Oligonucleotide Drug definition

Oligonucleotide Drug means any single stranded, [***] at physiological pH oligonucleotide including those [***] used as a human therapeutic and/or prophylactic compound containing between [***] nucleotides and/or nucleosides including oligonucleotide analogs which may include [***]. For purposes of this agreement, Oligonucleotide Drug shall specifically exclude oligonucleotides used in [***], oligonucleotides used as [***] an oligonucleotide, oligonucleotides used [***] or oligonucleotides used as [***];
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Oligonucleotide Drug means any single stranded, [...***...] oligonucleotide including those [...***...] used as a human therapeutic and/or prophylactic compound containing between [...***...] nucleotides and/or nucleosides including oligonucleotide analogs which may include [...***...
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Oligonucleotide Drug means any single stranded, [...***...] oligonucleotide including those [...***...] used as a human therapeutic and/or prophylactic compound containing between [...***...] nucleotides and/or nucleosides including oligonucleotide analogs which may include [...***...]. For purposes of this Agreement, Oligonucleotide Drug shall specifically exclude oligonucleotides used in gene therapy except [...***...] an oligonucleotide, oligonucleotides used as [...***...] or oligonucleotides used as adjuvants. Oligonucleotide Drug shall also specifically exclude polymers in which the linkages are amide based, such as peptides and proteins but shall not exclude [...***...]. Should Isis develop [...***...] oligonucleotides or should Elan independently discover drug delivery technology it believes to be potentially applicable to [...***...] oligonucleotides, then the Participants shall discuss in good faith whether such oligonucleotides can be formulated for Oral delivery using the Oral Platform, and whether such formulation appears feasible without requiring a significant further investment in developing or enhancing the Oral Platform; if such formulation appears feasible, the Participants shall discuss in good faith the inclusion of such oligonucleotides as Oligonucleotide Drugs.
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Examples of Oligonucleotide Drug in a sentence

  • Isis will notify Elan in writing of Isis' good faith intention to manufacture or have manufactured an Oligonucleotide Drug incorporating any Elan Intellectual Property.

  • If Elan fails to respond to Isis' notice within the [***] or if Elan declines in writing to exercise its right of first negotiation, then, Isis will be free to manufacture and supply (either on its own or with a third party) the Oligonucleotide Drug.

  • The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations.’’ It does not establish any rights for any person and is not binding on FDA or the public.You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

  • If Elan wishes to manufacture the Oligonucleotide Drug incorporating any Elan Intellectual Property, the parties will negotiate in good faith the terms of a manufacturing agreement.

  • If despite good faith negotiations, Elan and Isis do not reach agreement within [***] from Elan's exercise of its right of first negotiation, then Isis will be free to manufacture and supply (either on its own or with a third party) the Oligonucleotide Drug.

  • The draft guidance, when finalized, will represent the current thinking of FDA on “IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations.” It does not establish any rights for any person and is not binding on FDA or the public.

  • Elan will have [***] from the receipt of such notice to notify Isis in writing whether or not Elan wishes to negotiate with Isis regarding the manufacture of the Oligonucleotide Drug.

  • The draft guidance, when finalized, will represent the current thinking of FDA on “IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations.” It does not establish any rights for any person and is not binding on FDA or the public.

  • The effects of different modifications and scale on the manufacturing process as well as techniques for developing scaled-down process models will be discussed.9:00 Introduction to the TutorialLubomir Nechev, Ph.D., Senior Director, Process Chemistry,Alnylam Pharmaceuticals, Inc., USA9:10 A History of DNA/RNA SynthesizersJeffrey Christopher Strauss, Vice President, BioAutomation Corp., USA9:50 Challenges in the Preparation and Analysis of Conjugated Oligonucleotide Drug CandidatesKenneth W.

Related to Oligonucleotide Drug

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