Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

 


Exhibit 10.1


 


LICENSE AND SUPPLY AGREEMENT


 


This License and Supply Agreement (the “Agreement”)
is being entered into as of the 14th day of August 2013 (the “Effective Date”), by and between INNOCOLL
PHARMACEUTICALS, LIMITED, a company incorporated in Ireland (collectively, with its Affiliates “Innocoll”) whose
principal office is Midlands Innovation and Research Centre, Dublin Road, Athlone, Co. Westmeath, Ireland and Takeda GmbH,
Byk-Gulden-Straẞe 2, 78467 Konstanz, Germany, a company
incorporated in Germany (“Takeda”).


 


(together the “Parties”
and individually a “Party”)


 


Preliminary Statements


 


WHEREAS, Innocoll has developed the Product
and desires to grant to Takeda the exclusive right to distribute, promote and sell the Product in the Territory in the Field (as
each is defined below);


 


WHEREAS, Takeda is willing to act as Innocoll’s
sales, marketing and distribution partner for the Product in the Territory in the Field; and


 


WHEREAS, Innocoll and Takeda desire to enter
into this Agreement to set forth the terms and conditions of such distribution right and all other rights and obligations of the
parties relating thereto;


 


NOW, THEREFORE, the Parties agree as follows:


 


Terms and Conditions


 


		1.	Defined
                                         Terms:



 


		1.1.	Affiliate
                                         shall mean, with respect to either Party, a person, corporation, partnership or other
                                         entity controlled by, in control of, or under common control with such Party. A corporation
                                         or non-corporate business entity shall be regarded as in “control” of another
                                         corporation or business entity (i) if it owns or directly or indirectly controls fifty percent (50%)
                                         or more of the voting stock or other ownership interest of the other entity, or (ii)
                                         in the absence of the ownership of a majority of the voting stock or other ownership
                                         interest of such entity, if it possesses, directly or indirectly, the power to direct
                                         or cause the direction of the management and policies of such corporation or non-corporate
                                         business entity, as applicable.



 


		1.2.	Commercialize/Commercialization
                                         means all activities, whether initiated or conducted prior to or following Marketing
                                         Authorization for a Product in the Field and in the Territory, undertaken in support
                                         of the promotion, marketing, sale and distribution (including importing, exporting, transporting,
                                         customs clearance, warehousing, invoicing, handling and delivering Product to customers)
                                         of the Product.



 


		1.3.	Commercially
                                         Reasonable Efforts/Diligent Efforts means, with respect to the efforts to be expended,
                                         or considerations to be undertaken, by a Party or its Affiliate with respect to any objective,
                                         activity or decision to be undertaken hereunder, reasonable, good faith efforts to accomplish
                                         such objective, activity or decision as such Party would normally use to accomplish a
                                         similar objective, activity or decision under similar circumstances, it being understood
                                         and agreed that with respect to the development or commercialization of the Product,
                                         such efforts and resources shall be consistent with those efforts and resources commonly
                                         used by a Party under similar circumstances for similar compounds or products owned by
                                         it or to which it has similar rights, which compound or product, as applicable, is at
                                         a similar stage in its development or product life and is of similar market



 






    	1



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

 


potential taking
into account efficacy, safety, approved labeling, the competitiveness of alternative products sold by third parties in the marketplace,
the patent and other proprietary position of the compound or product, the likelihood of regulatory approval given the regulatory
structure involved, the profitability of the product taking into considerations, among other factors, third party costs and expenses
including the royalties, milestone and other payments, and the pricing and reimbursement relating to the product. Commercially
Reasonable Efforts shall be determined on a market-by-market and indication-by-indication basis for Product, as applicable, and
it is anticipated that the level of effort will change over time, reflecting changes in the status of the Product and the market(s)
involved. Notwithstanding the foregoing, neither Party shall be obligated to Develop, seek Marketing Authorization or Commercialize
Product: (i) which, in its reasonable opinion after discussion with the other Party, caused or is likely to cause a fatal,
life-threatening or other adverse safety event that is reasonably expected, based upon then available data, to preclude obtaining
Marketing Authorization for such Product, or if Marketing Authorization of such Product has already been obtained, to preclude
continued marketing of such Product; or (ii) in a manner inconsistent with applicable laws.


 


		1.4.	Competing
                                         Product shall mean a product used as an adhesion barrier. A product that Takeda is
                                         currently developing, manufacturing or commercializing anywhere in the world - including,
                                         but not limited to the haemostasis product Tachocomb®/Tachosil® - shall not be
                                         regarded as a Competing Product.



 


		1.5.	Field
                                         shall mean all current and future approved indications for the Product.



 


		1.6.	First
                                         Commercial Sale/Commercial Launch means, with respect to the Product, on a country
                                         by country basis, the first sale by a Party, a Party’s Affiliate or a Party’s
                                         sublicensee to a third party in a country after Marketing Authorization approval in such
                                         country.



 


		1.7.	Fiscal
                                         Year means the twelve (12) months period from April 1st until March 31st
                                         of the following year.



 


		1.8.	cGMP
                                         means the then-current good manufacturing practices detailed in the “Rules
                                         Governing Medicinal Product in the European Community – Volume IV Good Manufacturing
                                         Practice for Medicinal Products” and Q7A Good Manufacturing Practice Guidance for
                                         Active Pharmaceutical Ingredients (ICH Q7A); and any subsequent or future revisions of
                                         such guidelines and regulations, and comparable applicable laws related to the manufacture
                                         and testing of pharmaceutical materials in jurisdictions in the Territory.



 


		1.9.	Governmental
                                         Authority means any multi-national, federal, state, local, municipal or other government
                                         authority of any nature (including any governmental division, subdivision, department,
                                         agency, bureau, branch, office, commission, council, court or other tribunal).



 


		1.10.	Improvements
                                         shall mean any information, Know-How, finding, dosing, invention, addition, modification,
                                         formulation or changes whether patentable or not, made by Innocoll during the Term of
                                         this Agreement which relate to the Product, including but not limited to new formulations,
                                         combinations of the Product with one or several active ingredients, new or improved methods
                                         of administration, new indications as well as improvements in the Manufacturing of the
                                         Product for use in the Field in the Territory.



 


		1.11.	Initial
                                         Floor price shall mean the price set out in Exhibit B.



 




    	2



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


		1.12.	Initial
                                         Purchase Quantity shall have the meaning as set out in Section 3.2.



 


		1.13.	Innocoll
                                         Patents means any Patent that is necessary or material for the (i) Commercialization
                                         of the Product in the Field in the Territory, (ii) the storage of the Product outside
                                         the Territory for purposes of Commercialization in the Territory, and/or (iii) the import,
                                         transport of the Product into the Territory, that is Controlled by Innocoll or any of
                                         its Affiliates on the Effective Date or comes within Innocoll’s or any of its Affiliates’
                                         Control during the Term. Innocoll Patents existing on the Effective Date are set forth
                                         in Exhibit D.



 


		1.14.	Innocoll
                                         Know-How shall have the meaning as set out in Section 16.1.



 


		1.15.	Line
                                         Extension means any product in the Field in the Territory, other than the Product
                                         including an improvement of the presentation of the Product defined as (i) new forms
                                         of Packaging of the Product (ii) new dosages of the Product (iii), new pack sizes of
                                         the Product and (iv) new indications of the Product.



 


		1.16.	Know-How
                                         means all information owned or controlled by a Party, as of the Effective Date or
                                         during the Term, that is related to the Product in the Field that is necessary or useful
                                         for the development, Manufacture or Commercialization of such Product in the Field. Know-How
                                         excludes any Information contained within a Party’s Patents.



 


		1.17.	Manufacture
                                         means all activities related to the manufacturing of a pharmaceutical product, or
                                         any ingredient thereof, including manufacturing of finished Product for Commercialization,
                                         labeling, packaging, in-process and finished Product testing, validation, process improvement,
                                         and process development, release of Product or any component or ingredient thereof, quality
                                         assurance activities related to manufacturing and release of Product, ongoing stability
                                         tests and regulatory activities related to any of the foregoing.



 


		1.18.	Marketing
                                         Authorization means any approval or authorization of any Regulatory Authority in
                                         a particular jurisdiction in the Territory that is necessary for the Manufacture, use,
                                         storage, import, transport and/or Commercialization of a product in such jurisdiction
                                         in accordance with applicable laws.



 


		1.19.	Net
                                         Sales means the gross amounts invoiced for sales of the Product in the Territory
                                         by Takeda or any Affiliate or sub-licensee of Takeda to third parties, less the following
                                         accrual-basis deductions to the extent applicable to such invoiced amounts, *** on shipment of the Product to the third
                                         party, including *** upon the sale of the Product; and ***; each of the above, as determined in accordance with IFRS standard.



 


If the Product is sold for consideration
other than cash, the Net Sales from such sale or transfer shall be deemed the then fair market value of the Product. For clarity,
Net Sales shall include sales of the Product made pursuant to a pre-license sales program (such as a named patient basis sales
program) before or after the First Commercial Sale of the Product. Nothing in this definition of “Net Sales” or elsewhere
in this Agreement shall prevent Takeda, its Affiliates or sublicensees from establishing resale prices for the Product in their
sole discretion.


 




    	3



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


		1.20.	Net
                                         Selling Price shall mean Net Sales of the Product on a per unit basis in a given
                                         period.



 


		1.21.	Packaging/Packaging
                                         means the process of packaging the bulk packaged Products and labelling Products
                                         in accordance with the specifications set out in the Quality Agreement.



 


		1.22.	Patent
                                         means (a) any patent, re-examination, reissue, renewal, extension, supplementary
                                         protection certificate and term restoration, any confirmation patent or registration
                                         patent or patent of addition based on any such patent, (b) any pending application for
                                         patents, including without limitation continuations, continuations-in-part, divisional,
                                         provisional and substitute applications, and inventors’ certificates, (c) all foreign
                                         counterparts of any of the foregoing, and (d) all priority applications of any of the
                                         foregoing.



 


		1.23.	Plan
                                         shall have the meaning as set forth in Section 13.5.



 


		1.24.	Product
                                         shall mean product(s) identified in Exhibit A.



 


		1.25.	Product
                                         Trademark shall mean the trademarks listed in Exhibit E.



 


		1.26.	Regulatory
                                         Authority means any applicable governmental authority involved in granting Marketing
                                         Authorization in a country or jurisdiction in the Territory, including without limitation,
                                         in the U.S., the FDA and any other applicable Governmental Authority in the U.S. having
                                         jurisdiction over the Product, and, in the European Union, the EMA and any other applicable
                                         governmental authority having jurisdiction over the Product.



