Transplant Indications definition

Transplant Indications means all indications that involve the suppression of rejection of transplanted organs, bone marrow or other tissue, including, without limitation, solid organ transplantation (including tolerance induction and xenotransplantation), bone marrow transplantation, graft versus host disease and cell transplantation. In any event, if a given indication satisfies the criteria for both an Autoimmune Indication and a Transplant Indication, such indication shall be deemed a Transplant Indication and not an Autoimmune Indication, provided that an Autoimmune Indication shall not be deemed a Transplant Indication merely because it may cause the need for a transplant (e.g., Type I diabetes, even if it causes the need for an organ transplant).
Sample 1Sample 2Sample 3
Transplant Indications means the use of a product as an induction agent, an anti-rejection agent, or a chronic maintenance agent or for any other purpose in Solid Organ Transplant procedures.
Sample 1Sample 2Sample 3
Transplant Indications means all indications that involve the suppression of rejection of transplanted organs, bone marrow, or other tissue.
Sample 1Sample 2

Examples of Transplant Indications in a sentence

  • It shall be the JC's continuing obligation to review any such New Sales Tracking Data in good faith, with the overriding obligation to ensure fair and accurate compensation to the Parties under this Agreement by tracking as accurately as reasonably possible, purchases of the Product in the Transplant Indications, balancing the desirability of increased accuracy against the costs of obtaining same.

  • Prior to the Reversion Effective Date or the Put Right Effective Date, PDL shall consult Roche with respect to its patent prosecution strategy and decisions, as follows: Prior to the filing of a patent application in the Territory for Transplant Indications, PDL shall inform Roche concerning such proposed filing and shall consult with Roche concerning the proposed filing procedures, including specifically the determination of scope of any such patent and countries in which such application is to be filed.

  • The parties intend that, following the Effective Date, Roche will continue to market and sell Daclizumab in the Transplant Indications in the Roche Territory for the duration of the Commercialization Term, under the Trademarks.

  • At the start of the Royalty Term and for each calendar year thereafter, Roche shall provide to Aspreva a forecast of its anticipated Net Sales of the Product attributable to the Transplant Indications for each quarter of such calendar year (or portion remaining thereof) using such methodology as Roche otherwise uses in the forecasting of such Net Sales for its own internal purposes (the "PROJECTED GLOBAL TRACKED SALES").

  • For the purpose of each Reconciliation and the determination of actual Global Tracked Sales, Roche shall use a defined methodology (the "SALES TRACKING METHODOLOGY") to determine which portion of Net Sales in the Territory resulted from purchases of the Product for use in the Transplant Indications.

  • As of the Effective Date, PDL shall be responsible for all ex parte out-of-pocket expenses incurred by PDL after the Effective Date in connection with the prosecution and maintenance in the Territory of patent applications and patents included within the PDL Patents or Joint Roche-PDL Patents for which PDL makes filings with respect to Transplant Indications pursuant to Article XI of this Amended and Restated Worldwide Agreement.

  • After either the Reversion Effective Date or the Put Right Effective Date, PDL shall have full control over the strategy and decisions with respect to the filing of any patent applications and patents related to Transplant Indications in the Territory.

  • Subject to the limitations set forth below, PDL shall have the option to terminate Roche’s rights with respect to Daclizumab, which, if exercised, would allow PDL to replace Roche as the party responsible for the promotion, sales, distribution and manufacturing of Daclizumab for use in the Transplant Indications in the Roche Territory.

  • On either the Reversion Effective Date or the Put Right Effective Date, Roche shall transfer to PDL any Roche Know-How not previously transferred to PDL, including in particular, any Roche Know-How related to the Transplant Indications.

  • During such stated reasonable period, if the other party believes the manuscript contains information that is reasonably likely to have a material adverse impact on Daclizumab for Transplant Indications or Autoimmune Indications, as the case may be, in the Territory, then prior to the expiration of the stated period above, the other party shall notify the Publishing Party in writing of its determination and the reasons therefor.


