination of affiliation is being made. For purposes of this definition, the term “control” (including the correlative meanings of the terms “controlled by” and “under common control with”), as used with respect to any Person, shall mean the possession, directly or indirectly, of the power to direct or cause the direction of management policies of such Person, whether through the ownership of voting securities or by contract or otherwise
1
1.2 “Aggregate Product Sales” shall mean the revenue received by Astaria from the sale of the APIC Kits and APIC New Products by Astaria and its Affiliates during any calendar quarter not including freight, postage, insurance and other shipping charges, sales and use taxes, custom duties, and any other governmental tax or charge (including income taxes) imposed on or at the time of production, importation, use, or sale of APIC, including any value added tax (VAT). Aggregate Product Sales will be calculated in accordance with GAAP and consistently applied by Astaria. Any sale made for educational purposes, including but not limited to use by universities or other testing facilities, will not be included in the Aggregate Product Sales calculation.
1.3 “Agreement” shall mean this Exclusive Sales, Marketing, Manufacturing, and Distribution Agreement and all exhibits attached hereto.
1.4 “APIC System” and “APIC” shall mean the APIC PRP System and all associated products, whether or not designed, manufactured, patented, produced by or for Cytonics, including but not limited to the APIC Processing Kit (“APIC Kits”), the APIC Pump, and the APIC Centrifuge (the APIC Pump and the APIC Centrifuge known collectively as the “APIC Equipment”) as listed in Exhibit A, the APIC Mini, or any pump system or centrifuge designed or modified to work in conjunction with the APIC Kits and sold by Astaria for the purpose of producing Autologous Therapeutic Products (as defined herein), and any other related products used in conjunction with the APIC System including stands, carts, or other disposable products (“Related Products”).
1.5 “APIC Kit” shall mean the disposable kits for the collection and processing of Autologous Therapeutic Products (which includes the APIC Mini System).
1.6 “APIC New Products” shall mean for autologous therapies an improvement, new development, modification or enhancement to the APIC System for Veterinary Applications (as defined herein) that is developed by Cytonics and is used for Veterinary Applications, including but not limited to the APIC Mini System (“APIC Mini System”).
1.7 “Applicable Laws” shall mean, with respect to each Party, all laws, codes, ordinances, statutes, rules, regulations, orders, decrees, judgments, injunctions, notices or binding agreements promulgated or entered into by any Governmental Authority having jurisdiction over such Party or such Party’s obligations under this Agreement, as the same may be amended, modified or repealed from time to time, including, without limitation, the Regulatory Requirements.
1.8 “Autologous Therapeutic Products” shall mean a therapeutic product derived from a patient’s own blood or tissue.
1.9 “Business Day” shall mean any day other than a Saturday, Sunday or bank or other national public holidays in the USA.
3
1.10 “Clinical Trial” shall mean the human clinical study for the APIC Mini (“APIC Mini System”) or APIC Cell Free System (“APIC Cell Free System”).
1.11 “Commercially Reasonable Efforts” shall mean with respect to the efforts to be expended by a Party with respect to any objective, reasonable, diligent, good faith efforts to accomplish such objective as such Party would normally use to accomplish a similar objective under similar circumstances for such Party’s benefit exclusive of the other Party, taking into account issues of safety, efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the product, the regulatory structure involved, profitability of the product, and other relevant commercial factors.
1.12 “Customers” shall mean physicians, physician practice groups, hospitals and clinics treating any and all species of animals, and any other party purchasing the APIC System and the Related Products.
1.13 “Cytonics Technology” shall mean all Diagnostic and Therapeutic Technology developed by Cytonics.
1.14 “FDA” shall mean the U.S. Food and Drug Administration or any successor agency thereto.
1.15 “GAAP” shall mean generally accepted accounting principles as in effect from time to time in the USA.
1.16 “Governmental Authority” shall mean any United States or non-United States federal, national, supranational, state, provincial, local, or similar government, governmental, regulatory or administrative authority, agency or commission or any court, tribunal, or judicial or arbitral body.