 


		1.27.	Revised
                                         Floor Price shall have the meaning set forth in Section 5.2.



 


		1.28.	Specifications
                                         shall mean the specifications for the Product as set forth in Exhibit A, as the same
                                         may be modified or updated by Innocoll from time to time by written notice to Takeda.
                                         More detailed Specifications will be defined in the Quality Agreement.



 


		1.29.	Supply
                                         Price shall have the meaning set out in Section 5.



 


		1.30.	Tachosil
                                         Approval shall mean the approval by the Canadian Regulatory Authorities of the marketing
                                         authorization of Takeda’s haemostasis product Tachosil® in Canada.



 


		1.31.	Takeda
                                         Product Trademark shall have the meaning set out in Section 17.



 


		1.32.	Territory
                                         shall mean Canada, Russian Federation, Belarus, Ukraine, Moldova, Kazakhstan, Kyrgyzstan,
                                         Tajikistan, Uzbekistan, Turkmenistan, Azerbaijan, Armenia, Georgia and Mongolia, these
                                         last twelve (12) countries being hereinafter referred as to “CIS”.



 


		1.33.	Unit
                                         shall mean for the Product one (1) film which is individually packaged and sterilized.



 


		2.	Grant
                                         of License and Options



 


		2.1.	Innocoll
                                         hereby grants Takeda an exclusive license, ***, under the Innocoll Patents, the Innocoll
                                         Know-How, and the Product Trademarks for the following:



 


		(i)	to import, market, sell, advertise,
                                         promote, distribute, and otherwise Commercialize directly or through its Affiliates,
                                         the Product and the Line Extensions in the Field in the Territory;



 




    	4



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


		(ii)	storage of the Product and any Line
                                         Extensions outside the Territory, directly or through its Affiliates, for purpose of
                                         Commercialization in the Field in the Territory;



 


		(iii)	the import and transport of the
                                         Product and any Line Extensions into the Territory, directly or through its Affiliates,
                                         for purpose of Commercialization in the Field in the Territory; and



 


 


		(iv)	use of the Product and any Line
                                         Extensions for clinical trials and other pre-clinical and clinical activities worldwide,
                                         directly or through its Affiliates, for the purpose of Commercialization in the Field
                                         in the Territory.



 


Takeda hereby accepts such appointment.
To avoid any doubt, the Parties agree that Takeda may perform its obligations and enjoy its rights under this Agreement directly
or through its Affiliates.


 


		2.2.	Takeda
                                         has no obligation to Commercialize the Product in Canada before the granting of the Tachosil
                                         Approval. Takeda may however, at its sole discretion, decide to Commercialize the Product
                                         in Canada before such date of Tachosil Approval. Upon the granting of the Tachosil Approval,
                                         Takeda shall notify Innocoll within thirty (30) days in writing of its decision to Commercialize
                                         or not Commercialize the Product in Canada after the Tachosil Approval date (hereinafter
                                         to “Notify” or the “Notification”). If Takeda fails
                                         to Notify its decision within such thirty (30) days period, Innocoll shall have the right
                                         to terminate the Agreement for Canada as further stated in Section 22.7.



 


		2.3.	Innocoll
                                         covenants and agrees that during the Term, Innocoll will not enter into any such agreement
                                         or itself, directly or indirectly, Commercialize the Product or any Competing Product
                                         in the Territory in the Field. Takeda agrees that during the Term, Takeda will not, directly
                                         or indirectly, Commercialize a Competing Product in Canada for use as an adhesion barrier.



 


		2.4.	In
                                         the event Innocoll develops a Line Extension or an Improvement of the Product Innocoll
                                         shall notify Takeda in writing thereof. Following such notice, Takeda shall have the
                                         right to enter into exclusive good faith negotiations with Innocoll in respect of such
                                         Improvement Product(s) in the Territory by notifying Innocoll thereof in writing within
                                         *** from the date of such Innocoll’s notice (the “Right of First Negotiation”).
                                         Should Takeda fail to so notify Innocoll or should the Parties not enter into a mutually
                                         acceptable agreement within *** from the date of such Takeda’s notice, Innocoll
                                         shall be free to negotiate on commercializing of such Improvement Product(s) in the Territory
                                         through any third party pharmaceutical company or distributor.



 


		3.	License
                                         Fees and Initial Purchase



 


		3.1.	In the event Takeda Commercializes
                                         the Product in Canada after the Tachosil Approval, in consideration of the exclusive
                                         license granted for this country, Takeda shall pay to Innocoll a one-time milestone payment
                                         of ***, provided that the Marketing Authorization has been granted for the Product in
                                         Canada, such payment to be payable within fifteen (15) days upon receipt of the corresponding
                                         invoice. Innocoll shall communicate to Takeda a copy of the Marketing Authorization for
                                         the Product. The Parties shall confer within thirty (30) days if the indications of the
                                         Marketing Authorization granted for Canada are different from the indications granted
                                         by the Marketing Authorization for European Union or if such indications of the Product
                                         include severe restrictions which threaten the forecasts of Takeda for Canada. In such
                                         events, the one-time milestone before-mentioned will not be due to Innocoll and Takeda



 






    	5



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

 


shall not be obliged
to order Product according to the terms of Section 3.2. Furthermore, Takeda shall have the right to terminate the Agreement for
Canada according to the terms of Section 22.4 of this Agreement.


 


		3.2.	In
                                         addition to Section 3.1, Takeda shall purchase an initial quantity of Product for an
                                         amount of *** (the “Initial Purchase Quantity”) to be calculated as
                                         described in Section 5.1 and Exhibit B. The Initial Purchase Quantity shall be split
                                         up in quantities worth *** for Russia/CIS and *** for Canada. Payment for the Purchase
                                         of the Russian/CIS portion of the Initial Purchase Quantity, shall be due on the Effective
                                         Date and shall be made within thirty (30) days upon receipt of the invoice and this payment
                                         shall be a credit to be applied to the initial purchases of Product for Russia/CIS. The
                                         Initial Purchase Quantity for the Canadian portion shall be ordered by Takeda if it Commercializes
                                         the Product after Tachosil Approval and provided that the Marketing Authorization has
                                         been granted for the Product in Canada, and shall be paid within forty-five (45) days
                                         of the receipt of the corresponding invoice. For the avoidance of doubt, further to Section
                                         3.1, Takeda shall not be obliged to order any Product if the Marketing Authorization
                                         for Canada is granted to Innocoll with different(s) indication(s) or with severe restrictions
                                         compared to the conditions of the Marketing Authorization approved in European Union.



 


		4.	Manufacture
                                         and Supply of Product



 


		4.1.	Takeda
                                         shall place binding orders for Product by written or electronic purchase order to Innocoll.
                                         Innocoll shall acknowledge and accept or reject any Takeda purchase order in writing
                                         within five (5) business days of receipt. All such purchase orders shall be irrevocable.
                                         Purchase orders shall set forth the desired date of delivery with respect to the Product
                                         ordered and shall be placed at least ninety (90) days prior to such desired date of delivery.
                                         All Product ordered by Takeda under this Agreement shall be delivered on or before the
                                         delivery date set forth in the applicable purchase order.



 


		4.2.	Innocoll
                                         represents and warrants that the Products at the date of delivery of shall have a remaining
                                         shelf life of ***. Furthermore Innocoll represents and warrants that all
                                         Products supplied to Takeda or its appointee shall be Manufactured and Packaged in accordance
                                         with (i) the quality standards and testing methods of Innocoll and all laws and regulations
                                         applying at the place of Manufacture; (ii) cGMPs; (iii) the Quality Agreement and the
                                         Specifications; and (iv) any additional Manufacturing standards agreed in writing by
                                         the Parties.



 


		4.3.	Innocoll
                                         shall deliver the Product in finished packed form, inclusive of leaflet, ready for distribution,
                                         FCA (Incoterms 2010) premises of Innocoll in Saal, Germany and title shall pass to Takeda
                                         upon delivery effective according to the before mentioned FCA (Incoterms 2010). The Parties
                                         will cooperate to obtain the best commercial rates for shipping costs. All Products delivered
                                         by Innocoll shall be suitably packed and marked for shipment to such Takeda location
                                         as Takeda may designate. Innocoll shall ship all Products in accordance with the instructions
                                         specified in Takeda’s purchase orders. A Certificate of Analysis (“COA”)
                                         specific to testing of each lot/batch, must accompany each shipment. Innocoll shall maintain
                                         a copy of each such COA in compliance with cGMP/QSR. Innocoll shall provide a duplicate
                                         copy of the COA to Takeda, upon Takeda’s request.



 


		4.4.	Takeda
                                         shall have the right, at its sole discretion, to inspect each and every shipment of Product.
                                         Takeda shall have fifteen (15) days from receipt of each shipment of Product at its final
                                         destination to visually inspect the shipment (“Inspection Period”).
                                         Takeda may reject a shipment (or portion thereof) of Product if the Product fails to
                                         conform to the Specifications or in other ways is not suitable for sale, by providing
                                         Innocoll written notice



 




    	6



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


of such rejection
prior to the end of the Inspection Period. Takeda may then return all or a portion of the shipment of Product to Innocoll. In
addition to the foregoing, for any Product for which the defect identified by Takeda is a latent defect that could not reasonably
be detected upon visual inspection, Takeda shall have a period of forty-five (45) days from the date of identification of such
latent defect to return any such Product to Innocoll. Upon receipt of the non-conforming Product, Innocoll will make available
a replacement Product for shipment to Takeda.


 


		5.	Supply
                                         Price, Reconciliation and Additional Consideration



 


		5.1.	For
                                         the calculation of the prices for the Initial Purchase Quantity the Parties will use
                                         the Initial Floor Price.



 


		5.2.	Within
                                         18 (eighteen) months following the Effective Date the Parties will establish the supply
                                         price which will correspond to *** of the by then established Net Selling Price (“Supply
                                         Price”) and also agree on a new floor price lower than the “Supply Price”
                                         (the “Revised Floor Price)”.



