EX-10.11 16 a2236234zex-10_11.htm EX-10.11 Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting...
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
COLLABORATION AND OPTION AGREEMENT
This COLLABORATION AND OPTION AGREEMENT (the “Agreement”) is made effective as of the “Effective Date” by and between ARIDIS PHARMACEUTICALS LLC, a company organized and existing under the laws of California having its registered office at 0000 Xxxxxxx Xxxxx, Xxx Xxxx, XX, 00000 XXX (“ARIDIS”), and GLAXOSMITHKLINE BIOLOGICALS S.A., a company organized and existing under the laws of Belgium under number RPM Nivelles — BE — 0440 872918 and having its registered office at rue de l’Xxxxxxxx 00, 0000 Xxxxxxxxx, Xxxxxxx (“GSK”). ARIDIS and GSK are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
Unless the context otherwise requires, the terms in this Agreement with initial letters capitalized, shall have the meanings set forth below, or the meaning as designated in the indicated places throughout this Agreement.
1.1 “Affiliate” means, with respect to a particular Party, a person, corporation, partnership, or other entity that controls, is controlled by or is under common control with such Party. For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of such entity, whether by the ownership of fifty percent (50%) or more (or such lesser percentage which is the maximum allowed to be owned by a person, corporation, partnership or other entity in a particular jurisdiction) of the voting stock of such entity, or by contract or otherwise.
1.2 “Agreement” has the meaning set forth in the preamble.
1.3 “Alliance Manager” has the meaning set forth in Section 2.2.
1.4 “Anti-Corruption Laws” means the U.S. Foreign Corrupt Practices Act of 1977 and the UK Bribery Act, and any similar Laws in jurisdictions other than the U.S. and United Kingdom.
1.5 “ARIDIS Arising IP” has the meaning set forth in Section 7.2 (a).
1.6 “ARIDIS Background IP” means ARIDIS Intellectual Property existing as of the date of submission of the Final Report by ARIDIS as defined in and pursuant to Section 5.1(ii) of the FOA or arising outside of the FOA and this Agreement. For the avoidance of doubt the preparation and negotiation activities preliminary to this Agreement are considered as part of this Agreement and therefore ARIDIS Intellectual Property arising during such period is to be considered as ARIDIS Arising IP and not as ARIDIS Background IP.
1.7 “ARIDIS Intellectual Property” means collectively ARIDIS Patents, ARIDIS Know-How, and ARIDIS Materials.
1.8 “ARIDIS Know-How” means all technical information and Know-How that is (i) Controlled by ARIDIS or its Affiliates as of the Effective Date or during the Term, and (ii) necessary or useful for GSK and/or ARIDIS to carry out their obligations under the
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
Collaboration Program whether such Know-How has arisen before the performance of the Collaboration Program or arises outside of the performance of the Collaboration Program. For clarity, ARIDIS Know-How excludes Joint Know-How as well as any information, materials and/or know-how that are generally ascertainable from publicly available information or which ARIDIS cannot license without violating the terms of an agreement with a Third Party that has been entered into prior to the Effective Date.
1.9 “ARIDIS Materials” means the materials described in Schedule 1.9 which Schedule may be amended from time to time during the course of the Collaboration Program and that ARIDIS will deliver to GSK pursuant to this Agreement.
1.10 “ARIDIS Patents” means any Patents that (a) are Controlled by ARIDIS or its Affiliates as of the Effective Date or during the Term, and (b) would be infringed by GSK’s performance of its obligations under the Collaboration Program, absent the license granted hereunder under Section 5.
1.11 “Arising IP” means ARIDIS Arising IP and/or GSK Arising IP and/or Joint Arising IP as the case may be and as further described in Section 7.2.
1.12 “Business Day” means a day on which banking institutions are open for business both in Brussels, Belgium and in San Jose, California, but excluding the nine (9) consecutive calendar days beginning on December 24th and continuing through January 1st of each calendar year during the Term, and all Saturdays and Sundays.
1.13 “Chairperson” has the meaning set forth in Section 2.1(a).
1.14 “Change of Control” means the occurrence of any of the following: (a) a Party enters into a merger, consolidation, sale or transfer of all or substantially all of its assets to which this Agreement relates, or other similar transaction or series of transactions with a Third Party; or (b) any transaction or series of related transactions in which any Third Party or group of Third Parties acquires beneficial ownership of securities of a Party representing more than fifty percent (50%) (or such lesser percentage which is the maximum allowed to be owned by a Third Party in a particular jurisdiction) of the combined voting power of the then outstanding securities of such Party. Notwithstanding the foregoing, a stock sale to underwriters of a public offering of a Party’s capital stock or a stock sale to Third Parties or current shareholders solely for the purpose of financing or a transaction solely to change the domicile of a Party shall not constitute a Change of Control.
1.15 “Claims” has the meaning set forth in Section 9.1.
1.16 “Collaboration” has the meaning set forth in Section 3.1.
1.17 “Collaboration Funding” has the meaning set forth in Section 3.4.
1.18 “Collaboration Program” means the workplans as described in Exhibit B.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
1.19 “Collaboration Term” has the meaning set forth in Section 3.3(a) (as may be extended pursuant to Section 3.3).
1.20 “Collaboration Term Extension” has the meaning set forth in Section 3.3(c).
1.21 “Commercially Reasonable Efforts” means those efforts that are consistent with the efforts and resources that would be expended by a reasonable Third Party acting in good faith in the research, development and commercialization of a vaccine owned by it or to which it has exclusive rights, with similar product characteristics, which is of similar market potential at a similar stage in its development or product life, taking into account issues of patent coverage, safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory structure involved, the potential or actual profitability of the applicable products (including pricing and reimbursement status achieved or to be achieved), and other relevant factors, including technical, legal, scientific and/or medical factors. For purposes of clarity, Commercially Reasonable Efforts would be determined on a market-by-market and indication-by-indication basis for a particular Vaccine Product and it is anticipated that the level of effort may be different for different markets and may change over time, reflecting changes in the status of the Vaccine Product and the market(s) involved.
1.22 “Confidential Information” of a Party means any and all Know-How of such Party that is disclosed to the other Party under this Agreement, whether in oral, written, graphic, or electronic form. All Know-How disclosed by either Party pursuant to the Confidential Disclosure Agreement between the Parties dated 19 April 2016 (the “Confidentiality Agreement”) shall be deemed to be such Party’s Confidential Information disclosed hereunder.
1.23 “Control” means, with respect to any Material, Research Material, Know-How, Patent or other intellectual property right, that a Party (a) owns or (b) has a license (other than a license granted to such Party under this Agreement) to such Material, Research Material, Know-How, Patent or other intellectual property right and, in each case, has the ability to grant to the other Party access, a license, or a sublicense (as applicable) to the foregoing on the terms and conditions set forth in this Agreement without violating the terms of any then-existing agreement or other arrangement with any Third Party.
Subsection to Section 1.23, regarding certain exclusions:
With respect to ARIDIS the terms “Control,” “ARIDIS Intellectual Property,” “ARIDIS Know-How,” “ARIDIS Materials,” and “ARIDIS Patents” shall exclude any material, know-how, patent or other intellectual property for which any grant of license or option hereunder would require the payment of royalty or other consideration from ARIDIS to a Third Party. As of the Effective Date, ARIDIS represents to the best of its knowledge that the following is a complete list of intellectual property relevant to this Agreement and exclude by operation of this subsection (that is, any other excluded intellectual property in-licensed by ARIDIS relates to other product fields with no relevance to this collaboration):
· The W003035827 patent family, including PCT application PCT/US02/28320, EPO application 02795489.0, US Patent 7,101,693 and any additional foreign
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
counterparts thereof (as well as all continuations, continuations-in-part, divisionals and renewals thereof, patents which may be granted thereon, and all reissues, reexaminations and extensions);
· Any license rights of ARIDIS in any patent, know-how, material or other intellectual property pursuant to a United States Department of Health and Human Services National Institutes of Health XXX license #L-174-2005/0, effective 07/11/2005, titled “Multivalent Human-Bovine Rotavirus Vaccine —Exclusive and Non-Exclusive.”
Should ARIDIS acquire any intellectual property during the Term that is relevant to this Agreement and that would be excluded by operation of this subsection, it shall notify GSK. ARIDIS shall not knowingly use any third party intellectual property (whether licensed to it or not) in the Collaboration Program without consultation with and agreement from GSK.
1.24 “Development Costs” means the fixed amount for development costs agreed in the budget for each workpackage of the Collaboration Program as set forth in Exhibit B, such as process development costs and toxicology studies costs.
1.25 “Effective Date” means the date of January 15, 2017.
1.26 “Executive Officer” means, with respect to ARIDIS, its CEO, and with respect to GSK, its President or Senior Vice President Vaccines Discovery and Development.
1.27 “Field” means i) the Rotavirus Vaccine Field, and ii) the Rotavirus and Norovirus Combo Vaccine Field.
