Overall Project. The Parties desire to collaborate with respect to the research and development of Products, as set forth in more detail in this Article 2, within the Field, with the goal of identifying one or more Development Candidates for clinical development and commercialization in the Field.
Overall Project. The Parties desire to collaborate with respect to the pre-clinical development of a Development Candidate, as set forth in more detail in this Article 2, in each Subfield within the Field, with the goal of identifying one or more Development Candidates for clinical development and commercialization in each Subfield. Penn will be responsible for preclinical development activities, including all IND-enabling non-clinical studies, manufacture of research grade vectors to support pre-clinical studies, and all other activities assigned to Penn in the Research Plan. Licensee will be responsible for manufacture of vectors for IND-enabling studies, regulatory strategy and operations, clinical development, GMP manufacture in support of Licensee’s activities, and commercialization of all Licensed Product.
Overall Project. The Parties desire to collaborate with respect to the pre-clinical development of Licensed Products, as set forth in more detail in this Article 2, in each Indication within the Field of Use, with the goal of identifying one or more Licensed Products for clinical development and commercialization in each Indication. As more specifically outlined herein, Penn will be responsible, in consultation with Licensee through the JSC, for preclinical development activities, including all IND-enabling non-clinical studies and research grade manufacturing, and all activities set forth in the Research Plan that are not identified therein as Licensee’s responsibilities. Licensee will be responsible for regulatory strategy and operations, clinical development, GMP manufacture, and commercialization of all Licensed Product.
Overall Project. The Parties desire to collaborate with respect to the pre-clinical development of an AAV gene therapy product, as set forth in more detail in this Article 2, for each Indication within the Field of Use, with the goal of designating one Licensed Product for clinical development and commercialization for each Indication in the Field of Use. Penn will be responsible for preclinical development activities, including all IND-enabling non-clinical studies and research grade manufacturing, and all activities allocated to Penn as set forth in the Research Plan. Licensee will be responsible for those activities allocated to Licensee in the Research Plan and for regulatory strategy and operations, clinical development, cGMP manufacture, and commercialization of all Licensed Product(s).
Overall Project. The Parties desire to collaborate with respect to the pre-clinical development of a parvovirus gene therapy product, as set forth in more detail in this Article 2, for each Indication within the Field of Use, with the goal of designating one Licensed Product for clinical development and commercialization for each Indication in the Field of Use. Penn will be responsible for preclinical development activities, including all IND-enabling non-clinical studies and research grade manufacturing, and all activities allocated to Penn as set forth in a Research Plan. Licensee will be responsible for those activities allocated to Licensee in a Research Plan and for regulatory strategy and operations, clinical development, cGMP manufacture, and commercialization of all Licensed Product(s).
Overall Project. The Parties desire to collaborate with respect to the pre-clinical development of Licensed Products, as set forth in more detail in this Article 2, in each Indication within the Field of Use, with the goal of identifying one or more Licensed Products for clinical development and commercialization in each Indication. As more specifically outlined herein, Licensor will be responsible, in consultation with Licensee through the JSC, for preclinical development activities, including IND-enabling studies, GMP clinical manufacturing, natural history studies, FIH Clinical Studies and compassionate use studies (if authorized by Licensee) and all activities set forth in Research Program SRAs that are not identified therein as Licensee’s responsibilities. Licensee will be responsible for regulatory strategy and operations, clinical development, GMP commercial scale manufacture, process development, commercial development, business development, corporate infrastructure and commercialization of all Licensed Product.
Overall Project. 3.1 Each Party agrees that the Overall Project will be undertaken in a manner consistent with achieving the Overall Plan.
Overall Project. The Condominium is a part of a planned unit development (PUD) to be known as Union Place which has been generally approved under the Somerville Zoning Code amendments for this project. As presently conceived and permitted, the project entails Five primary phases. The first is the development of the 000-000 Xxxxxxx Xxxxxx Condominium; the second is a parking garage (eventually with additional space); the third is,432 Norfolk Street, a 35 unit building is complete; and the fourth is this condominium, a 46 unit residential building which is currently under construction. Under the applicable zoning ordinance, preliminary approval is first required for the entire project and then individual special permit approval is processed for each separate phase. The first 3 phases are complete. Phase five contemplates a commercial building in front of the garage that is presently in the design stage. Additionally, there is the possibility that the SELLER may incorporate abutting parcels, with existing or new buildings and improvements into the project, after first obtaining approval for such under the applicable zoning code provisions.
Overall Project. Pursuant to the First Collaboration Agreement, the Parties desired to, and did, collaborate with respect to the pre-clinical development of a parvovirus gene therapy product, for each Indication within the Field of Use, with the goal of designating one Licensed Product for clinical development and commercialization for each Indication in the Field of Use. From and after the Effective Date and during the Research Term, the Parties desire to collaborate with the goal of the Xxxxxx Lab completing those activities allocated to Penn and set forth in the Research Wind-Down Plan for the applicable Research Program for an Indication within the Field of Use [***] in order to enable a smooth and effective transition to Licensee (or its designee) of activities with respect to the further research, development, manufacture, and commercialization of Licensed Products for the relevant Indication. After the Effective Date, Licensee will be responsible for those activities allocated to Licensee in a Research Plan and for any development activities performed outside of the Research Program during the Research Term as contemplated by this Agreement and/or after expiration of the Research Term, as well as regulatory strategy and operations, clinical development, cGMP manufacture, and commercialization of all Licensed Product(s).
Overall Project
