BioCardia (BCDA) 10-Q2021 Q1 Quarterly report

Definitions

“Applicable Laws” shall mean all laws, ordinances, rules and regulations of any regulatory authority or any other state, local or federal governmental authority that apply to the conduct of the Study, the protection of the rights, safety and welfare of human subjects, the control of new devices under investigation, or the activities contemplated hereunder, including but not limited to: (i) the United States Federal Food, Drug and Cosmetic Act (“FDCA”); (ii) regulations and guidelines of the United States Food and Drug Administration (“FDA”), including but not limited to those set forth in the Unites States Code of Federal Regulation (“C.F.R.”); (iii) Good Clinical Practices, as set forth in 21 C.F.R. Parts 50 and 56 and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Guidelines; and (iv) all applicable privacy laws, rules and regulations (collectively “Privacy Laws”), including the United States Department of Health and Human Services privacy rules under the Health Insurance Portability and Accountability Act of 1996 45 C.F.R. Parts 160 and 164, as amended and including its implementing regulations (collectively “HIPAA”); and (v) laws and regulations governing payments, remuneration, and referrals to and from healthcare providers, disclosure thereof, and export, including, but not limited to the Foreign Corrupt Practices Act of 1977 (15 U.S.C. §§ 78dd-1, et seq.), the Stark Law (42 U.S.C. §§ 1395nn, et seq.), the Anti-Kickback Statute (42 U.S.C. §§ 1320a-7b(b), et seq.), and the Patient Protection and Affordable Care Act (42 U.S.C. § 1320a-7h).

“Confidential Information” means all confidential, proprietary, or trade secret information, property or material of SPONSOR and any derivatives, portions or copies thereof, including, without limitation, information resulting from or in any way related to the Consulting Services provided, the business practices, plans or relationships of SPONSOR and any other information or material that SPONSOR designates as Confidential Information. Confidential Information includes, without limitation, all information received from or on behalf of Sponsor, or the Study sites or personnel involved in the Study, or created, generated or developed in connection with the Study, the Consulting Services hereunder, or using or incorporating other Confidential Information, including the terms of this Agreement, investigator’s brochure, Protocol, Manual of Operations, the identity and characteristics of the Study Devices (and all information relating thereto), Inventions (as defined below), Study records, reports, data, newsletters, safety reports and analysis, and any information about the subjects participating in the Study, including personal health information, and medical records and reports.

“Consulting Services” means the services set forth in Schedule 1, with such modifications to Schedule 1 as SPONSOR may reasonably request from time to time.

“Parties” means SPONSOR and Consultant and “Party” shall mean either of SPONSOR or Consultant.

“Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision, department or agency of a government.

“Term” means the period beginning on the Effective Date and continuing until completion of Consulting Services unless earlier terminated in accordance with Section 10 of the Agreement.

Scope of Consulting Services

Compensation and Out-of-Pocket Expenses

Payments

SPONSOR agrees to provide payments to the Consultant for Consulting Services as set forth in Schedule 2.

All payments shall be made for Consulting Services carried out in accordance with this Agreement and all Applicable Laws governing such Consulting Services.

The Consultant acknowledges that the amounts to be paid by SPONSOR under this Agreement represent reasonable, fair market value compensation for the work performed and the Consultant has received no other compensation or other inducement in connection with this Agreement or its participation in Consulting Services for the Study. Except with respect to those expenses set out in Schedule 2, Consultant acknowledges and agrees that the payments made by SPONSOR under this Agreement represent SPONSOR’s total financial obligations under this Agreement, and fully cover the cost of conducting the Consulting Services for the Study.

Compensation/Reconciliation Upon Early Termination

All Costs

Payment will be remitted to Consultant according to the compensation and payment terms set forth in Schedule 2.

The payments set forth in Schedule 2 represent all Consulting Services costs for the Study, and no other moneys shall be payable, unless otherwise approved by SPONSOR in writing. All amounts payable by SPONSOR under this Agreement are stated inclusive of any tax, which CONSULTANT may be obligated to pay.

The CONSULTANT shall provide SPONSOR with a completed and signed SPONSOR-specific Form W-9 prior to any payments being made under this Agreement. In the event of a conflict between the Payee and Tax Identification Number set forth in Schedule 3 and the SPONSOR-specific Form W-9, the SPONSOR-specific Form W-9 shall control.