1.17 “IDE” shall mean any Investigational Device Exemption application, as contemplated by Section 505(i) of the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, and the regulations promulgated thereunder, filed with the FDA pursuant to Part 812 of Title 21 of the U.S. Code of Federal Regulations, including any amendments thereto. References herein to IDE shall include, to the extent applicable, any comparable filing(s) outside the United States necessary to commence or conduct clinical trials.
1.18 “IND” shall mean any Investigational New Drug application, as contemplated by Section 505(i) of the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, and the regulations promulgated thereunder, filed with the FDA pursuant to Part 312 of Title 21 of the U.S. Code of Federal Regulations, including any amendments thereto. References herein to IND shall include, to the extent applicable, any comparable filing(s) outside the United States necessary to commence or conduct clinical trials.
4
1.19 “Instructions for Use” shall mean the insert to be included in each APIC Kit setting forth the instructions for use of the APIC Kit in conjunction with the APIC System. A copy of the Instructions for Use is attached as Exhibit C.
1.20 “Know-how” shall mean all inventions, discoveries, improvements, trade secrets and proprietary methods and materials, whether or not patentable, including, but not limited to, samples of, methods of production or use of, and structural and functional information pertaining to, chemical compounds, proteins or other biological substances; other data; formulations; techniques; and know-how.
1.21 “Marks” shall mean the trademarks owned by Cytonics listed on Exhibit B.
1.22 “Non-autologous Therapeutic Products” shall mean therapeutic products not derived from the blood or tissue of the patient.
1.23 “Options” shall mean the options for first right of negotiation granted by Cytonics to Astaria.
1.24 “Patents” shall mean the rights and interests in and to issued patents and pending patent applications set forth on Exhibit D, including all substitutions, continuations, continuations-in-part, divisions, and renewals, all letters patent granted thereon, and all reissues, reexaminations and extensions thereof, whether owned or in-licensed with the right to sublicense and any foreign equivalents thereof.
1.25 “Person” shall mean an individual, corporation, partnership, limited liability company, association, trust or unincorporated organization, a Governmental Authority or any other entity or organization.
1.26 “Regulatory Requirements” shall mean the Federal Food, Drug, and Cosmetic Act, Good Clinical Practices, the Health Insurance Portability and Accountability Act of 1996 and regulations promulgated from time to time thereunder (“HIPAA”), Title 21 of the Code of Federal Regulations, including Parts 50, 56, 312, 812 (as applicable) and any applicable foreign counterparts.
1.27 “Sales Year” shall mean four (4) successive calendar quarters starting with the first full calendar quarter after the Effective Date and repeating thereafter for successive four (4) calendar quarters for each year during the Term.
1.28 “Specifications” shall mean the written specifications and instructions provided by Cytonics, as further described in Exhibit E, regarding the xxxx of material, purchasing specifications, assembly, manufacturing, production and use of APIC.
1.29 “Technology” shall mean the Patents and Know-how of a Party.
1.30 “Term” shall have the meaning set forth in Section 3.1.
5
1.31 “Territory” shall mean all states in the United States of America and world-wide
1.32 “Veterinary Applications” shall mean all conditions, maladies, and diagnosis involving pain, inflammation, or degradation of joints and spinal discs in all species of animals.
1.33 “Therapeutic Field” shall mean the treatment of Veterinary Applications in all species of animals.
1.34 “Third Party” shall mean a person or entity other than the Parties or Affiliates thereof.
2. | APPOINTMENT OF DISTRIBUTOR; RESTRICTIONS |
3. | TERM |
3.1 The term of this Agreement (the “Term”) shall commence on the Effective Date and shall continue in full force and effect thereafter in perpetuity, unless terminated pursuant to Section 15.1. This Agreement is, and shall always be interpreted as, a contract of indefinite duration.
4. | LICENSE GRANTS |
6
withheld or delayed unless the new licensee is unable or ill-equipped to perform Commercially Reasonable Efforts due to reasons including, but not limited to, an insufficient business plan, inexperienced management, ongoing legal disputes, etc. For the avoidance of doubt, Astaria shall not have any rights or options to the Cytonics Non-autologous Therapeutic Products as defined in Section 1.22 of this Agreement. Provided that Astaria is not in breach of this Agreement, Cytonics shall not market (including promotion and similar activities) or distribute the APIC System, or any competing Autologous Therapeutic Products for Veterinary Applications.
