License and Supply Agreement dated November 17, 2008 by and between Meda AB and ULURU Inc

1.  

DEFINITIONS

1.1.  

1.1.1.  

 “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but is restricted from electing such majority by contract or otherwise, until such time as such restrictions are no longer in effect.

1.1.2.  

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

1.1.3.  

“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.

1.1.4.  

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

1.1.5.  

“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.

1.1.6.  

“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.

1.1.7.  

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

1.1.8.  

“EMEA” means (a) the European Medicines Evaluation Agency, London, United Kingdom, or (b) any local regulatory agency or governmental entity which fulfills a role similar to the EMEA, or any successor entities thereto.

1.1.9.  

“Facility” and / or “Facilities” means any and all facilities regarding the Manufacture of the Products and the supply of the Materials, which are listed in Exhibit B or any subsequent or replacement facilities approved by MEDA.

1.1.10.  

“Field” means the prevention and treatment of aphthous ulcers.

1.1.11.  

“Force Majeure Event” has the meaning set forth in Article 11.

1.1.12.  

“Good Manufacturing Practice” or “GMP” means (a) the then current standards for the manufacture of pharmaceuticals, (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 C.

1.1.13.  

“Indemnified Party” has the meaning set forth in Section 8.1.3.

1.1.14.  

“Indemnifying Party” has the meaning set forth in Section 8.1.3.

1.1.15.  

“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 Products.

1.1.16.  

“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 Products, its Manufacture and/or use.

1.1.17.  

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

1.1.18.  

“Major Countries” shall mean (i) initially France, Germany, Italy, and United Kingdom and (ii) potentially later Spain, provided that ULURU had re-acquired the rights back from Esteve S.A., Spain, in accordance with Section 3.1.5.

1.1.19.  

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

1.1.20.  

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

1.1.21.  

“MEDA” has the meaning set forth in the Preamble.

1.1.22.  

“MEDA Confidential Information” means all information, specifications, know-how and data pertaining to MEDA’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 EMEA or any other Regulatory Authority, clinical study data, analytical data, operating procedures and all ordering and sales information.

1.1.23.  

“MEDA Trademarks” means any trademarks, trade name, trade dress, slogan, logo, or similar item selected by MEDA for use in connection with the Products, including but not limited to the trademark Apthasol®, as listed in Exhibit J.

1.1.24.  

“Methods of Analysis” means the methods of analysis for the Products which are mutually agreed upon in writing between the Parties and, on a date to be mutually agreed upon by the Parties, attached as an exhibit to this Agreement.

1.1.25.  

“Net Sales” means, with respect to the Product, the gross invoiced sales amount of the Products sold by MEDA 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 MEDA in return; (b) refunds, rebates, governmental 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 Products 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 MEDA and/or its Affiliates (excluding national, state or local taxes based on income). Such amounts shall be determined from the books and records of MEDA and its Affiliates maintained in accordance with generally accepted accounting principles, consistently applied. Sales of the Products 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.  

“Old Agreement” shall have the meaning as set fort in the Preamble of this Agreement

1.1.27.  

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

1.1.28.  

“Patents” shall mean (a) the patents listed in Exhibit D 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 Products.

1.1.29.  

“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.

1.1.30.  

 “Products” shall mean the Products listed in Exhibit A

1.1.31.  

 “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 Products to Third Parties that would have been subject to recall if it had been sold or shipped.

1.1.32.  

“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 Products in a country within the Territory.

1.1.33.  

“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 Products in the Territory.

1.1.34.  

“Rolling Forecast” has the meaning set forth in Section 3.4.

1.1.35.  

“Seizure” means any action by the EMEA or any other Regulatory Authority to detain or destroy the Products or prevent the release of the Products.

1.1.36.  

“Specifications” means the specifications for the Products as set forth in the Exhibit E or in the Quality Agreement.

1.1.37.  

“Supply Failure” shall have the meaning as set forth in Section 3.7.2.

1.1.38.  

“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 Article 9.

1.1.39.  

“Territory” means,

 

(aa)

Countries of the Old Agreement, which are: Denmark, Sweden, Norway, Finland, Estonia, Lithuania, Latvia and

 

(i)

European Union countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, France, Germany, Hungary, Ireland, Italy, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, United Kingdom, and

 

(iii)

Russia and CIS Markets: Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Moldova, Russia, Tajikstan, Ukraine, Uzbekistan and Kyrgyzstan

1.1.40.  

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

1.1.41.  

“Trademarks” means all ULURU trademarks OraDisc™.

1.1.42.  

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

1.1.43.  

“ULURU Confidential Information” means all information, specifications (including, without limitation, the Specifications), know-how and data pertaining to the Products and ULURU’s business or its Manufacturing operations disclosed to MEDA 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 Products, and any correspondence with the FDA, EMEA or any other Regulatory Authority, clinical study data, analytical data, or operating procedures.

1.2.  

2.  

TERMINATION OF THE OLD AGREEMENT

2.1.  

MEDA and ULURU hereby terminate by mutual agreement the Old Agreement effective as of the Effective Date.

2.2.  

The Parties hereby agree that neither Party shall have any rights and/or obligations towards the respective other Party resulting from the Old Agreement and/ or its termination.

3.  

SUPPLY

3.1.  

3.1.1.  

Subject to the terms and conditions of this Agreement, ULURU hereby grants to MEDA (a) the exclusive right and sub licensable license in the Field under ULURU’s Intellectual Property Rights to market, offer for sale, sell, distribute and import products, including the Products, in the Territory, (b) the exclusive right and sub licensable license in the Field under ULURU’s Intellectual Property Rights to use the Products in the Territory, provided that such right and license is limited to such use as is necessary for MEDA to market, offer for sale, sell, distribute and import and, subject to the terms and conditions set forth in Section 3.8, Manufacture the Products in the Territory, and (c) a exclusive right and sub licensable license to use the Products 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 Products. Except as expressly granted herein, ULURU retains all rights in the Intellectual Property Rights and the Products.

