LICENSE AND SUPPLY AGREEMENT dated as of October 19, 2012 between ULURU INC. and ORADISC GMBH

EXHIBIT 10.30




dated as of October 19, 2012



between






and


ORADISC GMBH

 
 
 

THIS LICENSE AND SUPPLY AGREEMENT (this “Agreement”) is made and entered into as of this 19th  day of October, 2012 (the “Effective Date”), between ULURU Inc., a corporation organized and existing under the laws of Nevada and having an address at ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (“ULURU”) and OradsicORADISC GmbH, a corporation organized and existing under the laws of Austria and having an address at ▇▇▇▇▇▇▇▇▇▇▇ ▇-▇, ▇▇▇▇▇▇ AT 1010 (“ORADISC”).

RECITALS

WHEREAS, ULURU  has developed a mucoadhesive oral drug delivery product as more fully described in Exhibit A attached hereto (the “Product”), and has obtained United States Patent No. 6,585,997 in connection with the Product

WHEREAS, ORADISC possesses substantial expertise in the commercialization and marketing of such products; and

WHEREAS, ULURU desires to grant to ORADISC, and ORADISC desires to obtain from ULURU, an exclusive license to market the Product and an exclusive right to purchase from ULURU and distribute the Product, all under the terms and subject to the conditions set forth herein.

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and for good and valuable consideration the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:

1.           DEFINITIONS

1.1           Definitions.

As used in this Agreement, the following capitalized terms have the meanings indicated below:

1.1.1           “ULURU” has the meaning set forth in the Preamble.

1.1.2           “ULURU Confidential Information” means all information, specifications (including, without limitation, the Specifications), know-how and data pertaining to the Product and ULURU’s business or its Manufacturing operations disclosed to ORADISC or its Affiliates, Third Party manufacturers or distributors hereunder, including, without limitation, all information, Specifications, know-how and data related to the design, implementation, performance and manufacture of the Product, and any correspondence with the FDA or any other Regulatory Authority, clinical study data, analytical data, or operating procedures.

1.1.3           “ULURU Trademark” means any trademark, trade name, trade dress, slogan, logo, or similar item used by ULURU prior to or as of the Effective Date, or subsequent to the Effective Date in connection with any ULURU product other than the Product.

 
 
 


1.1.4           “Affiliate” means, in the case of either Party, any corporation, joint venture, or other business entity which directly or indirectly controls, is controlled by, or is under common control with that Party.  The term “control,” as used in this definition, means having the power to direct, or cause the direction of, the management and policies of an entity, whether through ownership of voting securities, by contract or otherwise.  Notwithstanding the foregoing, for purposes of this Agreement, the term “Affiliate” does not include entities in which a Party or its Affiliates owns a majority of the ordinary voting power to elect a majority of the board of directors but is restricted from electing such majority by contract or otherwise, until such time as such restrictions are no longer in effect.

1.1.5           “Batch” means the volume of finished, packaged Product obtained from a validated Manufacturing run.

1.1.6           “Certificate of Analysis” means the document identifying the results of the Methods of Analysis for a specific Batch of Product in a form agreed to by the Parties in writing but which shall include, without limitation, the applicable Product Batch’s manufacturing date, expiration date, lot number and testing results and data.

1.1.7           “Confidential Information” means either ORADISC Confidential Information, ULURU Confidential Information, or both, as the context requires.

1.1.8           “Contract Year” means each consecutive twelve (12) month period during the Term, the first of which shall commence on the first day of the calendar month following the date of Launch and end on the first anniversary thereof.

1.1.9          “Control” means, with respect to any item of information or intellectual property right, the possession, whether by ownership or exclusive license, of the right to grant a license or other right with respect thereto.

1.1.10           “Effective Date” has the meaning set forth in the Preamble.

1.1.11           “Facility” means ULURU’s initial Third Party Manufacturing facilities, and any subsequent or replacement Third Party Manufacturing facilities identified to and approved by ORADISC in accordance with Section 2.8.

1.1.12           “FDA” means (a) the United States Food and Drug Administration, or (b) with respect to countries in the Territory other than the United States, any foreign regulatory agency or governmental entity which fulfills a role similar to the United States Food and Drug Administration, or any successor entities thereto.

1.1.13           “FD&C Act” means (a) the Federal Food, Drug and Cosmetic Act, and all regulations promulgated thereunder, or (b) with respect to countries in the Territory other than the United States, any foreign laws, statutes, rules or regulations fulfilling a role similar to the Federal Food, Drug and Cosmetic Act (and all regulations promulgated thereunder), as the same may be amended or supplemented from time to time.

1.1.14           “Field” means the human oral care and dental market.

1.1.15           “Force Majeure Event” has the meaning set forth in Article 10.

 
 
 



1.1.16           “Good Manufacturing Practice” or “GMP” means (a) the then current standards for the manufacture of pharmaceuticals, as set forth in the FD&C Act, (b) such standards of good manufacturing practice as are required by the applicable laws and regulations of countries in which the Product is intended to be sold, to the extent such standards are not inconsistent with the then current standards for the manufacture of pharmaceuticals as set forth in the FD&C Act, and (c) any quality requirements set forth in this Agreement or the Quality Agreement attached hereto as Exhibit B.

1.1.17           “Indemnified Party” has the meaning set forth in Section 7.1.3.

1.1.18           “Indemnifying Party” has the meaning set forth in Section 7.1.3.

1.1.19           “Intellectual Property Rights” means Patents, designs, formulae, trade secrets, know-how, industrial models, and technical information Controlled by ULURU and whether now existing or coming into existence during the Term and which are necessary for and/or related to the use or distribution of the Product.

1.1.20           “Invention” means any new or useful method, process, manufacture, compound or composition of matter, whether or not patentable or copyrightable, or any improvement thereof arising during the Term with respect to the Product, its Manufacture and/or use.

1.1.21           “Launch” means the date on which the Product is sold by ORADISC for the first time to a Third Party for commercial distribution in the Territory.

1.1.22           “Manufacture,” “Manufactured” or “Manufacturing” means all activities involved in the production of the Product, including, without limitation, the preparation, formulation, finishing, testing, packaging, storage and labeling of the Product and the handling, storage and disposal of any residues or wastes generated thereby.

1.1.23           “Materials” means all materials, including, without limitation, all raw materials, ingredients, packaging supplies and labels, required for the Manufacture of Product.

1.1.24           “Methods of Analysis” means the methods of analysis for the Product contained in the regulatory filings or internal quality control documents.

1.1.25           “Net Sales” means, with respect to the Product, the gross invoiced sales amount of the Product sold by ORADISC or its Affiliates to non-affiliate Third Parties, after deduction of the following items, to the extent that such deductions are reasonable and actually allowed, taken or incurred, and (provided that such items do not exceed reasonable and customary amounts in the country in which the sale occurred): (a) trade and quantity discounts, net of any give-backs received by ORADISC in return; (b) refunds, rebates, retroactive price adjustments, service allowances and broker’s or agent’s commissions; (c) credits or allowances given for rejection or return of previously sold Product or for wastage replacement actually taken or allowed; and (d) any tax, duties or government charge levied on the sale of Product and borne by ORADISC and/or its Affiliates (excluding national, state or local taxes based on income). Such amounts shall be determined from the books and records of ORADISC and its Affiliates maintained in accordance with generally accepted accounting principles, consistently applied.  Sales of the Product by and between a Party and its Affiliates for further distribution to a Third Party are not sales to Third Parties and shall be excluded from Net Sales calculations for all purposes.

 
 
 



1.1.26           “Party” or “Parties” means either ORADISC, ULURU or both, as the context requires.

1.1.27           “Patents” shall mean (a) U.S. Patent Nos. 6,585,997, and (b) any and all patents, patent applications, patent disclosures awaiting filing determination, patent divisionals, continuations, continuations-in-part, reissues, re-examinations, renewals and extensions thereof Controlled by ULURU during the Term, within the Territory, which are necessary for the Manufacture, use or distribution of the Product.

1.1.28           “Person” means any natural person, corporation, general partnership, limited partnership, limited liability company, limited liability partnership proprietorship, other business organization, trust, union, association or governmental authority.

1.1.29           “Product” has the meaning set forth in the first recital above.

1.1.30           “Recall” means any action by any Party to recover title to or possession of any Product sold or shipped to Third Parties or any action to prevent or interrupt the sale or shipment by a Party of the Product to Third Parties that would have been subject to recall if it had been sold or shipped.

1.1.31           “Regulatory Approval” means all consents, permits, approvals, licenses, authorizations, qualifications, notices or orders that are issued or granted by Regulatory Authorities which are required for the manufacture, marketing, promotion, pricing and sale of the Product in a country within the Territory.

