Commercial Sublicensee means any Person that has been approved by Shionogi and GARDP to Commercialize Licensed Product in one or more countries in the Territory and with which GARDP has entered into a commercial sublicense agreement (each a Commercial Sublicense Agreement). For clarity, the Sublicensee may also be a Commercial Sublicensee if and when it enters into a Commercial Sublicense Agreement with GARDP. Commercial Sublicense means the commercial sublicense granted to a Commercial Sublicensee under a Commercial Sublicense Agreement.
Manufacturing Approvals means any manufacturing approvals or quality assurance assessments that may be required for the Sublicensee to Manufacture Licensed Compound and Licensed Product at the Facility in accordance with this Sublicense Agreement and to sell Licensed Product to Customers for subsequent Commercialization in the Territory, including without limitation the WHO Prequalification for the Manufacture of Licensed Compound and Licensed Product by the Sublicensee at the Facility(ies).
Minor Changes means changes to the chemistry, manufacturing and controls information described in the marketing authorisation for a given medicinal product that have minimal or no impact on the quality, safety or efficacy of the medicinal product and that do not require prior approval from the competent Regulatory Authority before implementation by the marketing authorisation holder (and that would not, if such change were made to a marketing authorisation approved by the European Medicines Agency, require the prior approval of the competent European Regulatory Authority under applicable European regulations and guidelines).
Process Results – all inventions and results developed or generated by the Sublicensee related to the process to manufacture Licensed Compound or Licensed Product [§8.1(a)(i)].
Sublicense Results means any results and know-how and inventions, patentable or not, developed or generated by or for the Sublicensee in the performance of any activities conducted pursuant to this Sublicense Agreement. This includes all Process Results.
Sublicensed Rights means:
(a) the patents and patent applications owned or Controlled by Shionogi within India related to the Licensed Compound or Licensed Product or their Manufacturing or use that are listed on Schedule B;
(b) any continuation, continuation-in-part (but only to the extent that such application includes new data in support of claims previously submitted in a prior originally filed application), divisional, and continued-prosecution applications of any patent applications included in paragraph (a); and
(c) any patents issuing from any patent applications included in the paragraphs (a) and (b), in each case, including any renewals, extensions, patents of addition, supplementary protection certificates, revivals, re-examinations, and reissues thereof; and
(d) the data, information, and documentation that are owned or Controlled by Shionogi related to the Licensed Compound and/or the Licensed Product, and in particular the Manufacture thereof, that are necessary for the Manufacture of the Licensed Compound and/or the Licensed Product and disclosed or made available to the Sublicensee in connection with this Sublicense Agreement, all as set forth in Schedule C, which schedule may be updated from time to time by mutual agreement of the Parties. For clarity, the Sublicensed Rights include the Sublicensed Manufacturing Know-How.
Sublicensed Manufacturing Know-How means all technical information and know-how owned and/or Controlled by Shionogi or its Affiliates as of the Shionogi License Agreement Effective Date and licensed from Shionogi to GARDP under the Shionogi License Agreement (including all manufacturing data, the percentages and specifications of ingredients, the manufacturing process, specifications, assays, quality control, and testing procedures) that has been identified by Shionogi, in its good faith judgment, as reasonably necessary for the Manufacture of the Licensed Compound and/or Licensed Product in substantially the same manner that such Licensed Compound or Licensed Product have been manufactured by or for Shionogi as of the Shionogi License Agreement Effective Date, including without limitation all of such disclosed or made available pursuant to Sections 4.1 or 4.2 below.
Territory means the countries listed in Schedule D.
2. SHIONOGI LICENSE AGREEMENT
2.1 Compliance with Shionogi License Agreement
The Sublicensee confirms that it has reviewed the terms and conditions of the Shionogi License Agreement, as published on GARDP’s website. The Sublicensee acknowledges and agrees that this Sublicense Agreement and Sublicensee’s rights and obligations under it are subject and subordinate to, and the Sublicensee shall comply with, all terms and conditions of the Shionogi License Agreement applicable to GARDP’s sublicensees thereunder. To the extent that the Shionogi License Agreement explicitly requires that any terms or conditions be included in any agreement granting a sublicense under the Shionogi License Agreement, such terms and conditions are deemed to be incorporated by reference in this Sublicense Agreement. More generally, the Sublicensee shall not perform any acts or make any omissions that would place GARDP in breach of its obligations under the Shionogi License Agreement. For the avoidance of doubt, any right of GARDP under the Shionogi License Agreement not expressly sublicensed to the Sublicensee under this Sublicense Agreement remains the right of GARDP and is not implicitly sublicensed to the Sublicensee.
