COLLABORATIVE DATA SHARING AND CROSS-LICENSE AGREEMENT

Exhibit 10.2

 

COLLABORATIVE DATA SHARING AND CROSS-LICENSE AGREEMENT

FOR IL-21 PROTEIN

 

by and between

 

ZymoGenetics, Inc.

 

and

 

Novo Nordisk A/S

 

Effective Date: August 11, 2005

 

“[    *    ]” = omitted, confidential material, which material has been separately filed with the Securities and Exchange Commission pursuant to a request for confidential treatment.

 

Collaborative Data Sharing and Cross-License Agreement for IL-21 Protein

 

This Collaborative Data Sharing Agreement for IL-21 Protein (“Agreement”) is effective as of August 11, 2005 (the “Effective Date”) and is entered into by and between ZymoGenetics, Inc., a Washington corporation having a principal place of business at 1201 Eastlake Avenue East, Seattle, Washington 98102 (“ZGEN”), and Novo Nordisk A/S, a Danish corporation having a principal place of business at Novo Alle, DK-2880, Bagsvaerd, Denmark (“NN”).

 

WHEREAS, ZGEN and NN are parties to a certain Restated License Agreement for IL-21 effective as of January 1, 2003;

 

WHEREAS, ZGEN and NN are parties to a certain Collaborative Agreement for IL-21 effective as of December 14, 2002;

 

WHEREAS, ZGEN filed an IND with the FDA for a product containing the IL-21 Protein on March 2, 2004;

 

WHEREAS, ZGEN and NN are parties to a certain Agreement to Exchange Clinical Data for IL-21 Protein effective as of March 3, 2004;

 

WHEREAS, ZGEN and NN are parties to a certain Agreement to Exchange Process Development Data for IL-21 Protein effective as of March 3, 2004;

 

WHEREAS, NN filed a CTN with the TGA for a product containing the IL-21 Protein on August 13, 2004; and

 

WHEREAS, ZGEN and NN intend to perform separate (and possibly joint) research, non-clinical, clinical and development activities for products incorporating the IL-21 Protein, and are interested in having certain access and certain rights to each other’s data, results, intellectual property and other information generated from said research, non-clinical, clinical and development activities pursuant to the terms of this Agreement;

 

NOW THEREFORE, IT IS HEREBY AGREED AS FOLLOWS:

 

ARTICLE 1

Definitions

 

SECTION 1.1. “ Adverse Event ” or “ AE ” means: an Adverse Event as defined under applicable Agency regulations.

 

SECTION 1.2. “ Affiliate ” means, with respect to a party, any other business entity which directly or indirectly controls, is controlled by or is under common control with the party. The direct or indirect ownership of at least fifty percent (50%) or, if smaller, the maximum allowed by applicable law, of the voting securities of a business entity or of an interest in the assets,

 

 

profits or earnings of a business entity shall be deemed to constitute control of the business entity. For the avoidance of doubt, ZGEN and NN are not Affiliates of each other.

 

SECTION 1.3. “ Agency ” means: the FDA, EMEA or foreign equivalent of either.

 

SECTION 1.4. “ Approval ” means: any approval, registration, license or authorization from any Regulatory Authority required for the clinical trials or the marketing of a Product, including, without limitation, an approval, registration, license or authorization granted in connection with any Regulatory Submission.

 

SECTION 1.5. “ Assigning Party ” as used herein shall have the meaning set forth in SECTION 11.1.

 

SECTION 1.6. “ Background Intellectual Property ” means: intellectual property, including patents, patent applications and know-how, Controlled by either party or its Affiliates that (a) a party makes available to the other party during the Term and that the parties mutually agree in writing shall be considered to be “Background Intellectual Property”; or (b) is actually used (including foreign counterparts of any patents or patent applications) by or on behalf of either party in the performance of Shared Activities under this Agreement in connection with Common Products as licensed in Article 6; provided, however, that the term “Background Intellectual Property” shall not include Prior Intellectual Property, IL-21 Global Patents and IL21 Global Know-How.

 

SECTION 1.7. “ BLA ” means: a biologics license application or product license application filed with an Agency pursuant to the Agency’s regulations, including all amendments and supplements to the application, and any equivalent foreign filing with a Regulatory Authority.

 

SECTION 1.8. “ CEO ” means: chief executive officer.

 

SECTION 1.9. “ CIOMS ” means: the Council for International Organizations of Medical Sciences pursuant to the World Health Organization or the United States equivalent thereof.

 

SECTION 1.10. “ Claim(s) ” as used herein shall have the meaning set forth in SECTION 8.1.

