Combination Regimen definition

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.

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 (i) separately presented or packaged, (ii) sold separately and (iii) labelled for use together for the treatment, diagnosis or prophylaxis of such Indication.

Examples of Combination Regimen in a sentence

• 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.

• 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.

• Notwithstanding anything to the contrary herein, MacroGenics shall retain the exclusive right: (A) to conduct or have conducted (by Third Party subcontractors or licensees in accordance with Section 1.94, as applicable) the MacroGenics Combination Studies; and (B) subject to Section 3.1(a), to Exploit any MacroGenics Pipeline Asset, including as a component of a MacroGenics Combination Regimen.

• Without limitation of subsection (c) (in connection with MacroGenics Combination Studies), Combination Sponsor shall be solely responsible, at its sole cost and expense, for all filings, reports and communications with all Regulatory Authorities (including any INDs) with respect to its Pipeline Asset (including as a component of a Combination Regimen), as applicable, in its own name.

• 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.

More Definitions of 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 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, with respect to the Licensed Product for a given Indication, the use of such Licensed Product for such Indication together with one or more other pharmaceutical products (each, an “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; provided, that, for the purposes of this definition, none of (i) tislelizumab, (ii) any approved chemotherapy treatments, (iii) any Biosimilar Products and (iv) any Generic Products, shall constitute Other Products. For clarity, an Other Product could be a product that is proprietary to a Party or a product that is proprietary to Third Parties.

Combination Regimen means a Licensed Product that consists of the following sold for a single price: (a) a product or service that is Covered by one or more Patent Rights or satisfies the criteria in clause (1) of the definition of Licensed Product and (b) at least one other (i) therapeutically active ingredient, (ii) delivery device, or (iii) service or treatment that is reimbursable by private or government health insurance programs and is provided by a Third Party in connection with the administration of the product or service described in the foregoing clause (a), in each case ((i) – (iii)), that is not Covered by any Patent Right and does not satisfy the criteria in clause (1) of the definition of Licensed Product (each such other therapeutically active ingredient, delivery device or service or treatment described in the foregoing clause (b), an “Independent Component”).

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 means, with respect to the Licensed Product for a given Indication, the use of such Licensed Product for such Indication together with one or more other pharmaceutical products (each, an “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; provided, that, approved chemotherapy treatments shall not constitute Other Products for purposes of this definition. For clarity, an Other Product could be a product that is proprietary to a Party, a product that is proprietary to Third Parties, or that is a generic or biosimilar.

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