3. LICENSE GRANT
3.1 License to Sublicensed Rights and Sublicensed Manufacturing Know-How
(a) Upon the terms and subject to the conditions set out in this Sublicense Agreement, GARDP hereby grants to the Sublicensee, and the Sublicensee hereby accepts, a nonexclusive, non-sublicensable, royalty-free, non-transferable license under the Sublicensed Rights and the Sublicensed Manufacturing Know-How to Manufacture the Licensed Compound and Licensed Product at the Facility(ies) exclusively for sale to Customers for use and distribution in the Field in the Territory and to obtain Manufacturing Approvals, strictly in accordance with this Sublicense Agreement and the Sublicense Access Plan.
(b) Notwithstanding the non-exclusive nature of the license granted by GARDP to the Sublicensee, GARDP undertakes, so long as Orchid is complying with its diligence obligations in accordance with the Sublicense Access Plan and is otherwise in compliance with this Agreement, not to grant any other sublicense under the Sublicensed Rights and the Sublicensed Manufacturing Know-How to Manufacture the Licensed Compound and Licensed Product during a period of 5 years following the Effective Date. Further, GARDP undertakes that it will not grant any such other manufacturing sublicense for an additional 2 years (i.e. until the 7 year anniversary of the Effective Date) so long as the demand for cefiderocol in the Territory is at most 1.5 million doses per year, Orchid is complying with its diligence obligations in accordance with the Sublicense Access Plan and is otherwise in compliance with this Agreement and Orchid is able to supply that demand during such 2-year period.
(c) These sublicense rights shall also include the right for the Sublicensee to conduct Development activities relating to chemistry, manufacturing and controls (CMC) and Manufacturing process Development activities conducted as part of the Technical Transfer, including without limitation testing activities required to demonstrate the pharmaceutical equivalence of Licensed Compound and Licensed Product Manufactured by the Sublicensee with those Manufactured by Shionogi (such activities collectively, “CMC Development Activities”), but excluding any and all other Development activities; provided, however, that Sublicensee may not perform or have performed any CMC Development Activities without the prior written consent of GARDP and Shionogi. Notwithstanding the above, Development activities that only relate to potential Minor Changes to the CMC and/or Manufacturing process shall not require the prior written consent of GARDP and Shionogi, but the Sublicensee shall provide prior written notification describing in detail any of such proposed Minor Changes to GARDP and Shionogi at least fourteen (14) days before the date on which Orchid seeks to implement such Minor Changes (the “Proposed Implementation Date”). Orchid shall not implement any such changes before GARDP and Shionogi confirm in writing their agreement that such proposed changes constitute Minor Changes; provided, however, that Orchid shall be free to move forward with implementation if neither GARDP nor Shionogi object to the proposed Minor Changes prior to the Proposed Implementation Date. Without limiting the foregoing, any and all preclinical Development activities relating to the therapeutic indications of Licensed Compound or Licensed Product and all clinical Development activities are excluded from the license granted under this Sublicense Agreement, and the Sublicensee shall have no right to conduct any such activities under this Sublicense Agreement
(d) The Sublicensee will not have any right to practice the Sublicense granted under this Section 3.1 or otherwise exploit the Sublicensed Rights and Sublicensed Manufacturing Know-How for any other purpose. In particular, the Sublicensee may not Manufacture or sell the Licensed Compound and/or Licensed Product in combination with other active pharmaceutical ingredients.
(e) For sake of clarity, no Commercialization rights of Licensed Compound or Licensed Product are granted to the Sublicensee pursuant to this Sublicense Agreement. The Sublicensee may not sell, transfer or supply Licensed Compound to any other person (including any Customer) and shall only sell, transfer or supply Licensed Product to Customers.
3.3 Sublicensee Sublicense Access Plan Commitment
The Sublicensee shall use its best efforts to achieve the Manufacturing and Manufacturing Approval objectives and specific target dates set out in the Sublicense Access Plan in furtherance of the Access and Stewardship Objectives.
Should the Sublicensee not achieve any of the objectives set out in the Sublicense Access Plan by the corresponding target dates, the Parties shall consult in good faith to discuss the situation, the causes of any such delays, and possible actions to minimize the delay and/or prevent future delays. If requested by GARDP, the Parties shall discuss and agree an access action plan to remedy the situation (each an “Access Action Plan”), and the Sublicensee shall diligently and in good faith implement the Access Action Plan.
3.4 No Trademark License; No Trademark Registration
No right or license, express or implied, is granted to the Sublicensee under this Sublicense Agreement to use any trademark, trade name, logo, trade dress, or service mark owned or Controlled by GARDP or by Shionogi or any of its Affiliates.
The Sublicensee shall have no right pursuant to this Sublicense Agreement to develop, register or use any trademarks or distinctive trade dress or product markings in connection with Licensed Compound and/or Licensed Product Manufactured under this Sublicense Agreement, in respect of which the Sublicensee may only use the international nonproprietary name cefiderocol and/or cefiderocol sulfate tosylate.
