Lion Sample Clauses

Lion. Develop, implement, and evaluate GMP procedures for the large-scale production of unmodified TIL suitable for infusion into patients with metastatic melanoma, bladder, lung, breast, and HPV-associated cancers as specified in “Goals”. - Conduct studies including scale-out for the methods of expansion of individualized lymphocyte treatments, assays for product and in-process performance, and harmonization assays for centralized process development and determination of TIL product consistency. Additional studies may be conducted for the development of qualifying assays and process development related to scale-out of the TIL expansion process. - Consult with the FDA to determine the appropriate clinical trial design necessary to secure approval for the commercial development of unmodified TIL therapy for patients with those cancers as specified in “Goals” and sponsor the IND for these new clinical protocols. Serve as the coordinating center for the multicenter licensing clinical trials. - Supply TIL in sufficient quantities to complete the planned clinical trials sponsored by Lion (including the licensing trial) needed for FDA approval of unmodified ACT/TIL therapy Surgery Branch, NCI and Lion - Develop SOP for large scale TIL growth, selection and testing to support the FDA approval of unmodified ACT/TIL therapy. Attend joint meetings with the FDA to define the exact format and criteria needed in the clinical trial(s) to obtain FDA approval. Develop, conduct and evaluate multi-institutional clinical trials (to include the NCI Surgery Branch as a clinical trial site) for patients with metastatic melanoma, bladder, lung, breast, and HPV-associated cancers (as specified in “Goals”) treated with unmodified TIL that can be used as licensing trials required for FDA approval and subsequent commercialization of unmodified ACT/TIL therapy. - Conduct assays to be used in the selection of appropriate cells (based on both functional and phenotypic criteria) to optimize the effectiveness of the adoptive transfer. - Exchange information and expertise to further the successful development of unmodified TIL therapy for patients with those cancers as specified in “Goals”. For the avoidance of doubt, exchanging information includes but is not limited to the transfer of preclinical and clinical data. In addition, both Parties shall meet or conduct conference calls on a regular basis (no less than once a month) to exchange information and provide updates on the progress of the r...
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Lion releases and discharges Miles from any and all claims, known or unknown, asserted or not, arising from, by reason of, or related to, Miles's employment with LION, the termination of that employment, and any and all events through and including the date of this Agreement. This release includes, but is not limited to, any claim under any federal, state, or local law, or other authority, be they based in statute, contract, tort, or common law theories. LION agrees not to seek any personal recovery (of money damages, injunctive relief or otherwise) for the claims it is releasing herein, either through any complaint to any governmental agency or otherwise. LION further agrees never to start any lawsuit or arbitration asserting any of the claims it is releasing above.
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Lion. 3.3.4 Owl
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Lion. If no Default or Event of Default has occurred and is continuing, or would occur as a consequence thereof, the foregoing provisions shall not prohibit the following Restricted Payments:
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Lion. 3.3.4 Owl 3.3.5 Rose 3.3.6 Xxxxx
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Related to Lion

  • Logistics The Licensee shall be responsible for:

  • Cornerstone shall notify the LLC and confirm such advice in writing (i) when the filing of any post-effective amendment to the Registration Statement or supplement to the Prospectus is required, when the same is filed and, in the case of the Registration Statement and any post-effective amendment, when the same becomes effective, (ii) of any request by the Securities and Exchange Commission for any amendment of or supplement to the Registration Statement or the Prospectus or for additional information and (iii) of the entry of any stop order suspending the effectiveness of the Registration Statement or the initiation or threatening of any proceedings for that purpose, and, if such stop order shall be entered, Cornerstone shall use its best efforts promptly to obtain the lifting thereof.

  • Millwright In the case of a job site located outside a millwright’s region of residence, the employer may assign a millwright holding a journeyman competency certificate or an apprentice competency certificate anywhere in Quebec, provided the millwright has worked 1,500 or more hours for the employer in the construction industry in Quebec or elsewhere in Canada during the first 24 months of the 26 months preceding the issuance or renewal of his competency certificate, as follows:

  • Asset Management Supplier will: i) maintain an asset inventory of all media and equipment where Accenture Data is stored. Access to such media and equipment will be restricted to authorized Personnel; ii) classify Accenture Data so that it is properly identified and access to it is appropriately restricted; iii) maintain an acceptable use policy with restrictions on printing Accenture Data and procedures for appropriately disposing of printed materials that contain Accenture Data when such data is no longer needed under the Agreement; iv) maintain an appropriate approval process whereby Supplier’s approval is required prior to its Personnel storing Accenture Data on portable devices, remotely accessing Accenture Data, or processing such data outside of Supplier facilities. If remote access is approved, Personnel will use multi-factor authentication, which may include the use of smart cards with certificates, One Time Password (OTP) tokens, and biometrics.

  • Dewatering 4.7.1 Where a part of a site is affected by surface water following a period of rain, thus rendering some areas unsafe for productive work, consistent with the Employer’s obligations under the OH&S Act, all non- trades employees shall assist in ‘dewatering’ their own work site or area if it is so affected. Such work to be paid at single time rates. Productive work will continue in areas not so affected.

  • Management Company 14 Maturity....................................................................14

  • Transportation Management Tenant shall fully comply with all present or future programs intended to manage parking, transportation or traffic in and around the Building, and in connection therewith, Tenant shall take responsible action for the transportation planning and management of all employees located at the Premises by working directly with Landlord, any governmental transportation management organization or any other transportation-related committees or entities.

  • Energy 1. Cooperation shall take place within the principles of the market economy and the European Energy Charter, against a background of the progressive integration of the energy markets in Europe.

  • AGREEMENT MANAGEMENT A. Contractor may change Project Manager but the Energy Commission reserves the right to approve any substitution of the Project Manager.

  • Classroom Management The certificated classroom teacher demonstrates in his/her performance a competent level of knowledge and skill in organizing the physical and human elements in the educational setting.

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