3.1.2.  

Except as specifically provided to the contrary in Section 3.1.1, the license granted in Section 3.1.1 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 3.8, to grant any license relating to ULURU’s methods of formulating, fabricating and Manufacturing the Products; (c) to grant MEDA any rights in or to the use of the Intellectual Property Rights by implication or otherwise. MEDA shall mark or have marked all containers or packages of the Products in accordance with the patent marking laws of the jurisdiction in which such units of Products are to be used or distributed.

3.1.3.  

Upon expiration of the Term in any country due to (i)the expiration of the last-to-expire patent within the Patents in such country or (ii) due to a termination of the Agreement for cause by MEDA in accordance with the provisions of Section 3.7.3, 9.4 and/or 9.5, MEDA shall have a non-exclusive, transferable, timely unrestricted license to those licenses set forth in Section 3.1.1, provided that MEDA will pay to ULURU the royalties in accordance with Articles 3.1.3 a)- d) of this Agreement:

 

a)

In consideration for the license granted by ULURU to MEDA as set out above in Article 3.1.3, MEDA shall pay to ULURU a royalty of 5 % (five percent) on Net Sales of the Products.

 

b)

MEDA will pay to ULURU the royalties quarterly (meaning any calendar quarter ending on 31st March, 30th June, 30th September or 31st December) within 30 (thirty) days after the end of the relevant calendar quarter. The currency of the royalty payment shall be EURO. Each royalty payment shall be accompanied by a statement in a form as set forth in Article 3.9.3 d) of this Agreement.

 

c)

The rights and obligations of the Parties as to ULURU´s right to inspect and examine MEDA´s books - as laid down in Article 6.5.2 and 6.5.3 of this Agreement shall - apply accordingly.

 

d)

It is understood that MEDA´s obligation to pay royalties to ULURU shall cease on a product by product basis upon the expiration of the last-to-expire patent within the Patents in such country.

3.1.4.  

MEDA is free to decide whether (i) to use the Trademarks in the countries of the Territory or (ii) to register, at MEDA’s expense, and to use alternative MEDA Trademarks for the promotion, distribution and sale of the Products.

 

a)

 

b)

3.1.5.  

ULURU will provide commercially reasonable efforts to re-acquire from Esteve SA, Spain the exclusive rights for the Manufacture, marketing, promotion, sale and distribution of the Products in Spain, Greece and Portugal. ULURU will promptly inform MEDA once the rights had been re-acquired from Esteve SA. In such a case, the parties agree to extend the Territory and to add Spain, Greece and Portugal to this Agreement. The Parties will stipulate the extension of the Territory in an amendment to this Agreement. To avoid any misunderstandings, the license payments applicable for Spain mentioned in Exhibit I are subject to ULURU´s successful re-acquisition of the Product rights for Spain, Greece and Portugal.

3.2.  

3.2.1.  

At MEDA’s sole expense, MEDA agrees to make and maintain all Regulatory Approvals for the Products from the Regulatory Authorities in the countries of the Territory.

3.2.2.  

ULURU will provide MEDA with all documentation which is necessary for the registration process and the obtaining of the Regulatory Approvals, including but not limited to a certificate of pharmaceutical product (“CPP”) and the US dossiers of the Products. ULURU will use commercially reasonable efforts to assist MEDA in the obtainment of the Regulatory Approvals.

3.2.3.  

If MEDA decides not to register OraDisc™ A (amlexanox) in one of the Major Countries, the rights to the respective Product (and only to this Product) in the respective country granted by ULURU according to Section 3.1 shall revert to ULURU.

3.2.4.  

Any Regulatory Approval shall become, if legally permitted in the respective country of the Territory, the sole property of MEDA. MEDA shall be (if legally permitted in the respective country of the Territory) the holder of the Regulatory Approvals.

3.3.  

3.3.1.  

Subject to Section 3.4, ULURU shall Manufacture and deliver the Products to MEDA in such quantities and at such times as ordered by MEDA in accordance with this Agreement. During the Term, ULURU shall maintain the resources necessary to Manufacture the Products and shall provide, at its own expense, all Materials and labor necessary to do so.

3.3.2.  

ULURU may not transfer its Manufacturing and supply obligations under this Agreement to any Third Party without MEDA’s prior written consent. In any case, ULURU is solely responsible towards MEDA for the fulfillment of all of ULURU’s Manufacturing and supply obligations under this Agreement.

3.3.3.  

MEDA herewith approves the Third Party manufacturer of ULURU mentioned in Exhibit B.

3.3.4.  

If requested by MEDA, ULURU shall be responsible for (a), at MEDA’s cost and expense, supplying to MEDA, prior to the commencement of Manufacturing of the Product, a full scale validation Batch and the data reasonably requested by MEDA (including, without limitation, the final Product formulation, the processing requirements from start to finish for all production, the validated analytical methods, the Specifications and test method (both chemical and physical) for all elements of the disc component and the Product through the finished production of the Products and the validation protocols and schedules for processes, equipment, cleaning and packaging) and MEDA shall reimburse ULURU for ULURU’s actual, reasonable, out-of-pocket costs for the supply of such Batch and data, (b) at MEDA ’s cost and expense, scale-up, validation and stability of the Products for commercial production of the Products, including, without limitation, bulk production of the benzocaine gel, production of the mucoadhesive disc and development and validation of a mutually acceptable package configuration, (c) cooperating with MEDA with respect to the obtaining by MEDA of any Regulatory Approvals required to be obtained by MEDA with respect to the marketing, sale, offering to sell, importing and/or distribution of the Product, and (d) providing to MEDA complete Batch records for all validation Batches and, on an annual basis, providing one representative full Batch record.