Budget Non-Disclosure

Transparency

Relationship of the Parties

Intellectual Property

Ownership Any inventions, ideas, discoveries, processes, know-how, trade secrets, data, reports, conclusions, findings, original works, concepts, devices, new uses, improvements, modifications, patents and/or other intellectual property relating to the Study Device, Sponsor’s Confidential Information, or otherwise arising from or out of the Study or the Consulting Services, whether patentable or copyrightable or not, conceived, generated or first reduced to practice, as the case may be, during the term of this Agreement (hereinafter called “Inventions”), shall, without further remuneration for the Consultant, be the property of the SPONSOR. All Inventions and all original works of authorship relating to or arising out of the Study, the Consulting Services, the Study Device (including, but not limited to, any derivations, modifications, or alternative or new uses therefor), intellectual property, or Confidential Information, made or conceived by the Consultant during the term of this Agreement and for one (1) year thereafter shall be works made for hire and shall become and remain the sole and exclusive property of the Sponsor. To the extent that ownership of such Inventions and original works of authorship does not automatically vest in the Sponsor, the Consultant hereby transfers and assigns to the Sponsor all right, title and interest in and to the same, whether or not patent or copyright applications are filed thereon.

Disclosure The Consultant shall promptly disclose to SPONSOR and/or the SPONSOR, in writing, any Invention and/or works of authorship.

Cooperation The Consultant shall take all such actions throughout the term of this Agreement and thereafter as shall be necessary in order to ensure that the Inventions may be vested free of encumbrance in the SPONSOR in accordance with Section 5.1 above. The Consultant shall further cooperate with the SPONSOR, at the SPONSOR’s reasonable expense, by promptly executing any documents or carrying out any acts that may be required to vest the rights in or to Inventions in the SPONSOR and otherwise to enable the SPONSOR fully to protect its intellectual property.

Background Rights For the avoidance of doubt all intellectual property rights and rights of a similar nature owned by or licensed to a Party prior to the date of this Agreement shall remain that Party’s property.

Confidential Information

The Consultant agrees that he or she will have access to, or become acquainted with, Confidential Information of SPONSOR. Confidential Information may be disclosed to Consultant either orally, visually, in writing, by delivery of materials containing Confidential Information or in any other form or medium. The Consultant will keep Confidential Information in strict confidence, will use Confidential Information only in connection with the performance of the Consulting Services, and will not, during or after the Term, without SPONSOR’s prior written consent, disclose, disseminate or otherwise make available or allow access to Confidential Information to any third party. If the Consultant becomes aware of disclosure or misuse, he or she will immediately notify SPONSOR and take reasonable steps to prevent further disclosure or misuse, as requested by SPONSOR.

The obligations of non-disclosure do not apply where the Consultant can prove by competent written evidence (a) the Confidential Information was known to the Consultant prior to the Effective Date and that was not subject to any confidentiality restrictions, (b) the Confidential Information was lawfully obtained from a third party without any confidentiality obligations, or (c) the Confidential Information is or becomes part of the public domain through no fault of the Consultant.

Notwithstanding Section 6.1, if the Consultant is requested to disclose Confidential Information by a lawful, judicial, or government order, the Consultant will immediately notify SPONSOR to permit SPONSOR to defend against any such order of disclosure, and Consultant will assist in such defense to the extent permitted by law.

The obligations of nondisclosure set forth in this section 6 will commence upon the Effective Date and shall survive and continue for ten (10) years after the expiration or earlier termination of this Agreement.

Subcontractors

The Consultant shall not engage or make use of subcontractors for the purpose of providing the Consulting Services or any other obligations under this Agreement except as expressly authorized by SPONSOR in writing. Any such permitted subcontract shall be subject to the applicable terms and conditions of this Agreement, and, upon SPONSOR’s request, the Consultant shall require any such subcontractor to enter into an agreement, pursuant to which the terms and conditions of this Agreement shall apply directly between such subcontractor and SPONSOR prior to disclosing to such subcontractor any Confidential Information, provided, however, that no such subcontract shall release the Consultant from any of its obligations under this Agreement except to the extent such obligations are satisfactorily performed by such subcontractor in accordance with this Agreement.

SPONSOR may subcontract with an independent third party Contract Research Organization (“CRO”), as shall be more specifically identified in writing by Sponsor. CRO may perform some of SPONSOR’s obligations under this Agreement on SPONSOR’s behalf, as may be more specifically set forth in writing by Sponsor, including but not limited to, invoicing and administering and making payments to Steering Committee advisors, facilitating, assisting in, and monitoring the performance of the Steering Committee advisors, providing, collecting, receiving, generating and storing information on SPONSOR’s behalf. Notwithstanding SPONSOR’s use of the CRO, all obligations of Consultant under this Agreement are owed to SPONSOR and any payments made under this Agreement, whether made by SPONSOR or CRO, shall be attributable to SPONSOR. SPONSOR may, in its sole discretion, replace, cease to use, or modify the duties of CRO at any time and in such event, will provide Consultant with written notice of such replacement, modification of duties or termination. In no event shall CRO have the authority to amend, modify, terminate, or waive any rights under this Agreement on behalf of SPONSOR or otherwise enter into a legally binding agreement on behalf of SPONSOR.

