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Sharmela Thevarajaha Archives - JAG Shaw Baker

The Ins and Outs of Clinical Trials – Termination

By | Insights, Life Sciences

Clinical trials are costly, involve numerous parties and depending on the phase of the trial, are a lengthy process. Although it’s unpleasant to talk about how to end a relationship before it’s even begun, a frank and complete discussion at the outset on how a contract is to be terminated amicably will benefit all parties involved. In this post, we’ll address a termination provision that a sponsor, typically a pharmaceutical company, can exercise and negotiate. Such provision is particular to a clinical trial agreement and which can be challenging to negotiate with other parties to the agreement, i.e. the institution…

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Ins and Outs of Clinical Trials: Publication Rights

By | Insights, Life Sciences

Looking back to our last post in the Ins and Outs series on Confidentiality, you’ll see there’s an obvious disconnect and therefore potential conflict in relation to publication rights between a sponsor and the principal investigator (PI)/institution. Onerous restrictions on publication rights could be counterproductive and unlikely to be accepted by the institution and PI. For a start, it could potentially sour the goodwill and alliance established between the institution, PI and sponsor prior to commencing the clinical trial. Further, sponsors understand that for many institutions and PIs, in addition to facilitating the development of new medicines, conducting clinical trials has the allure…

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The Ins And Outs Of Clinical Trials – Confidentiality

By | Insights, Life Sciences

As we continue our 10-part series on clinical trials, this post addresses confidentiality in clinical trials. Confidentiality is an important provision in a clinical trial agreement. It’s a potentially divisive term for pharmaceutical companies (sponsor), principal investigators (PI) and institutions. Typically, from the sponsor’s perspective, it will want to: Keep the information confidential for as long as possible. Have a broad definition of confidential information in order to ensure that all information provided to the PI and institution for the trial is protected. Safeguard its commercial interests by ensuring that all information (particularly proprietary information such as information relating to…

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A New Blog Series: The Ins And Outs Of Clinical Trials

By | Insights, Life Sciences

In our new 10 part blog series on clinical trials, Sharmela Thevarajaha, Associate, Intellectual Property and Life Sciences, brings her wealth of private practice and in-house experience with clients such as Sanofi and Takeda, to take a look at some key clauses within a sponsor-initiated clinical trial agreement. In the series she highlights the crucial legal, ethical and business issues to consider when negotiating these key provisions including payments, intellectual property, insurance and publication rights. ______ Clinical research collaboration plays a significant role in developing medicines, advancing medical knowledge and enhancing patient care.   Without clinical trials, pharmaceutical companies (the…

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