Common use of Know-How Transfer Clause in Contracts

Know-How Transfer. 7.1.1 Within thirty (30) days after the Effective Date, Orion shall deliver to Licensee electronic or paper copies of the following Orion Know-How: (a) the NDA for Hospira’s Precedex product; (b) the “open part” of the DMF(s) related to Orion Dexmedetomidine API; (c) Orion’s most recent safety updates related to its Dexmedetomidine Products; and (d) to the extent not encompassed by subsection (b) above, information on the characterization of the reference standard and its history, API solubility profile in normal solvents, container/closure interaction with API (extractables), and characterization/qualification of any API impurities associated with manufacturing or stability testing that would require this under ICH guidelines, and updates to the DMF open section, including items listed above. 7.1.2 Subject to Section 7.2, and on a commercially reasonable schedule and in a commercially reasonable format to be agreed on by the Parties, Orion shall, or shall cause one or more of its Affiliates to, deliver to Licensee copies of reasonable documentation and/or embodiments of all Orion Know-How not listed in Section 7.1.1, which documents and embodiments of the Orion Know-How are readily available to Orion in electronic form and that shall document or embody the Orion Know-How in all material respects, including, to the extent relevant to the research, Development, manufacture and Commercialization of Recro Products and to the extent possible without breaching any obligation towards Hospira or any other Third Party, Orion’s and Hospira’s Regulatory Filings and clinical data related to Dexmedetomidine Products. Orion undertakes to convert, on a commercially reasonable schedule and at Licensee’s expense, into electronic form any such information referred to above that is readily available only as hard copy.

Know-How Transfer. 7.1.1 (i) Within thirty a mutually agreed time after the Effective Date, but in any case no later than four (304) days months after the Effective Date, Orion shall deliver to Licensee electronic or paper copies of the following Orion Know-How: (a) the NDA for Hospira’s Precedex product; (b) the “open part” of the DMF(s) related to Orion Dexmedetomidine API; (c) Orion’s most recent safety updates related to its Dexmedetomidine Products; and (d) , to the extent not encompassed by subsection (bsuch Know-How exists and is readily available: 1) above, information on the characterization of the reference standard and its history, API solubility profile in normal solvents, container/closure interaction with API (extractables), and characterization/qualification of any API impurities associated with manufacturing or stability testing that would require this under ICH guidelines, plus information on existing, sublicensable and updates to the DMF open sectiontransferable analytical methods, pharmacological models and methods and data, as well as copies of all nonclinical and clinical data (including items listed abovecase report forms), protocols, study reports, manufacturing and stability data and related. 7.1.2 2) Subject to Section 7.2, and on a commercially reasonable schedule and in a commercially reasonable format to be agreed on by the Parties, Orion shall, or shall cause one or more of its Affiliates to, deliver to Licensee copies of reasonable documentation and/or embodiments of all Orion Know-How not listed in Section 7.1.1, which documents and embodiments of the Orion Know-How are readily reasonably available to Orion in electronic form and that shall document or embody the Orion Know-How in all material respects, including, to the extent relevant to the research, Development, manufacture and Commercialization of Recro Products and to the extent possible without breaching any obligation towards Hospira or any other Third Party, Orion’s and Hospira’s possible Regulatory Filings (if any) and clinical data related to Dexmedetomidine Fadolmidine Products. Orion undertakes to convert, on a commercially reasonable schedule and at Licensee’s expense, into electronic form any such information referred to above that is readily available only as hard copy.