Section 365(n) of the Bankruptcy Code. Notwithstanding Section 16.1, all rights and licenses granted under or pursuant to any section of this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code.Each Party shall retain and may fully exercise all of their respective rights and elections under the Bankruptcy Code or equivalent legislation in any other jurisdiction. Upon the bankruptcy of either Party, the other Party shall further be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property, and such, if not already in its possession, shall be promptly delivered to the other Party, unless the party that is in bankruptcy elects to continue, and continues, to perform all of its obligations under this Agreement.
5. | OBLIGATIONS OF ASTARIA |
7
obligations under this Section 5.1 during the Cure Period or the Extension Period, as applicable, Astaria’s exclusive rights hereunder may continue uninterrupted during the Term unless this Agreement is otherwise terminated pursuant to Section 15.1.
a. promoting and selling the APIC System to Customers in the Territory through Astaria’s trained field sales representatives, and soliciting orders from current and potential Customers within the Territory;
b. consulting with and furnishing information to Cytonics concerning Customers’ requirements and other matters that may affect sales of the APIC System in the Territory;
c. being responsible for reporting to Cytonics all information in Astaria’s possession or of which Astaria is aware, upon reasonable request by Cytonics, to enable Cytonics to ensure that the APIC System meets all Applicable Laws;
d. refraining from any act or practice that reasonably might tend to adversely reflect upon Cytonics;
e. furnishing to Cytonics for prior review and approval copies of all proposed marketing materials in accordance with Section 5.4(a) and refraining from or discontinuing the use of any marketing materials which, in the reasonable opinion of Cytonics, are false or misleading or may subject Cytonics to liability;
f. providing forecasts to Cytonics during the Term in accordance with Section 5.4b
g. refraining from (i) acting in any manner that could expose Cytonics to anyliability beyond such exposure as is inherent in connection with offering a product in the market and Territory as is contemplated by this Agreement and (ii) pledging or purporting to pledge a Cytonics’ obligation;
h. promptly informing Cytonics of any infringements of its patents, trademarks and other proprietary rights known to Astaria and using Commercially Reasonable Efforts to assist Cytonics in the safeguarding of such legal rights as defined in Section 12.2.; and
i. not marketing, promoting, soliciting, or, directly or indirectly, knowingly selling the APIC System or allowing the APIC System to be sold for use in any application other than for Veterinary Applications.
8
j. not manufacturing marketing, selling, or distributing a product that is directly competitive to the APIC System, except for APIC New Products, with regards to its use as a treatment for veterinary conditions.
a. Astaria shall actively promote the APIC System throughout the Territory at its own expense. The methods by which Astaria shall promote the APIC System shall be within its sole discretion, subject to compliance with Applicable Law and the terms hereof. Astaria shall be responsible for: (i) the distribution of promotional materials; and (ii) the translation and distribution of such materials as well as all instructional materials provided to Astaria by Cytonics (such promotional and instructional materials, collectively, the “Cytonics Promotional Material”), as necessary to meet legal or business requirements in fulfilling its obligations hereunder and to develop the market for the APIC System in the Territory; provided, however, that Astaria shall have no obligation to use any Cytonics Promotional Material that Astaria determines in its sole discretion does not comply with Applicable Laws or will not benefit the promotion of the APIC System throughout the Territory. Astaria shall have the right to modify, amend or supplement any Cytonics Promotional Materials in accordance with Section 5.2 (e) so that they comply with Applicable Laws and/or benefit the promotion of the APIC System throughout the Territory. Astaria further agrees that Cytonics shall own all copyright and other rights to and interests in any such Cytonics Promotional Material (including translations thereof) and shall undertake any necessary action to perfect such rights and interests, including the written assignment to Cytonics, upon request, of all such rights and interests. Astaria may produce and distribute its own promotional materials with respect to the APIC System, (such promotional materials, collectively, the “Astaria Promotional Materials”); provided, however, that (i) all Astaria Promotional Materials shall comply with Applicable Laws and (ii) prior to the use of the Astaria Promotional Materials, Astaria shall provide copies thereof to Cytonics for its review and approval at least thirty (30) days prior to the intended date of distribution thereof. If for any reason, Cytonics does not object to the Astaria Promotional Materials provided for review within 30 days of receipt of the materials, such objection to be made in writing sent to Astaria, then Astaria shall be allowed to proceed with the distribution of the materials without further review or approval from Cytonics. Astaria shall own all Astaria Promotional Material, however Cytonics will have a non-exclusive right to use the Astaria Promotional Material that will survive the termination of this agreement.
