Monotherapy definition

Monotherapy means a therapy in which the Drug Product is used as a sole anti-hepatitis C virus (HCV) agent.

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Monotherapy treatment of a condition by means of a single drug

Monotherapy means the use or method of using a product comprising one (1) clinically or pharmacologically active ingredient as its sole active ingredient, and not in concomitant or sequential administration with any other product.

Examples of Monotherapy in a sentence

• With respect to Far East Single Presence Countries, the Singapore Partnership will own and an Affiliate of M or S-P which has been deemed to have the single presence in that Far East Single Presence Country shall have the exclusive right to use in those countries the E Monotherapy U.S. Trademark, the Z/E Combination Product U.S. Trademark and the M/E Combination Product U.S. Trademark and any back-up trademark relating thereto.

• With respect to Far East Co-Promotion Countries, the Singapore Partnership will own and the Affiliates of M and S-P shall have the exclusive right to use in those countries the E Monotherapy U.S. Trademark, the Z/E Combination Product U.S. Trademark and the M/E Combination Product U.S. Trademark and any back-up trademark relating thereto.

• 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.

• With respect to EMEA Single Presence Countries, the Singapore Partnership will own and an Affiliate of M or S-P which has the single presence in that EMEA Single Presence Country shall have the exclusive right to use in those countries the E Monotherapy U.S. Trademark, the Z/E Combination Product U.S. Trademark and the M/E Combination Product U.S. Trademark and any back-up trademarks related thereto.

• No NHS prescribing in primary or secondary care TA515 - Mar 18 BLACK Erlotinib (Tarceva®) NHSE Monotherapy for maintenance treatment of non-small-cell lung cancer - as per NICE TA 227 and NHS England policy Not commissioned.

• An Affiliate of M acting as toll packager pursuant to paragraph (f) below shall enter into one or more agreements with the Affiliate of S-P under which the M Affiliate shall furnish to the S-P QP such data and services regarding its operations as toll packager for the Ezetimibe Monotherapy Product as the S-P QP may reasonably require to discharge its responsibilities as a Qualified Person.

• The Parties will seek to optimize the use of the E Monotherapy U.S. Trademark, the Z/E Combination Product U.S. Trademark and the M/E Combination Product U.S. Trademark in each country in ▇▇▇▇, but only to the extent that the applicable Cholesterol Products are sold in the Field by or on behalf of S-P or M or any of their Affiliates in such country in ▇▇▇▇.

• An M Local Affiliate shall be entitled to use any back-up trademark that is not confusingly similar to the E Monotherapy U.S. Trademark filed in a ▇▇▇▇ Co-Marketing Country, other than any back-up trademark required to be used by an S-P Local Affiliate in that country.

• An M Local Affiliate shall be entitled to use any back-up trademark that is not confusingly similar to the E Monotherapy U.S. Trademark filed in an EMEA Co-Branding Country, other than any back-up trademark required to be used by an S-P Local Affiliate in that country.

• Further, MacroGenics shall supply all quantities of Licensed Compound Bulk Drug Substance that are required for any particular Incyte Monotherapy Study or Incyte Combination Study from the same MacroGenics Manufacturing Facility, provided that such supply requirements do not exceed the reasonably available then-current planned capacity of the applicable Manufacturing Facility.

More Definitions of Monotherapy

Monotherapy means a therapy using a Nektar Compound as an individual formulation for use in the Field.

Monotherapy means the delivery of Estradiol (or any other Estrogen added to the Field) using an MDTS, without delivering any other active ingredient using the MDTS. For clarity, delivery of Estradiol (or any other Estrogen added to the Field) using an MDTS, without delivering any other active ingredient using the MDTS, shall be considered Monotherapy notwithstanding any concurrent use or delivery of another active ingredient by a method other than spray delivery by the MDTS. For example, oral delivery of a progestin concurrently with delivery of Estradiol using the MDTS shall be considered Monotherapy.

Monotherapy means, with respect to the Licensed Product for a given Indication, the intended use of such Licensed Product alone for such Indication, and not as part of a Combination Regimen (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, use of the Licensed Product together with approved chemotherapy treatments shall be considered Monotherapy.

Monotherapy means [***].

Monotherapy means, with respect to a Licensed Product, that such Licensed Product is any of (a) labeled for use, (b) the subject of a Drug Approval Application for approval to be labeled for use or (c) the subject of a Phase 3 Clinical Trial for evaluation, in each case (clauses (a), (b) and (c)) by itself, without any other pharmaceutical product, to treat, prevent, cure or delay the progression of MDD.