3.4.  

3.5.  

3.6.  

3.7.  

3.7.1.  

It is of essence to this Agreement that ULURU delivers the Products at the date stated in the purchase order. In the event that ULURU fails to deliver the Products on or before the delivery date specified in the applicable purchase order, ULURU or its Affiliates shall notify MEDA of such delay and the Parties shall consult in good faith to determine the period of such inability to supply such Product.

3.7.2.  

If (i) MEDA reasonably determines that such or any other inability to so supply a Product will continue for more than 90 (ninety) days, or (ii) if ULURU fails to supply any of MEDA´s purchase orders for Product and fails to cure such failure within 60 (sixty) days after the requested delivery date therefore (each of (i) and (ii) shall be referred to as a “Supply Failure”), then MEDA may, at its option either (x) agree to have ULURU supply the undelivered Product at a future date agreed upon the Parties or (ii) have up to 100 (hundred) % supplied by a secondary supplier of such Product as provided for in Article 3.8 below.

3.7.3.  

If ULURU continues to be delayed with the delivery of the Products for a period of six (6) consecutive months, MEDA has, without any time restriction, the right to terminate this Agreement.

3.8.  

3.8.1.  

MEDA shall have the right to establish and maintain secondary supplier (s) for all Products (in finished form). MEDA and UULURU shall jointly select and agree on a secondary supplier(s), provided however that if the Parties can not agree on a secondary supplier, then MEDA shall be entitled to appoint a secondary supplier at its sole discretion.

3.8.2.  

ULURU shall cooperate with MEDA in the transfer of copies of the ULURU Confidential Information, technology and know- how necessary to Manufacture the Products to MEDA and/or its designated secondary supplier (s), (b) deliver to MEDA copies of such drawings, specifications, and other information in ULURU’s possession as may be necessary to Manufacture the Products or cause the Products to be Manufactured and (c) grant to MEDA 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 MEDA’s distribution of the Product in the Territory, the Products; 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 10 and MEDA’s designated secondary supplier shall be required to enter into a confidentiality agreement with ULURU containing substantially the same terms as Article 10; and further provided that all items provided under clauses (a) and (b) above will be subject to the license granted pursuant to clause (c).

3.8.3.  

Subject to Section 3.8.1 following the establishment of any secondary supplier hereunder, MEDA may obtain from such secondary supplier such portion of its supplier requirements with the respect to the Product as is necessary to maintain such secondary supplier’s regulatory qualification, but in no event more than 10% of MEDA´s total requirements for the Products. Product procured until this section 3.8.3 will be subject to a royalty of 5% of Net Sales in the Territory.

3.8.4.  

Notwithstanding the provisions of Section 3.8.3 above, but subject to Section 3.8.1 above, MEDA shall have the right to obtain from such secondary supplier(s) up to 100% of its supply requirements with respect to any Products in the event (a) of expiration of the Term of this Agreement or (b) MEDA terminates the Agreement with respect to such Product pursuant to Article 3.7.4, 9.4 and 9.5 of this Agreement, (c) in the event of a Supply Failure occurs with respect to such Product.

3.9.  

Marketing, Promotion and Distribution.

3.9.1.  

ULURU agrees that MEDA shall have only the obligation to market, promote, sell and distribute OraDisc™ A (amlexanox) in the countries of the Major Countries, Belgium, the Netherlands and in Turkey, provided that, nothing shall require MEDA to continue to market or sell the Products in any of these countries during a period of time that MEDA 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.

3.9.2.  

MEDA agrees to Launch in addition OraDisc™ A (amlexanox) in the countries of the Major Countries, Belgium, the Netherlands and in Turkey, within 6 (six) months after Regulatory Approval has been granted, provided that ULURU has delivered MEDA with Products as laid down in the respective purchase order.

3.9.3.  

Subject to Section 3.9.1 – 3.9.2 above, MEDA agrees

3.9.4.  

ULURU agrees to support MEDA, as far as possible for and available within ULURU, in the promotion, marketing, sale and/or distribution of the Products in the Territory. Any costs related to such support will be borne by MEDA. If possible (i.e. where marketed by ULURU’s partners e.g. USA), ULURU will provide MEDA with examples of promotional material from its sub-licensees and distributors.

3.10.  

3.11.  

3.11.1.  

If (i) the Parties mutually agree to conduct further clinical trials and/or (ii) if a clinical trial is required for regulatory approval purposes, ULURU will contribute fifty (50%) per cent towards the cost of the respective clinical trial.

3.11.2.  

MEDA shall have the right to use and reference all clinical and other technical data generated by ULURU and ULURU’S licensees relating to the Products. ULURU and its licensees shall have the right to use and reference all clinical and other technical data generated by MEDA relating to Products.

3.12.  

3.12.1.  

MEDA shall be responsible, at MEDA’s cost and expense, for any consumer product testing and commercialization of the Products, including, without limitation, all sales and marketing activities related to the Products and the design of all Product packaging and related artwork, and the design of all labeling.

3.12.2.  

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

4.  

COMPLIANCE, QUALITY AND ENVIRONMENTAL

4.1.  

4.2.  

4.2.1.  

All Products shall be Manufactured by ULURU at the Facilities 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 therefore. ULURU shall take all necessary steps to prevent contamination and cross contamination of Products.

