Updated Thursday, February 25, 2016


The following professional services terms and conditions (the “Terms”) governs any professional services made available by (the "Professional Services") and any quality management documents and/or materials produced by (the “ggMaterials”).

A person, entity or organization (the “Customer”) must enter into a separate written Proposal countersigned by (each, a “Proposal”) to obtain Professional Services and/or ggMaterials.

Professional Services and ggMaterials are made available by to Customers pursuant to the specific terms set forth in a Proposal and any related Addendum.

The Professional Services and ggMaterials are offered subject to each Customer acceptance of all of the terms and conditions contained herein, in the specific Proposal, and in any written addenda to these Terms countersigned by (each, an “Addendum” and, together with these Terms and the Proposal, the “Agreement”).

Please read this Agreement carefully before accepting any Professional Services or using any ggMaterials. By accepting any Professional Services or using any ggMaterials, each Customer agrees to become bound by the terms and conditions of this Agreement, as amended.  If a Customer does not agree to all the terms and conditions of this Agreement, then such Customer may not obtain or use any Professional Services or ggMaterials.

1. Professional Services and ggMaterials.

a. shall provide to the Customer the Professional Services specified on the applicable Proposal. shall render to the Customer the Professional Services in a timely, diligent and professional manner, consistent with industry standards, and in accordance with this Agreement. 

b.     Professional Services may include the preparation and delivery of ggMaterials to the extent specified on the applicable Proposal, including, but not limited to quality and regulatory documents which are specifically tailored to Customer’s needs.

c.       As used herein, “Work Product” shall include the ggMaterials and all other materials, results, proceeds and products specifically developed for the Customer in connection with the Professional Services.  For the avoidance of doubt, “Work Product” shall not include inventions (whether or not patentable), works of authorship, designations, designs, know-how, ideas and information made or conceived or reduced to practice by which describe, define, analyze, summarize or otherwise relate to the general industry in which the Customer operates, and shall not include any component of the Software.

d.     All Work Product shall be considered “work made for hire” (as such term is defined in 17 U.S.C. §101) and shall be the sole property of the Customer, with the Customer having the right to obtain and hold in its own name all intellectual property rights in and to such Work Product.  To the extent that the Work Product may not be considered “work made for hire,” hereby irrevocably assigns and agrees to assign to the Customer, without additional consideration, all right, title and interest in and to all Work Product, including, without limitation, all copyrights, trademarks, trade secrets, patents, industrial rights and all other intellectual property and proprietary rights related thereto, effective immediately upon the inception, conception, creation or development thereof. 

2. Fees; Term; Termination.

a.     General Terms.

                                               i.     In respect of Professional Services, including the preparation of ggMaterials, Customer agrees to pay the fees specified in the applicable Proposal. 

                                             ii.     Customer agrees to pay undisputed amounts under such invoices within 15 days of receipt.  Payment shall be made in U.S. Dollars by a check drawn on a U.S. bank or by wire transfer to the account listed on the invoice.  Customer agrees to accept electronic invoices.

                                            iii.     Customer will be responsible for paying any sales tax, license and use taxes, additional taxes, fees, or assessments levied by any local, state or federal government or governmental agency relating to, resulting from or based on use of Professional Services or Work Product pursuant to this Agreement.

b.     Term.

                                               i.     The term applicable to any provision of Professional Services shall be specified in the relevant Proposal.

c.     Termination.

                                               i.     In the event of a material breach of this Agreement (including these Terms, the Proposal or any Addendum) by either or Customer, the other party may terminate such Agreement, and the Professional Services specified therein, by giving the defaulting party fifteen (15) business days’ prior written notice of termination thereof; provided, however, that such termination will not be effective if the defaulting party has cured such material breach prior to the expiration of such fifteen (15) business day notice period. 

d.     Late Payments.

                                               i.     Customer shall pay interest on any unpaid balance of (a) ten percent (10%) of the outstanding amount on the date the payment becomes overdue, and (b) two percent (2%) per calendar month on the outstanding balance from and including the date the payment becomes overdue until the date of payment, or the maximum rate of interest that can legally be charged to Customer, if lower.

