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Terms and Conditions

TERMS AND CONDITIONS FOR BASIC OR NON-MANUFACTURING SERVICES 

These Terms and Conditions apply to the provision of Services by iBio CDMO, LLC, a Delaware limited liability company (hereinafter “iBio”) to Client (together with iBio, the “Parties” and individually a “Party”). 

1. Orders. 

Client shall purchase services (the “Services”) from iBio as set forth in a Work Order or similar document (the “Order”) and iBio shall provide such Services to Client in accordance with the Order and these Terms and Conditions. 

The Terms and Conditions cancel and supersede all other terms, oral representations, or documents which relate to the provision of Services by iBio to Client. Any terms stated in Client purchase orders, reply e-mails, reply or response purchase standards and conditions, or other documents automatically generated by Client, and/or any other supporting documents generated or created by Client, are hereby expressly and specifically rejected and shall not become integrated into these Terms or Conditions or supersede, replace, nullify or negate any of these Terms and Conditions, regardless of whether any such terms are inconsistent with or contrary to these Terms and Conditions. 

It is Client’s responsibility to read any corresponding written Order and descriptions therein. 

iBio reserves the right to accept or reject any Order for any reason at any time. Orders do not form a binding contract on iBio unless and until accepted by iBio. For avoidance of doubt, a contract for sale of Services is only formed when iBio accepts an Order, and such contract of sale is governed by these Terms and Conditions, which are incorporated therein by this reference. 

2. Change Order. 

The Order may be modified, amended or revised only upon the mutual execution by the Parties of a Change Order. A Change Order shall be approved or rejected by the non-requesting Party; provided, however, that Client shall not unreasonably withhold approval of an amendment to the Order, or execution of a Change Order if any of the proposed changes in pricing or timelines result from, among other things, circumstances outside the reasonable control of iBio or changes in the assumptions upon which iBio’s initial pricing and/or timelines were based. 

iBio shall not be obligated to perform any modified, revised, or additional Services until a Change Order has been executed by both Parties with respect to such Services. Change Orders shall be required for changes to any Order element, including, but not limited to: scope, timeline or schedule, budget, and Client-specific changes to process or Services. 

3. Compensation; Payment Terms. 

Fees, costs and other charges for Services provided by iBio under the Order shall be as set forth in the applicable Order, and shall be governed by the following terms and conditions: 

a. Payment Terms. 

Client shall remit payment of all amounts stated in the Order within thirty (30) days after the date thereof, except as otherwise specifically set forth in the Order. Client acknowledges and understands that iBio will not commence Services under an Order, nor will iBio order any raw materials, components and other equipment, consumables or other dedicated supplies specifically required for the Services until full payment under the Order is received by iBio in accordance with the terms of this section or as otherwise stated in the Order. All payments shall be made by Client in United States Dollars. 

b. Taxes. 

The amounts stated by iBio in the Order shall be exclusive of any applicable taxes (“Tax” or “Taxes”) required by law to be collected from Client or otherwise applicable in respect of the supply of Services by iBio (including, but not limited to, withholding, sales, use, excise, services, value added and/or transfer taxes, which may be assessed on the Services). If a Tax is assessed or otherwise applicable in respect of the Services supplied by iBio under the Order, Client will in all events be fully responsible for such Tax, and will pay or remit them directly, reimburse or indemnify iBio for such Tax, or otherwise provide iBio with a certificate or other proof, reasonably acceptable to iBio, evidencing an exemption from liability for such Taxes. For the avoidance of doubt, all prices for the Services expressed in the Order are exclusive of Taxes. 

4. Client Materials; Limited License. 

If and as applicable, Client shall provide to iBio materials required for performance of the Services described in the Order, such as samples, reference materials, or formations (“Client Materials”). Client shall furnish iBio with written instructions for the safe handling and storage of Client Materials and health and environmental information (including with respect to the storage and disposal of any waste, and material safety data sheets applicable to Client Materials). iBio shall only perform incoming inspection and identity testing with respect to any Client Materials, and shall notify Client if any such items are non-conforming as a result of such inspection and testing. iBio shall have no other obligation to test any such items to confirm that they meet their respective specifications, certificate of analysis or otherwise. 

During the term of the Order, Client hereby grants to iBio a non-transferable, non-sublicensable, non-exclusive, fully paid-up, royalty-free, license under Client’s intellectual property rights to the extent necessary for iBio to carry out its obligations under the Order and to perform the Services. 

5. Data and Deliverables. 

(a) Documentation, records, raw data, specifications, formulae, processes, procedures, and other work product generated during and in the course of performing Services under the Order (collectively, “Data”), and (b) items and outcomes that must be delivered to Client, by the required time (where specified in the Order), and meeting any criteria defined under the Order (for example, a Certificate of Analysis of a molecule for Client’s future biomanufacturing use) (collectively, “Deliverables”), shall, in each case, be the sole and exclusive property of Client; provided, however, that iBio shall at all times have the right to retain and maintain at all times (in iBio’s discretion) an archival copy of all Data and Deliverables for regulatory compliance purposes. 

