Document:

Exhibit 10.1

 

 

R. CHAD HUNT

AMENDED AND RESTATED

EMPLOYMENT AGREEMENT

 

 

THIS AMENDED AND RESTATED EMPLOYMENT AGREEMENT (“Agreement”) is made and entered into effective as of the 31st day of August, 2014 (the “Effective Date”), by and between Rhino GP LLC, a Delaware limited liability company (the “Employer”) and R. Chad Hunt (“Executive”).

 

Recitals:

 

Executive is currently employed by Employer pursuant to an Employment Agreement dated effective as of August 31, 2011 (the “Prior Agreement”).  The Employer is the general partner of Rhino Resource Partners L.P. and seeks to continue the Executive’s employment with the Employer.

 

The Employer and Executive desire to enter into this Agreement in order to amend and restate the terms of Executive’s employment.  Executive desires to enter into this Agreement, and to accept employment by Employer on the terms hereinafter set forth in this Agreement.  This Agreement amends, restates and supercedes the Prior Agreement.

 

Agreement:

 

NOW, THEREFORE, in consideration of the premises and mutual covenants herein and for other good and valuable consideration the receipt and sufficiency of which is hereby acknowledged, the parties hereby agree as follows:

 

1.                                 Term of Employment.  Unless terminated earlier in accordance with the provisions of Section 7, Executive’s employment under this Agreement shall be effective for a term commencing on the Effective Date and ending on August 31, 2017 (the “Employment Term”).

 

2.                                 Position and Duties.  As of the Effective Date, Executive shall serve as the Senior Vice President of Business Development of the Employer.  In such position, Executive shall report directly to the CEO of the Employer except, where appropriate and/or required by the rules of the New York Stock Exchange, Employer’s charter documents and/or other applicable rule or regulation, to the Board of Directors of Employer and/or Employer’s Audit Committee. Executive shall have the customary authority, responsibilities and duties of such position, subject to the direction and definition of such authority, responsibilities, and duties from time to time by Employer.  During the Employment Term, Executive will devote all of his business time and efforts to the performance of his duties hereunder.  Executive shall be subject to all of the employment and personnel policies and procedures in effect from time to time and applicable to executive employees of Employer.  Executive’s regular place of employment during the Employment Term shall be at Employer’s executive offices in Lexington, Fayette County, Kentucky, and Executive shall engage in such travel as may be reasonably required in connection with the performance of his duties hereunder.

 

 

3.                                 Base Salary.  The Employer shall pay Executive a base salary (the “Base Salary”) at the initial annual rate of $265,000 per year, which Base Salary shall be evaluated annually for potential increase, payable in regular installments in accordance with the usual executive payroll practices of Employer.  Executive’s annual salary shall be adjusted upward by an additional $10,000 on each September 1 of the Employment Term, to begin September 1, 2015.

 

4.                                 Incentive Compensation.  During the Employment Term, Executive shall participate in any annual or long-term cash or equity based incentive plans or other similar arrangements of the Employer on a comparable basis as Employer’s other executives, in each case, in accordance with the terms of such plans, provided that the specific grant to Executive under any such plan or arrangement shall be in Employer’s sole discretion.

 

5.                                 Discretionary Bonus.  The Employer may consider and approve in its sole discretion an annual performance-based discretionary bonus (“Discretionary Bonus”) for Executive of up to forty percent (40%) of Executive’s Base Salary.  The Discretionary Bonus will be calculated on a full calendar year basis for 2014, 2015, 2016, and on a prorated basis for 2017.  The prorated bonus for 2017 shall be paid on Executive’s last regularly scheduled pay date, in the event that this Agreement has not been extended prior to that date.

 

6.                                 Other Benefits.

 

(a) Retirement Benefits.  During the Employment Term, Executive shall be provided with the opportunity to participate in the Employer’s qualified 401(k) plan and profit sharing and non-qualified deferred compensation plans (if any), as they may exist from time to time, in each case, in accordance with the terms of such plans.

 

(b) Welfare Benefits; Vacation.  During the Employment Term, Executive shall be provided with the opportunity to participate in the Employer’s medical plan and other employee welfare benefits on a comparable basis as such benefits are generally provided by the Employer from time to time to Employer’s other executives, in each case, in accordance with the terms of such plans.  Executive shall be entitled to three (3) weeks of paid vacation each year during the Employment Term.

 

(c) Indemnification.  Employer shall indemnify and hold harmless Executive from and against any loss, cost, damage, expense, or liability incurred by Executive for any action taken by Executive in the scope of Executive’s employment for the Employer, provided such action (i) is within the scope, duties, and authority of Executive, (ii) is not in willful violation of any law, regulation, or code of conduct adopted by the Employer, and (iii) does not constitute gross negligence or intentional misconduct by Executive.  The obligations of Employer under this Section 6(c) shall survive the termination of this Agreement.

 

(d) Reimbursement of Business Expenses.  During the Employment Term, all reasonable business expenses incurred by Executive in the performance of his duties hereunder shall be reimbursed by the Employer upon receipt of documentation of such expenses in a form reasonably acceptable to the Employer, and otherwise in accordance with the Employer’s expense reimbursement policies.

 

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(e) Vehicle. Employer shall provide Executive with the use of a vehicle suitable for the intended duties of the Executive.

 

7.                                 Termination.  Notwithstanding any other provision of this Agreement:

 

(a)                                 For Cause by the Employer or Voluntary Resignation by Executive Without Good Reason.  If Executive is terminated by Employer for Cause (as defined in Section 11(d)) or if Executive voluntarily resigns without Good Reason (as defined in Section 11(j)), Executive shall be entitled to receive as soon as reasonably practicable after his date of termination or such earlier time as may be required by applicable statute or regulation: (i) any earned but unpaid Base Salary through the date of termination; (ii) payment in respect of any vacation days accrued but unused through the date of termination; and (iii) reimbursement for all business expenses properly incurred in accordance with Employer’s policy prior to the date of termination and not yet reimbursed by the Employer (the aggregate benefits payable pursuant to clauses (i), (ii), and (iii) hereafter referred to as the “Accrued Obligations”); and except as provided herein Executive shall have no further rights to any compensation (including any Base Salary or bonus, if any) or any other benefits under this Agreement.

 

(b)                                 Without Cause by the Employer or Voluntary Resignation by Executive for Good Reason.  If Executive is terminated by the Employer other than for Cause, Disability (as defined in Section 11(g)) or death, or if Executive voluntarily resigns for Good Reason, Executive shall receive:  (i) the Accrued Obligations; and (ii) subject to Section 7(f), Base Salary for a period of twelve (12) months from the termination of employment, payable in a lump sum within thirty (30) days of the date of termination.  Except as provided herein, Executive shall have no further rights to any compensation (including any Base Salary or bonus, if any) or any other benefits under this Agreement.

 

(c) Death.  Following termination of employment for death, Executive’s estate shall be entitled to receive the Accrued Obligations as well a pro-rated annual discretionary bonus as awarded by Employer as well as any other compensation Executive’s estate or beneficiary(ies) are entitled to receive under Employer’s workmen’s compensation insurance program and (if any) other death benefits payable to Executive’s estate or beneficiary(ies) under Employer’s benefits plans according to their terms if Executive has elected to participate in any such plans, as they may be amended from time to time.  Except as provided herein, Executive’s estate shall have no further rights to any other compensation or any other benefits under this Agreement.

 

(d) Disability.  Following termination of employment for Disability, Executive shall be entitled to receive the Accrued Obligations.  Except as provided herein, Executive shall have no further rights to any compensation (including any Base Salary) or any other benefits under this Agreement.

 

(e) Accrued & Vested Benefits.  Upon any termination of Executive’s employment, whether by Executive or Employer, Executive shall be entitled, in addition to any other benefits that may be payable hereunder, to all benefits accrued and vested as of the date of such termination, due to Executive under any plan, policy or practice of Employer (such as, for example, accrued health benefits or reimbursements) (collectively, “Accrued and Vested Benefits”).