                                             ii.     Notwithstanding anything to the contrary contained herein, may suspend the Professional Services in the event that any amount due remains unpaid for more than thirty (30) days after the date the payment becomes due. 

3. Warranties.

a. and its suppliers and licensors hereby disclaim all warranties of any kind in respect of the Professional Services or ggMaterials, including, without limitation, the warranties of merchantability, fitness for a particular purpose. Neither nor its suppliers and licensors, makes any warranty that the Professional Services or ggMaterials will be error free. Customer understands that use of the Professional Services or ggMaterials are at Customer’s own discretion and risk. 

b. does not make any warranties concerning the outcome of any quality or regulatory function undertaken using the Professional Services or ggMaterials, including, without limitation, the outcome of any application to any regulatory or governmental agency.

4. Limitation of Liability.

a.     In no event will, or its suppliers or licensors, be liable with respect to any subject matter of this Agreement under any contract, negligence, strict liability or other legal or equitable theory for: (i) any special, incidental or consequential damages; (ii) the cost of procurement for substitute products or services; or (iii) for amounts that exceed the fees paid by Customer to under this Agreement, if any, during the twelve (12) month period prior to the cause of action. shall have no liability for any failure or delay due to matters beyond their reasonable control. The foregoing shall not apply to the extent prohibited by applicable law.

b.     In no event will, or its suppliers or licensors, be liable for any deficiency or failure in the quality or regulatory functions of any Customer, any failure to obtain the approval of any regulatory or governmental agency, or liability arising from the products manufactured or distributed by any Customer under any contract, negligence, strict liability or other legal or equitable theory.

5. Indemnification.

a.     Customer agrees to indemnify and hold harmless, its contractors, and its licensors, and their respective directors, officers, members, managers, employees and agents from and against any and all claims and expenses, including attorneys’ fees, arising out of the negligent or unlawful act or omission or, or any violation of this Agreement.

b. agrees to indemnify, defend and hold harmless Customer, and Customer’s affiliates, officers, agents, and employees from and against any claims and expenses incurred as a result of any third-party claim to the extent arising from or connected with an allegation that Customer’s use of the Professional Services or ggMaterials in accordance with this Agreement, or any Work Product, infringes the intellectual property rights of a third party.  Notwithstanding the foregoing, in no event shall have any obligations or liability arising from: (i) use of the Work Product in a modified form or in combination with materials not furnished by

6. Miscellaneous.

a.     These Terms, together with the applicable Proposal and any Addendum, if applicable, constitutes the entire agreement between and the Customer concerning the subject matter hereof, and supersedes all prior representations, agreements and understandings, written or oral. This Agreement will be governed by the laws of the state of Indiana, U.S.A., excluding its conflict of law provisions, and the proper venue for any disputes arising out of or relating to any of the same will be the state and federal courts located in Marion County, Indiana. The prevailing party in any action or proceeding to enforce this Agreement shall be entitled to costs and attorneys’ fees.  If any part of this Agreement is held invalid or unenforceable, that part will be construed to reflect the parties’ original intent, and the remaining portions will remain in full force and effect.  A waiver by either party of any term or condition of this Agreement or any breach thereof, in any one instance, will not waive such term or condition or any subsequent breach thereof.  User may not assign User’s rights under this Agreement to any party without prior written consent of, which will not be unreasonably withheld. may assign its rights under this Agreement without condition. This Agreement will be binding upon and will inure to the benefit of the parties, their successors and permitted assigns.  The parties hereto are acting as independent contractors, and nothing in this Agreement shall be construed as establishing a partnership, joint venture, agency, employment or other similar relationship between the parties hereto.  If the performance of this Agreement or of any obligation hereunder, except for the payment of any amounts due hereunder, is prevented, restricted or interfered with by reason of any cause beyond the reasonable control of the affected party, such party, upon prompt written notice to the other party, shall be excused from such performance to the extent of the aforementioned prevention, restriction or interference.

b.     After the expiration or termination of this Agreement, except with regard to Sections 1(c), 1(d), 2(d), 5 and 6 which shall survive the termination of this Agreement, this Agreement shall be of no further force and effect and the parties shall have no further obligations hereunder.