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Indemnification Clauses

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					                                         Indemnification
                                         Sample Clauses

1.    Indemnification -- The basic one-way Sponsor indemnity, including liability for claims arising
      from our performance of our obligations and Sponsor’s use of the study results.

2.    Indemnification -- A standard mutual indemnity, where University indemnifies Sponsor with
      respect to negligence, and Sponsor indemnifies University with respect to Sponsor’s performance
      of the protocol and use of the results of the study.

3.    Indemnification -- A mutual indemnity with respect to each party’s negligence and further
      provides that the Sponsor will indemnify University regarding claims arising from its use of the
      results of the study. It may only be used where the protocol or procedure being used is the
      University’s.

4.    Indemnification -- A one-way Sponsor indemnity for the use of results only, for use when the
      protocol is University’s and Sponsor is not providing drugs, materials or devices, or such drugs,
      materials or devices are being supplied for already approved (FDA) uses.

5.    Indemnification -- A standard indemnity except that Sponsor limits its liability to claims for
      personal injury or death and places several conditions upon its obligation to indemnify: (1) proper
      conduct of the study, (2) notification, and (3) right to control defense. The indemnification also
      gives University a right to select its own counsel.

6.    Indemnification -- For use in materials transfer agreements, University transferring.

7.    Indemnification -- For use in materials transfer agreements - University receiving. Please see
      our Material Transfer Agreement Checklist for information about indemnification and other
      issues arising in this context.

8.    Indemnification -- For use in patent and technology license agreements.

9.    Indemnification -- For use in Software License Agreements where Institution is the
      developer/licensor of the software and licensee has the right to modify, enhance and/or make
      derivative works from the software.

10.   Indemnification -- This is a detailed and highly negotiated indemnification containing conditions
      which should only be accepted when firmly required by Sponsor. These conditions should be
      viewed as examples of what is acceptable; however, every effort should be made to limit the
      number of conditions imposed.

11.   Indemnification -- Two sample clauses: 1) for use in “off-label” (use of drug NOT approved by
      the FDA) clinical trial agreements; 2) for use in “on-label” (FDA approved use of drug) clinical
      trial agreements.

12.   Indemnification - Product Liability -- For use when Sponsor is obtaining University’s results,
      but the protocol is University’s.

13.   Indemnification Optional Paragraphs --
       13.1    Obligations concerning notification and defense of claims and cooperation (can be added
               to any indemnification upon Sponsor’s request or at the discretion of the component).

       13.2    Limited Sponsor indemnity when the study drug is to be used in connection with highly
               dangerous procedures such as bone marrow transplantation.

       13.3    Sponsor’s insurance coverage (can be added to any indemnification).

       13.4    Self-insurance (can be added to any indemnification).

       13.5    When Sponsor insists upon a temporal limitation to its obligations to indemnify.

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      [This is the basic one-way Sponsor indemnity, including liability for claims arising from our
                 performance of our obligations and Sponsor’s use of the study results.]

1.     INDEMNIFICATION

1.1    Sponsor agrees to indemnify and hold The University of Texas System (“System”), the
       University, their Regents, officers, agents and employees harmless from any liability, loss or
       damage they may suffer as a result of claims, demands, costs or judgments against them arising
       out of the activities to be carried out pursuant to the obligations of this Agreement, including, but
       not limited to, the use by Sponsor of the results obtained from the activities performed by
       University under this Agreement; provided, however, that any such liability, loss or damage
       resulting from the following Subsections “a” or “b” is excluded from this Agreement to
       indemnify and hold harmless:

       a.      the negligent failure of University to substantially comply with an applicable FDA or
               other governmental requirements; or

       b.      the negligence or willful malfeasance of any Regent, officer, agent or employee of
               University or System.


  [This is a standard mutual indemnification, where University indemnifies Sponsor with respect to its
negligence; Sponsor indemnifies University with respect to University’s performance of the protocol and
      Sponsor’s use of the results of the study. It should be offered as our first position regarding
indemnification where a one-way indemnification from Sponsor to Institution has already been rejected
                                               by Sponsor.]

