Common use of Product Commercialization Clause in Contracts

Product Commercialization. 9.1 Unless otherwise agreed by the Parties and subject to the remainder of this Article 9.1, Evonik shall have the right to manufacture clinical and commercial supplies of Product and supply polymer materials utilized in such manufacture as set forth below. Such rights would be set forth in manufacturing and supply sections of any license and supply agreement negotiated by the Parties in good faith on reasonable commercial terms and conditions (such agreement(s), the “License and Supply Agreement(s)”), which terms and conditions shall: (i) provide that Evonik shall manufacture commercial Product ***; (ii) provide that Evonik shall be the exclusive manufacturer of commercial Products (“Exclusive Manufacturer”) on behalf of Customer and, subject to the rights referenced in Article 9.1 (iii) below, Customer will purchase and Evonik will supply one hundred percent (100%) of Customer’s volume for commercial Products from the Evonik Primary Site and Evonik Backup Site ***; (iii) include rights that in the event Evonik fails to ***; (iv) provide that Evonik shall be the exclusive manufacturer of clinical supplies of Product on behalf of Customer and Evonik will supply one hundred percent (100%) of Customer’s clinical Product requirements unless ***; and (v) provide that Evonik shall be the exclusive manufacturer and/or supplier of all polymer materials utilized in the manufacture of Product ***, (vi) provide Customer with timely and reasonable access to *** including any information, documents and data related thereto, to the extent necessary for the preparation of regulatory filings and correspondence with regulatory or governmental agencies. Evonik shall further provide reasonable assistance to Customer, at Customer’s expense, for such matters in a timely manner. For clarity, none of the terms above are designed to be actual language to be included in future Supply Agreement(s) and are not final language. Any and all such language is subject to further drafting and negotiation between the Parties. Furthermore, the Parties are to negotiate all of the above listed manufacturing and License and Supply Agreement(s) in good faith and in no event shall be obligated to enter into one (1) or more of the above agreements if either Party is not satisfied with the form or result of all of the agreements. 9.2 The Parties acknowledge and agree that the rights and obligations of each Party with respect to the commercialization of a Product, *** shall be set forth in a separate license agreement negotiated by the Parties in good faith at reasonable commercial conditions. ***. The Parties shall use commercially reasonable, good faith efforts to negotiate a commercially reasonable form of such license agreement, consistent with the terms therefor set forth in this Agreement, within *** months of the Effective Date and, upon the Parties’ mutual agreement on such form of license agreement, it shall be attached hereto as Exhibit E (the “License”); provided, however, that, without limitation of the Parties’ obligation to use commercially reasonable, good faith efforts as set forth above, neither Party is under any obligation to complete such a license agreement. 9.3 Evonik hereby grants to Customer an exclusive option to acquire an exclusive royalty-free, worldwide license, with the right to grant sublicenses, to Evonik Foreground IP, except for any Foreground IP solely based on Evonik Process, (and related Foreground IPR) and Evonik’s interest in Joint Foreground IP (and related Foreground IPR) (“Option I”) only for the purpose of developing and commercializing the Product (including, subject to Article 9.1(iii) and/or Evonik’s rights under any License and Supply Agreement(s), ***. 9.4 Further, Evonik hereby grants to Customer an exclusive option to acquire a royalty-bearing, worldwide license, with the right to grant sublicenses, to Evonik Background IP (and Evonik Background IPR) (“Option II”) only for the purpose of developing and commercializing the Product ***. The royalty rate for such license under this Option II for Products, the manufacture of which is covered by valid claims of issued patents included within Evonik Background IPR covering the Evonik Process in the country of sale, shall be (i) *** of Net Sales of Products sold during any calendar quarter *** or (ii) *** of Net Sales of Products sold during any calendar quarter ***. If the manufacture of Products is not covered by valid claims of issued patents included within Evonik Background IPR covering the Evonik Process in the country of sale, the respective royalty rates shall be reduced by *** of the above referenced rates, subject to customary adjustments, as shall be negotiated and set forth in the license to be negotiated under Article 9.2 (or, if applicable, Article 9.7) and executed following exercise of Option II pursuant to Article 9.7. ***. 9.5 In the event that Evonik and Customer do not agree and execute one or more License and Supply Agreements (as referenced in Article 9.1) for the commercial manufacture of Product, ***. 9.6 In the event Customer exercises its rights to Options I and II under Article 9.3, 9.4 or 9.7, ***. Furthermore, in the event that Customer grants a sublicense to a Third Party under any license granted to Customer by Evonik pursuant to Articles 9.3, 9.4, and/or 9.7, Customer shall not transfer any Evonik Process Data to such Third Party manufacturer.