9
APIC Kits that Astaria reasonably and in good faith believes it will require, and Astaria’s plan for ordering components and kits from its suppliers including marketing and sales activities.
10
11
Astaria as soon as practicable but in no event later than five (5) Business Days after receipt by Astaria. Cytonics shall respond to such complaints within five (5) Business Days after receipt of such complaints.
1.
6. | OBLIGATIONS OF CYTONICS |
12
In addition to the other obligations of Cytonics set forth herein, Cytonics’ obligations under this Agreement during the Term shall consist of the following:
6.2 Training. Cytonics shall make available the training described in Section 5.6.
6.11 Subject to the Astaria’s performance of this Agreement, Cytonics shall not sell, whether directly or indirectly via a 3rd party, the APIC-PRP system in the Therapeutic Area.
6.12 Applicable Laws. During the Term, Cytonics shall comply with all Applicable Laws.
13
7. | PRICING. |
7.1 Astaria shall, from time to time, establish a price for the APIC System in the Territory, which shall be promptly provided to Cytonics in writing following its determination by Astaria. Nothing contained herein shall be deemed to limit in any way the right of Astaria to determine the prices or terms upon which the APIC System may be sold by Astaria. Astaria may sell the APIC Kit and the APIC Equipment and related products at any price determined by Astaria. Notwithstanding Astaria’s’ right to establish the price for the APIC System, for a period of 12 months following the Effective Date of this Agreement, any research institution that Cytonics authorizes to conduct a clinical trial on the APIC System will be allowed by Astaria to purchase kits at a cost of $275 per unit, or alternatively Cytonics will be allowed to purchase the kits for shipment to the research institution at cost of $275 per unit.
2.
7.2
8. | PAYMENT |
8.3 Royalties and Quarterly Minimum Payments.
i. | Calendar Year 2019 – No royalties or quarterly minimums due. |
ii. | Calendar Year 2020 – No royalties or quarterly minimums due. |
14
iii. | Calendar Year 2021 – Greater of 2% of Aggregate Product Sales or |
$10,000 per quarter
iv. | Calendar Year 2022 - Greater of 3% of Aggregate Product Sales or |
$15,000 per quarter
v. | Calendar Year 2023 and thereafter - Greater of 4% of Aggregate Product Sales or $20,000 per quarter |
c. Such Royalty Payments or Quarterly Minimums shall be made within fifteen (15) after the end of each calendar quarter, in accordance with the dates listed in Exhibit G, during a calendar year and shall be accompanied by a written report containing quarterly sales data within 15 days of quarter end, setting forth, for the immediately preceding calendar quarter, the:
(i) | Number of APIC Kits (including the APIC Mini) sold |
(ii) | Aggregate Product Sales applicable to each calender quarter; and |
(iii) | Calculation of the Royalty Payment. |
9. | Payments not received within thirty (30) days of the invoice date will be subject to 10% monthly penalties (non-compounding); and |
(i) | Payments not received within sixty (60) days of the invoice date will nullify this agreement. Cytonics shall provide written notice to Astaria and Astaria shall have thirty (30) days following receipt thereof (the “Cure Period”) to comply with its obligations under this Section 8.3; provided, further, that Astaria may extend the Cure Period for an additional 60 days (the “Extension Period”) by paying to Cytonics $50,000 as consideration for the Extension Period, over and above any other payments due and owing as listed in Section 8.3. |
15
more than once each calendar year (during normal business hours on a mutually agreed date with reasonable advance notice) by an independent Third Party auditor selected by Cytonics and approved by Astaria (such approval not to be unreasonably withheld, conditioned, or delayed) and subject to confidentiality and non-use obligations no less stringent than those set forth in Article 13 for the sole purpose of verifying the accuracy of the financial reports furnished by Astaria or of any payments made by Astaria to Cytonics pursuant to this Agreement; provided, however, that no calendar quarter may be reviewed more than once. Any such auditor shall not disclose Astaria’s Confidential Information to Cytonics, except to the extent such disclosure is necessary to verify the accuracy of the financial reports or the amount of payments due by Astaria under this Agreement. Any amounts shown to be owed but unpaid or overpaid and in need of reimbursement shall be paid or refunded (as the case may be) within thirty (30) days after the auditor’s report. Cytonics shall bear the full cost of such audit unless such audit reveals an underpayment by Astaria of five percent (5%) or more during the applicable audit period, in which case Astaria shall bear the full cost of such audit.