1.28 “GSK Background IP” means GSK Intellectual Property existing as of the date of submission of the Final Report by ARIDIS as defined in and pursuant to Section 5.1(ii) of the FOA or arising outside of the FOA and this Agreement. For the avoidance of doubt the preparation and negotiation activities preliminary to this Agreement are considered as part of this Agreement and therefore GSK Intellectual Property arising during such period is to be considered as GSK Arising IP and not as GSK Background IP.
1.29 “GSK Arising IP” has the meaning set forth in Section 7.2(b).
1.30 “GSK Intellectual Property” means collectively GSK Patents, GSK Know-How and GSK Materials.
1.31 “GSK Know-How” means all technical information and Know-How that is (i) Controlled by GSK or its Affiliates as of the Effective Date or during the Term, and (ii) necessary or useful for GSK and/or ARIDIS to carry out their obligations under the Collaboration Program. GSK Know How shall include without limitation all chemical, pharmacological, toxicological, clinical, assay, control and manufacturing data relevant to the performance of the Collaboration Program.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
1.32 “GSK Materials” means the materials including the Rotarix bulk vaccine described in Schedule 1.32 that will be delivered by GSK to ARIDIS and which are necessary for ARIDIS to conduct the activities under the Collaboration Progam and/or which will be used by ARIDIS to produce the Research Materials to be delivered to GSK in accordance with the Collaboration Program described in Exhibit B and to any subcontractor of GSK or ARIDIS as needed pursuant to this Agreement as well as all progeny and unmodified derivatives of such GSK Materials.
1.33 “GSK Patents” means any Patent that (a) is Controlled by GSK or its Affiliates as of the Effective. Date or during the Term, and (b) would be infringed by ARIDIS’ performance of its obligations under the Collaboration Program, absent the license granted hereunder under Section 5.
1.34 “GLP” means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or comparable regulatory standards promulgated by the EMA or other applicable regulatory authority, as they may be updated from time to time, including applicable quality guidelines promulgated under the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
1.35 “ICC” has the meaning set forth in Section 12.3
1.36 “Indemnified Party” has the meaning set forth in Section 9.1.
1.37 “Indemnifying Party” has the meaning set forth in Section 9.1.
1.38 “Indemnitees” has the meaning set forth in Section 9.1.
1.39 “Intellectual Property” means collectively Patents, Know-How and Materials.
1.40 “Joint Arising IP” has the meaning set forth in Section 7.2(c)
1.41 “Joint Collaboration Patents” means Patents that are claiming Joint Arising IP.
1.42 “Joint Materials” means the Materials described in Schedule 1.42 be produced under this Agreement in collaboration between ARIDIS and GSK using GSK Materials and formulating them in the form of OTF formulation based on ARIDIS and GSK Background IP.
1.43 “Joint Steering Committee” or “JSC” means the committee formed by the Parties as described in Section 2.1.
1.44 “Know-How” means all tangible and intangible: (a) information, techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, know-how, skill, experience, data, results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms; and (b) compositions of matter, cells, cell lines, assays, animal models and physical, biological or chemical material.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
1.45 “Laws” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision.
1.46 “Legal Requirement” has the meaning set forth in Section 10.4(b).
1.47 “License Agreement” means the agreement to be entered into by and between the Parties after exercise of the Option rights under Section 4.1(a), that will include the main terms set forth in Exhibit C.
1.48 “Losses” has the meaning set forth in Section 9.1.
1.49 “Materials” has the meaning set forth in Section 3.5(c)(i).
1.50 “Material Receiving Party” has the meaning set forth in Section 3.5(c)(i).
1.51 “Rotavirus Vaccine Field” means the prevention or treatment of diseases or infections caused by Rotavirus using any type of Rotavirus antigen (alone or in combination with any other active ingredient or adjuvant);
1.52 “Rotavirus and Norovirus Combo Vaccine Field” means the prevention or treatment of diseases or infections caused by Rotavirus and Norovirus using any type of Rotavirus antigen in combination with any type of Norovirus antigen (alone or in combination with any other active ingredient or adjuvant);
1.53 “Negotiation Period” has the meaning set forth in Section 4.1 (c).
1.54 “Option” has the meaning set forth in Section 4.1(a).
1.55 “Option Period” has the meaning set forth in Section 4.1 (b).
1.56 “Party” or “Parties” has the meaning set forth in the preamble.
1.57 “Patents” means (a) all patents and patent applications in any country or supranational jurisdiction in the Territory, (b) any substitutions, divisions, continuations, continuations-in-part, provisional applications, patents of addition, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like of any such patents or patent applications, and (c) foreign counterparts of any of the foregoing
1.58 “Personal Information” has the meaning set forth in Section 8.3.
1.59 “Public Statement” has the meaning set forth in Section 10.4(b).
1.60 “Purpose” has the meaning set forth in Section 3.5(c)(i).
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
1.61 “Research Materials” means any product generated by either Party under the performance of the Collaboration Program, including Joint Materials and/or, without limitation, bio-conjugated antigens, antibodies, strains, cell lines and intermediates.
1.62 “Sensitive Personal Information” has the meaning set forth in Section 8.3.
1.63 “Term” has the meaning set forth in Section 11 .1 .
1.64 “Territory” means any and all countries and territories of the world.
1.65 “Third Party” means any entity other than ARIDIS or GSK or their respective Affiliates.
1.66 “Transfer Record” has the meaning set forth in Section 3.5(c)(i).
1.67 “Transferring Party” has the meaning set forth in Section 3.5(c)(i).
1.68 “Vaccine Product” means a biological product that induces an antigen-specific immune response intended to prevent or treat the target disease or condition after administration to a human through any route of delivery, including intramuscular, intradermal, sublingual, intranasal or oral delivery.
1.69 “Valid Claim” means a claim of any issued and unexpired Patent included within ARIDIS Patents, ARIDIS Arising IP or Joint Collaboration Patents, which claim has not been revoked, held invalid or unenforceable by a patent office, court or other governmental agency of competent jurisdiction in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period) and which claim has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise.
1.70 Interpretation. In this Agreement, unless otherwise specified:
(a) “includes” and “including” shall mean respectively includes without limitation and including without limitation;
(b) words denoting the singular shall include the plural and vice versa and words denoting any gender shall include all genders;
(c) words such as “herein”, “hereof’, and “hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear; and
(d) the Exhibits, Schedules and other attachments form part of the operative provision of this Agreement and references to this Agreement shall include references to the Exhibits, Schedules and other attachments.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
items of the meeting minutes to which the members cannot agree and that are escalated to the Executive Officers as provided in Section 2.1(e)(i), definitive minutes of all JSC meetings shall be finalized no later than thirty (30) days after the meeting to which the minutes pertain.
(d) Responsibilities. The JSC shall:
(i) provide oversight over the conduct of the Collaboration Program and facilitate communication and discussion between the Parties with respect to the conduct of the Collaboration Program;
(ii) nominate members of a joint technical team (number to be determined by the JSC) which will meet regularly by TC to monitor and evaluate the technical progress of the Collaboration Program;
(iii) review and approve plans and progress of work related to technical and scientific publications according to Section 1 0.3 ;
(iv) review and approve amendments to the Collaboration Program and associated budgets;
(v) review and discuss Arising IP generated by the Parties in the course of performing the Collaboration Program and any further intellectual property matters under Articles 5 and 7 provided that any decision regarding such topic shall be made only if representatives from the IP departments of ARIDIS and GSK attend such meeting as ad-hoc member and have authority to decide on such matter;
(vi) discuss and resolve any disputes relating to the Collaboration Program;
(vii) track expenses against agreed budget and ensure compliance with timelines as set forth in the Collaboration Program; and
(viii) acknowledge and certify the completion of the work packages under the Collaboration Program (at the end of Stage 1 and if extended also the completion of the Collaboration Program at the end of Stage 2 as described in Exhibit B), which shall be done within thirty (30) days of the delivery of final data and results to be delivered by ARIDIS pursuant to the work packages under the Collaboration Program;
(ix) perform such other functions as agreed by the Parties in writing.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
(e) Decision Making; Governance Principles.
(i) All decisions of the JSC shall be made by unanimous vote, with ARIDIS’ representatives collectively having one (1) vote and representatives of GSK collectively having one (1) vote. The JSC shall strive to seek consensus in its actions and decision making process. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC, the representatives on the JSC cannot reach a unanimous decision on such matter within thirty (30) calendar days after such matter was raised to the JSC for resolution, then such disagreement shall be referred to the Executive Officers for resolution. ARIDIS shall provide GSK final deference on decisions regarding technical matters, provided such decisions are made in accordance with this Agreement and in good faith, and excluding any such matters as may increase ARIDIS’ obligations or decrease its rights hereunder.