 

SECTION 1.11. “ Clinical Data Sharing Agreement ” means: the Agreement to Exchange Clinical Data for IL-21 Protein effective as of March 3, 2004, between ZGEN and NN, which is being superseded and terminated by this Agreement, parts and definitions from which, as of the Effective Date, are being incorporated in this Agreement.

 

SECTION 1.12. “ Collaborative Agreement ” means: the Collaborative Agreement for IL-21 effective as of December 14, 2002, between ZGEN and NN.

 

SECTION 1.13. “ Common Product ” means: a Product having as an active agent the IL-21 Protein identified as [    *    ]. The parties may modify, supplement or change the definition of Common Product and may add a Unique Product to the definition of Common Product by amendment to this Agreement.

 

 

SECTION 1.14. “ Confidential Information ” means: information disclosed pursuant to this Agreement including, but not limited to, all proprietary information and materials, patentable or otherwise, of a party that is disclosed by or on behalf of such disclosing party to the receiving party or its Affiliates, such as DNA sequences, amino acid sequences, vectors, cells, substances, formulations, techniques, methodology, equipment, plans, data, reports, know-how, assay results, preclinical studies and clinical trials and the results thereof, patent positioning and business plans, including negative developments.

 

SECTION 1.15. “ Controls ” and “ Controlled ” mean: the entity referenced has the ability to exploit and to license or sublicense the right to exploit the referenced technology or rights, without (assuming the timely payment of all applicable royalties) violating the terms of any agreement or other arrangement between the entity referenced and a third party; provided, however, that the entity referenced will not be deemed to “Control” the referenced technology or rights if the party to receive a license or sublicense thereto under this Agreement does not agree in writing, after disclosure of the third-party agreement or other arrangement, to be responsible for and pay any amounts coming due under such agreement or other arrangement that result from or are attributable to such party’s use of the technology or rights (unless the parties otherwise agree pursuant to SECTION 3.6 with respect to non-royalty-based payments); provided, further, the entity referenced has disclosed the existence and terms of such third-party agreement or other arrangement promptly upon request or when it has become apparent that such technology or rights will most likely be used by such party receiving the license or sublicense hereunder.

 

SECTION 1.16. “ CRO ” means: contract research organization.

 

SECTION 1.17. “ CTN ” means: a Clinical Trial Notification or its foreign equivalent.

 

SECTION 1.18. “ EMEA ” means: the European Medicines Evaluation Agency or any successor agency thereto.

 

SECTION 1.19. “ Evaluation ” as used herein shall have the meaning set forth in SECTION 3.1(d).

 

SECTION 1.20. “ FDA ” means: the United States Food and Drug Administration or any successor agency thereto.

 

SECTION 1.21. “ Force majeure ” as used herein shall have the meaning set forth in SECTION 11.5.

 

SECTION 1.22. “ GMP ” means: current Good Manufacturing Practices or its foreign equivalent.

 

SECTION 1.23. “ Guiding Principles ” as used herein shall have the meaning set forth in SECTION 2.1.

 

SECTION 1.24. “ ICH ” means: current International Conference on Harmonization or its foreign equivalent.

 

 

SECTION 1.25. “ IL-21 Gene ” means: the polynucleotide sequence identified in [    *    ], and all species, fragments and modifications of such polynucleotide sequence that are disclosed in such application or any patents or patent applications included in an IL-21 Related Patent as defined in the Restated License Agreement or Appendix D or developed or discovered by a party or its Affiliates prior to or during the Term.

 

SECTION 1.26. “ IL-21 Global Know-How ” means: all inventions, discoveries, know-how, methodologies, technology, data and tangible materials (including nucleic acids, peptides, vectors, proteins, cells, cell lines, transgenic and knock-out animals, and the like) that are IL-21 Clinical Data Exchange Know-How as defined in the Clinical Data Sharing Agreement or that: (a) relate to an IL-21 Gene, IL-21 Protein or Common Product; (b) were invented, discovered, developed or otherwise generated by or for a party or its Affiliates during the Term; and (c) are Controlled by a party or its Affiliates during the Term; except the party’s Prior Intellectual Property or information and data from clinical studies after Product Approval unless such studies are required by a Regulatory Authority or constitute safety information required under SECTIONS 4.3 and 4.4. For the avoidance of doubt, information, data and materials related to Non-Clinical and clinical development activities, process development or manufacturing of Products that are not Common Products are not included in the term “IL-21 Global Know-How.”