9..3 Currency; Late Fees; Taxes.
a. When calculating Aggregate Product Sale, the amount of such sales in foreign currencies shall be converted into United States Dollars in a manner consistent with currency exchange rates as published in the Wall Street Journal as of the date Astaria received the payment.
b. Each Party shall comply with applicable tax authority guidelines regarding filing and reporting for income tax purposes. Neither Party shall treat their relationship under this Agreement as a partnership or as a pass-through entity for tax purposes. The Parties agree that any taxes that Astaria is required by Applicable Laws to withhold from amounts payable to Cytonics under this Agreement shall be deducted by Astaria from the amounts paid to Cytonics hereunder at the rate(s) required by Applicable Laws, and shall be promptly paid to the appropriate Governmental Authority on behalf of Cytonics. Astaria shall promptly provide to Cytonics receipts from the government or taxing authority evidencing payment of such taxes, if available, or other written proof of payment if official receipts are not available, and shall provide reasonable assistance to Cytonics to obtain refunds or tax credits therefor.
10. | REPRESENTATIONS AND WARRANTIES |
10..1 Of Astaria. Astaria represents and warrants to Cytonics as follows:
a. it has full limited liability company power and authority to enter into and carry out its obligations under this Agreement;
b. the execution, delivery and performance of this Agreement will not conflict with, are not inconsistent with and will not result in any breach of any terms, conditions or provisions of, or constitute (with due notice or lapse of time, or both) a default under any agreement, contract, document or instrument to which Astaria is a party or by which it is otherwise bound;
16
c. this Agreement has been duly executed and delivered by Astaria and constitutes the legal, valid and binding obligation of Astaria, enforceable against Astaria in accordance with its terms subject to the effect of applicable bankruptcy, insolvency, reorganization, moratorium or other similar federal or state laws affecting the rights of creditors and the effect or availability of rules of law governing specific performance, injunctive relief or other equitable remedies, regardless of whether any such remedy is considered in a proceeding at law or equity (collectively, “Bankruptcy Laws and Equitable Principles”);
d. no authorization, consent, approval or similar action of or by any Third Party is required for or in connection with Astaria’s authorization, execution, delivery or performance of this Agreement;
e. it has the requisite capabilities, experience, resources and personnel to perform its marketing and distribution obligations hereunder;
f. it is in compliance with Applicable Laws and has obtained all necessary permits and approvals to perform its obligations under this Agreement; and
g. it has not employed and will not employ any individual or entity that has been debarred by the FDA (or subject to a similar sanction of a foreign equivalent).
10..2 Of Cytonics. Cytonics represents and warrants to Astaria as follows:
a. it has full corporate power and authority to enter into and carry out its obligations under this Agreement;
b. the execution, delivery and performance of this Agreement will not conflict with, are not inconsistent with and will not result in any breach of any terms, conditions or provisions of, or constitute (with due notice or lapse of time, or both) a default under any agreement, contract, document or instrument to which Cytonics is a party or by which it is otherwise bound;
c. this Agreement has been duly executed and delivered by Cytonics and constitutes the legal, valid and binding obligation of Cytonics, enforceable against Cytonics in accordance with its terms, subject to Bankruptcy Laws and Equitable Principles;
d. the performance of the APIC System will not constitute a misappropriation of, or, to Cytonics’ knowledge, infringe upon, any Third Party’s intellectual property rights;
e. it has obtained all necessary permits and approvals to perform its obligations under this Agreement;
f. the labeling of the APIC Kit comply with Applicable Laws, and
17
g. no authorization, consent, approval or similar action of or by any Third Party is required for or in connection with Cytonics’ authorization, execution, delivery or performance of this Agreement.