2.     INDEMNIFICATION

2.1    Institution shall, to the extent authorized under the Constitution and laws of the State of Texas,
       indemnify and hold Sponsor harmless from liability resulting from the negligent acts or omissions
       of Institution, its agents or employees pertaining to the activities to be carried out pursuant to the
       obligations of this Agreement; provided, however, that Institution shall not hold Sponsor
       harmless from claims arising out of the negligence or willful malfeasance of Sponsor, its officers,
       agents, or employees, or any person or entity not subject to Institution’s supervision or control.



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2.2       Sponsor shall indemnify and hold System, Institution, their Regents, officers, agents and
          employees harmless from any liability or loss resulting from judgments or claims against them
          arising out of the activities to be carried out pursuant to the obligations of this Agreement,
          including but not limited to the use by Sponsor of the results of the Study; provided, however,
          that the following is excluded from Sponsor’s obligation to indemnify and hold harmless:

          a.      the negligent failure of Institution to substantially comply with any applicable
                  governmental requirements or to adhere to the terms of the protocol attached hereto as
                  Exhibit A; or

          b.      the negligence or willful malfeasance by a Regent, officer, agent, or employee of
                  Institution or System.


    [This is a mutual indemnity with respect to each party’s negligence and further provides that the
  Sponsor will indemnify University regarding claims arising from its use of the results of the study. It
may only be used where the protocol or procedure being used is the University’s. The second paragraph
  (Sponsor’s indemnification) can be used independently if Sponsor is not requiring an indemnification
from us. If Sponsor is providing drug, material, etc., the product liability indemnification may be better
suited. With some minor modifications, the first paragraph can be “mirrored” to create an interagency
 (for example, component to component) or state university to state university mutual indemnification.]

3.        INDEMNIFICATION

To the extent authorized by the Constitution and laws of the State of Texas, Institution shall indemnify
and hold Sponsor harmless against any and all claims, demands, damages, liabilities and costs incurred by
Sponsor which directly or indirectly result from, or arise in connection with, any negligent act or
omission of Institution, its agents, or employees, pertaining to its activities and obligations under this
Agreement.

Sponsor shall indemnify and hold Institution, System, their Regents, officers, agents, and employees
harmless against any and all claims, demands, damages, liabilities and costs which directly or indirectly
result from, or arise in connection with, any negligent act or omission of Sponsor, its agents, or
employees, pertaining to its activities and obligations under this Agreement or from Sponsor’s use of the
results of the Research Project.

NOTE: Under certain unusual circumstances, it may be appropriate not to require an indemnity from the
Sponsor. Always confer with OGC regarding this conclusion and never offer this position; we should
only accept this position under the appropriate circumstances and only after any form of indemnity from
the Sponsor, such as the negligence indemnity above, has been rejected. Given (i) a Protocol that is ours,
(ii) a study drug that will be used for an FDA approved use, (iii) that almost all conceivable negligence
would be ours, and (iv) that any injuries resulting from the drug itself would most probably result in
product liability claims from which the Institution would be immune (the State would most likely not
waive sovereign immunity with respect thereto), the minimal risks would not justify requiring an
indemnity from the Sponsor.


      [This is a one-way Sponsor indemnity for the use of results only, for when the protocol is ours and
      Sponsor is not providing drugs, materials or devices, or such drugs, materials or devices are being
                                 supplied for already approved (FDA) uses.]



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4.       INDEMNIFICATION

4.1      Sponsor agrees to indemnify and hold The University of Texas System (“System”), the
         University, their Regents, officers, agents and employees harmless from any liability, loss or
         damage they may suffer as a result of claims, demands, costs or judgments against them arising
         out of use by Sponsor of the results obtained from the activities performed by University under
         this Agreement; provided, however, that any such liability, loss or damage resulting from the
         following Subsections “a” or “b” is excluded from this Agreement to indemnify and hold
         harmless:

         a.      the negligent failure of University to substantially comply with any applicable FDA or
                 other governmental requirements; or

         b.      the negligence or willful malfeasance of any Regent, officer, agent or employee of
                 University or System.


      [This is more or less a standard indemnification except that Sponsor limits its liability to claims
        for personal injury or death and places several conditions upon its obligation to indemnify:
               (1) proper conduct of the study, (2) notification, and (3) right to control defense.
                  The indemnification also gives University a right to select its own counsel.]