 

SECTION 1.27. “IL-21 Global Patent Rights” means: (a) the patents and patent applications set forth in Appendix D appended hereto; (b) patents and patent applications Controlled by a party or its Affiliates that claim an invention with a date of conception prior to the Term (but not including Prior Patent Rights) or during the Term and that specifically recites as a claim element (i) an IL-21 Gene, IL-21 Protein or Product, (ii) a process, formulation and/or mixture comprising an IL-21 Gene, IL-21 Protein or Product, (iii) a method of making or manufacturing an IL-21 Protein or Product or (iv) a method of using an IL-21 Gene, IL-21 Protein or Product; (c) all divisional or continuation (in whole or in part) applications of the applications in described in (a) and (b); (d) all patents issuing from the applications described in (a), (b) and (c); and (e) all extensions, supplemental protection certificates (including any form of patent term extensions), reissues, reexaminations, substitutions or renewals of the patents described in (d). Notwithstanding the foregoing, if any portion of any application or patent described above does not specifically recite an IL-21 Gene, IL-21 Protein or Product as a claim element, then such portion of the application or patent is expressly excluded from the term “IL-21 Global Patent Rights” but only to the extent that such portion does not claim an IL-21 Gene, IL-21 Protein or Product. For the avoidance of doubt, IL-21 Global Patent Rights shall include Joint IL-21 Global Patent Rights.

 

SECTION 1.28. “ IL-21 Global Plan ” means: the combined IL-21 Plans to be undertaken by NN, ZGEN and their Affiliates. The parties are planning to undertake clinical studies of the Common Product to achieve Product Approval; however, unless post-approval clinical studies are required by a Regulatory Authority as a condition of Product Approval, clinical studies beyond those studies required for Product Approval shall not be included in the IL-21 Global Plan without further written agreement between the parties.

 

 

SECTION 1.29. “ IL-21 Plan ” means: individual work plans by each party and its Affiliates including its portion of the joint work plan for the Shared Activities for which such party and its Affiliates are responsible, comprising all activities in researching and developing Products during the Term, including process development, manufacturing and pursuing Regulatory Approvals. The current work plans of the parties and their Affiliates are appended to this Agreement as Appendix A (IL-21 Plan for NN), Appendix B (IL-21 Plan for ZGEN) and Appendix C (IL-21 Plan for Shared Activities). It is contemplated that the parties may update Appendices A, B and C on a yearly basis to reflect updates and significant changes in work plans.

 

SECTION 1.30. “ IL-21 Protein ” means: the protein identified in [    *    ] and any protein encoded by an IL-21 Gene and all species, fragments and modifications of such polypeptide sequence that are disclosed in such application or any patents or patent applications included in an IL-21 Related Patent as defined in the Restated License Agreement or Appendix D or developed or discovered by a party or its Affiliates prior to or during the Term.

 

SECTION 1.31. “ IMPD ” means: an Investigational Medicinal Product Dossier application or its foreign equivalent.

 

SECTION 1.32. “ IND ” means: an Investigational New Drug application or its foreign equivalent.

 

SECTION 1.33. “ Joint IL-21 Global Patent Rights ” means: all IL-21 Global Patent Rights arising or resulting from inventive work by one or more employees from both parties (or their Affiliates), as to which the employees would be inventors under the patent laws of the United States. Pursuant to SECTION 5.1, the parties have equal, undivided ownership interests in Joint IL-21 Global Patent Rights.

 

SECTION 1.34. “ JPT ” means: a joint IL-21 project team formed by NN and ZGEN to operate in accordance with ARTICLE 3.

 

SECTION 1.35. “ JSC ” means: a joint IL-21 steering committee formed by ZGEN and NN to operate in accordance with ARTICLE 3.

 

SECTION 1.36. “ Label ” means: the parts of an Agency approved official description of a drug product which include drug name and composition, indication, intended patient population, administration and dosing, general instructions for use, and instructions for use in special patient populations (including, e.g., pediatrics, geriatrics, pregnancy, hepatic/renal impairment, etc.) for the purposes of SECTION 3.10.

 

SECTION 1.37. “ Litigating Party ” as used herein shall have the meaning set forth in SECTION 5.7.

 

SECTION 1.38. “ MAA ” means: a Marketing Authorization Application or its foreign equivalent.

 

 

SECTION 1.39. “ MeDRA ” means: the Medical Dictionary for Regulatory Activities.

 

SECTION 1.40. “ MedWatch ” means: the Safety Information and Adverse Event Reporting Program known as MedWatch pursuant to the FDA or the foreign equivalent thereof.

 

SECTION 1.41. “ Narrative Summary ” as used herein shall have the meaning set forth in SECTION 4.4.