Product Commercialization. 9.1 Unless otherwise agreed by the Parties and subject to the remainder of this Article 9.1, Evonik shall have the right to manufacture clinical and commercial supplies of Product and supply polymer materials utilized in such manufacture as set forth below. Such rights would be set forth in manufacturing and supply sections of any license and supply agreement negotiated by the Parties in good faith on reasonable commercial terms and conditions (such agreement(s), the “License and Supply Agreement(s)”), which terms and conditions shall: (i) provide that Evonik shall manufacture commercial Product ***; (ii) provide that Evonik shall be the exclusive manufacturer of commercial Products (“Exclusive Manufacturer”) on behalf of Customer and, subject to the rights referenced in Article 9.1 (iii) below, Customer will purchase and Evonik will supply one hundred percent (100%) of Customer’s volume for commercial Products from the Evonik Primary Site and Evonik Backup Site ***; (iii) include rights that in the event Evonik fails to ***; (iv) provide that Evonik shall be the exclusive manufacturer of clinical supplies of Product on behalf of Customer and Evonik will supply one hundred percent (100%) of Customer’s clinical Product requirements unless ***; andand Confidential Treatment Requested by BioDelivery Sciences International, Inc. IRS Employer Identification No. 35-208985 Confidential treatment requested with respect to certain portions hereof denoted with “***” (v) provide that Evonik shall be the exclusive manufacturer and/or supplier of all polymer materials utilized in the manufacture of Product ***, (vi) provide Customer with timely and reasonable access to *** including any information, documents and data related thereto, to the extent necessary for the preparation of regulatory filings and correspondence with regulatory or governmental agencies. Evonik shall further provide reasonable assistance to Customer, at Customer’s expense, for such matters in a timely manner. For clarity, none of the terms above are designed to be actual language to be included in future Supply Agreement(s) and are not final language. Any and all such language is subject to further drafting and negotiation between the Parties. Furthermore, the Parties are to negotiate all of the above listed manufacturing and License and Supply Agreement(s) in good faith and in no event shall be obligated to enter into one (1) or more of the above agreements if either Party is not satisfied with the form or result of all of the agreements. 9.2 The Parties acknowledge and agree that the rights and obligations of each Party with respect to the commercialization of a Product, *** shall be set forth in a separate license agreement negotiated by the Parties in good faith at reasonable commercial conditions. ***. The Parties shall use commercially reasonable, good faith efforts to negotiate a commercially reasonable form of such license agreement, consistent with the terms therefor set forth in this Agreement, within *** months of the Effective Date and, upon the Parties’ mutual agreement on such form of license agreement, it shall be attached hereto as Exhibit E (the “License”); provided, however, that, without limitation of the Parties’ obligation to use commercially reasonable, good faith efforts as set forth above, neither Party is under any obligation to complete such a license agreement. 9.3 Evonik hereby grants to Customer an exclusive option to acquire an exclusive royalty-free, worldwide license, with the right to grant sublicenses, to Evonik Foreground IP, except for any Foreground IP solely based on Evonik Process, (and related Foreground IPR) and Evonik’s interest in Joint Foreground IP (and related Foreground IPR) (“Option I”) only for the purpose of developing and commercializing the Product (including, subject to Article 9.1(iii) and/or Evonik’s rights under any License and Supply Agreement(s), ***. 9.4 Further, Evonik hereby grants to Customer an exclusive option to acquire a royalty-bearing, worldwide license, with the right to grant sublicenses, to Evonik Background IP (and Evonik Background IPR) (“Option II”) only for the purpose of developing and commercializing the Product ***. The royalty rate for such license under this Option II for Products, the manufacture of which is covered by valid claims of issued patents included within Evonik Background IPR covering the Evonik Process in the country of sale, shall be (i) *** of Net Sales of Products sold during any calendar quarter *** or (ii) *** of Net Sales of Products sold during any calendar quarter ***. If the manufacture of Products is not covered by valid claims of issued patents included within Evonik Background IPR covering the Evonik Process in the country of sale, the respective royalty rates shall be reduced by *** of the above referenced rates, subject to customary adjustments, as shall be negotiated and set forth in the license to be negotiated under Article 9.2 (or, if applicable, Article 9.7) and executed following exercise of Option II pursuant to Article 9.7. ***.. Confidential Treatment Requested by BioDelivery Sciences International, Inc. IRS Employer Identification No. 35-208985 Confidential treatment requested with respect to certain portions hereof denoted with “***” 9.5 In the event that Evonik and Customer do not agree and execute one or more License and Supply Agreements (as referenced in Article 9.1) for the commercial manufacture of Product, ***. 9.6 In the event Customer exercises its rights to Options I and II under Article 9.3, 9.4 or 9.7, ***. Furthermore, in the event that Customer grants a sublicense to a Third Party under any license granted to Customer by Evonik pursuant to Articles 9.3, 9.4, and/or 9.7, Customer shall not transfer any Evonik Process Data to such Third Party manufacturer.