 

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(f) Release Etc.  Notwithstanding any other provision of this Agreement to the contrary, Executive acknowledges and agrees that any and all payments to which Executive is entitled under this Section 7 which are described as being subject to this Section 7(f) are conditioned upon and subject to (i) Executive’s execution of an agreement in such reasonable and customary form as shall be prepared by the Employer reaffirming Executive’s obligations under Section 8 hereof, and (ii) Executive’s execution of, and not having revoked within any applicable revocation period, a general release and waiver, in such reasonable and customary form as shall be prepared by the Employer, of all claims Executive may have against the Employer and its directors, officers, subsidiaries and affiliates, except as to (x) matters covered by provisions of this Agreement that expressly survive the termination of this Agreement, and (y) any Accrued and Vested Benefits to which Executive may be entitled.

 

(g) Resignation.  Upon Executive’s termination of employment for any reason, Executive shall be deemed to have immediately resigned from all offices with the Employer and any of the Employer’s subsidiaries or affiliates and shall, immediately upon the request of the Employer, confirm such resignations in writing.

 

8.                                 Covenants.

 

(a) Confidentiality.  Executive agrees that Executive will not at any time during Executive’s employment with the Employer or thereafter, except in performance of Executive’s duties for and obligations to the Employer hereunder, use or disclose, either directly or indirectly, any Confidential Information (as hereinafter defined) of the Employer or its subsidiaries or affiliates that Executive may learn by reason of his association with the Employer.  The term “Confidential Information” shall mean any past, present, or future confidential or sensitive plans, programs, documents, agreements, internal management reports, financial information, or other material relating to the business, strategies, services, or activities of the Employer, including, without limitation, information with respect to the Employer’s operations, processes, products, inventions, business practices, finances, principals, vendors, suppliers, customers, potential customers, marketing methods, costs, prices, contractual relationships, including leases, regulatory status, compensation paid to employees, or other terms of employment, and trade secrets, market reports, customer investigations, customer lists, and other similar information that is proprietary information of the Employer or its subsidiaries or affiliates; provided, however, the term “Confidential Information” shall not include any of the above forms of information which has become public knowledge, unless such Confidential Information became public knowledge due to an act or acts by Executive or his representative(s) in violation of this Agreement.  Notwithstanding the foregoing, Executive may disclose such Confidential Information when required to do so by a court of competent jurisdiction, by any governmental agency having supervisory authority over the business of the Employer or its subsidiaries or affiliates, as the case may be, or by any administrative body or legislative body (including a committee thereof) with jurisdiction to order Executive to divulge, disclose or make accessible such information; provided, further, that in the event that Executive is ordered by any such court or other government agency, administrative body, or legislative body to disclose any Confidential Information, Executive shall (i) promptly notify the Employer of such order, (ii) at the reasonable written request of the Employer, diligently contest such order at the sole expense of the Employer as expenses occur or at the election of Employer, cooperate with Employer’s effort to contest such order, and (iii) at the reasonable written request of the Employer, seek to

 

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obtain, at the sole expense of the Employer, such confidential treatment as may be available under applicable laws for any information disclosed under such order or at the election of Employer, cooperate with Employer’s effort to obtain such confidential treatment.

 

(b) Non-Compete.  During the Employment Term and for one (1) year immediately following a termination of employment for any reason, Executive shall not, without the prior written consent of the Employer, participate or engage in, directly or indirectly (as an owner, partner, employee, officer, director, independent contractor, consultant, advisor or in any other capacity calling for the rendition of services, advice, or acts of management, operation or control) any business for an individual or entity whose principal business involves coal mining or coal marketing in the following regions: Central Appalachia, Northern Appalachia, Illinois Basin, Western Bituminous and any other region in which the Employer or any of the Employer’s subsidiaries conduct business.

 

(c) Non-Solicitation.  During the Employment Term and for two (2) years immediately following a termination of Employment for any reason, Executive shall not, without the prior written consent of the Employer, solicit or induce any then-existing employee of the Employer or any of its subsidiaries or affiliates to leave employment with the Employer or any of its subsidiaries or affiliates, or contact any then-existing customer or vendor under contract with the Employer or any of its affiliates or subsidiaries for the purpose of obtaining business similar to that engaged in, or received (as appropriate), by the Employer or any of its affiliates or subsidiaries.

 

(d) Cooperation.  Executive agrees that during the Employment Term or following a termination of employment for any reason, Executive shall, upon reasonable advance notice, assist and cooperate with the Employer with regard to any investigation or litigation related to a matter or project in which Executive was involved during Executive’s employment.  The Employer shall reimburse Executive for all reasonable and necessary expenses related to Executive’s services under this Section 8(d) (i.e., consulting, travel, lodging, meals, telephone, overnight courier) within ten (10) business days of Executive submitting to the Employer appropriate receipts and expense statements.

 

(e) Survivability.  The duties and obligations of Executive pursuant to this Section 8 shall survive the termination of this Agreement and Executive’s termination of employment for any reason.

 

(f) Remedies.  Executive acknowledges that the protections of the Employer set forth in this Section 8 are fair and reasonable, and that any violation of such protections would cause serious and irreparable harm and damage to the Employer and its subsidiaries and affiliates.  Executive agrees that remedies at law for a breach or threatened breach of the provisions of this Section 8 would be inadequate and, therefore, the Employer shall be entitled, in addition to any other available remedies (including money damages), without posting a bond, to equitable relief in the form of specific performance, temporary restraining order, temporary or permanent injunction, or any other equitable remedy that may be then available.

 

(g) Limitation.  The terms of this Section 8 are intended to limit disclosure and competition by the Executive to the maximum extent permitted by law.  If the duration, scope, or

 

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nature of any limitation or restriction imposed by any provision of this Section 8 is finally determined by any court or tribunal of competent jurisdiction to be in excess of what is valid and enforceable under applicable law, such provision shall be construed to cover only that duration, scope or activity that is valid and enforceable.  Executive hereby acknowledges that this Section 8 shall be given the construction which renders its provisions valid and enforceable to the maximum extent, not exceeding its express terms, possible under applicable law

 

9.                                 Representations of Executive.  Executive hereby represents to the Employer that Executive has full lawful right to enter into this Agreement and carry out Executive’s duties hereunder, and that performance of Executive’s obligations hereunder will not constitute a breach of or default under any employment, confidentiality, non-competition or other agreement.  Executive further represents to the Employer that Executive is not listed in the Office of Surface Mining’s Applicant Violator System database.  Executive shall provide prompt notice to the Employer of Executive’s first employment subsequent to a termination of employment.

 

10.                          Miscellaneous.

 

(a) Satisfaction of Obligations Under Prior Agreement.  Employer and Executive hereby acknowledge that this Agreement amends, restates and supersedes the Prior Agreement.

 

(b) Governing Law.  This Agreement will be governed by, and interpreted in accordance with, the laws of the Commonwealth of Kentucky applicable to agreements made and to be wholly performed within the Commonwealth of Kentucky, without regard to the conflict of laws provisions of any jurisdiction which would cause the application of any law other than that of the Commonwealth of Kentucky.  Executive hereby consents to the jurisdiction of the state and federal courts of the Commonwealth of Kentucky, including the Fayette Circuit Court, and hereby waives any objection to venue of any action brought in such courts.

 

(c) Entire Agreement; Amendments.  This Agreement contains the entire understanding of the parties with respect to the employment of Executive by the Employer.  There are no restrictions, agreements, promises, warranties, covenants or undertakings between the parties with respect to the subject matter herein other than those expressly set forth or referred to herein.  This Agreement may not be altered, modified, or amended, nor may any of its provisions be waived, except by written instrument signed by the parties hereto which states that it is intended to alter, modify or amend this agreement or waive a right hereunder.  Sections 7 and 8 hereof shall survive the termination of Executive’s employment with the Employer, except as otherwise specifically stated therein.