1.1.32           “Regulatory Authority” means any domestic or foreign, federal, national, regional, state, county, city, municipal, local or other administrative, legislative regulatory or other governmental authority, agency, department, bureau, commission, or council involved in the granting of Regulatory Approval for the Product in the Territory.

1.1.33           “Rolling Forecast” has the meaning set forth in Section 2.3.

1.1.34           “Seizure” means any action by the FDA or any other Regulatory Authority to detain or destroy the Product or prevent the release of the Product.

1.1.35           “Shortfall” has the meaning set forth in Section 2.6.

1.1.36           “Specifications” means the specifications for the Product contained in a regulatory filing or internal quality control documents.

1.1.37           “Term” means, with respect to each country in the Territory, the period commencing on the Effective Date and ending upon the expiration of the last-to -expire patent within the Patents in such country, except as and if sooner terminated in accordance with Section 8.

1.1.38           “Territory” means the countries outlined on Exhibit F.

 
 
 


1.1.39           “Third Party” means any Person other than ORADISC, ULURU and their respective Affiliates.

1.1.40           “Trademark” means any trademark, trade name, trade dress, slogan, logo, or similar item selected by ORADISC for use in connection with the Product.

1.1.41           “ORADISC” has the meaning set forth in the Preamble.

1.1.42           “ORADISC Confidential Information” means all information, specifications, know-how and data pertaining to ORADISC’s business disclosed to ULURU, its Affiliates or its Third Party manufacturer hereunder, including, without limitation, marketing and sales plans, artwork, formats, equipment, logos, drawings, customer lists, regulatory filings, correspondence with the FDA or any other Regulatory Authority, clinical study data, analytical data, operating procedures and all ordering and sales information.

1.2           Construction of Certain Terms and Phrases.

Unless the context of this Agreement otherwise requires, (i) words of any gender include each other gender; (ii) words using the singular or plural number also include the plural or singular number, respectively; (iii) the terms “hereof,” “herein,” “hereby” and derivative or similar words refer to this entire Agreement; (iv) the terms “Article” or “Section” refer to the specified Article or Section of this Agreement; and (v) Article and Section headings shall not affect the meaning or construction of any provision of this Agreement.

2.           SUPPLY

2.1           Grant of License.

2.1.1           Subject to the terms and conditions of this Agreement, ULURU hereby grants to ORADISC (a) the exclusive right and license in the Field under ULURU’s Intellectual Property Rights to market, offer for sale, sell, distribute including sublicensing, and import products, including the Product, in the Territory, (b) the exclusive right and license in the Field under ULURU’s Intellectual Property Rights to use the Product in the Territory, provided that such right and license is limited to such use as is necessary for ORADISC to market, offer for sale, sell including sub-licensing, import and, subject to the terms and conditions set forth in Section 2.6, Manufacture the Product in the Territory, and (c) a non-exclusive right and license to use the Product and all information and Intellectual Property Rights with respect thereto (including, without limitation, data, studies and clinical trials) solely for the purpose of obtaining Regulatory Approvals for the Product.  Except as expressly granted herein, ULURU retains all rights in the Intellectual Property Rights and the Product.

                      2.1.2           Except as specifically provided to the contrary in Section 2.1.1, the license granted in Section 2.1.1 shall not be construed (a) to effect any sale of ULURU’s Intellectual Property Rights or any other proprietary ULURU technology; (b) subject to the terms and conditions set forth in Section 2.6, to grant any license relating to ULURU’s methods of formulating, fabricating and Manufacturing the Product; (c) to grant ORADISC any rights in or to the use of the Intellectual Property Rights by implication or otherwise.  ORADISC shall ▇▇▇▇ or have marked all containers or packages of the Product in accordance with the patent marking laws of the jurisdiction in which such units of Product are to be used or distributed.

 
 
 



2.2           Manufacture; Marketing.

Subject to Section 2.3, ULURU shall Manufacture and deliver the Product to ORADISC in such quantities and at such times as ordered by ORADISC in accordance with this Agreement.  During the Term, ULURU shall maintain the resources necessary to Manufacture the Product and shall provide, at its own expense, all Materials and labor necessary to do so.  ORADISC shall market and sell the Product in each country in the Territory; provided that, nothing shall require ORADISC to continue to market or sell the Product in any country within the Territory during a period of time that ORADISC determines, in its sole judgment, that such Product is reasonably likely to be subject to adverse regulatory or legal action, or infringe any intellectual property right of any Third Party in such country.

2.3           Forecasts.

At least four (2) months prior to Launch, ORADISC shall submit to ULURU a forecast of the quantity of the Product that ORADISC anticipates ordering from ULURU prior to ORADISC’s anticipated Launch of Product.  ORADISC shall submit to ULURU a forecast of the quantity of the Product that ORADISC anticipates ordering from ULURU during the twelve (12) month period (broken down by quarters) following Launch and ORADISC shall update such forecast on a rolling twelve (12) months basis every month thereafter (each, a “Rolling Forecast”).  ORADISC shall place purchase orders for at least the quantity of the Product specified in the first three (3) months of each such Rolling Forecast and the remaining nine (9) months shall be a non-binding good faith estimate.

2.4           Orders and Delivery.

2.4.1           ORADISC shall place its firm orders for the Product with ULURU by submitting a purchase order, at least ninety (90) days prior to the delivery date requested therein, which sets forth (a) the quantity of the Product ordered for delivery; and (b) the delivery date for that order.  Any such purchase order which is in accordance with the terms and conditions of this Agreement shall be deemed to be accepted by ULURU.  For all other purchase orders placed by ORADISC, unless ULURU notifies ORADISC in writing within seven (7) days of receipt of a purchase order that it is unable to deliver the Product in accordance with such purchase order, ULURU shall be deemed to have accepted such purchase order as a binding order.  If ULURU notifies ORADISC that it is unable to fill a purchase order that is not in accordance with the terms and conditions of this Agreement, it shall indicate the portion of such purchase order ULURU cannot supply by the requested delivery date and specify alternate delivery dates; provided that in the event that ORADISC delivers a purchase order less than ninety (90) days prior to the requested delivery date, ULURU shall use commercially reasonable efforts to meet such requested delivery date despite the shortened lead time, and ULURU will not be in breach of its obligations hereunder if, despite such commercially reasonable efforts, ULURU is not able to meet such requested delivery date with respect to such order.  All Product shall be delivered F.O.B. the Facility and in accordance with ORADISC’s instructions.  Title, possession and risk of loss shall pass to ORADISC upon delivery of Product to ORADISC’s designated carrier at the Facility’s loading dock.  The provisions of this Agreement shall prevail over any inconsistent statement or provisions contained in any document related to this Agreement passing between the parties hereto including, but not limited to, any purchase order, acknowledgment, confirmation or notice.

 
 
 



2.5           Shelf Life.

ULURU shall schedule Manufacturing operations so that all of the Product delivered has the latest expiry date possible, and in no event shall any Product be delivered to ORADISC with an expiry date less than the maximum established expiry date (as set forth in the Specifications) less three (3) months.  If Product is delivered to ORADISC whose expiry date does not conform with the requirements set forth in this Section 2.5, ULURU shall promptly, at its sole expense, replace the non-conforming Product.

2.6           Alternative Supply.

Notwithstanding any provision herein to the contrary, in the event that (1) ULURU is in default of its supply obligations under this Agreement with respect to one  (1) accepted ORADISC purchase orders  (a “Shortfall”), or (2) if during Manufacture or supply of the Product to ORADISC there is a material violation of the requirements set forth in Sections 2.8, 3.1, 3.2, 3.4, 3.6. or the representations set forth in Sections 6.2.1, 6.2.4 or 6.2.5 (a “Regulatory Shortfall”) that is not cured within ten  (10) days of the later to occur of the (i) date of the violation or (ii) notice to ULURU of such violation, then ORADISC, in addition to any other rights and remedies  shall have the right to Manufacture the Product itself and/or qualify an alternative supplier of Product.  ULURU shall, at its cost, (a) cooperate with ORADISC in the transfer of copies of the Confidential Information, technology and know-how necessary to Manufacture the Product to ORADISC and/or its designated alternative supplier, (b) deliver to ORADISC copies of such drawings, specifications, and other information in ULURU’s possession as may be necessary to Manufacture the Product or cause the Product to be Manufactured and (c) grant to ORADISC a limited license in the Field under ULURU’s Intellectual Property Rights during the Term of this Agreement to Manufacture, make, or have made for ORADISC’s distribution of the Product in the Territory, the Product; provided that to the extent that such technology and know-how constitutes ULURU Confidential Information (or any information constitutes Confidential Information of ULURU’s Third Party manufacturer) it shall be subject to the provisions of Article 9 and ORADISC’s designated alternative supplier shall be required to enter into a confidentiality agreement with ULURU containing substantially the same terms as Article 9; and further provided that all items provided under clauses (a) and (b) above will be subject to the license granted pursuant to clause (c).  In addition to ORADISC’s aforementioned right to Manufacture the Product itself and/or qualify an alternative supplier of the Product by reason of a Shortfall, ORADISC shall be relieved of its obligation to order its purchase requirements of the Product from ULURU if ULURU, for any reason, is unable, anticipates that it will be unable or is unwilling to supply Product meeting ORADISC’s forecasted requirements for a period of time of three (3) months until such ability or willingness to supply resumes; provided that ORADISC shall continue to be relieved of its obligation to order its purchase requirements of Product from ULURU to the extent necessary to fulfill any reasonable contractual commitment entered into during such period and to the extent that it has accumulated an inventory of Product during such period.  In the case of a Regulatory Shortfall, ORADISC shall immediately be relieved of any obligation to order its purchase requirements of the Product from ULURU and shall not be required to purchase or accept any Product from ULURU until and unless the Regulatory Shortfall has been remedied.