5.        INDEMNIFICATION

5.1      Institution shall, to the extent authorized under the Texas Constitution and the Texas Tort Claims
         Act, TEX. CIV. PRAC. & REM. CODE ANN., Title 5, 101 et. seq., indemnify and hold Sponsor
         harmless from liability resulting from the negligent acts or omissions of Institution, its agents, or
         employees pertaining to the activities to be carried out pursuant to the obligations of this
         Agreement; provided, however, that Institution shall not hold Sponsor harmless from claims
         arising out of the negligence of Sponsor, its officers, agents, or any person or entity not subject to
         Institution supervision or control.

5.2      Sponsor shall indemnify and hold System, Institution, their Regents, officers, agents, and
         employees harmless from any liability or loss resulting from judgments or claims for personal
         injury, including death, and property damage against them arising out of the activities to be
         carried out pursuant to the obligations of this Agreement, including but not limited to the use by
         Sponsor of the results of the Study; provided, however:

         a.      that the Study is conducted in accordance with the protocol, all written instructions
                 delivered by Sponsor concerning administration of the study drug and control drug,
                 regulations set forth in FDA Form 1572, 21 CFR Part 50 and Part 56, and such other
                 requirements as may be published by FDA from time to time, and in the exercise of
                 Investigator’s own medical judgment;

         b.      that Sponsor is notified promptly but in no event later than thirty (30) working days after
                 receipt of notice of the injury or claim of suit, with same identified so as to advise
                 Institution that it is related to the Study; and

         c.      that, to the extent to which Sponsor is required hereunder to provide an indemnification
                 for any claim or suit, to the extent permitted by law, and subject to the statutory duties of


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                  the Texas Attorney General, Sponsor shall have the right to select defense counsel and to
                  direct the defense or settlement of any such claim or suit.

        In the event that representation of indemnitees and Sponsor by the same counsel would be a
        conflict of interest for such counsel, indemnitees may select independent counsel without
        relieving Sponsor of its obligations of indemnification and defense as set forth above.

5.3     The following is excluded from Sponsor’s obligation to indemnify and hold harmless:

        a.        the negligent failure of Institution to comply with any applicable governmental
                  requirements or to adhere to the terms of the Protocol attached hereto as Exhibit ; or

        b.        the negligence or willful malfeasance by a Regent, officer, agent, or employee of
                  Institution or System.


             [This indemnity is for use in materials transfer agreements, University transferring.]

6.      INDEMNIFICATION

Recipient shall be liable for any damages resulting from any use or application of the Biological
Material(s) and other related materials, and shall defend, hold harmless and indemnify University,
System, their Regents, officers, employees and agents, against any and all claims, suits, actions, costs,
counsel fees, expenses, damages, judgments and decrees, by reason of any person or property being
injured or damaged directly or indirectly by use or application of the Biological Materials or activities
arising therefrom. Each party hereto agrees to notify the other as soon as one party becomes aware of a
claim or action under this Agreement.


            [This indemnity is for use in materials transfer agreements - University receiving.
      Please see our Material Transfer Agreement Checklist for information about indemnification
                                 and other issues arising in this context.]

7.      INDEMNIFICATION

Institution, to the extent permitted by the law and constitution of the State of Texas, will hold Sponsor
harmless from any claims or liability resulting from use of the Product(s) in accordance with Texas Civil
Practice and Remedies Code, Title 5, Section 101, et. seq., except insofar as such claims or liability arise
out of the negligence or wrongdoing of the Product(s) provider.


                   [This indemnity is for use in patent and technology license agreements.]

8.      INDEMNIFICATION

Licensee shall hold harmless and indemnify Board, System, University, its Regents, officers, employees
and agents from and against any claims, demands, or causes of action whatsoever, including without
limitation those arising on account of any injury or death of persons or damage to property caused by, or
arising out of, or resulting from, the exercise or practice of the license granted hereunder by Licensee, its
Subsidiaries or their officers, employees, agents, or representatives.