 

(d) Neutral Interpretation.  This Agreement constitutes the product of the negotiation of the parties hereto and the enforcement of this Agreement shall be interpreted in a neutral manner, and not more strongly for or against any party based upon the source of the draftsmanship of the Agreement.  Each party has been provided ample time and opportunity to review and negotiate the terms of this Agreement and consult with legal counsel regarding the Agreement.

 

(e) No Waiver.  The failure of a party to insist upon strict adherence to any term of this Agreement on any occasion shall not be considered a waiver of such party’s rights or deprive such party of the right thereafter to insist upon strict adherence to that term or any other term of this Agreement.

 

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(f) Severability.  In the event that any one or more of the provisions of this Agreement shall be or become invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions of this Agreement shall not be affected thereby.

 

(g) Successors.

 

(i)                                     This Agreement is personal to Executive and shall not be assignable by Executive otherwise than by will or the laws of descent and distribution.  This Agreement shall inure to the benefit of and be enforceable by Executive’s legal representatives.

 

(ii)                                  This Agreement shall inure to the benefit of and be binding upon the Employer and its successors and assigns.  The Employer shall require any successor (whether direct or indirect, by purchase, merger, reorganization, consolidation, acquisition of property or stock, liquidation, or otherwise) to all or a substantial portion of its business and/or assets, by agreement in form and substance reasonably satisfactory to Executive, expressly to assume and agree to perform this Agreement in the same manner and to the same extent that the Employer would be required to perform this Agreement if no such succession had taken place.  Regardless of whether such an agreement is executed, this Agreement shall be binding upon any successor of the Employer and such successor shall be deemed the “Employer” for purposes of this Agreement.  Notwithstanding anything to the contrary contained herein, the Executive shall have the right to terminate this Agreement if Employer’s assets or membership units are sold to an entity that is not a subsidiary or an affiliate of the Employer.  Such a sale shall include a merger, consolidation, sale of assets or membership units or other corporate reorganization; however it shall not include a change in ownership as a result of a public offering.  Such a termination by Executive shall not be deemed a termination for which Executive would be entitled to the severance payment set out in Section 7 (b) (ii) above.

 

(h) Notice.  For the purpose of this Agreement, notices and all other communications provided for in this Agreement shall be in writing and shall be deemed to have been duly given if delivered personally, if delivered by overnight courier service, if sent by facsimile transmission or if mailed by United States registered mail, return receipt requested, postage prepaid, addressed to the respective addresses or sent via facsimile to the respective facsimile numbers, as the case may be, as set forth below, or to such other address as either party may have furnished to the other in writing in accordance herewith, except that notice of change of address shall be effective only upon receipt; provided, however, that (i) notices sent by personal delivery or overnight courier shall be deemed given when delivered; (ii) notices sent by facsimile transmission shall be deemed given upon the sender’s receipt of confirmation of complete transmission, and (iii) notices sent by United States registered mail shall be deemed given two days after the date of deposit in the United States mail.

 

If to the Employer, to:

 

Rhino GP LLC

424 Lewis Hargett Circle

 

7

 

Suite 250

Lexington, Kentucky 40503

Attn:  CEO

 

cc:

 

Rhino GP LLC

5 Orchard Road

Wheeling, West Virginia 26003

Attn:  David Zatezalo

 

If to Executive, to such address as shall most currently appear on the records of the Employer.

 

(i) Withholding.  The Employer may withhold from any amounts payable under this Agreement such Taxes (as defined in Section 11(k)) as may be required to be withheld pursuant to any applicable law or regulation.

 

(j) Counterparts.  This Agreement may be signed in counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument.

 

(k) Code Section 409A.  It is intended that any amounts payable under this Agreement and the Employer’s and Executive’s exercise of authority or discretion hereunder shall comply with Code Section 409A (including the Treasury regulations and other published guidance relating thereto) so as not to subject Executive to the payment of any interest or additional tax imposed under Code Section 409A.  To the extent any amount payable under this Agreement would trigger the additional tax imposed by Code Section 409A, the Agreement shall be modified to avoid such additional tax.

 

(l) Confidential Terms.  Executive agrees to maintain as confidential the terms and conditions of this Agreement, provided however Executive may disclose the terms of this Agreement to his legal counsel, and accountant or tax preparer, or as may be otherwise required by law.

 

(m) Waiver of Jury Trial.  The parties hereby voluntarily and irrevocably waive the right to a trial by jury with regard to any action arising under or in connection with this agreement or the employment of the Executive by the Employer.

 

11.                          Definitions.

 

(a) Accrued Obligations.  “Accrued Obligations” has the meaning set forth in Section 7(a).

 

(b) Base Salary.   “Base Salary” has the meaning set forth in Section 3.

 

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(c) Board of Directors.  “Board of Directors” means the Board of Directors of the Employer.

 

(d) Cause.  “Cause” for termination by the Employer of Executive’s employment with the Employer means any of the following:

 

(i)                                     the failure of Executive to perform substantially his duties (other than any such failure resulting from incapacity due to disability), within ten days after written notice from the Employer; or

 

(ii)                                  Executive’s conviction of, or plea of guilty or no contest to (A) a felony or (B) a misdemeanor involving dishonesty or moral turpitude; or

 

(iii)                               Executive engaging in any illegal conduct, gross misconduct, or other material breach of this Agreement which is materially and demonstrably injurious to the business or reputation of the Employer; or

 

(iv)                              Executive engaging in any act of dishonesty or fraud involving Employer or any subsidiary or affiliate of Employer.

 

(e) Code.  “Code” means the Internal Revenue Code of 1986, as amended from time to time.

 

(f) Employer.   “Employer” means Rhino GP LLC, a Delaware limited liability company.

 

(g) Disability.   “Disability” means the inability of Executive to perform his normal duties as a result of any physical or mental injury or ailment for (i) any consecutive forty five (45) day period or (ii) any ninety (90) days (whether or not consecutive) during any three hundred sixty five (365) calendar day period.

 

(h) Employment Term.   “Employment Term” has the meaning set forth in Section 1.

 

(i) Executive.   “Executive” means R. Chad Hunt.

 

(j) Good Reason.  “Good Reason” for termination by Executive of Executive’s employment means the occurrence (without Executive’s express written consent) of any one of the following acts by the Employer or failures by Employer to act:

 

(i)                                     the assignment to Executive of any duties inconsistent in any material respect with those of the office to which Executive is assigned pursuant to Section 2 hereof (including status, office, title and reporting requirements), or any other diminution in any material respect in such position, authority, duties or responsibilities unless agreed to by Executive;

 

(ii)                                  a reduction in Base Salary;

 

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(iii)                               a reduction in Executive’s welfare benefits plans, qualified retirement plan, or paid time off benefit, other than a reduction as a result of a general change in any such plan; or

 

(iv)                              any purported termination of Executive’s employment under this Agreement by the Employer other than for Cause, death or Disability.

 

Prior to Executive’s right to terminate this Agreement, he shall give written notice to the Employer of his intention to terminate his employment on account of Good Reason.  Such notice shall state in detail the particular act or acts of the failure or failures to act that constitute the grounds on which Executive’s Good Reason termination is based and such notice shall be given within six (6) months of the occurrence of the act or acts or the failure or failures to act which constitute the grounds for Good Reason.  The Employer shall have thirty (30) days upon receipt of the notice in which to cure such conduct, to the extent such cure is possible and reasonable.

 

(k) Taxes.  “Taxes” mean the incremental United States federal, state and local income, excise and other taxes payable by Executive with respect to any applicable item of income.

 

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IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement as of the dates written below.

