Renal Indications definition

Renal Indications means, collectively, Pre-dialysis CKD Anemia and Dialysis CKD Anemia.
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Renal Indications means the use of the Product in the prevention, treatment or amelioration of anemia in patients with chronic kidney disease, whether or not on dialysis.
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Renal Indications means any renal or kidney disease, state or condition (whether acute or chronic) in humans, excluding renal cell carcinoma (all types), transitional cell carcinoma, Wilms tumor (nephroblastoma), renal sarcoma, renal adenoma, oncocytoma and angiomyolipoma.
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Examples of Renal Indications in a sentence

  • In the U.S., the Parties shall co-promote the Product for the Initial Indications and share profits from the Initial Indications equally, with Affymax primarily participating in the sales and marketing efforts in the Renal Indications, subject to the payment obligations in Article 8 and the other terms of this Agreement.

  • Notwithstanding the foregoing, the Parties agree that, to the extent permitted under applicable law, Affymax shall be the primary presenter and responder regarding the Renal Indications and Takeda shall be the primary presenter and responder with regard to Oncology Indications, unless otherwise agreed upon by the Parties beforehand.

  • From time to time as reasonably necessary during the term of Commercialization of a Product in the U.S., the JSC shall update the U.S. Commercialization Plan (it being understood that Affymax shall be responsible for generating draft updates relating to the Renal Indications and Takeda shall be responsible for generating draft updates relating to the Oncology Indications, for review and approval by the JSC).

  • The amounts payable to Biogen under this Section on sales of Chronic Products are in consideration of the contribution Biogen has made to development of the OP- 1 PROTEIN in Chronic Renal Indications.

Related to Renal Indications

  • Additional Indication means any indication other than the Initial Indication.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • Licensed Compound means [***].

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Major Market Countries means the United States, Japan, England, Germany, France, Italy and Spain.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Licensed Territory means worldwide.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Licensed Field means all fields of use.

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.