 


		5.3.	In
                                         the event that Takeda purchases Products after the Initial Purchase Quantity (of Section
                                         3.2) but before the end of the eighteen (18) months period stated in Section 5.2 then
                                         the Initial Floor Price shall be used by the Parties for such purchase of Products.



 


With the exception of the Product quantities supplied under the Initial Purchase
Quantity and the Product purchased within the eighteen (18) months period stated in Section 5.2, all other Product supplied will be subject to an “Additional
Consideration Reconciliation”
on a quarterly basis as described in this Section 5.3.


 


		(a)	Within fifteen (15) days at the end
                                         of any subsequent quarter (March, June, September, December) Takeda shall calculate its
                                         actual Net Sales during such quarter and shall notify Innocoll of such actual amount,
                                         together with information necessary to calculate such actual Net Sales, including, but
                                         not limited to, the amount of Product sold and the price invoiced (on a unit by unit
                                         basis) in each part of the Territory.



 


		(b)	The difference between the Supply
                                         Price and *** of the actual Net Selling Price during relevant reconciliation period shall
                                         determine the reconciliation due from one Party to another.



 


		i.	If *** of the actual Net Selling
                                         Price exceeds the Supply Price for the relevant reconciliation period, Takeda shall pay
                                         to Innocoll the difference within thirty (30) days upon agreement of the Parties on the
                                         evaluation of such difference.



 


		ii.	If the Supply Price exceeds ***
                                         of the actual Net Selling Price during the relevant reconciliation period, Innocoll shall
                                         credit the difference against future orders of Product by Takeda under the Agreement.



 




    	7



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


For clarification, the Additional
Consideration Reconciliation shall be calculated as follows:


 


***


 


Under no circumstances shall Innocoll
receive less than the agreed Initial Floor Price or the Revised Floor Price, whichever is applicable.


 


		6.	Payment
                                         Terms



 


		6.1.	Payment
                                         for the Initial Purchase Quantities and the one-time Milestone payment for Canada will
                                         be due as per Sections 3.1 and 3.2. All other payments will be due as follows:



 


		6.2.	For
                                         Product shipments to Canada payment will be made in Euros and will be due within sixty
                                         (60) days after receipt of the proper invoice.



 


		6.3.	For
                                         Product shipments to Russia/CIS payment will be made in Euros and will be due within
                                         ninety (90) days after receipt of the proper invoice.



 


		6.4.	In
                                         the event that a Party should fail to make payment of any amount due and payable pursuant
                                         to this Agreement within the time periods provided for in this Agreement, interest shall
                                         accrue at a rate of interest of three percent (3%) above the average rate(s) of the European
                                         Inter-Bank Offering Rate (“EURIBOR”) for Euros, as quoted on the Reuters
                                         (or such other source as may be mutually agreed by the Parties) from time to time, effective
                                         for the applicable days of the period of default provided, that if such failure to pay
                                         continues for more than ten (10) days, the applicable rate(s) of interest shall be the
                                         applicable monthly average rate(s) of EURIBOR plus four percent (4%) for the entire period
                                         of default. The applicable EURIBOR period shall be the period closest to the period for
                                         which interest is calculated. In the event that any payment, or portion thereof, is disputed
                                         in good faith by a Party, any subsequent settlement payment related to that dispute shall
                                         not include interest thereon.



 


		6.5.	Any
                                         withholding or other taxes that either Party is required by applicable law to withhold
                                         or pay on behalf of the other Party, with respect to any payments to such other Party
                                         hereunder, shall be deducted from such payments and paid to the appropriate tax authority
                                         contemporaneously with the remittance to the other Party, provided, however, that the
                                         withholding Party shall furnish the other Party with proper evidence of the taxes so
                                         paid. Each Party shall cooperate with the other and furnish the other Party with appropriate
                                         documents to secure application of the most favorable rate of withholding tax under applicable
                                         law (or exemption from such withholding tax payments, as applicable).



 


		7.	Minimum
                                         Requirements



 


		7.1.	*** Takeda and Innocoll shall negotiate
                                         in good faith and agree the minimum annual purchase requirements for the remainder of
                                         the Term of the Agreement (“Minimum Purchase Order Requirements”).



 




    	8



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


		8.	***



 


		8.1.	Innocoll will provide additional quantities of
Product *** equivalent to *** at the Initial Floor Price *** at Takeda’s request. Takeda will specify the required quantities by SKU for Canada and Russia with six (6) months notice.



 


		9.	Duties
                                         to inform



 


		9.1.	The
                                         Parties shall cooperate to keep each Party informed of notification of any action by,
                                         or notification or other information which it receives (directly or indirectly) from
                                         a Regulatory Authority in the Territory, (i) which raises any material concerns regarding
                                         the safety or efficacy of the Product, (ii) which indicates or suggests a potential material
                                         liability for either Party to Third Parties arising in connection with the Product, or
                                         (iii) which is reasonably likely to lead to a Recall or market withdrawal of the
                                         Product. Subject always to applicable laws and regulations, neither Party shall be obliged
                                         to disclose such information in breach of any contractual restriction which it could
                                         not reasonably have avoided.



 


		10.	Product
                                         Recall



 


		10.1.	Takeda
                                         shall be responsible for any batch recall of Products from the market and co-ordinate
                                         the same. In the event any governmental authority or agency requests a recall or takes
                                         similar action in connection with the Products, or in the event that Takeda determines
                                         an event or incident has occurred which may result in the need for a recall or a market
                                         withdrawal, Takeda will inform Innocoll by telephone or email within twenty-four (24)
                                         hours and the parties shall agree on an appropriate course of action. Innocoll shall
                                         bear the expense of any recall resulting from breach of its representation, warranties
                                         or obligations hereunder or from negligent manufacture, packaging or shipment of the
                                         Products by it. In the event the recall results from the material breach of Takeda then
                                         Takeda shall bear the expense of any recall or market withdrawal. For the purposes of
                                         this Agreement, the expenses of the recall shall be the expenses of notification and
                                         destruction or return of the recalled Products, as well as any reasonable out-of-pocket
                                         costs incurred by the Parties in connection with any corrective action taken by either
                                         Party.



 


		11.	Auditing



 


		11.1.	During
                                         normal business hours, Innocoll shall provide access to its premises to Takeda to permit
                                         audits of the relevant documents and facilities by Takeda. Takeda shall be entitled to
                                         one (1) audit per facility within each twelve (12) month period during the term of the
                                         Agreement. In connection with such audit, Takeda’s representatives shall be required
                                         to execute a confidentiality agreement with Innocoll.



 


		11.2.	Innocoll
                                         will ensure that any material deficiencies highlighted during any audit by Takeda or
                                         Regulatory Authorities will be dealt with as soon as is practically possible following
                                         receipt of an official signed audit report from Takeda.



 


		12.	Quality
                                         Agreement and Pharmacovigilance Agreement



 


		12.1.	The
                                         Parties shall negotiate and enter into a Quality Agreement and a Pharmacovigilance Agreement
                                         within ninety (90) days of the Effective Date.



 




    	9



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


		13.	Commercialization
                                         of Product



 


		13.1.	Launch
                                         of the Product:



 


		13.1.1.	Takeda
                                         shall use Commercial Reasonable Efforts to launch the Product within six (6) months after
                                         the Effective Date in Russia, provided that the Product has been delivered to Takeda
                                         and that Takeda has obtained all necessary regulatory documents to Commercialize the
                                         Product in Russia.



 


		13.1.2.	In
                                         Canada, according to Section 2.2, the Commercialization of the Product shall be an option
                                         for Takeda. Takeda shall be the sole decision maker regarding the launch of the Product
                                         in Canada.



 


		13.1.2.1.	Before
                                         the date of Tachosil Approval, Takeda shall have the right but not the obligation to
                                         Commercialize the Product in Canada.



 


		13.1.2.2.	In
                                         accordance with Section 2.2, after the date of Tachosil Approval, Takeda shall Notify
                                         Innocoll of its decision to Commercialize the Product in Canada. In the event Takeda
                                         decides to Commercialize the Product in Canada, Takeda shall use Commercial Reasonable
                                         Efforts to launch the Product within eight (8) months as of the date of the Notification.
                                         If Takeda decides not to launch the Product in Canada the Agreement shall terminate automatically
                                         for this country.



 


		13.1.3.	If
                                         Takeda fails to launch the Product within the timelines agreed according to this Agreement
                                         or according to any further agreement by the Parties, Innocoll will have the right to
                                         terminate the Agreement on a country by country basis. Innocoll acknowledges that in
                                         Russia, laws and regulations applicable to the regulatory process related to the Marketing
                                         Authorization may change and result in modifications of the conditions and of the timelines
                                         for approvals. Therefore, in Russia, Takeda will be considered as having received from
                                         Innocoll the Marketing Authorization documents solely upon effective and tangible receipt
                                         of any and all documents required and necessary to Commercialize the Product in this
                                         country.



 


		13.2.	Takeda
                                         shall provide, at its own expense, all staff and facilities necessary for the operation
                                         of the distributorship and the fulfilment of the terms of this Agreement.



 


		13.3.	Takeda
                                         shall handle and store the Products securely and with all due skill care and attention
                                         and shall not take any step to alter the condition of any of the Products from that in
                                         which the Products are delivered by Innocoll.



 


		13.4.	At
                                         the reasonable request of Innocoll, Takeda shall receive employees and representatives
                                         of Innocoll and shall render to them all reasonable facilities for investigating conditions
                                         of trade and to visit customers in the Territory. Each Party shall bear their own costs
                                         relating to such visits.



 


		13.5.	Takeda
                                         shall on or before January 31st of each year in good faith prepare and submit
                                         to Innocoll for its review, a detailed marketing plan (“the Plan”)
                                         for the Commercialization of the Product for the immediately succeeding calendar year,
                                         provided that Takeda hall have final decision making authority with respect to any decision
                                         regarding the Plan.



 


		13.5.1.	Takeda
                                         shall use all Commercially Reasonable Efforts to ensure that it conforms to the Plan
                                         during the relevant Fiscal Year.



 




    	10



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


		13.5.2.	Takeda
                                         shall keep Innocoll informed of competition experienced in the Territory and when so
                                         requested by Innocoll provide information on marketing activities and competitive products
                                         in the Territory.



 


		13.5.3.	Takeda
                                         shall prepare all advertising, promotional and marketing material for the Product and
                                         communicate in advance the key advertising, promotional and marketing material for the
                                         Product, in original language, to Innocoll for information. Takeda shall produce all
                                         such material at Takeda’s expense.



