Program Payload definition
Program Payload means, on a Program-by-Program basis, a polynucleotide sequence, whether single stranded or self-complementary, that: (a) is intended to have a therapeutic effect on the applicable Program Target when packaged into a Voyager Capsid and delivered to the appropriate cells; and (b) is the subject of efforts under the Development Plan for such Program. 1.149 “Program Target” means, with respect to any Program, the Target that is the subject of such Program. 1.150 “Prosecution and Maintenance” or “Prosecute and Maintain” means, with regard to a Patent Right, the preparation, filing, prosecution and maintenance of such Patent Right, as well as re-examinations, reissues, appeals, and requests for patent term adjustments and patent term extensions with respect to such Patent Right. Notwithstanding anything to the contrary, “Prosecution and Maintenance” or “Prosecute and Maintain” shall not include any enforcement actions taken with respect to a Patent Right. 1.151 “PRV” has the meaning set forth in Section 7.3. EXECUTION COPY CONFIDENTIAL 16 1.152 “PRV Sale” has the meaning set forth in Section 7.3. 1.153 “Public Official or Entity” means: (a) any officer, employee (including physicians, hospital administrators, or other healthcare professionals), agent, representative, department, agency, de facto official, representative, corporate entity, instrumentality or subdivision of any government, military or international governmental organization, including any ministry or department of health or any state-owned or affiliated company or hospital; or (b) any candidate for political office, any political party or any official of a political party. 1.154 “Receiving Party” has the meaning set forth in Section 11.1. 1.155 “Redacted Version” has the meaning set forth in Section 11.3.2. 1.156 “Regulatory Approval” means all approvals of the applicable Regulatory Authority necessary for the commercial marketing and sale of a product in a country(ies), excluding any pricing and reimbursement approvals that may be required. 1.157 “Regulatory Approval Application” means: (a) a BLA; or (b) any other application to seek Regulatory Approval of a product in any country or multinational jurisdiction, as defined in applicable Laws and filed with the relevant Regulatory Authorities of such country or jurisdiction. 1.158 “Regulatory Authority” means the FDA in the United States or any Governmental Authority in another country or regulatory jurisdiction in the Territory that is a counterp...
Program Payload means the HD Program Payload and/or the SMA Program Payload, as applicable.
Program Payload means, on a Program-by-Program basis, a polynucleotide sequence, whether single stranded or self-complementary, that: (a) is intended to have a therapeutic effect on the applicable Program Target when packaged into a Voyager Capsid and delivered to the appropriate cells; and (b) is the subject of efforts under the Development Plan for such Program.
Examples of Program Payload in a sentence
Novartis will promptly provide to Voyager all results of such Evaluation that are generated during the Capsid Evaluation Period that are related to biodistribution, expression level, and toxicity of the relevant Voyager Capsid(s) (“Novartis Evaluation Data”); provided that Novartis, in its sole discretion, may choose to redact, mask, or not provide any information related to an SMA Program Payload.
On and after the Designation Notice Date, Novartis shall be solely responsible, in its sole discretion (but subject to its obligations under this Agreement (including Section 6.2.1)), for Developing SMA Development Candidates, including the selection of an SMA Program Payload to utilize with an SMA Program Capsid.