Right of Reference. Each Party hereby grants to the other Party a “Right of Reference”, as that term is defined in 21 C.F.R. § 314.3(b), to any data Controlled by such Party or its Affiliates (a) that relates to the Licensed Product Candidates or Licensed Products and (b) that each Party reasonably believes may be necessary or useful to the Development, manufacture or Commercialization of any Licensed Product Candidate or Licensed Product pursuant to this Agreement, and each Party will provide a signed statement to the foregoing effect, if so requested by the other Party in accordance with 21 C.F.R. § 314.50(g)(3).
Appears in 2 contracts
Sources: Development and Commercial License Agreement (Precision Biosciences Inc), Development and Commercial License Agreement (Precision Biosciences Inc)
Right of Reference. Each Party hereby grants to the other Party a “Right right of Reference”, reference,” as that term is defined in 21 C.F.R. § 314.3(b), to any data Controlled controlled by such Party or its Affiliates (a) that relates to the Licensed Product Candidates or Licensed Products and (b) that each Party reasonably believes may be necessary or useful to the Development, manufacture or Commercialization of any Licensed Product Candidate or Licensed Product pursuant to this AgreementProduct, and each Party will shall provide a signed statement to the foregoing this effect, if so requested by the other Party Party, in accordance with 21 C.F.R. § 314.50(g)(3).
Appears in 2 contracts
Sources: License Agreement (Progenics Pharmaceuticals Inc), License and Co Development Agreement (Progenics Pharmaceuticals Inc)
Right of Reference. Each Party hereby grants to the other Party a “"Right of Reference”, ," as that term is defined in 21 C.F.R. § (S) 314.3(b), to any data Controlled by such Party or its Affiliates (a) that relates to the Licensed Product Candidates or Licensed Products and (b) that each Party reasonably believes may be necessary or useful to the Development, manufacture or Commercialization of any Licensed Product Candidate or Licensed Product pursuant to developed under this Agreement, and each a Party will shall provide a signed statement to the foregoing this effect, if so requested by the other Party other, in accordance with 21 C.F.R. § (S) 314.50(g)(3).
Appears in 2 contracts
Sources: Collaboration and License Agreement (Viropharma Inc), Collaboration and License Agreement (Viropharma Inc)
Right of Reference. Each Party hereby grants to the other Party a “Right of Reference”, ,” as that term is defined in 21 C.F.R. § 314.3(b), to any data Controlled by such Party or its Affiliates (a) that relates to any Agreement Compound or Product for which the Licensed Product Candidates or Licensed Products and (b) that each other Party reasonably believes may be necessary or useful to is the Development, manufacture or Commercialization of any Licensed Product Candidate or Licensed Product pursuant to this AgreementLead Developer, and each such Party will provide a signed statement to the foregoing this effect, if so requested by the other Party Party, in accordance with 21 C.F.R. § 314.50(g)(3).
Appears in 1 contract
Sources: Research and License Agreement (Pharmacopeia Drug Discovery Inc)
Right of Reference. Each Party hereby grants to the other Party a “Right of Reference”, ,” as that term is defined in 21 C.F.R. § 314.3(b), to any data Controlled by such Party or its Affiliates (a) that relates to the Licensed Product Candidates or Licensed Products and (b) that each Party reasonably believes may be necessary or useful to the Development, manufacture or Commercialization of any Licensed Product Candidate or Licensed Product pursuant to developed under this Agreement, and each a Party will shall provide a signed statement to the foregoing this effect, if so requested by the other Party other, in accordance with 21 C.F.R. § 314.50(g)(3).
Appears in 1 contract