 
 
 



2.7           Non-Compete.

During the Term, neither ORADISC nor any Affiliate of ORADISC may directly or indirectly market, offer for sale, sell, import or distribute in the Territory any product,  in the Field and in the form of the Product other than the Product.  For the avoidance of doubt, this Agreement shall not preclude ORADISC from continued manufacture and sale of any product which was marketed, offered for sale, sold, imported or distributed by ORADISC as of the Effective Date.

2.8           Third-Party Manufacturer.

ULURU shall, in accordance with the terms of this Section 2.8, establish a Manufacturing Facility (operated by a Third Party manufacturer) in compliance with the FDA’s requirements, including, without limitation, compliance with the written requirements of ORADISC as provided as of the Effective Date. As of the Effective Date, ULURU has identified to ORADISC the Third Party manufacturer it intends to use to Manufacture and supply to ORADISC the Product and the location of the Facility.  ULURU shall promptly provide ORADISC with access to the Facility for inspection by ORADISC.  In addition, ULURU shall promptly provide ORADISC with information requested by ORADISC regarding the Third Party manufacturer (including, without limitation, any information requested by ORADISC in accordance with ORADISC’s due diligence, its GMP audit procedures and its “Level One Compliance Assessment”).  During the Term and upon reasonable prior notice to ULURU, ORADISC shall have the right, from time to time, to audit the Facility and the performance of the Third Party manufacturer to ensure that the Facility and the Third Party manufacturer are in compliance with GMP and ORADISC’s other manufacturing standards.  Any such audits or inspections shall be undertaken by ORADISC in accordance with the provisions of Section 3.5.

2.9           Additional Responsibilities.

2.9.1           ORADISC shall be responsible, at ORADISC’s cost and expense, for commercialization of the Product, including, without limitation, all sales and marketing activities related to the Product and the design of all Product packaging and related artwork, and the design of all labeling as well as the trademark registration in the Territory.

2.9.2           ORADISC shall retain, at its own expense a selling and service organization with adequate experience, ability and training for purposes of marketing and selling the Product in the Territory.

2.10           ULURU Manufacturing and Supply Obligations.
 
                      It is understood and agreed by the Parties that ULURU will be entering into an agreement with a Third Party manufacturer to perform the Manufacturing and supply obligations that ULURU has under this Agreement.  In accordance with such understanding, ULURU acknowledges and agrees that with respect to ULURU’s obligations to ORADISC under this Agreement (a) , ULURU shall be fully responsible for the performance of such as though it were performing such Manufacturing and supply obligations itself, (b) all of the provisions of this Agreement (including, without limitation, indemnification) shall be interpreted in such a way as to impute any actions or omissions by the Third Party manufacturer to ULURU, and (c) except with respect to any matters falling within the scope of Section 10, ULURU shall not be relieved or excused of any of its obligations hereunder due to any action or failure to act by the Third Party manufacturer.  For avoidance of doubt, with respect to the obligations of ULURU regarding Manufacture and supply to ORADISC of the Product, reference to ULURU in this Agreement shall also mean ULURU’s contractors, Third Party manufacturer and Affiliates.

 
 
 


3           COMPLIANCE, QUALITY AND ENVIRONMENTAL

3.1           Compliance with Law.

ULURU shall conduct all Manufacturing hereunder in a safe and prudent manner, in compliance with all applicable laws and regulations (including, without limitation, those dealing with occupational safety and health, those dealing with public safety and health, those dealing with protecting the environment, and those dealing with disposal of wastes), and in compliance with all applicable provisions of this Agreement.  ULURU shall obtain and maintain all necessary Regulatory Approvals with respect to the Manufacture and supply to ORADISC of the Product.  To the extent necessary for the Regulatory Approval of the Product, ULURU, shall permit the inspection of its premises and the Facility by Regulatory Authorities and shall supply all documentation and information requested by ORADISC or such Regulatory Authority to obtain or maintain Regulatory Approval of the Product.

3.2           Manufacturing Quality; Storage.

All Product shall be Manufactured by ULURU at the Facility using Materials and processing aids free of animal derived materials.  ULURU shall sample and analyze all Materials upon receipt to ensure that such Materials are unadulterated, free of defects and meet the applicable Specifications therefor. ULURU shall take all necessary steps to prevent contamination and cross contamination of Product.  The Product shall be unadulterated and free from contamination, dilutents and foreign matter in any amount in accordance with the Product specifications and generally accepted pharmaceutical standards. ULURU shall perform the quality control tests (both when the Product is in-process and when it is finished) with respect to the Product in accordance with the Methods of Analysis. ULURU shall promptly, upon completion of such tests, deliver to ORADISC a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. Within thirty (30) days of the Effective Date, each of the Parties shall execute and deliver the Quality Agreement substantially in the form of Exhibit B and as mutually agreed to by the parties. Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement.  Prior to shipment, the Product shall be stored at all times in conditions at least as favorable as those set forth on the Product’s label, or in accordance with conditions reasonably specified by ORADISC.

3.3           Samples and Record Retention.

ULURU shall retain records and retention samples of each Batch of the Product for at least twelve (12) months after the expiration date of that Batch and shall make the same available to ORADISC upon request.  Retention samples shall only be destroyed after the required holding period; provided that in the event that ORADISC provides written notice to ULURU during such twelve (12) month period that it desires ULURU to retain such retention samples for a longer period of time, then ULURU shall comply with such request until notified by ORADISC that the sample need no longer be retained.  During and after the Term of this Agreement ULURU shall reasonably assist ORADISC with respect to any complaint, issue or investigation relating to the Product.

 
 
 


3.4           Inspection.

ULURU shall give access to representatives of ORADISC, at all reasonable times during regular business hours, to the Facility and any other facility in which Product is Manufactured, tested, packaged and/or stored, and to all Manufacturing records with respect to the Product, for the purpose of inspection.  ORADISC shall have the right while at any such Facility to inspect and copy (provided that to the extent that such copies constitute ULURU Confidential Information (or Confidential Information of ULURU’s Third Party Manufacturer) they shall be subject to the provisions of Article 9) records and Regulatory Approvals solely to evaluate work practices and compliance with all applicable FDA and other Regulatory Authority laws and regulations, occupational health and safety, and environmental laws and regulations, GMP and warehousing practices and procedures.  The conduct of (or right to conduct) any inspection under this Section 3.5 does not impose upon ORADISC responsibility or liability for the operation of the Facility.  Such inspection shall be conducted after prior written notice to ULURU, will be conducted consistently with the ORADISC policies and procedures provide to ULURU as of the Effective Date (and as such policies and procedures are modified and provided in writing to ULURU from time to time, which modified policies and procedures shall not conflict with any of the provisions of this Agreement) and in a manner that is not disruptive to ULURU’s operations, and shall not be more frequent than is reasonable.

3.5           Adverse Drug Experience Reporting.

Each Party shall fully, accurately and promptly provide the other Party with all data known to it at any time during the Term of this Agreement or thereafter, which data indicate that any Product is or may be unsafe, lacks utility, or otherwise does not meet the Specifications in accordance with the Adverse Event Reporting Procedures set forth in Exhibit C attached hereto (as the same may be amended from time to time by notice in writing from ORADISC to ULURU; provided that such amendment shall not conflict with any of the provisions of this Agreement).  ULURU shall determine whether such information is required to be reported to the FDA and any other Regulatory Authority.