3.5 No Implied License
No license or other right is or will be created or granted under this Sublicense Agreement by implication, estoppels or otherwise. All licenses and rights are or will be granted only as expressly provided in this Sublicense Agreement.
3.6 Retained Rights
(a) All rights not expressly granted under this Sublicense Agreement are reserved by Shionogi and GARDP, as applicable, and Shionogi’s and GARDP’s use thereof for any purpose is not restricted by this Sublicense Agreement.
(b) Without limiting the foregoing, Shionogi retains any and all rights under the Sublicensed Rights and Sublicensed Manufacturing Know-How to make, have made, use, offer for sale, sell, have sold, export, import, license or exploit:
(a) the Licensed Compound and products containing the Licensed Compound for any use whether within or outside the Territory and whether within or outside the Field; and
(b) compounds other than the Licensed Compound covered by one or more claims in the patents included in the Sublicensed Rights, for any use.
(c) Shionogi and GARDP also expressly reserve and retain the right to make or have made, and use, the Licensed Compound and the Licensed Product for any internal research purpose.
3.9 Sublicensee Contractors
The Sublicensee may perform its obligations under this Sublicense Agreement through one or more collaborators, consultants, agents or other contractors (Sublicensee Contractors) acting on behalf of the Sublicensee; provided that: (a) the activities of such Sublicensee Contractors would not require a sub-sublicense to the Sublicensed Rights (it being understood that the fact that a Sublicensee Contractor has had access to use Confidential Information in and of itself shall not require a sub-sublicense for the purposes hereof); (b) the Sublicensee remains entirely responsible for such performance in accordance with the terms and conditions of this Sublicense Agreement as if such obligations had been performed directly by the Sublicensee, and (c) the Sublicensee shall have entered into a written agreement with such Sublicensee Contractors ensuring that the Sublicensee shall be able to comply with its obligations under this Sublicense Agreement applicable to the activities conducted by the Sublicensee Contractor, including confidentiality obligations in accordance with Section 10.2(d) and, if applicable, obligations requiring the Sublicensee Contractor to assign to the Sublicensee all intellectual property rights in and to any results generated by them in a manner that enables the Sublicensee to comply with its obligations in relation thereto as set out in Section 8. The Sublicensee shall in particular ensure that all Sublicensee Contractors comply with all quality and Manufacturing standards applicable to the activities conducted by them, including without limitation those contemplated in Sections 6.2 through 6.4 hereto.
Schedule H attached hereto contains a table of all Sublicensee Contractors that the Sublicensee currently intends to engage to conduct any activities under this Sublicense Agreement, indicating for each the activities to be conducted by the Sublicensee Contractor and the location where such activities will be conducted. The Sublicensee shall from time to time, and in any case prior to engaging a Sublicensee Contractor that is not included in the table or modifying the activities to be conducted by a Sublicensee Contractor, provide GARDP with an updated version of the table.
The Sublicensee may not engage any Sublicensee Contractors to conduct activities involving the production or making of Licensed Compound or Licensed Product without GARDP’s prior written consent.
For clarity, the Sublicensee may not grant to Sublicensee Contractors any sublicense rights to Develop, Manufacture or Commercialize Licensed Compound or Licensed Product for their own account or benefit, or any right to produce, make or sell Licensed Compound or Licensed Product, it being understood that ancillary Manufacturing activities (such as conducting certain tests on samples or storage) that do not involve the production of Licensed Compound or Licensed Product may be subcontracted by the Sublicensee to Sublicensee Contractors solely to assist Sublicensee in the performance of its obligations hereunder.
8. INTELLECTUAL PROPERTY, PATENT MAINTENANCE, INFRINGEMENT
8.1 Intellectual property
(a) Manufacturing Process Results […]
(iii) Shionogi shall have the sub-licensable right to use all Process Results not owned by it for development, regulatory filings, manufacturing, commercialization or otherwise to enable or facilitate access to any product containing cefiderocol worldwide.
(b) General Conditions Applicable to all Sublicense Results
(i) The Sublicensee grants Shionogi a free, perpetual, nonexclusive, sub-licensable license to use Sublicense Results owned by the Sublicensee (including any intellectual property rights thereon) for the Development, Manufacture, and Commercialization, of the Licensed Product worldwide.
(ii) The Sublicensee grants GARDP a free, nonexclusive, sublicensable license to use Sublicense Results owned by the Sublicensee (including any intellectual property rights thereon) for the Development, Manufacture, and Commercialization of the Licensed Product in the Territory pursuant to the Agreement.
(iii) All Sublicense Results owned by Shionogi (including any intellectual property rights thereon) shall be included in the License Rights licensed to Shionogi pursuant to the Agreement and Sublicensed to Sublicensee pursuant to this Sublicense Agreement.