 

	
EXECUTIVE:
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
/s/   R. Chad Hunt
    	
 
    
	
R.   Chad Hunt
    	
 
    
	
 
    	
 
    
	
Date   signed:
    	
09/08/2014
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
RHINO   GP LLC
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
By:
    	
/s/   Christopher I. Walton
    	
 
    
	
Name:
    	
Christopher   I. Walton
    	
 
    
	
 
    	
 
    
	
Title:   CEO
    	
 
    
	
 
    	
 
    
	
Date   signed:
    	
09/08/2014
    	
 
    
				

 

11EXHIBIT 10.1

 

TRANSFER AGREEMENT

 

THIS TRANSFER AGREEMENT (the “Transfer Agreement”) is made and entered into as of July 31, 2014 (the “Effective Date”) by and between Geron Corporation, a corporation organized and existing under the laws of Delaware and having its principal place of business at 149 Commonwealth Drive, Menlo Park, CA 94025 (“Geron”) and Mayo Clinic, a charitable corporation, having a place of business located at 200 First Street, S.W., Rochester, MN 55905, organized under the laws of the State of Minnesota (“Institution”) on behalf of Institution’s employee Dr. Ayalew Tefferi, M.D. (“Investigator”).  Company and Institution are each referred to herein as a “Party” and collectively as the “Parties.”

 

RECITALS

 

WHEREAS, the Parties have previously executed an Investigator Initiated Clinical Trial Agreement effective October 5, 2012, as amended effective April 4, 2013, June 13, 2013, August 14, 2013, October 17, 2013 and May 2, 2014 (collectively, the “IST Agreement”), pursuant to which a clinical trial entitled “A Pilot Open-Label Study of the Efficacy and Safety of Imetelstat (GRN163L) in Myelofibrosis  and other Myeloid Malignancies” (the “Study”) has been conducted at Institution pursuant to protocol number MC1285 (the “Protocol”);

 

WHEREAS, the Investigator is the holder of Investigational New Drug application # 116129 (the “IND”) under which the Study has been conducted, and Institution and Investigator desire to transfer to Company, and Company desires to assume, responsibility as the holder of the IND;

 

WHEREAS, Institution and Investigator further desire to transfer to Company, and Company desires to receive, all rights, responsibilities and obligations of a “sponsor”, as defined by 21 C.F.R. § 312.3 (hereinafter referred to as a “Sponsor”), and to perform the responsibilities of a Sponsor, as set forth in 21 C.F.R. § 312, et seq., with respect to the Study, together with all data, information, and regulatory filings and submissions associated with the Study;

 

WHEREAS, the Parties desire to set forth herein the terms and conditions, and obligations of the Parties, applicable to the transfer of the IND by the Investigator to Company and the assumption by Company of all rights, responsibilities and obligations as Sponsor of the Study; and

 

WHEREAS, the Parties desire to terminate the IST Agreement, and to continue to conduct the Study under the Protocol at Institution, with Company as Sponsor, pursuant to the terms and conditions of a mutually acceptable clinical trial agreement (the “CTA”) to be executed by the Parties contemporaneously herewith, and to be effective as of the IND Transfer Date (as defined below).

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the Parties, intending to be legally bound, hereby agree as follows:

 

AGREEMENT

 

1.                                      TRANSFER OF DATA, INFORMATION AND REGULATORY FILES.

 

1.1                               In order to enable the transfer of the IND and acceptance by Company of all rights, responsibilities and obligations as Sponsor of the Study in accordance with Paragraphs 2 and 3 of this Transfer Agreement, respectively, on the Effective Date of this Transfer Agreement, Institution agrees to transfer to Company, in a mutually acceptable electronic format, all de-identified data in the clinical study database as of the Effective Date of this Transfer Agreement, (the “Data Transfer”).  In addition, each Party agrees to exercise its best efforts to promptly and expediently perform those activities, and to provide those deliverables, set forth in the mutually agreed transfer plan attached hereto as Exhibit 1, as such transfer plan may be amended by mutual written agreement of the Parties in an amendment hereto (hereinafter, such transfer plan, together with any such amendments, the “Transfer Plan”).  Such activities will include, without limitation, the prompt transfer of all additional de-identified Study data and

 

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information, correspondence with and submissions to the United States Food and Drug Association (“FDA”) regarding the Study or the IND, and any other matters mutually agreed by the Parties (collectively, the foregoing items, activities, deliverables and the Data Transfer are referred to herein as the “Transferred Information”).  Institution and Company shall transfer and receive the Transferred Information and perform the obligations set forth in the Transfer Plan in accordance with the timelines set forth in the Transfer Plan.

 

2.                                      TRANSFER OF IND.

 

2.1                               Subject to the performance of the activities and transfer and receipt of the Transferred Information set forth in the Transfer Plan, and compliance with all applicable laws, statutes and regulations (“Applicable Laws”), the Investigator shall transfer the IND to Company, and Company shall accept full responsibility for the IND after the IND Transfer Date (as hereinafter defined).  When the exact date of transfer of the IND (the “IND Transfer Date”), which in any case shall be no later than September 30, 2014,  is determined by the Parties, the Parties shall execute a Transfer Date Memorandum in the form attached hereto as Exhibit 2. To effect transfer of the IND, on the day immediately preceding the IND Transfer Date each Party shall submit to the U.S. Food and Drug Administration (“FDA”) mutually acceptable correspondence, in the form of Exhibit 3 and Exhibit 4 hereto, respectively, transferring all rights and responsibilities with respect to the IND from Investigator to Company.

 

2.2                               As of the Effective Date of this Transfer Agreement, Institution and the Investigator represent and warrant that the IND is active and open with the FDA.  Institution and the Investigator will notify Company in writing immediately if any change occurs with respect to the status of the IND on or before the IND Transfer Date.

 

2.3                               Company acknowledges its express intent to adhere to, and comply with, all requirements established by the FDA, and all commitments made by Institution and the Investigator to the FDA, as set forth in correspondence and submissions provided to Company hereunder and made prior to the IND Transfer Date, except to the extent otherwise agreed by the FDA and Company. For example, Company does not intend to enroll additional patients in the Study.

 

3.                                      TRANSFER OF STUDY.

 

3.1                               Assumption of Responsibilities as Sponsor.  Subject to the performance of the activities and transfer and receipt of the Transferred Information set forth in the Transfer Plan, and compliance with Applicable Laws, on the IND Transfer Date Institution shall transfer, and Company shall accept, all rights, responsibilities and obligations as Sponsor of the Study arising on and after the IND Transfer Date.

 

3.2                               Amendment of Protocol and Study-Related Documents.  The Parties agree that to effect the transfer to Company of all rights, responsibilities and obligations as Sponsor of the Study, certain Study-related documents, including, without limitation, the Protocol and the informed consent form to be used to obtain patient informed consent (collectively, “Study-Related Documents”), require amendment, which amendment must become effective on or immediately after the IND Transfer Date.  Accordingly, the Parties agree to cooperate to submit such amended Study-Related Documents to the applicable Institutional Review Board (“IRB”) or other applicable authority, in a timeframe to become effective on the IND Transfer Date or as soon thereafter as practicable, and to take all steps reasonably necessary to obtain prompt and expeditious review and approval of such Study-Related Documents.

 

3.3                               Execution of CTA.  In addition, contemporaneously with the execution of this Transfer Agreement, the Parties shall execute a mutually acceptable CTA, and upon prompt and expeditious completion of a mutually acceptable CTA budget, shall amend the CTA to incorporate the CTA budget and further, when executed, the Transfer Date Memorandum.  The CTA will be effective on the IND Transfer Date, and shall govern the rights and responsibilities of the Parties with respect to the performance of the Study after the IND Transfer Date.

 

2

 

4.                                      Transfer Costs.   Company will reimburse Institution’s actual and reasonable costs and expenses related to the prompt and expeditious performance of the activities, and transfer and receipt of the Transferred Information, set forth in the Transfer Plan (“Transfer Costs”).  Company will make payment of the Transfer Costs within thirty (30) days after receipt of an invoice from Institution for such Transfer Costs.