3.6           Recalls and Seizure.

3.6.1           Each Party shall keep the other Party promptly and fully informed of any notification or other information whether received directly or indirectly which might result in the Recall or Seizure of the Product.  If either Party determines that it is necessary to Recall any Product, it shall immediately notify the other Party and, prior to commencing any Recall, the Parties shall consult with one another to determine whether or not a Recall is necessary.  If it is mutually agreed that a Recall is necessary (or if ORADISC determines, in its sole discretion, that a Recall is necessary), then the parties shall meet and determine the manner in which the Recall is to be carried out and review any instructions or suggestions of the applicable Regulatory Authorities.  ULURU and ORADISC shall effect the Recall in the manner agreed upon between the Parties in as expeditious a manner as possible and in such a way as to cause the least disruption to the sales of any Product and to preserve the goodwill and reputation associated with the Product.  In any such situation, ORADISC shall have the right to make all final decisions regarding such Recall.

 
 
 


3.6.2           In the event that a Recall results from any cause or event arising from ULURU’s  breach of Sections 2.8, 3.1, 3.2, 3.4, 3.6. or the representations set forth in Sections 6.2.1, 6.2.4 or 6.2.5 and/or the defective Manufacture, storage or handling of the Product by ULURU (excluding defects relating to packaging or labeling supplied by or prepared at and in accordance with the direction of ORADISC), ULURU shall be responsible for all expenses of the Recall  incurred by ORADISC and indemnify ORADISC for all losses occurred by this Recall  and ULURU shall promptly replace such Product at no additional cost to ORADISC consistent with directions received from the appropriate Regulatory Authority.  In the event that a Recall results from any cause or event arising from defective Manufacture, storage, handling, or distribution of the Product by ORADISC or its Affiliates, distributors or contractors (including but not limited to defective Manufacture, storage, handling or distribution undertaken at the direction of ORADISC and consistently with ORADISC’s instructions), ORADISC shall be responsible for the expenses of the Recall, including the cost of replacement Product.  For the purposes of this Agreement, the expenses of a Recall shall include, without limitation, the expenses of notification and destruction or return of the recalled Product and all other costs incurred in connection with such Recall, including reasonable costs and attorneys’ fees.

4.           MANUFACTURING CHANGES

4.1           Voluntary Changes.

ULURU shall not make, nor shall any other Person make, any changes to the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the sources of Materials or the Methods of Analysis without the prior written consent of ORADISC.  If either Party requests in writing a change in the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the source of Materials or Methods of Analysis with respect to the Product that is not the result of a requirement of the FDA or any other Regulatory Authority, the other Party shall use commercially reasonable efforts to make or accept such change, as the case may be.  The requesting Party shall provide the other Party with a detailed written report of all proposed changes to the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the sources of Materials or the Methods of Analysis.

4.2           Required Changes.

If the FDA or any other Regulatory Authority requests or requires, or takes any action that requires, any change in the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the source of Materials or Methods of Analysis with respect to the Product, the Parties shall meet and discuss an implementation plan for such change and use commercially reasonable efforts to accommodate as soon as practicable such change to meet the FDA’s or such other Regulatory Authority’s requirements.  ULURU will bear its respective costs associated with, or incurred as a result of, such change.  Each Party agrees to promptly forward to the other copies of any written communication received by such Party from the FDA or any other Regulatory Authority that may affect the Manufacture, supply, or distribution of the Product as contemplated herein.

 
 
 


5.           PRICE AND PAYMENT

5.1           Price.

ULURU shall invoice ORADISC for the Product supplied to ORADISC hereunder at the applicable price per Product set forth on Exhibit D.

5.2           License Payments.

During the Term, the license payments set forth in Exhibit E shall be due and payable from ORADISC to ULURU within ten (10) days after signing of this Agreement.

5.3           Royalty Payments.

In addition to the payments set forth above, ORADISC shall pay to ULURU a royalty (the “Royalty”), on a country-by-country basis in the Territory, equal to five percent (5%) of Net Sales of the Product in such country during each calendar quarter (or portion thereof) during the Term (each such period, a “Royalty Period”), commencing as of the date on which the Product is sold by ORADISC for the first time to a Third Party for commercial distribution in such country.  Each Royalty will be payable not later than thirty (30) days following the expiration of each applicable Royalty Period.  ORADISC shall pay the Royalty with respect to a country that accrues during the Term of this Agreement for so long as the license granted by ULURU under Section 2.1.1 remains in effect in such country.  ORADISC will include with each such payment a written report detailing (i) the number of Product units, per country, and the sales price of such Product units by ORADISC and its Affiliates; and (ii) Net Sales of the Product during the applicable Royalty Period, all in a manner consistent with ORADISC’s internal sales reporting.

5.4           Payment.

ORADISC shall pay invoices for Product delivered hereunder not later than seventy five (75) days after the later of receipt of Product covered by such invoice and receipt of such invoice.

5.5           Taxes and Other Charges.

All Product prices are exclusive of taxes, shipping costs to the point of delivery, customs duties and other charges, and ORADISC agrees to bear and be responsible for the payment of all such charges imposed, excluding taxes based upon ULURU’s net income.

 
 
 


5.6           Audit Rights.

5.6.1           ORADISC shall maintain books of account with respect to its sales of the Product in each country in the Territory.  ULURU shall have the right, not more than once during each calendar year, to have an independent accountant selected and retained by ULURU to inspect and examine such books of ORADISC during regular business hours for the purpose of verifying the statements of the aggregate Net Sales resulting from sales of Product and determining the correctness of the Royalties paid.  Subject to Section 5.6.2, if such independent certified public accountant’s report shows any underpayment by ORADISC, ORADISC shall pay to ULURU within thirty (30) days after ORADISC’s receipt of such report, (a) the amount of such underpayment, and (b) if such underpayment exceeds five percent (5%) of the total amount owed for the period then being audited, the reasonable fees and expenses of any independent accountant performing the audit on behalf of ULURU. Subject to Section 5.6.2, if such independent certified public accountant’s report shows any overpayment by ORADISC, ULURU shall remit to ORADISC within thirty (30) days after ULURU’s receipt of such report, the amount of such overpayment. Any audit or inspection conducted under this Agreement by ULURU or its agents or contractors will be subject to the confidentiality provisions of this Agreement, and ULURU will be responsible for compliance with such confidentiality provisions by such agents or contractors.

5.6.2           If any dispute arises under this Section 5.6 between the Parties relating to overpayments or underpayments, and the Parties cannot resolve such dispute within thirty (30) days of a written request by either Party to the other Party, the Parties shall hold a meeting, attended by the Chief Executive Officer or President of each party (or their respective designees), to attempt in good faith to negotiate a resolution of the dispute.  If, within sixty (60) days after such meeting request, the Parties have not succeeded in negotiating a resolution of the dispute, either Party may pursue any other available remedy, including, upon prior written notice to the other Party, instituting legal action.

5.7           Late Payments.

If any payment due to ULURU under this Agreement is not received by ULURU within ten (10) days of the due date, then, commencing from the date on which such payment was due the amount of such payment shall accrue interest calculated at an annual rate equal to the prime rate plus two percent (2%) until such time as payment of the overdue amount is made in full; provided that no interest shall accrue on any amounts being disputed in good faith by ORADISC with respect to which ORADISC is making diligent and good faith efforts to resolve.

5.8           Currency Exchange.

All payments to be made pursuant to this Agreement shall be made in United States dollars.  Amounts based on Net Sales in currencies other than United States dollars shall be converted to United States dollars at the exchange rate being the average of the prior month’s rates as reported by a mutually agreed upon bank. In case of a significant change of the Currency Exchange rate the parties mutually agree to renegotiate the pricing conditions defined in EXHIBIT D.

 
 
 



5.9           Option.                      ULURU hereby grants to ORADISC a twenty four (24) month option to utilize the technology for drug delivery for migraine, nausea and vomiting, pain and cough and cold. A separate licensing agreement for these applications will be negotiated.

5.10           Purchase of Aphthasol United States Rights.

ORADISC is granted the right to acquire the United States rights to Aphthasol. These rights would be added to the license on terms to be negotiated once ULURU has secured these rights.



6.           REPRESENTATIONS AND WARRANTIES

6.1           Representation and Warranties of Each Party.

Each of ORADISC and ULURU hereby represents, warrants and covenants to the other Party hereto as follows:

6.1.1           it is a corporation or entity duly organized and validly existing under the laws of the state or other jurisdiction of incorporation or formation;

6.1.2           the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action and do not require any shareholder action or approval;

6.1.3           it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder;

6.1.4           the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions hereof does not and will not conflict with or result in a breach of any of the terms and provisions of or constitute a default under (a) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (b) the provisions of its charter or operative documents or by laws; or (c) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound; and

6.1.5           it shall comply with all applicable laws and regulations relating to its activities under this Agreement.