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       [This indemnification is for use in Software License Agreements where Institution is the
developer/licensor of the software and licensee has the right to modify, enhance, and/or make derivative
                                       works from the software.]

9.     INDEMNIFICATION

9.1    To the extent authorized by the Constitution and laws of the State of Texas, Institution shall
       indemnify, hold harmless and defend Licensee against any action brought against Licensee to the
       extent that such action is based on a claim that the unmodified [Software], when used in
       accordance with this Agreement, infringes a United States copyright and Institution shall pay all
       costs, settlements and damages finally awarded; provided, that Licensee promptly notifies
       Institution in writing of any claim, gives Institution sole control of the defense and settlement
       thereof and provides all reasonable assistance in connection therewith. If any [Software] is finally
       adjudged to so infringe, or in Institution’s opinion is likely to become the subject of such a claim,
       Institution shall, at its option, either:

       a.      procure for Licensee the right to continue using the [Software],

       b.      modify or replace the [Software] to make it noninfringing, or

       c.      refund the fee paid, less reasonable depreciation, upon return of the [Software].
               Institution shall have no liability regarding any claim arising out of: (w) use of other than
               a current, unaltered release of the [Software], unless the infringing portion is also in the
               then current, unaltered release, (x) use of the [Software] in combination with non-
               Institution software, data or equipment if the infringement was caused by such use or
               combination, (y) any modification or derivation of the [Software] not specifically
               authorized in writing by Institution, or (z) use of third party software. THE FOREGOING
               STATES THE ENTIRE LIABILITY OF INSTITUTION AND THE EXCLUSIVE
               REMEDY FOR LICENSEE RELATING TO INFRINGEMENT OR CLAIMS OF
               INFRINGEMENT OF ANY COPYRIGHT OR OTHER PROPRIETARY RIGHT BY
               THE [SOFTWARE].

9.2    Except for the foregoing infringement claims, Licensee shall indemnify and hold harmless
       System, Institution, their Regents, officers, agents and employees from and against any claims,
       demands, or causes of action whatsoever, including without limitation those arising on account of
       Licensee’s modification or enhancement of the [Software] or otherwise caused by, or arising out
       of, or resulting from, the exercise or practice of the license granted hereunder by Licensee, its
       Subsidiaries or their officers, employees, agents or representatives.


          [This is a detailed and highly negotiated indemnification containing conditions which
         should only be accepted when firmly required by Sponsor. These conditions should be
        viewed as examples of what is acceptable; however, every effort should be made to limit
        the number of conditions imposed. This indemnification stands, perhaps, as an example
                      of an unfavorable, but acceptable, indemnification provision.]




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10.    INDEMNIFICATION

10.1   Sponsor will defend, subject to the statutory duty of the Texas Attorney General, and indemnify
       the Institution, the System, their Regents, officers, employees, agents and the members of its
       Institutional Review Board against all claims and suits against them for personal injury, including
       death, allegedly arising out of: (1) administration pursuant to the Protocol of any Medication (as
       herein defined) supplied by or required by Sponsor, (2) the performance of any procedure called
       for by and administered pursuant to the Protocol or (3) the use by Sponsor of the results of the
       Study; provided that all of the conditions set forth below shall have been fully complied with:

       a.      All “Medication” (which term includes any drug or other substance required to be
               administered to patients pursuant to the Protocol, the investigational drug, and control
               drugs, including placebo, furnished by Sponsor) shall be administered to patients, and all
               procedures shall be conducted pursuant to the Protocol, except for such slight deviations
               as (i) arise out of necessity, or (ii) do not contribute to the alleged injury;

       b.      Except for the deviations set forth in clause “a.” above, all changes or modifications to
               the Protocol shall have been approved in writing by Sponsor;

       c.      The injury shall have been caused by Medication or a procedure called for by and
               administered pursuant to the Protocol unless the cause relates to the use by Sponsor of the
               results of the Study;

       d.      In performing the Investigation, the Institution and officers, agents, employees, members
               of the Institutional Review Board, and the Investigator(s) shall have complied with all
               local, state and federal laws and regulations pertaining to the administration of drugs and
               the conduct of clinical investigations, including but not limited to the Federal Food, Drug
               and Cosmetic Act;

