Common use of Documentation Deliverables Clause in Contracts

Documentation Deliverables. (a) In the event Defiante, its Affiliates and/or Sub-Licensees generates or obtains, during the Term, any Documentation relative to Finished Products or Bulk Active Material, Defiante, its Affiliates and/or Sub-Licensees shall promptly deliver copies of any and all Documentation to RegeneRx. In the event RegeneRx has in its possession, as of the Effective Date and during the Term, Documentation that RegeneRx determines that Defiante, its Affiliates and/or Sub-Licensees require or would aid Defiante, its Affiliates and/or Sub-Licensees, in obtaining and maintaining Commercial Marketing Approval or in conducting clinical studies as a result of access to and use of the Documentation, RegeneRx shall promptly provide such Documentation to Defiante, its Affiliates and/or Sub-Licensees. The Documentation of each party shall be considered Information, as subsequently defined. Additionally, certain Documentation may be subject to country laws and regulations, including patient privacy laws, relative to the release and use thereof, and, in such event, such Documentation may be withheld from a party unless appropriate approvals can be obtained for release. (b) Within a reasonable period of time following the conclusion of the positive phase II clinical trial and in anticipation of the conduct of a pivotal phase III trial and subject to Section 5.1, RegeneRx shall deliver, at its fully allocated cost, and at the request of Defiante, sample quantities of Bulk Active Material for the purposes of conducting the pivotal phase III clinical testing. RegeneRx shall not be considered to be in breach of this Agreement if RegeneRx does not deliver the sample quantities requested or delivers less than the sample quantities requested. (c) During the Term of this Agreement, RegeneRx shall promptly inform Defiante of any RegeneRx Improvements and/or Documentation that RegeneRx has developed. RegeneRx Improvements shall be embodied in or incorporated into the Finished Products only as provided under Article 6, Section 6.8. In the event the conditions recited in Section 6.8 do not occur regarding the embodiment or incorporation of RegeneRx Improvements into the Finished Products, then no RegeneRx Improvements shall be incorporated unless such RegeneRx Improvements are necessary for compliance with the Specifications or Commercial Marketing Approval. The use of the RegeneRx Improvements shall be governed by the Finished Products Grant and Bulk Active Material Manufacturing Grant recited in Article 2, Section 2.6. (d) During the Term of this Agreement, Defiante shall promptly inform RegeneRx of any Defiante Improvements. Such Defiante Improvements shall be governed by the Defiante Improvement Grant in Article 2, Section 2.9. Defiante Improvements shall be embodied in or incorporated into the Finished Products as recited in Section 6.8. If no mutual agreement occurs, such Defiante Improvements shall not be incorporated into the Finished Products unless such Defiante Improvements are necessary for compliance with the Specifications or Commercial Marketing Approvals.