 
 
 


6.2           Representations and Warranties of ULURU.

ULURU hereby further represents and warrants to ORADISC that:

6.2.1           as of the date of each delivery of the Product by ULURU to a carrier, the Product (a) has been Manufactured, stored and shipped in strict accordance with GMPs, all applicable laws, rules, regulations or requirements and all applicable Regulatory Approvals in effect at the time of Manufacture; (b) conforms to the Specifications and the Quality Agreement, and is free from defects and are merchantable; (c) is not adulterated or misbranded; and (d) has been shipped and stored in accordance with procedures requested by ORADISC;

6.2.2           as of the date of each delivery of the Product by ULURU to a carrier, ULURU has good and marketable title to the Product and the Product is free from all liens, charges, encumbrances and security interests;

6.2.3           to ULURU’s actual knowledge as of the Effective Date, the Manufacture, use, importation, offer for sale and sale of the Product does not infringe any intellectual property rights of any Third Party within the Territory;

6.2.4           as of the date of each delivery of the Product by ULURU to a carrier, neither ULURU not any Affiliate, contractor or Third Party manufacturer of ULURU, used or uses in any capacity the services of any person debarred under the U.S. Generic Drug Enforcement Act, 21 USA §335a(k)(l) and further it did not use any person who has been convicted of a crime as defined under the Generic Drug Enforcement Act in connection with the Manufacture of Product;

6.2.5           as of the date of each delivery of the Product by ULURU to a carrier, ULURU possesses all necessary Regulatory Approvals relating to ULURU’s Manufacture and supply to ORADISC of the Product;
6.2.6           as of the Effective Date, U.S. Patent No. 6,585,997  is existing and have not been held to be invalid or unenforceable, in whole or in part;

6.2.7           as of the Effective Date, ULURU is the sole and exclusive owner of the Intellectual Property Rights existing as of the Effective Date, all of which are free and clear of any liens, charges and encumbrances (other than any licenses granted by ULURU to Third Parties, which grants do not conflict with the license grants to ORADISC hereunder);

6.2.8           as of the Effective Date, and, except as disclosed to ORADISC in writing, as of the date of each delivery of the Product by ULURU to a carrier, ULURU has received no notice that the practice of the Intellectual Property Rights or the ▇▇▇▇  are subject to an infringement claim of any issued patent or ▇▇▇▇ owned or possessed by any Third Party within the Territory;
 
6.2.9           as of the Effective Date, the Intellectual Property Rights are not the subject to any funding agreement with any government or governmental agency; and

 
 
 


6.3           No Presumption.

Each Party hereto represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof.  In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption shall exist or be implied against the Party which drafted such terms and provisions.

6.4           Remedy.

As ORADISC’s sole and exclusive remedy for any breach of Section 6.2.1 discovered prior to the distribution by ORADISC or its Affiliates of the applicable Product, ULURU shall promptly replace, at its sole cost and expense, any Product which fails to comply with the representations set forth in Section 6.2.1; provided that such non-conforming Product shall be returned to ULURU   Except as otherwise provided expressly in this Agreement, each Party is free to seek legal and equitable recourse against the other in the event of any breach of this Agreement (including, without limitation, any breach of such other Party’s obligations, representations, or warranties under this Agreement), subject to the limitations of liability set forth in Section 6.7 and, in such case, the breaching party shall be liable for all damages, losses, liabilities, expenses or penalties (excluding attorneys’ fees and expenses) incurred, assessed or sustained by or against the non-breaching party, its Affiliates, directors, officers, employees or agents arising out of such breach.



6.5           ORADISC Responsibility.

           ORADISC shall not be responsible for any loss or cost incurred by ULURU during Manufacture of the Product in compliance with the requirements of Section 6.2.1.

6.6           Disclaimer.

6.6.1           THE FOREGOING WARRANTIES ARE THE SOLE AND EXCLUSIVE WARRANTIES GIVEN BY ULURU WITH THE RESPECT TO THE PRODUCTS AND SERVICES PROVIDED HEREUNDER, AND ULURU GIVES AND MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, OTHER THAN THE FOREGOING.
6.6.2           EXCEPT FOR THE WARRANTIES GIVEN BY ORADISC AS EXPRESSLY PROVIDED IN SECTION 6, ORADISC GIVES AND MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND OR NATURE, EXPRESS OR IMPLIED, WITH RESPECT TO THE MATTERS ADDRESSED IN THIS AGREEMENT.

6.6.3           The warranties set forth in this Section 6 do not apply to any non-conformity of the Product resulting from (a) repair, alteration, misuse, negligence, abuse, accident, mishandling or storage in an improper environment by any party other than ULURU (or its contract manufacturer), or (b) use, handling, storage or maintenance other than in accordance with Product Specifications or Product label.

 
 
 


           6.7           Limitation of Liability.

ULURU’S LIABILITY, AND THE EXCLUSIVE REMEDY, IN CONNECTION WITH THE SALE OR USE OF THE PRODUCT (WHETHER BASED ON CONTRACT, NEGLIGENCE, BREACH OF WARRANTY, STRICT LIABILITY OR ANY OTHER LEGAL THEORY), SHALL BE STRICTLY LIMITED TO ULURU’S OBLIGATIONS AND ORADISC’S RIGHTS AS SPECIFICALLY AND EXPRESSLY PROVIDED IN THIS AGREEMENT.

7.           INDEMNIFICATION AND INSURANCE

7.1           Indemnification.

7.1.1 ULURU shall indemnify ORADISC for, defend ORADISC against, and hold ORADISC harmless from any and all loss, liability, damage, claim, cost and expenses, including after prior written consent of ULURU reasonable attorney fees, incurred by ORADISC, arising from actions taken by third parties as a result of or in relation to the development and the manufacture of the Product by ULURU, according to provisions agreed between the Parties in this Agreement, and / or arising from actions taken by third parties as a result of alleged infringement of third party intellectual property rights by ORADISC by exercising its rights under this Agreement. Same obligation applies to ORADISC.

7.1.2 Any Party seeking to be indemnified by virtue of the terms hereof shall notify the Party from which indemnification is sought in writing promptly of any claims, suits, charges or proceedings made or instituted against it in respect of which indemnification may be sought hereunder.

7.1.3           The indemnification provided by this Section 7 shall be the Parties’ sole and exclusive remedy in connection with any third party claim.

7.2           Insurance.

At the time of Launch and continuing through the Term of this Agreement, ULURU shall maintain the following kinds of insurance with the minimum limits set forth below.
Kind of Insurance
Minimum Limits
   
Commercial General Liability, including Contractual, Completed Operations and Product Liability
$1,000,000 Per Occurrence
$5,000,000 Aggregate
   
Workers Compensation
Statutory with Employer’s Liability of not less than $1,000,000 Per Accident/Disease
   
Automobile Bodily Injury Liability (including hired automobile and non-ownership Liability)
$1,000,000 Each Accident Combined Single Limit

 
 
 



Upon request, ULURU shall furnish insurance certificates as directed by ORADISC, satisfactory in form and substance to ORADISC, showing the above coverages, and providing for at least thirty (30) days’ prior written notice to ORADISC by the insurance company of cancellation or modification.

8.           TERM AND TERMINATION

8.1           Term.

This Agreement shall commence on the Effective Date and continue, unless sooner terminated as set forth below in this Article 8 or as otherwise specifically stated in this Agreement, for the duration of the Term.

8.2           Termination Without Cause.

ORADISC may terminate this Agreement at any time after Launch by giving twelve (12) months prior written notice to ULURU if ORADISC, in its sole discretion, determines to cease marketing the Product.

8.3           Termination for Regulatory Action or Claim of Infringement.

ORADISC may terminate this Agreement in its entirety immediately if the FDA or any other Regulatory Authority takes any action, the result of which is to prohibit or permanently or otherwise restrict the Manufacture, storage, importation, sale, offer for sale or use of the Product in any way that will have a material, adverse effect on the sale price or sales volumes of the Product, or if any claim is made that the Manufacture, storage, importation, sale, offer for sale or use of the Product infringes any patent or other proprietary or protected right of any Third Party.

8.4           Termination for Breach.

If either Party shall at any time fail to discharge any of its obligations hereunder and shall fail to correct such default within thirty (30) days after the other Party shall have given written notice to it thereof, the aggrieved Party shall be entitled to notify the other Party that it intends to terminate this Agreement unless such default is corrected and may so terminate ten (10) days after the end of such thirty (30) day period if such default is continuing; provided that if such default by the other Party shall be a recurring default and the other Party does not reasonably satisfy the aggrieved party that such defaults shall cease to occur, the aggrieved Party shall be entitled to terminate this Agreement upon the occurrence of such default and the other Party shall not be entitled to correct such default.

8.5           Termination for Bankruptcy.

8.5.1           If either Party by voluntary or involuntary action goes into liquidation, dissolves or files a petition for bankruptcy or suspension of payments, is adjudicated bankrupt, has a receiver or trustee appointed for its property or estate, becomes insolvent or makes an assignment for the benefit of creditors, the other Party shall be entitled by notice in writing to such Party to terminate this Agreement forthwith.