6. Product Use Limitations; Voluntary Assumption of Risk. 

NO END PRODUCTS GENERATED BY IBIO AS A RESULT OF THE SERVICES (the “PRODUCTS”) OR DELIVERABLES ARE INTENDED FOR HUMAN USE (WHETHER THERAPEUTIC, PROPHYLACTIC OR DIAGNOSTIC) AND SHALL BE USED ONLY FOR RESEARCH, MANUFACTURING, DRUG DISCOVERY AND DEVELOPMENT, AND QUALITY CONTROL PURPOSES ONLY. Client agrees that the Product and replicates or derivates thereof will not be used for any human therapeutic or diagnostic use. 

Client also acknowledges that some Products contain an inherent pathogenic risk as biological material and that it is impossible to quantify or eliminate such risk. Client assumes all risk and agrees to take all necessary and appropriate handling and storage measures to manage any risk associated with the normal hazards of cell cultures. 

Client agrees to comply with all federal, state and local laws, statutes, regulations, rules, ordinances and orders applicable to the Products. 

ALL PRODUCTS SOLD BY IBIO ARE FOR THE EXCLUSIVE USE OF CLIENT AND ARE NOT TO BE RESOLD. 

7. Warranties. 

iBio represents, warrants and covenants that: (a) its performance will be in accordance with all applicable laws, rules and regulations, the highest industry standards and in a professional and workmanlike manner; (b) its performance, to the extent applicable, shall be in accordance with relevant regulatory requirements and (c) Services will be performed by personnel qualified to perform integral processes and procedures consistent with the technical requirements set forth in the Order. 

8. WARRANTY DISCLAIMER; REMEDY. 

EXCEPT AS STATED IN THE PRECEDING SECTION, IBIO MAKES NO REPRESENTATIONS, WARRANTIES OR GUARANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE SERVICES, PRODUCTS, DELIVERABLES OR DATA. SERVICES, PRODUCTS, DELIVERABLES AND DATA ARE BEING SUPPLIED TO CLIENT “AS IS,” AND IBIO EXPRESSLY DISCLAIMS ANY WARRANTY OF (A) MERCHANTABILITY, (B) FITNESS FOR A PARTICULAR PURPOSE OF CLIENT, (C) FITNESS FOR COMMERCIAL EXPLOITATION, PROFITABILITY OR APPROVAL BY ANY REGULATORY AUTHORITY, AND (D) NONINFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED ARE DISCLAIMED TO THE FULLEST EXTENT PERMITTED BY LAW. 

9. Limitation of Liability; Limitation of Damages. 

a. Limitation of Liability. 

UNDER NO CIRCUMSTANCES SHALL IBIO OR ITS AFFILIATES OR ANY OF THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, REPRESENTATIVES OR AGENTS, BE LIABLE TO CLIENT FOR ANY SPECIAL, INDIRECT, INCIDENTAL, EXEMPLARY, CONSEQUENTIAL, OR PUNITIVE DAMAGES OF ANY KIND OR NATURE WHATSOEVER (INCLUDING LOST REVENUE, PROFITS, USE OR OTHER ECONOMIC ADVANTAGE) ARISING OUT OF OR IN ANY WAY RELATED TO THE ORDER INCLUDING PERFORMANCE OR NON-PERFORMANCE OF SERVICES THEREUNDER, AND WHETHER IBIO KNOW OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES. 

b. Limitation of Damages. 

iBio’s aggregate liability to Client for any and all claims, demands or actions (“Claims”) arising out of its Services performed under the Order shall not exceed fifty percent (50%) of the total aggregate fees paid by Client under the Order. 

c. The limitations of liability and damages of this section: (a) apply even if iBio had or should have had knowledge, actual or constructive, of the possibility of such damages; (b) are a fundamental element of the basis of the bargain between the Parties and iBio would not have accepted the Order without such limitations and exclusions; and (c) shall apply whether a Claim is based on breach of contract, breach of warranty, tort (including negligence), product liability, strict liability or otherwise, under any legal or equitable theory, and notwithstanding any failure of essential purpose of any limited remedy herein. The remedies under this Section 9 are intended to be exclusive. 

10. Confidentiality. 

Client represents that is has sole and exclusive rights of ownership in all Confidential Information disclosed to iBio by Client. iBio agrees that it will not use any Confidential Information of Client except for the purposes of performing Services under the Order, unless otherwise specified therein. iBio agrees not to disclose any Confidential Information of the Client to any third party without the prior written consent of Client, unless such disclosure is required by a regulatory authority, including, but not limited to, the FDA and the Securities and Exchange Commission, or is required by law or regulation to be disclosed, provided that iBio has provided prompt, advance written notice to Client so as to enable Client to seek confidential treatment of such Confidential Information. Client acknowledges and agrees that iBio may disclose to its employees, agents and contractors Confidential Information received from Client as necessary for iBio to perform the Services. iBio shall return to Client all copies of Confidential Information in its possession, upon written request by Client at the termination or natural expiration of the Order or Services, whichever is later; provided, however, iBio is permitted to retain a single archival copy solely to meet its ongoing confidentiality obligations hereunder, any FDA regulatory requirements and/or as otherwise required by applicable law or regulation. 