 

SECTION 1.42. “ Non-Clinical ” means: activities supporting a clinical trial or a Regulatory Submission, including, but not limited to, animal safety and efficacy studies, animal studies supporting an IND or IMPD, human disease tissue sample studies supporting an IND or IMPD, toxicology, pharmacokinetic and pharmacodynamic studies.

 

SECTION 1.43. “ NA ” means: Canada, Mexico and the United States of America and its territories and possessions.

 

SECTION 1.44. “ Pivotal Study ” means: a human clinical trial that demonstrates the statistical efficacy and safety of a Product and that is the final stage of clinical testing prior to and in support of the filing of a BLA or MAA, whether constituting a phase II or III trial in the United States or a similar trial in other jurisdictions.

 

SECTION 1.45. “ Prior Intellectual Property ” means: (i) IL-21-Related IP as defined in the Restated License Agreement; (ii) IL-21 Program Know-How and IL-21 Program Patent Rights (including Joint IL-21 Program Patent Rights) as defined in the Collaborative Agreement; and (iii) IL-21 Process Development Patent Rights and IL-21 Process Development Know How as defined in the Process Development Agreement.

 

SECTION 1.46. “ Prior Patent Rights ” means: (i) IL-21-Related Patents as defined in the Restated License Agreement; (ii) IL-21 Program Patent Rights (including Joint IL-21 Program Patent Rights) as defined in the Collaborative Agreement; and (iii) IL-21 Process Development Patent Rights as defined in the Process Development Agreement. For the avoidance of doubt, IL-21 Clinical Data Exchange Patent Rights (as defined in the Clinical Data Sharing Agreement) are not included in the term “Prior Patent Rights” and are included in the definition of “IL-21 Global Patent Rights.

 

SECTION 1.47. “ Process Development Agreement ” means: the Agreement to Exchange Process Development Data for IL-21 Protein effective as of March 3, 2004, between ZGEN and NN.

 

SECTION 1.48. “ Product ” means: a product that incorporates an IL-21 Protein as an active agent.

 

SECTION 1.49. “ Product Approval ” means: the Approval from any Regulatory Authority on a Product specifically granted in connection with the Regulatory Submission of a BLA or MAA.

 

 

SECTION 1.50. “ Regulatory Authority ” means: any federal, national, multinational, state, provincial, or local regulatory agency, department, bureau, or other governmental entity with authority over clinical trials, safety, marketing, pricing and/or sale of any Product, including, but not limited to, the FDA in the United States, the EMEA in Europe and the TGA in Australia.

 

SECTION 1.51. “ Regulatory Submission ” means: the submission to the relevant Regulatory Authority of an appropriate application seeking Approval, registration, license or authorization of any Product, including, but not limited to, any relevant marketing authorization application, supplementary application or variation thereof, BLA, MAA, IND, IMPD or equivalent foreign application.

 

SECTION 1.52. “ Respective Territory ” means: RoW with respect to NN and NA with respect to ZGEN.

 

SECTION 1.53. “ RoW ” means: all countries of the world, except those within NA.

 

SECTION 1.54. “ Restated License Agreement ” means the Restated License Agreement for IL-21 effective as of January 1, 2003 between ZGEN and NN.

 

SECTION 1.55. “ Revised Appendices ” as used herein shall have the meaning set forth in SECTION 3.1(e).

 

SECTION 1.56. “ Secondary Party ” as used herein shall have the meaning set forth in SECTION 5.8.

 

SECTION 1.57. “ Serious Adverse Event ” or “ SAE ” means: a Serious Adverse Event as defined under applicable Agency regulations.

 

SECTION 1.58. “ Shared Activities ” means: those specifically identified activities shared between the parties and including the budget and apportionment of activities between the parties as approved in writing by the JSC. The IL-21 Plan including Shared Activities is appended to this Agreement as Appendix C.

 

SECTION 1.59. “ Sponsor ” means: a party who received the written approval of the other party to conduct Sponsored Clinical Trials in the other party’s Respective Territory.

 

SECTION 1.60. “ Sponsored Clinical Trials ” means: those specifically identified clinical trials for Common Products which have been approved pursuant to SECTION 4.12 to be conducted by the Sponsor.

 

SECTION 1.61. “ Sublicensee ” means: a third party to whom a party has extended rights that it received or reserved under this Agreement. For the avoidance of doubt, a Territorial Commercialization Partner is a Sublicensee.

 

 

SECTION 1.62. “ Term ” means: the period from the Effective Date of this Agreement through the earlier of the following dates: (i) date on which this Agreement expires or (ii) the date on which this Agreement is terminated.