       e.      The Institution shall have obtained, when required or appropriate, written, informed
               consent statements from the patient or the patient’s legal representative;

       f.      The Institution shall have advised all persons performing any acts or duties related to the
               conduct of the Investigation, including but not limited to its officers, appropriate
               employees, agents, members of its Institutional Review Board and the Investigator(s), of
               its obligations under the terms of this Agreement;

       g.      Sponsor shall have been promptly notified in writing of adverse reactions encountered
               during the Investigation, and of any claims or suits brought against the Institution, the
               System, their Regents, officers, employees, agents, and members of the Institutional
               Review Board with respect to the Investigation. The Institution will permit Sponsor at its
               discretion to settle any claim or suite indemnified by Sponsor hereunder, with the
               approval of the System and the Institution, which approval will not be unreasonably
               withheld, and agrees, subject to the statutory duty of the Texas Attorney General, to
               the complete control of such defense by Sponsor. Any settlement offer negotiated by
               Sponsor pursuant to this Agreement shall (i) be a bona fide offer of settlement that
               releases with prejudice all claims and liabilities against the Institution, the System, their
               Regents, officers, employees, agents and members of the Institutional Review Board,
               arising out of the claim or suit for which indemnity is sought; (ii) be made in good faith
               by Sponsor; (iii) be reviewed by, and discussed with the Institution and the System; and


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                 (iv) not include any terms or conditions which impose on the Institution, the System, their
                 Regents, officers, employees, agents or members of the Institutional Review Board any
                 obligation to perform or refrain from any act which would have a significant financial,
                 operational or medical impact to them and which would not be reimbursed by Sponsor as
                 part of the proposed settlement (hereinafter the “Offer”). Where Sponsor has obtained
                 plaintiff’s written approval of the Offer, and where subsequently the Institution or the
                 System does not approve the Offer within ten (10) days after it is communicated to the
                 Institution and the System, or such shorter period as may be required under the
                 circumstances to effectuate such settlement (the “Approval Period”), Sponsor’s
                 obligation to further defend such claim or suit and to indemnify the Institution, the
                 System, their Regents, officers, employees, agents and members of the Institutional
                 Review Board shall cease upon expiration of the Approval Period. No such claim or suit
                 shall be settled without the prior written consent of Sponsor, and Sponsor shall not be
                 responsible for any legal fees or other costs incurred other than as provided in this
                 Agreement;

        h.       Subject to the statutory duty of the Texas Attorney General, the Institution, the System,
                 their Regents, officers, employees, agents, members of its Institutional Review Board and
                 the Investigator(s) shall cooperate fully with Sponsor and its legal representatives in the
                 investigation and defense of any claims or suits covered by this Agreement; and

        i.       There were no negligent actions or omissions or willful misconduct on the part of the
                 Institution, the System, their Regents, officers, employees, agents, members of its
                 Institutional Review Board or the Investigator(s) and that the Investigator(s) have not
                 been otherwise negligent in the handling or administration of the Medication or in the
                 conduct of the procedures outlined in the Protocol.

        Notwithstanding any provision herein to the contrary, noncompliance by the Institution with the
        conditions set forth above will not diminish Sponsor’s obligations to defend, indemnify or
        reimburse the Institution, the System, their Regents, officers, employees, agents and members of
        the Institutional Review Board hereunder unless such noncompliance by the Institution
        contributed to the injury for which defense, indemnity, or reimbursement is sought.


             [This indemnity is for use in “off-label” (use of drug NOT approved by the FDA)
                                          clinical trial agreements.]

11.     INDEMNIFICATION

Sponsor shall be liable for any study related injury directly caused by a material defect in the design or
manufacture of the study drug. Use by the investigators of the study drug for uses not included in the
package insert shall not be considered a design defect.

NOTE: “Use of results” language must be included.

      [This indemnity is for use in “on-label” (FDA approved use of drug) clinical trial agreements.]