 


		13.6.	Innocoll
                                         shall share with Takeda any and all marketing and medical data or material that Innocoll
                                         owns or controls and has the right to disclose to Takeda.



 


		13.7.	Each
                                         Party shall, at its own expense, procure and maintain during the Term and for a period
                                         of five (5) years thereafter, insurance policy/policies, including product liability
                                         insurance, adequate to cover its obligations hereunder and which are consistent with
                                         normal business practices of prudent companies similarly situated. Such insurance shall
                                         not be construed to create a limit of a Party’s liability with respect to its indemnification
                                         obligations. Each Party shall provide the other Party with written evidence of such insurance
                                         or self-insurance upon request. Each Party shall provide the other Party with prompt
                                         written notice of cancellation, non-renewal or material change in such insurance or self-insurance
                                         that could materially adversely affect the rights of such other Party hereunder, and
                                         shall provide such notice within thirty (30) days after any such cancellation, non renewal
                                         or material change.



 


		14.	Regulatory
                                         Matters, Changes



 


		14.1.	Canada
                                         and Russia



 


Innocoll shall be responsible for
applying for and maintaining the Marketing Authorizations for the Product in Canada and Russia at its own cost and expense. These
Marketing Authorizations shall be owned by Innocoll in its own name. Within five (5) business days as from the receipt by
Innocoll of the approval of Marketing Authorizations, Innocoll shall inform Takeda of such approval and will communicate a copy
of the Marketing Authorizations to Takeda. In particular, Innocoll shall obtain and send to Takeda the documents necessary for
the customs clearance of the Product in Russia and in Canada. To avoid any doubt, as specified in Section 13.1, Takeda will be
considered for Russia as having received from Innocoll the Marketing Authorization solely upon effective and tangible receipt
of any and all documents required and necessary to Commercialize the Product in the country.


 


Following the approval of the Marketing
Authorization in Canada and Russia, Innocoll shall be solely responsible for any communications with the Regulatory Authorities
occurring or required in connection with obtaining or maintaining any Marketing Authorization for the Product.


 


		14.2.	Other
                                         countries in the Territory



 


Takeda, may apply for and maintain
the Marketing Authorizations for the Product in other countries of the Territory at its own cost and expense. These Marketing
Authorizations shall be owned by Takeda in its own name. In case Innocoll requires a translation into English of the regulatory
dossiers of such Marketing Authorizations, the costs of translation shall be solely borne by Innocoll.


 




    	11



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


Following the approval of the Marketing
Authorization in countries of the Territory other than Canada and Russia, Takeda shall be solely responsible for any communications
with the Regulatory Authorities occurring or required in connection with obtaining or maintaining any Marketing Authorization
for the Product.


 


		14.3.	Innocoll
                                         shall comply with all laws, rules and regulations applicable to the design, Manufacture,
                                         labelling, Packaging, storage and handling of the Product for sale in the Territory,
                                         including maintaining qualified manufacturing and quality facilities and/or procedures.
                                         Innocoll shall ensure that all third-party manufacturers of any raw materials for the
                                         Product comply in all material respects with all laws, rules and regulations applicable
                                         to the design, manufacture, labelling and packaging of the Product for sale in the Territory.
                                         Without limiting the generality of the foregoing, Innocoll (and all third-party manufacturers
                                         of any raw materials for Product) shall implement such quality control systems and procedures
                                         as shall be appropriate to ensure compliance with the requirements of ISO and cGMP/QSR,
                                         which are applicable to Innocoll or such third-party manufacturer as the manufacturer
                                         and supplier of the Product. Innocoll shall allow reasonable access to its records, manufacturing
                                         facilities, and its third-party manufacturers’ manufacturing facilities and records
                                         (if applicable) to allow any Regulatory Authority to conduct full compliance audits or
                                         inspections relating to the Product. Innocoll and any third party manufacturer shall
                                         ensure that the Products are manufactured in strict compliance with the Specifications.



 


		14.4.	Innocoll
                                         shall only after written approval by Takeda, such approval not to be unreasonably withheld
                                         or delayed, implement any changes to the Product and/or its Specifications that are required
                                         by law or by medical or scientific concerns in a country of the Territory as to the toxicity,
                                         safety and/or efficacy of the Product (collectively, “Required Changes”)
                                         in accordance with the change control procedure set forth in the Quality Agreement. For
                                         changes to the Product and/or its Specifications that are not Required Changes (collectively,
                                         “Discretionary Changes”) Innocoll shall notify Takeda in advance of
                                         such Discretionary Changes in order to obtain Takeda’s prior written approval,
                                         such approval not to be unreasonably withheld or delayed, in accordance with the change
                                         control process to be established under the Quality Agreement. Innocoll shall implement
                                         any such change only upon prior coordination with Takeda.



 


		14.5.	All
                                         costs and expenses associated with Required Changes shall be paid for by the Marketing
                                         Authorization holder, and all costs and expenses associated with Discretionary Changes
                                         shall be borne by the Party requesting such change, provided, however, that if a Discretionary
                                         Change is supported by both Parties and is foreseen to improve the commercial viability
                                         of a Product in the Territory, the costs of such Discretionary Change shall be shared
                                         equally between the Parties. Costs associated with changes by Innocoll in order to optimize
                                         the Manufacturing process of the Product (but which do not otherwise improve the commercial
                                         viability of a Product), shall be borne by Innocoll. All costs which are not fees to
                                         be paid to the Regulatory Authorities shall be subject to prior agreement between the
                                         Parties.



 


		15.	Confidentiality
                                         Obligations



 


		15.1.	Each
                                         Party agrees to maintain during the term of this Agreement and for a period of ***
                                         years thereafter the strictest confidence with regard to the confidential and/or proprietary
                                         information, in whatever medium, relating to the Product and its Manufacture, and any
                                         other information disclosed to it under this Agreement by the other Party and proprietary
                                         to it or its Affiliates or any third party contract partners (the “Confidential
                                         Information”). Neither Party shall directly nor indirectly pass on the Confidential
                                         Information to third parties nor use it for any purpose not mentioned in this Agreement.
                                         Each Party shall have the right to disclose the other Party’s Confidential Information
                                         to its 



 




    	12



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

 


employees or advisors who need this knowledge for the purposes authorized herein.
                                         To the extent that a Party discloses Confidential Information to an employee or advisor,
                                         such Party will be responsible for any failure by such persons or entities to hold such
                                         information in confidence or use such information solely for the purposes of this Agreement.


 


		15.2.	The
                                         obligations of confidentiality and use restrictions set forth herein above will not apply
                                         to the following information:



 


		15.2.1.	information
                                         that is or becomes publicly known or available by publication, commercial use or otherwise
                                         without breach of this Agreement by the receiving Party;



 


		15.2.2.	information
                                         that the receiving Party rightfully receives from a third party without a restriction
                                         on disclosure;



 


		15.2.3.	information
                                         that must be disclosed pursuant to governmental and regulatory requirements (including
                                         Certification Audits);



 


		15.2.4.	information
                                         that is independently developed by employees of the receiving Party who have not had
                                         access to the Confidential Information; or



 


		15.2.5.	information
                                         that is known by the receiving Party at the time of receipt, as demonstrated by its business
                                         records.



 


		16.	Proprietary
                                         Rights



 


		16.1.	All
                                         manufacturing and technical data, instructions, specifications and experiences regarding
                                         the Product as well as test methods developed or documented in the Specifications (“Innocoll
                                         Know-How”) is owned by Innocoll. Takeda shall have a limited, royalty-free
                                         license to use the Innocoll Know-How in accordance with and for the term of this Agreement.



 


		16.2.	Innocoll
                                         represents and warrants that the Product, Innocoll’s Manufacturing methods used
                                         for Manufacturing the Product, and use of the Product do not infringe any third party’s
                                         proprietary rights. Innocoll will indemnify and hold harmless Takeda for any and all
                                         claims arising out of or based on claims related to third party intellectual property
                                         rights relating to the Product, or use or Manufacture thereof.



 


		17.	Trademark



 


		17.1.	Innocoll
                                         shall at its own cost and expense be solely responsible for the filing, prosecution,
                                         maintenance and renewal of the Product Trademarks in the Territory. Innocoll shall keep
                                         Takeda promptly informed of all filings made for Product Trademarks including sending
                                         Takeda a copy of any such filing and otherwise shall keep Takeda informed of all material
                                         developments in relation to the Product Trademarks.



 


		17.2.	Neither
                                         Innocoll nor any Affiliate of Innocoll shall use the Product Trademark in the Territory
                                         or grant a license to a third party under the Product Trademark in the Territory during
                                         the Term or upon its transfer to Takeda in accordance with Section 22.14 below.



 


		17.3.	Should
                                         the Regulatory Authorities in a country of the Territory object to the Product Trademark
                                         set out in Exhibit E or should any application for registration of the Product Trademarks
                                         in any country of the Territory be withdrawn or be refused, Innocoll and Takeda shall
                                         consult and agree as to which alternative trademark or name shall be used.



 




    	13



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


		17.4.	In
                                         those countries of the Territory where registration of the Product Trademark has not
                                         been obtained by Innocoll at the Effective Date of this Agreement, Takeda shall have
                                         the right but not the obligation to Commercialize the Product under its own trademark
                                         (hereinafter “Takeda Product Trademark”). Such Takeda Product Trademark
                                         shall remain the exclusive property of Takeda or any Affiliate of Takeda during and after
                                         the term of this Agreement. Innocoll acknowledges that nothing in this Agreement shall
                                         confer to Innocoll any right, title or interest in any Takeda Product Trademark under
                                         which Takeda will Commercialize the Product in the Territory.



 


		17.5.	Throughout
                                         the term of this Agreement and thereafter, Innocoll shall not adopt, use, register or
                                         attempt to register anywhere in the world any trademark, trade name, domain name, or
                                         similar commercial symbol which includes any part of the Takeda Product Trademark or
                                         is confusingly similar with the Takeda Product Trademark.



 


		17.6.	Innocoll
                                         warrants and represents that, as the Effective Date, (i) Innocoll has filed for registration
                                         of the Product Trademark and (ii) Innocoll has the authority and is entitled to license
                                         the Product Trademark and (iii) Innocoll has no knowledge of any third party’s
                                         right in the Territory which could prevent Takeda from Commercializing the Product under
                                         the Product Trademark.