 

SECTION 1.63. “ Territorial Commercialization Partner ” means: a Sublicensee to whom a party has extended certain commercialization rights that it received or reserved under this Agreement including the right to develop, promote, market, offer to sell, import, export, distribute, sell or have sold Products as part of a co-marketing agreement, co-commercialization agreement, strategic partnership, joint venture relationship or the like with a party.

 

SECTION 1.64. “ TGA ” means: the Australian Therapeutic Goods Administration or any successor agency thereto.

 

SECTION 1.65. “ Unique Product ” means: A Product that is not a Common Product and that has been demonstrated with supportive experimental data to be biologically different from any Common Product (i) [    *    ], (ii) [    *    ], and (iii) for use in [    *    ] with any Common Product. The parties may add a Unique Product to the definition of Common Product by amendment to this Agreement. For the avoidance of doubt, a Unique Product, upon becoming a Common Product, shall cease to be a Unique Product.

 

Where words and phrases are used herein in the singular, such usage is intended to include the plural forms where appropriate to the context and vice versa. The words “ including ,” “ includes ” and “ such as ” are used in a non-limiting sense and have the same meaning as “ including without limitation ” and “ including, but not limited to .” Herein ” means anywhere in this Agreement. “ Hereunder ”, “ Hereinafter ” and “ hereto ” mean under or pursuant to any provision of this Agreement.

 

ARTICLE 2

Scope of the Collaboration

 

SECTION 2.1. Guiding Principles . The parties intend to conduct their relationship pursuant to this Agreement in accordance with the following principles (“Guiding Principles”):

 

(a)

With respect to research by the parties or their Affiliates relating to IL-21 Protein or a Product:

 

(i)

disclosure and sharing of all research plans and results;

 

(ii)

collaborative and open discussion between the parties; and

 

(iii)

royalty free license to the intellectual property resulting from such research pursuant to SECTION 5.2;

 

 

(b)

With respect to all Non-Clinical and clinical development by the parties or their Affiliates of the Common Product:

 

(i)

disclosure and sharing of all development plans and results;

 

(ii)

collaborative and open discussion between the parties;

 

(iii)

royalty free license to the intellectual property resulting from such development pursuant to SECTION 5.2; and

 

(iv)

disclosure and sharing of safety information for the lifetime of the Common Product.

 

(c)

With respect to all Non-Clinical and clinical development by the parties or their Affiliates of Products that are not the Common Product:

 

(i)

disclosure and sharing of all development plans;

 

(ii)

disclosure and sharing of summaries of development results, excluding data related to Non-Clinical and clinical development activities, process development and manufacturing; and

 

(iii)

royalty free license to certain intellectual property resulting from such development pursuant to SECTION 5.2.

 

(d)

With respect to a prospective Territorial Commercialization Partner: [    *    ] the Territorial Commercialization Partner [    *    ], including [    *    ] IL-21 Gene, IL-21 Protein or Common Product [    *    ] Territorial Commercialization Partner and its Affiliates. As an example of [    *    ] Territorial Commercialization Partner will [    *    ] prospective Territorial Commercialization Partner to [    *    ], and, if necessary, the parties will discuss any amendments to this Agreement that may cause the prospective Territorial Commercialization Partner to participate.

 

ARTICLE 3

Governance, Reporting and Activities

 

SECTION 3.1. Governance of Collaboration . NN and ZGEN shall establish the following in collaboration under this Agreement:

 

(a)

Joint IL-21 Steering Committee . The parties shall form the JSC consisting of three (3) members from each party. Each party may change its own JSC members from time to time. ZGEN and NN shall have co-leadership in the JSC. Where JSC approval is required, the JSC shall operate by consensus with each party having a single vote. The JSC will be responsible for monitoring the performance of the IL-21 Global Plan by the parties and soliciting and discussing input, feedback and comment thereon. The JSC will discuss changes or additions to the Common Product by a party, make recommendations to each party’s senior

 

 

management regarding such party’s Common Product or IL-21 Plan, approve Evaluations pursuant to SECTION 3.1(d), and approve all Shared Activities and changes or additions to Shared Activities. The JSC will resolve any disputes with respect to Shared Activities, joint publications, and will enforce timely data exchange pursuant to this Agreement. The JSC will be the principle means by which the parties coordinate and discuss their IL-21 Plans at a senior management level. The JSC will implement and facilitate the Guiding Principles and the terms of this Agreement. Disputes that cannot be resolved at the level of the JSC shall be subject to the dispute resolution procedures pursuant to SECTION 11.7.

