Drug Development Clause Samples
The Drug Development clause outlines the responsibilities and procedures related to the research, creation, and advancement of pharmaceutical products under an agreement. It typically specifies which party is responsible for conducting preclinical studies, clinical trials, and regulatory submissions, and may address timelines, reporting requirements, and standards for development activities. This clause ensures that both parties understand their roles and obligations in bringing a drug candidate from concept to market, thereby reducing misunderstandings and facilitating efficient progress in the development process.
Drug Development. Isis will use Commercially Reasonable Efforts to conduct all activities under the ISIS-SMNRx Development Plan on the timeline set forth in the ISIS-SMNRx Development Plan, including the following Development activities under this Agreement:
(a) Subject to Section 1.4 below, Develop ISIS 396443 through the completion of a PoC Trial; provided, however, Isis may discontinue such Development if at any time after having consulted, and having given good faith consideration to the recommendations of the JDC and a mutually-agreed Third Party expert, Isis in good faith believes that continuing such Development would (i) pose an unacceptable risk or threat of harm in humans, or (ii) violate any Applicable Law, ethical principles, or principles of scientific integrity. Prior to discontinuing Development of ISIS 396443, Isis will provide Biogen Idec with reasonable advance notice of such discontinuation, including the grounds for Isis’ determination. If Isis elects to discontinue Development of ISIS 396443 pursuant to this Section 1.3.2(a), Biogen Idec may, in its discretion, elect to continue Development of ISIS 396443 by providing Isis with written notice of Biogen Idec’s exercise of the Option within 90 days after Isis’ written notice to Biogen Idec of such discontinuation. If Biogen Idec timely executes its Option under this Section 1.3.2(a), then [***]. If Biogen Idec does not timely execute its Option under this Section 1.3.2(a), then the Option will expire.
Drug Development. Isis will use Commercially Reasonable Efforts to conduct the following drug development activities under this Agreement:
(a) Subject to Section 1.6 and Section 1.7 below, for each Collaboration Program, Develop at least one (1) Development Candidate through the completion of the first ▇▇▇▇▇ ▇ ▇▇▇ ▇▇▇▇▇; provided, however, Isis may discontinue such Development if at any time (i) Isis in good faith believes, and a majority of the JSC recommends, that continuing such Development is not warranted because the Development Candidate has not demonstrated sufficient efficacy or activity in human trials or animal studies, or (ii) after having consulted the JSC, Isis in good faith believes that continuing such Development would (x) pose an unacceptable risk or threat of harm in humans, or (y) violate any Applicable Law, ethical principles, or principles of scientific integrity; provided, further, that Isis will [***] the expiration or termination of the Collaboration Term;
Drug Development. Isis will use Commercially Reasonable Efforts to conduct all activities under each Development Plan on the timeline set forth in the applicable Development Plan, including the following Development activities under this Agreement:
(a) Subject to Section 1.6 below, Develop each Development Candidate through the completion of the first PoC Trial; provided, however, Isis may discontinue such Development if at any time after having consulted, and having given good faith consideration to the recommendations of the Neurology JSC and a mutually-agreed Third Party expert, Isis in good faith believes that continuing such Development would (i) pose an unacceptable risk or threat of harm in humans, or (ii) violate any Applicable Law, ethical principles, or principles of scientific integrity. Prior to discontinuing Development of a Development Candidate, Isis will provide Biogen Idec with reasonable advance notice of such discontinuation, including the grounds for Isis’ determination. If Isis elects to discontinue Development of a Development Candidate pursuant to this Section 1.5.3(a), Biogen Idec may, in its discretion, elect to continue Development of the Development Candidate by providing Isis with written notice of Biogen Idec’s exercise of the Option within 90 days after Isis’ written notice to Biogen Idec of such discontinuation. If Biogen Idec timely exercises its Option under this Section 1.5.3(a), then [***]. If Biogen Idec does not timely exercise its Option under this Section 1.5.3(a), then the Option will expire.
Drug Development. Ionis will use Commercially Reasonable Efforts to conduct all activities under each Development Plan on the timeline set forth in the applicable Development Plan, including the following Development activities under this Agreement:
(a) Subject to Section 1.6 below, Develop each Development Candidate through [***]; provided, however, that Ionis may discontinue such Development if at any time after having consulted, and having given good faith consideration to the recommendations of the Neurology JSC and a mutually-agreed Third Party expert, Ionis in good faith believes that continuing such Development would (i) pose an unacceptable risk or threat of harm in humans, or (ii) violate any Applicable Law, ethical principles, or principles of scientific integrity. Prior to discontinuing Development of a Development Candidate, Ionis will provide Biogen with reasonable advance notice of such discontinuation, including the grounds for Ionis’ determination. If Ionis elects to discontinue Development of a Development Candidate pursuant to this Section 1.5.3(a), Biogen may, in its discretion, elect to continue Development of the Development Candidate by providing Ionis with written notice of Biogen’s exercise of the Option within [***] after Ionis’ written notice to Biogen of such discontinuation. If Biogen timely exercises its Option under this Section 1.5.3(a), then [***].
Drug Development. Solithromycin shall remain in development or commercialization by one or more of the Borrowers at all times.
Drug Development