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.
Appears in 1 contract
Sources: Development, Option and License Agreement (Isis Pharmaceuticals Inc)
Drug Development. Isis will use Commercially Reasonable Efforts to conduct all activities under the ISIS-SMNRx Development DMPKRx R&D Plan on the timeline set forth in the ISIS-SMNRx Development DMPKRx R&D Plan, including the following Development activities under this Agreement:
(a) Subject to Section 1.4 below, Develop ISIS 396443 the Development Candidate through the completion of a the 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 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 ISIS 396443the 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 ISIS 396443 the Development Candidate pursuant to this Section 1.3.2(a1.3.3(a), Biogen Idec may, in its discretion, elect to continue Development of ISIS 396443 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 executes its Option under this Section 1.3.2(a1.3.3(a), then [***]. If Biogen Idec does not timely execute its Option under this Section 1.3.2(a1.3.3(a), then the Option will expire.
Appears in 1 contract
Sources: DMPK Research, Development, Option and License Agreement (Isis Pharmaceuticals Inc)