11. | LIMITATION OF LIABILITY |
12. | PROPRIETARY RIGHTS |
13. | ENFORCEMENT OF PATENT AND TRADEMARKS |
a. During the Term, Cytonics shall file, record, and maintain all Patents within the Cytonics Technology in the Territory, with the expense incurred with respect thereto being paid by Cytonics. Each Party shall keep the other Party reasonably informed, and shall respond to all reasonable requests for information, regarding Cytonics Technology or Marks. Astaria shall not have the right to review and approve any pending applications and other proceedings, however they may make recommendations to Cytonics concerning such actions with respect to the patents included in the Cytonics Technology.
13.2 Infringement and Prosecution.
18
Cytonics is responsible for all patent prosecution, enforcement, and defense; and once notified of a potential patent infringement, Cytonics may rigorously defend Cytonics’ patents.
a. If the defense of Cytonics’ patents results in either and in-court or an out- of-court settlement, whichever Party paid the associated legal expenses, shall be the sole beneficiary of the settlement (should both Parties participate in paying the associated legal expenses, then both Parties shall benefit from the settlement on the same pro-rata percentage of legal expenses each incurred).
b. It is acknowledged that Cytonics will not be expected to defend the patents at their own expense.
a. If either Astaria or Cytonics, or both of them, are sued by a Third Party alleging that the performance of the APIC System infringes any intellectual property rights of such Third Party, the Party who is sued shall immediately give the other Party written notice of same.
b. If proceedings as described in Section 12.3 are brought, Cytonics shall have the right to defend, but not the obligation to defend, such action on behalf of the Parties and any reasonable expenses or costs incurred by Cytonics in connection with such action(s), and any costs or amounts awarded to the counterparties in such action(s) shall be fully borne by Cytonics and any recovery in such action shall be retained by Cytonics in full.
a. The Parties agree to provide each other with reasonable cooperation in the defense of any claims brought against the other Party in connection with the substance of this Agreement and shall join any such litigation as a party if required by Applicable Law. The Parties agree to execute all documents reasonably necessary for the relevant Party to defend such action and shall provide documents and help with making contact with witnesses that are or were their employees, consultants or otherwise connected to them, whose assistance or testimony is necessary in the reasonable judgment of the lawyers who conduct of the proceedings.
b. In no event shall either Party enter into any settlement, consent order, consent judgment or any voluntary disposition of such action that would adversely affect the rights of the other without the prior written consent of such other Party, which consent shall not be unreasonably withheld or delayed.
14. | CONFIDENTIALITY |
19
without the prior written consent of the disclosing Party. Each Party agrees to use the same means it uses to protect its own confidential information, but in no event not less than reasonable means, to prevent the disclosure of such Information to Third Parties. However, neither Party will be prevented from disclosing Information to its counsel or regular public accountants, or from disclosing Information that is (a) already known by the recipient Party without an obligation of confidentiality other than pursuant to this Agreement; (b) publicly known or becomes publicly known other than through an unauthorized act of the recipient Party; (c) rightfully received from a Third Party without obligation of confidentiality; (d) independently developed without the use of the other Party's Information; (f) expressly approved by the disclosing Party for general disclosure; or (g) required to be disclosed pursuant to a requirement of a Governmental Authority or Applicable Laws if the disclosing Party uses its best efforts to provide the recipient Party with notice of this requirement prior to disclosure. Any combination of features or elements comprising Information shall not be deemed to be within the foregoing enumerated exceptions merely because any such individual feature(s) or element(s) are separately in the public domain or in the recipient Party’s possession, as the case may be, unless the combination itself, or its principle of operation, is publicly known or in the recipient Party’s possession.
