Clinical POC definition

Clinical POC. Clinical POC means demonstration of safety and a Pre-agreed level of therapeutic efficacy, including a change in the levels of a Pre-agreed disease relevant biomarker in some cases as a substitute for therapeutic efficacy, in a Pre-agreed number of human patients.

Clinical POC has the meaning set forth in Schedule 2; CMO means contract manufacturing organization; Collaboration Expansion Fee has the meaning set out in Schedule 2;

Clinical POC means the clinical proof of concept of a compound through a clinical trial which is reasonably designed to provide at least some initial evidence of efficacy of the relevant compound in a small number of patients and results in some clinical data, according to which a sponsor would reasonably decide to continue the Development of the compound in an enlarged or a separate clinical trial.

Examples of Clinical POC in a sentence

• If he is unable to make a decision without additional information or data, Demonstration of Clinical POC will be deemed not to have been achieved.

• The JSC shall be responsible for overseeing the overall collaboration established under this Agreement, and to that end, for (i) creating and maintaining a collaborative work environment within and among the Parties, and (ii) addressing any disputes as they may arise in the JRDC and (iii) determining whether Demonstration of Clinical POC has been achieved, and (iv) unless otherwise specified, serving as the initial point of contact to resolve any disputes between the Parties.

• Following a positive determination by the Expert that Demonstration of Clinical POC has been achieved, Dimension will invoice Bayer for the applicable milestone payment as set forth and in accordance with Section 6.2. For the avoidance of doubt, in determining the achievement of Demonstration of Clinical POC hereunder, either by the JSC or the Expert, the criteria stated in Exhibit E shall be strictly applied and shall not be modified in any way.

• The JSC shall be formed as soon as possible, but no later than […***…] following the Effective Date of this Agreement and, unless otherwise agreed by the Parties, shall dissolve at the time of initial Regulatory Approval in the U.S., or earlier should Dimension elect to discontinue the JSC following Demonstration of Clinical POC.

• In such case, each Party shall provide the Expert with the relevant data as well as a briefing document setting forth specific detailed reasons underlying such Party’s position, and the Expert shall within an additional […***…] following his appointment, apply the criteria and make the determination, in a writing stating his reasons for such position, of whether Demonstration of Clinical POC has been achieved, which determination shall be final and binding on the Parties.

• In the event […***…] Licensed GT Product is the subject of a POC Trial, but fails to achieve Demonstration of Clinical POC (as determined pursuant to Section 2.11.4), at Bayer’s discretion and request, the Parties shall amend the Research Plan and Research Budget to add activities to identify and develop […***…] GT Product and conduct a POC Trial for such […***…] GT Product (the “Backup Product”) and as needed, extend the then-current Research Term to conduct such activities.

• Such Backup Product, upon completion of its POC Trial, shall also become a Licensed GT Product, subject to the license grants set forth in Section 5.1, and the Parties shall determine if such Backup Product achieves Demonstration of Clinical POC pursuant to Section 2.11.4.

• If the initial Licensed GT Product or the Backup Product fails to achieve Demonstration of Clinical POC Bayer may, within […***…] of being notified of such failure, upon […***…] notice, terminate this Agreement.

• Notwithstanding the prior sentence, if Gilead Opts-In to an Extended Target after the Clinical POC Opt-In Point, but prior to the completion of the development activities described in the Development Plan for such Extended Target, then Tango shall complete such activities in accordance with such Development Plan.

• The process for determining achievement of Demonstration of Clinical POC for a Licensed GT Product shall be as set forth in this Section 2.11.4. Following receipt by a Party of POC Data for the Licensed GT Product, Bayer will present the results of such trial, and all other relevant data, to the JSC and the JSC will act in good faith to apply the criteria set forth in Exhibit E to such data and results and determine if such criteria for Demonstration of Clinical POC have been met.

More Definitions of Clinical POC

Clinical POC means database lock of the Phase 2 Study dose expansion set forth in the Initial Product Development Plan or an equivalent Phase 1b Study or Phase 2 Study in the Product Development Plan. “Clinical Study” means a Phase 1 Study, Phase 1b Study, Phase 2 Study, Phase 3 Study, or other study (including a non-interventional study) in humans to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging, or efficacy of a Product. “CMC” means chemistry, manufacturing, and control.

Clinical POC means the achievement of clinical results and manufacturing requirements that meet criteria for efficacy and safety as well as other conditions that enable the decision to enter pivotal trials. A complete listing of such criteria for the Initial Collaboration Product is attached as Appendix 1.16. The same or similar Clinical PoC criteria may be established, as judged by the JSC, for additional Collaboration Products, a SQZ Product or TCL Products.

Clinical POC means, with respect to a given Collaboration Program, the point at which the first Compound in such Collaboration Program reaches GSK’s standard portfolio management milestone referred to as [***] at which point pre-clinical and initial Clinical Studies have generated proof of concept that a [***] has sufficient efficacy, safety and development potential to commit resources to the conduct of further Clinical Studies of such [***] required to submit the NDA or BLA or other Regulatory Filing, as applicable, and for Commercialization activities, in each case as determined by GSK’s applicable internal committee in its sole discretion following its normal practice as applied to GSK Independent Programs and as documented in the committee’s minutes of the meeting at which such determination is made.