 

5.                                      INDEMNIFICATION AND RELEASE; LIMITATIONS OF LIABILITY.

 

5.1                               Indemnification.  Subject to the limitation of liability set forth in Paragraph 5.3, each Party (an “Indemnifying Party”) agrees to defend, indemnify and hold harmless the other Party (an “Indemnified Party”) from any third party suits, actions, claims, demands, judgments, costs, or liabilities (collectively “Claim(s)”) arising from any act or omission of the Indemnifying Party in the performance of its obligations under the IST Agreement or this Transfer Agreement, except to the extent determined by a court of competent jurisdiction to be due to (1) the material breach by the Indemnified Party of this Transfer Agreement, (2)  violation of Applicable  Laws, or (3) the gross negligence or willful misconduct of the Indemnified Party.  In addition, Company agrees to defend, indemnify and hold harmless Institution with respect to any third party Claims arising from Company’s use of the data, information results, or materials transferred to Company by Institution hereunder, including any products or tangible items developed or made therefrom.

 

5.2                               Release of Liability.  In consideration for Institution’s prompt and expedient performance of its obligations under this Transfer Agreement, Company shall, through its execution of the Certificate of Completion attached hereto as Exhibit 5, waive, release and discharge, and agree that it will not institute or pursue any known or unknown complaints, claims, demands, suits, or causes of action, whether in law or in equity, against Institution or its current and former officers, owners, directors, managers, agents, representatives, or employees, at common law or under any statute, rule, regulation, or law, whether federal, state or local, on any ground, arising under or relating, directly or indirectly, to the Transferred Information and the IND, except to the extent determined by a court of competent jurisdiction to be due to (1) violation of Applicable Laws; (2) breach of the IST Agreement; or (3) the negligence, gross negligence or willful misconduct of the Institution or the Investigator for the Study.  COMPANY EXPRESSLY ACKNOWLEDGES AND AGREES THAT THE TRANSFERRED INFORMATION IS PROVIDED TO COMPANY ON AN “AS IS” BASIS, AND INSTITUTION MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT THERETO, INCLUDING, WITHOUT LIMITATION, WITH RESPECT TO:  (A) MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE, OR (B) THE OPERATION THEREOF.

 

5.3                               Limitation of Liability.    IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, SPECIAL, PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING, WITHOUT LIMITATION, ANY LOSS OF PROFITS, LOSS OF BUSINESS, LOSS OF USE, LOSS OR INACCESSIBILITY OF DATA, OR INTERRUPTION OF BUSINESS, ARISING UNDER OR RELATING TO THIS TRANSFER AGREEMENT OR THE SUBJECT MATTER HEREOF, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

 

6.                                      CERTIFICATE OF COMPLETION.

 

6.1                               In consideration of the performance of the obligations, transfer and receipt of the Transferred Information, and assumption of the liabilities set forth herein, the Parties will execute a Certificate of Completion in the form attached hereto as Exhibit 5 upon completion of all activities and transfer and receipt of the Transferred Information set forth in the Transfer Plan.

 

7.                                      TERM AND TERMINATION.

 

7.1                               Term.  This Transfer Agreement shall be effective as of the Effective Date and shall remain in effect until the date of full execution by the Parties of the Certificate of Completion, upon which date this Transfer Agreement shall automatically expire.

 

3

 

7.2                               Termination.  This Transfer Agreement may only be terminated by a Party upon written notice in the event (a) of any breach or default in any material terms or conditions of this Transfer Agreement that remains uncured to the reasonable satisfaction of the non-breaching Party thirty (30) days after the receipt by the breaching Party of written notice thereof or (b)  this Transfer Agreement is found by a court of competent jurisdiction to be invalid or unenforceable; provided that the Parties have thereafter attempted to revise or perform this Transfer Agreement in accordance herewith.

 

7.3                               Effect of Termination or Expiration.  Paragraphs 2.3, 3.2, 3.3, 5, 7.3 and 8.5 of this Transfer Agreement shall survive expiration or termination of this Transfer Agreement for any reason.

 

8.                                      MISCELLANEOUS.

 

8.1                               Enforceability.  If a court of competent jurisdiction finds any provision of this Transfer Agreement legally invalid or unenforceable, such finding shall not affect the validity or enforceability of any other provision of this Transfer Agreement.  The Parties shall negotiate to revise the provision to make it valid and enforceable.  If the Parties cannot agree upon such revisions, the Transfer Agreement shall be performed in the absence of such provision or, if such performance is impossible, the Transfer Agreement shall terminate in accordance with Paragraph 7.2 hereof.

 

8.2                               Entire Agreement and Modification.  This Transfer Agreement, all exhibits and any amendments mutually agreed upon in writing by the Parties are the complete and entire agreement regarding the activities and obligations of the Parties hereunder and supersede any prior oral or written communications among the Parties.  The Parties may modify any of the provisions hereof only by an instrument in writing duly executed by the Parties.  This Transfer Agreement shall be binding upon and inure to the benefit of the parties, their heirs, legal representatives, successors and assigns.

 

8.3                               Dispute Resolution.  The Parties shall negotiate in good faith and use reasonable efforts to settle any dispute, controversy or claim related to performance under this Transfer Agreement or the breach hereof.  In the event that the Parties are unable to resolve any such dispute, claim or controversy, the Parties shall promptly submit the matter to the senior executive(s) of each Party for resolution.  If such executives are unable to resolve any such dispute, claim or controversy, the Parties agree to conduct non-binding mediation with respect thereto, pursuant to the then-current mediation rules and procedures of JAMS, Inc., using a mutually acceptable mediator to be selected within forty-five (45) days after the initial request for mediation.  The Parties shall bear the costs of mediation equally.  If the Parties are unable to resolve the matter through mediation the matter shall be resolved through binding arbitration.  Any arbitration thereafter conducted shall be limited to specific performance under this Transfer Agreement, and the Parties agree that the arbitrators shall have no authority to award monetary damages.

 

8.4                               Assignment.  Neither Party shall assign any of its rights or obligations under this Transfer Agreement to any Party without the express written consent of the other Party; provided, however, that Company may assign its rights and obligations under this Transfer Agreement without the consent of Institution to a third party who acquires control of all or substantially all of the business of Company to which this Transfer Agreement relates.

 

8.5                               Governing Law.  This Transfer Agreement shall be governed by and construed in accordance with the laws of the State of New York, without reference to any rules of conflict of laws.

 

8.6                               Notices.  All notices which are required or permitted hereunder shall be in writing.  Notices to Geron shall be made to the following address:

 

	
If   to Company:
    	
Geron   Corporation
    
	
 
    	
Attn:   Vice President, Legal Affairs
    
	
 
    	
149   Commonwealth Drive
    
	
 
    	
Menlo   Park, CA 94025
    
	
 
    	
Phone:   (650) 473-7775
    
	
 
    	
Fax:   (650) 566-7181
    
	
 
    	
 
    
	
If   to Institution:
    	
Mayo   Clinic
    
	
 
    	
Legal   Contract Administration
    

 

4

 

	
 
    	
Attn:   Randall S. Jones, Operations Manager
    
	
 
    	
200   First Street SW
    
	
 
    	
Rochester,   MN 55905
    
	
 
    	
Phone:   (507) 284-4391
    
	
 
    	
Fax:   (507) 284-4183
    
	
 
    	
Jones.randall@mayo.edu
    
	
 
    	
 
    
	
If   to Investigator:
    	
Mayo   Clinic
    
	
 
    	
Attn:   Ayalew Tefferi, M.D.
    
	
 
    	
200   First Street SW
    
	
 
    	
Rochester,   MN 55905
    
	
 
    	
Phone:   (507) 284-3159
    

 

8.7                               Further Assurances.  Each Party agrees to execute, acknowledge and deliver such further instructions, to deliver such other documents and materials and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Transfer Agreement.