(ii) GSK shall at all times exercise its final decision-making authority using reasonable scientific and business judgment, in compliance with applicable Laws, and in accordance with its obligations to use Commercially Reasonable Efforts. To the extent that GSK, determines that amendments to the Collaboration Program are desired, and such amendments would increase or decrease the quantity or the scope of activities to be performed by ARIDIS, then the Parties shall discuss such additional or reduced activities in good faith. ARIDIS shall use Commercially Reasonable Efforts to accommodate such additional activities, in consideration for additional funding as appropriate, though ARIDIS shall not be obligated to undertake additional activities which would materially increase its obligations hereunder except in its sole discretion. If additional material financial or other resources are required to fulfil the increased quantity or scope of activities requested by GSK, then the Parties shall discuss the funding of such additional resources. If the Parties cannot agree on the funding of these costs, then ARIDIS shall not be obligated to perform the increased quantity or scope of activities requested by GSK and GSK shall not be obligated to provide additional funding for such increased scope of activities. For the avoidance of doubt, nothing herein is intended to prevent the JSC from making non-material amendments to the Collaboration Program that do not impose on ARIDIS additional obligations, including financial obligations.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
2.3 Limitation on Committee Power. the JSC shall only have the powers expressly assigned to it in this Article 2 and elsewhere in this Agreement and shall not have the authority to: (a) modify or amend the terms and conditions of this Agreement; (b) waive either Party’s compliance with the terms and conditions of this Agreement; or (c) determine any such issue in a manner that would conflict with the terms and conditions of this Agreement.
ARTICLE 3 RESEARCH COLLABORATION PROGRAM
(a) Subject to the extension provided in Section 3.3(b) and 3.3 (c), the term of the Collaboration (the “Collaboration Term”) shall commence on the Effective Date and expire twenty-four (24) months thereafter.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
(b) If ARIDIS does not diligently perform its responsibilities under the Collaboration Program as specified in the initial Collaboration Program (covering Stage 1 and, if this Agreement is extended to Stage 2, also covering Stage 2) attached as Exhibit B (including but not limited to the timely delivery of information and/or Materials to be provided under the workplans under the Collaboration Program) and such breach of its diligence performance causes a delay in reaching the milestones as set forth in the Collaboration Program (whereby for both preceding elements the burden of proof lies with GSK), then at the option of GSK the Collaboration Ten-n (i) shall be extended by the amount of time completion of the ARIDIS’ activities is delayed provided that such extension shall not cause GSK to incur any additional cost or any other increase in Collaboration Funding or Option Fees or (ii) should such delay exceed 6 months GSK shall have the right to terminate the Agreement pursuant to Section 11.3.
(c) GSK shall also have the right to request extension of the Collaboration Term for reasons other than as described in sub-paragraph 3.3 (b) (including in order to proceed to Stage 2 of Exhibit B) above for up to three (3) additional periods (each a “Collaboration Term Extension”), each of twelve (12) months if additional scientific work is needed in GSK’s reasonable opinion to reach a successful completion of the Collaboration Program . In that case the Parties shall negotiate in good faith toward an extension of the Collaboration Program and Collaboration Funding to cover ARIDIS activities during the Collaboration Term Extension and the Option Period shall be extended automatically subject to the payment of the Annual Fee described in Section 6.1 (b) below.
(d) GSK may exercise the Collaboration Term Extension by providing written notice to ARIDIS at any time before the expiration of the current Collaboration Term (as may have already been extended as described in 3.3 (b) above); however, no extension is effective until the Parties agree upon terms of the additional Collaboration Funding.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
compliance with all applicable Laws, including applicable national and international guidelines such as GLP.
(i) data are being generated using sound scientific techniques and processes;
(ii) data are being accurately and reasonably contemporaneously recorded in accordance with good scientific practices by personnel conducting research or development hereunder;
(iii) data are being analyzed appropriately without bias in accordance with good scientific practices; and
(iv) data and results are being stored securely and can be easily retrieved.
(i) In order to facilitate activities of the Parties under the Collaboration Program, either Party (referred to in this Section 3.5(c) as the “Transferring Party”) may provide to the other Party (referred to in this Section 3.5(c) as the “Material Receiving Party”) certain materials, including Research Materials (such materials provided hereunder are referred to, collectively, as “Materials”) for use by the Material Receiving Party in furtherance of its rights and the conduct of its obligations under the Collaboration Program and, in the event GSK exercises the Option, in furtherance of its rights under the License, as applicable (the “Purpose”). All transfers of such Materials by the Transferring Party to the Material Receiving Party shall be documented in writing (the “Transfer Record”) in the form attached hereto as Exhibit F that sets forth the type and name of the Material transferred, the amount of the Material transferred, the date of the transfer of such Material and the Purpose.
(ii) Except as otherwise provided under this Agreement, all such Materials delivered by the Transferring Party to the Material Receiving Party shall remain the sole property of the Transferring Party, shall only be used by the Material Receiving Party in furtherance of the Purpose, and shall be returned to the Transferring Party upon the termination of this Agreement or upon the discontinuation of the use of such Materials (whichever occurs first). Notwithstanding anything to the contrary herein, Joint Materials will remain jointly owned irrespective of transfer of such Joint Materials between the Parties. The Material Receiving Party shall not cause the Materials to be used by or delivered to
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
or for the benefit of any Third Party without the prior written consent of the Transferring Party.
(iii) At the time the Transferring Party provides Materials to the Material Receiving Party as provided herein and to the extent not separately licensed under this Agreement, the Transferring Party hereby grants to the other Party a non-exclusive license under the Patents and Know-How Controlled by it to use such Materials solely for the Purpose.
(iv) The Parties agree that the exchanged Materials: (A) shall be used in compliance with applicable Laws; (B) shall not be used in animals intended to be kept as domestic pets; (C) shall not be transferred to a Third Party except if this is provided for and is done in accordance with this Agreement; and (D) shall not be reverse engineered or chemically analyzed, except if this is provided for in the applicable Collaboration Program.
(v) THE MATERIALS SUPPLIED BY THE TRANSFERRING PARTY UNDER THIS SECTION 3.5(c) ARE SUPPLIED “AS IS” AND NOT FOR USE IN HUMANS EXCEPT AS EXPRESSLY AGREED BY THE PARTIES IN WRITING, AND THE TRANSFERRING PARTY MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE MATERIALS DOES NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS OF A THIRD PARTY.
(vi) The Material Receiving Party assumes all liability for damages that may arise from its use, storage or disposal of the Materials. The Transferring Party shall not be liable to the Material Receiving Party for any loss, claim or demand made by the Material Receiving Party, or made against the Material Receiving Party by any Third Party, due to or arising from the use of the Materials, except to the extent such loss, claim or demand is caused by the gross negligence or willful misconduct of the Transferring Party.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
(a) Subject to the terms and conditions of this Agreement, ARIDIS hereby grants to GSK an exclusive option (the “Option”) to obtain :
(i) an exclusive, worldwide, royalty bearing license, with the right to grant sublicenses, under ARIDIS Arising IP and ARIDIS’ s interest in the Joint Arising IP and
(ii) a non-exclusive, worldwide, royalty bearing license, with the right to grant sublicenses, under ARIDIS Background IP
to research, have researched, develop, have developed, make, have made, use, have used, sell, have sold, offer for sale and import the Vaccine Products in the Field.
(b) GSK may exercise the Option by providing written notice to ARIDIS at any time during the Collaboration Term (as may be extended under Section 3.3) and 6 (six) months after the acknowledgment by the JSC of the completion of the Collaboration Program according to Section 2.1(d)(viii) (the “Option Period-).
(c) Upon GSK’s exercise of its Option rights under this Section 4.1 (a), the Parties shall negotiate the terms of the License Agreement in good faith within ninety (90) Business Days following notification by GSK of exercise of said Option rights, or for such additional time as may be mutually agreed by the Parties (the “Negotiation Period”). The License Agreement shall include the main terms that are set forth in Exhibit C as well as other usual terms in a license agreement which terms shall be negotiated in good faith by the Parties.
(d) Subject to Section 11.5, if as of the expiration of the Term, the License Agreement is not executed between the Parties, then:
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
(i) Subject to any other provision in this Agreement providing one Party with exclusive rights after the expiration of the Term, each Party and its Affiliates shall have the right (as joint owner and without any requirement of gaining the consent of, or accounting to, the other Party) to practice its interests in any Joint Arising IP and Joint Collaboration Patents in and outside the Field but if a Party decides to grant a license to a Third Party under Joint Arising IP for use in the Field, it shall be required to share equally the revenues of such license (to the extent relating to the license of Joint Arising IP) with the other Party and such license shall be non-exclusive only; and
(ii) For the avoidance of doubt, GSK shall have no obligation to enter into discussions with ARIDIS regarding any license or other access to GSK Intellectual Property.
(e) Notwithstanding anything to the contrary herein, if GSK exercises the Option in the Field and the Parties execute the License Agreement then, each Party and its Affiliates shall thereafter have the right to practice its interests in the Joint Collaboration Patents and, subject to confidentiality obligations, the Joint Arising IP solely outside the Field as joint owner, without any requirement of gaining the consent of, or accounting to, the other Party but not to grant license to Third Parties in the Field.
ARTICLE 5 COLLABORATION LICENSES
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
(a) a one time Execution Fee of [***] (“Execution Fee”) and
(b) an annual payment of [***] (“Annual Fees”) during the Collaboration Term and the Collaboration Term Extension(s).