Use of Name

Representations, Warranties and Covenants of Consultant

Termination; Effect of Termination

Termination for Breach. Either party may terminate the Agreement by upon thirty (30) days prior written notice at any time for any reason.

Effect of Termination Upon termination of this Agreement by SPONSOR, the Consultant shall promptly cease performance of his or her obligations under this Agreement. The expiration or termination of this Agreement shall be without prejudice to any rights or obligations of the Parties that may have accrued prior to the termination and, except as otherwise expressly provided herein, shall not limit any rights or remedies which may be available by law or otherwise.

Upon the termination or expiration of this Agreement, the Consultant shall at SPONSOR’s option and direction, either destroy or return to SPONSOR all Confidential Information received from SPONSOR and, upon SPONSOR’s request, certify Consultant’s destruction or return of all such Confidential Information.

In the event of such termination, the Consultant will be entitled to receive (a) any compensation due and payable under Section 3 but not yet paid as of the effective date of termination, and (b) payment of reasonable and necessary out-of-pocket expenses reimbursable under Section 3 that are paid or incurred by the Consultant prior to the effective date of termination.

Any invoice, together with the other information required pursuant to Section 3, must be received no later than thirty (30) days after the effective date of termination. Such payments will constitute full and complete settlement of all claims of the Consultant against SPONSOR in connection with this Agreement.

Assignment

Governing Law and Jurisdiction

Notices

Survival

Entire Agreement and Amendment

Anti- Bribery and Anti-Corruption

Steering Committee Consultant Fees. During the term of this Agreement, SPONSOR will pay the Contractor an hourly rate of $400 per hour for meeting attendance or preparation of meeting attendance.

Consultant will request payment by submitting an invoice to SPONSOR that identifies the date and nature of the Consulting Services rendered, the time spent by Consultant performing Services, and the total Consultant Fees earned.

Consultant will submit an invoice no later than 30 days after Consulting Services detailed in the invoice have been rendered.

SPONSOR will pay per Consultant Fees within 30 days after receipt of the invoice, unless there is a good faith dispute regarding any of the charges therein.

Pass-Through Expenses. SPONSOR will reimburse Consultant for reasonable and necessary travel expenses for travel required to perform Consulting Services and for certain other out-of-pocket expenses that have been prospectively approved, in writing, by SPONSOR (collectively, “Pass-Through Expenses”). It is agreed on that travel costs for intercontinental flights using “business class” and for flights within EU “economy class” will be reimbursed and that travel time will not be reimbursed.

Consultant will submit an invoice to SPONSOR within 30 days after incurring an authorized Pass-Through Expense. Consultant will include on the invoice a detailed accounting of the Pass-Through Expenses, accompanied by copies of the receipts.

SPONSOR will reimburse Pass-Through Expenses within 30 days after receipt of the invoice and accompanying receipts, unless there is a good faith dispute regarding any of the expenses therein.

Total Amount Payable. The total amount of Consulting Fees payable under this Agreement (exclusive of Pass-Through Expenses) shall not exceed $1,000 per month.

Final Invoices. Consultant will submit final invoices within 60 days after expiration or termination of this Agreement. Unless SPONSOR authorizes later submission, in writing, SPONSOR has no obligation to pay invoices received later than 90 days after expiration or termination of this Agreement.

Invoices should be sent to:

any financial arrangement entered into between the Sponsor of the Study, whereby the value of the compensation to me for conducting or participating in the clinical study could be influenced by the outcome of the study;

any significant payments (i.e. financial interests) of other sorts from the Sponsor of the Study that have a cumulative monetary value of $25,000 or more, including, but not limited to payments, retainers, and honoraria from Sponsor for participant on committees, providing consultation, or serving as a preceptor, grants to fund ongoing research (e.g., grants to Consultant or institution to fund Consultant’s ongoing research), compensation in the form of equipment, or honoraria;

any proprietary interest in the Investigational Device being evaluated in the Study, including but not limited to a patent, trademark, copyright or licensing agreement;

any significant equity interest in the Sponsor of the Study held by me, my spouse or dependent children.