 

8.8                               Use of Name.  Neither party shall use the names or trademarks of the other party or of any of the other party’s affiliated entities in any advertising, publicity, endorsement, or promotion unless the other party has provided prior written consent for the particular use contemplated.  Except as required by law, with regard to the use of Mayo’s name, all requests for approval pursuant to this Section must be submitted to the Mayo Clinic Public Affairs Business Relations Group, at the following E-mail address: BusinessRelations@mayo.edu at least five business days prior to date on which a response is needed.  The terms of this section survive the termination, expiration, non-renewal, or rescission of this Agreement.  This Agreement may be disclosed by either Party to the extent required by law.

 

NOW THEREFORE, the Parties have executed this Transfer Agreement effective as of the Effective Date set forth above.

 

REMAINDER OF PAGE INTENTIONALLY LEFT BLANK

SIGNATURE PAGE FOLLOWS IMMEDIATELY

 

5

 

	
Geron Corporation
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
By
    	
/s/   John A. Scarlett
    	
 
    
	
 
    	
Name:
    	
John   A. Scarlett, M.D.
    	
 
    
	
 
    	
Title:
    	
President   and Chief Executive Officer
    	
 
    
	
 
    	
 
    	
 
    
	
Date
    	
7/31/2014
    	
 
    
	
 
    	
 
    
	
Mayo Clinic
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
By
    	
/s/   Randall S. Jones
    	
 
    
	
 
    	
Name:   Randall S. Jones
    	
 
    
	
 
    	
Title:   Operations Manager
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
Date
    	
7/31/2014
    	
 
    
	
 
    	
 
    
	
I   have read this Transfer Agreement and agree to perform my obligations   hereunder.
    
	
 
    	
 
    
	
Investigator
    	
 
    
	
 
    	
 
    
	
By
    	
/s/   Ayalew Tefferi, M.D.
    	
 
    
	
 
    	
Name:   Ayalew Tefferi, M.D
    	
 
    
	
 
    	
Title:   Investigator
    	
 
    
	
 
    	
 
    
	
Date
    	
7/31/2014
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
Exhibits:
    	
 
    
	
 
    	
 
    
	
Exhibit 1:   Transfer Plan
    	
 
    
	
Exhibit 2:   Transfer Date Memorandum
    	
 
    
	
Exhibit 3:   Form of Mayo Correspondence to FDA
    	
 
    
	
Exhibit 4:   Form of Geron Correspondence to FDA
    	
 
    
	
Exhibit 5:   Form of Certificate of Completion
    	
 
    
					

 

6

 

Exhibit 1

 

Transfer Plan

 

	
#
    	
 
    	
Activity/Deliverable
    	
 
    	
Plan
    	
 
    	
Responsible
   Party
    	
 
    	
Target
   Completion
   Date (2014)
    
	
1
    	
 
    	
Initial   communication with FDA to inform them of planned IND Transfer
    	
 
    	
Conduct   initial communication with FDA informing them of planned IND Transfer   (copying Mayo Clinic)
    	
 
    	
Geron
    	
 
    	
Completed
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2
    	
 
    	
Formal   notices of IND sponsorship transfer and acceptance to be sent to FDA
    	
 
    	
Prepare   draft FDA correspondence documents re: transfer and acceptance of IND   sponsorship responsibilities
    	
 
    	
Geron
    	
 
    	
Completed
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Parties   to review both draft correspondence documents and prepare final drafts for   inclusion as Exhibit in Transfer Agreement
    	
 
    	
Geron   and Mayo Clinic
    	
 
    	
Completed
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Formal   notices to be sent to FDA on day immediately preceding IND Transfer Date
    	
 
    	
Geron   and Mayo Clinic
    	
 
    	
Sep   5
   (1 business day prior to IND Transfer Date)
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
3
    	
 
    	
Contracts   to govern activities related to IND Transfer and to post-transfer study   conduct
    	
 
    	
Prepare   draft Transfer Agreement
    	
 
    	
Geron
    	
 
    	
Completed
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Prepare   draft Clinical Trial Agreement
    	
 
    	
Geron
    	
 
    	
Completed
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Prepare   estimated Transfer Costs for reimbursement by Geron
    	
 
    	
Mayo   Clinic
    	
 
    	
August 8
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Finalize   Transfer Plan
    	
 
    	
Geron   and Mayo Clinic
    	
 
    	
July 31
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Finalize   and execute Transfer Agreement
    	
 
    	
Geron
   Mayo Clinic
    	
 
    	
July 31
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Finalize   all Terms of CTA except Budget, and execute CTA
    	
 
    	
Geron   and Mayo Clinic
    	
 
    	
July 31
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Finalize   CTA Budget
    	
 
    	
Mayo   Clinic
    	
 
    	
August 7
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Execute   budget related CTA Amendment
    	
 
    	
Mayo   Clinic and Geron
    	
 
    	
August 8
    

 

7

 

	
#
    	
 
    	
Activity/Deliverable
    	
 
    	
Plan
    	
 
    	
Responsible
   Party
    	
 
    	
Target
   Completion
   Date (2014)
    
	
4
    	
 
    	
Data   Transfer
    	
 
    	
Provide   snapshot of the database (based on CRFs) as of Effective Date of Transfer   Agreement and provide a CRF data dump of all available data in the format of   SAS transport files
    	
 
    	
Mayo   Clinic
    	
 
    	
July 31
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Provide   corresponding SAS variable specifications
    	
 
    	
Mayo   Clinic
    	
 
    	
July 31
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Provide   copies of complete Hematopathology Reports for all bone marrow/ peripheral   blood smear assessments
    	
 
    	
Mayo   Clinic
    	
 
    	
August 4
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Provide   copies of all available bone marrow images (i.e., from 2013 ASH   presentation)
    	
 
    	
Mayo   Clinic
    	
 
    	
August 15
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Provide   copies of baseline abdominal ultrasound reports
    	
 
    	
Mayo   Clinic
    	
 
    	
August 4
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
5
    	
 
    	
Follow-up   Data Transfer
    	
 
    	
Define   best mechanism for Mayo Clinic to capture and provide to Geron additional   data from the time of the above Data Transfer (item #4) to the date of IND   Transfer
    	
 
    	
Mayo   Clinic and Geron
    	
 
    	
Aug   8
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Provide   to Geron additional data via agreed mechanism
    	
 
    	
Mayo   Clinic
    	
 
    	
October 8
    

 

8

 

	
#
    	
 
    	
Activity/Deliverable
    	
 
    	
Plan
    	
 
    	
Responsible
   Party
    	
 
    	
Target
   Completion
   Date (2014)
    
	
6
    	
 
    	
Preparation   of Protocol and ICF amendments
    	
 
    	
Prepare   draft protocol amendment and forward to Mayo Clinic for review
    	
 
    	
Geron
    	
 
    	
Completed
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Prepare   draft ICF amendment and forward to Mayo Clinic for review
    	
 
    	
Geron
    	
 
    	
Completed
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Prepare   draft summary of changes with rationale
    	
 
    	
Geron
    	
 
    	
Completed
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Complete   study staff review of protocol and ICF amendments, and forward comments to   Geron
    	
 
    	
Mayo   Clinic
    	
 
    	
Completed
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Complete   investigator review of protocol and ICF amendments, and forward comments to   Geron
    	
 
    	
Mayo   Clinic
    	
 
    	
July 30
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Finalize   protocol amendment and summary of changes
    	
 
    	
Geron
    	
 
    	
July 31
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Finalize   updated ICF (after Geron review of final Mayo form)
    	
 
    	
Mayo   Clinic
    	
 
    	
July 31
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Prepare/compile   study startup regulatory package (for FDA submission):
    	
 
    	
Geron
    	
 
    	