 
 
 


8.5.2           All rights and licenses granted under or pursuant to this Agreement by each party to the other party are, and shall otherwise be deemed to be, for purposes of ▇▇▇▇▇▇▇ ▇▇▇ (▇) ▇▇ ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ Bankruptcy Code, or replacement provision therefor (the Code), that each party as a licensee hereunder shall retain and may fully exercise all of its rights and elections under the Code. The parties further agree that, in the event of the commencement of bankruptcy proceedings by or against either party as a licensor hereunder under the Code, the other party shall be entitled to retain all of its rights under the Agreement.

8.6           Effect of Termination.

Termination or expiration of this Agreement, in whole or in part, shall be without prejudice to the right of either Party to receive all payments accrued and unpaid at the effective date of such termination or expiration, without prejudice to the remedy of either Party in respect to any previous breach of any of the representations, warranties or covenants herein contained and without prejudice to any other provisions hereof which expressly or necessarily call for performance after such termination or expiration.

8.7           ORADISC’s Rights on Termination.

Upon termination or expiration of this Agreement for any reason, then (a) at ORADISC’s request, ULURU shall supply ORADISC with its inventory of Materials, Product and/or works-in-progress for the Manufacture, packaging and labeling of Product and ORADISC shall pay ULURU the manufacturing fee for the Product, a prorated portion thereof for work-in-progress commenced against firm orders by ORADISC and the cost of Materials; and (b) at ORADISC’s request, ULURU shall return to ORADISC all retention samples of the Product.

8.8           Survival.

The following provisions shall survive the expiration or termination of this Agreement: Sections 3.4, 3.6, 3.7, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 7.1, 8.7, 8.8, and 8.9 and Articles 6, 9, 11, 12 and 13.

 
 
 


9.           CONFIDENTIALITY

9.1           Nondisclosure Obligation.

Each of ULURU and ORADISC shall use only in accordance with this Agreement and shall not disclose to any Third Party the Confidential Information received by it from the other Party pursuant to this Agreement, without the prior written consent of the other Party.  The foregoing obligations shall survive for a period of five (5) years after the termination or expiration of this Agreement.  These obligations shall not apply to Confidential Information that: (a) is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by business records; (b) is at the time of disclosure or thereafter becomes published or otherwise part of the public domain without breach of this Agreement by the receiving Party; (c) is subsequently disclosed to the receiving Party by a Third Party who has the right to make such disclosure; (d) is developed by the receiving Party independently of the Confidential Information received from the disclosing Party and such independent development can be documented by the receiving Party; or (e) is required by law, regulation, rule, act or order of any governmental authority or agency to be disclosed by a Party, provided that notice is promptly delivered to the other Party in order to provide an opportunity to seek a protective order or other similar order with respect to such Confidential Information and thereafter the disclosing Party discloses to the requesting entity only the minimum Confidential Information required to be disclosed in order to comply with the request, whether or not a protective order or other similar order is obtained by the other Party.

9.2           Permitted Disclosures.

Each Party may disclose the other Party’s Confidential Information to its employees and Affiliates on a need-to-know basis and to its agents or consultants to the extent required to accomplish the purposes of this Agreement; provided that the recipient Party obtains prior agreement from such agents and consultants to whom disclosure is to be made to hold in confidence and not make use of such Confidential Information for any purpose other than those permitted by this Agreement.  Each Party will use at least the same standard of care as it uses to protect proprietary or confidential information of its own to ensure that such employees, agents, consultants, and Affiliates do not disclose or make any unauthorized use of the other Party’s Confidential Information.

9.3           Disclosure of Agreement.

Neither ULURU nor ORADISC shall release to any Third Party or publish in any way any non-public information with respect to the terms of this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed, provided that either Party may disclose the terms of this Agreement (a) to the extent required to comply with applicable laws, including, without limitation, the rules and regulations promulgated by the United States Securities and Exchange Commission; provided, further, that prior to making any such disclosure, the Party intending to so disclose the terms of this Agreement shall (i) provide the nondisclosing Party with written notice of the proposed disclosure and an opportunity to review and comment on the intended disclosure which is reasonable under the circumstances and (ii) shall seek confidential treatment for as much of the disclosure as is reasonable under the circumstances, including, without limitation, seeking confidential treatment of any information as may be requested by the other Party; or (b) to one or more Third Parties and/or their advisors in connection with a proposed spin-off, joint venture, divestiture, merger or other similar transaction involving all, or substantially all, of the Product, assets or business of the disclosing Party to which this Agreement relates or to lenders, investment bankers and other financial institutions of its choice solely for purposes of financing the business operations of such Party; provided, further, that either (i) the other Party has consented to such disclosure or (ii) such Third Parties have signed confidentiality agreements with respect to such information on terms no less restrictive than those contained in this Article 9; or (c) to its legal counsel.

9.4           Publicity.

All publicity, press releases and other announcements relating to this Agreement or the transactions contemplated hereby shall be reviewed in advance by, and shall be subject to the approval of, both Parties.

10.           FORCE MAJEURE

If the Manufacture, production, delivery, acceptance or use of Product specified for delivery under this Agreement or if the performance of any other obligation hereunder is prevented, restricted or interfered with by reason of fires, accidents, explosions, earthquakes, floods, breakdown of plant, embargoes, government ordinances or requirements, civil or military authorities, acts of God or of the public enemy, or other similar causes beyond the reasonable control of the Party whose performance is affected (any of the foregoing a “Force Majeure Event”), then the Party affected, upon giving prompt written notice to the other Party, shall be excused from such performance on a day-for-day basis to the extent of such prevention, restriction, or interference (and the other Party shall likewise be excused from performance of its obligations on a day-for-day basis to the extent such Party’s obligations relate to the performance so prevented, restricted or interfered with); provided that the Party so affected shall use commercially reasonable efforts to avoid or remove such causes of non-performance and both Parties shall proceed to perform their obligations with dispatch whenever such causes are removed or cease.  If such Force Majeure Event continues for a period of ninety (90) consecutive days or more and as a result either party has been unable to perform its obligations under this Agreement for such ninety (90) day period, the other Party may terminate this Agreement effective immediately, upon delivery of a notice of termination in writing, provided that such event of Force Majeure Event is continuing.  If as a result of any Force Majeure Event above, ULURU is unable to fully supply ORADISC’s orders hereunder, ULURU shall allocate all available quantities of Materials and Product to ORADISC in the ratio that the quantities ordered by ORADISC in the twelve (12) month period immediately preceding such force majeure event bears to ULURU’s requirements for its own use and for supply to Third Parties for that same period; provided that if this Agreement has not been in effect for a full twelve (12) month period, then such shorter period shall be used in lieu of a twelve (12) month period.


 
 
 


11.           INTELLECTUAL PROPERTY

11.1           Trademarks; ORADISC Intellectual Property.

11.1.1           ORADISC may advertise, promote, market and sell the Product either separately or as part of other products under any of its Trademarks and/or trade dress, whether registered or unregistered, in its sole discretion; provided that except as otherwise expressly permitted with respect to the ▇▇▇▇, (see Article 11.6) 11.1.2For the avoidance of doubt, ORADISC shall at all times retain sole and exclusive ownership of its intellectual property, including, without limitation, all marketing and sales plans, artwork, formats, equipment, logos, drawings, customer lists, regulatory filings, correspondence with the FDA or any other Regulatory Authority, clinical study data, analytical data, operating procedures and all ordering and sales information.

11.2           Inventions.

11.2.1           Except as otherwise provided for in this Section 11.2, each Party shall own all Inventions made solely by employees of such Party (or Third Parties acting on behalf of such Party) and shall jointly own with the other Party any Invention made jointly by employees of both Parties (or Third Parties on behalf of one or both Parties); provided that such Inventions were made without violation of any term or condition of this Agreement.  All determinations of inventorship under this Agreement shall be made in accordance with United States law.

11.2.2           If and to the extent applicable, Inventions Controlled by ULURU and know-how arising during the Term which relates to the Product and is Controlled by ULURU shall be automatically included in the Intellectual Property Rights under which ORADISC is licensed pursuant to Section 2.1.1 hereof.  With respect to any Inventions or know-how Controlled by ORADISC specifically relating to the Product, ORADISC hereby grants to ULURU an exclusive (subject to retained rights in ORADISC), royalty-free license to use such Invention for the Manufacture of the Product for ORADISC in the Territory during the Term.

11.2.3           During the Term of this Agreement both Parties shall require their employees and personnel involved in the performance of its duties under this Agreement to deliver such assignments, confirmations of assignments or other written instruments as are necessary to vest in the respective Party clear and marketable title to the Inventions.