4.2.2.  

The Products shall be unadulterated and free from contamination, dilutents and foreign matter in any amount and 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 Products in accordance with the Methods of Analysis, the cost of such to be included in the price hereinafter specified. ULURU shall promptly, upon completion of such tests, deliver to MEDA a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. ULURU shall deliver a representative sample from each Batch of Product to MEDA’s designated representative by the date reasonably specified by such representative.

4.2.3.  

Within sixty (60) days of the Effective Date, each of the Parties shall execute and deliver the Quality Agreement substantially in the form of Exhibit C 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 Products 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 MEDA.

4.3.  

4.4.  

4.5.  

4.6.  

4.6.1.  

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.

4.6.2.  

Within sixty (60) days of the Effective Date, each of the Parties shall execute and deliver the Pharmacovigilance Agreement substantially in the form of Exhibit G and as mutually agreed to by the parties. Each Party agrees to perform its respective obligations under the Pharmacovigilance Agreement in accordance with such agreement.

4.7.  

4.7.1.  

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 Products. 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 MEDA 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. MEDA and ULURU 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, MEDA shall have the right to make all final decisions regarding such Recall.

4.7.2.  

In the event that a Recall results from any cause or event arising from ULURU’s breach of Sections 4.1, 4.2, 4.4, 4.6. 4.8 or the representations set forth in Sections 7.2.1, 7.2.4 or 7.2.5 and/or the defective Manufacture, storage or handling of the Products by ULURU (excluding defects relating to packaging or labeling supplied by or prepared at and in accordance with the direction of MEDA), ULURU shall be responsible for all expenses of the Recall incurred by MEDA and ULURU shall promptly replace such Product at no additional cost to MEDA 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 Products by MEDA or its Affiliates, distributors or contractors (including but not limited to defective Manufacture, storage, handling or distribution undertaken at the direction of MEDA and consistently with MEDA’s instructions), MEDA 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, but shall not include lost profits of either party.

4.8.  

4.8.1.  

ULURU shall promptly report to MEDA after any of the following incidents related to the Manufacturing operations hereunder occurs: (a) fatalities and/or significant injuries or occupational illness; (b) property damage in excess of € 50,000; (c) inspections by any environmental protection agency or occupational health and safety agency; or (d) requests for information, notices of violations or other significant governmental and safety agency communications relating to environmental, occupational health and safety compliance.

5.  

MANUFACTURING CHANGES

5.1.  

5.2.  

6.  

PRICE AND PAYMENT

6.1.  

6.1.1.  

The prices for the Products are set forth in Exhibit H. The prices include all Manufacturing and supply obligations of ULURU under this Agreement.

6.1.2.  

The prices shall be fixed for the Term of this Agreement, if not otherwise stipulated in Section 6.1.3 below.

6.1.3.  

ULURU shall be entitled to revise the prices of the Products in case that ULURU’s labor costs and/or Material costs will increase by more than 2½% (two and one-half percent) compared to the costs/prices valid at the Effective Date, provided however that (i) ULURU will prove the increase in writing and (ii) MEDA´s gross margin will not be below 70 (seventy) % and (iii) MEDA´s prices for the products are not worse than the prices for the products to other licensees in Europe.

6.2.  

6.3.  

6.4.  

6.5.  

6.5.1.  

MEDA shall have the right, at its own expense, to access the books and records of ULURU and its Affiliates as may be reasonably necessary to verify the accuracy of the labor costs and Material costs referred to in Section 6.1.3. Such access shall be conducted after thirty (30) days’ prior written notice to ULURU and during ordinary business hours, will be conducted in a manner that is not disruptive to ULURU’s operations, and shall not be more frequent than once per Contract Year or in respect of any Contract Year ending not more than twenty-four (24) months prior to the date of such notice. Subject to Section 6.5.3, if such independent certified public accountant’s report shows any overpayment by MEDA, ULURU shall remit to MEDA within thirty (30) days after MEDA’s receipt of such report, (a) the amount of such overpayment, and (b) if such overpayment exceeds three percent (3%) 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 MEDA. Subject to Section 6.5.3., if such independent certified public accountant’s report shows any underpayment by MEDA, MEDA shall pay to ULURU within thirty (30) days after MEDA’s receipt of such report, the amount of such underpayment. Any audit or inspection conducted under this Agreement by MEDA or its agents or contractors will be subject to the confidentiality provisions of this Agreement, and MEDA will be responsible for compliance with such confidentiality provisions by such agents or contractors.

6.5.2.  

MEDA shall maintain books of account with respect to its sales of the Products 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 MEDA during regular business hours for the purpose of verifying the statements of the aggregate Net Sales resulting from sales of Products and determining the correctness of the date of the license payments paid (or not yet paid). If such independent certified public accountant’s report shows any (i) underpayment by MEDA, or (ii) late payment by MEDA (due to the fact that the cumulated Net Sales set fort in the Exhibit I (license payment no. 4) had been achieved earlier), MEDA shall pay to ULURU within thirty (30) days after MEDA´s receipt of such report, (a) the amount of such underpayment or late payment, and (b) if such (y) underpayment exceeds five percent (5%) of the total amount owed for the period then being audited or (z) late payment is more than three (3) months past due, the reasonable fees and expenses of any independent accountant performing the audit on behalf of ULURU. Otherwise, ULURU has to bear the costs of the independent accountant. 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.

6.5.3.  

If any dispute arises under this Section 6.5 between the Parties relating to overpayments, underpayments or late payments, 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.

6.6.  

6.7.  

Currency Exchange.

7.  

REPRESENTATIONS AND WARRANTIES

7.1.  