 

(b)

Joint IL-21 Project Team . The parties shall form the JPT consisting of a project director from each party and members from the project groups of each party who represent patent, research and discovery, Non-Clinical, clinical, regulatory, marketing and product supply matters with respect to the Common Product. Additional members may also be added or subtracted with the approval of the JSC. Each party shall choose its own JPT members and project director, who may be changed from time to time by the appointing party. The JPT shall operate by consensus with each party having a single vote. Each project director will serve as a primary contact and will coordinate reporting and activities under the IL-21 Global Plan, may attend JSC meetings, and will monitor the tasks and timelines. All planned research and development activities under the IL-21 Global Plan will be reviewed and discussed by the JPT. Any material changes to the IL-21 Global Plan will be brought to the JSC by the project directors for consideration and discussion. The project directors shall periodically review the performance of JPT members, monitor and convey public disclosure strategies under SECTION 3.4 for the Common Product, ensure review of joint publications under SECTION 3.5, record updates and changes in the IL-21 Global Plan and establish operating principles and procedures for the JPT and sub-teams. Any sub-teams shall operate by consensus with each party having a single vote, and shall report to the JPT. The project directors may identify and propose tasks and activities in furtherance of the IL-21 Global Plan that may be shared between the parties as prospective Shared Activities. In addition, the project directors will recommend to the JSC proposed IL-21 Plans for prospective Shared Activities including a budget and proposed apportionment of such activities between the parties consistent with SECTION 3.1(c). The project directors will implement and facilitate the Guiding Principles and the terms of this Agreement. Any disputes that may arise at the JPT level may be brought to the JSC for review.

 

(c)

Apportionment of Tasks and Activities between the Parties . Each party is solely responsible for its activities under its IL-21 Plan. The JSC will in writing approve Shared Activities, budget and apportionment thereof between the parties with a view to balancing resources over time, striving to reduce duplication of effort, optimizing resources and time, providing a mechanism for cost sharing on a

 

 

[    *    ] basis (considering FTE and external costs), and distributing between the parties an equitable share of work when practical.

 

(d)

Annual Evaluation of IL-21 Global Plan . On a yearly basis, as part of its review of the IL-21 Global Plan, the JSC will review and evaluate the activities of each party to be performed under its IL-21 Plan for the upcoming year, and after considering each party’s contributions for the prior year and earlier years, assess the adequacy of the overall contribution of each party toward furthering the aims of this Agreement (“Evaluation”). To the extent that a party has documentation, the types of information that may be used as part of the Evaluation include: (i) [     *    ]; (ii) [    *     ]; (iii) [    *    ] conducted, with special emphasis on [    *    ] which have lead to [    *    ] in both parties’ territories; (iv) [    *    ]; (v) [    *    ] for IL-21 Global Patent Rights; (vi) [    *    ] for IL-21 Global Patent Rights; (vii) contribution to [    *    ] of IL-21 Protein and Products; (viii) [    *    ]; (ix) [    *    ]; (x) [    *    ] on a party’s IL-21 Plan including [    *    ]; (xi) [    *    ]; (xii) [    *    ]; (xiii) IL-21 Proteins with [    *    ]; and (xiv) such other criteria as may be mutually agreed upon by the JSC. The JSC’s Evaluation and approval thereof (such approval not to be unreasonably withheld) will be recorded in its minutes or other document approved by the JSC. In addition, the JSC shall explicitly identify in the approved Evaluation those Pivotal Studies and activities intended to develop a Unique Products of each party that are considered balanced with the contributions of the other party.

 

(e)

Material Changes and Updates in Plan . The JSC shall be apprised at least quarterly in writing by the project directors of any material changes and updates to the IL-21 Global Plan, including, but not limited to, either party adding to, changing, or halting specific activities under its IL-21 Plan. On a yearly basis, Appendices A, B and C will be modified (“Revised Appendices”) to reflect such changes and updates to the IL-21 Global Plan, which shall be signed and dated by or on behalf of the JSC. The Revised Appendices shall serve as the IL-21 Global Plan for the next year.

 

(f)

Meetings . The JSC and JPT shall hold periodic meetings as follows:

 

(i)

The JSC shall hold meetings at least two (2) times per year in person. The JSC meetings should shortly follow JPT meetings. Copies of all materials presented at such meetings shall be exchanged within fifteen (15) days after the meeting. The JSC shall keep accurate meeting minutes, with this responsibility alternating between the parties. Such minutes shall be exchanged between the parties promptly after the meeting.

 

(ii)

The JPT shall hold meetings at least three (3) times per year in person or by videoconference, with at least two (2) such meetings in person. The JPT shall keep accurate meeting minutes, with this responsibility

 

 

alternating between the parties. Such minutes shall be exchanged between the parties promptly after the meeting.