 


		17.7.	Both
                                         Parties agree to notify each other in writing of any known or suspected conflicting use
                                         of any of the Takeda Product Trademark(s) or Product Trademark, and the application for
                                         registration or use of trademarks confusingly similar thereto, or of any known or suspected
                                         infringements or of unfair competition involving the Takeda Product Trademark(s) or Product
                                         Trademark in the Territory, promptly after it acquires knowledge thereof. Each Party
                                         shall be responsible for the defence of their Takeda Product Trademark(s) or Product
                                         Trademark and will use commercially reasonable efforts to defend their Takeda Product
                                         Trademark(s) or Product Trademark. At the reasonable request of one Party, the other
                                         Party shall cooperate with the other Party and render the other Party its commercially
                                         reasonable assistance in the defence of the Takeda Product Trademark(s) or Product Trademark,
                                         subject to reimbursement of the related out-of-pocket expenses of the assisting Party.
                                         Any damages and costs recovered shall be for the sole benefit of the owner of the Takeda
                                         Product Trademark(s) or Product Trademark.



 


		17.8.	In
                                         the event of a determination by final court decision or under a definitive settlement
                                         by Innocoll that the Commercialization of Product in the Territory, on account of the
                                         use of a Product Trademark, infringes the trademark rights of a third party in the Territory,
                                         then, Inncoll shall: (a) indemnify and hold Takeda harmless against any such third party
                                         claim or proceeding above brought against Takeda, including damages and reasonable attorney’s
                                         fees; provided, however, that any obligation to indemnify shall be excluded if Takeda
                                         fails to promptly notify Innocoll of the assertion of any such claims; (b) At Inncoll’s
                                         option, finance the re-packaging operation or, if necessary, replace, free of charge,
                                         all Products in stock at Takeda that are no longer saleable on account of the infringement
                                         of a third party trademark.



 


		18.	Patents



 


		18.1.	Patent
                                         Prosecution and Maintenance: Innocoll shall use Commercially Reasonable Efforts to
                                         prosecute and maintain the Innocoll Patents.



 


		18.2.	Defense
                                         of Third Party Infringement Claims: If Takeda or Innocoll is threatened with suit
                                         or sued by a third party for intellectual property infringement because of activities
                                         in connection with the Product, the Party which has been threatened with suit or sued
                                         shall promptly notify the other Party in writing of such event. In the case of an actual
                                         suit, Takeda shall have first right to take the lead for controlling the defense of the
                                         suit, 



 






    	14



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

 


	 	 	however if Takeda chooses not to take the lead then Innocoll shall have the right
                                         to take the lead. In either case, the non-controlling Party shall provide the controlling
                                         Party with reasonable co-operation and technical support (including access to technical
                                         experts at the controlling Party’s sole cost and expense) to allow the controlling
                                         Party to take the lead in defense of the suit. In the case of an actual suit, the Parties
                                         shall jointly obtain an opinion of counsel as to the merits of such suit and agree to
                                         take reasonable actions to mitigate potential damages from any such suit. The Parties
                                         acknowledge and agree, however, that no settlement, consent judgment or other voluntary
                                         final disposition of any suit may be entered into without the prior written consent of
                                         the non-threatened or non-sued Party, which consent shall not be unreasonably withheld
                                         or delayed. Each Party agrees that the Party shall cooperate with the other Party in
                                         defending the suit, even if not a party to the suit, and shall join the suit if deemed
                                         a necessary party. Takeda shall not enter into any settlement of any claim described
                                         in this Section that adversely affects Innocoll’s rights or interests without Innocoll’s
                                         consent. Each Party shall bear its own costs and expenses incurred in defending such
                                         actions. The Parties shall also cooperate in good faith to determine a commercially reasonable
                                         strategy for resolving such issue, which shall include, without limitation, obtaining
                                         a license under such third party intellectual property right by Innocoll (with the right
                                         to sublicense such license to Takeda).



 


		18.3.	Enforcement:
                                         Subject to the provisions of this Section, in the event that Takeda reasonably believes
                                         that any Innocoll Patent that claims the Product for the Field in the Territory is being
                                         infringed by a third party or is subject to a declaratory judgment action arising from
                                         such infringement, Takeda shall notify Innocoll. In such event, Innocoll shall have the
                                         initial right (but not the obligation) to enforce such Innocoll Patents with respect
                                         to the Product, or to defend any declaratory judgment action with respect thereto at
                                         its own expense (an “Enforcement Action”).



 


		18.4.	Recoveries:
                                         Any recovery or award received as a result of any Enforcement Action under Section 18.3
                                         or Infringement Action under Section 18.2 shall be used first to reimburse the Parties
                                         for the costs and expenses (including attorneys’ and professional fees) incurred
                                         in connection with such Action, and the remainder of the recovery shall be shared equally
                                         between the Parties.



 


		18.5.	Consultation:
                                         The Party assuming the lead role in the Enforcement Action (the “Controlling
                                         Party”) shall consult with the non-Controlling Party on all material aspects
                                         of the enforcement. The non-Controlling Party shall have a reasonable opportunity for
                                         meaningful participation in decision-making and formulation of strategy. The Parties
                                         shall reasonably cooperate with each other in all such actions or proceedings.



 


		19.	Registration
                                         of intellectual property licence



 


Where any intellectual property
licence granted under this Agreement is required to be registered or recorded at a national Intellectual Property office in order
to be effective and/or enforceable, the Parties shall cooperate in good faith to register/record at the earliest possible opportunity,
and shall execute all documents required for the same.


 


		20.	Representations
                                         and Warranties



 


		20.1.	Innocoll
                                         represents and warrants that, as of the time of delivery by Innocoll to Takeda of the
                                         Products in accordance with this Agreement, all Products will be free of defects in design,
                                         material and workmanship and conform to the Specifications.



 


		20.2.	Innocoll
                                         represents and warrants that the Products at the date of delivery shall have a remaining
                                         shelf life of ***. Furthermore Innocoll represents and warrants



 




    	15



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


that all Products
supplied to Takeda or its appointee shall be Manufactured and Packaged in accordance with (i) the quality standards and testing
methods of Innocoll and all laws and regulations applying at the place of Manufacture; (ii) cGMPs; (iii) the Quality Agreement
and the Specifications; and (iv) any additional Manufacturing standards agreed in writing by the Parties.


 


		20.3.	Innocoll
                                         shall be responsible for all claims related to the Product to the extent arising from
                                         (a) a material breach of this Agreement by Innocoll including a material breach of the
                                         warranty set forth in Sections 20.1 and 20.2, or (b) material breach of any law or regulation
                                         (that Innocoll is required to comply with hereunder) by Innocoll. Takeda shall be responsible
                                         for all claims related to the Product to the extent arising from: (a) the negligence
                                         or misconduct of Takeda in the marketing and promotion of the Product, (b) material
                                         breach of this Agreement by Takeda or (c) material breach of any law or regulation (that
                                         Takeda is required to comply with hereunder) by Takeda.



 


		20.4.	Except
                                         for those warranties expressly set forth in Sections 16.2, 17, 20.1 and 20.2 of this
                                         Agreement, Innocoll makes no warranties, written, oral, express or implied, with respect
                                         to the Product or the production of the Product. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
                                         INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS
                                         FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT HEREBY ARE DISCLAIMED. NO WARRANTIES OF
                                         INNOCOLL MAY BE CHANGED BY ANY REPRESENTATIVES OF INNOCOLL EXCEPT IN A WRITING SIGNED
                                         BY INNOCOLL.



 


		21.	Indemnification



 


		21.1.	Innocoll
                                         agrees to indemnify, defend and hold harmless Takeda from and against any claims, losses,
                                         damages, liabilities, causes of action, suits, costs and expenses, including all reasonable
                                         attorneys’ fees and disbursements of counsel, incurred by Takeda in connection
                                         with any third party claims to the extent arising out of or relating to (i) any material
                                         breach by Innocoll of its representations, warranties, covenants and agreements under
                                         this Agreement, (ii) the Manufacture, use handling storage, and other disposition of
                                         the Product by Innocoll or its Affiliates and (ii) actions, suits or proceedings alleging
                                         personal injury or death, including any product liability claims, or any damage to any
                                         property only to the extent it is claimed that the personal injury, death or property
                                         damage was caused by the failure of the Product to conform to the Specifications at the
                                         time of delivery to Takeda under this Agreement, except to the extent resulting from
                                         the negligence or willful misconduct of, or material breach of this Agreement by Takeda
                                         which directly results in the alleged injury.



 


		21.2.	Takeda
                                         agrees to indemnify, defend and hold harmless Innocoll from and against any claims, losses,
                                         damages, liabilities, causes of action, suits, costs and expenses, including all reasonable
                                         attorneys’ fees and disbursements of counsel, incurred by Innocoll in connection
                                         with any third party claims to the extent arising out of or relating to (i) any material
                                         breach by Takeda of its representations, warranties, covenants and agreements under this
                                         Agreement, and (ii) actions, suits or proceedings arising from or relating to the marketing’s,
                                         promotion, sale, handling or distribution by Takeda or its sub-distributors or sub-licensees
                                         of the Product except with respect to patent infringement actions.



 


		21.3.	Whenever
                                         any indemnification claim arises under this Agreement, the Party seeking indemnification
                                         (the “Indemnified Party”) shall promptly notify the other Party (the
                                         “Indemnifying Party”) of the claim and, when known, the facts constituting
                                         the basis of such claim; provided, however, that failure to give such notice shall not
                                         relieve the Indemnifying Party of its obligation hereunder unless and to the extent that
                                         such failure substantially prejudices the Indemnifying Party.



