GSK Product definition

GSK Product means a Product Developed and commercialized by GSK or its Affiliate or Sublicensee under or resulting from a GSK Development Program.

GSK Product means an investigational or licensed medicinal product, consumer healthcare product, vaccine, biological product or device whether under development by, or manufactured, marketed, supplied or distributed by or on behalf of, any division or operating company of GSK, whether in the Territory or in any other country.

GSK Product shall have the meaning set forth in Section 11.1. -----------

Examples of GSK Product in a sentence

• All RMPs will outline standard risk mitigation activities that will be performed and tracked for each GSK Product, regardless of the product’s relative risk ranking (Standard RMPs).

• Standard risk mitigation activities will consist of the monitoring activities to be conducted for each GSK Product in the upcoming year, such as monitoring of speaker programs, speaker training, advisory boards, sampling, verbatim reviews, medical information requests and ride-alongs with sales personnel.

• For clarity, GSK would have the right to use the Zymeworks Modification and Zymeworks Modified Scaffolds solely for purposes of performing the Research Collaboration; researching and developing GSK Antibodies to be incorporated in any GSK Product; and researching, developing and commercializing such GSK Products, in each case in accordance with this Agreement.

• The terms and conditions of a GSK Product --------------------- Agreement (including the term itself) will be negotiated by the Parties in good faith, with the understanding that the Parties anticipate that the structure of such arrangement will most likely be a ** of the **.

• In the event that PROSENSA reasonably believes that GSK has failed to comply with the obligations of this Section 5.1(c) in any Calendar year with respect to a GSK Development Program or GSK Product, PROSENSA shall have the right to terminate this Agreement by operation of the applicable provisions of Article 12 with respect to such GSK Development Program and/or GSK Product.

More Definitions of GSK Product

GSK Product means an investigational or licensed medicinal product, consumer healthcare product, vaccine, biological product or device whether under development by, or manufactured, marketed, supplied or distributed by or on behalf of, any division or operating company of the Supplier or the GSK group of companies, whether in Australia, New Zealand or in any other country. A list of GSK Products is available on the GSK website;

GSK Product means any product Commercialised by or on behalf of any member of the GSK Group at any time on or after Completion;

GSK Product is defined as an investigational or licensed medicinal product, consumer healthcare product, vaccine, biological product or device whether under development by, or manufactured, marketed, supplied, or distributed by or on behalf of, any division or operating company of GSK and includes ViiV Healthcare, whether in the Territory or in any other country. All HSI/AEs shall be reported to GSK within 24 hours of initial receipt (or next working day if over a weekend) using GSK provided HSI/AE form. Reports for this engagement should be sent via secure email/fax to the contact details found on the reporting form. HSI is defined as information relating to human health and/or wellbeing following exposure to GSK products, including AE information. AE shall mean any untoward medical occurrence in a patient, clinical investigation subject or consumer and is temporally associated with the use of a GSK Product, whether or not related to the product. HSI/AEs can include: • Any unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). • Failure to produce expected benefits (i.e. lack of efficacy). • Off-label use. • Medication errors or misuse, including drug overdose, whether accidental or intentional. • Drug abuse or effects of drug withdrawal. • Occupational exposure. • Patients taking GSK products whilst pregnant or breastfeeding. • Paternal exposure to a GSK product before and during pregnancy. • Transmission of an infectious agent via a medicinal product. • Safety information received as part of a product quality complaint. • Drug interaction. • Unexpected therapeutic benefits (i.e. an unexpected improvement in a concurrent condition other than the one being treated). Third Party confirm that the HSI/AEs that it sends to GSK were sent successfully without error. If a failure notification is received, Third Party shall immediately re-send the HSI/AE and take reasonable steps to ensure it does not occur again. Third Party is responsible to follow all local regulations for reporting of HSI/AEs. The Third Party is required to keep records of successful confirmation and provide upon request by GSK. This information should be readily available in case of audit/inspection. In no event will personally identifiable information of any patient be provided to GSK in connection with any HSI/AE without consent from the respondent. Personal data of a healthcare professional who has reported an HSI/AE under this Agreement may be disclosed...

GSK Product means an investigational or licensed medicinal product, consumer healthcare product, vaccine, biological product or device whether under development by, or manufactured, marketed, supplied or distributed by or on behalf of, any division or operating company of the Purchaser or the GSK group of companies, whether in Australia, New Zealand or in any other country. A list of GSK Products is available on the GSK website;

GSK Product means GlaxoSmithKline’s Argatroban product that has received Regulatory Approval from the FDA on or before the Effective Date.

GSK Product means any product that is Covered by a Valid Claim of any Patent that has issued from any Data Patent Application where such Patent contains any [***] Data or [***] Data provided by 23andMe under this Third Amendment.

GSK Product means (a) a GSK Mono-Specific Product or (b) a GSK Multi-Specific Product. The Antibodies described in (a) and (b) above may be referred to in this Agreement as “GSK Antibodies.” For clarity, (x) GSK Product shall not include Products containing Mono-Valent Antibodies or Multi-Specific Antibodies that are not GSK Multi-Specific Antibodies; and (y) GSK Products Directed To a particular Target(s) may be limited to GSK Mono-Specific Products or GSK Multi-Specific Products, but not both, as determined pursuant the Target selection and gatekeeping mechanisms set forth in Article 3.