Provision Language
Definitions
“Collaboration Know-How” means Know-How first developed during and in performance of the Collaboration by any Party and/or its Affiliates and/or its Service Providers, in whole or in part, using or incorporating (a) Licensed Technology and/or (b) Licensed Improvements.
“Collaboration Materials” means Materials first developed during and in performance of the Collaboration by any Party and/or its Affiliates and/or its Service Providers, in whole or in part, using or incorporating (a) Licensed Technology and/or (b) Licensed Improvements.
“Collaboration Patents” means Patents filed in respect of inventions conceived during and in performance of the Collaboration by any Party and/or its Affiliates and/or its Service Providers which invention, in whole or in part, was conceived using or which incorporates (a) Licensed Technology and/or (b) Licensed Improvements.
“Collaboration Technology” means collectively the Collaboration Know-How, Collaboration Materials and Collaboration Patents.
“Licensed Improvement” means any Know-How or Materials that are, or any Patent filed claiming, any improvement, modification, refinement, correction, evolution or enhancement of any (i) Licensed Technology or (ii) any Translate Bio Collaboration Technology, made by Translate Bio and/or its Affiliates and/or its Service Providers which is created or conceived outside of the Collaboration after the Execution Date and is necessary or reasonably useful in the development, manufacture, sale or use of any Product in a Licensed Field, provided, however that “Licensed Improvements” shall not include any Patent, Know-How or Materials which (a) includes or comprises any Third Party technology or (b) are not included in the license under Section 9.1.3 in accordance with Section 6.4.2 or (c) any improvement, modification, refinement, correction, evolution or enhancement of any (i) Licensed Technology or (ii) any Translate Bio Collaboration Technology, in each case made by Translate Bio and/or its Affiliates and/or its Service Providers which is created or conceived more than [**] after the Closing Date.
“Licensed Know-How” means the Know-How Controlled by Translate Bio or any of its Affiliates as of the Execution Date that is necessary or reasonably useful in the development, manufacture, sale or use of any Product in a Licensed Field that has been identified by Translate Bio in writing as its proprietary Know-How, and the use of which by Sanofi (and/or any of its Affiliates) to make, sell or use Products absent the licenses granted herein would constitute unauthorized use by Sanofi (and/or its Affiliates). Schedule 1.51 (Licensed Know-How) lists in part 1 the Licensed Know-How acquired by Translate Bio from Shire per the Shire Agreement and in part 2 Licensed Know-How independently developed by Translate Bio following the Closing (the terms “Closing” as used in this Section 1.51 has the meaning as defined in the Shire Agreement) and prior to the Execution Date, which will be updated from time to time by Translate Bio, as appropriate. No item listed on Schedule 1.51 shall be considered Licensed Know-How hereunder until (1) Translate Bio has provided sufficient detail in writing regarding such item (whether through pre–read of any JSC meeting with regard to the Collaboration, the Technology and Process Transfer Plan or otherwise) to enable Sanofi to determine the identity and need for such Know-How, and (2) Sanofi has accepted, by written notice to Translate Bio (which during the Collaboration Term may be through minutes of JSC meetings), that it wishes to include such item within the licenses granted to Sanofi by Translate Bio pursuant to Section 9.1.
“Licensed Materials” means the Materials that are Controlled by Translate Bio or its Affiliates as of the Execution Date that are necessary or reasonably useful in the development, manufacture, sale or use of any Product in a Licensed Field and listed on Schedule 1.52 (Licensed Materials), which will be updated from time to time by Translate Bio, as appropriate, the use of which by Sanofi (and/or any of its Affiliates and/or Service Providers) to make, sell or use Products absent the licenses granted herein, would constitute unauthorized use of such Materials.
“Licensed Technology” means collectively the Licensed Know-How, Licensed Materials and Licensed Patents.
“Licensed Patents” means those Patents Controlled by Translate Bio or any of its Affiliates as of the Execution Date that, but for the licenses granted herein, the research, development, manufacture, use, offer for sale, sale, or importation or other exploitation of a Product in a Licensed Field would infringe a Valid Patent Claim of such Patent in the country in which such activity occurs (or, in the case of a Valid Patent Claim that has not yet issued, would infringe such Valid Patent Claim if it were to issue). Licensed Patents, as of the Execution Date, are those listed in Schedule 1.54 (Licensed Patents), which will be updated from time–to–time by Translate Bio, as appropriate, to reflect the issuance of patents included therein and other changes to the status of the Licensed Patents.