6.2 Such payments shall be payable by wire transfer of immediately available funds in accordance with wire transfer instructions of ARIDIS provided in writing to GSK on or prior to the Effective Date. The Execution Fee shall be due only once at Effective Date. The Annual Fees shall be due annually and being first payable one year after the Effective Date. Such payments shall be performed by GSK within ninety (90) days from the end of the month of GSK’s receipt of an invoice from ARIDIS, which invoice shall refer to a purchase order number to be supplied by GSK and be sent in paper format to Xxxx-Xxxx Karlshausen, GSK finance xxxxxxxxxx, xxxxxx Xxxxxxx 00, 0000 Xxxxx, Xxxxxxx, with an electronic copy sent to Xxxx-Xxxxx Puaux (xxxx-xxxxx.x.xxxxx@xxx.xxx).
6.3 The Parties agree that the Execution Fee and Annual Fees are non-refundable and non-creditable unless following the exercise of rights under Article 4 by GSK the Parties enter into a License Agreement. In such case the Execution Fee and Annual Fees paid to ARIDIS by GSK under Section 6.1 will be credited against any payment due by GSK to ARIDIS under such License Agreement including without limitation milestone payments and payment for royalties, but expressly excluding the License Initiation Fee that would be payable if GSK enters into a License Agreement with ARIDIS.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
electronic copy sent to Stephane Xxxxxx (xxxxxxxx.x.xxxxxx@xxx.xxx). For the avoidance of doubt, the Collaboration Funding paid to ARIDIS by GSK shall be used by ARIDIS solely to cover the costs of the conduct of the Collaboration Program that are incurred after the Effective Date.
ARTICLE 7 INTELLECTUAL PROPERTY MATTERS
(b) By GSK. GSK shall solely own all Arising IP that is made solely by or on behalf of GSK and solely related to GSK Background IP (“GSK Arising IP”).
7.3 Use and Disclosure of Arising IP.
(a) Each Party shall promptly disclose to the other Party under confidentiality all Arising IP owned by it, at the latest before filing a patent application, including any invention disclosures, or other similar documents, submitted to it by its employees, agents or independent contractors describing the inventions.
(b) Neither Party shall disclose to, or use with any Third Party any Arising IP before the expiration of the Term. For clarity, (1) each Party shall have the right to use its own Arising IP and Joint Arising IP for internal research purposes during the Term, (2) neither Party shall have the right to grant nonexclusive or exclusive licenses to any Third Party for any reason to its interests in the Joint Arising IP and the Joint Collaboration Patents during the Term.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
(i) ARIDIS shall have the sole and exclusive right, to prepare, file, prosecute and maintain all ARIDIS Patents at its sole cost and expense. ARIDIS shall keep GSK duly informed during the course of the Patent process regarding Patents claiming ARIDIS Arising IP. To the extent that Patents claiming ARIDIS Arising IP contain subject matter that could conflict with Joint Collaboration Patents, such ARIDIS Patents shall be discussed with GSK, and ARIDIS shall inform GSK regarding any material change in protection and consult with GSK how to minimise conflict during patent prosecution provided however that ARIDIS shall have the final say.
(ii) If ARIDIS decides to cease the prosecution or maintenance of any Patent claiming ARIDIS Arising IP, it shall notify GSK in writing sufficiently in advance so that GSK may, at its discretion, assume the responsibility for the prosecution or maintenance of such Patent, at GSK’s cost and expense. GSK shall notify ARIDIS of its decision to assume the responsibility of such prosecution and/or maintenance within thirty (45) days of ARIDIS’ s notice to cease such activities. If, within such time, ARIDIS has not received notice of GSK’s decision to assume prosecution and maintenance ARIDIS shall be free to cease such prosecution and maintenance.
(b) Joint Collaboration Patents.
(i) The responsibility and strategy for filing prosecution and maintenance, and for enforcement, of any Joint Collaboration Patents shall rest, at GSK’s option, (1) exclusively with GSK, at its cost, or (2) if desired by GSK and upon agreement by ARIDIS, jointly with GSK and ARIDIS, at joint cost and expense shared equally between the Parties (unless otherwise agreed by the Parties). GSK shall keep ARIDIS reasonably informed as to material developments with respect to the prosecution and maintenance, and enforcement, of such Joint Collaboration Patents. GSK shall give ARIDIS a reasonable opportunity to review the application or submission before filing, shall provide a copy thereof to ARIDIS and shall consult ARIDIS with respect thereto and in particular, if at joint cost, with respect to all costs arising (whether to patent attorneys or otherwise) in relation to the prosecution and maintenance, and enforcement, of such Joint Collaboration Patents. ARIDIS agrees to give GSK its consent to allow GSK to enforce Joint Collaboration Patents vis-à-vis Third Parties in jurisdictions where such consent is required, (except if such Third Parties have been properly licensed by ARIDIS or GSK).
(ii) If, during the Term, GSK intends to allow any Joint Collaboration Patent to lapse or become abandoned without having first filed a substitute, GSK shall notify ARIDIS of such intention at least sixty (60) calendar
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
days prior to the date upon which such Patent shall lapse or become abandoned, and ARIDIS shall thereupon have the right, but not the obligation, to assume responsibility for the prosecution and maintenance, and enforcement, thereof at its sole cost and expense, with counsel of its own choice. Such prosecution and maintenance by ARIDIS shall be made in the name of ARIDIS (or an Affiliate of ARIDIS) as assignee of GSK, including the conduct of defense of any claims or proceeding related to such claim, patent or patent application and GSK shall assign to ARIDIS its entire right in such claim, patent or patent application.
7.5 Patent Challenge by Third Parties
(i) If a Third Party files a claim challenging the validity or enforceability of the Joint Collaboration Patents, GSK shall have the sole rights to defend and control any action or proceeding at its own cost and with a counsel of its own choice. ARIDIS shall have the right to be represented in such proceedings at its own cost. If GSK decides to cease the defence of any Joint Collaboration Patent, it shall notify ARIDIS in writing sufficiently in advance so that ARIDIS may, at its discretion, assume the responsibility for the defence of such Joint Collaboration Patent, at ARIDIS cost and expense. ARIDIS shall notify GSK of its decision to assume the responsibility of such defence within thirty (30) days of GSK’s notice to cease such defence. If, within such time, GSK has not received notice of ARIDIS’ decision to assume such defence, GSK shall be free to cease such defence. In any case the defence of such action or proceeding shall be discussed by the representatives of the Parties at the Joint Steering Committee.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
ARTICLE 8 REPRESENTATIONS AND WARRANTIES; COVENANTS
(a) To the best of its knowledge it Controls the ARIDIS Background IP, and has all rights necessary under the ARIDIS Background IP to grant the options, licenses and other rights to GSK as purported to be granted pursuant to this Agreement;
(b) It has not received any written notice from any Third Party asserting or alleging that the development or practice of the ARIDIS Background IP infringes or misappropriates the intellectual property rights of such Third Party, and it has no knowledge that GSK’s practice of the rights granted to GSK hereunder would infringe the intellectual property rights of any Third Party;
(c) There are no pending, and to ARIDIS’ knowledge, no threatened, adverse actions, suits or proceedings against ARIDIS involving the ARIDIS Background IP;
(d) It has not granted any right or license to any Third Party relating to any of the ARIDIS Know-How or ARIDIS Patents that would conflict with any of the rights or licenses granted to GSK hereunder and prohibit GSK from exercising such rights;
(e) It has disclosed to GSK all material information received by ARIDIS concerning the institution of any interference, opposition, reexamination, reissue, revocation, or nullification or any official proceeding involving any ARIDIS Patent anywhere in the Territory (for the avoidance of doubt, the phrase “official proceeding” as used herein is not intended to mean ordinary prosecution and maintenance activities);
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
(f) To its knowledge, it is not in violation of any Anti-Corruption Laws;
(g) It acknowledges receipt of GSK’s “Prevention of Corruption —Third Party Guidelines” which are attached hereto as Exhibit D, and agrees to perform its obligations under the Agreement in accordance with the principles set out therein;
(h) It acknowledges that, in entering into this Agreement, GSK has relied upon information supplied by ARIDIS and information which ARIDIS has caused to be supplied to GSK by ARIDIS’s officers regarding ARIDIS Background IP. ARIDIS represents and warrants to GSK that, to ARIDIS’ knowledge the information provided to GSK in connection with this Agreement is accurate in all material respects. ARIDIS further warrants and represents to GSK that it has not, as of the Effective Date, intentionally omitted to furnish GSK with any material information known to ARIDIS concerning ARIDIS Background IP or the transactions contemplated by this Agreement, which would reasonably be considered to have a materially adverse effect on ARIDIS Background IP or the performance of the Collaboration Program.