7.1.1.  

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

7.1.2.  

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;

7.1.3.  

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

7.1.4.  

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

7.1.5.  

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

7.2.  

7.2.1.  

as of the date of each delivery of the Product by ULURU to a carrier, the Products (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 stored in accordance with procedures requested by MEDA;

7.2.2.  

as of the date of each supply of the Products by ULURU, ULURU has good and marketable title to the Products and the Products are free from all liens, charges, encumbrances and security interests;

7.2.3.  

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

7.2.4.  

as of the date of each supply of the Products by ULURU, ULURU possesses all necessary Regulatory Approvals relating to ULURU’s Manufacture and supply to MEDA of the Products;

7.2.5.  

as of the Effective Date, the Patents are existing and have not been held to be invalid or unenforceable, in whole or in part;

7.2.6.  

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 MEDA hereunder);

7.2.7.  

as of the Effective Date, and, except as disclosed to MEDA in writing, as of the date of each supply of the Products by ULURU, ULURU has received no notice that the practice of the Intellectual Property Rights or the Trademarks are subject to an infringement claim of any issued patent or Trademark owned or possessed by any Third Party within the Territory;

7.2.8.  

as of the Effective Date, the Intellectual Property Rights are not the subject to any funding agreement with any government or governmental agency; and

7.2.9.  

as of the Effective Date, or within ten (10) days thereof, ULURU has provided MEDA with any and all information relating to the Products, its Manufacture and formulation necessary for MEDA to conduct a freedom to operate opinion relating to the Territory, and all information has been provided so that MEDA may complete its due diligence.

7.3.  

7.4.  

7.5.  

7.6.  

7.6.1.  

THE FOREGOING WARRANTIES ARE THE SOLE AND EXCLUSIVE WARRANTIES GIVEN BY ULURU WITH 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. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, EXCEPT FOR THE WARRANTIES EXPRESSLY PROVIDED IN SECTION 6, NO IMPLIED WARRANTY OF MERCHANTABILITY, VALIDITY, NON-INFRINGEMENT, TITLE, FITNESS FOR ANY PARTICULAR PURPOSE, AND NO IMPLIED WARRANTY ARISING BY USAGE OF TRADE, COURSE OF DEALING OR COURSE OF PERFORMANCE IS GIVEN OR MADE BY ULURU OR SHALL ARISE BY OR IN CONNECTION WITH ANY SALE OR PROVISION OF PRODUCTS OR SERVICES BY ULURU, OR MEDA’S USE OR SALE OF THE PRODUCT, OR ULURU’S AND/OR MEDA’S CONDUCT IN RELATION THERETO OR TO EACH OTHER. NO REPRESENTATIVE OF ULURU IS AUTHORIZED TO GIVE OR MAKE ANY OTHER REPRESENTATION OR WARRANTY OR TO MODIFY THE FOREGOING WARRANTY IN ANY WAY.

7.6.2.  

EXCEPT FOR THE WARRANTIES GIVEN BY MEDA AS EXPRESSLY PROVIDED IN ARTICLE 7, MEDA GIVES AND MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND OR NATURE, EXPRESS OR IMPLIED, WITH RESPECT TO THE MATTERS ADDRESSED IN THIS AGREEMENT.

7.6.3.  

The warranties set forth in this Article 7 do not apply to any nonconformity 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.

7.7.  

8.  

INDEMNIFICATION AND INSURANCE

8.1.  

8.1.1.  

ULURU shall defend, indemnify and hold harmless MEDA, its Affiliates, directors, officers, employees and agents from and against all damages, losses, liabilities, expenses, claims, demands, suits, penalties or judgments or administrative or judicial orders (including, without limitation, reasonable attorneys’ fees and expenses) incurred, assessed or sustained by or against MEDA, its Affiliates, directors, officers, employees or agents with respect to a claim by a Third Party arising out of (a) the negligent acts or omissions of ULURU; (b) any breach by ULURU of this Agreement or its representations, warranties or covenants hereunder; (c) any Recall or Seizure attributable to ULURU’s performance (including, without limitation, amounts MEDA pays or credits to its customers for Products so Recalled or Seized); (d) product liability, tort, nuisance or other claim arising out of the defective manufacture, storage or supply of the Products by ULURU; (e) any allegation that the Manufacture, importation, sale, offer for sale or use of the Products infringe any patent or other intellectual property, proprietary or protected right within the Territory; provided that ULURU will not be obligated to indemnify MEDA if and to the extent that the alleged infringement is caused by: (i) MEDA’s (including, without limitation, its Affiliates, agents, contractors, and sub-distributors) or its customers misuse or modification of the Products; or (ii) MEDA’s (including, without limitation, its Affiliates, agents, contractors, and sub- distributors) or its customers use of the Products in combination with any products or materials not provided by ULURU; and further provided that if the Product is held to constitute an infringement or misappropriation of any Third Party’s intellectual property rights or if in ULURU´s opinion, the Products are, or is likely to be held to constitute, an infringement or misappropriation, ULURU may at its expense and option: (x) procure the right for MEDA to continue distributing the Products (y) upon prior approval by MEDA, which approval will not be unreasonably withheld or delayed, promptly replace the Product with a non-infringing and non-misappropriating equivalent product conforming to the applicable Product Specifications and Regulatory Approvals; provided that there shall not be any material delay in any such replacement; or (z) upon prior approval by MEDA, which approval will not be unreasonably withheld or delayed, modify the Product to make it non-infringing and non-misappropriating while conforming to the applicable Product Specifications and Regulatory Approvals; provided that there shall not be any material delay in any such modification; (f) any enforcement or other action by any Regulatory Authority relating to the Manufacture, the pricing of the Products by ULURU to MEDA or sale of the Products by ULURU to MEDA, or (f) ULURU’s failure to comply with any applicable law, regulation or order (including, without limitation, environmental laws, regulations and orders). The foregoing indemnification obligation shall not apply in the event and to the extent that such claim arose as a result of any indemnitee’s negligence, intentional misconduct or breach of this Agreement. The provisions of this Section shall survive the termination or expiration of this Agreement.