15. | DISPUTE RESOLUTION |
15.1 Any controversy, claim or dispute (a “Dispute”) arising out of or in connection with, or relating to, this Agreement, its validity, interpretation, performance, or termination shall be resolved as follows:
a. Either Party may provide a written notice to the other Party that a Dispute has arisen and requiring that the matter be submitted to dispute resolution under this Article 14 (a “Dispute Notice”). The Dispute shall immediately be referred to each Party’s CEO (or its designee), respectively, (“Designated Executives”), who shall meet in person at a mutually acceptable time and location or by means of telephone or video conference within thirty (30) Business Days of the Dispute Notice and attempt to negotiate a settlement.
b. If the matter remains unresolved after thirty (30) Business Days after the date of the Dispute Notice or if the Designated Executives fail to meet within thirty (30) Business Days of the date of the Dispute Notice, either Party shall be free to pursue any and all remedies that may be available to such Party at law or equity, subject to the provisions on this Agreement.
16. | TERMINATION |
20
c. This Agreement may be terminated at any time during the Term by written mutual agreement between the Parties.
a. | All licenses and rights granted to Astaria hereunder shall terminate. |
b. Astaria shall cease to be a distributor of Cytonics, the APIC System and shall immediately cease any reference to its status as a Cytonics distributor and any use of, or reference to, the Marks for any purpose. In such event, Astaria shall, at Cytonics’ option, either destroy all promotional materials and all other materials concerning the APIC System or the Marks, or return them to Cytonics. Notwithstanding the foregoing, in the event of termination, Astaria shall, at Cytonics’ option, either distribute all APIC Kits then held in inventory subject to the terms of this Agreement, or sell such APIC Kits to Cytonics at Astaria’s cost and Astaria shall xxxx Cytonics and Cytonics shall pay Astaria for the inventory, less any amount owed to Cytonics by Astaria.
c. Astaria shall cease all communication with Contract Manufacturers and will no longer order the APIC System, Equipment, or Related Products from any supplier.
d. All Options not yet exercised shall terminate.
e. All monies then owed to Cytonics hereunder shall become immediately due and payable and Astaria’s obligation to pay any sum of money due, payable or accrued under this Agreement shall survive such termination.
f. All customer lists and agreements.
21
All manufacturing lists and agreements.
17. | FORCE MAJEURE |
17.1 Except with respect to the payment of monies due hereunder and the responsibility to maintain the Information in confidence and to respect the proprietary rights of Cytonics, neither Party shall be responsible for failure to perform hereunder due to causes beyond its reasonable control, including, but not limited to, governmental requirements (including, without limitation, export control laws and regulations), work stoppages, fires, civil disobedience, embargo, war, riots, rebellions, strikes, inability to secure products, raw materials or transport, acts of God, and similar occurrences; provided, however, the Party so affected shall use commercially reasonable and diligent efforts to avoid, remove or mitigate such cause of non- performance. Performance shall be resumed as soon as possible after the cessation of such cause, and the Party not affected by the event of Force Majeure shall have the right in any case to terminate this Agreement if such event extends beyond a period of sixty (60) days.
18. | INDEMNITY; PRODUCT WARRANTY; DISCLAIMER OF WARRANTIES |
22
19. | MISCELLANEOUS |
19.2 Governing Law. This Agreement shall be governed and interpreted in all respects by and according to the laws of the State of Florida, U.S.A., excluding its choice of law provisions. It is the express intent and agreement of the Parties that the United Nations Convention for the International Sale of Goods shall not apply to this Agreement or to purchase orders hereunder.
19.3 Consent to Jurisdiction. The Parties each hereby irrevocably consent to exclusive jurisdiction in any federal or state court situated in Palm Beach County, Florida, U.S.A. in connection with any and all legal actions and processes relating to this Agreement initiated by Astaria or Cytonics and to the service of process, pleadings and notices in connection therewith.
23
To: | Cytonics, Corporation |
000 X. Xxxxxxxxxx Xxxx, Xxxxx 000 | |
Xxxxxxx, XX 00000
| |
To: | Astaria Global, LLC |
00000 Xxxx Xxxxxx Xxxx, Xxxxx 000 | |
Xxxxxxx, XX 00000 Attention: Xxxxxxx Xxxxxx |
24
[Signature page follows]
25
Cytonics Corporation
By: /s/ Xxxxxxx Xxxxxxx
Name: Xxxxxxx Xxxxxxx
Title: Founder and Chairman
Astaria Global, LLC
By: /s/ Xxxxxxx X. Xxxxxx
Name: Xxxxxxx X. Xxxxxx
Title: CEO
By:
Name:
Title:
26