 




    	16



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


		21.4.	In
                                         the event of a third-party claim giving rise to indemnification hereunder, the Indemnifying
                                         Party may, upon prior written notice to the Indemnified Party, assume the defense of
                                         such claim with counsel reasonably satisfactory to the Indemnified Party, and shall thereafter
                                         be liable for all expenses incurred in connection with such defense, including attorneys’
                                         fees and expenses; provided, however, that if the Indemnifying Party assumes the defense
                                         of any such claim, the Indemnified Party may participate in such defense at its own expense
                                         and with counsel of its choice; provided further, however, that if there are one or more
                                         legal defenses available to the Indemnified Party that conflict with those available
                                         to the Indemnifying Party or there exists any other conflict of interest, the Indemnifying
                                         Party shall not have the right to assume the defense of such claim but the Indemnified
                                         Party shall have the right to employ separate counsel at the expense of the Indemnifying
                                         Party and to participate in the defense thereof. If the Indemnifying Party elects to
                                         control the defense of such claim, it shall do so diligently and shall have the right
                                         to settle any claim for monetary damages, provided such settlement includes a complete
                                         and absolute release of the Indemnified Party and shall not admit any fault or liability
                                         on the part of the Indemnified Party. Notwithstanding anything to the contrary, the Indemnifying
                                         Party may not settle any claims for fines, penalties or the like or in any way adverse
                                         to the Indemnified Party without the prior written consent of the Indemnified Party,
                                         which shall not unreasonably be withheld or delayed.



 


		21.5.	IN
                                         NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL,
                                         PUNITIVE, EXEMPLARY, COLLATERAL OR INCIDENTAL DAMAGES, HOWEVER CAUSED AND BASED ON ANY
                                         THEORY OF LIABILITY, ARISING OUT OF THIS AGREEMENT, AND WHETHER OR NOT THE OTHER PARTY
                                         HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THIS LIMITATION SHALL APPLY NOTWITHSTANDING
                                         ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY PROVIDED FOR HEREIN. THE PARTIES
                                         AGREE, HOWEVER, NONE OF THE FOREGOING LIMITATIONS OF THIS SECTION 21.5 APPLY TO
                                         ANY AMOUNTS PAID OR PAYABLE DUE TO ANY THIRD-PARTY RELATED CLAIM, DEMAND, PROCEEDING,
                                         SUIT OR ACTION FOR WHICH A PARTY IS OBLIGATED TO INDEMNIFY THE OTHER PARTY PURSUANT TO
                                         SECTION 21.1 OR SECTION 21.2, AND ANY SUCH AMOUNTS WILL BE CONSIDERED COMPENSATORY OR
                                         DIRECT DAMAGES AND NOT INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE, EXEMPLARY, COLLATERAL
                                         OR INCIDENTAL DAMAGES.



 


		22.	Term
                                         and Termination



 


		22.1.	This
                                         Agreement shall become effective on the Effective Date and shall continue in full force
                                         and effect for fifteen (15) years following First Commercial Sale on a country-by-country
                                         basis. Thereafter, this Agreement shall automatically renew for additional five (5) year
                                         periods on a country by country basis (each a “Renewal Term”) unless
                                         (a) written notice of non-renewal is provided by either Party to the other at least
                                         twelve (12) months in advance of the expiration of this Agreement or the applicable Renewal
                                         Term, or (b) the Agreement is terminated sooner as permitted hereunder. Provided this
                                         Agreement is renewed for one (1) Renewal Term, Takeda will have the right to acquire
                                         all Product rights, title and interest as per Section 22.12.



 


		22.2.	Either
                                         Party (the “Non-Breaching Party”) may terminate this Agreement in
                                         its entirety, or on an country-by-country basis, in the event the other Party (the “Breaching
                                         Party”) has materially breached this Agreement, and such material breach has
                                         not been cured within thirty (30) days after receipt of written notice of such breach
                                         by the Breaching Party from the Non-Breaching Party (the “Cure Period”).
                                         The written notice describing the alleged material breach shall provide sufficient detail
                                         to put the Breaching Party on notice of such material breach. Any termination of this
                                         Agreement pursuant to this Section shall become effective at the end of the Cure Period,
                                         unless the Breaching Party has cured 



 




    	17



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

 


any such material breach prior to the expiration
                                         of such Cure Period, The right of either Party to terminate this Agreement as provided
                                         in this Section shall not be affected in any way by such Party’s waiver or failure
                                         to take action with respect to any previous breach under this Agreement.


 


		22.3.	Termination
                                         by Takeda for Safety Reasons. Takeda shall have the right to terminate this entire
                                         Agreement with respect to a Product in the Territory at any time upon providing thirty
                                         (30) days prior written notice to Licensor (i) if senior executives responsible for Takeda’s
                                         Pharmacovigilance and Clinical Science functions determine in good faith and in consideration
                                         of Commercially Reasonable Efforts that the risk/benefit profile of the Product is such
                                         that the Product cannot continue to be administered to patients safely; or (ii) upon
                                         the occurrence of serious adverse events related to the use of the Product that cause
                                         Takeda to conclude that the continued use of the Product by patients will result in patients
                                         being exposed to a product in which the risks outweigh the benefits.



 


		22.4.	Termination
                                         by Takeda in the event the approval of indications of the Marketing Authorization in
                                         Canada is different from the indications granted by the Marketing Authorization for European
                                         Union or in the event such indications for the Product include severe restrictions which
                                         threaten the forecasts of Takeda for Canada. In this case, Takeda shall have the
                                         right to terminate immediately the Agreement for Canada with thirty (30) days prior written
                                         notice.



 


		22.5.	Termination
                                         for Bankruptcy. Either Party may terminate this Agreement in its entirety upon providing
                                         written notice to the other Party on or after the time that such other Party makes a
                                         general assignment for the benefit of creditors, files an insolvency petition in bankruptcy,
                                         petitions for or acquiesces in the appointment of any receiver, trustee or similar officer
                                         to liquidate or conserve its business or any substantial part of its assets, commences
                                         under the laws of any jurisdiction any proceeding involving its insolvency, bankruptcy,
                                         reorganization, adjustment of debt, dissolution, liquidation or any other similar proceeding
                                         for the release of financially distressed debtors, or becomes a party to any proceeding
                                         or action of the type described above, and such proceeding or action remains un-dismissed
                                         or un-stayed for a period of more than seven (7) calendar days.



 


		22.5.1.	Without
                                         prejudice to the generality of the foregoing clause 22.5, Takeda may terminate this Agreement
                                         in whole or in part with immediate effect (and for the avoidance of doubt, without incurring
                                         any liability or charges for such termination) by giving written notice to Innocoll if
                                         any of the following occurs or is threatened to occur:



 


		22.5.1.1.	If
                                         Innocoll is or becomes insolvent or unable to pay its debts within the meaning of Section
                                         214 of the Companies Act 1963 (as amended) or suspends or threatens to suspend making
                                         payments with respect to all or any class of its debts;



 


		22.5.1.2.	an
                                         order has been made, petition presented, resolution passed or meeting convened for the
                                         winding up of, or making of any administration order for, Innocoll;



 


		22.5.1.3.	a
                                         receiver or examiner has been appointed over the whole or any part of the property, assets
                                         or undertaking of Innocoll;



 


		22.5.1.4.	a
                                         composition in satisfaction of debts, scheme of arrangement, or compromise or arrangement
                                         with creditors or members (or any class of creditors or members) has been proposed, sanctioned
                                         or approved in relation to Innocoll;



 




    	18



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    




 


		22.5.1.5.	Innocoll
                                         is or becomes related to any other company for the purpose of Section 140 of the Companies
                                         Act 1990 (as amended), is or becomes liable to an order made under that section by virtue
                                         of any act (whether of commission or omission); or



 


		22.5.1.6.	an
                                         encumbrancer takes possession of, or a trustee or administrative receiver or similar
                                         officer is appointed in respect of, all or any part of the business or assets of innocoll,
                                         or distress or any form of execution is levied or enforced upon or sued out against any
                                         such assets and is not discharged within seven (7) calendar days of being levied, enforced
                                         or sued out.



 


		22.6.	If
                                         Takeda Notifies innocoll under Section 3.2 that it decides not to Commercialize or not
                                         to continue Commercialization of the Product in Canada after Tachosil Approval, the Agreement
                                         shall terminate automatically for Canada with immediate effect, without any compensation
                                         due to Innocoll.



 


		22.7.	If
                                         Takeda has failed to Notify Innocoll as further stated in Section 2.2, then Innocoll
                                         shall have the right to terminate the Agreement for Canada by written notice with immediate
                                         effect without any compensation due to Innocoll, such termination notice however to be
                                         provided not later than ninety (90) days after the Tachosil Approval date.



 


		22.8.	All
                                         of the following effects of termination are in addition to the other rights and remedies
                                         that may be available to either of the Parties under this Agreement and shall not be
                                         construed to limit any such rights or remedies. In the event this Agreement is not terminated
                                         in its entirety, but rather is terminated on a country-by-country basis (the “Terminated
                                         Country”), then, the consequences of termination described under this Section
                                         22 shall only apply to the Terminated Country, and this Agreement shall remain in full
                                         force and effect in accordance with its terms with respect to all, in all countries of
                                         the Territory other than the Terminated Countries.



 


		22.9.	Upon
                                         termination of this Agreement, only accounts payable and/or receivable and liabilities
                                         provided for under this Agreement shall remain in effect, and neither Party shall be
                                         entitled to any costs compensation or damages whatsoever sustained resulting from, or
                                         arising out of or alleged to have been sustained, to have resulted from, or to have arisen
                                         out of such termination.



 


		22.10.	In
                                         the event of termination of this Agreement:



 


		22.10.1.	Notwithstanding
                                         anything contained in this Agreement to the contrary, all rights and licenses granted
                                         herein to Takeda shall terminate, and Takeda shall cease any Commercialization activities
                                         with respect to the Product;



 


		22.10.2.	All
                                         payment obligations hereunder shall terminate, other than those that are accrued and
                                         unpaid as of the effective date of such termination.



 


		22.11.	Takeda
                                         shall, as soon as reasonably practical after the effective date of such termination,
                                         provide to Innocoll, as applicable and to the extent permitted under any applicable third
                                         party contract, (i) any information, materials, and data, relating to the Product, including
                                         control of, and all information relating to, the global safety database, and (ii) other
                                         documents to the extent relating to the Product that are necessary in the continued Commercialization
                                         of the Product throughout the Territory.



 




    	19



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


		22.12.	Takeda
                                         shall have the right to sell or otherwise dispose of any inventory of any Product on
                                         hand at the time of such termination; provided, however, at Innocoll’s request,
                                         Takeda shall transfer to Innocoll any Product that has not been sold or used within six (6) months
                                         following such termination.



 


		22.13.	Takeda
                                         shall transfer to Innocoll any and all Marketing Authorizations directly and solely related
                                         to the Product.



 


		22.14.	Upon
                                         expiration of the first Renewal Term under Section 22.1, Takeda shall have the right
                                         to *** for a one-time consideration equivalent to *** in the respective country.