8.4 Except as set forth in this Article 9 concerning the ARIDIS Background IP ARIDIS disclaims any warranty or guarantee that the application of the ARIDIS Background IP to Vaccine Products in the Field or the development of Vaccine Products will be successful in whole or in part or that the Vaccine Products will be suitable for commercialization. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, EACH PARTY SPECIFICALLY DISCLAIMS ANY GUARANTEE THAT THE CONDUCT OF THE COLLABORATION PROGRAM WILL BE SUCCESSFUL, IN WHOLE OR IN PART. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY, AND ALL SUCH
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.
9.1 Each Party (the “Indemnifying Party”) shall defend, indemnify, and hold the Other Party (the “Indemnified Party”) and its Affiliates and their respective officers, directors, employees, and agents (the “Indemnitees”) harmless from and against any and all liabilities, damages, losses, costs and expenses including the reasonable fees of attorneys (collectively, “Losses”), arising out of or resulting from any Third Party suits, claims, actions, proceedings or demands (“Claims”) to the extent that such Claims arise out of, are based on, or result from: (a) the breach of any of the Indemnifying Party’s obligations under this Agreement, including Indemnifying Party’s representations and warranties set forth herein; (b) the willful misconduct or grossly negligent acts of Indemnifying Party, its Affiliates, sublicensees, subcontractors, or the officers, directors, employees, or agents of Indemnifying Party or its Affiliates; (c) the negligent conduct of Indemnifying Party’s activities under the Collaboration Program. The foregoing indemnity obligation shall not apply to the extent that (i) the Indemnitees fail to comply with the indemnification procedures set forth in Section 9.2 and Indemnifying Party’s defense of the relevant Claims is prejudiced by such failure or that (ii) the Indemnitees caused such Losses by their willful misconduct or negligent acts.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
NOTHING IN THIS SECTION 9.3 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 9.1, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 10.
9.5 Special note regarding limitation of ARIDIS’ liability and limitation of ARIDIS’ indemnification rights. In no circumstance shall ARIDIS be liable to GSK or any party for any liability under this Agreement in excess of the amounts paid to it by GSK hereunder. WITH RESPECT TO ANY VACCINE PRODUCT OR OTHER DRUG OR SERVICE CONTEMPLATED BY THIS AGREEMENT OR THE LICENSE OPTIONED UNDER SECTION 4, EXCEPT FOR THE CASE OF ARIDIS’ GROSS NEGLIGENCE OR WILLFUL MISCONDUCT TO THE EXTENT SUCH GROSS NEGLIGENCE OR WILLFUL MISCONDUCT HAVE CONTRIBUTED TO SAID LIABILITY. IN NO CIRCUMSTANCE SHALL ARIDIS BE LIABLE TO GSK, ITS AFFILIATES, SUBLICENSEES, DISTRIBUTORS OF PRODUCT, AGENTS OR OTHER INDEMNITEES, NOR ANY RECIPIENT, FOR ANY USE OF SUCH VACCINE PRODUCT, DRUG OR SERVICE BY GSK, WHETHER IN CLINICAL TRIAL OR OTHERWISE, AND GSK SHALL INDEMNIFY ARIDIS AGAINST ALL LIABILITIES RESULTING FROM ANY SUCH USE.
ARTICLE 10 CONFIDENTIALITY- PUBLICATION- PUBLICITY
(a) was already known to the receiving Party or its Affiliate, other than under an obligation of confidentiality, at the time of disclosure by the other Party;
(b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
(c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement;
(d) was disclosed to the receiving Party or its Affiliate on a non-confidential basis by a Third Party who has a legal right to make such disclosure and who did not obtain such information directly or indirectly from the other Party; or
(e) was independently discovered or developed by the receiving Party or its Affiliate without access to or aid, application or use of the other Party’s Confidential Information, as evidenced by written records made contemporaneous with such discovery or development and kept in the ordinary course of business, or other similar documentary proof of actual knowledge by the receiving Party.
Notwithstanding the definition of “Confidential Information” in Article 1, all Joint Arising IP, shall be treated confidentially by both Parties and shall be owned in accordance with Section 7.3.
(a) such disclosure is reasonably necessary (i) for the filing or prosecuting Patents as contemplated by this Agreement; (ii) in the case of GSK, to comply with the requirements of regulatory authorities with respect to obtaining regulatory approval of a Vaccine Product; or (iii) for pro secuting or defending litigation as contemplated by this Agreement;
(b) such disclosure is reasonably necessary to its employees, agents, consultants, contractors, licensees or sublicensees on a need-to-know basis for the sole purpose of performing its obligations or exercising its rights under this Agreement; provided that in each case, the disclosees are bound by written obligations of confidentiality and non-use consistent with those contained in this Agreement; or
(c) such disclosure is reasonably necessary to comply with applicable Laws, including regulations promulgated by applicable security exchanges, court order, administrative subpoena or order.
Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to Section 10.2(a) or 10.2(c), such Party shall promptly notify the other Party such required disclosure and shall use reasonable efforts to obtain, or to assist the other Party in obtaining, a protective order preventing or limiting the required disclosure.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
shall provide the other Party the opportunity to review and comment on any proposed publication that contains the results of studies carried out under the Collaboration Program at least ninety (90) days prior to its intended submission for publication. The other Party shall provide the Party seeking publication with its comments in writing, if any, within ninety (90) days after receipt of such proposed publication. The Party seeking publication shall consider in good faith any comments thereto provided by the other Party and shall comply with the other Party’s request to remove any and all of such other Party’s Confidential Information from the proposed publication. In addition, the Party seeking publication shall delay the submission for a period up to ninety (90) days after the other Party’s receipt of the proposed publication in the event that the other Party can demonstrate reasonable need for such delay to prepare and file a patent application. If the other Party fails to provide its comments to the Party seeking publication within such ninety (90) day period, such other Party shall be deemed not to have any comments, and the Party seeking publication shall be free to publish in accordance with this Section 10.3. The Party seeking publication shall provide the other Party and the JSC a copy of the manuscript at the time of the submission. Each Party agrees to acknowledge the contributions of the other Party and its employees in all publications as scientifically appropriate. Disputes among the Parties with regard to technical and scientific publications shall be discussed by the JSC whose decision thereon shall be final and binding for the Parties.
10.4 Publicity; Terms of this Agreement.
(a) The Parties agree that the terms of this Agreement are the Confidential Information of both Parties, subject solely to the authorized disclosure provisions set forth in this Section 10.4 and Section 10.2.
(b) Neither Party nor such Party’s Affiliates will make any public announcements, press releases, regulatory filing or other public disclosures, written or oral, whether to the public, the press, to GSK’s stockholders or otherwise, concerning this Agreement or the terms or the subject matter hereof, the performance hereof or the Parties’ activities hereunder, or any results or data arising hereunder (a “Public Statement”), except: (i) with the prior written consent of the other Party (such consent not to be unreasonably delayed or withheld but may be conditional upon certain restrictions as to the content and/or distribution of such Public Statement to ensure consistency with GSK’s policies, including GSK’s standards for Scientific Engagement); or (ii) for such Public Statements, as in the opinion of the counsel for the Party intending to make such Public Statement, are required to comply with applicable Laws (including the regulations of any stock exchange) (a “Legal Requirement”) and which in any event contain only the minimum disclosure necessary to comply with the relevant Legal Requirement.
(c) Each Party agrees to provide the other Party with a copy of any proposed Public Statement as soon as reasonably practicable under the circumstances prior to its scheduled release. Each Party shall provide the other with an advance copy of any such Public Statement at least ten (10) business days prior to its scheduled release; provided, that if the Party proposing such Public Statement cannot provide the reviewing Party with ten (10) business days notice due to extraordinary circumstances beyond that Party’s control, such Party will use reasonable efforts to provide the reviewing Party with
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
the proposed Public Statement for comment at least forty-eight (48) hours before release. Each Party furthermore shall have the right to review and recommend changes to any such Public Statement and, except as otherwise required by Legal Requirement, the Party whose Public Statement has been reviewed shall remove any Confidential Information of the reviewing Party that the reviewing Party reasonably deems to be inappropriate for disclosure.
(d) In addition to the foregoing each Party agrees to give the other Party a reasonable opportunity (to the extent consistent with Legal Requirements) to review all Public Statements required by Legal Requirements to be filed with the SEC or similar body prior to submission of such filings, and will give due consideration to any reasonable comments by the non-filing Party relating to such filing, including the provisions of this Agreement for which confidential treatment should be sought.
ARTICLE 11 TERM AND TERMINATION
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
Party’s filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors by such other Party (or an equivalent procedure including administration). Upon the bankruptcy of any Party, the non-bankrupt Party shall further be entitled to a complete duplicate of, or complete access to, any such intellectual property, and such, if not already in its possession, shall be promptly delivered to the non-bankrupt Party, unless the bankrupt Party elects to continue, and continues, to perform all of its obligations under this Agreement.
(a) The following consequences shall apply only in the event of termination by GSK pursuant to Section 11.2 (Termination for Convenience) or by Aridis to Section 11.3 (Termination for Breach), or expiration of the Term:
(i) Option. GSK loses its right to exercise the Option.
(ii) Collaboration funding. GSK shall pay ARIDIS for the Collaboration Funding incurred for activities performed up to the effective date of termination and for all non-cancellable costs according to the budget provided that ARIDIS shall exercise all Commercially Reasonable Efforts to minimize such costs, expenses and commitments.