iBio’s confidentiality obligations hereunder shall not apply to Confidential Information that: (i) is now or subsequently becomes generally available to the public through no wrongful act or omission of iBio; (ii) iBio can demonstrate in its written records to have had lawfully in its possession prior to its disclosure to iBio by Client; (iii) is independently developed by iBio without access to, knowledge or use of (directly or indirectly) any Confidential Information received from Client as evidenced by iBio’s written records; or (iv) iBio lawfully obtains from a third party, who has the right to disclose such information. Notwithstanding the foregoing, iBio may disclose Confidential Information to bona fide actual or prospective underwriters, investors, lenders or other financing sources or to potential acquirers of the business to which the Order relates. 

Nothing herein prohibits iBio from disclosing Confidential Information to the extent compelled by applicable law, rule or order of a court of competent jurisdiction, or government regulation; provided, however, that iBio shall take reasonable measures to preserve confidentiality of any such disclosure, and shall provide sufficient prior written notice to Client to permit Client to take steps to avoid the need for such disclosure and/or to obtain a protective order governing same. 

iBio’s obligations regarding Confidential Information under this section shall continue in full force and effect during the Term of the Order and for a period of two (2) years after its natural expiration or earlier termination. 

For purposes of these Terms and Conditions, “Confidential Information” means know-how, knowledge, technology, techniques, processes, procedures, methods, formula, formulation, expertise, trade secrets, documents, reports, analyses, results, data or information of any type, either owned, controlled or possessed by Client as of the date of the Order which, in each case, is not known to the public. 

11. Force Majeure. 

In the event of a Force Majeure event, iBio reserves the right, in its sole and absolute discretion, to withhold, cancel or suspend performance of Services. For purposes of this section, “Force Majeure” means labor troubles or strikes, accidents, civil commotion, war, Acts of God, government regulations or restrictions, unavailability of raw materials, components or products, power failure, fires, floods, disasters (including, but not limited to pandemics and other public health emergencies), terror attacks, or any cause or event beyond iBio’s reasonable control. 

12. Integration; Entire Agreement. 

The Order (including all appendices, exhibits and/or attachments hereunder or attached Thereto, including) together with these Terms and Conditions constitutes the full and complete agreement and understanding between the Parties concerning the subject matter thereof and hereof, and shall supersede any and all prior and contemporaneous communications, understandings and agreements (whether written or oral) concerning such subject matter (including, but not limited to, any confidentiality and non-disclosure agreements previously entered into between the Parties, estimates, proposals and/or response(s) to Request for Proposal). 

13. Modification/Waiver. 

The Order may not be altered, amended, or modified, unless such amendment or modification is in writing and signed by the Parties. Any handwritten modifications to the Order or any appendices, exhibits or attachments thereto shall be null and void unless such modifications are initialed by both Parties. 

14. Choice of Law and Forum. 

The Order and all Services performed thereunder shall be governed by the laws of the State of Texas, without regard to any choice of law provisions. Client and iBio each hereby submits itself for the sole purpose of the Order and Services rendered thereunder any controversy arising therefrom to arbitration in Brazos County, as set forth in the following section. 

15. Arbitration. 

Any dispute, controversy or claim initiated by either Party arising out of, resulting from or relating to the Order, or the performance by iBio of the Services under the Order, shall be finally resolved by binding arbitration. Whenever a Party shall decide to institute arbitration proceedings, it shall give written notice to that effect to the other Party. Any such arbitration shall be conducted under the then-prevailing Commercial Arbitration Rules of the American Arbitration Association by a panel of three (3) arbitrators appointed in accordance with such rules. The arbitrators shall have the authority to grant specific performance and to allocate between the Parties the costs of arbitration in such equitable manner as they determine. Judgment upon the award so rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of any award and an order of enforcement, as the case may be. In no event shall a demand for arbitration be made after the date when institution of a legal or equitable proceeding based upon such claim, dispute or other matter in question would be barred by the applicable statute of limitations. 

16. Independent Contractors. 

For purposes of the Order, iBio shall be deemed to be an independent contractor and not an agent or employee of Client and nothing in the Order or these Terms and Conditions shall be construed to create any other relationship between iBio and Client. Neither Party shall have any right, power, or authority to assume, create, or incur any expense, liability or obligation, expressed or implied, on behalf of the other. 

17. Severability/Enforceability. 

If any provision(s) of the Order or these Terms and Conditions shall be held invalid, illegal, or unenforceable by a court of competent jurisdiction, the Order and these Terms and Conditions shall continue in full force and effect without said provision(s), consistent with the intent of the Parties at the time of its execution. If deletion of such provision materially alters the basis of the Order or these Terms and Conditions, then the Parties shall negotiate a good faith alternative. 

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