Provision Language
Definitions
“Exploiting Party” means the Party or Parties undertaking development and exploitation pursuant to Clauses 11 and 12;
11. EXPLOITATION
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11.2 Each Party agrees that it shall promptly, (and in the case of PTC, will procure that the relevant member of the PTC Group shall promptly), inform and deliver written details to the other Parties of, any safety concerns or issues raised by any Competent Authority that relate to the Products.
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11.9 During the Programme Term, PTC shall keep the Trust reasonably informed on all matters relating to the Development and Exploitation of the Programme Intellectual Property and Products by or on behalf of PTC via the [**] RSG reports required pursuant to Clause 5.7. Following the Programme Term, PTC shall provide all matters relating to the Development and Exploitation of the Programme Intellectual Property and Products by or on behalf of PTC [**].
12. TRUST STEP-IN RIGHTS
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12.5 The Exploiting Party shall determine the regulatory plans and strategies and clinical trials (“Key Product Strategy”) for any Products and shall be responsible for filing all regulatory filings with respect to the Products and will be responsible for obtaining and maintaining regulatory approvals in the name of the Exploiting Party. The Exploiting Party shall keep the Non-Exploiting Party informed regarding the Key Product Strategy for each Product and take into account the reasonable recommendations of the Non-Exploiting Party relating to such Key Product Strategy. Notwithstanding the above, the Parties acknowledge and agree that if the Non-Exploiting Party can reasonably demonstrate that any aspect of the Key Product Strategy proposed by the Exploiting Party will materially prejudice the Exploitation of any Product(s) which have been launched, the Exploiting Party will not proceed with such aspect of the Key Product Strategy.