 


		23.	Miscellaneous
                                         Provisions



 


		23.1.	In
                                         case of force majeure, official orders, strike or lockout or similar hindrances which
                                         the parties are unable to avert, the Parties shall be released for the duration of such
                                         hindrance from the contractual obligations which they are prevented from performing;
                                         provided however that if such suspension shall continue in excess of one hundred eighty (180)
                                         days the Parties shall meet and attempt to arrive at a mutually acceptable compromise
                                         within the spirit and intent of this Agreement.



 


		23.2.	This
                                         Agreement and all disputes arising out or related to this Agreement shall be governed
                                         by and construed in accordance with the substantive provisions of Switzerland law. All
                                         disputes arising out of or in connection with this Agreement which cannot be settled
                                         in an amicable way between the Parties hereto shall be finally settled under the Rules
                                         of Arbitration of the International Chamber of Commerce by three (3) arbitrators. Each
                                         Party appoints one arbitrator and the Chamber appoints a third arbitrator who is to be
                                         the chairman of the arbitration tribunal. If a Party fails to appoint an arbitrator within
                                         thirty (30) days of having filed or received a request for arbitration, the Chamber shall
                                         appoint such arbitrator. The award rendered shall be final and binding upon both Parties.
                                         Such arbitration shall be held in Zurich, Switzerland and be conducted in the English
                                         language.



 


		23.3.	If
                                         individual provisions or rules of this Agreement are invalid or become invalid, the Parties
                                         hereby agree that this shall not affect the validity of the remainder of the terms and
                                         provisions. The Parties undertake to replace the invalid provisions by others which come
                                         closest to the effect originally intended.



 


		23.4.	This
                                         Agreement and its Exhibits which form an integral part of this Agreement and are incorporated
                                         herein by reference, represents the entire agreement of the Parties relating to the subject
                                         matter. The General Terms and Conditions of each Party shall not apply to this Agreement.



 


		23.5.	Any
                                         amendments to this Agreement or, the Exhibits may only be made by mutual agreement of
                                         the Parties, and must be in writing and executed by both Parties.



 


		23.6.	If
                                         any one or more of the provisions of this Agreement is held to be invalid or unenforceable
                                         by any court of competent jurisdiction from which no appeal can be or is taken, the provision
                                         shall be considered severed from this Agreement and shall not serve to invalidate any
                                         remaining provisions hereof. The Parties shall make a good faith effort to replace any
                                         invalid or unenforceable provision with a valid and enforceable one such that the objectives
                                         contemplated by the Parties when entering this Agreement may be realized.



 




    	20



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


		23.7.	Any
                                         expiration or termination of this Agreement shall not release the Parties from liabilities
                                         or obligations accrued as of the date thereof.



 


		23.8.	Neither
                                         Party may assign or transfer this Agreement or any rights or obligations hereunder without
                                         the prior written consent of the other, except that a Party may make such an assignment
                                         without the other Party’s consent to Affiliates. It is expressly acknowledged that
                                         Takeda will enter into this Agreement only for a short limited interim period and that
                                         the Agreement will be assigned to the Swiss Affiliate of Takeda, Takeda Pharmaceuticals
                                         International GmbH, Thurgauerstr.130, 8152 Glattpark-Opfikon, Switzerland, as soon as
                                         the latter satisfies all requirements from a Swiss legal and regulatory perspective.
                                         Takeda will inform Innocoll about the assignment accordingly. Any successor or assignee
                                         of rights and/or obligations permitted hereunder shall, in writing to the other Party,
                                         expressly assume performance of such rights and/or obligations. Any permitted assignment
                                         shall be binding on the successors of the assigning Party. Any assignment or attempted
                                         assignment by either Party in violation of the terms of this Section shall be null, void
                                         and of no legal effect.



 


		23.9.	This
                                         Agreement has been prepared in the English language, and English shall govern its interpretation
                                         and meaning.



 


		23.10.	This
                                         Agreement may be executed in two or more counterparts, each of which shall be deemed
                                         an original and all of which, taken together, shall constitute one instrument. For purposes
                                         hereof, a facsimile or email copy of this Agreement, including the signature pages hereto,
                                         shall be deemed to be an original.



 


		23.11.	All
                                         notices, requests, claims, demands and other communications hereunder shall be in writing
                                         and shall be given (and shall be deemed to have been duly given upon receipt) by delivery
                                         in person, facsimile or by registered certified mail, to the other Party at the following
                                         address (or at such other address for which such Party gives notice hereunder):



 


	 	If to Takeda:	Takeda GmbH
	 	 	Byk-Gulden-Str. 2
	 	 	78467 Konstanz
	 	 	Germany
	 	 	Attention :  Managing Director
	 	 	Telefon:  +49 7531 840
	 	 	Facsimile:  +49 7531 84 2982
	 	 	 
	 	 	A copy of such notices, requests, claims, demands and other communications shall be sent to
    Takeda Head of Legal. Contact details are:
	 	 	Takeda Pharmaceuticals International GmbH,
	 	 	Thurgauerstrasse 130,
	 	 	8152 Glattpark-Opfikon (Zurich),
	 	 	Switzerland
	 	 	Attention:  Head of Legal
	 	 	Telephone:  +41 44 555 10 00
	 	 	Facsimile:  +41 44 555 10 01


 




    	21



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


	 	If to Innocoll:	Innocoll Pharmaceuticals Limited
	 	 	Midlands Innovation and Research Centre,
	 	 	Dublin Road, Athlone, Co. Westmeath, Ireland
	 	 	Attention:  President
	 	 	Telephone:  +353(0)90 648 6834
	 	 	Facsimile:  +353(0)90 648 6835


 


Neither Party may issue any press release
or make any public announcement concerning the transactions contemplated by this Agreement without the prior consent of the other
Party (which consent shall not be unreasonably withheld, conditioned or delayed).


 




    	22



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

 


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


 


	Takeda GmbH	 	Innocoll Pharmaceuticals Limited
	 	 	 
	/s/ ppa Christina Peusch	 	/s/ Denise Carter
	Christina Peusch	 	Denise Carter
	Head of Legal CCO EUCAN, Emerging	 	Executive Vice President Business
	Markets, North Asia	 	Development
	 	 	 
	/s/ ppa Bernd Kratzer	 	 
	Bernd Kratzer	 	 
	Head of IP	 	 


 


 



    	23



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    




 





	Exhibit A:  Products


 


CollaGUARD Adhesion Barrier


 


DESCRIPTION


 


	·		The Product is a sterile, bioresorbable, translucent membrane composed of collagen.



 


COMPOSITION


 


	·		Renatured equine collagen



 


INDICATION


 


·             Prevention
of postoperative adhesions in several surgical fields such as digestive, general, gynecological and urological surgeries.


 






    	A-1



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

 








	Exhibit B:  Prices


 


***




    	B-1



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    



 


	Exhibit C:  Minimum Annual Purchase Requirements


 


Minimum Annual Purchase Requirements to be
agreed by the Parties in good faith based on ***.


 






    	C-1



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

 








	Exhibit D:  Innocoll Patents existing
    on the Effective Date



 





	

        Invention

        Name
	Country	Application
    No.	Application

    Date	Date

    of

    Grant	Patent

    No.	Expiration

    Date	Patent
    Status
	A Modified Collagen	EU	12150527.5	9th of Jan 

    2012	N/A	N/A	N/A	Pending
	A Modified Collagen	UK	1220868.2	20th of 

    Nov 2012	N/A	N/A	N/A	Pending
	A Modified Collagen	International	PCT/EP2013/050333	9th of 

    Jan 2013	N/A	N/A	N/A	International Phase



 






    	D-1



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

 









	Exhibit E:  Product Trademarks



 





	

        Name
	Country	Application
    

    No.	Application

    Date	Date
    of

    Allowance

    Notice	Registration

    No. and Date
	CollaGUARD	Canada	1622815	4/18/13	-	-
	CollaCare	Canada	1520577	3/28/11	4/5/13	-
	Collexa	Canada	1520578	3/28/11	4/5/13	-



 



    	E-1



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

 


AMENDMENT 1 TO THE LICENSE AND SUPPLY
AGREEMENT


 


This amendment to the license and supply agreement
effective on August 14, 2013 (the “Amendment”) is made and entered into as of this 19th day of March 2014 (the “Amendment
Effective Date”) by and between


 


INNOCOLL PHARMACEUTICALS, LIMITED,
a company incorporated in Ireland whose principal office is Midlands Innovation and Research Centre, Dublin Road, Athlone, Co.
Westmeath, Ireland, (collectively, with its Affiliates “Innocoll”)


 


And


 


Takeda Pharmaceuticals International GmbH,
a company incorporated in Switzerland, whose principal office is Thurgauerstrasse 130, 8152 Glattpark-Opfikon, Switzerland, (“Takeda”).


 


Takeda and INNOCOLL are hereinafter
individually or collectively referred to as a “Party” or the “Parties”.


 


WHEREAS, Innocoll and Takeda GmbH have signed
a license and supply agreement effective on August 14, 2013 to grant to Takeda GmbH the exclusive right to distribute, promote
and sell the Product in the Territory in the Field (hereinafter the “Agreement”);


 


WHEREAS in a letter dated February 28, 2014,
pursuant to Section 23.8 of the Agreement, Takeda GmbH has informed Innocoll of its decision to assign the Agreement and all rights
and obligations attached to its Affiliate Takeda Pharmaceuticals International GmbH, effective on March 1st, 2014;


 


WHEREAS, the Parties have discussed and agreed
to amend the Agreement, in order to extend the Territory and set forth additional terms and conditions;


 


For the purpose of this Amendment, capitalized
terms shall have the meanings ascribed to them in the Agreement.


 


NOW, THEREFORE, in consideration of
the mutual promises, covenants and agreements hereinafter set forth, the sufficiency of which is hereby acknowledged, and intending
to be legally bound, the Parties mutually agree as follows:


 


Article 1 - Modifications to the Agreement


 


		1.	Defined Terms



 


		1.1	The Parties have agreed to modify
                                         the definition of cGMP (Section 1.8) as follows:



 


		“1.8.	cGMP means the then-current
                                         good manufacturing practices detailed in the Council Directive 93/42/EEC concerning medical
                                         devices, and any subsequent or future revisions of such guidelines and regulations, and
                                         comparable applicable laws related to the manufacture and testing of medical devices
                                         in jurisdictions in the Territory.”