11.2.5           All rights, title, and interest in and to know-how, which is developed jointly by the Parties during the Term of this Agreement and related to the Product, its Manufacture and/or use shall be owned jointly by the Parties.  All rights, title, and interest in and to any Regulatory Approval the primary responsibility for which is allocated to a particular Party hereunder that is developed or collected solely or jointly by the Parties in the Territory during the Term of this Agreement shall be owned exclusively by such Party.

11.3           Confidentiality of Information related to Intellectual Property.

Any and all information and material, including, without limitation, any and all intellectual property rights therein and thereto, assigned to a Party pursuant to the terms of this Agreement shall constitute Confidential Information of such Party which shall be deemed the Disclosing Party with respect to such Confidential Information.

 
 
 


11.4           Patent Rights to New Inventions.

11.4.1           ULURU, at its own expense, shall use commercially reasonable efforts to prepare, file, prosecute and maintain its Intellectual Property Rights in the agreed countries of the Territory.

11.4.2           With respect to any filings after the Effective Date, ULURU shall consult in good faith with ORADISC with respect to such applications in the Territory, and shall supply ORADISC with a copy of such applications in the Territory as filed, together with notice of its filing date and serial number.  ULURU shall inform ORADISC about the status of the prosecution of all patent applications included within the ULURU Intellectual Property Rights and its Intellectual Property Rights to Inventions and the maintenance of any patents included within the ULURU Intellectual Property Rights and its Intellectual Property Rights to Inventions in a country in the Territory.

11.4.3           ULURU shall consider in good faith, but will not be bound by, ORADISC’s suggestions with respect to all submissions in the Territory made to any Regulatory Authority in the Territory with respect to any such patent application or patent.

11.4.4           If ULURU elects not to file a patent application with respect to its new Inventions or to cease the prosecution and/or maintenance of any Patent under the ULURU Intellectual Property Rights in a country in the Territory, ULURU shall provide ORADISC with written notice promptly after the decision to not file or continue the prosecution of such patent application or maintenance of such patent.

11.4.5           In such event, ULURU shall permit ORADISC, in ORADISC’s sole discretion, to file a patent application with respect to such Invention or continue prosecution or maintenance of any such Patent under the ULURU Intellectual Property Right in such country at ORADISC’s own expense.  If ORADISC elects to continue such prosecution or maintenance, ULURU shall execute such documents and perform such acts, at ORADISC’s expense, as may be reasonably necessary to permit ORADISC to file, prosecute or maintain such application or Patent in such country. In such event, ORADISC shall own such patent application or Patent filed by ORADISC hereunder.

11.4.6           In the event that ORADISC continues the prosecution or maintenance of such patent application or Patent pursuant to this Section, ORADISC’s Royalty obligations hereunder, and this Agreement, shall expire if, and at such time, that such patent application or Patent becomes the only non-expired Patent rights within the Intellectual Property Rights.

11.4.7           (a)           The Parties shall mutually agree in good faith on a case-by-case-basis on which of the Parties shall have the first right to prepare, file, prosecute and maintain any jointly owned Invention and patent rights thereon (“Joint Patent Rights”) throughout the world as well as on the split of the applicable expenses and costs.

 
 
 


(b)           The acting Party shall keep the other Party completely informed during the whole application procedure as well as during the whole patent duration.  The acting Party shall provide the other Party advance copies of any official correspondence related to the filing, prosecution and maintenance of such patent filings, and shall provide the other Party a reasonable opportunity to comment on all correspondence received from and all submission to be made to any government patent office or authority with respect to any such patent application or patent, and shall consider in good faith the other Party’s suggestions with respect to all submission made to any government office or authority.

(c)           If either Party (the “Declining Party”) at any time declines to share in the costs of filing, prosecuting and maintaining any such Joint Patent Right, on a country by country basis, the Declining Party shall provide the other Party (the “Continuing Party”) with thirty (30) days prior written notice to such effect, in which event, the Declining Party shall (i) have no responsibility for any expenses incurred in connection with such Joint Patent Right and (ii) if the Continuing Party elects to continue prosecution or maintenance, the Declining Party, upon the Continuing Party’s request, shall execute such documents and perform such acts, at the Continuing Party’s expense, as may be reasonably necessary (x) to assign to the Continuing Party all of the Declining Party’s right, title and interest in and to such Joint Patent Rights and (y) to permit the Continuing Party to file, prosecute and/or maintain such Joint Patent Right.

(d)           If ORADISC is (i) the sole owner of a Joint Patent Right or (ii) the Continuing Party, such Joint Patent Right shall no longer be considered to be part of the ULURU Intellectual Property Rights for purposes of this Agreement and thereafter shall be part of ORADISC’s intellectual property.

(e)           If ULURU is (i) the sole owner of a Joint Patent Right or (ii) is the Continuing Party, such Joint Patent Rights shall no longer be considered to be part of ORADISC’s intellectual property for purposes of this Agreement and thereafter shall be part of the ULURU Intellectual Property Rights.

11.4.8           Each Party shall, and shall cause its Affiliates, employees, attorneys and agents to, cooperate fully with the other Party and provide all information and data and execute any documents reasonably required or requested in order to allow the other Party to prosecute, file, and maintain patents and patent applications pursuant to this Section 11.4.  Neither Party shall require the other Party to make any payment or reimburse for any expenses in connection with such cooperation, provision of information and data and execution of documents.

11.5           Enforcement of Intellectual Property Rights.

11.5.1           If either Party becomes aware of any infringement of any of the Intellectual Property Rights or the ▇▇▇▇, or the validity of any of the Intellectual Property Rights or the ▇▇▇▇ is challenged by a Third Party in the Territory, such Party will notify the other Party in writing to that effect.  Any such notice shall include, as applicable, evidence to support an allegation of infringement by such Third Party.

11.5.2           ULURU shall have the first right, but not the obligation, to take action to obtain a discontinuance of infringement or bring suit against a Third Party infringer of Intellectual Property Rights and/or the ▇▇▇▇ in the Territory.  Such right shall remain in effect until ten (10) days after the date of notice given under Section 11.5.1.  In the event that ULURU exercises such right, then: (a) ULURU shall not consent to the entry of any judgment or enter into any settlement with respect to such an action or suit without the prior written consent of ORADISC (not to be unreasonably withheld), and (b) ULURU shall bear all the expenses of any such suit brought by ULURU claiming infringement of any Intellectual Property Rights and/or the ▇▇▇▇.  If, after the expiration of the ninety (90) day period, ULURU has not obtained, or is not diligently pursuing, a discontinuance of infringement of the Intellectual Property Rights and/or the ▇▇▇▇, filed suit against any such Third Party infringer of the Intellectual Property Rights and/or the ▇▇▇▇, or provided ORADISC with information and arguments demonstrating to ORADISC’s reasonable satisfaction that there is insufficient basis for the allegation of such infringement of the Intellectual Property Rights and/or the ▇▇▇▇, then ORADISC shall have the right, but not the obligation, to bring suit against such Third Party infringer of the Intellectual Property Rights and/or the ▇▇▇▇ and to join ULURU as a party plaintiff, provided that ORADISC shall bear all the expenses of such suit.  In such event, ORADISC shall not consent to the entry of any judgment or enter into any settlement with respect to such an action or suit without the prior written consent of ULURU (which consent shall not unreasonably be withheld) if such judgment or settlement includes a finding or agreement that such Intellectual Property Right and/or the ▇▇▇▇ is invalid or would enjoin or grant other equitable relief against ULURU.

11.5.3           Each Party shall cooperate (including, without limitation, by executing any documents reasonably required to enable the other Party to initiate such litigation, testifying when requested or providing relevant documents) with the other Party in any suit for infringement of Intellectual Property Rights and/or the ▇▇▇▇ brought by the other Party against a Third Party in accordance with this Section and shall have the right to consult with the other Party and to participate in and be represented by independent counsel in such litigation at its own expense.

11.5.4           Neither Party shall be required pursuant to this Section 11.5 to undertake any activities, including, without limitation, legal discovery at the request of a Third Party except as may be required by lawful process of a court of competent jurisdiction.

11.5.5           Neither Party shall incur any liability to the other Party as a consequence of any such litigation or any unfavorable decision resulting therefrom, including, without limitation, any decision holding any of the patents within the Intellectual Property Rights invalid or unenforceable.

11.5.6           Any recovery obtained by either Party as a result of any such proceeding against a Third Party infringer shall be allocated as follows: (a) such recovery shall first be used to reimburse each Party for all litigation costs in connection with such litigation paid by that Party; and (b) the Party bringing the action shall receive the remaining portion of such recovery after payment of the amounts specified in clause (a).

