Provision Language
Definitions
“Licensed Manufacturing Know-How” means all Know-How that (a) is Controlled by VALNEVA or any of its Affiliates as of the Effective Date, (b) is Developed by VALNEVA during the Term of this Agreement, and (c) directly relates to the fill & finish Manufacture of the VALNEVA Product but does not include the Know-How relating to VALNEVA Drug Substance and/or related processes. The detailed scope of the Licensed Manufacturing Know-How is defined in the Technology Transfer Agreement.
“Licensed Patents” means i) the patents listed in Annex 2 of this Agreement and ii) any other future patents that may be filed during the Term of this Agreement by VALNEVA both i) and ii) in as far they are related to the Licensed Manufacturing Know-How.
“Licensed Technology” means the Licensed Manufacturing Know-How, and the Licensed Patents.
“VALNEVA Drug Substance” shall mean the active ingredient of the VALNEVA Product as further defined in the Drug Substance Supply Agreement.
3. License Grant to SIIPL.
3.1 Commercial License. Subject to terms and conditions of this Agreement, VALNEVA hereby grants to SIIPL an exclusive, sub-licensable, and profit sharing license to use the Licensed Technology solely together with the VALNEVA Drug Substance supplied by VALNEVA to Develop, Manufacture Commercialize and otherwise Exploit, either through SIIPL directly or through its pre-approved Sub-licensees or Subcontractors, the SIIPL Product, in the SIIPL Territory in the Field during the Term of this Agreement (“Commercial License“). For clarification, the license granted as it relates to the use of VALNEVA’s regulatory dossier (“Dossier“) is restricted to the limited use necessary for regulatory purposes.
3.2 Covenant Not to Sue. SIIPL will not sue VALNEVA and/or any of VALNEVA Affiliates or sublicensee(s) on any matter relating to any Improvement made and/or Controlled by VALNEVA and/or its Affiliates to its Licensed Technology, and further SIIPL will not challenge the validity of the Licensed Patents.
3.3 Sublicense and Subcontractors. The Parties agree that SIIPL may grant, subject to preapproval by VALNEVA, a sublicense (in whole or in part) under the licenses as set forth in this Section 3 to a Sub-licensee. A sublicense to SIIPL’s affiliates does not require any pre-approval, however SIIPL agrees to provide VALNEVA with not less than [***] prior written notice of such affiliate. For clarity, a sub-license to any Third Party requires VALNEVA’s prior written consent. SIIPL shall provide VALNEVA with a redacted copy of each agreement with such pre-approved Sub-licensee. SIIPL shall ensure that any sublicense granted in accordance with the terms of this Agreement shall be on similar terms and conditions as stipulated in this Agreement, however such terms and conditions may not be less stringent than those provided in this Agreement. SIIPL shall remain responsible for the performance of its Sub-licensees, hereunder. For the sake of clarity, it is hereby agreed between the Parties that, as of the Effective Date of this Agreement, SIIPL will be the sole legal entity provided with a license to the Licensed Technology. […]
6. Development Plan, Regulatory Activities, Diligence, and potential Clinical Trials
[…]
6.5 Diligence Obligations. SIIPL will perform all activities set forth in the Development Plan in accordance with Applicable Law and use its best efforts to perform all such activities in accordance with the applicable timeframes set forth in the Development Plan, including but not limited to the obligation to apply for and use Commercially Reasonable Efforts to 1) obtain Regulatory Approval and/or licensure of the SIIPL Product within the SIIPL Territory, 2) obtain WHO prequalification, and 3) Commercialize the SIIPL Product in the SIIPL Territory. The Parties have agreed that SIIPL shall prioritize and use Commercially Reasonable Efforts to obtain Regulatory Approval and licensure of the SIIPL Product in the Key Countries. SIIPL shall use best efforts to implement the Launch Readiness Plan for Key Countries in accordance with agreed timelines. In case SIIPL fails to provide and implement such Launch Readiness Plan within the agreed timelines, Section 4.5 shall apply. SIIPL shall use Commercially Reasonable Efforts to apply for WHO prequalification no later than [***] after Regulatory Approval in India. SIIPL shall further use Commercially Reasonable Efforts to pursue UNICEF procurement of the SIIPL Product within the SIIPL Territory within [***] of obtaining WHO prequalification. SIIPL shall use best efforts to ensure the SIIPL Product is added onto the National Immunization Program of India and other Key Countries within [***] of Regulatory Approval of the SIIPL Product in India and other Key Countries, as applicable.
8. Manufacture and Commercialization.
[…]
8.26 Supply Commitment.
8.26.1 Diligent Commercial Efforts. SIIPL shall at all times during the Term of this Agreement diligently Commercialize and otherwise Exploit the SIIPL Product in the SIIPL Territory in sufficient quantities to satisfy market demands the same being subject to fulfillment of VALNEVA’s obligations under the Drug Substance Supply Agreement to adequately supply VALNEVA Drug Substance without material delay. In addition, SIIPL shall supply the SIIPL Product in accordance with the requirements set forth in the CEPI Side Letter.
9. Trade Name and Trademarks.
9.1 Product Trade Name and Product Trademarks. SIIPL shall market, distribute, sell or otherwise Commercialize the SIIPL Product in the SIIPL Territory under a different trade name and/or trademark(s) than the VALNEVA Product (“SIIPL Trade Name” and “SIIPL Trademark” respectively). SIIPL shall be the owner and exclusively hold all rights in the SIIPL Trade name and SIIPL Trademark.
9.2 Trademark. Neither Party shall use any trademark of, or any trademark similar to that of, the other Party.