“Materials” means tangible compositions of matters, whether chemical or biological, such as, by way of example, cell lines, reagents, lipids, LNPs, delivery vehicles, antibodies, strains, proteins, nucleic acids and other materials used in the research, development and manufacture of pharmaceutical products. Materials exclude those tangible compositions of matters, whether chemical or biological, which a Party may independently obtain from a Third Party for commercial use.
“Sanofi Background Technology” means the Patents, Know-How and Materials Controlled by Sanofi or its Affiliates (i) prior to the Execution Date or (ii) after the Execution Date outside of the Collaboration, which is set forth in Schedule 1.89 (Sanofi Background Technology), which will be updated by Sanofi from time to time in accordance with Section 6.3 (Reporting by Sanofi), or as is otherwise appropriate.
10. COLLABORATION TECHNOLOGY
10.1 Inventorship. Inventorship of Collaboration Technology shall be determined in accordance with U.S. patent Laws and such principles shall be applied to determine whether a Party solely, or the Parties jointly, invented any Patents, Know-How or Materials arising from the performance of the Collaboration. In the event that the Parties have a dispute regarding inventorship or ownership of Collaboration Technology, such dispute shall be referred to an independent external counsel having appropriate experience mutually selected by the Parties for resolution. The costs of such adjudication regarding inventorship or ownership shall be borne equally by the Parties.
10.2 Ownership. Subject to Sections 10.3, 10.4 and 10.5, (a) Sanofi shall own all Collaboration Technology discovered, invented or created solely by Sanofi, its Affiliates or its Service Providers, (b) Translate Bio shall own all Collaboration Technology discovered, invented or created solely by Translate Bio, its Affiliates or its Service Providers, and (c) Sanofi and Translate Bio shall jointly own all Collaboration Technology discovered, invented or created jointly by Translate Bio and Sanofi or their respective Affiliates or Service Providers. Each Party, on behalf of itself and its Affiliates, hereby assigns to the other Party such right, title and interest in and to the applicable Collaboration Technology sufficient to vest in such other Party the appropriate ownership of the relevant Collaboration Technology in accordance with this Section 10.2, Section 10.3, Section 10.4 and Section 10.5, as applicable.
10.3 Exceptions to Ownership of Collaboration Technology: Translate Bio. Subject to Sections 10.4 and 10.5, Translate Bio shall own all Collaboration Technology regardless of inventorship where such Collaboration Technology is an improvement, modification, refinement, correction, evolution or enhancement to any Licensed Technology or Licensed Improvement.
10.4 Exceptions to Ownership of Collaboration Technology: Sanofi. Sanofi shall own all Collaboration Technology regardless of inventorship to the extent that such Collaboration Technology [**]. The technology described in items (b), (c) and (d) of this Section 10.4 is the “Sanofi Reserved Property”.
10.5 Exceptions to Ownership of Collaboration Technology: Sanofi Background Technology. Sanofi shall own all Collaboration Technology regardless of inventorship to the extent that such Collaboration Technology contains or was made using Sanofi Background Technology that is used during and in performance of the Collaboration and that is disclosed as such, in writing to Translate Bio, prior to such use or is otherwise identified as such in a Collaboration Plan.
10.6 Translate Bio access to Sanofi Reserved Property. If Sanofi elects not to develop or commercialize any Sanofi Reserved Property described in Section 10.4(b) or (c) or (d) above, Sanofi shall include such information in its annual report under Section 6.3 (Reporting by Sanofi). Translate Bio shall have [**] from the date of receipt of such report to elect in writing to either acquire (by way of an assignment) or be granted a perpetual, irrevocable, worldwide, exclusive, royalty–free, fully–paid, sub-licensable (through multiple tiers) license in the Translate Bio Field to such Sanofi Reserved Property described in Section 10.4(b) or (c) or (d), which assignment or license shall be automatically granted. Sanofi may, in any such transaction, reserve for itself the use of any such Sanofi Reserved Property outside of the Translate Bio Field.
10.7 No exploitation of Joint Interest. No Party may license or transfer (except in connection with an assignment of this Agreement pursuant to Section 17.2) its interest in any jointly–owned Collaboration Technology to any Third Party without the other Party’s prior written consent, which consent shall not be unreasonably conditioned, withheld or delayed. Each Party (and its Affiliates) may use its interest in any jointly–owned Collaboration Technology for any and all purposes, subject to the applicable terms and conditions of this Agreement.