August 29
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
-FDA Form 1572
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
-Medical License and CV for Dr. Tefferi
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
-Financial disclosure
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
-Lab reference ranges
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
-Pharmacy manual
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
-Regulatory binder with copies of all regulatory   documents (i.e., safety reporting form)
    	
 
    	
 
    	
 
    	
 
    

 

9

 

	
#
    	
 
    	
Activity/Deliverable
    	
 
    	
Plan
    	
 
    	
Responsible
   Party
    	
 
    	
Target
   Completion
   Date (2014)
    
	
7
    	
 
    	
IRB   review and approval of protocol and ICF amendments
    	
 
    	
Provide   information on IRB Meeting schedule and review/approval process to Geron so   Parties can coordinate IRB submission, review and approval to coincide with   IND Transfer Date
    	
 
    	
Mayo   Clinic
    	
 
    	
Completed
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Determine   if Scientific Review is required
    	
 
    	
Mayo   Clinic
    	
 
    	
August 1
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Decide   on target SRC and IRB submission dates
    	
 
    	
Geron   and Mayo Clinic
    	
 
    	
Completed
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Prepare   and submit SRC submission package with protocol and ICF amendments
    	
 
    	
Mayo   Clinic
    	
 
    	
August 1
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Prepare   and submit IRB submission package with protocol and ICF amendments
    	
 
    	
Mayo   Clinic
    	
 
    	
August 7
   (Assumes SRC approval by Aug 6)
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
IRB   review and approval completed
    	
 
    	
Mayo   Clinic
    	
 
    	
September 4
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
8
    	
 
    	
Transfer   of complete regulatory file related to Study MC1285 and IND 116129
    	
 
    	
Provide   updated log of all regulatory submissions, copies of all regulatory   submissions, copies of all correspondence between Mayo Clinic and FDA, and   any minutes of teleconferences between Mayo Clinic and FDA
    	
 
    	
Mayo   Clinic
    	
 
    	
Archive   of email correspondence between Dr. Tefferi and FDA — to be uploaded by   August 14
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
9
    	
 
    	
FDA   submission of protocol amendment, updated ICF and study startup regulatory   package
    	
 
    	
Prepare   and submit to FDA protocol amendment, updated ICF and other components of   study startup regulatory package
    	
 
    	
Geron
    	
 
    	
September 8   (Tentative IND Transfer Date)
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
10
    	
 
    	
Patient   Re-Consent
    	
 
    	
Re-consent   patients under updated ICF reflecting Geron sponsorship (incl. patients on   active treatment, patients in LFT follow-up, and patients in Event Follow-up)
    	
 
    	
Mayo   Clinic
    	
 
    	
As   patients come in for visits, or via (e)mail, post-IND Transfer Date
    

 

10

 

	
#
    	
 
    	
Activity/Deliverable
    	
 
    	
Plan
    	
 
    	
Responsible
   Party
    	
 
    	
Target
   Completion
   Date (2014)
    
	
11
    	
 
    	
Updated   Geron CRFs
    	
 
    	
Prepare   mock eCRFs, mock paper CRFs, and draft CRF Completion Guidelines, and forward   to Mayo Clinic for preview
    	
 
    	
Geron
    	
 
    	
July 31
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Prepare   draft SAE Form and instructions and forward to Mayo for preview
    	
 
    	
Geron
    	
 
    	
July 31
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Complete   Mayo Clinic review of CRFs and Forms and discuss any significant concerns   with Geron
    	
 
    	
Mayo   Clinic
    	
 
    	
August 7
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Finalize   mock eCRFs, mock paper CRFs, and CRF Completion Guidelines
    	
 
    	
Geron
    	
 
    	
August 11
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
12
    	
 
    	
Workplans,   budgets and project orders for related Geron service providers
    	
 
    	
Finalize   and execute workplan, budget and project order for EDC vendor
    	
 
    	
Geron
    	
 
    	
August 14
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Finalize   and execute safety mgt plan, budget and project order for safety CRO
    	
 
    	
Geron
    	
 
    	
August 21
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
13
    	
 
    	
Site   initiation visit at Mayo Clinic
    	
 
    	
Conduct   site initiation visit with Mayo Clinic staff to train on new study conduct   procedures under Geron sponsorship
    	
 
    	
Geron   and Mayo Clinic
    	
 
    	
Week   of August 25
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
14
    	
 
    	
Patient   Visit Schedule
    	
 
    	
Provide   to Geron prospective Patient Visit Schedule for visits scheduled after IND   Transfer Date, if available
    	
 
    	
Mayo   Clinic
    	
 
    	
Week   of August 25 (during site initiation visit)
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
15
    	
 
    	
Training   on new EDC
    	
 
    	
Conduct   training new Geron database (can be remote training)
    	
 
    	
Geron
    	
 
    	
Week   of October 6
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
16
    	
 
    	
Study   Monitoring Plan and Study Management Plan
    	
 
    	
Prepare   Study Monitoring Plan and Study Management Plan documents
    	
 
    	
Geron
    	
 
    	
August 29
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
17
    	
 
    	
Trial   Master File
    	
 
    	
Transfer   Existing Trial Master File to Geron
    	
 
    	
Mayo   Clinic
    	
 
    	
Any   critical missing documents to be provided by Mayo by Sept 8 (IND Transfer   Date)
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
Establish   new Trial Master File at Geron
    	
 
    	
Geron
    	
 
    	
September 8
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
18
    	
 
    	
Establish   new Clinicaltrials.gov posting
    	
 
    	
Establish   new Clinicaltrials.gov posting
    	
 
    	
Geron
    	
 
    	
Sept   19
    

 

11

 

	
#
    	
 
    	
Activity/Deliverable
    	
 
    	
Plan
    	
 
    	
Responsible
   Party
    	
 
    	
Target
   Completion
   Date (2014)
    
	
19
    	
 
    	
Geron   clinical database
    	
 
    	
“Go   live” date for implementation of Geron clinical database
    	
 
    	
Geron
    	
 
    	
October 14
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
20
    	
 
    	
Assess   need for SAE reconciliation
    	
 
    	
Complete   reconciliation of pre-IND Transfer SAEs to clinical database, as needed
    	
 
    	
Geron   and Mayo Clinic
    	
 
    	
As   needed
    

 

12

 

Exhibit 2

 

Transfer Date Memorandum

 

	
AGREEMENT:
    	
Transfer   Agreement effective July 31, 2014
    
	
 
    	
 
    
	
PARTIES TO TRANSFER AGREEMENT:
    
	
 
    	
 
    
	
INSTITUTION:
    	
Mayo   Clinic
    
	
 
    	
200   First Street, S.W.,
    
	
 
    	
Rochester,   MN 55905
    
	
 
    	
 
    
	
COMPANY:
    	
Geron   Corporation
    
	
 
    	
149   Commonwealth Drive
    
	
 
    	
Menlo   Park, CA 94025
    

 

Pursuant to Section 2.1 of the above-referenced Transfer Agreement, the IND Transfer Date is hereby established as                         .  Capitalized terms not otherwise defined herein shall have the meaning set forth in the Transfer Agreement.

