Regulatory Exclusivity Clause Samples
The Regulatory Exclusivity clause establishes the rights of a party to benefit from exclusive marketing or use of a product based on regulatory protections granted by government authorities. Typically, this clause applies to pharmaceuticals or other regulated products, where a regulatory body grants a period during which competitors cannot market generic or similar versions. Its core function is to protect the investment made in developing a product by preventing competitors from entering the market for a defined period, thereby incentivizing innovation and recouping development costs.
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Regulatory Exclusivity. On a Product-by-Product and country-by-country basis, if the sole basis for the continuance of a Royalty Term is the existence of Regulatory Exclusivity, the applicable royalty rate under Section 4.1 shall be reduced by fifty percent (50%).
Regulatory Exclusivity. The term “
Regulatory Exclusivity. The JDC shall oversee the process of applying for and securing exclusivity rights that may be available under regulatory laws of countries in the Territory. Each Party shall cooperate with the other to take such reasonable actions to assist the other Party in obtaining such exclusivity rights in each country, as directed by the JDC.
Regulatory Exclusivity. The Licensee agrees, where applicable and to the extent that it is able, to not seek, and to waive, regulatory exclusivity in the Territory in relation to any data relating to Licensed Product.
Regulatory Exclusivity. Pfizer shall use Commercially Reasonable Efforts to obtain all applicable Regulatory Approvals and Regulatory Exclusivities in each Major Market Country.
Regulatory Exclusivity. In the event that either Party reasonably believes that exclusivity rights under any Marketing Approval for the Product within the Field in the Territory are being violated (whether by making, using, offering, for sale or selling any biosimilar equivalent of Product, or otherwise) by a Third Party, such Party shall promptly notify the other Party. For clarity, as holder of the Marketing Approval for a Product, Grünenthal shall have the first right to bring any action to enforce such exclusivity rights arising from a Marketing Approval for the Product within the Field in the Territory.
Regulatory Exclusivity. On a Royalty Bearing Product-by-Royalty Bearing Product basis, if the sole basis for the continuance of a Royalty Term is the existence of Regulatory Exclusivity, the applicable royalty under Section 5.2 and/or Section 5.3 shall be reduced by fifty percent (50%).
Regulatory Exclusivity. If Rain decides to seek regulatory and/or data exclusivity for a Product, Rain will be responsible, at its sole expense, for preparing and filing such requests with the applicable Regulatory Authority. Daiichi Sankyo will, upon request, provide reasonable support to Rain in preparing and filing such requests to Regulatory Authority in [***] and [***] at Rain’s expense.
Regulatory Exclusivity. During the Term, Licensee (or its Affiliate(s) or Sublicensee(s)) shall have the sole right, but not the obligation, to apply for and secure any regulatory exclusivity rights that may be available under Applicable Laws for Products in the Field in the Territory.
Regulatory Exclusivity. The JSC shall oversee the process of applying for and securing exclusivity rights that may be available under the Law of countries in the Territory, including any data or market exclusivity periods such as those periods listed in the FDA’s Orange Book or Purple Book (as applicable) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 (including any pediatric exclusivity extensions or other forms of regulatory exclusivity that may be available), and all international equivalents.