Disclosure of CMC Information for Regulatory Purposes Sample Clauses

Disclosure of CMC Information for Regulatory Purposes. 4.7.1. With respect to each Existing Product, if and for so long as Supplied Product is manufactured by AstraZeneca using MedImmune Manufacturing [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. Technology, AstraZeneca will, at SPINCO’s reasonable request, and at SPINCO’s [sole] cost and expense, provide SPINCO one or more letters providing SPINCO a right of reference to the relevant IND or other relevant filing with a Regulatory Authority, or shall otherwise provide SPINCO via such other methods as may be available, to allow SPINCO to reference with the applicable Regulatory Authority the relevant CMC Data solely to the extent necessary for SPINCO to obtain or maintain an IND or BLA or other Regulatory Approval for such Product. Such alternate methods may entail AstraZeneca providing such CMC Data directly to such Regulatory Authority (to the extent permitted by Applicable Law and Regulations) or at AstraZeneca’s sole election, directly to SPINCO; provided that SPINCO shall permit AstraZeneca to seek any and all measures available to protect the confidentiality of and AstraZeneca’s interests in and to such CMC Data, including, if such information is provided directly to SPINCO, restricting access to such CMC Data through a secure data room or portal to specified members of SPINCO’s regulatory affairs and quality assurance departments who need to know such CMC Data in order to prepare, submit, obtain, or maintain an IND or BLA or Regulatory Approval for the Product and who have entered into confidentiality agreements with AstraZeneca in a form reasonably acceptable to AstraZeneca, and SPINCO shall provide full cooperation and assistance to AstraZeneca in seeking to obtain such protection.