(iii) Sole license to Joint Collaboration Patents. ARIDIS shall have the right to request from GSK a sole license (with GSK and its Affiliates retaining rights for its own purposes), with the right to grant sublicenses, under GSK’s interest in any Joint Arising IP for use in and outside the Field on terms to be negotiated in good faith and agreed between the Parties, and GSK may grant such license or not in its sole discretion.
(iv) Transfer of Material Data. GSK shall, at the option of ARIDIS, transfer to ARIDIS a copy of all material data, filings regarding the conduct of the Collaboration Program and ARIDIS will have the non-exclusive right to use such data and filings. GSK shall, at the Option of ARIDIS, return to ARIDIS, and cease using, all Confidential Information of ARIDIS as well as Research Materials received from ARIDIS, except as required to continue its obligations set forth in this Section 11.5(a).
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
(b) The following consequences shall apply only in the event of termination by GSK pursuant to Section 11.3 (Termination for Breach):
(i) GSK shall retain the right to exercise the Option, pursuant to the terms of this Agreement, in particular Section 4.1;
(ii) If GSK exercises the Option:
(A) Joint Collaboration Patents will continue to be managed as set out in section 7. GSK shall provide ARIDIS, for its review and comment, with drafts of any material filings or responses to be made to any patent authority with respect to Joint Collaboration Patents at least ten (10) Business Days in advance of intended submission, and shall provide ARIDIS with copies of material filings made with, and communication received from, patent authorities with respect to Joint Collaboration Patents. GSK shall reasonably consider incorporating ARIDIS’s comments thereto. ARIDIS may decide, in its sole discretion, to assign all its rights and interests in the Joint Collaboration Patent(s) to GSK, in that event if GSK agrees to such assignment all costs related to the prosecution and maintenance of such Joint Collaboration Patents shall be borne by GSK;
(iii) ARIDIS shall, at GSK’s request, return to GSK, and cease using, all Confidential Information of GSK as well as Research Materials received from GSK, except as required to continue its obligations set forth in this Section 11.5(b).
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
the Parties shall refer such dispute to the Executive Officers of the Parties (SVP R&D for GSK Biologicals and CEO for ARIDIS) for attempted resolution by good faith negotiations within thirty (30) days after such notice is received by or referred to the Executive Officers.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
agreements, warranties, representations, conditions and understandings between the Parties hereto with respect to the subject matter hereof and supersedes, as of the Effective Date, all prior and contemporaneous agreements and understandings between the Parties with respect to the subject matter hereof, including the Confidentiality Agreement (except to the extent it relates to Information disclosed by or to IntelGenx Corp) and the FOA. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.
If to ARIDIS:
If by courier to:
ARIDIS 0000 Xxxxxxx Xxxxx, Xxx Xxxx, XX 00000, XXX Attention: CEO
If by facsimile:
x0 (000) 000-0000
If to GSK:
If by courier:
GlaxoSmithKline Biologicals S.A.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
Xxx xx x’Xxxxxxxx 00 0000 Xxxxxxxxx, Xxxxxxx Attention: Senior Vice President, Business Development
If by facsimile:
x00 00 00 00 00
With a copy to (which shall not constitute notice):
GlaxoSmithKline Biologicals S.A. Xxxxxx Xxxxxxx, 00 0000 Xxxxx Attention: Legal Telephone: x00 00 00 00 00 Facsimile: x00 00 00 00 00
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
13.10 English Language; Governing Law. This Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this Agreement. This Agreement and all disputes arising out of or related to this Agreement (including non-contractual disputes) or any breach hereof shall be governed by and construed under the laws of England and Wales, without giving effect to any choice of law principles that would require the application of the laws of a different state.
{Signature page follows}
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
GLAXOSMITHKLINE BIOLOGICALS S.A. |
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ARIDIS | ||
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By: |
/s/ Xxxxxx Xxxxxxx |
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By: |
/s/ Xx Xxxxx |
Name: |
Xxxxxx Xxxxxxx |
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Name: |
Xx Xxxxx |
Title: |
Senior Vice President Legal Affairs |
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Title: |
Chief Executive Officer |
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By: |
/s/Xxxxxxxx Xxxxx |
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Name: |
Xxxxxxxx Xxxxx |
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Title: |
Senior Vice President |
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Vaccines Discovery & Development |
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Date: |
January 15, 2017 |
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
LIST OF EXHIBITS:
Exhibit A: |
Existing ARIDIS Patents |
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Exhibit B: |
Collaboration Program, Budget, Schedule of Payments and Timelines |
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Exhibit B1 |
List of approved subcontractors |
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Exhibit C: |
Main License Agreement Terms |
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Exhibit D: |
Third Party Guidelines |
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Exhibit E: |
R&D Principles |
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Exhibit F : |
Material Transfer Record |
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Schedule 1.9: |
ARIDIS Materials |
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Schedule 1.32: |
GSK Materials |
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Schedule 1.42: |
Joint Materials |
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
EXHIBIT A EXISTING ARIDIS PATENTS
Aridis Ref |
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Attorney Docket Number |
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CC |
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Status |
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Application Number/ Publication No |
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Application Date |
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Patent Number |
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Grant Date |
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Title |
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Expiration Date |
P108USp |
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136-000200US |
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US |
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Inactive |
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60/995,291 |
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9/25/2007 |
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Formulations for Preservation of Rotavirus |
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P108EPCH |
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136-000210CH |
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CH |
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Inactive |
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8834341,3 EP219728381 |
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9/24/2008 |
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2197283 |
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7/17/2013 |
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P108EPDE |
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136-000210DE |
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DE |
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Granted |
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8834341,3 EP2197283B1 |
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9/24/2008 |
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2197283 |
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7/17/2013 |
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9/24/2028 |
P108EP |
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136-000210EP |
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EP |
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Granted |
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8834341,3 EP2197283B1 |
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9/24/2008 |
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2197283 |
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7/17/2013 |
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9/24/2028 |
P108EPFR |
|
136-000210FR |
|
FR |
|
Granted |
|
8834341,3 EP2197283B1 |
|
9/24/2008 |
|
2197283 |
|
7/17/2013 |
|
|
|
9/24/2028 |
P108EPGB |
|
136-000210GB |
|
GB |
|
Granted |
|
8834341,3 EP2197283B1 |
|
9/24/2008 |
|
2197283 |
|
7/17/2013 |
|
|
|
9/24/2028 |
P108EPIT |
|
136-0002101T |
|
IT |
|
Granted |
|
8834341,3 EP2197283B1 |
|
9/24/2008 |
|
2197283 |
|
7/17/2013 |
|
|
|
9/24/2028 |
P108PC |
|
136-000210PC |
|
PCT |
|
Inactive |
|
PCT/US2008/01 1169 |
|
9/24/2008 |
|
|
|
|
|
|
|
|
P108US |
|
136-000210US |
|
US |
|
Granted |
|
12/733,920 |
|
9/24/2008 |
|
8,241,886 |
|
8/14/2012 |
|
|
|
4/30/2029 |
P112USprov |
|
136-001100US |
|
US |
|
provisional |
|
62347009 |
|
6/7/2016 |
|
|
|
|
|
Method for Preparation of Quick Dissolving Thin Films Containing Bioactive Material With Enhanced Thermal Stability |
|
|
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
Patent number |
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Publication date |
