definiens: shall mean ( a ) all preclini cal and clinical protocols, studies, data, results, study - related forms, materials and reports ( e.g., investigator br ochures, informed consent forms, data safety monito ring board related documents, patient recruitment related mate rials, biocompatibility studies, animal studies, sa fety studies, and chemistry, manufacturing and control data ) resu lting from any preclinical or clinical study or tri al of any Product in the Collaboration Field that is conducte d by or under the direction of Alimera or CDS, or t heir Permitted Subcontractors or sublicensees, pursuant to this Agreement, and any audit of any such precli nical or clinical study or trial, and ( b ) all INDs, NDAs, an y unfiled applications, components or materials nor mally associated with an IND or NDA, regulatory filings o r applications comparable to INDs or NDAs in any fo reign jurisdictions, and other regulatory applications an d Approvals regarding any Product in the Collaborat ion Field that are prepared or submitted by or under the dire ction of Alimera or CDS, or their Permitted Subcont ractors or sublicensees, pursuant to this Agreement ; provided, however, that Clinical IP shall not include any Pr e - Existing Clinical IP