 

SECTION 3.2. Limited Cost Sharing . The parties do not contemplate a sharing of costs for the activities under each party’s respective IL-21 Plan and each party shall individually bear the costs for its respective activities. From time to time, in the interest of expediting time and cost efficiency, the JSC may approve cost sharing between the parties for Shared Activities in accordance with SECTION 3.1(c). An accounting and balancing between the parties of costs for Shared Activities will occur quarterly at the end of March, June, September and December.

 

SECTION 3.3. Reports and Data . The project directors will follow the progress of the parties’ activities under the IL-21 Global Plan and shall be responsible for submitting bi-annual presentations or written reports to the JSC, which shall include the results of the JPT meetings, updates on progress under the IL-21 Global Plan, any material changes to each party’s respective IL-21 Plan, inventions for which IL-21 Global Patent Rights may be sought, significant Non-Clinical and clinical plans, significant process development plans, manufacturing and supply plans for the Common Product, projected timelines for Products and other material information for the JSC to consider that is related to this Agreement. The parties and each of their Affiliates shall keep true, complete and accurate records with respect to Shared Activities and their clinical development progress under the IL-21 Global Plan. In addition, the parties shall cause each of its Territorial Commercialization Partners and Sublicensees to keep true, complete and accurate records with respect to Shared Activities and progress under the IL-21 Global Plan.

 

The parties shall establish procedures to ensure that the parties exchange on a timely basis all necessary information to be provided under this Agreement. In addition, the following reports and information shall be exchanged between the parties:

 

(a)

General Reporting and Data Exchange for Research Activities .

 

(i)

Research Updates . Each party shall provide the other periodic written updates on the planned, ongoing and completed research activities and results under its respective IL-21 Plan. Such updates may be provided in JPT and JSC meeting minutes, presentations and reports exchanged between the parties.

 

(ii)

Delivery of Raw Data upon Request by a Party . Upon the reasonable written request of one party (“Requestor”) to the other party (“Provider”), the Provider shall provide to the Requestor within [    *    ] after the date of the request, raw data from the specific research experiments and activities performed by the Provider and its Affiliates under the IL-21 Plan during the Term. The information that will be included in such raw data and the format by which such data will be exchanged will be determined in good faith and agreed upon by the parties.

 

 

(iii)

Final Research Report . After the completion of all research activities under its respective IL-21 Plan, each party shall provide the other party a final written report, as soon as reasonably possible and in no event later than [    *    ] after completion of the research activities. Such final report shall include all additional reports not previously provided to the other party.

 

(b)

Reporting and Data Exchange for Non-Clinical Development Activities .

 

(i)

Quarterly Non-Clinical Reports . The parties shall exchange on a quarterly basis concurrent with the quarterly clinical reports in SECTION 3.3(c)(i), a written summary of their respective planned, ongoing and completed Non-Clinical studies for Common Products.

 

(ii)

Final Non-Clinical Study Reports and Post-Study Delivery of Raw Data . After the completion of each Non-Clinical study for a Common Product each party shall provide the other party (with respect to completed Non-Clinical studies) a copy of the final study report including the supportive raw data, as soon as reasonably possible. In the event that a submission is made to Regulatory Authorities, the copy of the final report shall be submitted no later than [    *    ] of submission to each applicable Regulatory Authority.

 

(c)

Reporting and Data Exchange for Clinical Development Activities .

 

(i)

Quarterly Clinical Reports . The parties shall exchange on a quarterly basis, by the last day of March, June, September and December of each calendar year, a written summary of their respective planned, ongoing and completed clinical studies and data for Common Products. Each summary shall include the items in Appendix E.

 

(ii)

Clinical Trial Reports and Post-Study Delivery of Raw Data . After the completion of each clinical trial for a Common Product, each party shall provide to the other party (with respect to completed clinical trials):

 

(A)

a report, as soon as reasonably possible and in no event later than [    *    ] of submission to each applicable Regulatory Authority, that includes a copy of the report as submitted to the Regulatory Authority. Such report should be submitted no later than [    *    ] after the last patient’s last visit according to the protocol, or the study report is received from a party’s respective third-party clinical research organization, whichever is later; and

 

(B)

raw data from each clinical trial of a Common Product as soon as reasonably possible following database lock but no later than [    *    ]

 

 

after the clinical trial reports described in this SECTION 3.3(c)(ii). In the event a party thereafter updates its data on such a clinical trial, the updated data shall be transferred to the other party within [    *    ] from the update. The information that will be included with the raw data, and the format by which such data will be exchanged, will be determined in good faith and agreed upon by the parties.