8.1.2.  

MEDA shall defend, indemnify and hold harmless ULURU, its directors, officers, employees and agents from and against all damages, losses, liabilities, expenses, claims, demands, suits, penalties or judgments or administrative or judicial orders (including, without limitation, reasonable attorneys’ fees and expenses) incurred, assessed or sustained by or against ULURU, its directors, officers, employees or agents with respect to a claim by a Third Party arising out of (a) the negligent acts or omissions of MEDA; (b) any breach by MEDA of this Agreement or of its representations, warranties or covenants hereunder; (c) any allegation that the Trademarks or MEDA’s packaging or MEDA’s (or any Affiliate of MEDA’s) marketing materials infringes any patent or other proprietary or protected right of any Third Party; (d) any Recall or Seizure attributable to MEDA’s performance; (e) any enforcement or other action by any Regulatory Authority relating to the distribution or the pricing of the Products by MEDA or sale of the Products by MEDA to Third Parties; (f) MEDA’s failure to comply with any applicable law, regulation or order (including, without limitation, environmental laws, regulations and orders), or (g) the marketing and distributing of the Products by MEDA, its Affiliates or sub-distributors. The foregoing indemnification obligation shall not apply in the event and to the extent that such claim arose as a result of any indemnitee’s negligence, intentional misconduct or breach of this Agreement. The provisions of this Section shall survive the termination or expiration of this Agreement.

8.1.3.  

To receive the benefit of indemnification under this Section 8.1, the Party and its Affiliates, directors, officers, employees or agents seeking indemnification (an “Indemnified Party”) shall promptly notify the other Party (the “Indemnifying Party”), in writing, of any claim asserted or threatened against such Indemnified Party for which such Indemnified Party is entitled to indemnification hereunder from the Indemnifying Party. With respect to any such claim the Indemnified Party shall, at no out-of-pocket expense to it, reasonably cooperate with and provide such reasonable assistance to such Indemnifying Party as such Indemnifying Party may reasonably request. Such reasonable assistance may include, without limitation, providing copies of all relevant correspondence and other materials that the Indemnifying Party may reasonably request. The obligations of an Indemnifying Party under Sections 8.1.1 and 8.1.2 are conditioned upon the delivery of written notice to the Indemnifying Party of any asserted or threatened claim promptly after the Indemnified Party becomes aware of such claim; provided that the failure of the Indemnified Party to give such notice or any delay thereof shall not affect the Indemnified Party’s right to indemnification hereunder, except to the extent that such failure or delay impairs the Indemnifying Party’s ability to defend or contest any such claim. The Indemnifying Party shall have the right to assume the defense of any suit or claim for which indemnification is sought with counsel reasonably acceptable to the Indemnified Party. If the Indemnifying Party defends the suit or claim, the Indemnified Party may participate in the defense thereof at its sole cost and expense. An Indemnifying Party may not settle a suit or claim without the consent of the Indemnified Party if (a) such settlement would impose any monetary obligation on the Indemnified Party for which indemnification is not provided hereunder, (b) or require the Indemnified Party to submit to an injunction or otherwise limit the Indemnified Party’s rights under this Agreement, or (c) does not include a release of the Indemnified Party from all liability arising out of such suit or claim. Any payment made by an Indemnifying Party to settle any such suit or claim shall be at its own cost and expense.

8.1.4.  

The indemnification provided by this Article 8 shall be the Parties’ sole and exclusive remedy in connection with any third party claim.

8.2.  

9.  

TERM AND TERMINATION

9.1.  

9.2.  

9.3.  

9.4.  

9.5.  

9.6.  

9.7.  

9.8.  

10.  

CONFIDENTIALITY

10.1.  

10.2.  

10.3.  

10.4.  

11.  

FORCE MAJEURE

12.  

INTELLECTUAL PROPERTY

12.1.  

12.1.1.  

MEDA may advertise, promote, market and sell the Products either separately or as part of other products under any of the MEDA Trademarks and/or trade dress, whether registered or unregistered, in its sole discretion; provided that except as otherwise expressly permitted under Section 3.1.4 with respect to the Trademark, MEDA may not use or adopt any Trademark or trade dress, or any such item confusingly similar thereto used or intended to be used prior to the first use of such Trademark. ULURU shall have no right, title or interest in or to any such MEDA Trademark or trade dress, and MEDA shall have no right, title or interest in or to any such Trademark (except for the license to the Trademark granted under Section 3.1.4). So long as MEDA or any Affiliate of MEDA shall have any interest in any such MEDA Trademark or trade dress, whether registered or unregistered, whether as proprietor, owner, or licensee in any country of the world, ULURU shall not adopt, use, apply for registration, register or own such MEDA Trademark or trade dress, or any such item confusingly similar thereto in any country of the world, or take any action which weakens or undermines MEDA’s proprietary rights therein. So long as ULURU or any Affiliate of ULURU shall have any interest in any such Trademark or trade dress, whether registered or unregistered, whether as proprietor, owner, or licensee in any country of the world, except as otherwise expressly permitted under Section 3.1.4 with respect to the Trademark, MEDA shall not adopt, use, apply for registration, register or own such Trademark or trade dress, or any such item confusingly similar thereto in any country of the world, or take any action which weakens or undermines ULURU’s proprietary rights therein.