 
 
 


11.6           Trademarks.

Subject to the restrictions in Sections 11.1, ORADISC shall select and own all Trademarks in connection with the marketing, promotion and sale of the Product in the Territory. ORADISC hereby grants to ULURU a limited, non-exclusive, non-transferable, fully paid, royalty free, sublicensable license in and to all ORADISC Trademarks and copyrights to be contained in any such labeling for the sole purpose of manufacturing and applying such labels to the Product in the conduct of ULURU’s obligations hereunder; provided, however, that ULURU agrees to cooperate with and offer reasonable assistance to ORADISC in facilitating ORADISC’s control of the quality of the Product branded with ORADISC’s trademarks hereunder; but further provided that in no event is ULURU obligated to provide such cooperation or assistance in any way that will (i) lower the quality of the Product below that which ULURU deems acceptable for general commercial distribution, (ii) be contrary to or in violation of any regulatory or statutory obligations, or (iii) increase the cost of manufacturing and delivering the Product hereunder beyond that contemplated by the parties as of the Effective Date.

11.7           Publications.

11.7.1           The Parties recognize that limited rights of review and/or comment exist for certain Third Party publications, such as medical, academic and scientific publications.  Each Party agrees to provide the other Party with any such proposed publication or presentation promptly upon its receipt.  Each Party may advise the other of any comments that it may have relating to such proposed publication or presentation and do so within the applicable time frame.

11.7.2           During the Term of this Agreement, unless otherwise prohibited by law, each Party shall submit to the other Party for review and approval any proposed publication or public presentation, especially including, without limitation, academic, scientific and medical information, which contains the non-disclosing Party’s Confidential Information or which disclose any non-public information contained within the Intellectual Property Rights or which makes any reference to the subject matter of this Agreement or the Product.

11.7.3           Written copies of each such proposed publication or presentation required to be submitted hereunder shall be submitted to the non-disclosing Party no later than fifteen (15) days before its intended submission for publication or presentation.  The non-disclosing Party shall provide its comments with respect to such publications and presentations within ten (10) business days of its receipt of such written copy.  The review period may be extended for an additional thirty (30) days in the event the non-disclosing Party can demonstrate reasonable need for such extension.  By mutual agreement of the Parties in writing, this period may be further extended.

11.7.4           Regarding their publications under this Section 11.7, ULURU and ORADISC will each comply with standard academic practice regarding authorship of scientific publications and recognition of contribution of other parties in any publication.

 
 
 


12.           NOTICES

12.1           Ordinary Notices.

Correspondence, reports, documentation, and any other communication in writing between the Parties in the course of ordinary implementation of this Agreement shall be delivered by hand, sent by facsimile or by overnight courier to the employee or representative of the other Party who is designated by such other Party to receive such written communication at the address or facsimile numbers specified by such employee or representative.

12.2           Extraordinary Notices.

Extraordinary notices and communications (including, without limitation, notices of termination, Force Majeure Event, material breach, change of address, requests for disclosure of Confidential Information, claims or indemnification) shall be in writing and shall be delivered by hand, sent by facsimile or by overnight courier (and shall be deemed to have been properly served to the addressee upon receipt of such written communication) to the address set forth in Section 12.3 or such other address as notified in writing by such Party to the other Party.

12.3           Addresses.

If to ULURU:

▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇ ▇. ▇▇▇▇, President & CEO
Facsimile No.:  (▇▇▇) ▇▇▇-▇▇▇▇

With a copy to:

▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, Esq.
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ LLP
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇  ▇▇▇▇▇
Facsimile No.:  (▇▇▇) ▇▇▇-▇▇▇▇

 
If to ORADISC:

 
▇▇▇▇▇▇▇  ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇ ▇-▇
▇▇▇▇▇▇, ▇▇ ▇▇▇▇
Attention:
Facsimile No.:  ▇▇▇ ▇▇ ▇▇▇ ▇▇▇▇

 
 
 


 13.           GENERAL

13.1           Governing Law.

This Agreement shall be construed in accordance with and governed by the law of the State of Delaware, without giving effect to its conflict of laws provisions, and to the exclusion of the provisions of the United Nations Convention on Contracts for the International Sale of Goods.

13.2           Assignment.

This Agreement shall not be assignable or transferable by either Party without the prior written consent of the other Party(which consent shall not be unreasonably withheld); provided that either Party may assign this Agreement and its rights and obligations hereunder without the other Party’s consent in connection with the transfer or sale of all or substantially all of the business of such party to which this Agreement relates (or, if applicable, the business unit or division of such Party primarily responsible for performance under this Agreement) to another party, whether by merger, sale of stock, sale of assets or otherwise.  In the event that ORADISC sublicenses the Agreement, with ULURU’s consent which shall not be unreasonably withheld, or any rights or obligations hereunder in accordance with the previous sentence, then ORADISC shall guaranty the performance of the sublicensee.  In the event that either ORADISC or ULURU assigns this Agreement in accordance with this Section 13.2, then the assigning Party shall be released from its obligations hereunder and shall have no further obligations to the other Party pursuant to this Agreement.  The rights and obligations of the parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the parties. Any attempted assignment in violation of this Section 13.2 shall be null and void, without any force or effect.

13.3           Entire Agreement.

This Agreement and all Exhibits attached hereto (as the same may be amended from time to time by the written agreement of the Parties) constitute the entire agreement between the Parties with respect to the subject matter hereof and supersedes all other documents, agreements, verbal consents, arrangements and understandings between the Parties with respect to the subject matter hereof.  This Agreement shall not be amended orally, but only by an agreement in writing, signed by both Parties that states that it is an amendment to this Agreement.

 
 
 


13.4           Severability.

If any term of this Agreement shall be found to be invalid, illegal or unenforceable, it is the intention of the parties that the remainder of this Agreement shall not be affected thereby; provided that neither Party’s rights under this Agreement are materially adversely affected.  It is further the intention of the parties that in lieu of each such provision which is invalid, illegal or unenforceable, there be substituted or added as part of this Agreement a provision which shall be as similar as possible in the economic and business objectives intended by the Parties to such invalid, illegal or unenforceable provision, but which shall be valid, legal and enforceable.  In the event that either Party’s rights are materially adversely affected as a result of a change in this Agreement as contemplated by this Section, such Party may terminate this Agreement by notice in writing to the other Party given no later than sixty (60) days after such change.

13.5           Independent Contractor.

Each Party shall act as an independent contractor and neither Party shall have any authority to represent or bind the other Party in any way.

13.6           No Waiver.

Any waiver by one Party of any right of such Party or obligation of the other Party must be in writing and shall not operate as a waiver of any subsequent right or obligation.


13.7           Counterparts.

This Agreement may be executed in two or more counterparts (including, without limitation, by facsimile transmission), each of which when so executed and delivered shall be an original, but all of which together shall constitute one and the same instrument.


 
 
 


IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.




By:           /s/ ▇▇▇▇▇ ▇. ▇▇▇▇
Name:  ▇▇▇▇▇ ▇. ▇▇▇▇
Title:           President & CEO

ORADISC  GmbH


By:           /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇
Name:
Title:


 
 
 

EXHIBIT A

Product


Means OraDisc Erodible Film Technology, in Bulk or in finished form.
All applications of OraDisc Erodible Film
Technology for dental applications including:
▬  
Benzocaine
▬  
Amlexanox (Exclusive of Europe, Canada, Korea, Taiwan and Hong Kong) Disc
▬  
Re-mineralization Dental Strips
▬  
Fluoride Dental Strips
▬  
Long Acting Breath Freshener



ORADISC will be granted a 24 month option to utilize the technology for drug delivery for migraine, nausea and vomiting, pain and cough and cold. A separate License Agreement would be signed on terms to be negotiated.

 
 
 

EXHIBIT B

Quality Agreement


TO BE AGREED WITHIN 60 DAYS OF SIGNING THE LICENSE AGREEMENT.

 
 
 

EXHIBIT C

Procedures for Reporting Adverse Events


TO BE AGREED WITHIN 60 DAYS OF SIGNING THE LICENSE AGREEMENT.




 
 
 

EXHIBIT D

Price


▇▇▇▇▇▇ HOLDING will pay ULURU to manufacture and supply ▇▇▇▇▇▇ Holding®. An amount equal to the manufacturing cost of the product paid by ULURU to third parties plus 5% of this cost to cover internal administrative and production planning costs.




































 
 
 

EXHIBIT E

License Payments


Licensing fee of $250,000 will be paid on signing.

































 
 
 





EXHIBIT F

Territory


Worldwide – Excluding
Aphthasol and OraDisc A in Europe
Canada, Korea, Taiwan and Hong Kong and Aphthasol in the United States

 
 
 



EXHIBIT G

Investment Agreement














































 
 
 

Document Metadata

Filed: March 29th, 2013