Combination Regimen definition

Combination Regimen means the administration of two or more drugs or biological products together for the treatment, diagnosis or prophylaxis of any Indication, including a Licensed Product and at least one other distinct drug or biological product that is not a Licensed Product, where such Licensed Product and other drug or biological product are packaged and sold separately.

Combination Regimen has the meaning set forth in Section 1.106.

Combination Regimen means, with respect to a given Licensed Product, the intended use of such Licensed Product for an Indication together with one or more other pharmaceutical products as two or more entities of active ingredients in a combination therapy, including concomitant or sequential therapy for commercial sale for such Indication as set forth in the approved label for such Licensed Product.

Examples of Combination Regimen in a sentence

• Notwithstanding the foregoing, any safety data that is related to the Licensed Compound or MacroGenics Combination Regimen shall not be excluded from the data sharing obligations under Sections 5.1, 5.2 and 5.3 but rather shall be shared to the extent set forth in the Pharmacovigilance Agreement.

• For clarity, despite the date changes set forth herein, Section 4.1(d) shall remain unchanged and Incyte shall continue to bear any and all FTE Costs and Third Party Expenses incurred by MacroGenics following the Effective Date directly related to the Ongoing Clinical Study in accordance with the Study Transition Plan, other than any costs specifically related and allocable to any MacroGenics Combination Regimen.

• Among other things, the Pharmacovigilance Agreement shall require MacroGenics and any Collaborators to submit safety data concerning any adverse experiences and any other safety information arising from or related to the use of the Licensed Compound as a single agent or as a component of any Combination Regimen in any MacroGenics Combination Study or Collaborator Combination Study, as applicable, as necessary for Incyte to maintain the Global Safety Database.

• Notwithstanding anything to the contrary herein, each Party shall provide the other Party with any Licensed Compound “components of care” data that is owned or Controlled by such Party, as required or requested by a Regulatory Authority to support Regulatory Approval by the other Party of any Monotherapy Regimen, Incyte Combination Regimen, Collaborator Combination Regimen, or MacroGenics Combination Regimen, as applicable.

• In the event that Incyte notifies MacroGenics in writing that Incyte does not have an Incyte Facility that is equipped for commercial supply purposes (in Incyte’s reasonable discretion), MacroGenics shall have the right to Manufacture such quantities of the Licensed Compound Drug Product, in order to meet [**] of the global supply requirement for the MacroGenics Combination Regimen.

More Definitions of Combination Regimen

Combination Regimen means the administration of two or more drugs, biological products, cell therapies or gene therapies contemporaneously to a patient for the treatment, diagnosis or prophylaxis of any indication in the Field, including a Product and at least one other distinct drug, biological product, cell therapy or gene therapy that is not a Product, where such Product and other drug, biological product, cell therapy or gene therapy are packaged and sold separately. For clarity, the administration of a drug, biological product, cell therapy or gene therapy as an induction therapy prior to the administration of a Product (or vice versa), shall not be treated as a Combination Regimen.

Combination Regimen means any product or treatment regimen that comprises, or is a combination of (a) a BLU-285 Product, BLU-554 Product, or BLU-667 Product, and (b) any other product containing an Active Ingredient other than BLU-285, BLU-554, or BLU-667, where (a) and (b) are labeled for use together either simultaneously or in a separate or sequential administration, whether or not sold for a single price. For clarity, any Amalgamated Product that satisfies the requirement set forth in both clauses (a) and (b) is a Combination Regimen.

Combination Regimen means any product or treatment regimen that comprises, or is a combination of (a) a BLU-285 Product, BLU-554 Product, or BLU-667 Product, and (b) any other product containing an Active Ingredient other than XXX-000, XXX-000, or BLU-667, where (a) and (b) are labeled for use together either simultaneously or in a separate or sequential administration, whether or not sold for a single price. For clarity, any Amalgamated Product that satisfies the requirement set forth in both clauses (a) and (b) is a Combination Regimen.

Combination Regimen means any product or treatment regimen that comprises, or is a combination of [***] For clarity, any Combination Product that satisfies the requirement set forth in both clauses (a) and (b) is a Combination Regimen.

Combination Regimen has the meaning set forth in Section 3.3(c).

Combination Regimen means, with respect to a given Licensed Product for a given Indication, intended use of such Licensed Product for such Indication together with one or more other pharmaceutical products (the “Other Product”) as two or more entities of active ingredients in a combination therapy, including concomitant or sequential therapy, either (a) in a Clinical Trial for such Licensed Product for such Indication as set forth in the protocol for such Clinical Trial or (b) for commercial sale for such Indication as set forth in the approved label for such Licensed Product. For clarity, an Other Product could be [...***...].

Combination Regimen means, with respect to a given therapeutic product (other than a Licensed Product) for a given Indication, intended use of such therapeutic product for such Indication together with one or more Other Products as two or more entities of active ingredients in a combination therapy, including concomitant or sequential therapy, either (i) in a Clinical Trial for such other therapeutic product for such Indication as set forth in the protocol for such Clinical Trial or (ii) for commercial sale for such Indication as set forth in the approved label for such therapeutic product.