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Application number |
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|
|
AU2002360245A1 |
|
20030506 |
|
AU2002360245A |
|
|
|
|
|
CA2458794A1 |
|
20030501 |
|
CA2458794A |
|
|
|
|
|
CA2458794C |
|
20130122 |
|
CA2458794A |
|
|
|
|
|
EP1430117A2 |
|
20040623 |
|
EP02795489A |
|
|
|
|
|
EP1430117A4 |
|
20060125 |
|
EP02795489A |
|
|
|
|
|
US2004014164A1 |
|
20040122 |
|
US19906102A |
|
|
|
|
|
US7101693B2 |
|
20060905 |
|
US19906102A |
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
EXHIBIT B
Collaboration Program, Budget (including Go/No Go criteria), Schedule of Payments and Timelines
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
verable,success criteria and constraints rabl e elop thenro-stable OTF whiCh complies wth the following crlena· bjl!tv: Xxxxx.xx :12Uo ..s•c folowed 24Uo +JO'C.and 3 day'Sat ...co•c (accod&.g to WHO) Optimal:36Mo +30"C (kovel3).arid 24Uo at +37'C (m.atch toSII), and 6Mo +40 C (match 10 F size: ma11et tMn 2:2'-20mm (e.g 15•15tnmOf 22"'11 rnm equrvalent based 011 p. e flf!otS s.cze) solut!on tme o more tlw150 seconds but duly 1().1$ seconds {method to be de!'!"'td) ky behavior(method to be demed) trai nts e of GRAS and non-animalongfl exclplents mulation COI'I1)8tlble wrthlrarge scale manutadumg process e oftraceable Raw Matenalftti'lg with quaificabonlvaildationGSK requirements sesstechnicalreprodudbily.,ts ... stones (technical) 1 (!NP 1-2-3)-Go/No Go -Stage 2 (Tech transfertto CMO for GMP) Act1v1t1es l nd1ca Durati (montn Aridis AridisiGSK First screening-manufacturing 2-First screening-characterization 2-Aridis AridisiGSK 1-Second screening-manufacturing-optimization Second screening-characterization 2-Aridis AridisiGSK 1-Best candidates selection & repro lot manufacturing Repro lots - characterization (without realtime stability) 2-- 2 Repro lots -realtime stability GSK CMO selection Tb ech tra nsferto Cl.10 Tb Who
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
st stage:Formulation Development : First screening p miinary work import permit ava.i li iilty supply Rotavirusoono=ntrated d-:velopm=nt purpose t scraning :n\anufacturing Series of OTF cancfdates Wxd on agre:d excni ts. (10-40 cancf""t.s) OTF surface pH OTF dissolution time Dim=nsions & th.ickness Pouch . ng conditions {T... atmospttere composition, OOiding t me before xxxxx.xxx) Pouch. ntegrity test k tt\awing to pouching} t scre:ning:ct\aracrtiz: ation Buffer cap.acity ·ith. BRR m applyaoo:erated stabiilty conditions {Arrh..xxxxx) and m:asureinfect vityus ng t potency m:tt.od on candid. m=:ting tM BRR spec. isture content OTF dissolution t me(Ph..U Sel:ction of xxxxxxx.xx:s for sec scre:nir.Q Budget :600. 000 USS st stage:Formulation Development : Secondscreening p ond scre:nir.g : Op t mization of Selected OTF xxxxxxx.xx:s{e.g.exc pi=nt concentration, drying process oonditiollS} OTF surfao:pH OTF <frssoJtrtion time Oin'tensjons & th:ickness Pouching ooncfrtions{T'". atmosphere oom ion, OOJcfu-rg xxx:-: before pouciUng) Pouctl integrity t-est nufactur ng{bulk tt\ a :, ing to x.xxx) oncl scre:n:ing: Suffer capacity xxxx.BRR m acterization applyaooel:rat-:<:1 stability ooncfrtions {Arrttenn:ius) an measure infect vityusing t pot-:ncy mett.ocl. Moisture content OTF <frssoJtrtion xxx:-:{Ph.U Pre clinical t-est inPig mod sel:ct-:<:1cancfdat-=s. Sel:ction of cancfdat-=s for reprodooibility lots Budget :500. 000 USS And S And S
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
t stage:Formulation Development Reproducibility lots p o lots:manufactur ng Produce 3 repro lots{ ·ittl rotavirus bu ks}of eactl sel;>ct:d candid.ates {nux 3candid.ai:S} OTF surface pH OTF <frssoJution tin't:o: Oin'xxxxX,xxxx & tttickness PouctUng ooncfrtions {F. atmosphere oompositio'l, Suffer capacity xxxx. BRR m o lots:ctwacterization Applyaoo:l:rated stability ooncfrtions {Arrttennius) an measure infect vityusing t potency mett.ocl. Moisture content OOJcflflg time before xxx,xXxx Pouctl int-egrity test OTF <frssoJution tin't:o:{Ph.U Pre clinical test inPig mOO 4 Rtim= c;,t.=.hility initi.:ltirlort Conclusjonof ttt.e ftrSt stag-eo oollaboration xxxx. Aricfrs. Budget::XX.XXX USS ipients contributions ci pients knownby GSK vaccine toincrease Rotavi rus stab iity: pH 6.5 Sucrose 1Ww/v Calcium SmU H.istidineo,z,w-/v Arginine 0.w/v rHSA 0.w/v TPGS 1m:M {int-:raction withI nfect vity tes6ng} Polymer for ttteOTF structure to be defined Travasol {amino acid pooi) tacids:CaC03. adioic acid. Ca citrate.comb:nat ons ing process: ) And S
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
ytical strategy t ng plan has been discussed with Aridis imal tes t ngplan willbe: Potency by FFU onFmlSulk and FrulContainer {R&DPteclinicJ.I) Suff etcap.acity by &by Xxxxx-Xxxx mod on DP{TRD OP) Dissolutiontirn:on DP - shotAd besta.nd.atd pharmacopeia method{both teams). Moisture content byF on OP{TRD OP) pH ofdissolvedOTFandlotOTF surface{to bediscussedwith Aricfis{m:thodand R&R) OTF dimension:size and thic:kns$s
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
Schedule of Payments to finance the Collaboration Program :
GSK agrees to make advance payments to ARIDIS corresponding to [***] of the Collaboration Funding (for the corresponding WP) at initiation of each of WP 1, WP2, and WP 3 above. Thus, upon initiation of WP1: [***] (on the Effective Date); initiation of WP2: [***]; initiation of WP3: [***]; with the remaining [***] —[***]— upon completion of Stage 1.
The Parties shall agree the Collaboration Funding for Stage 2 at least sixty (60) days before the commencement of Stage 2.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
EXHIBIT B1 LIST OF APPROVED SUBCONTRACTORS
(None at this time: any subcontractors will be presented to the Joint Steering
Committee for review prior to subcontracting.)
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
EXHIBIT C
MAIN LICENCE AGREEMENT TERMS
“Licensed IP” is Intellectual Property subject to the Option Rights granted to GSK as defined in the Collaboration and Option Agreement (“Agreement”) section 4.1(a) namely ARIDIS Background IP, ARIDIS Arising IP and ARIDIS’ s interest in Joint Arising IP.
In the event GSK exercises the Option under Section 4.1(a) of the Agreement the Parties shall enter into a license agreement based on the following terms and conditions (“License Agreement”). Unless specified otherwise herein the meaning of capitalized terms in this Exhibit C is the same as in the Agreement. :
(A) License Initiation Fee
A license initiation fee of six hundred thousand dollars [***] shall be due by GSK to ARIDIS within thirty (30) days from the execution of the License Agreement.
(B) Milestone Payments
GSK shall make the following milestone payments to ARIDIS:
· Upon successful completion of the first phase I clinical trial conducted by GSK with the first Product: [***]
· Upon successful completion of the first phase II clinical trial conducted by GSK with the first Product: [***]
· Upon successful completion of the first phase Ill clinical trial conducted by GSK with the first Product: [***]
· Upon the first PLA approval of the first Product in the EU: [***]
· Upon the first PLA approval of the first Product in the US : [***]
For the purpose of the above milestone payments the term “PLA” shall mean a Product Licence Application.
Each milestone payment set forth above shall be payable only once.
For the avoidance of doubt and in accordance with Section 6.3 of the Agreement the Execution Fee and all Annual Payments paid by GSK pursuant to the Agreement shall be fully creditable against the milestones payments described above and against royalties to be paid by GSK as described below but shall however not be creditable against the License Initiation Fee.
The term “Product” shall be defined in the License Agreement and shall include any Vaccine Product in the Field which comprises, contains, incorporates, is covered by or is developed through
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
the use of any Licensed 1P. GSK’s non-exclusive and exclusive rights to develop, manufacture, market and distribute Products in the Field and Territory are as described in section 4.1 of the Agreement.
(C) Royalties
GSK shall pay the following royalties on Net Sales (as such term is defined below in Section D of this Exhibit C) to ARIDIS:
· (i) For any Product which, in the absence of the license granted by ARIDIS, would infringe a Valid Claim of any Patent falling within ARIDIS Patents, ARIDIS Arising IP and/or ARIDIS’ interest in Joint Arising IP (in the case of Joint Arising IP, including Products which would, in the absence of either a license granted by ARIDIS or ownership of Joint Arising IP by GSK, infringe a Valid Claim of any Joint Collaboration Patent) (in each case such Product being hereinafter referred to as “Patented Product”) :
[***] on Net Sales
· (ii) Net Sales of any Product sold under contract or arrangement with GAVI or UNICEF (or similar GAVI contractor) in all countries qualifying as GAVI countries at the time of sales of the relevant Product :
[***] on Net Sales
· (iii) For any Product that does not fall within the categories described in sub-paragraph (i) or (ii) above but comprises, contains, incorporates, or is developed through the use of any ARIDIS Know-How and/or ARIDIS Materials :
[***] on Net Sales
· In the event that a license to patents owned and/or controlled by Third Parties is necessary for GSK in order to avoid infringement in practicing ARIDIS Intellectual Property under the License Agreement, [***] of the royalties payable by GSK to such Third Parties under such license shall be deducted from the royalties due under the License Agreement provided however that such deductions shall not cause the royalties due under the License Agreement to be reduced by more than [***]. (Note: This royalty reduction applies only to Third Party licenses required for the practice of Licensed IP; not for Third Party licenses as may be otherwise required for Product.)
