Provision Language
Definitions
“Development” and Develop means any and all non–clinical and clinical drug development activities related to or involving the Licensed Product, including without limitation those conducted for the purposes of the development and submission of information to a Regulatory Authority, including toxicology, microbiology, pharmacology and other discovery efforts, test method development and stability testing, process development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, and clinical studies (including pre– and post–approval studies).
“Licensed Compound” means the compound cefiderocol as described in Schedule A.
“Licensed Product” means any human pharmaceutical product or products produced under license from GARDP and/or Shionogi in the Field and containing the Licensed Compound as an active ingredient, in finished form. Notwithstanding anything to the contrary contained herein, the Parties acknowledge and agree that the license granted hereunder shall be limited to a license to rights relative to cefiderocol (for injection) in the form, presentation, dose and formulation approved by the United States Food and Drug Administration and/or European Medicines Agency as of the Effective Date, as described in Schedule A, and do not include rights to any other form, presentation, dose or formulation of cefiderocol.
8. INVENTIONS, PATENT MAINTENANCE, INFRINGEMENT
8.1 Inventions
(a) Shionogi (or its Affiliates) will own the entire right, title and interest in and to any and all inventions conceived solely by its employees and agents before, on and after the Effective Date relating to the Licensed Compound or any Licensed Product, including the Licensed Rights and any such inventions that constitute an adaptation of any Manufacturing process or proprietary drug delivery or formulation technology of Shionogi or its Affiliates for the production of the Licensed Compound or any Licensed Product, and any patents covering such invention (Shionogi Sole Inventions), subject to the license grant to GARDP set out in Section 2.
8.2 Manufacturing Process Results
(a) To the extent a Sublicensee accepts a Technical Transfer Package, or otherwise has access to any Shionogi non–public proprietary information or Confidential Information relating to the Manufacturing process used by Shionogi to Manufacture Licensed Compound and Licensed Product (not including the specifications of the Licensed Compound or Licensed Product that are required for a Sublicensee to demonstrate that the Licensed Compound or Licensed Product Manufactured by the Sublicensee using its process are pharmaceutically equivalent to the Licensed Compound or Licensed Product Manufactured using the Shionogi Manufacturing process):
(i) Shionogi shall own (and shall have the sole right to patent or not to patent) all inventions and results developed or generated by the Sublicensee related to the process to Manufacture Licensed Compound or Licensed Product (Process Results) (whether or not patentable) that are specific to the Licensed Product and/or that incorporate any Shionogi non–public proprietary information or Confidential Information or intellectual property; and
(ii) GARDP or the Sublicensee, as applicable, shall own (and shall have the sole right to patent or not to patent) all Process Results (whether or not patentable) solely to the extent separable from the Licensed Product (i.e., that such can be used to Manufacture products other than the Licensed Product) and that do not incorporate any Shionogi non–public proprietary information or Confidential Information.
(b) If a Sublicensee has not accepted a Technical Transfer Package, and has not had access to any Shionogi non–public proprietary information or Confidential Information relating to Shionogi’s Manufacturing process (not including the specifications of the Licensed Compound or Licensed Product that are required for a Sublicensee to demonstrate that the Licensed Compound or Licensed Product Manufactured by the Sublicensee using its process are pharmaceutically equivalent to the Licensed Compound or Licensed Product Manufactured using the Shionogi Manufacturing process):
(i) GARDP or the Sublicensee, as applicable, shall own (and shall have the sole right to patent or not to patent) all Process Results (whether or not patentable) developed or generated by or for them that do not incorporate any Shionogi non–public proprietary information or Confidential Information.
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8.3 Development Activity License Results
(a) With respect to any inventions, know–how or results (whether or not patentable) developed or generated by or for GARDP and/or a Sublicensee in the performance of any Development activities conducted pursuant to this License Agreement or any Sublicense Agreement other than Development activities relating to Manufacturing (the results of which are governed by Section 8.2) (Development Results):
(i) Shionogi shall own (and shall have the sole right to patent or not to patent) all Development Results that are specific to the Licensed Product and/or that incorporate any Shionogi non–public proprietary information or Confidential Information or intellectual property.