12.1.2.  

For the avoidance of doubt, MEDA 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 EMEA or any other Regulatory Authority, clinical study data, analytical data, operating procedures, MEDA Trademarks and all ordering and sales information.

12.2.  

12.2.1.  

Except as otherwise provided for in this Section 12.2, 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 the laws applicable in the respective country where the employee made the respective invention..

12.2.2.  

If and to the extent applicable, Inventions Controlled by ULURU and know-how arising during the Term which relates to the Products and is Controlled by ULURU shall be automatically included in the Intellectual Property Rights under which MEDA is licensed pursuant to Section 3.1.1 hereof. With respect to any Inventions or know-how Controlled by MEDA specifically relating to the Products, MEDA hereby grants to ULURU an exclusive (subject to retained rights in MEDA), royalty-free license to use such Invention for the Manufacture of the Products for MEDA in the Territory during the Term. However, it is understood that in the event of Article 3.8.3 and 3.8.4., a secondary supplier will also be entitled to use such Invention for the Manufacture of the Products for MEDA without any additional costs, provided that this Agreement has not been terminated.

12.2.3.  

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.

12.2.4.  

All rights, title and interest in and to the ULURU Intellectual Property Rights shall remain exclusively owned by ULURU. The Inventions owned by ULURU under this Section shall be referred to herein as “ULURU Inventions”.

12.2.5.  

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 Products, 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.

12.3.  

Confidentiality of Information related to Intellectual Property.

12.4.  

12.4.1.  

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

12.4.2.  

With respect to any filings after the Effective Date, ULURU shall give MEDA a reasonable opportunity to review and comment upon the text of such applications in the Territory before filing, shall consult in good faith with MEDA with respect to such applications in the Territory, and shall supply MEDA with a copy of such applications in the Territory as filed, together with notice of its filing date and serial number. ULURU shall inform MEDA 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.

12.4.3.  

ULURU shall consult with MEDA and provide MEDA with reasonable opportunity to comment on all correspondence received from and all submissions to be made to any Regulatory Authority in the Territory with respect to any such patent application or patent. ULURU shall consider in good faith, but will not be bound by, MEDA’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.

12.4.4.  

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 MEDA with written notice promptly after the decision to not file or continue the prosecution of such patent application or maintenance of such patent.

12.4.5.  

In such event, ULURU shall permit MEDA, in MEDA’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 MEDA’s own expense. If MEDA elects to continue such prosecution or maintenance, ULURU shall execute such documents and perform such acts, at MEDA’s expense, as may be reasonably necessary to permit MEDA to file, prosecute or maintain such application or Patent in such country. In such event, MEDA shall own such patent application or Patent filed by MEDA hereunder.

12.4.6.  

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.

12.4.7.  

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 12.4. 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.

12.5.  

12.5.1.  

If either Party becomes aware of any infringement of any of the Intellectual Property Rights, the Trademark, the MEDA Trademark or the validity of any of the Intellectual Property Rights, Trademark or the MEDA Trademark 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.

12.5.2.  

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 Trademark in the Territory. Such right shall remain in effect until ninety (90) days after the date of notice given under Section 12.5.1. 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 MEDA (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 Trademark. 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 Mark, filed suit against any such Third Party infringer of the Intellectual Property Rights and/or the Trademark, or provided MEDA with information and arguments demonstrating to MEDA’s reasonable satisfaction that there is insufficient basis for the allegation of such infringement of the Intellectual Property Rights and/or the Trademark, then MEDA shall have the right, but not the obligation, to bring suit against such Third Party infringer of the Intellectual Property Rights and/or the Trademark and to join ULURU as a party plaintiff, provided that MEDA shall bear all the expenses of such suit. In such event, MEDA 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 Trademark is invalid or would enjoin or grant other equitable relief against ULURU.

12.5.3.  

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 Trademark 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.

12.5.4.  

Neither Party shall be required pursuant to this Section 12.5 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.

12.5.5.  

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.

12.5.6.  

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).

12.6.  

12.7.  

12.7.1.  

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.

12.7.2.  

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 Products.

12.7.3.  

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.

12.7.4.  

The Parties acknowledge that as publicly held corporations, the Parties may not lawfully disclose in advance certain information to any party, including, without limitation, the other Party. This may affect the Parties’ ability to submit for review certain proposed publications and public presentations.

12.7.5.  

Regarding their publications under this Section 12.7, MEDA and ULURU will each comply with standard academic practice regarding authorship of scientific publications and recognition of contribution of other parties in any publication.

13.  

NOTICES

13.1.  

13.2.  

13.2.1.  

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 13.3 or such other address as notified in writing by such Party to the other Party.

13.3.  

14.  

GENERAL

14.1.  

14.2.  

14.2.1.  

If one Party is of the opinion that the other Party has infringed any of its Confidential Information under this Agreement, then this Party may commence proceedings for infringement in any court of competent jurisdiction to enforce the said Confidential Information, including without limitation to apply injunctive relief.

14.2.2.  

All disputes arising out of or in connection with this Agreement (other than those which a Party has elected to submit to national courts under Section 14.2.1) shall first be attempted to be settled between the Parties on a good faith basis. If the Parties are unable to resolve the dispute within 60 (sixty) days from the receipt by one Party of the other Party’s written notice asking for such amicable settlement discussions, then such dispute shall be finally settled by arbitration in accordance with the International Chamber of Commerce (ICC) Rules of Arbitration by three arbitrators, appointed in accordance with said rules. The place of arbitration shall be Zurich, Switzerland. The proceedings shall be conducted and all documentation shall be presented in English.