 

(iii)

Reports and Data for Sponsored Clinical Trials . For the avoidance of doubt, the reporting and data exchange obligations of SECTION 3.3(c) with respect to Common Products shall also apply to Sponsored Clinical Trials.

 

(d)

Requests for Expedited Data Exchange . A party may reasonably request the other party to provide such raw data described in SECTIONS 3.3(b)(ii), 3.3(c)(ii)(B), 3.3(c)(iii) within an expedited timeframe for such raw data that directly supports key results. Such request shall be in writing, and shall include an explanation and compelling rationale for early transfer of such raw data. Upon such request, the expedited timeframe shall be agreed upon by the parties following acceptance of the request by the non-requesting party (such acceptance not to be unreasonably withheld). In general, such expedited timeframe would not exceed [    *    ].

 

(e)

Reports for Products that are not Common Products . For Products other than Common Products, summaries of data and information from Non-Clinical and clinical development activities related to any such Product shall be provided to the other party after the completion of each clinical trial for such Product. Each party shall provide the other party a summary of the report submitted to its respective Regulatory Authorities for such Product, as soon as reasonably possible and in no event later than [    *    ] after such submission. Such report should be provided no later than [    *    ] after the last patient’s last visit according to the protocol, or the study report is received from a party’s respective third-party clinical research organization, whichever is later. For the avoidance of doubt, Non-Clinical and clinical development raw data and manufacturing raw data will not be exchanged between the parties with respect to Products that are not Common Products unless otherwise agreed by the parties.

 

SECTION 3.4. Public Disclosure Strategies . Every six (6) months the parties shall exchange their strategies for public disclosure related to the IL-21 Protein and development activities for the Common Product. The parties shall keep each other informed of material changes to such strategy and identify the expected publications, presentations and other such public disclosures within the next six (6) months. Notwithstanding the above, neither party nor its Affiliates shall make any public disclosure regarding the other party’s activities under this Agreement (to the extent the activities have not been publicly disclosed by the other party) without the prior written consent of such party. In addition, each party shall cause each of its Territorial Commercialization Partners and Sublicensees to not make any public disclosure regarding the

 

 

other party’s activities under this Agreement (to the extent the activities have not been publicly disclosed by the other party) without the prior written consent of the other party.

 

SECTION 3.5. Joint Publications . The parties will each be free to publish the results of their respective activities under their respective IL-21 Plans. In the event that the parties wish to jointly publish results under the IL-21 Global Plan or to publish the results of Shared Activities, such publication will acknowledge the contribution, authorship and materials from each party, where applicable. Each party shall furnish the other party with copies of all proposed joint oral, written, graphic or electronic public disclosures. Each party may review such proposed joint disclosure for a period not to exceed [    *    ] prior to submission for publication or presentation to ensure that its Confidential Information is not inadvertently disclosed. In order to fully protect the rights of both parties, any contemplated joint publication or other joint public disclosure containing the details of an invention, whether or not patentable, may be withheld for an additional period of [    *    ] or until a patent application is filed thereon, whichever is first in time.

 

SECTION 3.6.  Agreements with Third Party Commercial Use Fees . Each party shall be free to enter agreements during the Term that may subject a Product to third party commercial use fees, including royalties, within its Respective Territory and at its sole cost; provided, however, that each party shall in writing promptly notify the other party of its intent to enter such an agreement that may subject a Product to such fees in the other party’s Respective Territory. Where a worldwide agreement containing third party commercial use fees [    *    ] of a Product, the parties will [    *    ] obtaining such an agreement [    *    ], including a [    *    ] such third party commercial use fees [    *    ]. Likewise, in the event intellectual property acquired by license or otherwise from a third party becomes Background Intellectual Property licensed to the other party hereunder, the parties will discuss in good faith the allocation of any payments owed in the future to the third party that relate to such Background Intellectual Property and that are in addition to customary royalties payable to the third party that are the responsibility of the party selling a Product.

 

SECTION 3.7. Data Sharing under Third Party Agreements . Each party shall seek to provide that data related to the IL-21 Protein and Common Product that is generated through third party research agreements, CRO agreements and material transfer agreements entered into after the Effective Date can be shared with the other party pursuant to the terms of this Agreement; provided however, each party shall ensure that data related to Shared Activities that is generated through third party research agreements, CRO agreements and material transfer agreements entered into after the Effective Date can be shared with the other party pursuant to the terms of this Agreement.

 

SECTION 3.8. Diligence Obligations for Shared Activities. Subject to SECTION 9.6, the parties shall use c