More Definitions of Transplant Indications

Transplant Indications means the treatment or prevention of renal transplantation rejection in humans, including acute antibody-mediated rejection or delayed graft function.
Sample 1Sample 2
Transplant Indications means all indications that involve the suppression of rejection of transplanted organs, bone marrow or other tissue, including, without limitation, solid organ transplantation (including tolerance induction and xenotransplantation), bone marrow transplantation, graft versus host disease and cell transplantation. In any event, if a given indication satisfies the criteria for both an Autoimmune Indication and a Transplant Indication, such indication shall be deemed a Transplant Indication and not an Autoimmune Indication, provided that an Autoimmune
Sample 1
Transplant Indications means all indications that are not Autoimmune Indications, including, without limitation, solid organ transplantation (including tolerance induction and xenotransplantation), bone marrow transplantation, graft versus host disease and cell transplantation. In any event, should a given indication have applicability in both Autoimmune Indications and transplantation, such indication shall be deemed a Transplant Indication and not an Autoimmune Indication; provided that an Autoimmune Indication shall not be deemed a Transplant Indication merely because it may cause the need for a transplant (e.g., Type I diabetes, even if it causes the need for an organ transplant).
Sample 1
Transplant Indications means all indications that are not Autoimmune Indications, including, without limitation, solid organ transplantation (including tolerance induction and xenotransplantation), bone marrow transplantation, graft versus host disease and cell transplantation. In any event, should a given indication have applicability in both Autoimmune Indications and transplantation, such indication shall be deemed a Transplant Indication and not an Autoimmune Indication, provided that an Autoimmune Indication shall not be deemed a Transplant Indication merely because it may cause the need for a transplant (e.g., Type I diabetes, even if it causes the need for an organ transplant). 1.18 "Adjusted Gross Transplant Sales" means the sum of Adjusted Gross Sales of (i) Daclizumab in all Transplant Indications and (ii) all Licensed Products other than Daclizumab. "Net Transplant Sales" means the amount determined by deducting [CONFIDENTIAL TREATMENT REQUESTED] from Adjusted Gross Transplant Sales to cover all other expenses or discounts, including but not limited to cash discounts, custom duties, transportation and insurance charges and other direct expenses, to the extent not already deducted from the amount invoiced. 1.19 "Adjusted Gross Autoimmune Sales" means the amount determined by subtracting Adjusted Gross Transplant Sales from Adjusted Gross Sales. "Net Autoimmune Sales" means the amount determined by deducting [CONFIDENTIAL TREATMENT REQUESTED] from Adjusted Gross Autoimmune Sales to cover all other expenses or discounts, including but not limited to cash discounts, custom duties, transportation and insurance charges and other direct expenses, to the extent not already deducted from the amount invoiced. 1.20 "Total Net Sales" means the sum of Net Transplant Sales and Net Autoimmune Sales. 1.21 "Cost of Goods Sold" means the manufacturing cost of unformulated bulk Daclizumab, calculated in accordance with reasonable cost accounting methods consistently applied by a party for its other pharmaceutical products, provided that such methods comply with generally accepted accounting principles. Cost of Goods Sold shall include direct labor (including fringe benefits), direct materials (including taxes and duties), and a reasonable allocation of indirect labor and materials, facilities expense (including occupancy costs and depreciation of property, plant and equipment), administration costs and other costs allocable to the manufacturing process. 1.22 "Reimbursable Promotion Cost...
Sample 1
Transplant Indications means all indications that involve the suppression of rejection of transplanted organs, bone marrow or other tissue, including, without limitation, solid organ transplantation (including tolerance induction and xenotransplantation), bone marrow transplantation, graft versus host disease and cell transplantation. In any event, if a given indication satisfies the criteria for both an Autoimmune Indication and a Transplant Indication, such indication shall be deemed a
Sample 1

Related to Transplant Indications

  • Antipsychotic medications means that class of drugs

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Medication means any drug, chemical, compound, suspension, or preparation in suitable form for use as a curative or remedial substance taken either internally or externally by any person.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Cannabis products means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Pre-Licensed Therapist means an individual who has obtained a Master’s Degree in Social Work or Marriage and Family Therapy and is registered with the BBS as an Associate CSW or MFT Intern acquiring hours for licensing. An individual’s registration is subject to regulations adopted by the BBS.

  • 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.

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

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Covered Products means Your Applications, Libraries, Passes, Safari Extensions, Safari Push Notifications, and/or FPS implementations developed under this Agreement.

  • Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • 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.

  • Step therapy means a program for Insureds who take Prescription Drugs for an ongoing medical condition, such as arthritis, asthma or high blood pressure, which ensures the Insured receives the most appropriate and cost-effective drug therapy for their condition. The Step Therapy program requires that before benefits are payable for a high cost Covered Drug that may have initially been prescribed, the Insured try a lower cost first-step Covered Drug. If the prescribing Physician has documented with SHL why the Insured’s condition cannot be stabilized with the first-step Covered Drug, SHL will review a request for Prior Authorization to move the Insured to a second-step drug, and so on, until it is determined by SHL that the prescribed Covered Drug is Medically Necessary and eligible for benefit payment.

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • Licensed Territory means worldwide.