Provision Language
7. With regard to the BMGF [*****] Vaccines, GSK hereby grants to CureVac and BMGF for these products or product candidates at any stage of development the following licenses (provided that BMGF confirms that it will not be entitled to exercise the licenses unless and until the Global Access License (as defined in the Global Access Commitments Agreement on the Effective Date) is properly exercised:
a) a non–exclusive, royalty–free, fully paid–up, perpetual, irrevocable license under the Licensed GSK IP for the sole purpose of researching and developing the BMGF [*****] Vaccines (including associated import and export) anywhere in the world; provided, that clinical studies conducted outside the Access Countries and interactions with regulatory authorities outside the Access Countries must be approved in advance and in writing by GSK, with this approval not to be unreasonably conditioned, withheld, or delayed; and
b) a non–exclusive, royalty–free, fully paid–up, perpetual, irrevocable license under the Licensed GSK IP to manufacture or have manufactured the BMGF [*****] Vaccines (including associated import and export) anywhere in the world, for the sole purpose of supporting the making available and accessible of BMGF [*****] Vaccines for the benefit of people in Access Countries (as defined in the Global Access Commitments Agreement on the Effective Date) in accordance with the BMGF Agreements; and
c) a non–exclusive, royalty–free, fully paid–up, perpetual, irrevocable license under the Licensed GSK IP to market, distribute, offer for sale and/or sell BMGF [*****] Vaccines in Access Countries; and
CureVac may sublicense the rights granted under the aforementioned licenses as reasonably necessary to conduct Projects for BMGF [*****] Vaccines or satisfy its Global Access commitments for BMGF [*****] Vaccines.
BMGF may sublicense the rights granted under the aforementioned licenses in accordance with the terms of the Global Access License set forth in the Global Access Commitments Agreement if such Global Access License is exercised. Where CureVac or BMGF subcontracts portions of the activities set forth in items (a) and (c) above to a third party, such subcontractor shall equally constitute a sublicensee. CureVac and BMGF shall remain liable to GSK for any act or omission of their respective sublicensees (whereby CureVac shall not be liable to GSK for any act or omission by BMGF and BMGF shall not be liable to GSK for any act or omission by CureVac).
Where as a result of the use or exploitation by CureVac or BMGF or their permitted sublicensees of Licensed GSK IP through the development, manufacture or commercialisation of the BMGF [*****] Vaccines, GSK would owe a consideration to third party licensor of a Patent or Know-How Controlled by GSK pursuant to a license held by GSK or its affiliates that is in addition to the consideration owed for the development, manufacture or commercialisation of GSK [*****] Vaccines or other GSK products licensed under such head license, GSK may restrict the scope of such head license to the GSK [*****] Vaccines unless GSK, CureVac and BMGF, acting reasonably and in good faith, have reached an agreement regarding the reimbursement of such additional consideration attributable to the development, manufacture or commercialization of the BMGF [*****] Vaccines (provided, that BMGF may elect in writing to forego such license, in which case, GSK may restrict such head license without engaging in such negotiation).
Consistent with the principles set forth in Section 6 and this Section 7, GSK grants CureVac an exception to the exclusivity of the license granted by CureVac to GSK under the Patents and Know-How Controlled by CureVac pursuant to the CLA, limited to the specific purpose of enabling CureVac to grant BMGF the Global Access License (as defined in the Global Access Commitments Agreement on the Effective Date) under those Patents and Know-How Controlled by CureVac with regard to the BMGF [*****] Vaccines.
For the purpose of this letter agreement, the following capitalized terms will have the following meanings:
“Licensed GSK IP” shall mean the Patents and Know-How Controlled by GSK resulting from the development, manufacture or other exploitation of the GSK [*****] Vaccines in accordance with the CLA, excluding any GSK Background IP, whereby: –
“Patents” shall mean any and all patents and patent applications, including provisional and non–provisional applications, reissues, extensions, substitutions, confirmations, re–registrations, re–examinations, re–validations, patents of addition, supplementary protection certificates or the equivalents thereof, continuations, continuations–in–part and divisionals thereof and all foreign counterparts, and the like of any of the foregoing.
“Know-How” shall mean all technical, scientific and other information, inventions, discoveries, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, expressed ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, development data, results, non–clinical, clinical, safety, process and manufacturing and quality control data and information (including trial designs and protocols), and registration dossiers, in each case solely to the extent confidential and/or proprietary and in written, electronic or any other form now known or hereafter developed.
“Controlled” shall mean with respect to a Patent or item of Know-How, that a party or its affiliate owns or co–owns or has a license as of or after the Effective Date under such Patents or Know-How sufficient to grant the license in question, provided that any Patents and Know-How licensed by CureVac to GSK under the CLA will not constitute Patents and Know-How Controlled by GSK for the purpose of this letter agreement.
“GSK Background IP” means any Patents and Know-How Controlled by GSK at the Effective Date or generated or acquired by or on behalf of GSK thereafter outside of the scope of the CLA or this letter agreement.
8. BMGF acknowledges and agrees that in consideration of the aforementioned access to information, development data and the aforementioned acknowledgements and agreements by GSK and the aforementioned licenses granted by GSK, CureVac shall remain released with regard to the CLA Products as set forth in Sections 1 and 2, notwithstanding the fact such products may benefit from, rely on or incorporate data, intellectual property or other elements that qualify as Funded Developments (as defined in the BMGF Agreements on the Effective Date). GSK acknowledges and agrees that in consideration of the aforementioned access to information, development data and the aforementioned acknowledgements and agreements by BMGF and the hereinafter licenses granted by CureVac, CureVac shall have the right under the license granted above to use any Licensed GSK IP and Patents and Know-How licensed by CureVac to GSK under the CLA in connection with any Project(s) relating to a BMGF [*****] Vaccine and that such Licensed GSK IP and Patents and Know-How may become incorporated in BMGF [*****] Vaccines or other Funded Developments related thereto. GSK confirms that it will disclose to CureVac during the term of the CLA any “Invention” which shall mean an invention or discovery, whether or not patentable, discovered, made, conceived and/or first reduced to practice during the term of the CLA by or on behalf GSK or Affiliates of GSK, alone or jointly with each other and/or any third party, which arise from the performance of activities under the CLA, including all related patents and patent applications, and will ensure that CureVac has access to all Know–Now included in the Licensed GSK IP.