· GSK’s obligation to pay royalties under the License Agreement shall commence on the date of first commercial sale of the Product in the first country of the Territory and, shall continue until the later of:
· 10 years from first commercial sale in the U.S. or the E.U. or in a major market country (such term to be defined in the License Agreement, though in any case this
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
term shall be no shorter than at least 8 years from the first commercial sale in the U.S. or E.U.) of the Territory (and other than GAVI/UNICEF countries); or
· If longer, with respect to Patented Products, in each country of the Territory, the last to expire of any licensed Patent falling within ARIDIS Patents, ARIDIS Arising IP and/or ARIDIS’ interest in Joint Arising IP.
(D) Net Sales
Net Sales shall be calculated on the gross receipts from sales of Product by GSK, sublicensees or their Affiliates in the Territory minus the following standard deductions:
· [***] of the gross receipts (the purpose of this percentage is to cover transportation charges, including insurance charges, and other similar charges);
· Sales and excise taxes, which shall include actual payment of contributions and payments required by any governmental authorities as liability provisions and/or made pursuant to injury compensation schemes and duties paid or allowed by a selling party and any other governmental charges imposed upon the production, importation, use or sale of Product where noted on customer invoices;
· Trade, quantity and cash discounts actually taken and other GSK standard rebates actually paid, including without limitation rebates given to the federal government such as MEDICAID and federal supply schedule rebates; and
Allowances or credits to customers or charge backs from customers actually paid on account of rejection or return of Product subject to royalty under the License Agreement or on account of retroactive price reductions affecting such Product.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
EXHIBIT D
PREVENTION OF CORRUPTION — THIRD PARTY GUIDELINES
The GSK Anti-Bribery and Corruption Policy (POL-GSK-007) requires compliance with the highest ethical standards and all anti-corruption laws applicable in the countries in which GSK (whether through a third party or otherwise) conducts business. POL-GSK-007 requires all GSK employees and any third party acting for or on behalf of GSK to ensure that all dealings with third parties, both in the private and government sectors, are carried out in compliance with all relevant laws and regulations and with the standards of integrity required for all GSK business. GSK values integrity and transparency and has zero tolerance for corrupt activities of any kind, whether committed by GSK employees, officers, or third-parties acting for or on behalf of the GSK.
Corrupt Payments — GSK employees and any third party acting for or on behalf of GSK, shall not, directly or indirectly, promise, authorise, ratify or offer to make or make any “payments” of “anything of value” (as defined in the glossary section) to any individual (or at the request of any individual) including a “government official” (as defined in the glossary section) for the improper purpose of influencing or inducing or as a reward for any act, omission or decision to secure an improper advantage or to improperly assist the company in obtaining or retaining business.
Government Officials — Although GSK’s policy prohibits payments by GSK or third parties acting for or on its behalf to any individual, private or public, as a “quid pro quo” for business, due to the existence of specific anticorruption laws in the countries where we operate, this policy is particularly applicable to “payments” of “anything of value” (as defined in the glossary section), or at the request of, “government officials” (as defined in the glossary section).
Facilitating Payments — For the avoidance of doubt, facilitating payments (otherwise known as “greasing payments” and defined as payments to an individual to secure or expedite the performance of a routine government action by government officials) are no exception to the general rule and therefore prohibited.
GLOSSARY
The terms defined herein should be construed broadly to give effect to the letter and spirit of the ABAC Policy. GSK is committed to the highest ethical standards of business dealings and any acts that create the appearance of promising, offering, giving or authorizing payments prohibited by this policy will not be tolerated.
Anything of Value: this term includes cash or cash equivalents, gifts, services, employment offers, loans, travel expenses, entertainment, political contributions, charitable donations, subsidies, per diem payments, sponsorships, honoraria or provision of any other asset, even if nominal in value.
Payments: this term refers to and includes any direct or indirect offers to pay, promises to pay, authorizations of or payments of anything of value.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
Government Official shall mean:
· Any officer or employee of a government or any department, agency or instrument of a government;
· Any person acting in an official capacity for or on behalf of a government or any department, agency, or instrument of a government;
· Any officer or employee of a company or business owned in whole or part by a government;
· Any officer or employee of a public international organization such as the World Bank or United Nations;
· Any officer or employee of a political party or any person acting in an official capacity on behalf of a political party; and/or
· Any candidate for political office.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
EXHIBIT E
R&D POLICY PRINCIPLES
A. Ethical Conduct Requirements
Ethical Conduct
The Parties are committed to the highest standards of conduct in all aspects of their respective businesses and to conduct their business with honesty and integrity, and in compliance with all applicable legal and regulatory requirements.
· Always act with integrity and honesty and protect the Parties’ public image and reputation in relationships with customers, competitors, suppliers, business partners and staff
· Promptly raise any concerns about possible unethical or illegal conduct
· Be free from actual or potential conflicts of interest that might influence, or appear to influence their judgment or actions when performing duties on behalf of the Parties
· The Parties’ reputation and the respect of those who deal with the Parties must not be put at risk by acceptance of any entertainment, gifts or favors intended or perceived by others to influence their business judgment
· Communications with external audiences, i.e., Investors and the Media, should be managed through appointed company spokespersons to minimize risk to the Parties’ reputation
· Provide accurate and reliable information in records submitted, safeguard the Company’s confidential information, and respect the confidential information of other parties with whom the Company does business or competes
Care and Ethical Treatment of Animals in Research
· Animals should be used in research only when required by regulatory authorities or where there are no alternatives through adherence to the “3R” Principles—reducing the number of animals used, replacing animals with non-animal methods whenever possible and refining the research techniques used. In addition, the Parties include two more R’s: Responsibility and Respect for animals involved in animal research.
· The Parties believe in using the highest standards for the humane care and treatment of all animals used in research, development and testing, including adherence to the principles (listed below), and all applicable legal and regulatory requirements, with a default to which ever is more stringent.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
· Access to species appropriate food and water
· Access to species specific housing, including species appropriate temperature and humidity levels
· Access to humane care and a program of veterinary care
· Animal housing that minimizes the development of abnormal behaviors and allows for normal species specific behavior,
· Adherence to principles of replacement, reduction and refinement in the design of in vivo studies
· Study design reviewed by institutional ethical review panel
· Commitment to minimizing pain and distress during in vivo studies
· Work performed by appropriately trained staff
· No Great Apes should be used for research
B. Requirements for Engaging External Experts and Healthcare Professionals
Use of External Experts within R&D
The Parties believe that the engagement of external experts in R&D should be done in accordance with the following principles:
· There must be a legitimate need for the services of the expert that cannot be fulfilled in-house, and the minimum number of experts needed should be used
· Selection of experts should be based solely on the expert’s qualifications and expertise in the subject matter for which such expert is retained
· The expert’s services must be documented in a written signed agreement
· Compensation must be based on fair market value for the services provided
· Reimbursement or pre-payment for costs associated with travel, lodging, meals and hospitality (i.e. refreshments, background music at meetings) for an expert are acceptable if permitted by all law for the location in which the services are rendered and are modest in value
· Experts shall not receive any gifts of any value, especially where the expert is also a healthcare professional
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
· Gift includes anything of value, regardless of amount, given to show friendship, appreciation, or support, including meals, entertainment or recreational activities (excludes fair market value for services rendered).
· Healthcare Professionals includes, but is not limited to, physicians, their allied health professionals, and medical office staff This term also applies to pharmacists and employees of pharmacy benefit managers.
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
EXHIBIT F
MATERIAL TRANSFER RECORD
[ Aridis Pharmaceuticals LLC (“[Providing or Receiving] Party”)
to
GlaxoSmithKline Biologicals SA
(“[Receiving or Providing] Party”)
The Material described below is supplied by the Providing Party to the Receiving Party subject to the terms and conditions of the Collaboration and Option Agreement between Aridis Pharmaceuticals LLC (“Aridis”) and GlaxoSmithKline Biologicals SA (“GSK”) dated as of the day of , 201 (“Agreement”). Duplicate originals of this form shall be executed and one fully-executed form shall be given to the Providing Party and one to the Receiving Party.
Description of Material:
Quantity of Material provided to the Receiving Party:
Purpose of the transfer :
In signing below, the Receiving Party acknowledges that it understands and will abide by the terms and conditions under which the Material is provided.
Date of Material Sent/Provided to Receiving Party: |
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(Signature) Providing Party: |
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Name: |
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Date : |
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(Signature) Receiving Party: |
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Name: |
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Date: |
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
Schedule 1.9: ARIDIS Materials
· Any specific excipients or material jointly agreed to be supplied by ARIDIS to GSK
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
Schedule 1.32: GSK Materials
· Rotavirus purified bulks: 3 different lots will be provided
· DMEM medium: different lots could be supplied as the shelf-life is about 1 month
· Specific excipients: for example: recombinant Human Serum Albumin
· Any specific excipients or material jointly agreed to be supplied by GSK to ARIDIS
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended
Schedule 1.42: Joint Materials
· OTF containing rotavirus
· OTF corresponding placebo (non-containing Rotavirus)
· Liquid formulations corresponding to OTF containing Rotavirus
· Liquid formulations corresponding to OTF corresponding placebo (non-containing Rotavirus)
· Any formulation intermediates needed for the liquid formulations or OTF development