 

	
 
    	
Geron Corporation
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By
    	
 
    
	
 
    	
 
    	
Name:
    	
Melissa   A. Kelly Behrs
    
	
 
    	
 
    	
Title:
    	
Executive   Vice President, Portfolio and Alliance Management
    
	
 
    	
 
    
	
 
    	
Date
    	
 
    
	
 
    	
 
    
	
 
    	
Mayo Clinic
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
Date
    	
 
    
	
 
    	
 
    
	
 
    	
Read and Understood:
    
	
 
    	
 
    
	
 
    	
Investigator
    
	
 
    	
 
    
	
 
    	
By
    	
 
    
	
 
    	
 
    	
Name:   Ayalew Tefferi, M.D
    
	
 
    	
 
    	
Title:   Investigator
    
	
 
    	
 
    
	
 
    	
Date
    	
 
    
					

 

13

 

Exhibit 3

 

Form of Mayo Correspondence to FDA

 

 

	
 
    	
200   First Street SW
    
	
 
    	
Rochester,   Minnesota 55905
    
	
 
    	
507-284-2511
    

 

<<DD Month>> 2014

 

Food and Drug Administration

Center for Drug Evaluation and Research

Office of Hematology and Oncology Products

Division of Hematology Products

5901- B Ammendale Road

Beltsville, MD 20705-1266

 

Attn:                    Kristopher Kolibab, Regulatory Project Manager

 

Re:                             IND 116129, Serial No. 0XXX

Imetelstat Sodium (GRN163L)

General Correspondence: Transfer of IND Sponsorship

 

Dear Mr. Kolibab,

 

This letter is to inform you that effective <<DD Month>> 2014, all ownership rights to IND 116129 are being transferred from sponsor-investigator, Dr. Ayalew Tefferi, to the Sponsor listed below:

 

Patricia Harada, Executive Director, Regulatory Affairs

Geron Corporation

149 Commonwealth Drive

Menlo Park, CA 94025

Tel: 650-566-7299

Email: pharada@geron.com

 

Complete copies of the IND, including all protocol amendments, information amendments, annual reports and official FDA correspondence, have been transferred to Geron.

 

Geron will be submitting a separate letter notifying the Agency of their acceptance of the IND and the new contact information for future correspondence relating to this IND.

 

Sincerely,

 

 

Ayalew Tefferi, M.D.

 

cc: Patricia Harada, Geron Corporation

 

14

 

Exhibit 4

 

Form of Geron Correspondence to FDA

 

[To be placed on Geron Letterhead]

 

<<DD Month>> 2014

 

Food and Drug Administration

Center for Drug Evaluation and Research

Office of Hematology and Oncology Products

Division of Hematology Products

5901- B Ammendale Road

Beltsville, MD 20705-1266

 

Attn:                    Kristopher Kolibab, Regulatory Project Manager

 

Re:                             IND 116129, Serial No. 0XXX
 Imetelstat Sodium (GRN163L)
 General Correspondence: Acceptance of Sponsorship of IND 116129

 

Dear Mr. Kolibab,

 

This letter is to inform you that effective <<DD Month>> 2014, Geron Corporation hereby accepts the ownership and regulatory responsibility for the Investigational New Drug (IND) application 116129 for Imetelstat Sodium from Dr. Ayalew Tefferi of Mayo Clinic.

 

In accepting sponsorship of IND 116129, Geron agrees to assume responsibility for maintaining an effective IND as defined under 21 CFR 312 and for all commitments and agreements previously made between the sponsor-investigator, Dr. Tefferi, and FDA.  Dr. Tefferi has transferred complete copies of the IND, including all protocol amendments, information amendments, annual reports and official FDA correspondence, to Geron

 

As previously communicated to the Division on 10 July 2014, Geron will continue Protocol CP14B019 (formerly MC1285), entitled “A Pilot Open-Label Study of the Efficacy and Safety of Imetelstat (GRN163L) in Myelofibrosis and other Myeloid Malignancies,” with Dr. Tefferi as the principal investigator.  This study will remain closed to enrollment, as previously communicated from Dr. Tefferi to FDA on 29 January 2014 (SN 0009) and 15 May 2014 (SN 0020).

 

In light of the full clinical hold on IND 72072, Geron will not initiate any new clinical studies under IND 116129 until we have had further communication with the Division regarding IND 72072 and our development plans for imetelstat.

 

The new sponsor contact information for IND 116129 is provided below:

 

Patricia Harada, Executive Director, Regulatory Affairs

Geron Corporation

149 Commonwealth Drive

Menlo Park, CA 94025

Tel: 650-566-7299

Email: pharada@geron.com

 

15

 

Please find enclosed the following documents:

 

·                  Form FDA 1571;

·                  Copy of the notification submitted by Dr. Tefferi (former sponsor-investigator) transferring IND sponsorship to Geron (SN 0XXX);

 

If you have any questions, please feel free to contact me at +1 (650) 566-7299 or by e-mail at pharada@geron.com.  In the event I cannot be reached, Raheela Kausar Steiner is available by phone at +1 (650) 566-7303 or by e-mail at rkausarsteiner@geron.com.

 

Sincerely,

 

 

Patricia Harada, M.P.H.

Executive Director, Regulatory Affairs

 

cc:  Ayalew Tefferi, MD, Mayo Clinic

 

16

 

Exhibit 5

 

FORM OF CERTIFICATE OF COMPLETION

 

This Certificate of Completion is hereby agreed by and between Geron Corporation, a corporation organized and existing under the laws of Delaware and having its principal place of business at 149 Commonwealth Drive, Menlo Park, CA 94025 (“Geron”) and Mayo Clinic, a charitable corporation, having a place of business located at 200 First Street, S.W., Rochester, MN 55905, organized under the laws of the State of Minnesota (“Institution”) on behalf of Institution’s employee Dr. Ayalew Tefferi, M.D. (“Investigator”) with respect to that certain Transfer Agreement made and entered into as of July 31, 2014 (the “Transfer Agreement”).  Capitalized terms not otherwise defined herein shall have the meaning set forth in the Transfer Agreement.  Geron and Institution each hereby certifies as of the date of last signature below:

 

1.              That each Party has fully and finally satisfied all obligations and provided the Transferred Information under the Transfer Agreement, including those set forth in the Transfer Plan;

 

2.              In consideration for the promises and undertakings set forth in the Transfer Agreement, including, without limitation, the performance of the Transfer Plan, each Party hereby waives, releases and discharges, and agrees that it will not institute or pursue any known or unknown complaints, claims, demands, suits, or causes of action, whether in law or in equity, against the other Party or its current and former officers, owners, directors, managers, agents, representatives, or employees, at common law or under any statute, rule, regulation, or law, whether federal, state or local, on any ground, arising under or relating, directly or indirectly, to the Transfer Agreement.

 

3.              In consideration for the promises and undertakings set forth in the Transfer Agreement, including, without limitation, the performance of the Transfer Plan, Company hereby waives, releases and discharges, and agrees that it will not institute or pursue any known or unknown complaints, claims, demands, suits, or causes of action, whether in law or in equity, against Institution or its current and former officers, owners, directors, managers, agents, representatives, or employees, at common law or under any statute, rule, regulation, or law, whether federal, state or local, on any ground, arising under or relating, directly or indirectly, to the Transferred Information and the IND, except to the extent determined by a court of competent jurisdiction to be due to (1) violation of Applicable Laws; (2) breach of the IST Agreement; or (3) the negligence, gross negligence or willful misconduct of the Institution, the Investigator for the Study, or Investigator.

 

REMAINDER OF PAGE INTENTIONALLY LEFT BLANK

SIGNATURE PAGE FOLLOWS IMMEDIATELY

 

17

 

IN WITNESS WHEREOF, an authorized representative of each Party has executed this Certificate of Completion as of the dates set forth below, with effectiveness as of the date of last signature below.

 

	
Geron Corporation
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
By
    	
 
    	
 
    
	
 
    	
Name:
    	
John   A. Scarlett, M.D.
    	
 
    
	
 
    	
Title:
    	
President   and Chief Executive Officer
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Date
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Mayo Clinic
    	
 
    
	
 
    	
 
    
	
By
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Date
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
I   have read this Certificate of Completion and agree that it is accurate and   complete.
    
	
 
    	
 
    
	
Investigator
    	
 
    
	
 
    	
 
    
	
By
    	
 
    	
 
    
	
 
    	
Name:   Ayalew Tefferi, M.D
    	
 
    
	
 
    	
Title:   Investigator
    	
 
    
	
Date
    	
 
    	
 
    
	
 
    	
 
    

 

 

18

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