Sponsor agrees to indemnify and hold harmless the Investigator, Institution, The University of Texas
System, its Board of Regents, officers, employees and agents (Indemnitees) from and against any and all
liability, damages, losses, costs, expenses, judgments, and reasonable attorney fees arising out of


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Sponsor’s failure to manufacture the Study Drug in accordance with FDA specifications. Notwithstanding
anything to the contrary contained herein, Sponsor shall not have any obligation to defend, indemnify, or
hold Indemnitees harmless from claims, suits, or damages arising as a result of, or in connection with,
willful malfeasance or negligent acts or omissions of Indemnitees.

NOTE: No “use of results” language is needed.


               [This indemnification is for use when Sponsor is obtaining our results, but
                                      the protocol is University’s.]

12.     INDEMNIFICATION - PRODUCT LIABILITY

To the extent authorized by the Constitution and laws of the State of Texas, Institution shall indemnify
and hold Sponsor harmless against any and all claims, demands, damages, liabilities and costs incurred by
Sponsor which directly or indirectly result from, or arise in connection with, any negligent act or
omission of Institution, its agents, or employees, pertaining to its activities and obligations under this
Agreement.

Sponsor shall indemnify and hold Institution, System, their Regents, officers, agents, and employees
harmless against any and all claims, demands, damages, liabilities and costs which directly or indirectly
result from, or arise in connection with defects in the design or manufacture of the Study Drug or from
Sponsor’s use of the results of the Study.


13.     INDEMNIFICATION OPTIONAL PARAGRAPHS

[This paragraph adds obligations concerning notification and defense of claims and cooperation. It may
    be added to any indemnification upon Sponsor’s request or at the discretion of the component.]

13.1    Both parties agree that upon receipt of a notice of claim or action arising out of the activities to be
        carried out pursuant to the project described in Attachment A, the party receiving such notice will
        notify the other party promptly. Sponsor agrees, at its own expense, to provide attorneys to
        defend against any actions brought or filed against Institution, System, their Regents, officers,
        agents and/or employees with respect to the subject of the indemnity contained herein, whether
        such claims or actions are rightfully brought or filed, and, subject to the statutory duty of the
        Texas Attorney General, Institution agrees to cooperate with Sponsor in the defense of such claim
        or action.


 [This paragraph may be used in place of the Sponsor’s indemnity in an otherwise standard indemnity
   (such as Paragraph 2.2) to create a limited Sponsor indemnity when the study drug is to be used in
connection with highly dangerous procedures such as bone marrow transplantation. In such a situation,
 the Sponsor will only be liable for injuries arising from the use of the study drug and not from injuries
            arising from the bone marrow transplant procedure or other similar procedures.]

13.2    Sponsor shall indemnify and hold System, Institution, their Regents, officers, agents or
        employees harmless from any liability or loss resulting from judgments or claims against them
        arising directly out of administration of the study compound pursuant to the obligations of this




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       Agreement or the use by Sponsor of the results of the Study; provided, however, that the
       following is excluded from Sponsor’s obligation to indemnify and hold harmless:

       a.         the negligent failure of Institution to comply with any applicable governmental
                  requirements or to adhere to the terms of the protocol attached hereto as Exhibit ; or

       b.         the negligence or willful malfeasance by a Regent, officer, agent or employee of
                  Institution or System.


   [This paragraph concerning Sponsor’s insurance coverage can be added to any indemnification.]

13.3   Sponsor agrees to maintain reasonable coverage for such liabilities either through commercial
       insurance or a reasonable self-insurance mechanism, and information concerning commercial
       insurance of a reasonable self-insurance mechanism will be reasonably provided to the
       University.


            [This paragraph concerning our self-insurance can be added to any indemnification.]

13.4   University, as a component of System, is an agency of the State of Texas and is self-insured
       pursuant to The University of Texas System Professional Medical Malpractice Self-Insurance
       Plan, under the authority of Section 59.01, Texas Education Code. University has and will
       maintain in force during the term of this Agreement adequate insurance to cover its
       indemnification obligations hereunder.


  [This paragraph may be added when Sponsor insists upon a temporal limitation to its obligations to
                                         indemnify.]

13.5   This indemnification is effective with respect to any covered damage or liability occurring after
       the date of this Agreement and shall continue in effect after the expiration or earlier termination
       of the Agreement until the expiration of the personal injury statute of limitations in the State of
       Texas.




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