 


		1.2	The Parties have agreed that
                                         the Agreement shall be extended to an additional country. The definition of Territory
                                         (Section 1.32) shall be deleted and replaced by the following provision:



 




    	1



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


		“1.32.	Territory shall
                                         mean



 


Canada, Russian Federation, Belarus,
Ukraine, Moldova, Kazakhstan, Kyrgyzstan, Tajikistan, Uzbekistan, Turkmenistan, Azerbaijan, Armenia, Georgia and Mongolia, these
last twelve (12) countries being hereinafter referred as to “CIS”, and Mexico.”


 


		2.	Grant of License and Options



 


The Parties have agreed to the following
amendment to Section 2.3 of the Agreement, such newly agreed provision to prevail on the former draft of Section 2.3.


 


		2.3.	Innocoll covenants and agrees
                                         that during the Term, Innocoll will not enter into any such agreement or itself, directly
                                         or indirectly, sell or distribute the Product or any Competing Product in the Territory
                                         in the Field. Takeda agrees that during the Term, Takeda will not, directly or indirectly,
                                         sell or distribute a Competing Product in the Territory.



 


		3.	License Fees and Initial Purchase
                                         Requirements



 


The Parties have agreed to modify
the Section 3. - License Fees and Initial Purchase - of the Agreement to add additional Purchase Requirements related to the Commercialization
of the Product in Mexico.


 


Therefore the Parties have agreed
to insert the following provision in the Agreement:


 


		3.3.	In addition to Sections 3.1 and
                                         3.2, Takeda shall purchase an initial quantity of Product for an amount of *** (added
                                         to the “Initial Purchase Quantity”) to be calculated as described in Section
                                         5.1 and Exhibit B. Payment for this portion of the Initial Purchase Quantity shall be
                                         due on the approval of the Marketing Authorizations of the Product in Mexico and shall
                                         be made within thirty (30) days upon receipt of the invoice and this payment shall be
                                         a credit to be applied to the initial purchases of Product for Mexico.



 


		4.	Manufacture and Supply of
                                         Product



 


The Parties have agreed to modify
the Section 4. - Manufacture and Supply of Product- of the Agreement to include separate shelf life requirements for Mexico.


 


Therefore the Parties have agreed
to the following amendment to Section 4.2 of the Agreement, which shall prevail on the former Section 4.2:


 


		4.2	Innocoll represents and warrants
                                         that the Products at the date of delivery shall have a remaining shelf life of *** for Product in Russia and Canada and *** for Product
                                         in Mexico. Furthermore Innocoll represents and warrants that all Products supplied to
                                         Takeda or its appointee shall be Manufactured and Packaged in accordance with (i) the
                                         quality standards and testing methods of Innocoll and all laws and regulations applying
                                         at the place of Manufacture; (ii) cGMPs; (iii) the Quality Agreement and the Specifications;
                                         and (iv) any additional Manufacturing standards agreed in writing by the Parties.



 




    	2



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


		5.	Payment Terms



 


The Parties have agreed to modify
Section 6 - Payment Terms - of the Agreement in order to include payment terms for Mexico and to review the numbering of the clause.
Therefore the Parties have agreed that Section 6 shall be deleted and replaced with the following provision:


 


		6.	Payment terms



 


		6.1	Payment for the Initial Purchase
                                         Quantities and the one-time Milestone payment will be due as per Sections 3.1, 3.2 and
                                         3.3. All other payments will be due as follows:



 


		6.1.1	For Product shipments to Canada
                                         and Mexico payment will be made in Euros and will be due within sixty (60) days after
                                         receipt of the proper invoice.



 


		6.1.2	For Product shipments to Russia/CIS
                                         payment will be made in Euros and will be due within ninety (90) days after receipt of
                                         the proper invoice.



 


		6.2	In the event that a Party should
                                         fail to make payment of any amount due and payable pursuant to this Agreement within
                                         the time periods provided for in this Agreement, interest shall accrue at a rate of interest
                                         of three percent (3%) above the average rate(s) of the European Inter-Bank Offering Rate
                                         (“EURIBOR”) for Euros, as quoted on the Reuters (or such other source as
                                         may be mutually agreed by the Parties) from time to time, effective for the applicable
                                         days of the period of default provided, that if such failure to pay continues for more
                                         than ten (10) days, the applicable rate(s) of interest shall be the applicable monthly
                                         average rate(s) of EURIBOR plus four percent (4%) for the entire period of default. The
                                         applicable EURIBOR period shall be the period closest to the period for which interest
                                         is calculated. In the event that any payment, or portion thereof, is disputed in good
                                         faith by a Party, any subsequent settlement payment related to that dispute shall not
                                         include interest thereon.



 


		6.3	Any withholding or other taxes
                                         that either Party is required by applicable law to withhold or pay on behalf of the other
                                         Party, with respect to any payments to such other Party hereunder, shall be deducted
                                         from such payments and paid to the appropriate tax authority contemporaneously with the
                                         remittance to the other Party, provided, however, that the withholding Party shall furnish
                                         the other Party with proper evidence of the taxes so paid. Each Party shall cooperate
                                         with the other and furnish the other Party with appropriate documents to secure application
                                         of the most favorable rate of withholding tax under applicable law (or exemption from
                                         such withholding tax payments, as applicable).



 


		6.	Free Goods



 


The Parties have agreed to modify
Section 8 - Free Goods - of the Agreement to include free goods for Mexico. Therefore the Parties have agreed to insert the following
provision as Section 8.2:


 


		8.2	Innocoll will provide *** Units of Product *** at Takeda’s request.



 




    	3



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


		7.	Commercialization of Product



 


The Parties have agreed to modify
Section 13 - Commercialization of Product - of the Agreement to include Commercialization obligations for Mexico. Therefore, the
Parties have agreed to insert the following provision as Section 13.1.4:


 


		13.1.4	Launch of Product in Mexico: Takeda
                                         shall use Commercial Reasonable Efforts to launch the Product within six (6) months after
                                         the grant of the Marketing Authorizations for the Product in Mexico, provided that the
                                         Product has been delivered to Takeda and Takeda has obtained all necessary regulatory
                                         documents to Commercialize the Product in Mexico.



 


		8.	Regulatory Matters, Changes



 


The Parties have agreed to modify
the Section 14 - Regulatory Matters, Changes - of the Agreement to include Mexico. Therefore, the Parties have agreed that Section
14.1 shall be deleted and replaced by the following provision:


 


		14.1.	Canada, Russia and Mexico



 


		14.1.1	Obtaining Marketing Authorizations



 


Innocoll shall be responsible for
applying for the Marketing Authorizations for the Product in Canada, Russia and Mexico at its own cost and expense. These Marketing
Authorizations shall be owned by Innocoll in its own name. Within five (5) business days as from the receipt by Innocoll
of the approval of Marketing Authorizations, Innocoll shall inform Takeda of such approval and will communicate a copy of the
Marketing Authorizations to Takeda. In particular, Innocoll shall obtain and send to Takeda the documents necessary for the customs
clearance of the Product in Russia, Canada and Mexico. To avoid any doubt, as specified in Section 13.1, Takeda will be considered
for Russia as having received from Innocoll the Marketing Authorizations solely upon effective and tangible receipt of any and
all documents required and necessary to Commercialize the Product in the country.


 


		14.1.2.	Maintenance of Marketing Authorizations



 


Following the approval of the Marketing
Authorizations in Canada and Russia, Innocoll shall be solely responsible for any communications with the Regulatory Authorities
occurring or required in connection with obtaining or maintaining any Marketing Authorization for the Product.


 


Following the approval of the Marketing
Authorizations in Mexico, Innocoll shall enable Takeda to act on its behalf for any communications with the Regulatory Authorities
occurring or required in connection with maintaining any Marketing Authorization for the Product and shall bear the related costs.


 




    	4



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

  


		9.	Term and Termination



 


A misprint has occurred in the Agreement
in Section 22.6 of the Agreement. Then the Parties have agreed that such Section 22.6 shall be deleted and replaced with the following
provision:


 


		22.6.	If Takeda Notifies Innocoll under
                                         Section 2.2 that it decides not to Commercialize or not to continue Commercialization
                                         of the Product in Canada after Tachosil Approval, the Agreement shall terminate automatically
                                         for Canada with immediate effect, without any compensation due to Innocoll.



 


		10.	Product Trademark



 


The Parties have agreed to modify
the Exhibit E – Product Trademarks - of the Agreement to include the Product Trademarks for Mexico. Therefore, the Parties
have agreed that the EXHIBIT E shall be deleted and replaced by EXHIBIT E attached in annex to this Amendment:


 


Article 2 - Term


 


This Amendment enters into force on the Amendment
Effective Date for the term of the Agreement.


 


Article 3 - Miscellaneous


 


All provisions of the Agreement, that do not
contradict the terms set forth in this Amendment, shall continue in full force and effect.


 


IN WITNESS WHEREOF, the Parties hereto have
caused this Amendment Agreement to be executed by their duly authorized officers in two counterparts, each of which shall be deemed
to be an original.


 


	Takeda Pharmaceuticals International GmbH	INNOCOLL PHARMACEUTICALS, LIMITED
	 	 
	/s/ Jastein Davidsen	/s/ Denise Carter
	 	 
	Name: Jastein Davidsen	Name: Denise Carter
	Title: Head Commercial Operations	Title: Executive Vice President Business Development
	Date: 20.03.2014	Date: 28.03.14


 


	Takeda Pharmaceuticals International GmbH
	 
	/s/ Juevgen Heitmann
	 
	Name: Juevan Heitmann
	Title: Director Business Development
	Date: 20.03.2014


 




    	5



    	Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential portions are marked: [ *** ]



    

 


ANNEX


 




	Exhibit E:  Product Trademarks



 




	Name
	Country	Application

    No.	Application

    Date	Date
    of Allowance

    Notice	Registration
    No. 

    and Date
	CollaGUARD	Canada	1622815	4/18/13	-	-
	CollaCare	Canada	1520577	3/28/11	4/5/13	-
	Collexa	Canada	1520578	3/28/11	4/5/13	-
	CollaGUARD	Mexico	1446989

    (class 5)	2/10/14	 	 
	CollaGUARD	Mexico	1446988

    (class 10)	2/10/14	 	 


 




    	6