(ii) notwithstanding the above, GARDP shall own the clinical data associated with or arising from clinical studies conducted by or for GARDP and/or a Sublicensee pursuant to this License Agreement and/or the Collaboration Agreement or any Sublicense Agreement (Clinical Data), but may use such Clinical Data only for the purposes consistent with this License Agreement and/or the Collaboration Agreement; provided that Shionogi shall have the right to access and use all such Clinical Data in accordance with the licenses set forth in Section 8.4; and GARDP shall provide, at a minimum and at its expense, at least one copy of the Clinical Data to Shionogi upon completion of each applicable clinical study.
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Schedule F: Provisions for Sublicense Agreement
6. Intellectual Property.
Licensor (or its Affiliates) will own the entire right, title and interest in and to any and all inventions conceived solely by its employees and agents before, on or after the Effective Date relating to the Licensed Compound or any Licensed Product, including the Licensed Rights and any such inventions that constitute an adaptation of any manufacturing process or proprietary drug delivery or formulation technology of Licensor or its Affiliates for the production of the Licensed Compound or any Licensed Product, and any patents covering such invention (Licensor Sole Inventions), subject to the license granted to Sublicensor.
Manufacturing Process Results
(a) To the extent Sublicensee accepts a Technical Transfer Package, or otherwise has access to any non–public proprietary information or confidential information of Licensor relating to the manufacturing process used by Licensor to manufacture Licensed Compound and Licensed Product (not including the specifications of the Licensed Compound or Licensed Product that are required for a Sublicensee to demonstrate that the Licensed Compound or Licensed Product manufactured by the Sublicensee using its process are pharmaceutically equivalent to the Licensed Compound or Licensed Product manufactured using Licensor’s manufacturing process):
(i) Licensor shall own (and shall have the sole right to patent or not to patent) all inventions and results developed or generated by the Sublicensee related to the process to manufacture Licensed Compound or Licensed Product (Process Results) (whether or not patentable) that are specific to the Licensed Product and/or that incorporate any non–public proprietary information or confidential information or intellectual property of Licensor and Sublicensee will provide reasonable assistance to Licensor, as may be required, for such prosecution; and
(ii) Sublicensee shall own (and shall have the sole right to patent or not to patent) all Process Results (whether or not patentable) solely to the extent separable from the Licensed Product (i.e., that such can be used to manufacture products other than the Licensed Product) and that do not incorporate any non–public proprietary information or confidential information of Licensor.
(b) If Sublicensee has not accepted a Technical Transfer Package, and has not had access to any non–public proprietary information or confidential information of Licensor relating to Licensor’s manufacturing process (not including the specifications of the Licensed Compound or Licensed Product that are required for a Sublicensee to demonstrate that the Licensed Compound or Licensed Product manufactured by the Sublicensee using its process are pharmaceutically equivalent to the Licensed Compound or Licensed Product manufactured using Licensor’s manufacturing process):
(i) Sublicensee shall own (and shall have the sole right to patent or not to patent) all Process Results (whether or not patentable) developed or generated by or for them that do not incorporate any non–public proprietary information or confidential information of Licensor.
Development Activity Sublicense Results
(a) With respect to any inventions, know–how or results (whether or not patentable) developed or generated by or for Sublicensor and/or Sublicensee in the performance of any Development activities conducted pursuant to this Sublicense Agreement other than Development activities relating to Manufacturing (the results of which are Process Results governed by the terms above) (Development Results):
(i) Licensor shall own (and shall have the sole right to patent or not to patent) all Development Results that are specific to the Licensed Product and/or that incorporate any non–public proprietary information or confidential information or intellectual property of Licensor.
(ii) notwithstanding the above, Sublicensor shall own the clinical data associated with or arising from clinical studies conducted pursuant to this Sublicense Agreement (Clinical Data), but may use such Clinical Data only for the purposes consistent with this Sublicense Agreement and the License Agreement; and Licensor and Sublicensor shall have the right to access and use all such Clinical Data in accordance with the licenses set forth in this Sublicense Agreement and the License Agreement, and Sublicensor or Sublicensee, as applicable, shall provide at least one copy of the Clinical Data to Licensor upon completion of each applicable clinical study.