14.3.  

14.4.  

14.5.  

14.6.  

14.7.  

14.8.  

14.9.  

5% amlexanox paste

amlexanox

3 g tube

OraDisc A (amlexanox)

amlexanox

2 mg (per disc)

Use of Amlexanox for the Manufacture of a Medicament for Treating Aphthous Ulcers

97202524

0836852

4/22/1998

Austria

Use of Amlexanox for the Manufacture of a Medicament for Treating Aphthous Ulcers

97202524

0836852

4/22/1998

Belgium

Use of Amlexanox for the Manufacture of a Medicament for Treating Aphthous Ulcers

97202524

0836852

4/22/1998

Switzerland

Use of Amlexanox for the Manufacture of a Medicament for Treating Aphthous Ulcers

97202524

0836852

4/22/1998

Germany

Use of Amlexanox for the Manufacture of a Medicament for Treating Aphthous Ulcers

97202524

0836852

4/22/1998

Denmark

Use of Amlexanox for the Manufacture of a Medicament for Treating Aphthous Ulcers

97202524

0836852

4/22/1998

Spain

Use of Amlexanox for the Manufacture of a Medicament for Treating Aphthous Ulcers

97202524

0836852

4/22/1998

France

Use of Amlexanox for the Manufacture of a Medicament for Treating Aphthous Ulcers

97202524

0836852

4/22/1998

Great Britain

Use of Amlexanox for the Manufacture of a Medicament for Treating Aphthous Ulcers

97202524

0836852

4/22/1998

Greece

Use of Amlexanox for the Manufacture of a Medicament for Treating Aphthous Ulcers

97202524

0836852

4/22/1998

Italy

Use of Amlexanox for the Manufacture of a Medicament for Treating Aphthous Ulcers

97202524

0836852

4/22/1998

Luxembourg

Use of Amlexanox for the Manufacture of a Medicament for Treating Aphthous Ulcers

97202524

0836852

4/22/1998

Monaco

Use of Amlexanox for the Manufacture of a Medicament for Treating Aphthous Ulcers

97202524

0836852

4/22/1998

Netherlands

Use of Amlexanox for the Manufacture of a Medicament for Treating Aphthous Ulcers

97202524

0836852

4/22/1998

Portugal

Use of Amlexanox for the Manufacture of a Medicament for Treating Aphthous Ulcers

97202524

0836852

4/22/1998

Sweden

Appearance

Homogenous granular beige/tan colored paste free of lumps and foreign particles, packaged in tubes

Amlexanox Identification

Positive

Amlexanox Assay

4.75% - 5.25%

Benzyl Alcohol Assay

2.25% - 2.75%

AA-896 Content

< 0.005%

Viscosity

0.25 x 106 cps – 4.50 x 106 cps

Particle Size (<30 μm)

2 – 25 μm

Fill Weight

5.0 – 5.8 g

Microbial Limits

 

Aerobic Plate Count

< 500 CFU/g

Yeast/Molds

< 100 CFU/g

Absent

Absent

Absent

Absent

Appearance

Round, ½” diameter patch, red on one side and white on the other side

Amlexanox Content

2.00± 0.10 mg

Degradants:

Total

AA-896

Unidentified

 

 

≤ 0.1% Amlexanox Content

≤ 0.1% Amlexanox Content

≤ 0.1% Amlexanox Content

 

Content Uniformity

(d.u. = dosage unit)

1.70 – 2.30 mg for at least 9 of 10 d.u. tested, no d.u. outside of 1.50 – 2.50 mg; RSD ≤6.0%

OR

1.70 – 2.30 mg for at least 27 of 30 d.u. tested, no d.u. outside of 1.50 – 2.50 mg; RSD ≤7.8%

 

Dissolution

Q = 75% for Amlexanox Released in 60 min.

Acceptance per USP<711> Unit Sample

Weight

35 – 45 mg

Microbial Limits:

Aerobic Count

Aerobic Spore Count

Fungi

 

<10 CFU/patch

<10 CFU/patch

<10 CFU/patch

<10 CFU/patch

Negative

Negative

Negative

Negative

Spain*                                                75,000 Euros

1.2

In the event that the Regulatory Authorities does not grant the Regulatory Approval for OraDisc™ A, for whatever reason, in a country mentioned above, ULURU shall pay back to MEDA 50 (fifty) % of the license payment for the respective country.

1.3

For the remaining countries of the Territory there are no license payments applicable on the Effective Date.

2.1

Upon Launch of Apthasol Paste (amlexanox) in the countries mentioned below, MEDA will pay ULURU the following license payments:

2.2

For the remaining countries of the Territory there are no license payments applicable upon Apthasol Paste.

3.1

Upon Launch of OraDisc™ A in the countries mentioned below, MEDA will pay ULURU the following license payments:

3.2

For the remaining countries of the Territory there are no license payments applicable upon launch of OraDisc™.

4.)

4.1

Upon the achievement of certain Net Sales of the Products within the countries of the Territory in a calendar year, MEDA will pay ULURU the following license payments, whereupon it is understood that these license payments are to be one time payments:

4.2

Cumulative Net Sales in the countries of the Territory will be converted from local currency into Euros based on currency exchange rates published in the Wall Street Journal.

Denmark

AFTASOL

Finland

AFTASOL

Norway

AFTASOL

Sweden

AFTASOL

United Kingdom

Aphtheal

United Kingdom

Aftasol

Netherlands

Miraftil

Luxembourg

Miraftil

Austria

Aftasol

Ireland

Aphtheal

Germany

Miraphtil