Development Timelines Sample Clauses

Development Timelines. The development timeline will be developed and agreed to by the Abbott and Epizyme Project Timeline Leads.

Development Timelines. It is hereby acknowledged that the Parties’ mutual strategic objective is to move one Supplemental MABA Alliance Product into Development at the earliest opportunity ([***]), to initiate and undertake clinical Development of at least one Supplemental MABA Alliance Product having regard to progress made with respect to the MABA Alliance Product currently in clinical Development and to move at least one MABA Alliance Product or one Supplemental MABA Alliance Product into subsequent Commercialization at the earliest opportunity. GSK will consult with the Joint Program Committee and will share, modify and further develop all applicable Development Plans and timelines in that forum. GSK will use Diligent Efforts to secure the necessary resources and will keep the Joint Program Committee informed on the progress of individual studies and activities relating to Supplemental MABA Alliance Products in accordance with Section 3.2.3 of the Agreement as amended by this Amendment.

Development Timelines. It is hereby acknowledged that GSK's strategic objective is [*]. GSK will consult with the Joint Project Committee and will share, modify and further develop all applicable Development Plans and timelines in that forum. It is recognised that success can be optimised [*]. At a strategic level, GSK is committed to this objective. However, at an operational level it is recognised that [*]. GSK will use Diligent Efforts to secure the necessary resource and will keep the Joint Project Committee informed on the progress of individual studies and activities relating to Collaboration Products as part of any changes to Development Plans and timelines. The current objective of the Collaboration is to achieve Marketing Authorization Approval in the US and other Major Markets for a Collaboration Product from one of the eight Pooled Compounds which can be used as a single agent and/or in combination with other therapeutically active components (including but not limited to a Long Acting Inhaled Corticosteroid) for the treatment and/or prophylaxis of one or more respiratory diseases [*] and Development Plans and timelines will be developed and/or refined in an effort to achieve this objective.

Development Timelines. MPP will require any Sublicensee that intends to further develop the compound into Licensed Product(s) to agree upon reasonable diligence requirements and development milestones. MPP will require any Sublicensee that intends to commercialize the Licensed Product(s) to agree upon reasonable registration and commercialization timelines.

Development Timelines. It is hereby acknowledged that GSK’s strategic objective is to move one or more of the Collaboration Products into Development at the earliest opportunity. GSK will consult with the Joint Project Committee and will share, modify and further develop all applicable Development Plans and timelines in that forum. It is recognised that success can be optimised by pursuing a number of Collaboration Products through various phases of clinical Development up to the point of Technical or Commercial Failure, and/or until the first Collaboration Product for both single agent and combination therapy achieves regulatory agency approval. At a strategic level, GSK is committed to this objective. However, at an operational level it is recognised that internal and external resources will be constrained from time to time, resulting in the need to prioritise individual studies and activities relating to Collaboration Products. GSK will use Diligent Efforts to secure the necessary resource and will keep the Joint Project Committee informed on the progress of individual studies and activities relating to Collaboration Products as part of any changes to Development Plans and timelines. The current objective of the Collaboration is to achieve Marketing Authorization Approval in the US and other Major Markets for a Collaboration Product from one of the eight Pooled Compounds which can be used as a single agent and/or in combination with other therapeutically active components (including but not limited to a Long Acting Inhaled Corticosteroid) for the treatment and/or prophylaxis of one or more respiratory diseases [***] and Development Plans and timelines will be developed and/or refined in an effort to achieve this objective.

Development Timelines. Licensee will use reasonable efforts to research and develop the Licensed Product through Phase 2 and, if the Licensed Product is determined to meet Licensee’s target regimen profile (“TRP”) and strategic objectives and receives marketing approval, help facilitate the distribution of the Licensed Products in the Field in the Target Countries (which Target Countries will be prioritized by Licensee based on cost- effectiveness, impact and other relevant factors) and in accordance with Licensee’s charitable mission, strategies, and priorities. In conducting its research, development, and other activities for the Licensed Product, Licensee will adhere with the then-current open access policy and Global Access objectives of the ▇▇▇▇ & ▇▇▇▇▇▇▇ ▇▇▇▇▇ Foundation (see ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/How-We-Work/General-Information/Open-Access- Policy and ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/How-We-Work/General-Information/Global- Access-Statement). In addition, subject to applicable laws and regulations, Licensee will broadly share data and results of its research and development of the Licensed Product, including with other collaborations and public-private partnerships working to develop new TB drugs and drug regimens. Licensee will be presumed to be in noncompliance of its diligence obligations hereunder if it fails to reach the milestones at the time points as defined in Exhibit C unless Licensee can demonstrate that its failure to achieve a particular milestone was caused by scientific or clinical findings, delays caused by ethics committees or regulatory authorities, third party claims, the inability to obtain access to other compositions or compounds on appropriate terms as needed for the intended drug regimen, the lack of late stage development partners or funding, or other similar unexpected events or delays, including events beyond its reasonable control. If it is determined that a failure of due diligence has occurred and is not reasonably cured or adequately rebutted within thirty (30) days of MPP’s written notice to Licensee of such failure, MPP will have the right to terminate the licenses granted to Licensee pursuant to Section 6.3 hereof. Such termination is MPP’s sole and exclusive remedy for failure to satisfy any of the requirements of this Section 3.1.

Development Timelines. It is hereby acknowledged that the Parties' mutual strategic objective is to move Alliance Products into Development and subsequent Commercialization at the earliest opportunity. GSK will consult with the Joint Program Committee and will share, modify and further develop all applicable Development Plans and timelines in that forum. GSK will use Diligent Efforts to secure the necessary resources and will keep the Joint Program Committee informed on the progress of individual studies and activities relating to Alliance Products in accordance with Section 3.2.3.

Development Timelines. ProQR will perform the following Development activities for the Licensed Product on the following timelines: (i) within [***] from the Effective Date, submit an IND to the FDA; (ii) within [***] following IND approval, Initiate the first Proof of Concept Study; (iii) within [***] following the successful completion of a Proof of Concept Study, Initiate a Pivotal Clinical Study or extend the Proof of Concept Study into a Pivotal Clinical Study for such Licensed Product; and (iv) within [***] following successful completion of the Pivotal Clinical Study, file an NDA.